California Code of Regulations

TITLE 17. Public Health

Division 1. State Department of Health Services

(Originally Printed 8-15-45)

Chapter 1. Administration

Subchapter 1. State Department of Health Services [Repealed]

(Originally Printed 6-30-73)

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Chapter 1252, Statutes of 1977.

HISTORY

1. New Subchapter 1 (Sections 1 through 4) filed 6-29-73 as an emergency; designated effective 6-30-73 (Register 73, No. 26).

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43).

3. Amendment filed 6-30-78 as an emergency; designated effective at 11:59 p.m. on 6-30-78 (Register 78, No. 26).

4. Certificate of Compliance transmitted to OAH 10-27-78; filed 10-31-78 (Register 78, No. 44).

5. Repealer of Subchapter 1 (Sections 1-5) filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40). For prior history, see Register 78, No. 44; 78, No. 26; and 74, No. 41.

Subchapter 2. Hospital Districts

Article 1. Liability Loans

§100. Eligibility Requirements.

Note • History

(a) Hospital districts may apply for State loans to pay for medical injury tort claims or judgments that are in excess of $300,000. Such hospital districts shall meet all of the following:

(1) Be the Chowchilla Memorial Hospital District, or a hospital district which has entered into a joint powers agreement with the Chowchilla Memorial Hospital District.

(2) Be located in a county that has areas that are designated as rural medically undeserved areas by the Health Manpower Policy Commission, pursuant to Section 1188.4, Chapter 4, Part 4, Health and Safety Code (Rural Health Services, October 1976).

(3) Have a licensed bed capacity of less than 100 beds.

(4) Have submitted to the Department on or before September 8, 1977, a statement which includes the following:

(A) A utilization review plan or its equivalent which has been officially adopted by the governing body of the hospital districts and which:

1. Provides for the participation of the entire medical staff in a review committee.

2. Provides that at least one committee member is a nonphysician health professional.

3. Prohibits the participation on the committee of any person who has a financial interest in the hospital.

4. Prohibits any person from participation in the review of any care in which that person has been professionally involved.

5. Provides for at least monthly meetings of the review committee.

6. Provides for the retention for at least seven years of records of the review committee's activities, including the number and types of cases received, the findings and recommendations, and the subsequent actions taken.

(B) Proof of either insurance against medical injury liability claims or judgments up to $300,000 or the establishment of a reserve account in that amount, along with a plan for the investment of such reserves.

(C) A written plan for the preliminary investigation of medical injury claims and for procurement of legal counsel when indicated.

(D) A written plan to repay the State loan within forty (40) years detailing the resources available to the hospital district including taxing powers.

NOTE

Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.

HISTORY

1. New Subchapter 2 (Sections 100-103) filed 12-6-79; effective thirtieth day thereafter (Register 79, No. 49).

§101. Loan Application.

Note

(a) The hospital district shall make application for a State loan to the Director of Health Services, 714 P Street, Sacramento, CA 95814.

(b) Within ninety (90) days after the receipt of the application the Department of Health Services will notify the applicant of its preliminary finding and recommendation. The notice will contain the information that the Department's final recommendation to the Legislature must be made within the next thirty (30) days and that any information that the applicant has that will affect the preliminary recommendation should be forwarded immediately.

NOTE

Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.

§102. Coverage.

Note

(a) The Department shall grant all loans which qualify, to the extent that funds are available, provided that:

(1) Such amount represents an excess of $300,000 in a medical injury tort judgment or settlement, the $300,000 being covered by insurance or reserve account, as specified in Section 100(a)(4)(B).

(2) The total amount of such loans does not exceed $1,000,000 in the aggregate.

(b) Physicians in the local community who are employees of the hospital district shall be covered for medical injury tort liability by the district.

NOTE

Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.

§103. Repayment of Loans.

Note

(a) Repayment of loans shall be on an amortized schedule agreed upon by the Department and the hospital district. The repayment period shall not exceed forty (40) years. The interest rate shall not exceed the five-year average on the return on the investment of State funds pursuant to Chapter 3 (commencing with Section 16430), Part 2, Division 4, Title 2 of the Government Code.

(b) In event of default of repayment of a loan, the Department may attach real property and assets of the hospital district to recover the amount of the loan and appropriate interest as specified in (a) above.

NOTE

Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355 and 32358, Health and Safety Code, Division 23.

Subchapter 3. Hospital Inspection [Repealed]

(Originally Printed 8-15-45)

HISTORY

1. Group 1 (sections 161-198) repealed Register 74, No. 41; Group 2, Subgroups 1-1.5 (sections 229-395.4) repealed Register 75, No. 24; Group 2, Subgroup 2 (sections 400-488) repealed Register 82, No. 4; Group 3 (section 850) repealed Register 75, No. 24; Group 4 (sections 860.0-875.0) repealed Register 75, No. 31; Group 5 (sections 880-881) repealed Register 75, No. 24.

Subchapter 4. Records and Statistics

(Originally Printed 8-15-45)

Article 1. Access to the Records in the Office of the State Registrar and in the Offices of Local Registrars

§901. Access to the Records in the Office of the State Registrar and in the Offices of Local Registrars. [Repealed]

Note • History

NOTE

Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Sections 10066 and 10125.5, Health and Safety Code.

HISTORY

1. Amendment filed 1-9-78; effective thirtieth day thereafter (Register 78, No. 2). For prior history, see Register 76, No. 12.

2. Amendment filed 2-8-78 as an emergency; effective upon filing (Register 78, No. 6).

3. Certificate of Compliance filed 5-1-78 (Register 78, No. 18).

4. Amendment filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 7).

5. Change without regulatory effect repealing section filed 11-17-2011 pursuant to section 100, title 1, California Code of Regulations (Register 2011, No. 46).

§902. Conditions of Examination.

Note • History

(a) Authorization to examine the index or records in the Office of the State Registrar and in offices of the local registrars must be obtained from the registrar or deputy in charge.

Written application shall be made by the applicant stating sufficient information to identify the record or records to be examined.

The following information for the type of record specified below should, whenever possible, be provided by the applicant:

(1) Birth

(A) Name of child;

(B) Maiden name of mother;

(2) Death

(A) Name of decedent;

(B) Date or year of death, or date last known alive;

(3) Marriage

(A) Name of Groom or Maiden name of Bride;

(B) Date or year of marriage.

Where the above information is not available, the applicant shall provide whatever information is available, and the State Registrar or local registrar shall make all reasonable effort to locate the requested records.

(b) The State Registrar or local registrar shall supervise the examination of the records.

NOTE

Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1, Health and Safety Code. Reference: Section 10066, Health and Safety Code.

HISTORY

1. Amendment filed 12-24-75 as an emergency; effective upon filing (Register 75, No. 52). For prior history, see Register 64, No. 4.

2. Amendment filed 2-27-76 as an emergency; effective upon filing (Register 76, No. 9).

3. Certificate of Compliance as to the 12-24-75 and 2-27-76 filings filed 3-18-76 (Register 76, No. 12).

4. Amendment filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 7).

§903. Fee for Examination or Search. [Repealed]

Note • History

NOTE

Authority cited: Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Section 10066, Health and Safety Code.

HISTORY

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

2. Amendment filed 2-11-64; effective thirtieth day thereafter (Register 64, No. 4).

3. Repealer filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 7).

Article 2. Late Registration of Births and Deaths

§908. Late Registration of Births and Deaths.

Note • History

The local registrar and the State Registrar of Vital Statistics shall accept for registration only those records of birth and death which are received by the local registrar within one year of the date of occurrence of the event, except as provided under Division 9, Chapters 9 and 10 of the Health and Safety Code.

NOTE

Authority cited: Section 10001, Health and Safety Code. Reference: Section 10577, Health and Safety Code.

HISTORY

1. New section filed 2-4-47 (Register 7).

2. Amendment filed 3-8-55; effective thirtieth day thereafter (Register 55, No. 4).

3. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

4. Editorial correction of NOTE filed 3-22-84 (Register 84, No. 12).

Article 3. Birth Certificates of Deceased Persons

§910. Responsibilities of Local Registrar or County Recorder.

Note • History

(a) Upon notification by the State Registrar that a person whose birth is registered in the local office is deceased, the local registrar or county recorder of such office shall make at least one of the following:

(1) A notation of the death in the birth index.

(2) A notation of the date of death and the death certificate number upon the record of birth.

(b) The local registrar or county recorder shall notify the State Registrar of any application for a certified copy of a deceased person's birth certificate in which it is indicated that the requested birth record is the applicant's own birth record.

NOTE

Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038, and 10575.5, Health and Safety Code.

HISTORY

1. Renumbering of Article 3 to Article 4 and new Article 3 (Sections 910-912) filed 5-1-78; effective thirtieth day thereafter (Register 78, No. 18).

2. Editorial correction of NOTE filed 3-22-84 (Register 84, No. 12).

§911. Identification of Deceased Registrants by Local Registrars and County Recorders.

Note • History

Local registrars and county recorders may match deaths occurring in their jurisdictions to births registered in their office and, for any registrants thereby identified as deceased, make any of the notations specified in Section 910(a) (1) and (2).

NOTE

Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code.

HISTORY

1. New NOTE filed 3-22-84 (Register 84, No. 12).

§912. Certified Copies of Birth Certificates of Deceased Persons.

Note • History

(a) All certified copies of birth records for which the registrant is identified as deceased shall display the legend “DECEASED,” which shall be in boldface style not less than one-half inch in height, near the space reserved for the registrant's name.

(1) Unless produced by a photographic process or through the medium of an overlay employed in the copying process, the legend “DECEASED” shall be printed or stamped in indelible ink.

(2) The local registrar or county recorder shall obtain prior approval by the State Registrar of the method to be employed in producing the legend “DECEASED.”

NOTE

Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code.

HISTORY

1. New NOTE filed 3-22-84 (Register 84, No. 12).

Article 4. Definitions of Live Birth and Fetal Death

§915. Live Birth.

Note • History

“Live birth” means the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy) which, after such separation, breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.

NOTE

Authority cited: Section 10001, Health and Safety Code. Reference: Sections 10100 and 10102, Health and Safety Code.

HISTORY

1. New Article 3 (§§ 915 and 916) filed 6-14-56; effective thirtieth day thereafter (Register 56, No. 12). For history of former Article 3, see Register 55, No. 4.

2. Renumbering of Article 3 to Article 4 (Sections 915 and 916) filed 5-1-78; effective thirtieth day thereafter (Register 78, No. 18).

3. Editorial correction of NOTE filed 3-22-84 (Register 84, No. 12).

§916. Fetal Death.

Note • History

“Fetal death” means a death prior to the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy); the death is indicated by the fact that after such separation, the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles. Registration of fetal deaths is subject to the provisions of Division 9, Chapter 4 of the Health and Safety Code.

NOTE

Authority cited: Section 10001, Health and Safety Code. Reference: Section 10175, Health and Safety Code.

HISTORY

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

2. New NOTE filed 3-22-84 (Register 84, No. 12).

Subchapter 5. Home Health Agency Licensing Requirements [Repealed]

NOTE

Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 1725, 1726, 1727, 1728, 1728.1, 1729, 1731, 1734, 1735, 1736, 1737, 1737.5, 3123 and 3124, Health and Safety Code.

HISTORY

1. New Subchapter 5 (§§ 917 through 947) filed 7-1-66 as an emergency; effective upon filing (Register 66, No. 20).

2. Certificate of Compliance--Section 11422.1, Gov. Code, filed 10-25-66, as to emergency filing on 7-1-66 (Register 66, No. 37).

3. Amendment filed 10-25-66; effective thirtieth day thereafter (Register 66, No. 37).

4. Amendment filed 12-13-66; effective thirtieth day thereafter (Register 66, No. 44).

5. Repealer of Subchapter 5 (Articles 1-9, Sections 917-948) filed 6-21-79; effective thirtieth day thereafter (Register 79, No. 25). For prior history, see Registers 67, No. 2; 69, No. 13; 72, No. 36; 72, No. 53; 75, No. 24; 76, No. 41; 77, No. 5; 78, No. 45; and 79, No. 18.

Chapter 2. Laboratories

(Originally Printed 8-15-45)

Subchapter 1. Service Laboratories

Group 1. Production and Distribution of Biologics

Article 1. Licenses

§950. General Provisions.

Note • History

(a) As used in this chapter “person” includes firm, association and corporation.

(b) As used in this chapter “department” means State Department of Health.

NOTE

Authority cited for Group 1 (§§ 950 to 1021, inclusive): Sections 208, 1600, 1603, 1604, 1605, and 1606, Health and Safety Code. Issuing agency: State Department of Public Health.

HISTORY

1. Amendment of subsection (b) filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10). For prior history, see Register 20, No. 6.

§951. Issuance of License.

History

(a) All persons desiring to produce process or distribute biologics shall make application to the department on a form provided by the department, and shall supply such other information as may be required by the department for the intelligent appraisal of the status of the laboratory, the product to be licensed, and the personnel with respect to the intent and purpose of the law.

(b) Licenses shall not be issued to any person not at the time fully prepared, equipped and actually processing (though not distributing), but the department will provide anyone contemplating the establishment of a processing laboratory with full information concerning the requirements and conditions for the preparation of the products that it is proposed to manufacture or distribute.

(c) A license shall not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technic and in the preparation of biologics as defined in Section 1601, Health and Safety Code, whose qualifications have been approved by the department.

(d) A license shall not be issued unless the condition of the establishment and methods of preparation are such as to reasonably insure that the biologics produced will not be contaminated, dangerous, or harmful.

(e) A license shall not be issued for the preparation of any biologic as defined in Section 1601, Health and Safety Code, if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped, bears or contains any statement, design, or device which is false or misleading in any particular.

(f) A license shall not be issued for a biologic product that has been specifically forbidden or disapproved by the United States Department of Health, Education and Welfare excepting products that may be specifically approved by the department, for experimental purposes but not for general sale and distribution.

(g) A license shall not be issued for the processing or distributing of any product without satisfactory scientific evidence of therapeutic or prophylactic value.

HISTORY

1. Amendment of subsection (f) filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

§952. Application for Renewal of License.

History

Each licensee applying for renewal of license shall be subject to such review of his activities during the previous licensing period, and to such inspections of his premises, equipment and biologics produced by him as may be determined by the department for consideration in passing upon the application for renewal. Similarly, such licensee shall submit such data, records, and samples of products as may be designated by the department.

HISTORY

1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

§953. License Fees.

Note • History

The fees for license application and for annual license renewal are six hundred dollars ($600).

NOTE

Authority cited: Sections 102, 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.

HISTORY

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Article 2. Exemptions

§956. Autogenous Vaccines.

Laboratories whose principal activity is general clinical work and whose only biologic product is autogenous bacterial vaccines do not require a license for the preparation of autogenous vaccines unless the making of autogenous vaccines constitutes 10 percent or more of the activity or source of income of the laboratory.

Article 3. Inspection and Records

§962. Inspection by Department.

(a) Each licensee or applicant shall permit any duly authorized employee of the department to enter his establishment at any reasonable hour, and shall permit said representative of the department to inspect without previous notification the entire premises of such establishment, including all buildings, compartments, and other places, and all equipment, such as chemicals, instruments, apparatus, and the like, as well as the methods used in the manufacture of, and all records maintained relative to biologics as defined in Section 1601, Health and Safety Code.

(b) Each licensee or applicant shall provide to the department such stock cultures or other materials from which biologics are produced and such completed products as may be required by the department for testing of identity, purity, potency or other analysis.

§963. Records.

The licensee shall keep records of the source of the preparation, of tests for purity and potency, and of the methods of preparation of each batch of biologics as defined in Section 1601, Health and Safety Code, and the sale, shipment or other disposition of the same. The licensee shall supply to the department monthly, on forms provided by the department, such information from said records as the department may require, the licensee retaining a full and complete copy thereof in his files.

Article 4. Storage

§967. Storage.

Each licensee shall maintain a refrigerator of sufficient capacity to store all of those products in his possession which require refrigeration and the entire stock of such products shall be kept within the refrigerator at all times. The temperature of the refrigerator shall not be permitted to rise above 10 degrees C. or fall below 1 degree C., as indicated by a required standard mercury thermometer, except that storage below 1 degree C. is allowed if not specifically damaging to the product. Licensee shall not sell or distribute for resale or redistribution biologics which require refrigeration unless the purchaser or distributor for resale or redistribution is equipped to store said biologics in the manner above provided.

Article 5. Containers and Labeling

§972. Containers and Labeling.

History

(a) No biological product either for human or animal use shall be distributed except in the original final container bearing the original label of the manufacturer; provided, however, that a licensed laboratory may purchase products from other producers likewise licensed by the State, and repack and relabel such products in smaller containers; provided, there are no changes, substitutions or additions in the product or the label, and further provided, that all such repacked biological products shall bear on the label the name of the manufacturer as well as the name of the distributor together with a statement that the product has been repacked. All such repacked products are subject to the requirements of Sections 1600 to 1621, inclusive, Health and Safety Code, and are not exempted from inspection and license by the department.

(b) The labels of all biologic products on the containers for general distribution shall show the name of the product, the lot number that will identify the lot or batch in the record of the manufacturer, the expiration date, and the name of the manufacturer. The expiration date shall be based on a period of duration approved by the department.

(c) The labels on all bottles and individual packages of bacterial vaccines (bacterins) shall give the correct name of the organism concerned and mixed bacterins shall give the names of each organism according to the classification of Bergey in the mixture and the proportion that each organism represents in the mixture. The concentration may be expressed in number per mil or in terms of a turbidity standard acceptable to the department.

(d) The labels on products requiring refrigeration or maintenance of uniform temperatures to avoid deterioration, shall specify the temperature range within which the product shall be maintained.

(e) To prevent accidental use, all stocks of labels and advertising not accepted by the department shall be destroyed.

HISTORY

1. Repealer of subsection (e) and relettering of subsection (f) to (e) filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

Article 6. Advertising

§977. Advertising.

History

(a) No statements regarding preventive or therapeutic value shall be made either on labels or circulars or in any form of advertising that are not in accord with the opinion held by the recognized authorities of the medical profession and no descriptive matter or discussion of mode of action of the product or theory of its applicability may be used that is not acceptable to the same authorities.

(b) No mention of the department shall be made in advertising either directly or indirectly.

(c) All advertising matter, statements, and representations pertaining to biologics licensed under Sections 1600 to 1620, Health and Safety Code, shall be submitted to the department at least 30 days prior to their use by the licensee.

HISTORY

1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Article 7. Samples

§982. Potency.

History

Licensees producing, processing or distributing biologics for which a potency test is recognized or prescribed by the United States Department of Health, Education, and Welfare, shall upon the request of the department, provide a representative sample of each lot of such product for purposes of checking. The particular lot so sampled shall not be distributed until approval is given by the department.

HISTORY

1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Article 8. Vaccine Culture

§987. Vaccine Culture.

History

No culture shall be used in the preparation of live culture vaccine unless it is nonvirulent or has sufficiently low virulence as not to be reasonably likely to produce the disease in the inoculated person, or be dangerous from the standpoint of contagion. Such cultures must be tested and approved by the department before use.

HISTORY

1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Article 9. Preparation and Distribution of Whole Blood (Human)

The following conditions must be met and observed in the procurement, processing, storage, and distribution of whole blood (human) or blood derivatives for transfusion purposes:

§997. Definitions.

Note • History

As used in this article:

(a) Blood Bank is a medical facility designed, equipped, and staffed to procure, to process, to store, or to distribute human whole blood or blood derivatives for transfusion purposes.

(b) For implementation of these regulations, a blood bank depository also is designated as a transfusion service.

A transfusion service shall be a component of a clinical laboratory holding a license in accordance with the provisions of Chapter 3 (commencing with Section 1200) Division 2 of the Business and Professions Code, or such other place where services essentially equivalent are maintained as determined by the department.

A transfusion service shall be responsible for all functions related to storage and preparation of blood for transfusion, except those activities requiring a biologics license, in accordance with the Health and Safety Code, Division 2, Chapter 4 (commencing with Section 1600).

Institutions which fulfill criteria for both a clinical laboratory license and a biologics license may maintain the combined services of a blood bank and a transfusion service.

(c) Blood collection center is a stationary auxiliary to a blood bank which is designed, equipped and staffed to procure human whole blood and to transport this blood to the blood bank for processing, storing and distribution.

(d) Mobile unit is a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the blood bank for processing, storing and distribution.

(e) Whole blood is the fluid component of the human cardiovascular system composed of liquid and cellular elements.

(f) Plasma is the extracellular portion of anticoagulated whole blood.

(g) Blood derivatives or fractionation products are the individual elements of whole blood which have been processed or manufactured into their individual component parts, in accordance with procedures contained in Articles 10 and 11.

(h) Donor means the individual from whom blood is procured.

(i) All references to temperature are expressed in degrees centigrade.

NOTE

Authority cited: Sections 1602.5, 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.

HISTORY

1. Repealer and new Article 10 (Sections 997 through 1003) filed 10-25-66; effective thirtieth day thereafter (Register 66, No. 37). For history of former Article 10, see Registers 56, No. 2, 59, No. 17, 60, No. 19 and 63, No. 17.

2. Amendment of subsection (b) filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

3. Renumbering of Article 10 to Article 9 and amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10). For history of former Article 9 (Section 992) see Register 71, No. 34.

4. Change without regulatory effect repealing subsections (i)-(k), relettering subsections, and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§998. Personnel of Blood Banks and Their Auxiliaries.

Note • History

(a) Physicians and surgeons, clinical laboratory bioanalysts, clinical laboratory technologists, clinical laboratory technologist trainees and nurses who comprise the staff of the blood bank shall be duly licensed by or registered in the State of California. The staff may include such other persons, when approved by the director, as may be necessary for the proper operation of the blood bank, including volunteer workers.

(b) Director of Blood Bank. The blood bank and its auxiliaries shall be under the direction of a physician and surgeon duly licensed by the State of California, and who shall have a minimum of six months experience in blood bank methods, transfusion principles, and transfusion practices, satisfactory to the department. Attending Physician refers to the duly licensed physician and surgeon supervising blood collection activities.

(c) Laboratory Personnel. The laboratory personnel shall be licensed pursuant to the Clinical Laboratory Laws (California Business and Professions Code, Division 2, Chapter 3), except that unlicensed persons may be used to assist licensed personnel under their supervision, so long as such unlicensed persons do not perform laboratory tests or render judgment on such tests.

NOTE

Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603(c), Health and Safety Code.

HISTORY

1. Amendment of subsection (b) filed 7-31-68; effective thirtieth day thereafter (Register 68, No. 29).

2. New NOTE filed 3-20-84 (Register 84, No. 12).

§999. Blood Bank Equipment, Facilities and Manual. [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Change without regulatory effect repealing section and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1000. Blood Bank Records; Identification of Human Blood with Its Donor.

Note • History

(a) A system which carries through from donor to recipient must be used to identify the blood. This shall be accomplished by having blood container and pilot tube labels identified with the donor before venesection. The labels and personal history shall carry the same identification number. These labels shall accompany the donor to the collection room and shall be applied to the blood container and pilot tubes while it is still possible to check accurately the identity of the blood with the donor and his history. Other documents related to the blood such as invoices, if used, shall also contain the same identification number.

(b) Every California licensed blood bank shall obtain reports of reactions in individuals receiving its blood, or blood derivatives, where it appears that these materials from the blood bank may be implicated in such reactions. Reporting shall include also any illness whose cause may be related to transfusion of blood or blood derivatives provided by the blood bank. Forms for these purposes may be devised by the blood bank as a reminder to the transfusion services and as encouragement to them to comply with this requirement.

(c) In addition to the applicable portions of the regulations set forth in Section 963 and the first two paragraphs of this section, the blood bank shall keep complete records of each donor, which shall include all information specified in Section 1002. Records are required also which contain information related to the disposition of all blood collected or distributed.

(d) These records shall be kept for an interval of not less than five years after the expiration date of the blood unit involved. All such records shall be correlated in such a way that checking the complete history of each blood unit may be quickly and conveniently performed.

(e) Records of refrigerator temperatures shall fulfill the requirements contained in Section 1002(g)(2) of these regulations.

(f) All blood bank records shall be dated.

NOTE

Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code.

HISTORY

1. New NOTE filed 3-20-84 (Register 84, No. 12).

§1001. Labels. [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Repealer of subsection (k) filed 4-20-77; effective thirtieth day thereafter (Register 77, No. 17). For prior history, see Register 76, No. 10.

2. Change without regulatory effect repealing section and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1002. Requirements--Donors, Medical History, Blood Collection, Storage and Testing.

Note • History

(a) Responsibilities. Final responsibility for the acceptance of donors rests with the attending physician.

Any time blood is collected under license, adequate medical care for the donor shall be provided. Blood shall be drawn from the donor under the supervision of a physician or registered nurse trained in the procedure. Blood may be collected when a physician is not present on the premises under the following conditions:

(1) The medical director and his medical advisory committee, if he has one, must approve.

(2) The employee placed in charge, in the absence of a qualified physician must be a registered nurse.

(3) The nursing staff and medical director must have a mutually clear understanding of the criteria for donor selection. Consultation with the medical director by telephone from mobile unit operations about certain donors may be necessary.

(4) A qualified physician or emergency medical facility shall be available nearby. Having a physician or emergency medical facility available is for the purpose of attending to donors who have a severe reaction or accident related to the blood donation. “Available” means no longer than 15 minutes away.

(5) Written emergency standing orders for donor care must be prepared by the medical director and be made available to the nursing staff. Appropriate training and refresher courses in emergency resuscitative methods must be planned. The nursing staff must be given special training on the symptomatology and emergency treatment of such conditions as cardiac and vascular disease, syncope, fractures, etc.

The attending physician shall sign all donor records, except that he may delegate the responsibility for signature to an employee of the blood bank whose license permits him to perform functions related to medical practice when under medical supervision.

Irrespective of location, the blood bank under whose license the blood is to be processed shall be responsible for all personnel engaged in examining donors and collecting blood, as well as the space and equipment used.

(b) Collection of Blood. (Refer to Section 1000(a) for requirements relative to donor identification.)

(1) Protection of the Donor Against Infection and Injury.

The preparation of the skin at the sites of venipuncture and of injections incidental to venipuncture shall be adequate to protect the donor against infection.

Apparatus or instruments such as syringes, needles, and lancets or other blood-letting devices capable of transmitting infection from one donor to another shall be sterile single-use instruments insofar as possible.

All such instruments intended for reuse shall be heat sterilized prior to each use and protected against contamination. Heat sterilization shall be by autoclaving for 30 minutes at 121.5 C (15 lb. p.s.i. pressure), by dry heat for two hours at 170 C, or by boiling in water for 30 minutes. Times, temperatures and pressures in excess of those stated are permissible.

Such heat sterilization shall include the use of a heat indicator satisfactory to the department, which will serve as evidence of proper sterilization. The heat indicator used shall be retained for one year as a record relating to the sterilization in which it was used. The record of temperature attained shall be kept on file in the blood bank for five years. This record may be kept either as hand-written chart showing temperatures at different times, or as information from an automatic recorder.

Instruments used in puncturing the skin, if not prepared for reuse, shall be disposed of in such a way that they cannot be reused.

Thermometers shall be sufficiently cleansed before use to minimize the transmission of disease.

The staff concerned with blood collection shall be instructed in the first aid procedures to be used in the event of a reaction, and suitable drugs and supplies shall be immediately available for use. Donors shall be kept under continuous observation throughout the entire procedure of blood collection and for at least 15 minutes thereafter.

(1) Serologic Tests for Syphilis. A serologic test for syphilis approved by the department shall be made on a sample of blood taken from the donor at the time of blood collection. Blood shall not be used for transfusion unless the result of this test is nonreactive (negative), except in emergency situation with the consent of the blood bank director and the patient's attending physician.

All California licensed blood banks must accept and test evaluation sera provided by the department or a proficiency testing service approved by the department, and report test results to the department. Any blood bank laboratory showing unsatisfactory performance shall make changes as recommended by the department.

(d) Issue of Blood. Issuance of blood shall be in compliance with the provisions of the Health and Safety Code, Division 2, Chapter 4, Sections 1600.3 and 1604.

The laboratory tests and other procedures with respect to the preparation of blood for transfusion after it has been delivered to a transfusion service by the blood bank shall be the sole responsibility of the transfusion service. (See Section 1605 of the Health and Safety Code.)

As a condition to supplying blood, the blood bank director may inquire into the pretransfusion procedures used by the transfusion service and he may suggest as a minimum those described in the latest edition of “Standards for Blood Banks and Transfusion Services,” published by the American Association of Blood Banks. Blood banks shall not supply blood to transfusion services in which the department finds pretransfusion procedures which differ from these standards, or from such other standards which are essentially equivalent to these, as determined by the department.

NOTE

Authority cited: Sections 1602.5 and 1603, Health and Safety Code. Reference: Sections 1602.5 and 1603, Health and Safety Code.

HISTORY

1. Amendment of subsections (b) and (c) filed 5-25-77; effective thirtieth day thereafter (Register 77, No. 22). For prior history, see Register 76, No. 10.

2. Amendment of subsections (a)(3), (c)(6), (g)(1) and (i) filed 1-18-78; effective thirtieth day thereafter (Register 78, No. 3).

3. Amendment of subsection (b)(6) filed 2-6-79 as an emergency; effective upon filing (Register 79, No. 6).

4. Certificate of Compliance filed 5-18-79 (Register 79, No. 20).

5. Amendment of subsection (a)(3) filed 4-10-86; effective thirtieth day thereafter (Register 86, No. 15).

6. Amendment of subsection (a)(4) filed 10-2-87: operative 10-2-87 pursuant to Government Code Section 11346.2(d) (Register 87, No. 41).

7. Editorial correction of subsection (a)(2) (Register 87, No. 41).

8. Change without regulatory effect repealing subsections (a)-(c)(6), (e)(2)-(g)(5), (h)(2)-(i) and (k)-(l)(4), relettering subsections, amending newly designated subsection (b) and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1002.1. Use of AIDS Antibody (HTLV-III) Test by Blood Banks. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code.

HISTORY

1. New section filed 3-8-85 as an emergency; effective upon filing (Register 85, No. 15). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 7-8-85.

2. Repealer filed 5-22-85 as an emergency; effective upon filing (Register 85, No. 22). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 9-19-85.

3. Emergency language filed 3-8-85 and 5-22-85 expired by operation of Government Code Section 11346.1 (Register 87, No, 2).

§1003. Exceptions for Emergency Purposes.

History

In the event that an emergency occurs as defined in Chapter 7 (California Emergency Services Act), Division 1, Title 2 of the Government Code deviation from the provisions of Section 1001 and subsections (a) through (h) of Section 1002 of this Article will be permissible. The extent of deviation shall be determined by the blood bank director with concurrence by the department and shall be commensurate with the degree of emergency.

HISTORY

1. Amendment filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1004. Reporting Requirements.

Note • History

(a) Notification of Positive Laboratory Finding for Syphilis. To assist the local health officer in the discharge of his duties under Section 3110 and 3194 of the Health and Safety Code, any person who is in charge of a blood bank in which a laboratory examination of any specimen derived from a donor yields serological or other evidence of syphilis shall promptly notify the health officer of the local health jurisdiction of the address of the donor. This notification shall contain the type of specimen, the date it was obtained, the nature and result of the test performed, and the name, address, and the date of birth of the donor who provided the specimen.

The notification may be made by mailing or otherwise delivering a legible copy of the laboratory report containing all of the required information or by a telephone communication which is documented in the blood bank's records.

(b) The notifications required in this section are confidential and not open for public inspection.

NOTE

Authority cited: Sections 1603, 1603.1(g), 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.

HISTORY

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10.)

2. Amendment of subsection (a) filed 3-8-85 as an emergency; effective upon filing (Register 85, No. 15). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 7-8-85.

3. Repealer and new subsection (a) filed 4-2-85 as an emergency; effective upon filing (Register 85, No. 15). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 7-31-85.

4. Subsection (a) repealed by operation of Government Code Section 11346.1(g) (Register 85, No. 37).

5. Repealer and new subsection (a) filed 9-11-85 as an emergency; effective upon filing. Certificate of Compliance included (Register 85, No. 37).

6. Change without regulatory effect repealing subsections (a)-(c), relettering subsections, and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

Article 10. Preparation and Distribution of Normal Human Plasma

The following must be met and observed for the procurement, processing, storage and transportation of human blood for plasma:

§1010. Procurement of Blood for Plasma Processing. [Repealed]

Note • History

NOTE

Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.

HISTORY

1. Repealer and new Article 11 (Sections 1010 through 1022) filed 10-25-66; effective thirtieth day thereafter (Register 66, No. 37). For history of previous Article 11, see Registers 56, No. 2 and 59, No. 17.

2. Amendment of subsection (b) filed 11-24-69; effective thirtieth day thereafter (Register 69, No. 48).

3. Renumbering of Article 11 to Article 10 and amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

4. Change without regulatory effect repealing section and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1011. Personnel and Equipment.

Blood shall be processed into plasma only in blood banks adequately staffed and equipped for that purpose. The individual directly in charge of plasma processing shall be a physician and surgeon duly licensed by the State of California or an individual sufficiently trained in laboratory procedures relating to blood banking and plasma processing and whose qualifications have been approved by the department. The staff may include other trained persons necessary for the proper operation of plasma processing.

§1012. Single Donor Plasma and Single Donor Fresh Frozen Plasma (Antihemophilic). [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Amendment filed 4-1-71; effective thirtieth day thereafter (Register 71, No. 14).

2. Renumbering from Section 1022 and amendment filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44). For history of former Section 1012, see Register 71, No. 14.

3. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10.

4. Change without regulatory effect repealing section and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1013. Storage. [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Renumbering from Section 1019 and amendment filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44). For history of former Section 1013, see Register 71, No. 14.

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10.)

3. Change without regulatory effect repealing section and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1014. Expiration Date. [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Renumbering from Section 1020 and amendment filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44). For history of former Section 1020, see Register 71, No. 14.

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10.)

3. Change without regulatory effect repealing section and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1015. Other Tests. [Repealed]

History

HISTORY

1. Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1016. Filling the Final Container. [Repealed]

History

HISTORY

1. Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1017. Labeling. [Repealed]

History

HISTORY

1. Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1018. Diluent for Dried Plasma. [Repealed]

History

HISTORY

1. Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1021. Requirements for Release. [Repealed]

History

HISTORY

1. Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

Article 11. Preparation of Other Blood Derivatives

§1024. Red Blood Cells (Human). [Repealed]

Note • History

NOTE

Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.

HISTORY

1. Repealer of Article 12 (§§ 1025-1026) filed 10-25-66; effective thirtieth day thereafter (Register 66, No. 37). for former history of Article see Registers 56, No. 2 and 61, No. 3.

2. Amendment filed 4-1-71; effective thirtieth day thereafter (Register 71, No. 14).

3. Renumbering of Article 12 to Article 11 and amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

4. Change without regulatory effect repealing section and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1024.1. Frozen Red Blood Cells. [Repealed]

Note • History

NOTE

Authority cited: Sections 1602.5, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.

HISTORY

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

2. Change without regulatory effect repealing section and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1025. Plasmapheresis.

Note • History

(a) Requirements:

(1) No more than 500 milliliters of whole blood shall be removed from a donor at one time, unless the donor's weight is 175 pounds or greater in which case no more than 600 milliliters of whole blood shall be removed from the donor at one time.

(2) A duly licensed physician and surgeon shall be available as described in Section 1002(a) when plasmapheresis is performed.

(3) A system shall be employed which gives maximum assurance against any possibility of return of the separated red cells to an individual other than their donor.

(b) Examination and Laboratory Tests. Examinations and laboratory tests to assist in determining the donor's health shall include the following:

(1) Within no more than one week prior to the initial plasmapheresis, the donor shall be examined and certified to be in good health by a duly licensed physician and surgeon, as indicated in the applicable sections of the regulations. All donors shall have a physical examination by a duly licensed physician and surgeon at least once a year.

(2) A whole blood hemoglobin or hemoglobin or hematocrit concentration shall be performed prior to each plasmapheresis procedure.

(3) Determination of total protein shall be done at the time of each plasmapheresis procedure. the total protein shall not be less than 6.0 grams per 100 ml of plasma.

(4) The ratios of the various protein components of the donor's serum shall be determined from a sample taken at the time of his initial plasmapheresis and at intervals of not more than four months thereafter so long as he remains on a plasmapheresis program.

(5) To qualify for further plasmapheresis, all of the values determined under this section must be within the acceptable normal range.

(c) Samples for Laboratory Tests. Samples for laboratory tests shall not exceed 30 ml of whole blood in a seven-day period.

NOTE

Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.

HISTORY

1. Amendment filed 11-24-69; effective thirtieth day thereafter (Register 69, No. 48).

2. Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10).

3. Change without regulatory effect repealing subsections (a)-(b)(2)(B), (c)(1)-(c)(3) and (e)-(e)(1), relettering subsections, amending newly designated subsections (a)(2) and (b)(2) and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).

§1026. Other Blood Fractions; Procedures; Standards; Consultative Service.

History

Since procedures and standards for the preparation of other blood fractions, such as immune serum globulin, albumin, etc., for transfusion purposes are not as yet well suited for blood bank production, any biologies producer operating under the license of the department shall submit a complete protocol of procedures to be followed and shall be subject to the current specifications of the department regarding such products. This shall include specific licensure for the production of such materials, inspection, and the maintenance of appropriate standards. Such standards as are necessary will, in general, follow the usual blood banking procures with deviations general, follow the usual blood banking procedures with deviations only for specific reason. Such deviations and specific procedures shall be outlined in writing to the department by the biologics producer. Potential producers of such biologics should avail themselves of the consultative services of this department in order to provide for a proper production procedure consistent with regulations of the department, thus avoiding the installation of methods which must later be amended or changed.

HISTORY

1. Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10).

Article 12. Transportation of Etiologic Agents

§1027. Definitions and Procedures to Be Followed.

Note • History

(a) For the purpose of this article “person” includes laboratory, firm, association, corporation, co-partnership, and educational institutions, and “department” means State Department of Health.

(b) Etiologic Agents.

(1) For the purpose of this article microorganisms which may produce disease in man shall be referred to as etiologic agents.

(2) The provisions of this article do not apply to specimens transmitted to a laboratory operated by the State Department of Health or equivalent containers are used, or those of other public health department laboratories operating under certificates issued by the department.

(3) The provisions of this article do not apply to biological products licensed by the department or by the United States Department of Health, Education and Welfare.

(1) Containers shall be used which are constructed in a manner equivalent to those referred to in (b)(2) of this section.

(2) In the case of frozen materials the etiologic agent shall be packed in sufficient dry ice and insulation material to insure that the material will remain frozen for at least 24 hours longer than the expected time in transportation.

(3) The proposed recipient shall be notified when transportation of the etiologic agent begins. This shall include type of transportation and probable time of arrival at a designated place.

(4) The approved type of container, referred to in (b)(2) above, shall be labeled in such a way that the etiologic agent which it contains is clearly indicated in bold type. The label shall state clearly that material of an infectious nature is present within the container.

(5) The label shall state that if breakage or leakage occurs whoever first has knowledge of the accident will immediately notify the department and the local health officer having jurisdiction at the site of the accident. This report should also contain the names and addresses of those who may have been exposed to the etiologic agent as a result of the accident. If loss occurs the person first aware of this occurrence shall notify the department promptly and shall supply such additional details as may be available.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1603.5, Health and Safety Code.

HISTORY

1. New section filed 2-1-61; effective thirtieth day thereafter (Register 61, No. 3).

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Article 13. Research Projects

§1028. Waiver of Regulations.

Note • History

Notwithstanding the other provisions of Group 1, Subchapter 1, Chapter 2 of Part I (commencing with Section 950) of Title 17 relating to the production and distribution of biologics, the Director may at his discretion waive such regulations for research projects approved by the Director. The waiver shall be for a specific period of time and subject to all conditions which the Director finds necessary to protect the public health.

NOTE

Authority cited: Section 102 and 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety code.

HISTORY

1. New Article 13 (Section 1028) filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).

Group 2. Clinical Laboratory Regulations

Article 1. Definitions

§1029. General Definitions. [Repealed]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1244, 1265, 1281, 1282, 1285, 1288.5 and 1300, Business and Professions Code.

HISTORY

1. Amendment of group, article and section headings, and renumbering and amendment of former section 1053 to section 1029 filed 1-22-96 as an emergency; operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96 or emergency language will be repealed by operation of law on the following day.

2. Amendment of section and Note filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency language will be repealed by operation of law on the following day.

3. Editorial correction of subsection (gg) (Register 96, No. 25).

4. Certificate of Compliance as to 1-22-96 order including amendment of Note transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

5. Editorial correction of subsection (k)(1) (Register 96, No. 41).

6. Amendment of section and Note refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 or emergency language will be repealed by operation of law on the following day.

7. Amendment of article heading filed 11-6-96 as an emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-7-96 order, including repealer of section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

9. Certificate of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No. 16).

§1029.5. Accreditation Body.

Note • History

“Accreditation body” means an approved accreditation organization for laboratories, as defined in 42 Code of Federal Regulations, Section 493.2.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

§1029.6. Accredited Institution. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Change without regulatory effect renumbering former section 1029.6 to section 1029.9 filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20).

§1029.7. Accredited College or University.

Note • History

“Accredited college or university” means an educational facility which has met the standards of the United States of America Accrediting Commission for Senior Colleges and Universities or the Accrediting Commission for Community and Junior Colleges; or, if a non-United States college or university, one that is evaluated and found equivalent by the American Association of Collegiate Registrars and Admissions Officers.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1260, 1261, 1261.5, 1263 and 1264, Business and Professions Code.

HISTORY

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.9. Accredited Institution.

Note • History

“Accredited institution” has the same meaning as given in Title 42 of the Code of Federal Regulations, Section 493.2.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.

HISTORY

1. Change without regulatory effect renumbering former section 1029.6 to section 1029.9 filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20). For prior history, see Register 98, No. 7.

§1029.10. Accusation.

Note • History

“Accusation” means a written statement filed in order to initiate a hearing to determine whether a right, authority, license, or privilege should be revoked, suspended, limited or conditioned, and which:

(a) Sets forth in ordinary and concise language the acts or omissions with which a person, entity, or laboratory and its owners or directors are charged with committing to the end that the person, entity or laboratory and its owners or directors will be able to prepare a defense; and

(b) Specifies the statutes and regulations alleged to have been violated.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Section 11503, Government Code; and Section 14123, Welfare and Institutions Code.

HISTORY

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.11. Antigen. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.

HISTORY

1. New section filed 11-6-96 as an emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No. 16).

3. Renumbering of former section 1029.11 to new section 1029.25 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.13. Approved Public Health Laboratory. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.13 to new section 1029.30 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.15. Alternative Sanction.

Note • History

“Alternative sanction” means one or more of the following sanctions:

(a) Directed plan of correction;

(b) Civil money penalty; or

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c.510, Section 1; and Section 1310, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.15 to new section 1029.35 and new section 1029.15 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.17. CLIA Certificate. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.17 to new section 1029.45 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.19. CLIA Exempt Status. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6).

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.19 to new section 1029.50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.20. Antibody.

Note • History

“Antibody” means an immunoglobulin molecule that, due to its specific amino acid sequence, reacts to the antigen that induced its synthesis in the cells of the lymphoid series.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.

HISTORY

1. Renumbering of former section 1029.9 to new section 1029.20 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.23. Direct Patient Care. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.23 to new section 1029.70 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.25. Antigen.

Note • History

“Antigen” means any viral component including, but not limited to, proteins and nucleic acids.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.25 to new section 1029.80 and renumbering of former section 1029.11 to new section 1029.25 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.27. HHS. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.30. Approved Public Health Laboratory.

Note • History

“Approved public health laboratory” means a laboratory that has been issued a certificate of approval by the department after its determination that the public health laboratory, as defined in Business and Professions Code section 1206(a)(11), is in conformity with chapter 7 (commencing with section 1000) of part 2 of division 1 of the Health and Safety Code and the regulations adopted thereunder.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.13 to new section 1029.30 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.31. Arterial Puncture.

Note • History

“Arterial puncture” means the penetration of an artery with a needle to withdraw blood for clinical laboratory test or examination purposes.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). For prior history, see Register 2001, No. 14.

§1029.32. Certified Phlebotomy Technician I.

Note • History

“Certified phlebotomy technician I” means a person who has completed the education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures and venipunctures.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). For prior history, see Register 2001, No. 14.

§1029.33. Certified Phlebotomy Technician II.

Note • History

“Certified phlebotomy technician II” means a person who has completed education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures, venipunctures and arterial punctures.

NOTE

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). For prior history, see Register 2001, No. 14.

§1029.34. Certifying Organization.

Note • History

“Certifying organization”, also called a national accreditation or accrediting board or agency, means an organization, agency or body that creates competency examinations that measure the skill, knowledge and aptitude required of an individual in a profession, occupation or discipline.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1246, 1262, 1264 and 1270, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.35. Chapter 3.

Note • History

“Chapter 3” means chapter 3 (commencing with section 1200) of division 2 of the Business and Professions Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code.

HISTORY

2. Certificate of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No. 16).

3. Renumbering of former section 1029.35 to new section 1029.90 and renumbering and amendment of former section 1029.15 to new section 1029.35 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.37. Instrument. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.37 to new section 1029.100 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.39. Licensed General Acute Care Hospital. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.39 to new section 1029.110 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.40. Civil Money Penalties.

Note • History

“Civil money penalties” means the civil money penalties imposed by the department under the procedures identified in section 1067.5.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Section 1310, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.40 to new section 1029.115 and new section 1029.40 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.43. Patient. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.43 to new section 1029.130 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.44. Preceptor. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.44 to new section 1029.135 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.45. CLIA Certificate.

Note • History

“CLIA certificate” means an unsuspended and unrevoked certificate of compliance, certificate for provider-performed microscopy procedures, certificate of accreditation, certificate of registration or a certificate of waiver, as defined in 42 Code of Federal Regulations section 493.2.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.17 to new section 1029.45 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.47. Respiratory Care Practitioner. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.47 to new section 1029.150 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.49. Specimen. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225, 1241, 1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.49 to new section 1029.155 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.50. CLIA Exempt Status.

Note • History

“CLIA exempt status” means that the United States Department of Health and Human Services (HHS) has exempted clinical laboratories licensed, registered or otherwise approved by the department from the requirements of CLIA pursuant to subsection (p) of section 263a of title 42 of the United States Code and section 493.513 of title 42 of the Code of Federal Regulations.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6).

HISTORY

1. Renumbering and amendment of former section 1029.19 to new section 1029.50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.51. Clinical Consultant.

Note • History

“Clinical consultant” means a person who meets the requirements of Section 493.1455 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides clinical consultation of a laboratory in accordance with Section 1036 of this title and Section 493.1457 of Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.31 to section 1029.51 filed 4-3-2001; operative 4-3-2001 (Register 2001, No. 14). For prior history, see Register 98, No. 7.

§1029.52. Clinical Cytogenetics.

Note • History

“Clinical cytogenetics” means the techniques used to isolate, replicate and identify whole or parts of human chromosomes including culturing, manipulation, banding, staining and hybridizing, and analysis with respect to genotype and phenotype.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.32 to section 1029.52 filed 4-3-2001; operative 4-3-2001 (Register 2001, No. 14). For prior history, see Register 98, No. 7.

§1029.53. Clinical Genetic Molecular Biology.

Note • History

“Clinical genetic molecular biology” means the determination of all the aspects of molecular organizations of the nucleic acids of the human genome with respect to genotype and phenotype.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.33 to section 1029.53 filed 4-3-2001; operative 4-3-2001 (Register 2001, No. 14).

§1029.55. Condition Level Deficiency.

Note • History

“Condition level deficiency” means noncompliance with one or more condition level requirements.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.55 to new section 1029.185 and new section 1029.55 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.57. Test Purposes. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.57 to new section 1029.180 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.59. Unprofessional Conduct. [Renumbered]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code.

HISTORY

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.59 to new section 1029.190 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.60. Condition Level Requirement.

Note • History

“Condition level requirement” means any of the requirements specified in section 1066.

NOTE

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.65. Deficiency.

Note • History

“Deficiency” or “Violation” means noncompliance with one or more of the requirements in chapter 3, division 2 of the Business and Professions Code (commencing with section 1200) or any rule or regulation adopted thereunder.

NOTE

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.70. Direct Patient Care.

Note • History

“Direct patient care” means medical, psychiatric, nursing or other health care which is legally provided by a care giver or healthcare provider directly to a patient, and which includes observation of the patient's physical or mental condition to enable the care giver or healthcare provider to report changes in the patient's condition.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.23 to new section 1029.70 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.75. Directed Plans of Correction.

Note • History

“Directed plans of correction” means the directed plans of correction imposed by the department under the procedures identified in section 1067.

NOTE

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.80. Electrolytes.

Note • History

“Electrolytes” means ionized calcium, sodium, potassium and/or chloride.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.25 to new section 1029.80 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.81. Evidence of Satisfactory Performance.

Note • History

“Evidence of satisfactory performance” means a copy of a document issued to an examinee by the department for satisfactory performance on a department-administered licensing written examination, or by a certifying board or organization indicating satisfactory performance by the examinee on a written certifying examination.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.82. Field Related to Genetics.

Note • History

“Field related to genetics” means a major in molecular biology, reproductive biology, biochemistry, clinical genetics, medical genetics, clinical cytogenetics, biochemical genetics, human genetics, clinical laboratory science, or clinical molecular genetics.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.83. General Supervisor.

Note • History

“General supervisor” means a person who meets the requirements of Section 493.1461 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides general supervision of a laboratory in accordance with Section 1036.1 of this title and Section 493.1463 of Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.85. HHS.

Note • History

“HHS” means the federal Department of Health and Human Services, or its designee.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.86. High Complexity Tests or Examinations.

Note • History

“High complexity tests or examinations” mean those clinical laboratory tests or examinations classified as high complexity under CLIA.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.90. Human Immunodeficiency Virus.

Note • History

“Human Immunodeficiency Virus” or “HIV” means the etiologic virus of Acquired Immune Deficiency Syndrome, or AIDS.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.

HISTORY

1. Renumbering of former section 1029.35 to new section 1029.90 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.95. Immediate Jeopardy.

Note • History

“Immediate jeopardy” means a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more conditions has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public. This term is synonymous with imminent and serious risk to human health and significant hazard to the public health.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Sections 1310, 1320, 1323 and 1326, Business and Professions Code; and Section 14123, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.100. Instrument.

Note • History

“Instrument” means a device, apparatus, implement, machine or contrivance that is used for the performance of a clinical laboratory test or examination,

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.37 to new section 1029.100 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.105. Intermediate Sanction.

Note • History

“Intermediate sanction” means either or both:

(a) Temporary suspension of a license, registration or approval; or

(b) Temporary suspension of a provider of service under the Medi-Cal program.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Section 1323, Business and Professions Code; Section 1002, Health and Safety Code; Section 14123, Welfare and Institutions Code; 42 United States Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act).

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.108. License.

Note • History

For the purposes of this chapter, “license” means license, certificate, registration or other means to engage in a business or profession regulated by Chapter 3.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 23.7, 1203, 1204, 1205, 1206.5, 1207, 1208, 1209, 1210, 1220, 1227, 1242, 1246, 1246.5, 1260, 1260.1, 1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269.5, 1270, 1275, 1280, 1281, 1285, 1288.5, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324 and 1325, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.110. Licensed General Acute Care Hospital.

Note • History

“Licensed general acute care hospital” means a facility as defined in section 1250(a) of the Health and Safety Code that has been licensed pursuant to chapter 2 (commencing with section 1250) of division 2 of the Health and Safety Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.39 to new section 1029.110 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.111. Licensed Healthcare Professional. [Repealed]

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1208, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including repealer of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.115. Licensed Surgical Clinic.

Note • History

“Licensed surgical clinic” means a facility as defined in section 1204(b)(1) of the Health and Safety Code that has been licensed pursuant to chapter 1 (commencing with section 1200) of division 2 of the Health and Safety Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.40 to new section 1029.115 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.116. Limited Phlebotomy Technician.

Note • History

“Limited phlebotomy technician” means a person who has completed the education, training and experience requirements pursuant to Section 1034 and is certified by the department to perform skin punctures.

NOTE

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.117. Medical Laboratory Technician.

Note • History

“Medical laboratory technician” means a person who has completed education, training or experience, and examination requirements pursuant to Section 1032.5(a), and who is authorized to perform clinical laboratory tests and examinations specified in Section 1032.5(b).

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1210, 1242, 1260.3, 1264 and 1300, Business and Professions Code.

HISTORY

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-13-2005 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Register 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 9-12-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-12-2005 order transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1029.118. Moderate Complexity Laboratory Technical Consultant.

Note • History

“Moderate complexity laboratory technical consultant” means a person who meets the qualifications of Section 493.1411 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical oversight in accordance with Section 1036.2 of this title and Section 493.1413 of Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.119. Moderate Complexity Tests or Examinations.

Note • History

“Moderate complexity tests or examinations” mean those clinical laboratory tests or examinations classified as moderate complexity under CLIA.

NOTE

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.120. Notice of Defense.

Note • History

“Notice of Defense” means a writing signed by or on behalf of the person, entity or laboratory, stating the mailing address of the person, entity, or laboratory, and may:

(a) Request a hearing.

(b) Object to the accusation upon the ground that it does not state acts or omissions upon which the agency may proceed.

(c) Object to the form of the accusation on the ground that it is so indefinite or uncertain that the person, entity, or laboratory cannot identify the transaction or prepare a defense.

(d) Admit the accusation in whole or in part.

(e) Present new matter by way of defense.

(f) Object to the accusation upon the ground that, under the circumstances, compliance with the requirements of a regulation would result in material violation of another regulation enacted by another department affecting substantive rights.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.124. On-the-Job Experience in Phlebotomy.

Note • History

“On-the-job experience in phlebotomy” means employment as a phlebotomist in a clinical laboratory performing the techniques pursuant to Section 1035.1(f).

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.125. Onsite Monitoring.

Note • History

“Onsite monitoring” means the onsite monitoring imposed by the department under the procedures identified in section 1067.10.

NOTE

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.126. Oral and Maxillofacial Pathology Laboratory Director.

Note • History

“Oral and maxillofacial pathology laboratory director” means a dentist who possesses a valid, unexpired license to direct an oral pathology laboratory in all areas of anatomic and clinical pathology related to the oral and maxillofacial region.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208 and 1209, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section heading and section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.127. Oral Pathology.

Note • History

“Oral pathology” means the subspecialty of pathology that deals with the nature, identification and management of diseases affecting the oral and maxillofacial regions, which investigates the causes, processes and effects of these diseases, and includes research and diagnosis of diseases using clinical, radiographic, microscopic, biochemical or other examinations.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1207, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.130. Patient.

Note • History

“Patient” means a person who is an inpatient or outpatient of a licensed health facility, licensed clinic or a clinic that is exempt from licensure, licensed home health agency, or who is a patient of a licensed physician and surgeon or osteopath, licensed dentist, or licensed podiatrist.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.43 to new section 1029.130 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.132. Phlebotomist.

Note • History

“Phlebotomist” means a person who collects blood for clinical laboratory test or examination purposes.

NOTE

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.133. Phlebotomy.

Note • History

“Phlebotomy” means the process of collecting blood by venipuncture, arterial puncture or skin puncture for the purpose of obtaining blood for clinical laboratory test or examination purposes.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.134. Practical Experience.

Note • History

“Practical experience” means hands-on, direct work experience in clinical laboratory science and phlebotomy techniques on real patients in a clinical laboratory certified by CLIA, using equipment, instruments, kits and materials routinely found in clinical laboratories performing moderate or high complexity tests or examinations, and does not include work done in academic, research, forensic, pharmaceutical or veterinary laboratories.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1222.5, 1242, 1242.5, 1243, 1246, 1260, 1260.3, 1261, 1261.5, 1264, 1269 and 1286, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including amendments, transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1029.135. Preceptor.

Note • History

“Preceptor” means:

(a) The laboratory director or the technical consultant of the laboratory, as that term is defined under CLIA; or,

(b) A person who:

(1) Meets the qualifications of a technical consultant under CLIA and of chapter 3 to perform clinical laboratory tests or examinations classified as of moderate complexity; and,

(2) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor; or,

(c) Any person listed in subdivision (b) of section 1206.5 of the Business and Professions Code, except for those persons listed in subsections (10), (11), or (12) of subdivision (b), and who:

(1) Has two years of experience performing moderate complexity tests upon the instrument(s) for which she or he will act as a preceptor; and

(2) Meets any CLIA requirements necessary to perform his or her duties and responsibilities in a preceptor program; and

(3) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.44 to new section 1029.135 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.140. Principal Sanction.

Note • History

“Principal sanction” means:

(a) Suspension or revocation of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code; or

(b) Suspension or revocation of the approval to operate a public health laboratory granted under chapter 7 (commencing with section 1000) of the Health and Safety Code; or

(c) Suspension of a provider of service from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Sections 1320 and 1322, Business and Professions Code; Section 1002, Health and Safety Code; and Section 14123, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.145. Provider of Service.

Note • History

“Provider of service” has the same meaning as given in 22 CCR 51051.

NOTE

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.150. Respiratory Care Practitioner.

Note • History

“Respiratory care practitioner” means an individual licensed pursuant to chapter 8.3 (commencing with section 3700) of division 2 of the Business and Professions Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.47 to new section 1029.150 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Editorial correction (Register 98, No. 7).

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.153. Satisfactory Performance.

Note • History

“Satisfactory performance” means achieving at least the minimum grade that an examinee must obtain to get a passing score on a written or oral examination.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.154. Skin Puncture.

Note • History

“Skin puncture” means penetration of the skin for the purpose of collecting capillary blood for clinical laboratory test or examination purposes.

NOTE

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.155. Specimen.

Note • History

“Specimen” has the same meaning as given for “biological specimen” in section 1206(a)(1) of the Business and Professions Code.

NOTE

HISTORY

1. Renumbering and amendment of former section 1029.49 to new section 1029.155 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.160. State License.

Note • History

“State license” or “license” means the license identified in section 1265(a)(1) of the Business and Professions Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.51 to new section 1029.160 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.165. State Registration.

Note • History

“State registration” or “registration” means the registration identified in section 1265(a)(2) of the Business and Professions Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.52 to new section 1029.165 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.168. Statement of Issues.

Note • History

“Statement of issues” means a written statement served on the person, entity or laboratory which:

(a) Specifies the statutes and regulations with which the person, entity or laboratory must show compliance by producing proof at the hearing, and

(b) Includes any particular matters which have come to the attention of the department that could form the basis for a denial of the departmental action sought.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.169. Subspecialty of Histocompatibility.

Note • History

“Subspecialty of histocompatibility” means those clinical laboratory analyses of factors that determine the acceptance or rejection of grafted tissues or organs and that are performed in a histocompatibility laboratory as specified in Section 493.1265 of Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.170. Temporary Suspension of a License, Registration or Approval.

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Sections 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, Section 1; Section 1323, Business and Professions Code; and Section 1002, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

3. Change without regulatory effect renumbering former section 1029.170 to section 1029.173 filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20).

§1029.171. Technical Supervisor.

Note • History

“Technical supervisor” means a person who meets the qualifications of Section 493.1449 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical supervision in accordance with Section 1036.4 of this title and Section 493.1451 of Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.173. Temporary Suspension of a License, Registration or Approval.

Note • History

“Temporary suspension of a license, registration or approval” means immediate suspension or limitation of a public health laboratory's approval to perform testing or a clinical laboratory's license or registration to perform tests or examinations in one or more, or all, specialties or subspecialties, prior to a hearing, based on a departmental finding of immediate jeopardy.

NOTE

HISTORY

1. Change without regulatory effect renumbering former section 1029.170 to section 1029.173 filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20).

§1029.175. Temporary Suspension of a Provider of Service Under the Medi-Cal Program.

Note • History

“Temporary suspension of a provider of service under the Medi-Cal program” means the immediate suspension imposed by the department pursuant to 22 CCR 51529(g) under the procedures identified in section 1067.15.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Section 14123, Welfare and Institutions Code; 42 United States Code; Section 1395w-2 (Section 1846 of the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act).

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.180. Test Purposes.

Note • History

“Test purposes,” as it relates to arterial puncture, venipuncture, and skin puncture, means withdrawal, or injection of any test materials specifically required for a clinical laboratory test, provided that appropriate instructions relative to injection technique have been given and that a licensed physician and surgeon is immediately available when test materials are injected. Unlicensed personnel may not inject test material for any purpose.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code.

HISTORY

1. Renumbering of former section 1029.57 to new section 1029.180 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.185. Testing Event.

Note • History

“Testing event” means the performance of the preanalytical, analytical, and postanalytical activities related to performing a clinical laboratory test or examination on a biological specimen.

NOTE

HISTORY

1. Renumbering of former section 1029.55 to new section 1029.185 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.190. Unprofessional Conduct.

Note • History

“Unprofessional conduct,” pursuant to the provisions of Section 1320(m), Business and Professions Code, means:

(a) Acts of gross negligence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code.

(b) Acts of gross incompetence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code.

HISTORY

1. Renumbering and amendment of former section 1029.59 to new section 1029.190 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1029.195. Venipuncture.

Note • History

“Venipuncture” means the penetration of a vein with a needle to withdraw blood for clinical laboratory test or examination purposes.

NOTE

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.196. Waived Laboratory Technical Consultant.

Note • History

“Waived laboratory technical consultant” means a person who meets the qualifications specified in Section 1036.3(a) and provides technical oversight of a waived laboratory as specified in Section 1036.3(b) and (c).

NOTE

Authority cited: Sections 1208 and 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

§1029.197. Waived Tests.

Note • History

“Waived tests” mean those clinical laboratory tests categorized as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L.100-578) at Title 42, Code of Federal Regulations, Section 493.15, as published October 1, 1994.

NOTE

HISTORY

Article 1.5. Licensure of Clinical Laboratory Personnel

§1030. Examination for Bioanalysts' Licenses.

Note • History

(a) The examination for license as a clinical laboratory bioanalyst shall consist of three sections; namely, written, oral, and practical. The subjects covered in this examination shall have to do with the technical procedures performed in clinical laboratories for the purpose of obtaining scientific data which may be used to ascertain the presence, progress, and source of disease.

(b) An official transcript of college or university training shall be furnished by each applicant. The college or university training shall include as a minimum the indicated number of semester or equivalent quarter units of standard resident courses or their subject equivalent as follows:

General inorganic chemistry 8

Quantitative analysis 3

Organic chemistry 3

Biochemistry 8

Bacteriology 8

Physics 3

Biology or zoology 4

Physiology 3

Parasitology 3

Hematology 2

NOTE

Authority cited for Group 2: Section 208, Health and Safety Code, and Sections 1220 through 1223, Business and Professions Code. Additional authority cited: Section 102, Health and Safety Code.

HISTORY

1. Originally published 8-15-45 (Title 17).

2. Revision filed 12-24-47 (Register 10, No. 8).

3. Repealer and new Group 2 filed 12-26-51; effective thirtieth day thereafter (Register 26, No. 7).

4. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

5. New article 1.5 heading (containing sections 1030-1034.2) filed 11-6-96 as an emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No. 16).

7. Amendment of article heading filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day.

8. Amendment of article heading refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.

9. Amendment of article heading refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1030.5. Licensure of Clinical Chemists, Clinical Microbiologists, Clinical Toxicologists, Clinical Genetic Molecular Biologists and Clinical Cytogeneticists.

Note • History

A written and oral examination shall be given to each applicant for licensure as a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist or clinical cytogeneticist. In addition to the requirements for licensure as specified in Section 1264 of the Business and Professions Code, an applicant shall have completed one year of training as a licensed trainee or equivalent in his or her specialty or subspecialty pursuant to Section 1207 of the Business and Professions Code. Also, each applicant shall have completed three years of experience in his or her specialty pursuant to Section 1210 of the Business and Professions Code in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in that specialty, two years of which shall have been at a supervisory level.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1204, 1205, 1207, 1210, 1264 and 1265, Business and Professions Code.

HISTORY

1. New section filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

2. Certificate of Compliance--Sec. 11422.1, Gov. Code, filed 1-20-71 (Register 71, No. 4).

3. Amendment of section heading, section and Note filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section heading, section and Note refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section heading, section and Note refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1030.6. Licensure of Clinical Cytogeneticists.

Note • History

(a) Except for a clinical laboratory bioanalyst licensed by the department who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, or a pathologist who meets the laboratory director qualifications in Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of clinical cytogenetics within the specialty of genetics shall possess a valid clinical cytogeneticist license issued by the department.

(b) In order to be eligible for licensure as a clinical cytogeneticist, an applicant shall:

(1) Be a physician and surgeon licensed by the State to practice medicine pursuant to Chapter 5 of the Business and Professions Code, and have:

(A) Two years' training in clinical cytogenetics in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Business and Professions Code, Chapter 3, and

(B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and

(C) Evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and

(D) Demonstrated satisfactory performance on an oral examination regarding Business and Professions Code, Chapter 3, and Title 42, CFR, Part 493, as published October 1, 1994; or

(2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with thirty semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and

(A) Have two years' training in clinical cytogenetics in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3, of Business and Professions Code; and

(B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical cytogenetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and

(C) Provide evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and

(D) Have demonstrated satisfactory performance on the oral examination administered by the Department regarding Business and Professions Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as published October 1, 1994; or

(3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of cytogenetics on or before December 31, 1997 and either;

(A) Meet the laboratory director qualifications of Section 493.1443(b)(2) or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or

(B) Hold an earned doctoral degree, have four years' clinical cytogenetics training or experience in a clinical laboratory certified by HCFA in clinical cytogenetics, and provide evidence of satisfactory performance on a written certifying examination in cytogenetics administered by the ABMG or the CCMG.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of subsections (b)(1)(B) and (b)(2)(B), transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1030.7. Licensure of Clinical Genetic Molecular Biologists.

Note • History

(a) Except for a clinical laboratory bioanalyst licensed by the department pursuant to Business and Professions Code, Chapter 3, who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, and a pathologist who meets the laboratory director qualifications in Section 493.1443 of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of molecular biology related to the diagnosis of abnormalities related to human genetic disorders shall possess a valid clinical genetic molecular biologist license issued by the department.

(b) In order to be eligible for licensure as a clinical genetic molecular biologist, an applicant shall:

(1) Be a physician and surgeon licensed by the State, pursuant to Chapter 5 of the Business and Professions Code, to practice medicine and have:

(A) Two years of training in clinical genetic molecular biology in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Chapter 3 of the Business and Professions Code; and

(C) Evidence of satisfactory performance on a written examination in genetic molecular biology administered by the ABMG or CCMG or the department; and

(D) Demonstrated satisfactory performance on an oral examination administered by the department regarding Chapter 3 of the Business and Professions Code and Part 493 of Title 42, Code of Federal Regulations, as published October 1, 1994; or

(2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with 30 semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and

(A) Have two years' training in clinical genetic molecular biology in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3 of Business and Professions Code; and

(B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical genetic molecular biology in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and

(C) Provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG or the department; and

(D) Have demonstrated satisfactory performance in the oral examination regarding Chapter 3 of Business and Professions Code and Part 493 of Title 42 Code of Federal Regulations as published October 1, 1994; or

(3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities on or before December 31, 1997, and either:

(A) Meet the qualifications of Section 493.1443(a), (b)(2), or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or

(B) Hold an earned doctoral degree, have four years' clinical genetic molecular biology training or experience in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of molecular biology, and provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1030.8. Licensure of Oral Pathology Laboratory Directors.

Note • History

(a) Except for a pathologist who meets the laboratory director qualifications of Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of an oral pathology laboratory shall possess a valid oral pathology laboratory director license issued by the department.

(b) In order to be eligible for licensure as an oral pathology laboratory director, an applicant shall:

(1) Be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and have:

(A) Advanced training in oral and maxillofacial pathology in a training program approved by the American Dental Association (ADA) Committee on Accreditation of Dental and Dental Auxiliary Education Programs in an educational institution; and

(B) Full time experience in oral pathology which, together with advanced training approved by the ADA, shall total a minimum of four years; and

(C) Evidence of satisfactory performance on the oral pathologist certification examination administered by the American Board of Oral Pathology (ABOP); and

(D) Demonstrated satisfactory performance on an oral (verbal) examination administered by the department regarding Chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 as published October 1,1994; or

(2) Have served as a laboratory director of an oral pathology laboratory on or before January 1, 1996, and be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and provide evidence of satisfactory performance on a certifying examination in oral and maxillofacial pathology administered by the ABOP.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208, 1209 and 1264, Business and Profession Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section heading and section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1031. Licensure of Clinical Laboratory Specialists.

Note • History

(a) The minimum requirements for admission to the limited scientist examinations shall be as follows:

(1) An applicant for admission to the examination for a clinical chemist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including courses in analytical chemistry and instrumentation. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of chemistry, as listed in (b)(1) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of chemistry.

(2) An applicant for admission to the examination for a clinical microbiologist scientist shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in microbiology or an equivalent major which shall include at least 25 semester or 38 quarter units in microbiology including courses in medical or pathogenic microbiology or bacteriology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of microbiology, as listed in (b)(2) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology.

(3) An applicant for admission to the examination for a clinical immunohematologist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in biology, clinical laboratory science or equivalent major which shall include at least 25 semester or 38 quarter units in biology, including genetics and immunology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of immunohematology, as listed in (b)(3) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of immunohematology.

(4) An applicant for admission to the examination for clinical toxicologist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including analytical chemistry or quantitative analysis. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by a college or university from an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experience in the specialty of toxicology, as specified in (b)(4) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of toxicology.

(5) An applicant for admission to the examination for a clinical hematologist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate degree from an accredited college or university in biology, clinical laboratory science or an equivalent major which shall include at least 25 semester or 38 quarter units in biology, including hematology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and

(B) Have one year of post-baccalaureate training or experience in all areas of the specialty of hematology, as specified in (b)(5) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of hematology.

(b) Any license issued under this section shall specify the particular specialty or subspecialty in which the licentiate may perform tests under such license. A license issued for:

(1) A clinical chemist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of chemistry, including routine chemistry, clinical microscopy, endocrinology and toxicology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.

(2) A clinical microbiologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of microbiology including bacteriology, mycobacteriology, mycology, parasitology, and virology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.

(3) A clinical immunohematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of immunohematology including ABO/Rh Type or Group, unexpected antibody detection, compatibility testing and antibody identification.

(4) A clinical toxicologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the subspecialty of toxicology.

(5) A clinical hematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of hematology including routine hematology and coagulation.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code.

HISTORY

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

2. Amendment filed 6-13-69; effective thirtieth day thereafter (Register 69, No. 24).

3. Amendment filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

4. Certificate of Compliance--Sec. 11422.1, Gov. Code. filed 1-20-71 (Register 71, No. 4).

5. Amendment of section heading, section and Note filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day.

6. Amendment of section heading, section and Note refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.

7. Amendment of section heading, section and Note refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1031.1. Licensure of Clinical Histocompatibility Scientists.

Note • History

(a) Each person performing high complexity laboratory tests or examinations in the subspecialty of histocompatibility in a licensed clinical laboratory shall possess a valid clinical histocompatibility scientist license except for the following persons:

(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of the Business and Professions Code; or

(2) A histocompatibility laboratory director licensed pursuant to chapter 3 of the Business and Professions Code; or

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3 of the Business and Professions Code; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3 of the Business and Professions Code.

(b) In order to be eligible for licensure as a clinical histocompatibility scientist an applicant shall have been certified as a Clinical Histocompatibility Technologist by the American Board of Histocompatibility and Immunogenetics, either:

(1) Prior to January 1, 1997 and have had at least 6 years' experience in all areas of clinical histocompatibility testing in a clinical laboratory, or

(2) After January 1, 1997 and have a baccalaureate degree in biological or clinical science and one year of clinical laboratory experience in all areas of clinical histocompatibility testing in a clinical laboratory.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1031.2. Licensure of Clinical Cytogeneticist Scientists.

Note • History

(a) Each person performing high complexity tests or examinations in the specialty of cytogenetics in a licensed clinical laboratory shall possess a valid clinical cytogeneticist scientist license except for the following persons:

(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or

(2) A clinical cytogeneticist licensed to direct a cytogenetics laboratory pursuant to chapter 3; or

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3.

(b) In order to be eligible for licensure as a clinical cytogeneticist scientist, an applicant shall:

(1) Hold a baccalaureate or an equivalent or higher degree, which shall include at least 25 semester or 38 quarter hours in biology, chemistry or clinical laboratory science from an accredited college or university, and

(2) Provide evidence of satisfactory performance on a written examination in the specialty of cytogenetics administered by the National Credentialing Agency for Laboratory Personnel (NCA), prior to October 23, 2009, or by the American Society for Clinical Pathology (ASCP), on or after October 23, 2009, and either:

(A) On or after March 14, 2003, have completed at least one year of training and/or experience in clinical cytogenetics in a clinical laboratory certified by the Centers for Medicare and Medicaid Services (CMS) in clinical cytogenetics. This training shall be approved by the department pursuant to Section 1035 and acceptable for admission to an examination administered by the NCA prior to October 23, 2009, or by the ASCP on or after October 23, 2009, in the specialty of cytogenetics; or

(B) Prior to March 14, 2003, have completed training and/or experience in clinical cytogenetics, acceptable for admission to an examination in the specialty of cytogenetics administered by the NCA, or on or after October 23, 2009, by the ASCP. Such training and/or experience shall have been obtained in a clinical laboratory certified by CMS in clinical cytogenetics or in histopathology (cytogenetics).

NOTE

Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions Code; and Sections 100275 and 131200, Health and Safety Code. Reference: Sections 1203, 1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business and Professions Code; and Sections 131050 and 131051, Health and Safety Code.

HISTORY

1. New section filed 3-13-2003 as an emergency; operative 3-13-2003 (Register 2003, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2003 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL 7-10-2003 and filed 8-21-2003 (Register 2003, No. 34).

3. Change without regulatory effect amending subsections (b)(2)-(b)(2)(B) and Note filed 4-7-2010 pursuant to section 100, title 1, California Code of Regulations (Register 2010, No. 15).

§1031.3. Licensure of Clinical Genetic Molecular Biologist Scientists.

Note • History

(a) Each person performing high complexity tests or examinations in the subspecialty of genetic molecular biology in a licensed clinical laboratory shall possess a valid clinical genetic molecular biologist license except for the following persons:

(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or

(2) A clinical genetic molecular biologist licensed to direct a genetics laboratory pursuant to chapter 3; or

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3.

(b) In order to be eligible for licensure as a clinical genetic molecular biologist scientist, an applicant shall hold a baccalaureate or an equivalent or higher degree in a biological or clinical laboratory science, or field related to genetics from an accredited college or university; and

(1) Have completed at least one year training and/or experience in clinical genetic molecular biology in a clinical laboratory certified by the Center for Medicare & Medicaid Services (CMS), performing high complexity testing in clinical genetic molecular biology. This training and/or experience shall be acceptable for admission to an examination administered by the National Credentialing Agency for Laboratory Personnel (NCA) or the American Society for Clinical Pathology (ASCP) in the specialty of molecular biology. On or after March 14, 2003, this training shall be approved by the department pursuant to Section 1035; and

(2) Provide evidence of satisfactory performance on a written examination in molecular biology administered by the NCA prior to October 23, 2009, or the ASCP on or after October 23, 2009.

NOTE

HISTORY

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL 7-10-2003 and filed 8-21-2003 (Register 2003, No. 34).

3. Change without regulatory effect amending subsections (b)(1)-(2) and Note filed 4-7-2010 pursuant to section 100, title 1, California Code of Regulations (Register 2010, No. 15).

§1031.4. Requirements and Timeframes for Applications for Licensure and Certification.

Note • History

(a) Applications for admission to a state-administered licensing examination shall be complete when the information specified in Section 1031.4(b) has been received by the department. For an applicant to be eligible for a scheduled examination, the completed application must be postmarked at least 120 days prior to the examination date as published by the Department of Health Services. When applying for admission to the examination, the applicant shall state whether he or she has previously applied to the department for admission to an examination.

(b) An application for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations under Chapter 3 shall be considered complete when the following is provided to the department:

(1) Name and address of the applicant, including city, state and zip code; and

(2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and

(3) Gender and birthdate; and

(4) License for which the applicant is applying; and

(5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and

(6) Documentation of the applicant's education including:

(A) Name, address, major course of study, dates of attendance, number of credits, and degree/completion date for all colleges and universities attended by the applicant; and

(B) Official transcripts from the registrar of all accredited colleges or universities attended by the applicant showing all courses, course credits, degrees conferred and date of conference; and

(C) Official transcripts from non-United States colleges or universities which are not in English shall be returned to the applicant to obtain translation from a translation service approved in the United States for legal or government documents.

(7) Documentation of the applicant's training including:

(A) Name and address of training program, dates of training, specialty and subspecialty areas of training, length of time in each specialty and subspecialty area of training; and

(B) Signed documentation from the training program director that this training has been successfully completed; and

(8) Documentation of the applicant's experience, appropriate to the specific license for which the applicant is applying, including the following:

(A) Facility name, address, dates of employment, number of hours per week employed, the specialties and subspecialties in which clinical laboratory tests or examinations were performed and a description of clinical laboratory tests or examinations performed; and

(B) Signed documentation of such experience from the director of the laboratory; and

(9) Evidence of satisfactory performance on a licensing examination pursuant to Section 1029.81; and

(10) Signature of the applicant, telephone number and date of application; and

(11) Payment of license application fee pursuant to Business and Professions Code Section 1300.

(c) An application for certification in phlebotomy shall be considered complete when the following is provided to the department:

(1) Name and address of the applicant, including city, state and zip code; and

(3) Gender and birthdate; and

(4) Category of phlebotomy certification for which the applicant is applying; and

(5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and

(6) Documentation of the applicant's education including:

(A) Name, address, dates of attendance, coursework completed and graduation as verified by official school transcripts; or

(B) Documentation of a passing score on the general educational development (GED) test or equivalent education as evaluated by the American Association of Collegiate Registrars and Admissions Officers for secondary education; or

(C) For official school transcripts which are not in English, documentation of equivalent education as obtained through translation into English from a translation service approved in the United States for legal or government documents; and

(7) Certification of the applicant's instruction in phlebotomy as specified in Section 1035.1(h); and

(8) Certification of the applicant's on-the-job experience in phlebotomy, if applicable, including:

(A) Name and address of laboratory where employed, dates of employment, number of hours of experience in techniques specified in Section 1035.1(f) and an estimate of the number of skin punctures, venipunctures or arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfills all the sampling requirements of all clinical laboratory tests or examinations; and

(B) Signed documentation from the director of the laboratory that the above information accurately represents the applicant's experience in phlebotomy; and

(9) Evidence of satisfactory performance on a certification examination in phlebotomy administered by a certifying organization that was approved by the department pursuant to Section 1031.7 at the time the examination was administered; and

(10) Signature of the applicant, telephone number and date of application; and

(11) Payment of a two-year certification fee of $50.

(d) Timeframes for processing applications for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations or for certification to perform phlebotomy pursuant to Chapter 3 shall be as follows:

(1) The department shall notify the applicant in writing, within 90 days of receipt of an application, of one of the following:

(A) The application is complete and will be processed by the department; or

(B) The application is incomplete and not accepted for processing. The department's written notification shall include the specific information, documentation or fee in which the application is deficient; or

(C) The application has been reviewed and does not meet the requirements and that approval is denied. The department shall give written notification of the basis for the denial.

(2) The department shall notify the applicant within 90 days of postmark date of resubmission of application requirements pursuant to Section 1031.4(d)(1)(B) whether the application has been approved or denied.

(3) Written notification by the department to applicants shall be deemed to occur on the date of the postmark from the department.

(4) The department shall deem an application abandoned by an applicant who fails to respond or to supply all information, documents, verifications or payment of applicable fees within 30 days of notification by the department.

(5) The department's time periods for processing an application for licensure or certification from the date the application is complete to the date the final decision is made regarding an approval are as follows:

(A) The median time for processing an application is 90 days;

(B) The minimum time for processing an application is 30 days; and

(e) Certification shall be valid for a period of 2 years unless revoked.

(f) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.

(g) All applicants, licensees and certificants pursuant to Section 1031.4 shall notify the department in writing of any change(s) of name and /or address within 30 days after the change(s) has occurred.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 17520, Family Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1220, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301, 1301.1 and 1320, Business and Professions Code; Section 120580, Health and Safety Code; and Section 15376, Government Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section and Note, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

5. Amendment of section heading, section and Note filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1031.5. Requirements and Timeframes for Renewal of Licenses and Certificates.

Note • History

(a) In order to maintain a license in active status, licenses shall be renewed by filing a renewal application within 60 days prior to the end of the license period.

(b) A complete license renewal application shall include name and address of the licensee, license number, current work location(s), documentation of continuing education credits, an attestation stating whether the licensee has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, license renewal fee, signature and date of application for renewal.

(c) In order to maintain a phlebotomy certificate in active status, certificates once approved shall be renewed at biennial intervals by filing a renewal application within 60 days prior to the end of the certificate period.

(d) A complete phlebotomy certificate renewal application shall include name and address of the certificant, certificate number, current work location(s), documentation of continuing education performed during the previous 24 months, an attestation stating whether the certificant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, certification renewal fee of $50, signature and date of application for renewal.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1226, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301 and 1301.1, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

5. Amendment of section heading, section and Note filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1031.7. Conditions for Approval of Certifying Organizations to Administer Phlebotomy Certification Examinations.

Note • History

(a) In order for a certifying organization to be eligible for approval by the department to administer a phlebotomy certification examination for state certification purposes, the certifying organization shall meet the following conditions:

(1) The certifying organization shall be a national, independent, not-for-profit, professional certifying organization; and

(2) The certifying organization shall offer examinations in phlebotomy; and

(3) The certifying organization shall provide the following to the department:

(A) The organization's name and address; and

(B) Names of the organization's officers and board of directors; and

(D) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and

(E) A schedule of dates and times that the examination will be conducted within the state; and

(F) Listing of procedures for monitoring the content, quality, validity and relevance of the phlebotomy examinations pursuant to Section 1031.7 (b); and

(G) The philosophy of the organization, demonstrating a commitment to accurate assessment of a candidate's preparation for phlebotomy certification.

(b) In order for a certifying organization's examination to be approved for certification purposes, the organization shall document the following standards to support a request for approval:

(1) Evaluation of relevant standards in phlebotomy and how the organization's examinations address knowledge and skills that would assure competence of the candidate; and

(2) Explanation of how the examinations are developed by the organization and the qualifications of person(s) who develop the examination questions; and

(3) Documentation that the organization's examinations are subject to annual review for current relevance; and

(4) Demonstration of the ability of the organization to evaluate its examinations, subjecting the examinations to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least once yearly or upon request to the department.

(1) Agree to make the content of its examinations available to the department for confidential review; and

(2) Demonstrate how it will maintain security during administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and

(3) Document how it will make its records accessible to the department regarding those persons participating in the examination and their scores; and

(4) Provide verification of those persons successfully passing the certification examination to the department and shall maintain these records for five years; and

(5) Issue a certificate to those passing the examination with the examinee's name, name of the certifying organization, type of certificate, effective date and official signature.

(d) Timeframes for processing applications for approval of a certifying organization's certification examination shall be as follows:

(1) Within 90 calendar days of receipt of an application, the department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application.

(2) Within 180 calendar days from the date of filing a completed application, the department shall inform the applicant certifying organization in writing whether the organization has been approved or denied as a certifying organization for the administration of the certification examination.

(3) The department shall deem an application abandoned by an applicant certifying organization that fails to respond or to supply all information, documents, or verifications within 30 days of notification pursuant to Section 1031.7(d)(1).

(4) The department's time periods for processing an application for approval as a certifying organization, from the receipt of the initial application to the final decision regarding the approval, are as follows:

(A) The median time for processing is 180 calendar days.

(B) The minimum time for processing is 90 calendar days.

(e) Approval shall be valid for a period of four years unless revoked.

(f) To apply for renewal, a certifying organization shall file a renewal application at least 120 days prior to the end of the approval period providing the following:

(1) The name and address of the certifying organization; and

(2) Names of the organization's officers and board of directors; and

(3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and

(4) A schedule of dates and times that the examination will be conducted within the state for the next 12 months; and

(5) A copy of the current examination; and

(6) Signature of the program director and date of application for renewal.

(g) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.

(h) A certifying organization shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (c) within 30 days after the change(s) has occurred.

NOTE

Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1031.8. Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes.

Note • History

(a) In order for a certifying organization to be eligible for approval by the department to administer a category of certifying examination, the organization shall file a complete application that consists of the following:

(1) Documentation that the certifying organization is a national, independent, not-for-profit, professional certifying organization; and

(2) The organization's name and address; and

(3) Names of the organization's officer(s) and board of directors; and

(4) Description of the organization's structure and organizational chart; and

(5) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of examination activities; and

(6) A mission statement that demonstrates the philosophy of the certifying organization commits to an accurate assessment of a candidate's preparation in the clinical laboratory science category in which the candidate is examined; and

(7) Schedule of dates that the examination will be available to California licensure applicants during the next four years; and

(8) Listing of procedures for monitoring the content, quality, validity, reliability and relevance of the examination in the specialty being tested, and

(9) Demonstration of how the organization's examination addresses the relevant standards in the clinical laboratory science category being examined, and how it evaluates the knowledge and skills that would assure competence of the candidate; and

(10) Explanation of how the examination structure is developed by the organization, and the qualifications of person(s) who develop the examination questions; and

(11) Documentation that the organization's examination is subject to annual review for current relevance; and

(12) Demonstration of the ability of the organization to evaluate its examination, subjecting it to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least annually or upon request to the department; and

(13) Explanation of how the examination is developed and weighted using a job task survey to determine knowledge and skills required to be competent in the examination category; and

(14) Explanation of how examination questions are established, evaluated and updated to match current practice for the category; and

(15) Explanation of how the cutoff score for those successfully passing the examination is determined; and

(16) Documentation of performance statistics for the examination during the previous five years, including pass/fail rate, number of applicants and number accepted to the examination for each time that the examination has been administered by the certifying organization during the five years immediately prior to the date of application, or, for specialties that have been established for less than five years, during the period dating from the establishment of the specialty to the date of the application; and

(17) Submission of printed copies of examinations given each year for the previous four years, if the examinations were offered. These examination shall be subject to confidential review by the department, shall not be copied, and shall be returned to the organization; and

(18) Submission of an agreement to provide the examination to candidates who have been approved for admission to the examination by the department; and

(19) Submission of an agreement to provide verification of those persons successfully passing the examination to the department and to maintain these records for five years; and

(20) Submission of an agreement to give evidence of satisfactory performance as official notification to those passing the examination with the examinee's name, name of the certifying organization, examination category, effective date and official signature; and

(21) Demonstration how the organization will maintain security during development and administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and

(22) Listing of procedures in use and required of the organization's personnel to ensure security and confidentiality of the examination, and steps to be taken if a breach is discovered; and

(23) An agreement that a breach of security shall be reported to the department and that the department is authorized to investigate and withdraw approval of the examination category; and

(24) Documentation how the organization will make its records accessible to the department regarding those persons participating in the examination and their scores; and

(25) The name, title, and signature of the person who is responsible for overseeing the administration and coordination of all examination activities, and the date the application was signed.

(b) Initial approval of an organization's examination category shall include confidential review of an examination given each year up to four years immediately preceding the date of approval, so that examinations taken during this time shall be acceptable for licensure purposes.

(c) Timeframes for processing applications for approval of a certifying organization's examination in a clinical laboratory science category for licensure purposes shall be as follows:

(1) The department shall notify the applicant organization within 90 days of submission of an application of one of the following:

(A) That the application is complete and acceptable for processing by the department; or

(B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or

(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.

(2) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1031.8(c)(1)(B).

(d) Written notification by the department to the applicant organization shall be considered to occur on the date the documents are postmarked,

(e) A certifying organization shall notify the department in writing of any change in the information and materials required by this section within 30 days after the change has occurred.

(f) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 1262, 1263 and 1264, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including amendment of subsections (a)(12), (a)(17), (a)(20), (a)(25) and (b) and repealer of subsection (c) with subsection relettering, transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1031.9. Conditions for Renewal of a Certifying Organization's Approval to Administer Examinations Acceptable for Licensure Purposes.

Note • History

(a) Approval of a certifying organization shall be valid for a period of four years unless revoked. At least 120 days prior to the end of the approval period, the certifying organization that wants to continue approval of its examination shall apply for reapproval. Failure to reapply 120 days in advance shall cause a lapse in approval after which time the examination would not be acceptable for licensure purposes until the certifying organization regains approval. A certifying organization that fails to reapply at least 120 days in advance and subsequently elects to seek approval shall make application pursuant to Section 1031.8.

(b) To apply for renewal of a certifying organization's approval to administer examinations, the organization shall provide the following:

(1) The name and address of the certifying organization; and

(2) Names of the organization's officer(s) and board of directors; and

(3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and

(4) A schedule of dates that the examination will be available to California applicants during the next four years; and

(5) A summary of the performance statistics of the examination during the previous approval period, including the number of California applicants applying for, and successfully passing, the certifying examination, the applicant scores, what efforts have been made to evaluate the examination and update the examination questions to match current practice for the category; and

(6) The name, title and signature of the person responsible for overseeing the administration and coordination of all examination activities and date of application for renewal.

(c) The timeframes for processing an application of a certifying organization seeking renewal of its examination approval shall be as follows:

(1) The certifying organization shall submit an application for renewal of approval of its examination at least 120 days prior to the end of the approval period.

(2) Within 30 days of receipt of a renewal application, the department shall inform the organization in writing that the renewal application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application.

(3) Within 30 days of receiving a completed renewal application, the department shall inform the applicant organization in writing whether the examination has been reapproved or denied.

(d) Failure to meet and maintain the requirements of this section shall be good cause for denial of reapproval by the department.

NOTE

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including amendment of subsections (a), (b)(6) and (c)(2), transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1032. Examination for Clinical Laboratory Technologist's License.

Note • History

With the exception as provided in Section 1262 of the Business and Professions Code, written, oral, or practical examinations shall be conducted by the department to aid it in judging the qualifications of applicants for licensure as clinical laboratory technologists. In addition to the requirements for licensure as specified in Section 1261 of the Business and Professions Code, the prerequisites for entrance into the licensing examination shall be one of the following:

(a) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and a major in clinical laboratory science, the last year of which course shall have been primarily clinical laboratory procedures in a clinical laboratory training school acceptable to the department; or

(b) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Eastern Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department plus one year as a clinical laboratory technologist trainee or the equivalent as determined by the department in a clinical laboratory acceptable to the department; provided, however, that a baccalaureate obtained after July 1, 1973, must include at least:

(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;

(2) 18 semester or equivalent quarter hours of biological science, including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology;

(3) 3 semester or equivalent quarter hours of physics, including instruction in principles of light and electricity; or

(c) A minimum of two years of experience as a licensed trainee or the equivalent as determined by the department doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory acceptable to the department and 90 semester hours or equivalent quarter hours of university or college work in which are included the following coursed, or essential equivalent as may be determined by the department: general inorganic chemistry--8; quantitative analysis--3; basic biological sciences--8; bacteriology--4; provided, however, that university or college work completed after July 1, 1973, must include at least:

(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;

(2) 18 semester or equivalent quarter hours of biological science including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology;

(3) 3 semester or equivalent quarter yours of physics, including instruction in principles of light and electricity.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1246, 1261, 1262, 1263, 2164 and 1301, Business and Professions Code.

HISTORY

1. New section filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

2. Certificate of Compliance--Sec. 11422.1, Gov. code, filed 1-20-71 (Register 71, No. 4).

3. Amendment filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 24).

§1032.5. Licensure of Medical Laboratory Technicians.

Note • History

(a) In order to qualify for licensure as a medical laboratory technician, a person shall apply for a license pursuant to Section 1031.4 (b) and meet the following requirements:

(1) Have successfully completed at least 60 semester (90 quarter) units from an accredited college or university. The coursework shall consist of at least 36 semester units of physical and biological sciences with an emphasis on applied clinical science. Coursework shall include 6 semester units of chemistry and 6 semester units of biology appropriate for transfer to a baccalaureate program in science, taken prior to, or concurrently with, training or experience; and

(2) Have met the following training or experience requirements by documenting one of the following:

(A) Graduating from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS); or

(B) Graduating from a medical laboratory technician training program approved by the department pursuant to Section 1035.3; or

(C) Meeting admission requirements for a clinical laboratory scientist licensing examination, as determined by the department pursuant to Section 1032; or

(D) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a medical laboratory technician, with evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This work experience shall include at least 480 hours in each of these specialties and shall be documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or

(E) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a clinical laboratory scientist, with evidence of satisfactory performance on an examination given by a certifying organization for clinical laboratory scientists, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This clinical laboratory scientist, also called medical technologist in some states, need not be California licensed pursuant to Business and Professions Code section 1204, but shall have work experience outside California of at least 480 hours in each of these specialties as documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or

(F) Completing a minimum of three years on-the-job practical experience within the previous five years, as a medical laboratory technician or clinical laboratory scientist in a California physician office laboratory or in a laboratory owned and operated by the United States of America. This person shall have evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians or clinical laboratory scientists, respectively, and have performed tests in the specialties of chemistry, hematology, microbiology and immunology. This work experience shall include at least 480 hours in each of these specialties, and shall be documented by the physician(s) directing the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); and

(3) Have passed a written examination for medical laboratory technicians administered by a certifying organization for medical laboratory technicians approved by the department pursuant to Section 1031.8. The department shall, for licensure purposes, accept evidence of satisfactory performance on examinations taken within the four years previous to department approval of a certifying organization's medical laboratory technician examination. The applicant shall have also passed a separate written, self-administered examination on California clinical laboratory law provided by the department. This self-administered test shall accompany the application. A minimum passage rate of 70 percent shall be required.

(b) A licensed medical laboratory technician shall be authorized to:

(1) Perform tests and examinations classified as waived and moderate complexity by Centers for Disease Control and Prevention in the specialties of chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology including coagulation; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology, with the exception of those moderate complexity tests requiring microscopy, or in the specialty of immunohematology.

(2) Perform phlebotomy, but shall not perform skin tests for specific diseases pursuant to Section 1242 of the Business and Professions Code.

(3) Perform tests and examinations under the supervision of a licensed physician and surgeon, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist, or clinical laboratory specialist licensed under Chapter 3. On-site supervision shall be required during the entire time the medical laboratory technician performs moderate complexity clinical laboratory tests or examinations. The ratio of medical laboratory technician to supervisor at the site of moderate complexity testing shall not exceed four to one.

(4) Report test results and perform phlebotomy only after competency has been documented by the laboratory director pursuant to Section 1209(e) of the Business and Professions Code.

(5) Supervise Limited Phlebotomy Technicians or Certified Phlebotomy Technician Is.

(c) The license application fee and license renewal fee for a medical laboratory technician shall be the same as the license application fee and license renewal fee for a clinical laboratory scientist pursuant to Section 1300(c) and (e) of the Business and Professions Code.

(d) A medical laboratory technician shall complete twelve hours of continuing education each year as a condition for renewal.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1204, 1206, 1206.5, 1208, 1209, 1210, 1242, 1260.3, 1261, 1275, 1300 and 1320, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including amendment of subsections (a)(3), (b)(1), (b)(3) and (b)(5), transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1033. Trainee Requirements.

Note • History

In addition to the requirements for licensure as specified in Section 1263 of the Business and Professions Code, the prerequisites for licensure as a trainee shall be as follows:

(a) Clinical Laboratory Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent agency with a baccalaureate and a major in clinical laboratory science, or a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department. An individual who is not a graduate but possesses at least 90 semester hours or equivalent quarter hours of university or college work may be licensed as a clinical laboratory technologist trainee, provided he will be granted a baccalaureate at the conclusion of 12 months of training, and have completed at least 90 semester hours or equivalent quarter hours, must have included in the college work the following courses or essential equivalent as may be determined by the department: general inorganic chemistry--8; quantitative analysis--3; basic biological sciences--8; bacteriology--4; provided, however, that university or college work completed after July 1, 1973, must include at least:

(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;

(3) 3 semester or equivalent quarter hours of physics including instruction in principles of light and electricity.

(b) Limited Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate and a major in the specialty for which licensure is sought. If the major is not designated by the college or university as one of those required under this chapter for limited technologist licenses in clinical chemistry, clinical microbiology, immunohematology, or toxicology, the department may determine the essentially equivalent major.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: sections 1246, 1261, 1262, 1263, 1264 and 1301, Business and Professions Code.

HISTORY

1. New section filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

2. Certificate of Compliance--Sec. 11422.1, Gov. Code, filed 1-20-71 (Register 71, No. 4).

3. Amendment of subsection (a) filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 24).

§1034. Certification of Phlebotomy Technicians.

Note • History

(a) The education, training and experience required for certification in phlebotomy shall be as follows:

(1) For a person to be eligible for certification as a Limited Phlebotomy Technician, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 20 hours basic didactic instruction pursuant to Section 1035.1(e)(1) from a phlebotomy training program approved by the department; and

(C) Have completed a minimum of 25 skin punctures, performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations, in a clinical setting on patients, under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, or licensed clinical laboratory scientist, who will certify in writing with a signed certificate that this training has been completed; and

(D) Apply to the department for certification as a Limited Phlebotomy Technician pursuant to Section 1031.4(c).

(2) For a person with no on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:

(A) Be a high school graduate, or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and

(C) Have completed a minimum of 40 hours practical instruction from a phlebotomy training program approved by the department pursuant to Section 1035.1(f), which instruction shall include completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).

(3) For a person who has less than 1040 hours on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and

(C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years, which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).

(4) For a person who has 1040 hours or more of on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 20 hours advanced didactic instruction pursuant to Section 1035.1(e)(2) from a phlebotomy training program approved by the department; and

(C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c).

(5) For a person to be eligible for certification as a Certified Phlebotomy Technician II, he or she shall:

(A) Be a Certified Phlebotomy Technician I who holds a current, valid certificate from the department or who meets certification requirements as a Certified Phlebotomy Technician I pursuant to Section 1034(a)(4)(A)-(D) and who has at least 1040 hours on-the-job experience in phlebotomy in the previous 5 years as certified in writing by the director(s) of the laboratory(ies) employing the person; and

(B) Have completed a minimum of 20 arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and performed under the general overall responsibility of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, respiratory care practitioner or a licensed clinical laboratory scientist, who will certify in writing that this person has completed this practical instruction; and

(b) Performance of phlebotomy by a person certified by the department shall be limited as follows:

(1) A Limited Phlebotomy Technician shall perform skin punctures only when he or she:

(A) Maintains a current, valid certification with the department as a Limited Phlebotomy Technician; and

(B) Performs skin punctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures and other duties related to blood collection performed by the Limited Phlebotomy Technician. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation when blood is being collected; and

(C) Is shown to be competent to perform skin punctures after employment without direct and constant supervision before being allowed to perform skin puncture on patients. Documentation of competency shall be done at least annually; and

(D) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and

(E) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Limited Phlebotomy Technician. When performing skin punctures away from the posted location, the Limited Phlebotomy Technician shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Limited Phlebotomy Technician.

(2) A Certified Phlebotomy Technician I shall perform skin punctures and venipunctures only when he or she:

(A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician I; and

(B) Performs skin punctures and venipunctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be a person licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures, venipunctures and other duties related to blood collection performed by the Certified Phlebotomy Technician I. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation as needed; and

(C) Is shown to be competent to perform skin puncture and venipuncture after employment without direct and constant supervision before being allowed to perform skin punctures or venipunctures on patients. Documentation of competency shall be done at least annually; and

(E) Has posted at the work location of the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician I. When performing skin punctures or venipunctures away from the posted location, the Certified Phlebotomy Technician I shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician I.

(3) A Certified Phlebotomy Technician II shall perform skin punctures and venipunctures only under conditions pursuant to Section 1034(b)(2), and shall be limited to performing arterial punctures only when a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner is present at the location during performance of an arterial puncture, and when he or she:

(A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician II; and

(B) Is shown to be competent to perform arterial punctures after employment by direct, personal observation and documentation of his or her expertise in arterial punctures by a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner. Documentation of competency shall be done at least annually; and

(C) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and

(D) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician II. When performing arterial punctures, skin punctures, or venipunctures away from the posted location, the Certified Phlebotomy Technician II shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician II.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1220, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. Amendment filed 7-2-73 as an emergency; effective upon filing (Register 73, No. 27). For prior history, see Register 72, No. 32.

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43).

3. Amendment filed 1-18-74; effective thirtieth day thereafter (Register 74, No. 3).

4. Amendment filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50).

5. Repealer and new section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1034.1. Unlicensed Personnel, Laboratory Aides.

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code.

HISTORY

1. New section filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 24).

2. Repealer of section and new Note filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1034.2. Unlicensed Personnel, Cytotechnologist.

Note • History

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 208, Health and Safety Code. Reference: Section 1270, Business and Professions Code; Section 1002, Health and Safety Code.

HISTORY

1. Amendment filed 12-12-78; effective thirtieth day thereafter (Register 78, No. 50). For prior history, see Register 74, No. 18.

2. Repealer filed 11-18-93 as an emergency; operative 11-18-93 (Register 93, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-18-94 or emergency changes will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 11-18-93 order transmitted to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 17).

Article 2. Training

§1035. Training Schools.

History

(a) Any person operating a school or conducting any course for the purpose of training or preparing individuals for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code shall submit, on forms provided by the department and subject to periodic renewal, such information as may be required by the department to satisfactorily evaluate the personnel, equipment, quality of instruction, and scope of activities of said schools.

(b) Persons providing instruction in general or specialized technic shall provide training which when successfully completed will fully qualify individuals to meet the minimum requirements for licensure under the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code.

(c) A training school shall accept a person licensed for training in clinical laboratory procedures only if there are on active duty in the laboratory a minimum of two full-time actively employed persons who possess any of the following licenses: clinical laboratory technologist, clinical laboratory bioanalyst, physician and surgeon, or appropriate laboratory specialty.

(d) The ratio of licensed clinical laboratory personnel to trainees shall be no less than 2:1.

(e) The following shall be minimum requirements for approval of laboratories to employ clinical laboratory technologist trainees as provided for in Article 2 of Chapter 3, Division 2 of the Business and Professions Code:

(1) There shall be adequate space and necessary equipment as defined by the department to carry out the procedures of the laboratory and to provide training for the clinical laboratory technologist trainees.

(2) The workload of the laboratory training clinical laboratory technologist trainees shall meet minimum standards set by the department and shall include at least the following: routine chemical determinations commonly required on blood, spinal fluid, and other body fluids; morphological, cultural, chemical and immunological tests for microbial pathogens; tests for helminths and protozoa; examinations for normal and abnormal blood cells; sedimentation rates, bleeding and coagulation time determinations and other commonly employed tests in hematology; precipitation, flocculation, agglutination or complement fixation tests; blood typing, Rh factor determinations and pretransfusion procedures; commonly employed serological tests; routine and microscopic urinalyses and such other technics as may be required to properly instruct clinical laboratory technologist trainees in current clinical laboratory procedures.

(3) The amount of practical training required by each clinical laboratory technologist trainee in order to fulfill the minimum requirements for admission to the licensing examinations shall be in accordance with the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code. When one year of practical training in all subjects is necessary, the minimum time devoted to each shall be as follows:

Biochemistry 12 Weeks

Hematology 8 Weeks

Pretransfusion Procedures 4 Weeks

Urinalysis 4 Weeks

Bacteriology 9 Weeks

Serology 4 Weeks

Parasitology 3 Weeks

Miscellaneous and review 8 Weeks

(4) When less than one or more than one year of practical training is required toward admission to the clinical laboratory technologists' examination, the above time devoted to the various subjects shall be decreased or increased proportionately after the laboratory director has secured approval from the department for the modification.

(5) However, when one or more years of practical training in any one basic science or specialty is necessary, the laboratory director shall modify this schedule, subject to prior approval by the department, so that the area of concentration is in one or more subjects.

(6) Unless a trainee is a college graduate, he must receive during the course of his training program a minimum of 40 clock hours of recitation or instruction in the subjects covered in clinical laboratory work other than that received as practical training in the laboratory. Any laboratory school approved for specialist or limited technologist training must provide the department with adequately documented workload and program information and must comply with the minimum requirements heretofore stated in that special field of training.

(7) The requirements for the members of the teaching staff must be those considered minimum for licensure, and in addition, persons with an advanced degree in one or more of the fields covered in the curriculum may be included on the teaching staff.

(8) The director of any school shall supply sufficient information to the department to satisfy the department that adequate specimen material will be made available for training purposes.

(9) There shall be available to persons receiving training a technical library adequate in the number of copies of each text book.

(10) The names and addresses of persons receiving training are to be reported to the department at the time of entrance to course and again at completion of course.

(11) The department may require such other information as may be necessary to satisfactorily evaluate the application for approval including periodic on-site reviews.

(12) Approval for training granted by the department pursuant to requirements of this section may be denied or withdrawn if the school is unable to meet or maintain these requirements.

(f) Colleges or universities accredited by the Western College Association or the Northwest Association of Secondary and Higher Schools or an essentially equivalent accrediting agency, as determined by the department, conducting courses for the purpose of training or preparing persons for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code, shall be considered approved by the department. Provided, however, that when such training is carried out in cooperation with other laboratories than those of said institutions, specific approval shall be obtained.

HISTORY

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

3. Amendment filed 5-18-64; effective thirtieth day thereafter (Register 64, No. 11).

4. Repealer and new section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).

§1035.1. Phlebotomy Training Program Requirements.

Note • History

(a) In order to be eligible for approval by the department to provide didactic and/or practical phlebotomy instruction leading to certification of phlebotomists, a phlebotomy training program shall meet the requirements of this section and be offered by either a:

(1) National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) approved program for training phlebotomists; or

(2) Accredited college or university; or

(3) Private, post-secondary program or occupational program registered or approved by the Bureau for Private Postsecondary and Vocational Education; or

(4) California Adult Education or Regional Occupational Program (ROP); or

(5) United States of America military medical laboratory specialist program; or

(6) California licensed clinical laboratory.

(b) A phlebotomy training program shall be directed by a licensed physician and surgeon, licensed physician assistant, registered nurse, or person licensed under Chapter 3, who shall be responsible for:

(1) Overall operation and administration of the phlebotomy training program; and

(2) Ensuring the quality of the technical, scientific and clinical instruction; and

(3) Ensuring that the person(s) providing instruction meets the qualifications of this section; and

(4) Ensuring that the person(s) providing instruction is competent and that his or her work performance is periodically evaluated, monitored and documented.

(1) Licensed physician and surgeon; or

(2) Licensed physician assistant; or

(3) Registered nurse; or

(4) Person licensed under Chapter 3; or

(5) Respiratory care practitioner with a minimum of 2 years experience in the previous 5 years; or

(6) Certified phlebotomy technician with a minimum of 3 years of experience in the previous 5 years or a phlebotomist with 3 years of experience in the previous 5 years and employed as a phlebotomy instructor, who shall meet certification requirements pursuant to Section 1034(a)(4) on or before December 31, 2003.

(d) Person(s) specified in Subsection (c)(1) through (5) shall pass a written examination in phlebotomy, administered by a certifying organization approved by the department pursuant to Section 1031.7 either:

(1) Prior to employment by a phlebotomy training program approved by the department pursuant to this section; or

(2) No later than December 31, 2003, if employed as a phlebotomy instructor on or before April 9, 2003.

(e) An approved phlebotomy training program shall provide the following didactic instruction to its students:

(1) A basic phlebotomy curriculum consisting of a minimum of 20 hours lecture and testing for knowledge of:

(A) Basic infection control, universal precautions and safety; and

(B) Basic anatomy and physiology of body systems with emphasis on the circulatory system, the appropriate medical terminology; and

(D) Proper selection and preparation of skin puncture site, including selection of antiseptic; and

(E) Blood collection equipment, types of tubes and additives, proper order of draw when additives are required, special precautions; and

(F) Post-puncture care; and

(G) Appropriate disposal of sharps, needles and waste.

(2) An advanced phlebotomy curriculum consisting of a minimum of 20 hours of lecture and testing for knowledge of:

(A) Advanced infectious disease control and biohazards; and

(B) Anti-coagulation theory; and

(D) Anatomical site selection and patient preparation; and

(E) Risk factors and appropriate responses to complications which may arise from phlebotomy; and

(F) Recognition of, and corrective actions to take, with problems in test requisitions, specimen transport and processing; and

(G) Applications of basic concepts of communication, interpersonal relations, stress management, professional behavior, ethics and legal implications of phlebotomy; and

(H) Quality assurance in phlebotomy necessary to provide accurate and reliable laboratory test results; and

(I) Legal issues related to blood collection.

(f) An approved phlebotomy training program shall provide a clinical setting for a minimum of 40 hours of practical instruction in phlebotomy. This setting shall provide access to patients whose blood is being tested by a clinical laboratory. In order for a program to be eligible for approval by the department, it shall provide documentation of a training curriculum that includes:

(1) Selection of blood collection equipment appropriate to test requisitions; and

(2) Preparation of the patient and infection control; and

(3) Skin punctures for testing purposes from patients of varying ages, including pediatric and geriatric, and of varying health and obesity status; and

(4) Venipunctures from patients of varying ages, health and obesity status; and

(5) Post-puncture care; and

(6) Processing of blood containers after collection, including centrifugation; and

(7) Proper disposal of needles, sharps and medical waste; and

(8) Observation of arterial punctures; and

(9) A practical examination showing evidence of successful completion of Subsections (f)(1) through (7).

(g) A phlebotomy training program shall be responsible for assuring that a student completes a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations during or after his or her practical instruction.

(h) A phlebotomy training program shall provide a certificate of completion to its students upon satisfactory completion of the program. The program shall maintain a copy of this certificate for five years. This certificate shall be signed by the director of the program and shall include:

(1) Name and address of the training program; and

(2) Name of the student; and

(3) Statement of satisfactory completion of the program; and

(4) Dates that training began and ended.

(i) A phlebotomy training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section. Verification may include an on-site inspection of the program.

(j) A complete application for phlebotomy training program approval shall include the following:

(1) Name and address of the training program; and

(2) Location(s) of all sites where didactic and practical instruction occur; and

(3) Name(s) and license number(s) of the physician and surgeon, physician assistant, registered nurse, or person licensed under Chapter 3 who is directing the program; and

(4) Name(s), license number(s) or certificate number(s), experience in phlebotomy, and evidence of satisfactory performance on a phlebotomy certification examination administered by a certifying organization with departmental approval in effect at the time the examination was administered, of every physician and surgeon, physician assistant, registered nurse, person licensed under Chapter 3, respiratory care practitioner, certified phlebotomy technician, or phlebotomist pursuant to Subsection (c)(6) who is supervising or providing instruction; and

(5) List of equipment, supplies and educational materials used for instruction; and

(6) Curriculum and instructional objectives, including hours spent at each activity.

(k) Timeframes for approval of training programs shall be as follows:

(1) Submission of an application for approval shall be deemed to occur on the date the complete application is received by the department.

(2) Written notification by the department to the applicant shall be considered to occur on the date the documents are postmarked.

(3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following:

(A) That the application is complete and acceptable for processing by the department; or

(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.

(4) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.1(k)(3)(B).

(5) The department's time periods for processing an application, from the date the initial application is received to the date the final decision is made regarding approval, are as follows:

(A) The median time for processing an application is 90 days.

(B) The minimum time for processing is 30 days.

(l) Approval shall be valid for a two-year period.

(m) To apply for renewal, a training program shall file a renewal application at least 60 days prior to the end of the approval period and provide the following:

(1) The name and address of the training program; and

(2) The name and license number of all directors; and

(3) The name, license or certificate number of all instructors; and

(4) The name(s) and location(s) of all didactic and practical instruction; and

(5) The curriculum and instructional objectives, including hours spent at each activity; and

(6) The schedule of didactic and practical instruction for the next 24 months; and

(7) The listing of students who completed its program and the total number of students who enrolled in its program in the previous approval period; and

(8) The signature of the director(s) and date of the application for renewal.

(n) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.

(o) The training program shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (h) within 30 days after the change(s) has occurred.

NOTE

Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220, 1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code; and Section 120580, Health and Safety Code.

HISTORY

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1035.3. Medical Laboratory Technician Training Program Standards.

Note • History

(a) In order to be eligible for approval by the department, a medical laboratory technician training program shall be offered by either a:

(1) California licensed clinical laboratory; or

(2) Accredited college or university in the United States of America; or

(3) United States of America military medical laboratory specialist program of at least 26 weeks duration; or

(4) Laboratory owned and operated by the United States of America.

(b) The program director of a medical laboratory technician training program shall be a physician and surgeon licensed under Chapter 5, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist or clinical laboratory specialist licensed under Chapter 3. The program director shall be responsible for the content, quality and conduct of the training program and shall:

(1) Employ instructors who are physicians and surgeons licensed under chapter 5; doctoral scientists, clinical laboratory bioanalysts, clinical laboratory scientists, or clinical laboratory specialists licensed under chapter 3; medical laboratory technicians with five years practical experience licensed under Chapter 3; or public health microbiologists certified pursuant to Health and Safety Code Section 101160.

(2) Assure that training includes at least 26 weeks, consisting of at least 1040 hours, of instruction and practical experience in moderate complexity testing in chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology. The training shall include at least 160 hours each in chemistry, hematology, microbiology and immunology.

(3) Provide didactic training in:

(A) Pre-analytical skills including phlebotomy, specimen processing, reagent preparation, and infection control, as specified in Section 1035.1(e) and (f); and

(B) Analytical skills required for performing tests of waived or moderate complexity, including quality control, test calibration, quality assurance, legal requirements for documentation of testing, data storage and retrieval, safety and standard precautions, troubleshooting, preventive maintenance, reagent preparation and storage; and

(C) Post-analytical skills such as knowledge of factors that influence test results and the ability to access and verify the validity of patient test results through review of quality control values prior to reporting patient test results; and

(D) Test methods commonly used in chemistry, hematology, microbiology and immunology, including clinical significance of test results, how the tests interrelate and how the tests impact diagnosis and treatment, quality assessment of test results, information processing and regulatory compliance in state and federal law.

(4) Provide practical training in:

(A) Phlebotomy that shall include 40 hours instruction and successful completion of a minimum of 10 skin punctures and 50 venipunctures, as specified in Section 1035.1(f); and

(B) Instruction and practical experience in the use of instruments; and

(D) Knowledge of instrument and test parameters to assess reasonableness of results; and

(E) Validation of moderate complexity test methods and clinical correlation of test results.

(c) A medical laboratory technician training program shall provide a certificate of completion to its students upon satisfactory completion of the program. The program shall maintain a copy of this certificate for at least five years. This certificate shall be signed by the director of the program and shall include:

(1) Name and address of the training program; and

(2) Name of the student; and

(3) Statement of satisfactory completion of the program; and

(4) Dates that training began and ended.

(d) A program approved to train medical laboratory technicians shall maintain records of its students for at least five years and shall make available to the department documentation of the students successfully completing their training.

(e) A medical laboratory technician training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section.

(f) A medical laboratory technician training program shall be allowed to document program compliance with the requirements of this section for a period dating up to four years prior to their initial application, after the date of implementation of these standards. The program shall document that, during the time preceding initial approval, the training program met the standards pursuant to Section 1035.3(a) and (b).

(g) A complete application for a medical laboratory technician training program shall include the following:

(1) The name and address of the primary training program, including city, state, county and zip code; telephone number, FAX number and e-mail address; and

(2) The location(s) of all sites where training will be conducted, including city, state and zip code; and

(3) The name(s) and qualifications of the person(s) directing and instructing in the program including a copy of current licensure for each person. Training programs in the United States of America but outside California shall provide evidence that the director(s) and instructor(s) substantially meet this licensure requirement by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards; and

(4) Dates the training program was conducted if prior approval is requested as specified in Section 1035.3(f); and

(5) The didactic curriculum listing each class or topic with instructional objectives, the instructor(s) and the amount of time allocated for each class or topic, pursuant to Section 1035.3(b)(3); and

(6) Documentation of practical training in pre-analytical, analytical and post-analytical skills, including instructor(s) and hours spent at each activity, list of equipment, supplies and materials used pursuant to Section 1035.3(b)(4); and

(7) The signature(s) of the program director(s), telephone number(s) and date of application.

(h) A medical laboratory technician training program approval shall be valid for a four-year period. To apply for renewal, the training program shall file an application at least 120 days prior to the end of the approval period providing the following:

(1) The name and address of the primary training program, including city, state, county and zip code, telephone number, FAX number and e-mail address; and

(2) The name, address, and telephone number(s) of the director(s) and instructor(s), providing documentation of their current licensure; and

(3) Any changes in training locations, didactic and practical instruction, course objectives, equipment, supplies and materials, that shall be made to the program from that approved in the previous application; and

(4) A listing of all students who completed its program and the total number of students who enrolled in its program during the previous approval period; and

(5) The signature(s) of the program director(s) and the date of application for renewal.

(i) The training program shall notify the department in writing of any change(s) in the information and materials required by Section 1035.3(b) through (d) within 30 days after the change(s) has occurred.

(j) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1222, 1222.5, 1242, 1246, 1260.3, 1269,1286 and 1300, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including amendment of subsection (b)(4)(E), transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1035.4. Timeframes for Approval of Training Programs.

Note • History

(a) Timeframes for approval of training programs to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows:

(1) Submission of an application for approval shall be deemed to occur on the date the application is received by the department.

(2) Written notification by the department to the applicant program shall be considered to occur on the date the documents are postmarked.

(3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following:

(A) That the application is complete and acceptable for processing by the department; or

(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.

(4) The department shall consider an application to have been abandoned by any applicant program which fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.4(a)(3)(B).

(b) Timeframes for processing applications for renewal of approval to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows:

(1) The training program shall submit a renewal application at least 120 days prior to the end of the approval period.

(2) Within 30 days of receipt of a renewal application, the department shall inform the training program in writing that the application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application.

(3) Within 30 days of submitting a completed renewal application, the department shall inform the training program in writing whether its application has been approved or denied.

(4) The department may authorize a training program to extend its approval during the time its application is being reviewed when that training program is in good standing and its application was submitted at least 120 days prior to the end of the approval period.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1261.5, 1263, 1264, 1286 and 1302, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 5-12-2005 order, including subsection (b)(2), transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

Article 2.3. Clinical Laboratory Supervisors

§1036. Clinical Consultant.

Note • History

(a) Every clinical laboratory director, under whom moderate or high complexity tests or examinations are performed, shall either perform the duties of a clinical consultant or employ a clinical consultant who can provide consultation about the appropriateness of testing ordered and interpretation of test results, as specified in Section 1209, chapter 3 of the Business and Professions Code.

(b) The clinical consultant shall possess a current, valid license issued by the State to direct a clinical laboratory pursuant to chapter 3, Business and Professions Code, or to practice medicine, osteopathy or podiatry pursuant to chapter 5, Business and Professions Code appropriate to the specialties and subspecialties for which he or she is consulting.

(1) Provide clinical consultation to the clients of the laboratory; and

(2) Assist in ordering tests appropriate to meet clinical expectations; and

(3) Ensure that test results include pertinent information required for interpretation; and

(4) Communicate matters about quality of test results reported and interpretation in relation to specific patient conditions.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

1. New article 2.3 (sections 1036-1036.4) and section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 72, No. 1.

2. New article 2.3 (sections 1036-1036.4) and section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.

3. New article 2.3 (sections 1036-1036.4) and section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of subsections (a) and (b), transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1036.1. General Supervisor.

Note • History

(a) Every clinical laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a general supervisor or employ a general supervisor who shall be responsible for day-to-day supervision of laboratory operation and personnel performing and reporting high complexity tests, pursuant to Section 1209, chapter 3 of Business and Professions Code.

(b) A general supervisor shall:

(1) Possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and

(2) Have a minimum of two years' experience in high complexity testing in the specialty or specialties they are supervising.

(c) The general supervisor shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems.

(d) The general supervisor shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1036.2. Moderate Complexity Laboratory Technical Consultant.

Note • History

(a) Every laboratory director, under whom moderate complexity tests or examinations are performed, shall either perform the duties of a moderate complexity laboratory technical consultant or employ a moderate complexity laboratory technical consultant who is responsible for providing technical and scientific consultation for each of the specialties and subspecialties performed.

(b) A moderate complexity laboratory technical consultant of a laboratory performing moderate complexity testing shall:

(1) Possess an active, valid license issued by the State pursuant to chapter 3 of the Business and Professions Code to perform high complexity testing, or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which he or she is consulting; and

(2) Have a minimum of two years' experience in moderate or high complexity testing in the specialty or specialties for which he or she is consulting.

(c) A moderate complexity laboratory technical consultant shall be responsible for the technical and scientific oversight of the laboratory as specified in Section 493.1413, Title 42, Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of subsections (a) and (b)(1)-(2), transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1036.3. Waived Laboratory Supervisor.

Note • History

(a) A laboratory director of a clinical laboratory performing waived tests may delegate or reapportion his or her responsibilities, as allowed by Section 1209 of the Business and Professions Code, by utilizing a waived laboratory supervisor. Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code and pursuant to subsection (c) and (d), a waived laboratory supervisor shall:

(1) Be listed in Section 1206.5 of the Business and Professions Code; and

(2) Possess at least a baccalaureate degree from an accredited college or university; and

(3) Have at least one year of training or experience in clinical laboratory testing in those tests or examinations that he or she will be supervising; and

(4) Document competency in those tests he or she will be supervising to the laboratory director at least semiannually during the first year and annually, or whenever new instrumentation is added, thereafter.

(b) Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code, a waived laboratory supervisor shall be responsible for:

(1) Selecting, in consultation with the laboratory director, the test methodology appropriate for clinical use of test results; and

(2) Establishing a quality control program appropriate for the tests performed, which follows the test manufacturer's parameters for acceptable levels of analytical performance and ensures that these levels are maintained throughout the entire testing process from initial receipt of the specimen through sample analysis and test result reporting; and

(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications; and

(4) Ensuring patient test results are not reported until all corrective actions have been taken and the test system is performing properly; and

(5) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for waived testing; and

(6) Evaluating and documenting that the staff maintain their competency to perform test procedures and report tests promptly, accurately and proficiently by:

(A) Directly observing routine test performance, including patient preparations (if applicable), specimen handling, processing and testing; and

(B) Monitoring the recording and reporting of test results; and

(D) Directly observing performance of instrument maintenance and function checks; and

(E) Assessing problem solving skills; and

(F) Evaluating and documenting the performance of individuals responsible for waived testing at least semiannually during the first year the individual tests patient specimens. Thereafter evaluations shall be performed at least annually unless test methodology or instrumentation changes (in which case and prior to reporting patient test results, the individual's performance shall be re-evaluated to include the use of the new test methodology or test instrumentation).

(c) A waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code shall:

(1) Hold a current, active license as an Emergency Medical Technician-Paramedic pursuant to Health and Safety Code Section 1797.194, as a registered nurse pursuant to Chapter 6 (commencing with Section 2700) or as a person under Chapter 3 (commencing with Section 1200) authorized to engage in clinical laboratory practice or to direct a clinical laboratory; and

(2) Have at least one year training or experience in blood glucose testing in the method or procedure that he or she will be supervising.

(d) The waived laboratory supervisor of a laboratory performing blood glucose testing as specified in subsection (c) shall be responsible for:

(1) Documenting that each individual performing blood glucose is competent to perform the test before he or she starts testing and whenever new methodologies or technologies are added; and

(2) Ensuring that manufacturer's instructions for test performance, equipment maintenance and quality control are followed; and

(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications.

(e) A waived laboratory technical supervisor shall be accessible to the laboratory testing personnel to provide onsite, telephone or electronic consultation. The laboratory director of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code may designate a licensed physician and surgeon or an authorized registered nurse at the hospital serving as the base hospital to provide such consultation.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order, including amendment of section heading and section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1036.4. Technical Supervisor.

Note • History

(a) Every laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a technical supervisor or employ a technical supervisor who is responsible for the technical and scientific oversight of the laboratory.

(b) A technical supervisor of a laboratory performing high complexity testing shall:

(1) Possess an active, valid, license issued by the state to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry, pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which they are consulting; and

(2) Meet the experience requirements in Section 493.1449 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.

(c) While not required to be on site at all times testing is performed, a technical supervisor shall be available to laboratory testing personnel at all times to provide either on-site, telephone or electronic consultation.

(d) A technical supervisor shall be responsible for all the activities listed in Section 493.1451 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.

HISTORY

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

Article 2.5. Continuing Education

§1038. Definitions.

Note • History

(a) The definitions set forth in subsections b through j inclusive shall govern the interpretation of this article.

(b) “Contact Hour” means the actual time a licensee participates in continuing education offered by an approved provider, utilizing the following conversion standards:

50-60 minutes = 1 contact hour

0.1 continuing education unit (CEU) = 1 contact hour

1 quarter unit = 10 contact hours

1 semester unit = 15 contact hours

(c) “Accredited Academic Institution” means an academic institution accredited by the Western Association of Schools and Colleges or an accrediting organization recognized by the Council of Post Secondary Education.

(d) “Accrediting Agency” means an organization approved by the Department pursuant to Section 1038.2 which evaluates and grants approval to providers of continuing education who comply with the standards of that agency, and who are other than those identified in (c) above.

(e) “Approved Provider” means an accredited academic institution or any person or entity offering continuing education who has been approved by an accrediting agency.

(f) “Licensee” means those persons other than clinical laboratory technologist trainees licensed pursuant to Chapter 3 (commencing with section 1200) of Division 2 of the Business and Professions Code.

(g) “Quarter Unit” and “Semester Unit” means the hours of instruction offered by an accredited academic institution which are credited by that institution as a quarter unit and semester unit respectively.

(h) “Active Status” means a current license in good standing which authorizes the licensee to perform the functions described in this chapter.

(i) “Inactive Status” means a license which is not in good standing because the holder has not completed the continuing education requirements of this article or has voluntarily requested that the license be made inactive.

(j) “Continuing Education Program” means a presentation given by an approved provider at a scheduled time or times which conforms to the requirements of section 1038.3.

NOTE

Authority cited: Sections1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New Article 2.5 (sections 1038-1038.7) and section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.1. Continuing Education Requirements.

Note • History

(a) All persons licensed under Division 2, Chapter 3 of the Business and Professions Code, commencing with Section 1200, whose license is in active status shall complete 12 contact hours of continuing education each calendar year. All persons licensed with more than one active license type pursuant to Division 2, Chapter 3 of the Business and Professions Code shall be able to renew all license types after completion of a total of 12 contact hours of continuing education each calendar year.

(b) At the time of renewal, each licensee shall provide the Department with the date, name and number of contact hours received for each continuing education program successfully completed by the licensee in the previous calendar year.

(c) The licensee shall retain continuing education documents received from approved providers under Section 1038.4 for a minimum of four years.

(d) A random sample of licensees shall be audited by the Department to determine compliance with the continuing education requirement. Those licensees selected for audit shall submit to the Department, within 30 calendar days of notification of selection, a copy of each document provided the licensee under section 1038.4(c) since the date of last license renewal.

(e) Any licensee who is found to have not successfully completed the continuing education requirement of this article will be placed in inactive status. The licensee shall have the right to appeal such findings to the Department. An appeal shall be conducted in compliance with chapter 5 (commencing with section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.2. Accrediting Agencies.

Note • History

(a) Any organization seeking approval as an accrediting agency shall submit an application to the Department which shall include documentation of the following:

(1) The organization's name, address, and owner(s);

(2) The organization's structure, function, and philosophy for monitoring the content, quality, and faculty of approved programs; and,

(3) The person designated by the organization to be responsible for overseeing the administration and coordination of all continuing education providers approved by the organization.

(b) The Department's review of an accrediting agency shall include an evaluation of the following:

(1) Whether the organization's philosophy shows an identifiable commitment to continuing education;

(2) Whether the organization's mechanism for monitoring the content, faculty, education methods, quality, and facilities of approved providers meets the criteria of section 1038.3; and,

(3) Effective mechanisms for responding to complaints about approved providers and the ability to take effective action to insure that approved providers comply with sections 1038.3 and 1038.4.

(c) The Department shall approve an organization as an accrediting agency and issue an approval upon satisfactory review under subsections (a) and (b). Such approval may be subject to special terms as specified by the Department.

(d) Within 30 calendar days of receipt of an application by an organization for approval as an accrediting agency, the Department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application.

(e) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as an accrediting agency.

(f) The Department's time periods for processing an application for approval as an accrediting agency, from the receipt of the initial application to the final decision regarding the approval, are as follows:

(1) The median time for processing is 60 calendar days.

(2) The minimum time for processing is 45 calendar days.

(3) The maximum time for processing is 90 calendar days.

(g) An accrediting agency shall maintain for five years and shall make available to the Department, the name of each approved provider, the title, date, and number of contact hours awarded for each program offered by its approved providers, and a list of all participants in each program offered.

(h) An accrediting agency shall be subject to review by the Department to determine adherence to requirements of this article. Failure of an accrediting agency to meet the requirements of this article or its terms of approval is good cause for revocation of approval by the Department.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.3. Approval of Providers.

Note • History

(a) An accrediting agency shall approve only providers who offer continuing education programs that meet all of the following criteria:

(1) Use instructors who are competent in subject matter by education, training or experience;

(2) Are a minimum of 50 minutes in duration excluding evaluation by participants of the continuing education program;

(3) Are relevant to the scope of practice of clinical laboratory science and may include education, supervision, and management;

(4) Have clearly stated, measurable, education objectives; and,

(5) Use teaching methods which are consistent with the objectives of the continuing education program.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.4. Approved Providers.

Note • History

(a) No person or entity shall represent itself as an approved provider unless approved by an accrediting agency or unless it is an accredited academic institution.

(b) Approved providers shall issue certificates to participants which include:

(A) The participant's name;

(B) Contact hours;

(D) Name and address of both program provider and accrediting agency; and,

(E) Signature of instructor and/or provider or provider designee.

(c) Accredited academic institutions shall provide certificates to every participant upon completion of a continuing education program which includes all the information in subsection (b), except the approved provider will not be required to issue a certificate when the continuing education program is a regularly scheduled class and documented on a student transcript.

(d) An approved provider shall maintain an official record verifying all participants' attendance at continuing education programs for at least four years after the completion date. The provider shall include the participant on the official record of attendance only if the participant's signature was obtained at the time of attendance at the program. The official record of attendance shall contain the name of the participant and shall identify the time, date, location, subject matter, and length of the continuing education program and shall be provided to the Department upon request at no cost to the Department.

(e) If two or more approved providers jointly provide a continuing education program, the providers shall designate the provider responsible for keeping records and issuing certificates to participants.

(f) An approved provider shall evaluate the effectiveness of continuing education programs to determine whether the program objectives required under section 1038.3 subsection (a)(5) were met. This evaluation shall include a written evaluation by the participants, or pre- and post-examination.

(g) An approved provider shall allow, at no cost, in-person observation of continuing education programs by employees of the Department of Health Services for purposes of monitoring compliance with sections 1038.3 and 1038.4.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.5. Waiver of Requirement.

Note • History

(a) At the time of making application for renewal of a license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code (BPC), a licensee may request a waiver of all or part of the continuing education requirement. To be eligible for a waiver, a license holder shall verify in writing that he or she:

(1) Was residing in another country for at least half the license period since the license was issued or, if the license was previously renewed, since it was last renewed, and that this reasonably prevented completion of the continuing education requirements; or

(2) Was absent from California for at least half the license period since the license was issued or, if previously renewed, since it was last renewed, because of military service, and that this reasonably prevented completion of the continuing education requirements; or

(3) Was prevented from completing the continuing education requirements for reasons of ill health or other good cause, including, but not limited, to:

(A) Total physical and/or mental disability of the licensee for at least half of the period since the license was issued or, if previously renewed, since it was last renewed; or

(B) Total physical and/or mental disability of an immediate family member for at least half of the period since the license was issued or, if previously renewed, since it was last renewed, where the licensee has total responsibility for the care of that family member.

(4) Verification of a disability under paragraph (3) shall include a corroborating statement by a licensed physician.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.6. Inactive Status.

Note • History

A licensee whose license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code is in inactive status shall document 12 hours of continuing education for the year prior to reinstatement or pass the examination for licensure prior to reinstatement to active status.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

§1038.7. Fees.

Note • History

(a) A fee of $250.00 shall accompany an application for approval or renewal as an accrediting agency.

(b) At the time of initial application or renewal of a clinical laboratory personnel license, an additional fee of $8.00 shall be paid by each licensee to support the costs of administering and enforcing the continuing education requirements of this article.

NOTE

Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.

HISTORY

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 4).

Article 2.8. CLIA Certification/State Licensure

§1039.1. Recognition of CLIA Certification for Limited Purpose and Period.

Note • History

(a) Except for a certificate of accreditation issued by HHS, a CLIA certificate issued to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered to be a state license or registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the CLIA certificate is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS.

(b) A certificate of accreditation issued by HHS to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered a state license or registration issued pursuant to Chapter 3 until such time as the accreditation body, upon whose accreditation the certificate of accreditation was issued by HHS, fails to be approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure; and, provided that:

(1) The certificate of accreditation issued by HHS is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked; and

(2) After exempt status is obtained, the accredited laboratory pays the department the $100 annual certificate of accreditation renewal fee.

(c) A certificate of waiver issued by HHS, to a clinical laboratory that on December 31, 1995 was required to obtain a state license, and that performs only waived tests, physician performed microscopy, or both, shall be considered to be a state registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the certificate of waiver remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. New article 2.8 (sections 1039.1-1039.3) and section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency language will be repealed by operation of law on the following day.

2. New article 2.8 (sections 1039.1-1039.3) and section refiled 10-7-96 as an emergency, including amendment of subsections (a) and (c); operative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-7-96 order, including amendment of subsection (b), transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§1039.2. Clinical Laboratory Personnel Requirements.

Note • History

(a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations in California shall meet the requirements for performing, supervising, consulting on, or directing laboratory tests or examinations as set forth in Chapter 3 for the type and complexity of tests performed and irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration.

(b) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations outside California on biological specimens originating in California, and irrespective of whether the clinical laboratory where the tests or examinations are performed is operated under a CLIA certificate or under a state license or registration, shall meet all personnel requirements set forth in Chapter 3 for the type and complexity of testing performed, or shall provide evidence to the department that they substantially meet those requirements by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

1. New section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-7-96 order, including amendment section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§1039.3. State Licensure or Approval Required During CLIA Exemption.

Note • History

All clinical laboratories except those identified in subdivision (b) of Section 1241, or in Section 1244 of the Business and Professions Code, shall have in effect a state license or state registration, and all public health laboratories shall be approved public health laboratories during any period for which HHS grants CLIA exempt status for clinical laboratories or public health laboratories licensed, registered or approved by the department.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 10-7-96 order transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

Article 3. License

§1040. Forfeited Licenses.

Note • History

(a) No license which has been forfeited for failure to pay the required fee shall be reinstated until a written request for reinstatement and all unpaid fees have been received by the department.

(b) If the renewal fee is not paid for five or more years, an examination will be required in addition to the requirements of subsection (a) above before the license may be reinstated, except as otherwise provided in Division 2, Chapter 3, Section 1301 of the Business and Professions Code.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1303, Business and Professions Code.

HISTORY

1. Amendment filed 2-18-58; effective thirtieth day thereafter (Register 58, No. 3).

2. Amendment filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

3. Certificate of Compliance--Sec. 11422.1, Gov. Code, filed 1-20-71 (Register 71, No. 4).

§1041. Fee Credits.

Note • History

Each clinical laboratory that pays a fee subject to reduction under subdivision (u) of Section 1300 of the Business and Professions Code shall have any reduction credited against the clinical laboratory's future license, registration or other fees payable under Chapter 3.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1300, Business and Professions Code.

HISTORY

1. New section filed 11-25-70 as procedural and organizational; designated effective 11-24-70 (Register 70, No. 48).

2. Certificate of Compliance--Sec. 11422.1, Gov. Code, filed 1-20-71 (Register 71, No. 4).

3. Amendment of subsection (a) filed 6-5-78; effective thirtieth day thereafter (Register 78, No. 23).

4. Repealer filed 4-22-82; effective thirtieth day thereafter (Register 82, No. 17).

5. New section heading, section and Note filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency language will be repealed by operation of law on the following day.

6. New section heading, section and Note refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 10-7-96 order, including amendment of section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§1042. Substantial Relationship Criteria.

Note • History

Four purposes of denial, suspension or revocation of a license, certificate or permit pursuant to Division 1.5 (commencing with Section 475) of the Business and Professions Code, a crime or act shall be considered to be substantially related to the qualifications, functions, or duties of a person who is an applicant or holder of a license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code if to a substantial degree it evidences present unfitness of a person holding a license, certificate or permit to perform the functions authorized by such license, certificate or permit in a manner consistent with the public health, safety or welfare. Such crimes or acts shall include but not be limited to the following:

(a) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of Chapter 3, Division 2 of the Business and Professions Code.

(b) Acts of dishonesty, fraud or deceit with intent to substantially benefit himself or another, or substantially injure another.

(c) Acts of gross negligence in the performance of functions authorized by the license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code.

A license, certificate or permit shall not be denied, suspended or revoked because of a lack of good moral character or any similar ground relating to a person's character, reputation, personality or habits.

NOTE

Authority cited: sections 208, 3901, 15020 and 25800-25870, Health and Safety Code; section 1224, Business and Professions Code. Reference: Sections 3901, 15000-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482, and 1242.5, Business and Professions Code.

HISTORY

1. New section filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50). For former history, see Register 71, No. 4.

§1042.1. Criteria for Evaluating Rehabilitation.

Note • History

(a) When considering the denial of a license, permit or certificate under Section 480 of the Business and Professions Code, for which application has been made under Chapter 3, Division 2, of the Business and Professions Code, the Department, in evaluating the rehabilitation of the applicant and his present eligibility for a license, permit or certificate, shall consider the following criteria:

(1) The nature and severity of the act(s) or crime(s) under consideration as grounds for denial.

(2) Evidence of any act(s) committed subsequent to the act(s) or crime(s) under consideration as grounds for denial which also could be considered as grounds for denial under Section 480 of the Business and Professions Code.

(3) The time that has elapsed since commission of the act(s) or crime(s) referred to in subsection (a) (1) or (a) (2).

(4) The extent to which the applicant has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed upon the applicant.

(5) Evidence, if any, of rehabilitation submitted by the applicant.

(b) When considering the suspension or revocation of a license, permit or certificate issued under Chapter 3, Division 2 of the Business and Professions Code on the grounds of conviction of a crime, the Department, in evaluating the rehabilitation of such person and his present eligibility for a license, permit or certificate shall consider the following criteria:

(1) Nature and severity of the act(s) or offense(s).

(2) Total criminal record.

(3) The time that has elapsed since commission of the act(s) or offense(s).

(4) Whether the licensee has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed against the licensee.

(5) If applicable, evidence of expungement proceedings pursuant to Section 1203.4 of the Penal Code.

(6) Evidence, if any, of rehabilitation submitted by the licensee.

(c) When considering a petition for reinstatement of a license, permit or certificate, the Department shall evaluate evidence of rehabilitation, considering those criteria of rehabilitation listed in subsection (b).

NOTE

Authority cited: Sections 208, 3901, 15020 and 25800-25870, Health and Safety Code: Section 1224, Business and Professions Code. Reference: Sections 3901, 15000-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482 and 1242.5, Business and Professions Code.

HISTORY

1. New section filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50).

Article 4. Personnel Report

§1045. Personnel Report.

All clinical laboratory directors shall on or before December 15th of each calendar year transmit to the department, on forms provided by the department, the names of all persons performing clinical laboratory procedures including, but not limited to biochemical, bacteriological, parasitological, hematological, or serological procedures. All clinical laboratory directors shall keep the department advised of current changes in employment of such technical personnel giving employment and/or separation dates of personnel.

Article 5. Issuance of License

§1050. Clinical Laboratory Standards.

Note • History

(a) All licensed clinical laboratories shall be conducted, maintained, and operated without injury to the public health and shall maintain records, equipment, and facilities which are adequate and appropriate for the services rendered and demonstrate satisfactory performance in a proficiency program approved by the department.

(b) Proficiency Testing.

(1) The laboratory must participate in a state approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialties that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, and immunohematology.

(2) The participating laboratory must test applicable materials each time they are distributed by the approved proficiency testing service according to a schedule approved by the department.

(3) Those procedures performed by the laboratory for which test materials are provided by the approved proficiency testing service and which have been designated by the department as a requirement for measuring test performance, must be proficiency tested by the participating laboratory each time test materials are received.

(4) The participating laboratory must authorize the approved proficiency testing service to report proficiency test results to the department.

(5) The participating laboratory must test applicable materials only in the laboratory to which the license and the proficiency testing requirement applies using personnel and equipment used in that facility in providing services.

(6) A laboratory may be required to discontinue providing a service in a procedure or category of procedures if:

(A) For three consecutive quarters the laboratory fails to report on test materials received for procedures for which the laboratory is required to be proficiency tested, or

(B) For three consecutive quarters the laboratory demonstrates unsatisfactory performance in a procedure or category of procedures. A determination of satisfactory performance for a procedure shall be based upon results being within acceptable limits established by the proficiency testing service for that procedure and approved by the department. A determination of satisfactory performance for a category of procedures shall be based upon an average of performance within the category over four consecutive quarters.

(7) A laboratory whose services have been disapproved because of unsatisfactory performance may apply to the department for reapproval to provide these services after demonstrating satisfactory performance during the two consecutive quarters or testing periods immediately prior to requesting reapproval.

(c) Direction. The person or persons directing a licensed clinical laboratory shall assume the following responsibilities:

(1) Determine what laboratory procedures will be performed, the techniques that will be followed, and the equipment and reagents that will be used.

(2) Determine the scope and nature of procedures to control the reliability of test performance and personally monitor these control programs.

(3) Regularly assess the activities of the laboratory by personal observation, evaluation, and review of reports of laboratory findings.

(4) Establish qualification criteria of laboratory personnel.

(5) Determine the format of laboratory report forms and decide what information is to be contained on these report forms.

(6) Regularly consult with supervisors and other staff members.

(7) Confer with those served by the laboratory on matters that relate to test performance and determine the nature and scope of technical and administrative information to be released by the laboratory staff.

(8) Be available daily in any laboratory performing cytology and serve as director of no more than three (3) laboratories.

(9) Cause a licensed physician or dentist, qualified in cytopathology, to personally examine and report findings on abnormal or questionable gynecologic and all non-gynecologic specimens.

(d) Facilities. The laboratory must provide for and assure that:

(1) There is adequate space including working surface to conduct and control the performance of all test procedures performed in the laboratory.

(2) There is adequate area for safe storage and use of equipment and supplies.

(3) All areas are well lighted and properly ventilated.

(4) Fume hoods and biological safety cabinets, properly installed and regulated, are used if required for safe performance of tests or for safe preparation of materials.

(5) Instructions to be followed in case of fire and other emergencies are posted in a conspicuous place.

(e) Equipment and Test Materials.

(1) The laboratory must provide for and assure that equipment, instruments, glassware, and reagents are maintained in proper working order by periodic inspection, testing, or calibration in a manner acceptable to the department.

(2) All reagents and stains shall be dated at the time of preparation and initialed by the person making the reagents or stains, or the date received and date opened if commercially prepared reagents or stains are used. All reagents and stains shall be labeled to indicate identity, and titer, strength, or concentration. Recommended storage temperature and expiration date, and other pertinent information necessary for quality control must be on the label.

(f) Records.

(1) Retention of Records: The laboratory must maintain for a period of at least two years documentation of the following:

(A) Records of specimens received and tested, including identification of the patient, name of the submitter, dates of receipt and report, type of test performed, and test results.

(B) Records of inspection, validation, calibration, repair, and replacement to insure proper maintenance and operation of equipment and proper reactivity of test materials.

1. Name of procedure.

2. Source or reference for the test method.

3. Date the procedure was last reviewed or modified by the director or supervisor.

4. Current specific instructions for test performance.

5. The standards and controls required.

6. Instructions for collecting and handling specimens to insure test reliability.

(D) Records of quality control procedures in use in the various technical areas of the laboratory, including results on standards and reference materials and action limits when appropriate.

(E) Additional requirements for cytology. The laboratory shall retain all cytology slides and cell blocks for a minimum of five (5) years and all cytology reports for a minimum of ten (10) years.

(2) Cytology Specimen Documents. The laboratory shall maintain cytology records indicating the daily accession of specimens, each of which is numbered, and an appropriate cross-filing system according to patient's name.

(A) Requests shall contain at least the following information:

1. The laboratory accession number when assigned by the laboratory.

2. The name of the person from whom the specimen was taken.

3. The name of the licensed physician or other authorized person or clinical laboratory who submitted the specimen.

4. Minimum information provided shall include: source of specimen (anatomic site), age of patient, previous therapy (endocrine, surgical, radiation, birth control, etc.), gynecologic history on cervical-vaginal specimens, including date and normalcy of patient's last menstrual period, duration of patient's current pregnancy, if any, and patient's menopausal status or essential history on non-gynecologic specimen.

5. The date the specimen was collected.

(B) Reports shall contain at least the following information:

1. The dates the specimen was collected, received in the laboratory and reported by the laboratory; and the accession number.

2. The result of the laboratory examination.

(3) Cytology Laboratory Records.

(A) The laboratory director shall be responsible for the final laboratory report and shall sign all abnormal and all non-gynecological reports. Each report, or a laboratory copy, shall be signed or initialed by the cytopathologist and/or cytotechnologist who examined the preparation and evaluated the final report. The names of all persons who examined the specimen and their evaluation, if inconsistent with the final report, shall be indicated on the laboratory work sheet or report copy.

(B) Duplicate copies of laboratory reports are filed in a manner which permits ready identification and accessibility.

(C) Laboratories shall utilize reporting systems that are as explicit as is cytologically feasible and must include acceptable morphologic terminology.

(D) If a specimen is judged by the laboratory director or cytotechnologist to be suboptimal, an accompanying statement shall indicate the reason, e.g., samples of sparse cellularity, poor preservation, or exhibiting other factors interfering with the laboratory evaluation, such as, excessive blood, inflammatory cells, etc.

(g) Quality Control.

(1) The laboratory must conduct, maintain, and operate programs for controlling the quality of test performance in a manner acceptable to the department.

(2) Additional Cytology.

(A) Specimen Identification. All smears and other specimens shall be labelled for patient identification and appropriately prepared by the submitter.

(B) Specimen Preparation.

1. The laboratory shall use the Papanicolaou staining technique or its equivalent as determined by the laboratory director.

2. Staining quality of cytologic specimens shall be checked at least once daily, with suboptimal results corrected immediately.

3. Gynecologic specimens shall be processed totally separately from non-gynecologic specimens.

1. Each specimen shall be evaluated to determine whether the material is satisfactory and consistent with the patient source. For satisfactory specimens, a cytologic evaluation shall be rendered according to the reporting system, as outlined in Section 1050(f)(3)(C).

2. The laboratory shall have a sufficient number of certified cytotechnologists to handle, under general supervision, the volume and diversity of tests performed requiring the exercise of independent judgment. No cytotechnologist shall be required to examine more than 75 one-slide gynecologic cases or 50 two-slide gynecologic cases per day; not including aspiration cytology specimens, cell block specimens, and other not normally examined by a cytotechnologist. Work load ratios for cytotechnologists who also prepare and stain slides shall be based on time spent in examining cytologic preparations.

3. The director or a supervising cytotechnologist shall examine (to verify proper staining and correct interpretation) at least ten (10) percent of all gynecologic smears previously examined and classified as not abnormal or questionable, including smears initially examined by a supervising cytotechnologist.

(3) Clinical Correlation. The laboratory shall maintain records for a minimum of 10 years of histologic or clinical confirmation of cytologic findings on abnormal cases and false negative and false positive results for each category of specimens, when such results are made available to them.

(h) Clinical Laboratory Test Results. Clinical laboratory test results shall not be reported from the laboratory until these results have been critically reviewed and verified for accuracy, reliability, and validity by a licensed physician and surgeon or a person, other than a trainee, duly licensed under Chapter 3, Division 2, Business and Professions Code (commencing with Section 1200).

NOTE

Authority cited: Sections 1224 and 1245, Business and Professions Code. Reference: Sections 1220, 1224 and 1245, Business and Professions Code.

HISTORY

1. New subsection (h) filed 2-17-77; effective thirtieth day thereafter (Register 77, No. 8). For prior history, see Register 76, No. 51.

2. Amendment of subsections (c), (f)(2)(A) and (B), (f)(3)(A), (g)(2)(A) and (B)3, (g)(2)(C)2, (g)(3) filed 10-13-78; effective thirtieth day thereafter (Register 78, No. 41).

§1051. Proficiency Testing Services.

History

A service may be approved by the department for proficiency testing laboratories providing the service:

(a) Makes available to each participating laboratory

(1) Materials not less than four times during each calendar year for testing those procedures which have been designated by the department for evaluation,

(2) Acceptable forms for reporting results of proficiency testing,

(3) An evaluation of test results reported by the participating laboratory showing acceptable results based on a reference system approved by the department, and

(4) A summary of results reported by all participating laboratories prepared at least annually.

(b) Provides the department with an adequate description of acceptable procedures for

(1) The preparation and distribution of test materials,

(2) The determination of limits of acceptable test results, and

(3) The reporting of results of performance to the laboratories subscribing to the service.

(c) Establishes and maintains an adequate reference system for each procedure evaluated. The names and addresses of all laboratories used as reference or referee laboratories by the service must be provided to and approved by the department.

(d) Maintains records of proficiency testing including reports for participating laboratories for a period of not less than five years, such records being available to the department for reference upon request. These records must include:

(1) The names and addresses of laboratories subscribing to the service,

(2) The test procedures evaluated,

(3) The results of performance reported by each laboratory, and

(4) The results or range of results which were considered acceptable performance by the service.

(e) Makes application for approval on forms provided by the department.

HISTORY

1. New section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).

§1052. Satisfactory Performance in Proficiency Testing.

Note • History

The standards for satisfactory performance for laboratories operating in accordance with Subsections (b) and (g), Sections 1241, Division 2, Chapter 3, Business and Professions Code shall be those outlined in Section 1050(b) of this Title.

NOTE

Authority cited: Sections 1224 and 1241.1, Business and Professions Code.

HISTORY

1. New section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).

2. Amendment filed 2-17-77; effective thirtieth day thereafter (Register 77, No. 8).

§1053. Definitions.

Note • History

NOTE

Authority cited: Sections 1220(a), 1224 and 1245, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1224, 1245, 1265, 1282 and 1285, Business and Professions Code.

HISTORY

1. New section filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 24).

2. Amendment of subsection (e) and new subsections (f), (g) and (h) filed 2-17-77; effective thirtieth day thereafter (Register 77, No. 8).

3. New subsection (i) filed 10-13-78; effective thirtieth day thereafter (Register 78, No. 41).

4. Amendment of section and Note filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section and Note refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language will be repealed by operation of law on the following day.

6. Amendment refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency language will be repealed by operation of law on the following day.

7. Reinstatement of section as it existed prior to 12-27-94 emergency amendment by operation of Government Code section 11346.1(f) (Register 96, No. 4).

8. Renumbering and amendment of former section 1053 to section 1029 filed 1-22-96 as an emergency; operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 1-22-96 order transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

Article 5.2. Test Kits Approved for Over-the-Counter Sale to the Public by the United States Food and Drug Administration

§1053.5. HIV Tests.

Note • History

The Department hereby adds to the tests that may be requested and reported pursuant to Business and Professions Code section 1246.5 any laboratory test or examination to identify HIV, a component of HIV, or antibodies or antigens to HIV when the test or examination has been approved by the United States Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit.

NOTE

Authority cited: Sections 1224 and 1246.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1246.5, Business and Professions Code; and Section 120775, Health and Safety Code.

HISTORY

1. New article 5.2 (section 1053.5) and section filed 11-6-96 as an emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No. 16).

Article 5.3. Blood Electrolyte Analysis by Respiratory Care Practitioners

§1054.1. Conditions for Performance.

Note • History

(a) A Respiratory Care Practitioner may engage in clinical laboratory practice by performing a blood electrolyte analysis when all of the following conditions are met:

(1) The blood electrolyte analysis is performed on an instrument which is designed to perform both blood gas analysis and blood electrolyte analysis simultaneously or concurrently and from the same blood specimen;

(2) The blood electrolyte analysis is performed in a licensed laboratory that:

(A) is within a licensed surgical clinic or a licensed general acute care hospital;

(B) has a CLIA certificate to perform blood gas analysis and blood electrolyte analysis; and

(C) has established and maintains protocols for the performance and reporting of blood gas analysis and blood electrolyte analysis simultaneously or concurrently from the same blood specimen by Respiratory Care Practitioners;

(3) The blood electrolyte analysis is performed:

(A) under the overall operation and administration of the laboratory director, as required in Section 1029 of the Business and Professions Code; and

(B) in conformity with the protocols required in (2)(C), above; and

(4) The Respiratory Care Practitioner:

(A) has been trained in accordance with Section 1054.2; and,

(B) performs and reports simultaneous or concurrent blood gas analysis and blood electrolyte analysis in compliance with the requirements in (3), above; and

NOTE

Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220, 1265, 1282 and 1285, Business and Professions Code.

HISTORY

1. New Article 5.3 (sections 1054.1 - 1054.2) and section filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed by operation of law on the following day.

2. New article 5.3 (sections 1054.1-1054.2) and section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language will be repealed by operation of law on the following day.

3. New article 5.3 and section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 96, No. 4).

5. New section filed 1-22-96 as an emergency; operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of subsection (a)(2) (Register 96, No. 25).

7. Certificate of Compliance as to 1-22-96 order including amendment of NOTE transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

§1054.2. Training.

Note • History

(a) Prior to performing a blood electrolyte analysis, a Respiratory Care Practitioner shall have completed the following training:

(1) instruction by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA, depending on the type and complexity of the tests being performed, in:

(A) the operation of each instrument to be used for simultaneous or concurrent blood gas analysis and blood electrolyte analysis by the Respiratory Care Practitioner, including the following:

1. Equipment maintenance and calibration;

2. Method performance including the normal ranges and critical values for each test protocol;

3. Quality Control and Assurance requirements including remedial action and reagent and specimen handling and integrity; and,

4. Clinical significance of test results and clinical applications for simultaneous or concurrent blood gas analysis and blood electrolyte analysis.

NOTE

Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1209, 1220 and 1265, Business and Professions Code.

HISTORY

1. New section filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 96, No. 4).

6. Certificate of Compliance as to 1-22-96 order including amendment of NOTE transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

Article 5.5. Use of Point-of-Care Laboratory Testing Devices by Registered Nurses

§1054.5. Conditions for Performance.

Note • History

NOTE

Authority cited: Sections 1220(a) and 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1265, 1282 and 1285, Business and Professions Code.

HISTORY

1. New Article 5.5 (sections 1054.5 - 1054.6) and section filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed by operation of law on the following day.

2. New article 5.5 (sections 1054.5-1054.6) and section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language will be repealed by operation of law on the following day.

3. New article 5.5 and section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 96, No. 4).

Article 5.6. Moderately Complex Laboratory Testing by Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Nurse Assistants, and Certified Home Health Aides

§1054.6. Testing Authority for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Nurse Assistants, and Certified Home Health Aides.

Note • History

NOTE

Authority cited: Section 1224 Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, and 1209, Business and Professions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 96, No. 4).

5. New article 5.6 (sections 1054.6-1054.7), section heading, section, and Note filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency language will be repealed by operation of law on the following day.

6. New article 5.6 (sections 1054.6-1054.7) and section refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 10-7-96 order, including repealer of section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§1054.7. Preceptor Program Requirements for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Emergency Medical Technicians II, Paramedics, Certified Nurse Assistants, and Certified Home Health Aides Performing Moderate Complexity Testing on Point-of-Care Laboratory Testing Devices.

Note • History

(a) Prior to the performance of any clinical laboratory test or examination authorized in Business and Professions Code Section 1206.5(b)(11), a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide shall have been trained by a preceptor in:

(1) The operation of each instrument to be used by the licensed psychiatric technician, licensed vocation nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide including:

(A) Each instrument's requirements for maintenance and calibration which shall include training regarding all manufacturer's instructions;

(B) Each instrument's performance criteria including the reference ranges, critical values for each test method, and actions to be taken for values outside the analytical range; and

(C) Each instrument's quality control and quality assurance protocols, including remedial action and reagent and specimen handling and integrity; and,

(2) The clinical significance of test results for each instrument and the clinical application for use of the instruments by licensed psychiatric technicians, licensed vocational nurses, licensed midwives, certified emergency medical technicians II, paramedics, certified nurse assistants or certified home health aides; and,

(3) The common physiological conditions of patients that may impact specimen integrity and cause inaccurate test results; and

(4) Principles of good laboratory practice including laboratory safety and universal precautions.

(b) Prior to the utilization, for patient care, prognosis, monitoring, treatment, or disease prevention, of any clinical laboratory test or examination performed by him or her, a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant, certified home health aide shall have the following experience and shall have been determined to be competent to perform moderate complexity tests by the laboratory director or a person who qualifies as a technical consultant pursuant to Business and Professions Code Section 1209:

(1) He or she shall participate in a preceptor program until such time as he or she is able to perform clinical laboratory tests or examinations with results that are consistent with the preceptor's results 90% of the time over 20 separate testing events which taken together, cover the entire range of expected values for the instrument.

(2) The experience requirement in subsection (b)(1) shall be met for each instrument to be used by the licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1209, and 1220, Business and Professions Code.

HISTORY

3. Certificate of Compliance as to 10-7-96 order, including amendment of section heading and section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

Article 6. Laboratory Reports

§1055. Reports.

Note • History

Any report of results issuing from a clinical laboratory operating under the provisions of Chapter 3, Division 2, Business and Professions Code shall show clearly the name of a director of said laboratory.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1220, 1225, 1284 and 1285, Health and Safety Code.

HISTORY

1. New section filed 9-30-60; effective thirtieth day thereafter (Register 60, No. 21).

§1056. Prenatal and Neonatal Blood Typing.

Note • History

For purposes of compliance with Sections 291 and 304 of the California Health and Safety Code, rhesus (Rh) blood typing (as defined in Title 17, California Administrative Code, Chapter 2, Subchapter 1, Group 1, Section 1002, Number 3, [Determination of Rh type]) shall consist of D and if this is negative, Du typing.

NOTE

Additional authority cited: Sections 290-293 and 304-305, Health and Safety Code.

HISTORY

1. New Sections 1056 and 1057 filed 3-16-70; effective thirtieth day thereafter (Register 70, No. 12).

2. Amendment filed 2-2-71; effective thirtieth day thereafter (Register 71, No. 6).

3. Editorial correction (Register 72, No. 31).

§1057. Prenatal Blood Typing Reports.

History

Licensed clinical laboratories or approved public health laboratories performing tests on pregnant women as required by Sections 290 and 291 of the California Health and Safety Code shall provide the requesting physician with a copy of the report to be stamped or imprinted as follows: “State law requires that the woman tested be informed as to the rhesus (Rh) typing test results.”

Every licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman, or attending such woman at time of delivery after receiving such report, shall be responsible for notifying the woman tested of the results of the test.

HISTORY

1. Amendment filed 2-2-71; effective thirtieth day thereafter (Register 71, No. 6).

Article 7. Cytotechnology

§1060. Definitions: Cytotechnologist License.

Note • History

(a) The definitions in subsections (b) though (i) shall govern the interpretation of this article.

(b) “Competency testing service or program” means an organization that has been approved by the Department pursuant to section 1270 of the California Business and Professions Code to administer a cytotechnology competency examination.

(c) “Cytotechnologist competency examination” means an examination which evaluates a person's entry level skills and abilities in cytotechnology, including his or her understanding of: (1) the underlying scientific principles, technical and procedural aspects of cytotechnology; (2) the identification of cellular changes in gynecological and non-gynecological specimens through both a written and visual component; (3) cytopreparatory techniques; and (4) cytology laboratory operations; and which include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both the genital system and breast); 13% to 17% respiratory system; 9% to 12% male and female genitourinary systems; 6% to 10% alimentary system; and 13% to 17% body cavity fluids and other body sites.

(d) “Entry Level Skills” means the following skills and abilities expected at career entry:

(1) Knowledge and understanding of:

(A) the underlying scientific principles as well as the technical and procedural aspects of the examination of cytology specimens;

(B) the physiological, biochemical, microbiological, and genetic factors which affect cell health and disease, and the importance of cytology laboratory examinations to medical care;

(D) the introduction and implementation of new procedures and the evaluation of new instruments;

(E) basic management theory and functions.

(2) Technical skills so that the examinee is capable of:

(A) performing examinations on cytology specimens;

(B) exercising initiative and independent judgment in dealing with the broad scope of procedural and technical problems;

(C) participating in, or being delegated, the responsibility for decisions involving quality control programs, or reagent purchases;

(D) communicating technical or general information to medical, paramedical, or lay individuals;

(E) participating in and developing responsibility for the establishment of technical and administrative procedures;

(F) supervising technicians, aides, and clerical personnel, as directed; and,

(G) providing instruction in the basic theory, technical skills, and application of cytology laboratory procedures.

(e) ”Examinee” means an individual who meets the following requirements:

(1) Has a baccalaureate degree from a college or university accredited by the Western Association of Schools and Colleges or its equivalent with 20 semester hours (30 quarter hours) of biological science, 8 semester hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter hours) of mathematics; and

(2) Has completed:

(A) A 12-month cytotechnology program accredited by the Council on Accreditation of Allied Health Educational Program (CAAHEP) or its equivalent; or

(B) Five years, of at least 40 hours a week, clinical laboratory experience in cytopreparatory techniques, microscopic analysis and evaluation of the body systems within the last ten years. At least two of these years must be subsequent to the completion of the academic component and at least two years must be under the supervision of a licensed physician who is a pathologist certified or eligible for certification by the American Board of Pathology in Anatomic Pathology or has other qualifications acceptable to the competency testing service or program.

(f) “Evidence of Satisfactory Performance” means (1) a copy of a document issued to an examinee after January 1, 1993 by a cytotechnology competency testing service or program indicating satisfactory performance by the examinee on a cytotechnologist competency examination; or (2) a copy of a document issued to an individual by the American Society of Clinical Pathologists (ASCP) Board of Registry (BOR) indicating satisfactory performance by the individual on an ASCP Cytotechnology Examination taken prior to the approval of a competency testing service or program under the provisions of this article.

(g) “Satisfactory performance” means (1) receipt of a passing score on a cytotechnologist competency examination given after January 1, 1993; or (2) passage of an ASCP Cytotechnology Examination prior to the approval of a competency testing service or program under the provisions of this article.

(h) ”Passing score” means a score determined by a cytotechnologist competency testing service or program utilizing the criteria approved by the Department pursuant to section 1062.

(i) “Owner(s)” means any person who is a sole proprietor, or holds a partnership interest in, or who is an officer, director, or 5% (five percent) or more shareholder in a corporation which owns an organization that is applying for approval as a cytotechnologist testing service or program.

NOTE

Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code.

HISTORY

1. New article 7 and section filed 11-18-93 as an emergency; operative 11-18-93 (Register 93, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-18-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 11-18-93 order transmitted with amendment of subsections (e)(2)(A) and (f) to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 17).

§1061. Cytotechnology Licensure.

Note • History

(a) A cytotechnologist license shall be issued to an individual who submits the following to the Department:

(1) A verified and complete application as described in subsection (b);

(2) Evidence of satisfactory performance;

(3) The application fee required under Business and Professions Code Section 1300 and Health and Safety Code Section 116.

(b) A complete application for a cytotechnologist license shall include the following verified information on a form, Application for Cytotechnologist License (LAB 124, Rev. 11/93), provided by the Department:

(1) Name, address, social security number (optional), and ASCP registration number, if any, of the applicant; and

(2) The applicant's education, training and experience in gynecological and non-gynecological cytology including:

(A) An official copy of any and all college credits including a statement of any degrees conferred; and

(B) Documentation of each of the following, if completed or obtained by the applicant:

1. The completion of a 12 month training program approved by CAAHEP or its equvalent, or

2. The completion of five years of full-time, of at least 40 hours a week, clinical laboratory experience in cytology;

3. ASCP registration certificate;

4. Licensure by the Department under Business and Professions Code section 1270 subsection (c) or subsection (d); and

(3) The name and address of the applicant's current laboratory employer(s), and the number of hours employed (by each) and the time devoted, and volume of types of specimens examined at each location.

(c) Within 30 calendar days of receipt of an application for a cytotechnologist license, the Department shall inform the applicant in writing that the application is either complete and accepted for filing or that it is incomplete and what specific information is required before the application may be accepted for filing.

(d) Within 90 calendar days from the date the Department receives the information and documentation required in subdivision (a), it shall inform the applicant in writing whether a cytotechnologist license shall be issued or denied. If a license is denied, the Department shall indicate the reasons therefor.

(e) The Department's time periods for processing an application for cytotechnologist license, from receipt of the initial application to the final decision regarding the license, are as follows:

(1) The median time for processing is 240 calendar days.

(2) The minimum time for processing is 120 calendar days.

(3) The maximum time for processing is 360 calendar days.

(f) Each licensed cytotechnologist shall notify the Department within 30 calendar days of any and all changes in his or her employment, including any changes in the name and address of his or her employer(s), the hours employed by each, and the information specified in subsection (b)(3) above.

NOTE

Authority cited: Sections 1224, 1270 and 1271(f), Business and Professions Code. Reference: Sections 1270, 1271 and 1300, Business and Professions Code; Section 15376, Government Code; and Section 116, Health and Safety Code.

HISTORY

1. New section filed 11-18-93 as an emergency; operative 11-18-93 (Register 93, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-18-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 11-18-93 order transmitted with amendment of subsection (b)(2)(B)1 to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 17).

§1062. Cytotechnologist Competency Testing Services Or Programs.

Note • History

(a) Any organization seeking approval by the Department as a cytotechnologist competency testing service or program shall submit an application to the Department which shall include documentation of the following:

(1) The organization's name, address, and owner(s);

(2) The organization's mechanism for assuring that each individual for whom a cytotechnologist competency testing examination is administered meets the criteria as an examinee;

(3) The organization's mechanism for assuring that each cytotechnologist competency examination administered by the organization shall test each examinee on his or her entry level skills and understanding of:

(A) The underlying scientific principles and the technical and procedural aspects of cytology;

(B) The identification of cellular changes in gynecologic and non-gynecologic specimens through both a written and visual component;

(D) Cytology laboratory operations, and that each test shall include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both genital system and breast); 13%-17% respiratory system; 9%-12% male and/or female genitourinary system; 6%-10% alimentary system; and 13%-17% body cavity fluids and other body sites;

(4) The organization's mechanism for determining the validity and passing score for each cytotechnologist competency examination administered by the organization in order that there is a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and,

(5) The organization's mechanism for assuring the security of each cytotechnologist competency examination administered by it.

(b) Upon receipt of the above, and the determination by the Department that the documentation provides assurances of the following, the Department shall approve the organization as a cytotechnologist competency testing service or program and shall issue an approval document indicating the terms of the organization's approval:

(1) The organization shall only administer cytotechnologist competency examinations to persons who qualify as an examinee;

(2) Each cytotechnologist competency examination administered by the organization shall challenge each examinee on his or her entry level skills and understanding of the subjects, and shall contain the subject matter in the ratios identified in subsection (a) (3), above;

(3) Each cytotechnologist competency examination administered by the organization shall be validly constructed and have a passing score that fosters a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and,

(4) Each cytotechnologist competency examination shall be administered in a secure fashion.

(c) Within 15 days of receipt of an application by an organization for approval as a cytotechnologist competency testing service, the Department shall inform the organization in writing that the application is complete and accepted for review or deficient and what specific information or documentation is required to complete the application.

(d) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as a cytotechnologist competency testing service or program.

(e) The Department's time periods for processing an application for approval as a cytotechnologist competency testing service or program, from the receipt of the initial application to the final decision regarding the approval, are as follows:

(1) The median time for processing is 90 calendar days.

(2) The minimum time for processing is 45 calendar days.

(3) The maximum time for processing is 135 calendar days.

(f) Cytotechnologist competency testing services or programs shall issue a document to each examinee who obtains a passing score on each cytotechnologist competency examination administered by the service or program.

(g) Cytotechnologist competency testing services or programs shall maintain, for a minimum of five years, and shall make available to the Department, records showing the validation, content, passing score, date and place of each competency testing examination administered by it, and a record of each examinee tested.

(h) A cytotechnologist competency testing service or program shall be subject to review by the Department to determine adherence to the requirements of this article and its approval. Failure of a cytotechnologist competency testing service or program to meet the requirements of this article or its terms of approval shall constitute good cause for revocation of approval by the Department.

NOTE

Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code; and Section 15376, Government Code.

HISTORY

2. Certificate of Compliance as to 11-18-93 order transmitted with amendment of subsection (a)(3)(D) to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 17).

Article 8. Enforcement

§1065. Imposition of Sanctions.

Note • History

(a) The department may impose, as applicable, one or more of the following sanctions on a clinical laboratory, a public health laboratory or a provider of service:

(1) Principal sanctions.

(2) Intermediate sanctions.

(3) Alternative sanctions.

(4) Automatic suspension of a license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate.

(5) State-initiated exclusions from the Medicaid and Medi-Cal programs.

(6) Exclusion from ownership or operation for two years following license or registration revocation.

(7) Civil suit to enjoin statutory or regulatory violations.

(8) Criminal sanctions for unlawful activity.

(9) Automatic revocation of license/registration or other approval based on intentional referral of proficiency testing samples for analysis.

(10) Suspension of Medi-Cal and Medicaid payments for failure to permit an inspection.

(b) The department's decision to impose sanctions shall be based on one or more of the following:

(1) Deficiencies found by the department or its agents in the conduct of inspections or through review of materials submitted by a laboratory (e.g., personnel qualifications).

(2) Unsuccessful participation in proficiency testing.

(c) The department shall base its choice of sanction or sanctions to impose on consideration of one or more factors that include, but are not limited to, the following, as assessed by the department or its agents:

(1) Whether the deficiencies pose immediate jeopardy.

(2) The nature, incidence, severity, and duration of the deficiencies or noncompliance.

(3) Whether the same condition level deficiencies have been identified repeatedly.

(4) The accuracy and extent of laboratory records (e.g., of remedial action) in regard to the noncompliance, and their availability to the department, to its agents, or to the United States Health Care Financing Administration and its agents.

(5) The relationship of one deficiency or group of deficiencies to other deficiencies.

(6) The overall compliance history of the laboratory.

(7) The corrective and long-term compliance outcomes that the department hopes to achieve through application of the sanction.

(8) Whether the laboratory has made any progress toward improvement following a reasonable opportunity to correct deficiencies.

(d) The department shall impose a separate sanction for each condition level deficiency or a single sanction for all condition level deficiencies that are interrelated and subject to correction by a single course of action.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

1. New article 8 (sections 1065-1067.15) and section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.5. Principal Sanctions.

Note • History

(a) The department may impose on a clinical laboratory the principal sanctions of denial, revocation or suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code whenever it determines that any of the grounds identified in Business and Professions Code section 1320 exist and it has complied with the requirements of Business and Professions Code sections 1267 and 1322. A clinical laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A clinical laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code.

(b) The department may impose on a public health laboratory the principal sanctions of denial, revocation or suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code whenever it determines that the requirements identified in 17 CCR section 1078 are not being met and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code. A public health laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its approval to operate may defend itself by filing a notice of defense in accordance with section 11506 of the Government Code. A public health laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code.

(c) The department may impose on a provider of service the principal sanction of suspension from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs whenever it determines that any of the grounds identified in Welfare and Institutions Code section 14123 exist and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director. A provider of service that has had an Accusation filed against it for its suspension from further participation in the Medi-Cal program may defend itself, its owner(s) or director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A provider of service that is dissatisfied with a final decision regarding suspension from further participation in the Medi-Cal program may seek judicial review in accordance with section 11523 of the Government Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.10. Intermediate Sanctions.

Note • History

(a) The department may impose on a clinical laboratory the intermediate sanction of temporary suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code based on a departmental finding of immediate jeopardy or other grounds identified in Business and Professions Code section 1323. The intermediate sanction becomes effective upon the serving of an Accusation. A clinical laboratory that has had an Accusation filed against it for temporary suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 1323 of the Business and Professions Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A clinical laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.

(b) The department may impose on a public health laboratory the intermediate sanction of temporary suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code based on a departmental finding of immediate jeopardy. The intermediate sanction becomes effective upon the serving of an Accusation. A public health laboratory that has had an Accusation filed against it for temporary suspension of its approval may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A public health laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.

(c) The department may impose on a provider of service the intermediate sanction of temporary suspension from participation in, including reimbursement from, the Medi-Cal and Medicaid programs based on a departmental finding of immediate jeopardy or condition level deficiencies and when in the opinion of the director of the department such action is necessary to protect the public welfare or the interests of the Medi-Cal program. The intermediate sanction becomes effective upon the serving of an Accusation. A provider of service that has had an Accusation filed against it for temporary suspension from participation in the Medi-Cal program may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A provider of service that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.15. Alternative Sanctions.

Note • History

(a) The department may impose on a clinical laboratory one or more of the following alternative sanctions in lieu of or in addition to imposing a principal sanction:

(1) Directed plans of correction, as set forth in section 1067.

(2) Onsite monitoring, as set forth in section 1067.10.

(3) Civil money penalties, as set forth in section 1067.5.

(b) Prior to the imposition of an alternative sanction a clinical laboratory shall be given a Notice of Intent and an opportunity to respond. A clinical laboratory that is dissatisfied with the imposition of an alternative sanction may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.20. Automatic Suspension.

Note • History

The department shall automatically suspend a clinical laboratory license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate. A clinical laboratory that is dissatisfied with the imposition of an automatic suspension may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.25. State-Initiated Exclusions from Medicaid and Medi-Cal.

Note • History

The department may initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a permissive exclusion under 42 CFR part 1002 exist. The department shall initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a mandatory exclusion under 42 CFR part 1002 exist. Before imposing an exclusion, the department shall give a provider of service an opportunity to submit documents and written argument against the exclusion. A provider of service that is dissatisfied with the imposition of an exclusion may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.30. Exclusion from Ownership or Operation.

Note • History

The department shall exclude for a period of two years following revocation any person or entity from owning, operating, or directing a laboratory, whenever the person or entity has been the owner, operator or laboratory director of a clinical laboratory that has had its clinical laboratory license or registration revoked. A person or entity that is dissatisfied with the imposition of an exclusion from owning or operating a clinical laboratory may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.35. Civil Suit to Enjoin Violations.

Note • History

The department shall initiate a civil suit whenever such suit is necessary to enjoin the violation or threatened violation of chapter 3 (commencing with section 1200) of the Business and Professions Code or the regulations adopted thereunder. A person or entity against whom a civil suit is filed shall have all the rights of defense afforded by California civil law.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.40. Criminal Sanctions for Unlawful Activity.

Note • History

The department may refer for prosecution to the Attorney General's office or a District Attorney's office, when appropriate, any person or entity it has reason to believe has engaged in any of the unlawful activities identified in sections 1280 through 1287, inclusive of the Business and Professions Code. A person or entity against whom a criminal action is filed shall have all the rights of defense afforded by California criminal law.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC , Section1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1065.45. Revocation for Referral of Proficiency Testing Samples.

Note • History

If the department determines that a laboratory has intentionally referred proficiency testing samples to another laboratory for analysis, it shall take action to revoke the license/registration or other approval for at least one year and may take action to impose any other available sanction.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1066. Condition Level Requirements.

Note • History

(a) Any requirement specified in subsections (b) through (i) shall constitute a condition level requirement.

(b) Each clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain and maintain a valid clinical laboratory license issued pursuant to section 1265 of the Business and Professions Code.

(1) A sufficient number of laboratory personnel with the appropriate education and either experience or training to:

(A) Provide appropriate direction, supervision and consultation;

(B) Accurately perform tests; and

(2) Laboratory personnel who meet the personnel qualifications, duties, and responsibilities required in CLIA and sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and Professions Code.

(d) Each clinical laboratory shall:

(1) Enroll in a proficiency testing program approved by the department or by the United States Health Care Financing Administration if required to enroll under Business and Professions Code section 1220(a)(2)(A); and if required to enroll, demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, to the same extent as required under CLIA,

(2) Authorize its proficiency test results to be reported to the department in an electronic format that is compatible with the department's proficiency testing data monitoring system, and

(3) Authorize the release of proficiency tests results to the public to the same extent required by CLIA.

(e) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(A) shall establish and maintain a patient test management system that meets the standards of CLIA;

(f) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(B) shall:

(1) Establish and maintain a quality control program that meets the requirements of CLIA,

(2) Perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer's instructions.

(g) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(C) shall:

(1) Establish and maintain a comprehensive quality assurance program that meets the standards of CLIA,

(2) Maintain records, equipment, and facilities that are adequate and appropriate for the services rendered,

(3) Be conducted, maintained and operated without injury to the public health, and

(4) If providing cytology services and its licensee ceases operation, preserve

(A) Records,

(B) Reports,

(D) Cell blocks as prescribed in subdivision (g) of section 1271 and section 1274 of the Business and Professions Code.

(h) Each licensed or registered clinical laboratory shall submit to the inspections identified in Business and Professions Code section 1220, which inspections may be conducted by department employees or contractors, or the United States Health Care Financing Administration (HCFA), or HCFA agents. The department may conduct announced or unannounced inspections of any premises, building, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of chapter 3 of division 2 of the B&P Code. A clinical laboratory shall permit, as part of this inspection, the department or its contractors or agents to:

(1) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto. (The laboratory shall make all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.);

(2) Secure any sample, photograph, or other evidence from any building or premises for the purpose of enforcing chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto;

(3) Observe laboratory personnel performing tests (including proficiency testing), data analysis and reporting;

(4) Interview all personnel of the clinical laboratory concerning compliance with chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder;

(5) Upon request, review all information and data necessary to:

(A) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health;

(B) Evaluate complaints from the public; and

(C) Determine whether or not the laboratory is performing tests without a license or registration applicable to the category of tests or examinations being performed; and

(6) Provide copies to the department or its contractors or agents of all records and data required under chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder.

(i) Each laboratory shall comply with the requirements identified as “conditions” in subparts G through P of CLIA.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Reference: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1067. Procedures for the Imposition of Directed Plans of Correction.

Note • History

(a) The department may impose a directed plan of correction as an alternative sanction for any clinical laboratory that has condition level deficiencies.

(b) If the department is imposing a directed plan of correction, the following procedures shall apply:

(1) The department shall give the laboratory a written Notice of Intent to impose a directed plan of correction. The Notice of Intent shall include the following:

(A) The condition level deficiency that has been identified,

(B) The sanction or sanctions that the department proposes to impose against the laboratory,

(D) The projected effective date and duration of the proposed sanction or sanctions,

(E) The authority for the proposed sanction or sanctions, and

(F) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.)

(2) After the period specified in (b)(1)(F) has elapsed, the department shall give the laboratory a written Notice of Sanction to impose a Directed Plan of Correction that acknowledges any evidence or information received from the laboratory and specifies the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions,

(D) A direction to the laboratory to take specific corrective action within specific time frames in order to achieve compliance.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b)(1)(F), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1067.5. Procedures for the Imposition of Civil Money Penalties.

Note • History

(a) The department may impose civil money penalties as an alternative sanction for any clinical laboratory that has condition level deficiencies.

(b) If the department is imposing civil money penalties, the following procedures apply:

(1) In determining the amount of the penalty, the department shall take into account the following factors:

(A) The nature, scope, severity, and duration of the deficiency or noncompliance.

(B) Whether the same condition level deficiencies have been identified during prior inspections.

(D) The accuracy and extent of laboratory records and their availability to the department or its contractors or agents.

(2) For a condition level deficiency that does not pose immediate jeopardy, the range of the penalty amount shall be $50-$3,000 per day of noncompliance or per violation. The department may, before any hearing, propose to increase the penalty amount into the range specified in (b)(3) for a laboratory that has deficiencies which, after imposition of a lower penalty amount, become sufficiently serious to pose immediate jeopardy.

(3) For a condition level deficiency that poses immediate jeopardy, the range of the penalty shall be $3,050-$10,000 per day of noncompliance or per violation. If the immediate jeopardy is removed, but the deficiency continues, the department shall shift the penalty amount to the range specified in (b)(2).

(4) The department shall send the laboratory written notice of intent to impose a civil money penalty. The notice shall include the following information:

(A) The statutory basis for the penalty,

(B) The proposed daily or per violation amount of the penalty,

(D) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.)

(5) After the period specified in (b)(4)(D) has elapsed, the department shall give the laboratory a written Notice of Sanction that acknowledges any evidence or information received from the laboratory and specifies the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions,

(D) A specific statement regarding the laboratory's appeal rights and a Notice of Defense in the following form: Unless a written request for a hearing signed by the laboratory owner(s) or director(s) is delivered or mailed to the department within 15 days after the Notice of Sanction was mailed, the department may proceed upon imposition of the sanctions identified in the Notice of Sanction without a hearing. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of the proceedings.

(6) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director.

(7) The effective date of an alternative sanction of a civil money penalty shall be delayed if the laboratory has appealed and the hearing or the hearing decision is pending.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Section 11505, Government Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b)(4)(D), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1067.10. Procedures for the Imposition of On-site Monitoring.

Note • History

(a) The department may require continuous or intermittent monitoring of a plan of correction to ensure that the laboratory makes the improvements necessary to bring it into compliance with the condition level requirements.

(b) The laboratory shall pay the costs of on-site monitoring by the department.

(1) The department shall provide written notice of the following:

(A) The condition level noncompliance that it has identified,

(B) The sanction or sanctions that the department proposes to impose against the laboratory,

(D) The projected effective date and duration of the proposed sanction or sanctions,

(E) The authority for the proposed sanction or sanctions, and

(F) The time allowed for the laboratory to respond to the notice. [During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.]

(2) After the period specified in (c)(1)(F) has elapsed, the department shall give the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions, and

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§1067.15. Procedures for the Imposition of a Temporary Suspension of a Laboratory or Clinical Laboratory under the Medi-Cal Program.

Note • History

(a) The department may impose a Temporary Suspension on a provider of laboratory services prior to hearing if the laboratory has condition level deficiencies or there is immediate jeopardy and in the director's opinion such action is necessary to protect the public welfare or the interests of the Medi-Cal program.

(b) If the department is imposing a Temporary Suspension on a provider of service, the following procedures apply:

(1) The department shall serve the laboratory with a Notice of Sanction which includes the following information:

(A) The sanction or sanctions to be imposed against the laboratory, and

(B) The effective date and duration of sanction.

(2) At the same time as the Notice of Sanction is served, the department shall serve the laboratory with an Accusation. Included with the Accusation is a Notice of Defense in the following form: Unless a written request for a hearing signed by the owner(s) or director(s) of the laboratory is delivered or mailed to the department within 15 days after the Notice of Sanction and Accusation were served, no hearing shall be held regarding the imposition of the sanctions identified in the Notice of Sanction. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of these proceedings.

(3) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director.

(4) The effective date of a Temporary Suspension of a clinical laboratory or laboratory under the Medi-Cal program shall not be delayed because the laboratory has appealed the sanction under (b)(3), above, and the hearing or the hearing decision is pending.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c.510, Section 1; Section 1265, Business and Professions Code; Section 14123, Welfare and Institutions Code; 42 United States Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act); and Sections 11503, 11505 and 11506, Government Code.

HISTORY

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

Group 3. County and Municipal Laboratories

Article 1. Official Public Health Laboratory Service Required

§1075. Local Health Departments.

Note • History

Each local health department shall have available the services of an official public health laboratory. The laboratory of the State Department of Health is hereby designated as the official laboratory for all local health department jurisdictions not covered by local laboratory service.

NOTE

Authority cited for Article 1: Sections 208, 1000, and 1002 of the Health and Safety Code. Reference: Sections 1000 and 1002, Health and Safety Code. Issuing agency: State Department of Public Health.

HISTORY

1. Article 1 (§§ 1075 to 1085, inclusive) originally published 8-15-45 (Title 17).

2. Revised Article 1 (§§ 1075 to 1084, inclusive) filed 10-26-49 (Register 18, No. 4).

3. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1076. Certificates of Approval Required.

History

A certificate of approval issued after inspection by the Department shall be required to be in the possession of and be on display in every principal and branch public health laboratory and no such laboratory shall continue to operate following receipt of notice of cancellation of any existing certificate, or of refusal of the Department to issue a certificate.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

2. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1076.1. Public Health Laboratory.

Note • History

The official public health laboratory shall consist of a principal public health laboratory and may include branch public health laboratories.

(a) The principal public health laboratory is the laboratory facility that provides the major or total laboratory services to a public health department.

(b) A branch public health laboratory is any laboratory facility that provides minor or auxiliary laboratory services.

NOTE

Authority cited: Sections 208, 1000 and 1002, Health and Safety Code. Reference: Sections 1000 and 1002, Health and Safety Code.

HISTORY

1. New section filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1077. Reports Required.

Note • History

The following reports shall be transmitted to the Department by all laboratories approved under Section 1076. Standard forms shall be used if provided by the Department.

(a) A report shall be made semiannually during the months of January and July, of work load data and personnel information as requested by the Department.

(b) A report shall be given within 30 days:

(1) Of any change in the directorship of the laboratory.

(2) Of any proposed expansion, reduction or shift in laboratory services.

(3) Of any change in the location of the laboratory.

NOTE

Authority cited: Sections 208 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. Amendment filed 8-3-67; effective thirtieth day thereafter (Register 67, No. 31).

2. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

3. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

4. Editorial correction of NOTE filed 11-5-84 (Register 84, No. 45).

§1078. Minimum Requirements Specified.

History

Any laboratory approved under Section 1076 shall meet the following minimum requirements:

(a) Maintain adequate equipment and facilities and sufficient personnel to carry on dependable public health laboratory work.

(b) Employ procedures, technics, and reporting practices approved by the Department.

(d) Conduct, maintain, and operate programs, acceptable to the Department, for controlling the quality of test performance.

(e) Demonstrate satisfactory performance in a proficiency testing program approved by the Department.

(f) Maintain and conduct the laboratory in a manner approved by the Department.

(g) Employ personnel as provided in this article.

(h) Accept specimens for examination as an aid to patient management only from, and issue reports only to, persons licensed under the provisions of the law relating to the healing arts or their representatives.

(i) Employ procedures and precautions to provide for the safety and health protection of all persons in the laboratory.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

2. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1079. Professional Personnel to Be Certified.

Note • History

(a) No person may act as a Public Health Microbiologist in any laboratory certified under Section 1076 who is not in possession of a Public Health Microbiologist's Certificate issued by the Department.

(b) The Department may issue temporary certificates to applicants who meet the requirements for admission to the next scheduled examination when this is deemed to be reasonably necessary for the provision of public health laboratory services. Temporary certificates may not be issued to applicants who have failed to pass certification examinations.

(c) Examinations, either written or oral, or both, for the certificate of Public Health Microbiologist shall be held as needed and where designated by the Department. Such examinations shall be under the supervision of the Department.

(d) The minimum requirements for admission to the examinations for a certificate as Public Health Microbiologist shall be as follows:

(1) Holds an earned doctoral degree from an accredited institution with a chemical, physical or biological science as a major, and has completed at least one year of postdoctoral laboratory training in medical and public health microbiology approved by the Department; or

(2) A baccalaureate or higher degree with a major in Medical or Public Health Microbiology, or equivalent major as determined by the Department, with courses acceptable to the Department, from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department; and experience represented by at least six months as a Public Health Microbiologist-trainee in a public health laboratory approved by the Department for such training; or experience equivalent to this training as determined by the Department in a laboratory acceptable to the Department.

(e) No person shall perform any test or make any examination in any laboratory certified under Section 1076 unless he is in possession of a valid Public Health Microbiologist's certificate or is otherwise approved by the Department to perform specified laboratory procedures.

(f) Every person certified as a Public Health Microbiologist shall report to the Department within 30 days any change of name or mailing address giving both the old and new names and addresses.

(g) Certificates may be denied, revoked or suspended for any of the following reasons:

(1) Conviction of a felony or of any misdemeanor involving moral turpitude, under laws of any State or of the United States, arising out of or in connection with public health laboratory practice. The record of conviction or a certified copy thereof shall be conclusive evidence of such conviction.

(2) Violation of any provision of the Business and Professions Code governing the practice of medicine and surgery.

(3) Violation of these regulations.

(4) Knowingly making a false statement concerning a material matter on an application for certification, or on an application for approval as a trainee.

(5) The use of any degree, certificate or title in any manner, which has been purchased or procured by barter or any unlawful means or obtained from any institution which at the time said degree, certificate or title was obtained was not recognized or accredited by the proper authorities of the state where said institution was located to give training in the field of study in which the degree, certificate or title is claimed.

(6) The use of drugs or alcoholic beverages to the extent, or in such a manner, that such use impairs the ability of the certified person to practice his profession with safety to other persons in the laboratory or to the public.

(h) Proceedings under paragraph (g) above shall be conducted in accordance with Chapter 5, Part 1, Division 3 of Title 2 of the Government Code.

NOTE

Authority cited: Section 1224, Business and Professions Code; Section 208, Health and Safety Code. Reference: Section 1270, Business and Professions Code; Section 1002, Health and Safety Code.

HISTORY

1. Amendment of subsection (d) filed 12-12-78; effective thirtieth day thereafter (Register 78, No. 50). For prior history, see Register 77, No. 4.

2. Amendment of subsection (d)(2) filed 10-24-80; effective thirtieth day thereafter (Register 80, No. 43).

§1080. Professional Training.

History

(a) For purposes of this section a person receiving professional training required for certification as a Public Health Microbiologist shall be designated as a Public Health Microbiologist-trainee.

(b) The credentials of a Public Health Microbiologist-trainee shall be approved by the Department prior to appointment.

(c) The appointment or separation of a Public Health Microbiologist-trainee shall be reported within 5 days to the Department giving the date of appointment or separation.

(d) Laboratories which accept personnel for training as Public Health Microbiologist-trainees shall be specifically approved for such training by the Department. The minimum requirements for approval as training laboratories shall be established by the Department.

(e) A Public Health Microbiologist-trainee shall not be entrusted with any microbiological examination except under the supervision of qualified personnel, nor shall he issue or sign a laboratory report for any test which he is scheduled for training for certification as a Public Health Microbiologist.

HISTORY

1. Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No. 5).

2. Renumbering of Section 1081 and amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

3. Amendment of subsection (e) filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1081. Certain Cultures and Specimens to Be Sent to the State Laboratory.

History

(a) All laboratories making examinations for identification of typhoid carriers shall, in all positive cases, forward to the Department a culture of the organism, the isolation of which established the diagnosis.

(b) Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human cases of plague or botulism such laboratory shall communicate immediately by telephone or telegraph with the Department for instructions.

(c) Any other specimens or cultures shall be submitted as required by the communicable disease regulations, Sections 2500 to 2699.

HISTORY

1. Renumbering of Section 1079 and amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

2. Amendment of subsection (c) filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1082. Certain Specimens to Be Sent to Approved Laboratories.

History

Whenever specimens are taken for laboratory diagnosis of rabies or botulism, or for release from isolation of cases of diphtheria, typhoid fever, salmonellosis, or shigellosis, they shall be sent by the physician to a Public Health Laboratory approved for such work by the Department in accordance with Section 1076.

HISTORY

1. Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No. 5).

2. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

3. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

§1083. Inspections to Be Made.

History

Laboratories approved under Section 1076 shall be inspected by a duly authorized representative of the Department, for maintenance and conduct in conformity with these regulations. When deemed advisable, the Department may send check specimens to local laboratories to evaluate the accuracy and precision of specific test performance.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

§1084. Health Departments May Contract with Private Laboratories.

History

A health officer of a municipality or county may designate any laboratory as an official public health laboratory to perform any of the basic services, as defined under Section 1276(f). Any such laboratory shall be subject to the same requirements as an official public health laboratory as heretofore provided under Sections 1075 to 1083, inclusive.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

2. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

Group 4. Tests for Syphilis Under the Premarital and Prenatal Laws

Article 1. Serologic Tests

§1125. Application Required.

Note • History

The director of any laboratory in which performance of serologic tests is planned in connection with premarital and prenatal examinations, as required by Sections 4300-4309 of the Civil Code and Sections 3220-3229 of the Health and Safety Code, shall apply to the State Department of Health for approval to perform these tests. The laboratory director shall submit to the State Department of Health, on forms provided by the department, such information as may be required by the department to satisfactorily evaluate the personnel, equipment, and scope of activity in relation to these tests.

NOTE

§§ 1125 to 1134, inclusive, originally issued under authority contained in Section 79.04, Civil Code, and Deering's General Laws, Act 6265. Source of §§ 1125 to 1134, inclusive, is the Rules and Regulations issued by State Department of Health. Additional authority cited for revision of Article 1: Sections 102 and 208, Health and Safety Code. Reference: Sections 3180-3199 and 3220-3229, Health and Safety Code.

HISTORY

1. Amendment filed 10-5-71 as procedural and organizational; effective upon filing (Register 71, No. 41). For prior history, see Register 60, No. 19.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

§1126. Approved Tests.

Note • History

The serologic tests for syphilis approved by the Department for use in connection with legally required premarital and prenatal examinations are as follows: VDRL slide, Automated Reagin, Fluorescent Treponemal Antibody (absorption), Reagin Screen, and the Rapid Plasma Reagin (circle) Card. Any one of these tests shall constitute the “standard test” as required by the California Civil Code and California Health and Safety Code.

The serologic tests for rubella approved by the department for use in connection with legally required premarital examinations shall be the hemagglutination-inhibition (HI) test performed according to the standard method of the U.S. Public Health Service, Center for Disease Control, or modifications thereof approved by the Center for Disease Control and the Department, and such other tests approved by the Center for Disease Control and Food and Drug Administration, U.S. Public Health Service, as the Department may evaluate and determine to be equal in reliability and specificity to the approved hemagglutination-inhibition test.

Commercially prepared antigens and diagnostic kits utilized for the approved rubella tests shall have been evaluated by, and shown to meet specifications of the U.S. Public Health Service and such evaluation shall be evidenced by a statement on the label of, or accompanying, the product.

NOTE

Authority cited: Section 11426, Government Code; Sections 4300, 4301, 4302 and 4304, California Civil Code; Sections 102 and 208, Health and Safety Code. Reference: Sections 3180-3199 and 3220-3229, Health and Safety Code.

HISTORY

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26). For prior history, see Register 71, No. 34.

2. Amendment filed 8-17-78; effective thirtieth day thereafter (Register 78, No. 33).

§1127. Method of Conducting Tests.

History

All tests for syphilis must be conducted exactly as outlined by the author of the test. All equipment recommended by the author of the test must be available in the laboratory before approval can be granted.

For syphilis serology, the latest United States Department of Health, Education and Welfare, Public Health Service publication pertaining to the performance of these tests, or its replacement, shall be the reference on equipment and methods.

All tests for rubella must be conducted exactly according to the protocols for each method or modification that has been approved by the Center for Disease Control and the Department. All necessary equipment for the approved rubella test to be performed must be available in the laboratory before approval to perform legally required tests can be granted.

The references for approved rubella test methods and equipment shall be protocols issued by the Center for Disease Control, or the Department, or provided by manufacturers for use with commercially distributed diagnostic kits or components which have been approved by the Center for Disease Control and the Department.

HISTORY

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 19). See history note to Section 1125.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

3. Amendment filed 8-17-78; effective thirtieth day thereafter (Register 78, No. 33).

§1128. Evaluation Sera.

History

Any laboratory approved to perform premarital and prenatal serologic tests must accept and test, evaluation sera provided by the department or a proficiency testing service approved by the department, and report test results to the department. Any laboratory showing unsatisfactory performance shall make changes as recommended by the department or discontinue the testing of legally required premarital and prenatal blood specimens, and return all outstanding “Marriage Health Certificates.”

HISTORY

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 19). See history note to Section 1125.

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 71, No. 7).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 66, No. 34).

§1129. Marriage Health Certificates.

History

“Marriage Health Certificates” shall be assigned by the State Department of Public Health to an individual laboratory at a specified location, and shall be used by no other. These certificates must not be transmitted to the physician until the tests have been performed.

HISTORY

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26). For prior history, see Register 66, No. 7.

§1130. Persons Permitted to Perform Tests.

Note • History

Only a person who is duly licensed as a physician and surgeon pursuant to Sections 2000-2497 of the Business and Professions Code, or duly authorized under the provisions of Chapter 3, Division 2 (commencing with Section 1200) of the Business and Professions Code, or who is certified under the provisions of Sections 1075-1084 of Title 17 of the California Administrative Code, shall be permitted to conduct premarital and prenatal serologic tests.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3220, 4300 and 4302, Health and Safety Code.

HISTORY

1. Amendment filed 2-18-58; effective thirtieth day thereafter (Register 58, No. 3). See history note to Section 1125.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

§1131. Change of Personnel.

History

Within 30 days after new personnel are employed to perform legally required prenatal and premarital serologic tests, their names shall be transmitted to the State Department of Health. This rule does not apply to the rotation of staff members from one phase of laboratory work to another.

HISTORY

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 19). See history note to Section 1125.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

§1132. Change of Director or Location.

History

Reapplication for approval to perform legally required premarital and prenatal serologic tests shall be made when there is a change of laboratory director or location.

HISTORY

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

§1133. Advertising Prohibited.

Laboratories shall not be approved to perform premarital and prenatal serologic tests if they advertise the performance of these tests to the lay public.

§1134. Withdrawal of Approval.

History

Approval granted under this article may be withdrawn following violation of any of the provisions of Sections 1125-1134 of Title 17 of the California Administrative Code, Sections 3220-3229 of the Health and Safety Code, Sections 4300-4309 of the Civil Code pertaining to the performance of premarital and prenatal serologic tests and all outstanding “marriage health certificates” shall be returned to the State Department of Public Health.

HISTORY

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 19). See history note to Section 1125.

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 66, No. 7).

3. Amendment filed 10-5-71 as procedural and organizational; effective upon filing (Register 71, No. 41).

Group 5. Care of Laboratory Animals

Article 1. Definitions

§1150. Definitions.

History

(a) For purposes of these regulations, “person” includes: laboratory, firm, association, corporation, copartnership, and educational institution.

(b) For purposes of these regulations, “board” means: the State Department of Health Services.

(d) For purposes of these regulations, “animal” means: any live, warm-blooded animal kept or used by any person for the purposes defined herein.

(e) For purposes of these regulations, “individual” means: the one whom the laboratory, firm, association, corporation, copartnership or educational institution designates as being responsible for proper care of the animals kept or used for experimentation, demonstration, or test; the propriety of the procedures used; and the scientific justification for the use of the animals in experiments, demonstrations, or tests.

HISTORY

1. New Group 5 (§§ 1150 through 1159) filed 3-28-52; effective thirtieth day thereafter (Register 28, No. 1). For history of previous Group 5, see Register 26, No. 7.

Article 2. Certification Requirements

§1151. Issuance of the Certificate of Approval.

(a) All persons desiring to keep or use animals for the study, diagnosis, and treatment of human and animal diseases, for education or research in the advancement of veterinary, dental, medical, and biological sciences for education and research in animal and human nutrition, and for the testing and diagnosis, improvement and standardization of laboratory specimens, biologic products, pharmaceuticals and drugs shall make application to the department on the forms provided by the department for a certification of approval for such activities. They shall supply such other information as may be required by the department for the establishment, and its physical facilities with respect to the care of animals as related to the intent and purpose of this law.

(b) Certificates of approval shall not be issued to any person unless he is at the time of application prepared and equipped to keep and use the animals in accordance with the provisions of this law, and rules and regulations of the board adopted in accordance thereof. The department will provide anyone contemplating keeping or using animals information concerning the requirements and conditions for the compliance with the law.

(c) Each applicant for certification shall designate an individual who will be directly responsible for the use and care of animals and for making appropriate reports thereof. Such individuals shall occupy a responsible position of authority in the applicant organization. A certified institution which transfers such responsibility shall immediately notify the department of such fact. The department may deny any application unless it is satisfied that the responsible individual so designated is qualified and will require that the animals kept or used by the applicant be used and cared for in a humane manner acceptable to this department.

(d) A certificate of approval must be obtained for each address or campus where animals are kept or used for the purposes specified in this law.

(e) A new application or amendment to existing and approved application must be made for any change of the responsible individual, or change in location of the laboratory or animal quarters.

(f) Any major change in equipment or methods of management must be approved in advance by the department.

(g) The certificate of approval or duplicate thereof as supplied by the department shall be displayed in a prominent place in the approved animal quarters or approved laboratory.

(h) A certificate of approval shall not be issued unless the conditions of the establishment and facilities are such as to reasonably insure that the animals kept or used receive humane care and treatment.

(i) Denial, revocation, or suspension of certificates of approval must be in accordance with the provisions of the Administrative Procedure Act.

§1152. Fees.

(a) The application and renewal fees must be in accordance with the provisions of Article 5 of Chapter 5 of Division 2 of the Health and Safety Code.

(b) For the purpose of these regulations the fiscal year shall be from January 1st to December 31st.

§1153. Application for Renewal of Certificate of Approval.

(a) Application for renewal of certificates of approval shall be on forms provided by the department.

(b) Each holder of a certificate applying for renewal of his certificate of approval shall be subject to a review of his activities during the previous licensing period and to such inspections of his records, premises, equipment, and animals as may be determined by the department for consideration by the board in passing upon the application for renewal.

§1154. Records.

Holders of certificates of approval shall keep the following records:

(a) Monthly census of animals kept according to type;

(b) Total number of animals used per month according to type;

Such records may be open to inspection by authorized agents of the department during the normal working hours of operation.

Article 3. Minimum Standards

§1155. Care and Treatment of Animals.

(a) Careful consideration shall be given to the bodily comfort of such animals. They shall be kindly treated, properly fed, and their quarters shall be clean, properly lighted and maintained at the proper temperature. Exception may be made to this rule only with expressed permission of the responsible individual. This permission may be granted only when the foregoing considerations would defeat the purpose of the work.

(b) Any operation likely to cause greater discomfort than the attending anesthetization shall not be undertaken until the animal be first rendered incapable of perceiving pain. The animals shall be maintained in that condition until the operation is completed. Exceptions to this rule may be made only when provisions for maximum comfort including anesthesia would defeat the object of the experiment, and then only with the expressed permission of the responsible individual.

(c) At the conclusion of experiments, the animals must be killed painlessly or given care to minimize discomfort which is essentially equivalent, as determined by the department, to that rendered human beings following an operation. In any event, animals which have been used for any purpose described herein shall not be disposed of as pets, except with the expressed permission of the responsible individual. Due consideration in this master shall be given to public health and to the animal's welfare.

§1156. Quarters.

The animal quarters shall be provided with proper lighting, ventilation, and heating to maintain comfort of the animal except where the provisions of Section 1155 otherwise provide. Equipment must be adequate for the proper care and treatment of all animals kept or used. Cages, or other enclosures, shall be large enough to permit reasonable freedom of movement. Adequate facilities shall be provided for keeping animal quarters and equipment clean. Overcrowding must be avoided in order to limit the transmission of animal diseases. The animals shall be maintained in a room separate from any other activity of the establishment, or under other physical conditions satisfactory to the department.

§1157. Personnel.

Capable personnel shall be employed for the adequate care and feeding of the animals. In small, as well as in extensive animal facilities, one individual shall be in complete charge of, and therefore, responsible for, the entire operation of the unit. Selection of animal caretakers shall be made with care. Nonprofessional personnel shall be chosen for their dependability and their liking for animals. The training should include a knowledge of the means of transmission of disease and an understanding of the precautions necessary to prevent this. Caretakers should be trained in recognizing early symptoms of the common diseases of the animals under their care.

§1158. Feeding.

(a) The animals shall be well fed and shall receive wholesome food suitable to the species and shall receive sufficient clean water except where special studies require specified diet for the animal.

(b) Rules and regulations adopted by the board with reference to shelter, food, sanitation, and the care and treatment of animals shall be prominently displayed in all animal rooms.

Article 4. Filing of Complaint

§1159. Filing of a Complaint.

Anyone who files a complaint to the department against an individual, or person, violating this law shall supply in writing specific information regarding the alleged violation, or violations. Such complaint shall include the time, date, place, individual, or person involved; and the names of other witnesses who may be called to testify. This statement must be in the form of a sworn affidavit and must be notarized.

Group 5.5. Methadone Drug Analysis Laboratories

Article 1. Application

§1160. Application of Subchapter.

Note • History

Group 5.5 shall apply to all laboratories performing urine testing or other body fluids analysis for methadone programs operating in California.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. New Group 5.5 (Articles 1-8, Sections 1160-1196) filed 11-30-81; effective thirtieth day thereafter (Register 81, No. 49).

2. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 2. Definitions

§1161. Methadone Drug Analysis.

Note • History

“Methadone drug analysis” means the practical application of specialized devices, instruments and methods by trained laboratory personnel to detect the presence of chemical substances named in Section 1186 in samples of urine or other body fluids obtained from persons receiving treatment from a methadone program.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1162. Methadone Drug Analysis Laboratory.

Note • History

“Methadone drug analysis laboratory” means a place at which specialized apparatus, instruments and methods are used by trained laboratory personnel to detect the presence of chemical substances named in Section 1186 in urine or other body fluids obtained from persons receiving treatment from a methadone program.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1163. Methadone Drug Analysis Supervisor.

Note • History

“Methadone drug analysis supervisor” means a person, employed by a methadone drug analysis laboratory, who is directly responsible for all aspects of the performance of methadone drug analysis and for the supervision of personnel who perform such analysis.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1164. Method.

Note • History

“Method” means the steps used by a trained person to determine the presence of drugs in urine or other body fluids.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1165. Instrument or Device.

Note • History

“Instrument” or “device” means any item or combination of items of equipment used to determine the presence of drugs; simple and complex devices are included in this meaning.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1166. Sample or Specimen.

Note • History

“Sample” or “specimen” means a representative portion of urine or other body fluid or of an artificially constituted material, taken for the purpose of determining the presence of drugs.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1167. Department.

Note • History

“Department” means the State Department of Health Services.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1168. May, Shall.

Note • History

“May” is permissive; “Shall” is mandatory.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1169. Methadone.

Note • History

“Methadone” means the substance that can be described as 6-dimethyl-amino-4, 4-diphenyl-3-heptanone. Methadone doses are usually administered as methadone chloride.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1170. Primary Metabolite of Methadone.

Note • History

“Primary Metabolite of Methadone” means: 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 3. Requirements for Methadone Drug Analysis Laboratories

§1171. Licensing Requirement.

Note • History

Every methadone drug analysis laboratory performing urine testing or other body fluid analysis for any methadone program operating in California shall have a valid license issued by the Department in accordance with these regulations.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11886 and 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1172. Qualifications for Licensing.

Note • History

A methadone drug analysis laboratory meets the qualifications for licensing if it:

(a) Employs at least one methadone drug analysis supervisor.

(b) Furnishes the Department with detailed, written descriptions of each method it uses for drug analysis. Such description shall clearly describe the initial test and confirmatory test methods.

(d) Demonstrates satisfactory performance in an initial proficiency testing program conducted by the Department.

(e) Demonstrates satisfactory performance in a continuing external proficiency testing program conducted by or approved by the Department.

(f) Passes such on-site inspections as the Department may require.

(g) Demonstrates an ability to meet the requirements of these regulations.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11890, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1173. Qualifications of Methadone Drug Analysis Supervisor.

Note • History

A methadone drug analysis supervisor shall have the following qualifications:

(a) Possesses a baccalaureate or higher degree, or an equivalent in chemistry, biochemistry, or other appropriate discipline as determined by the Department.

(b) Has two years practical experience in performing drug analysis on biological fluids or tissues, such experience to include experience in interpretation of chromatographic, spectrophotometric and immunochemical testing results.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1174. Use or Access of Patients.

Note • History

A methadone drug analysis laboratory shall not employ or utilize the services of a patient of any methadone program in, nor permit any such patient access to, any of its activities involving urinalysis or other body fluids testing for any methadone program.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 4. Licensing Procedures

§1175. Qualifying for License.

Note • History

Upon receipt of a completed application and upon payment of the required fee, the Department shall submit such proficiency test samples and perform such examinations as are required for that laboratory to complete the qualifications. Upon the laboratory's successfully completing all the qualifications, the Department shall issue to the applicant laboratory a methadone drug analyses laboratory license.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1176. Renewal of Licenses.

Note • History

A license issued under these regulations shall be renewed annually as long as the activity requiring licensure continues. Renewal shall be contingent upon the laboratory continuing to fulfill the qualifications as set forth in these regulations, and is further subject to the following:

(a) A methadone drug analysis laboratory license shall be valid from July 1 to June 30 of the next succeeding calendar year. Applications for renewal and all applicable fees shall be submitted to the Department on or before April 1 of each year.

(b) Failure to apply for renewal shall result in forfeiture after a period of three months from the day on which the application for renewal should have been submitted, with the exception that the Department may grant a temporary extension under special circumstances.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1177. Application Forms.

Note • History

Application for a license and a renewal thereof, shall be made on forms furnished by the Department. The applicant shall set forth all pertinent information called for by the form. Application forms may be obtained from, and shall be sent to: Clinical Chemistry Laboratory, Department of Health Services, 2151 Berkeley Way, Berkeley, CA 94704.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1178. Report of Change or Discontinuance.

Note • History

The person responsible for the operation of a methadone drug analysis laboratory shall report to the Department in writing within 30 days any change in ownership, change in supervisorial personnel, changes in methods of analysis, change of address or discontinuance of an activity authorized under these regulations.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1179. License Implications.

Note • History

Licenses issued under these regulations shall not imply approval of anything carried out by a laboratory other than what is specified on the license.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1180. Display of Licenses.

Note • History

Licenses issued under these regulations shall be displayed on request to representatives of the Department.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1181. Fees.

Note • History

The annual application fee for a methadone drug analysis laboratory license or its renewal shall be $100.00. A laboratory operated by the state, a county, a city, a city and county, other public agency or a clinical laboratory licensed pursuant to subdivision (f) of Section 1300 of the Business and Professions Code shall be exempt from the fee.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 5. Substances Approved for Analysis, Requirements for Collection and Handling of Samples

§1182. Urine.

Note • History

The only presently approved body fluid which may be tested for a methadone program is urine.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11886, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1183. General.

Note • History

Urine samples taken for methadone drug analysis shall be collected and handled in a manner subject to the approval of the Department. The identity and the integrity of the sample shall be maintained through collection to analysis and reporting. The only approved urine sample shall be one which has been collected under direct observation by a staff member of the methadone program. The sample shall be deposited in a clean container.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1184. Sample Preservation.

Note • History

While not in transit to a laboratory, or being analyzed, any urine sample not containing a preservative shall be refrigerated.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 6. Methods of Analysis and Standards of Performance

§1185. General.

Note • History

All methods used for methadone drug analysis shall be subject to the standards as set forth in these regulations. Each licensed methadone drug analysis laboratory shall have on file with the Department detailed, current written descriptions of each method it uses for drug screening. Such descriptions shall be immediately available to the person performing an analysis and shall be available for inspection by the Department on request.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1186. Standards of Performance.

Note • History

The methods of analysis used by a laboratory shall be able to detect the following drugs, and at least at the following concentrations, in urine:

Methadone 2 micrograms per milliliter

Primary Metabolite of Methadone 1 microgram per milliliter

Morphine (total of free and conjugated) 1 microgram per milliliter

Codeine 1 microgram per milliliter

Amphetamine 2 micrograms per milliliter

Methamphetamine 5 micrograms per milliliter

Phenobarbital 1 microgram per milliliter

Pentobarbital 1 microgram per milliliter

Secobarbital 1 microgram per milliliter

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1187. Specificity.

Note • History

In order to insure adequate specificity, all positive findings, with the exception of methadone, shall be confirmed using an alternate method of analysis, fundamentally different from that used in the initial test.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1188. Evaluation of Standards of Performance.

Note • History

The ability of methods to meet the standards of performance, as contained in this Article, shall be subject to evaluation by the Department using either a laboratory's internal quality control or external proficiency testing results, or both.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1189. Expression of Analytical Results.

Note • History

All analytical results shall be expressed in terms of the generic or chemical name of any drug found to be present, and analytical results shall not be expressed in equivocal terms, such as “possible traces” or “plus-minus.”

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 7. Inspections, Quality Control, Proficiency Testing

§1190. Inspections and Proficiency Testing.

Note • History

Licensed methadone drug analysis laboratories and laboratories applying for licensure shall be subject to on-site inspections by representatives of the Department, and shall cooperate in the quality control proficiency testing program conducted by or approved by the Department. These tests shall be used by the Department to evaluate the accuracy of the analyses performed by the laboratory.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11888 and 11890, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1191. Access to Premises.

Note • History

The Department may enter any methadone drug analysis laboratory at any reasonable time for the purpose of determining whether or not the laboratory is complying with the provisions of these regulations.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11888 and 11890, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No 45).

§1192. Quality Control Program and Proficiency Testing.

Note • History

Methods for methadone drug analysis shall be performed in accordance with the following quality control program:

(a) Each laboratory shall have its own internal quality control program and shall analyze a suitable control sample with each set of 50 samples.

(b) Each laboratory shall demonstrate acceptable performance in an external proficiency testing program. The Department shall submit blind proficiency test samples on a random basis to each methadone program director; at least 12 samples per quarter shall be submitted. The methadone program director shall, in turn, submit this sample to the methadone drug analysis laboratory in a container which is normally used by the program. Each container shall bear identifying numbers and letters that are indistinguishable from those used by patients in that program. The proficiency test samples shall arrive at the laboratory intermingled with other regular specimens. When the analysis is completed, the methadone program director shall forward the results of the analysis to the Department. The Department shall notify both the methadone program director and the director of the methadone drug analysis laboratory of the results of the proficiency test at the end of each month.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1193. Standard of Performance in Proficiency Testing Program.

Note • History

Whenever a laboratory fails to correctly analyze at least 90 percent of the external proficiency test samples, the Department may take such action as it deems necessary or desirable to correct the source of error. Such action may include, but is not limited to, the removal of the laboratory from the List of Certified Methadone Laboratories, and, concurrently or separately, the commencement of disciplinary proceedings to suspend or revoke the license of the laboratory.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11889 and 11893, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1194. List of Certified Methadone Laboratories.

Note • History

The Department shall compile, maintain and publish a current List of Certified Methadone Laboratories, which shall contain all licensed methadone drug analysis laboratories which are currently able to meet the acceptable level of performance required by the provisions of this subchapter. Whenever the Department determines that any licensed laboratory is presently unable to meet the acceptable level of performance, the Department shall remove the name of the laboratory from said list and notify all programs in the State of such removal. A laboratory so removed from the list shall not be restored to the list unless and until the laboratory demonstrates to the satisfaction of the Department that it is able to meet the acceptable level of performance.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11889, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Article 8. Records

§1195. General.

Note • History

Methadone drug analysis laboratories shall maintain records which clearly describe their activities under these regulations. Such records shall be available for inspection by the Department upon request.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11890, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1196. Methadone Drug Analysis Laboratory Records.

Note • History

Each licensed methadone drug analysis laboratory shall keep and preserve, for at least three years, the following records:

(a) A record, which is kept current, of persons in its employ who are qualified as methadone drug analysis supervisors. This record shall include the qualifications of each such person, including education, experience, training and performance in examinations and tests conducted by the Department.

(b) A detailed, current written description of each method it uses for drug screening.

(c) Complete records of samples analyzed under these regulations, which shall include sample number, date sample received, date sample analyzed, results and date results sent to methadone program director.

(d) Records of the internal quality control program.

(e) Records of laboratory performance as shown by results in the external proficiency testing program.

NOTE

Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

Group 6. Water Laboratories

NOTE

Authority cited: Sections 208 and 4025, Health and Safety Code. Reference Section 4025, Health and Safety Code.

HISTORY

1. New Group 6 (§§ 1174-1184) filed 7-27-51; effective thirtieth day thereafter (Register 25, No. 2).

2. Repealer of Group 6 (Sections 1174-1184) filed 10-22-79; effective thirtieth day thereafter (Register 79, No. 43).

Group 7. Human Tissue Preservation

Article 1. Approval

§1200. Definitions.

Note • History

(a) As used in this group, “person” includes teaching institution, university, college, legally licensed hospital, nonprofit blood bank, artery bank, eye bank, or other therapeutic service operated by any agency approved by the State Director of Health Services.

(b) As used in this group, “department” means State of California Department of Health.

NOTE

Authority cited for Group 7: Sections 102 and 208, Health and Safety Code

HISTORY

1. New Group 7 (Sections 1200 through 1205) filed 4-30-59; effective thirtieth day thereafter (register 59, No. 7).

2. Editorial Correction (Register 73, No. 26).

§1201. Approval Required for Tissue Preservation.

No person shall collect, process, store, or distribute human tissues obtained in accordance with Sections 7100 or 7115 of the Health and Safety Code, or Section 20 of the Probate Code, unless such person shall have received approval from the department.

§1202. Provisions for Approval.

(a) An application for approval shall be made to the department, which shall include the following items.

(1) Complete and detailed description of the methods, equipment, and technics used in relation to each tissue which is to be processed.

(2) The name and address of the person owning the place, establishment, or institution, in which the processing is to be carried on.

(3) The name and address of the director who shall be a duly licensed physician and surgeon in the State of California.

(4) Kinds of tissues to be processed.

(5) Such additional information as the department may require in order to determine compliance with these regulations.

(b) The operation of the tissue bank shall be under the direct supervision of a physician and surgeon duly licensed in this State.

(d) Application will be approved only when establishment and the methods used are such that the tissues processed will not be contaminated, dangerous, or harmful.

(1) Representative samples shall be provided for the department of each lot of tissues, if requested by the department, for the purpose of checking sterility, quality, or other factor.

(2) Any duly authorized representative of the department shall have free access to the establishment and the records thereof at all reasonable hours for the purpose of ascertaining compliance with these regulations.

(e) Approval may be granted only for the processing of tissues for which there is scientific evidence of therapeutic value and for which methods of preservation have been developed.

(f) Renewal of Approval.

(1) The department shall issue renewal notices annually prior to the end of each calendar year.

(2) Each person on applying for renewal shall review his activities in the field for the preceding year if requested to do so by the department.

(g) There is no fee required in connection with this approval, or with renewal of approval.

§1203. Exemptions from Approval.

This group does not apply to autogenous tissue grafting, or to homografts where tissues are obtained from living donors, or to other biologic products as defined in Section 1601 of the Health and Safety Code.

§1204. Records.

(a) The director or supervisor of approved tissue processing programs shall keep records of all tissues processed.

(b) Records may be designated by number (instead of by name of donor) to conform with individual specimens or lots of tissue.

(1) Name and address of institution from which material was obtained, also name of physician responsible for procurement.

(2) Date and hour of death of donor.

(3) Cause of death and age of donor and, when available, pathologic results including autopsy reports.

(4) Date and hour of obtaining tissue. If more than four hours post mortem, state whether refrigeration was used and, if so, give length of time and temperature.

(5) Date and method of processing tissue, if applicable.

(6) Date final storage begins.

(7) Date and place of use.

(8) Results of tests for contamination and other examinations.

(9) Pertinent laboratory data, including serologic tests for syphilis, from donor. Prospective donors with histories of hepatitis shall not be accepted.

(10) Information relating to consent or authorization.

(d) Unless otherwise required by other provisions of law, all records and information shall be retained for not less than two (2) years.

§1205. Labels.

(a) A method which will positively identify each specimen during the period from procurement to the beginning of final storage shall be placed in effect by each person.

(b) The final label shall show:

(1) The name of the product, and method used in processing.

(2) A number which will identify the processing information related to the specimen.

(3) A date prior to which use must be made of the product, or prior to which use of the product is recommended, whichever is applicable.

(4) Name and address of the processor.

(5) If temperature is a factor in preservation, the temperature range within which deterioration is avoided shall be specified.

(6) Other data descriptive of the product may also be included in the label.

(7) Directions for reconstitution of the product, and preparation for its use may be included in the label or in an accompanying circular.

(8) Altered or supplementary labels shall not be used.

Group 8. Forensic Alcohol Analysis and Breath Alcohol Analysis

Article 1. General

§1215. Authority.

Note • History

Chapter 5 Sections 436.50-436.63 of Part 1 of Division 1 of the Health and Safety Code.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code.

HISTORY

1. New Group 8 (Sections 1215, 1215.1, 1216, 1216.1, 1217, 1217.1 through 1217.8, 1218, 1218.1 and 1218.2) filed 8-10-70; effective thirtieth day thereafter (Register 70, No. 33).

§1215.1. Definitions.

History

(a) “Alcohol” means the unique chemical compound, ethyl alcohol, with the exception that reference in these regulations to compounds to be avoided as skin antiseptics includes the generic class of organic compounds known as alcohols.

(b) “Forensic Alcohol Analysis” means the practical application of specialized devices, instruments, and methods by trained laboratory personnel to measure the concentration of ethyl alcohol in samples of blood, breath, urine, or tissue of persons involved in traffic accidents or traffic violations.

(c) “Breath Alcohol Analysis” means analysis of a sample of a person's expired breath, using a breath testing instrument designed for this purpose, in order to determine the concentration of ethyl alcohol in the person's blood.

(d) “Concentration” means the weight amount of alcohol contained in a unit volume of liquid or a unit volume of gas under specified conditions of temperature and pressure; in the case of a solid tissue specimen, “concentration” means the weight amount of alcohol contained in a unit weight of specimen.

(e) “Forensic Alcohol Laboratory” means a place at which specialized apparatus, instruments, and methods are used by trained laboratory personnel to measure the concentration of alcohol in samples of blood, breath, urine, or tissue of persons involved in traffic accidents or in traffic violations; this may be an activity of a laboratory engaged in activities other than alcohol analysis.

(f) “Forensic Alcohol Supervisor” means a person employed by a forensic alcohol laboratory who can be responsible for all aspects of the performance of forensic alcohol analysis and for the supervision of personnel who perform such analysis.

(g) “Forensic Alcohol Analyst” means a person employed by a forensic alcohol laboratory who performs the technical procedures of forensic alcohol analysis.

(h) “Forensic Alcohol Analyst Trainee” means a person employed by a forensic alcohol laboratory for the purpose of receiving comprehensive practical experience and instruction in the technical procedures of forensic alcohol analysis under the supervision of a forensic alcohol supervisor or forensic alcohol analyst.

(i) “Method” means the steps used by a trained person to make a measurement of alcohol concentration.

(j) “Instrument” or “Device” means any item or combination of items of equipment used to make a measurement of alcohol concentration; simple and complex devices are included in this meaning.

(k) “License” means a document issued by the State Department of Health to a laboratory to perform the tests referred to in the Health and Safety Code, Sections 436.51 and 436.52.

(l) “Sample” or “Specimen” means a representative portion of breath, blood, urine, or tissue or of an artificially constituted material, taken for the purpose of measuring its alcohol concentration.

(m) “Alveolar” refers to the smallest air sacs in the lungs and to that portion of the expired breath which is in equilibrium with respect to alcohol with the immediately adjacent pulmonary blood.

(n) “Department” means the California State Department of Health and its duly authorized representatives.

HISTORY

1. Amendment of subsections (b), (c), (d) and (e) filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

Article 2. Requirements for Forensic Alcohol Laboratories

§1216. Authorization Requirement.

History

(a) Every laboratory performing forensic alcohol analysis shall have a valid license issued in accordance with the provisions of these regulations.

(1) Forensic alcohol analysis shall be performed only by persons who meet the qualifications set forth in these regulations for forensic alcohol supervisors, forensic alcohol analysts, or forensic alcohol analyst trainees.

(A) A trainee may perform forensic alcohol analysis only under the supervision of a forensic alcohol supervisor or forensic alcohol analyst.

(2) The Department shall not be limited by these regulations in performing functions in administration of the alcohol analysis and licensing program.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48.)

§1216.1. Qualifications for Licensing.

History

(a) A laboratory meets the qualifications for licensing by:

(1) Employing at least one forensic alcohol supervisor. If forensic alcohol analysis is performed by persons other than forensic alcohol supervisors, such persons shall meet the qualifications set forth in these regulations for forensic alcohol analysts or forensic alcohol analyst trainees;

(2) Maintaining a quality control program in forensic alcohol analysis procedures;

(3) Demonstrating satisfactory performance in a proficiency testing program conducted by or approved by the Department;

(4) Passing such on-site inspections as the Department may require;

(5) Showing ability to meet the requirements set forth in these regulations.

(b) These qualifications shall be maintained at all times by each licensed laboratory.

(c) The Department may deny a license or renewal thereof, or take disciplinary action against a licensee, for failure to maintain these qualifications in a manner which meets the Department's standards for approval.

(d) Whenever a licensed laboratory employing only one forensic alcohol supervisor loses that person, the Department may upon petition of the laboratory extend the license for a period not exceeding 90 days during which time the laboratory shall hire another forensic alcohol supervisor.

(1) Such an extension shall be contingent on the laboratory's having in its employ at least one forensic alcohol analyst and upon the laboratory's successfully demonstrating to the Department continued competence in forensic alcohol analysis through such proficiency tests, examinations, and on-site inspections as the Department may require.

(e) A forensic alcohol supervisor is a person who meets the following qualifications:

(1) Possesses a baccalaureate or higher degree, or an equivalent, in chemistry, biochemistry, or other appropriate discipline as determined by the Department;

(2) Has two years of experience in performing forensic alcohol analysis, such experience to include experience in interpretation and correlation of alcohol analyses with subjective observations of the demeanor and behavior of persons who have ingested known amounts of ethyl alcohol; or, in lieu of such two years of experience, satisfactorily completes a training course approved by the Department, such training course to include at minimum the following schedule of subjects:

(A) Value and purpose of forensic alcohol analysis, including breath alcohol analysis;

(B) Physiological action of alcohol;

(D) Laboratory methods of alcohol analysis;

(E) Instruments and procedures for breath alcohol analysis;

(F) Practical laboratory demonstration of the student's ability to perform alcohol analysis;

(G) Interpretation of results of alcohol analysis, including correlation of alcohol analyses with subjective observations of the demeanor and behavior of persons who have ingested known amounts of alcohol;

(H) Court testimony;

(I) Court decisions regarding chemical tests of alcohol to determine alcohol influence; and

(J) Requirements of these regulations;

(3) Successfully demonstrates accuracy in the analysis of proficiency test samples submitted by the Department, and successfully passes examinations prescribed by the Department;

(4) Demonstrates the ability to adhere to the provisions of these regulations; or (in lieu of (1) and (2) above)

(5) Either is a person who, prior to January 1, 1971, qualified as director of a clinical laboratory operating under the provisions of the California Business and Professions Code, or is a person who, for a period of one year prior to January 1, 1971, has been employed in the activities of a forensic alcohol supervisor.

(f) A forensic alcohol analyst is a person who meets the following qualifications:

(1) Successfully completes at least 60 semester-hours, or their equivalent in quarter-hours, of college level courses, including 8 hours of general chemistry and 3 hours of quantitative analysis;

(2) Successfully completes a training period in alcohol analysis on forensic or clinical specimens in a forensic alcohol laboratory or in a clinical laboratory;

(3) Performs during the training period a minimum of 25 analyses of alcohol concentration in blood samples, at least half of which contain alcohol;

(4) Successfully demonstrates accuracy in the analysis of proficiency test samples submitted by the Department, and successfully passes examinations prescribed by the Department;

(5) Demonstrates ability to adhere to the provisions of these regulations; or (in lieu of (1), (2), and (3) above)

(6) Either is a person who, prior to January 1, 1971, was a clinical laboratory technologist licensed under the provisions of the California Business and Professions Code, or is a person who, for a period of one year prior to January 1, 1971, has been employed in the activities of a forensic alcohol analyst.

(g) A forensic alcohol analyst trainee is a person who meets the following qualifications:

(1) Meets the educational qualification set forth as (1) for a forensic alcohol analyst;

(2) Is employed by a licensed forensic alcohol laboratory.

HISTORY

1. Amendment of subsection (c)(1) filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment of subsection (b)(2) filed 8-2-72; effective thirtieth day thereafter (Register 72, No. 32).

3. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

4. Editorial correction (Register 76, No. 24).

Article 3. Licensing Procedures

§1217. Forensic Alcohol Laboratory License.

History

(a) Upon receipt of a completed application which shows ability to meet the requirements set forth in these regulations, and upon payment of any required fee, the Department shall submit such proficiency test samples and perform such examinations as are required for that laboratory to complete the qualifications.

(b) Upon the laboratory's successfully completing all the qualifications, the Department shall issue to the applicant laboratory a forensic alcohol laboratory license.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1217.1. Renewal of Licenses.

History

(a) Licenses under these regulations shall be renewed as required by the Department as long as the activity requiring authorization continues. Renewal shall be contingent upon the laboratory continuing in the qualifications set forth in these regulations.

(1) A forensic alcohol laboratory license shall be valid from January 1 to December 31 of a calendar year. Applications for renewal and applicable fees shall be submitted to the Department on or before October 1 of each year.

(2) Failure to apply for renewal shall result in forfeiture after a period of three months from the day on which the application for renewal should have been submitted, with the exception that the Department may grant a temporary extension under special circumstances.

(3) An application for renewal shall not list as a forensic alcohol analyst trainee any person who fails to comply with the requirements of Section 1216.1 (f) (4) within a period of one year after he was first listed with the Department as a trainee. The Department may extend this period for a justifiable reason, such as illness.

HISTORY

1. New subsection (c) filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 15).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1217.2. Application Forms.

Application for a license and renewal thereof, shall be made on forms furnished by the Department. The applicant shall set forth all pertinent information called for by the form.

§1217.3. Report of Change or Discontinuance.

History

(a) A person responsible for the operation of a forensic alcohol laboratory shall report to the Department in writing within 30 days any change in qualified personnel who may be performing forensic alcohol analysis, change of ownership, change of address or change or discontinuance of an activity authorized under these regulations.

(b) Such reports shall be made on forms furnished by the Department and shall set forth all pertinent information called for by the form.

(c) Persons who formerly qualified as forensic alcohol supervisors or forensic alcohol analysts in another laboratory may be required to demonstrate again their ability to meet the requirement of Section 1216.1 (e) (3) or 1216.1 (f) (4) using the method, apparatus and facilities of the forensic alcohol laboratory which newly lists them in such a Report of Change or Discontinuance.

HISTORY

1. Amendment filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

3. Editorial correction (Register 76, No. 24).

§1217.4. License Implications.

Licenses issued under these regulations shall not imply approval of anything carried out by a laboratory other than what is specified on the document.

§1217.5. Licensing Records.

Forensic Alcohol Laboratory Licenses shall become part of permanent records available to the courts for legal proceedings or to the Department.

§1217.6. Inspection and Additional Requirements.

(a) Display of Licenses. Licenses issued under these regulations shall be displayed on request to representatives of the Department.

(b) Access to Premises. The Department may enter at all reasonable times upon any laboratory for the purpose of determining whether or not there is compliance with the provisions of these regulations.

§1217.7. Surveys and Proficiency Tests.

History

(a) Laboratories having been licensed or applying for licensing as forensic alcohol laboratories shall be subject to on-site surveys by representatives of the Department, the results of which must meet the requirements of these regulations, and shall accept periodic evaluation samples, perform analyses and report the results of such analyses to the Department.

(b) These analytical results shall be used by the Department to evaluate the accuracy of the forensic alcohol analyses performed by the laboratory, and the results must meet the requirements of these regulations.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1217.8. Fees and Other Procedures.

The annual application fee for a Forensic Alcohol Laboratory License or its renewal shall be one hundred dollars ($100). A laboratory operated by the state, city or county or other public organization shall be exempt from the annual application fee requirement. Other procedures in the administration of these regulations shall be carried out as set forth in Chapter 5 (commencing with section 436.50) of Part 1 of Division 1 of the Health and Safety Code. Such other procedures include suspension or revocation of license, denial of license, and disciplinary action.

Article 4. Training of Personnel

§1218. Training Program Approval.

Any organization, laboratory, institution, school, or college conducting a course of instruction for persons to qualify under these regulations shall submit a course summary and list of instructors and their qualifications to the Department for approval.

§1218.1. Additional Requirements.

At the discretion of the Department, any phase or portion of a training program shall be subject to alteration in an effort to update the program as technological advances are made or if a portion has been judged inappropriate.

§1218.2. Contracts.

The Department may contract with persons it deems qualified to administer such practical tests and written or oral examinations as may be required under these regulations. This section shall not be construed to authorize the delegation of any discretionary functions conferred on the Department by law, including, but not limited to, the evaluation of tests and examinations.

Article 5. Collection and Handling of Samples

§1219. General.

Note • History

Samples taken for forensic alcohol analysis and breath alcohol analysis shall be collected and handled in a manner approved by the Department. The identity and integrity of the samples shall be maintained through collection to analysis and reporting.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code.

HISTORY

1. New Article 5 ( 1219, 1219.1, 1219.2, 1219.3), filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1219.1. Blood Collection and Retention.

History

(a) Blood samples shall be collected by venipuncture from living individuals as soon as feasible after an alleged offense and only by persons authorized by Section 13354 of the Vehicle Code.

(b) Sufficient blood shall be collected to permit duplicate determinations.

(c) Alcohol or other volatile organic disinfectant shall not be used to clean the skin where a specimen is to be collected. Aqueous benzalkonium chloride (zephiran), aqueous merthiolate or other suitable aqueous disinfectant shall be used.

(d) Blood samples shall be collected using sterile, dry hypodermic needles and syringes, or using clean, dry vacuum type containers with sterile needles. Reusable equipment,if used, shall not be cleaned or kept in alcohol or other volatile organic solvent.

(e) The blood sample shall be deposited into a clean, dry container which is closed with an inert stopper.

(1) Alcohol or other volatile organic solvent shall not be used to clean the container.

(2) The blood shall be mixed with an anticoagulant and a preservative.

(f) When blood samples for forensic alcohol analysis are collected post-mortem, all practical precautions to insure an uncontaminated sample shall be employed, such as:

(1) Samples shall be obtained prior to the start of any embalming procedure. Blood samples shall not be collected from the circulatory system effluent during arterial injection of embalming fluid. Coroner's samples do not need a preservative added if stored under refrigeration.

(2) Care shall be taken to avoid contamination by alcohol from the gastrointestinal tract directly or by diffusion therefrom. The sample shall be taken from a major vein or the heart.

(g) In order to allow for analysis by the defendant, the remaining portion of the sample shall be retained for one year after the date of collection.

(1) In coroner's cases, blood samples shall be retained for at least 90 days after date of collection.

(2)Whenever a sample is requested by the defendant for analysis and a sufficient sample remains, the forensic alcohol laboratory or law enforcement agency in possession of the original sample shall continue such possession, but shall provide the defendant with a portion of the remaining sample in a clean container together with a copy or transcript of the identifying information carried on the original sample container.

HISTORY

1. Amendment of subsection (d) filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 15).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1219.2. Urine Collection and Retention.

History

(a) The only approved urine sample shall be a sample collected no sooner than twenty minutes after first voiding the bladder.

(b) The specimen shall be deposited in a clean, dry container which also contains a preservative.

(c) In order to allow for analysis by the defendant, the remaining portion of the sample shall be retained for one year after the date of collection.

(1) Whenever a sample is requested by the defendant for analysis and a sufficient sample remains, the forensic alcohol laboratory or law enforcement agency in possession of the original sample shall continue such possession, but shall provide the defendant with a portion of the remaining sample in a clean container together with a copy or transcript of the identifying information carried by the original sample container.

HISTORY

1. Amendment of subsection (a) filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 15).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1219.3. Breath Collection.

History

A breath sample shall be expired breath which is essentially alveolar in composition. The quantity of the breath sample shall be established by direct volumetric measurement. The breath sample shall be collected only after the subject has been under continuous observation for at least fifteen minutes prior to collection of the breath sample, during which time the subject must not have ingested alcoholic beverages or other fluids, regurgitated, vomited, eaten, or smoked.

HISTORY

1. Amendment filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 15).

Article 6. Methods of Forensic Alcohol Analysis

§1220. General.

Note • History

(a) All laboratory methods used for forensic alcohol analysis shall be subject to standards set forth in this Article.

(b) Each licensed forensic alcohol laboratory shall have on file with the Department detailed, up-to-date written descriptions of each method it uses for forensic alcohol analysis.

(1) Such descriptions shall be immediately available to the person performing an analysis and shall be available for inspection by the Department on request.

(2) Each such description shall include the calibration procedures and the quality control program for the method.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code.

HISTORY

1. New Article 6 ( 1220, 1220.1 through 1220.4) filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1220.1. Standards of Performance.

History

(a) Methods for forensic alcohol analysis shall meet the following standards of performance:

(1) The method shall be capable of the analysis of a reference sample of known alcohol concentration within accuracy and precision limits of plus or minus 5 percent of the value; these limits shall be applied to alcohol concentrations which are 0.10 grams per 100 milliliters or higher;

(2) The method shall be capable of the analysis of ethyl alcohol with a specificity which is adequate and appropriate for traffic law enforcement.

(3) The method should be free from interference from anticoagulants and preservatives added to the sample;

(4) Blood alcohol results on post-mortem samples shall not be reported unless the oxidizable substance is identified as ethyl alcohol by qualitative test;

(5) The method shall give a test result which is always less than 0.01 grams of alcohol per 100 milliliters of blood when living subjects free of alcohol are tested.

(b) The ability of methods to meet the standards of performance set forth in this Section shall be evaluated by the Department using a laboratory's proficiency test results and such ability must meet the requirements of these regulations.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1220.2. Standards of Procedure.

History

(a) Methods for forensic alcohol analysis shall meet the following standards of procedure:

(1) The method shall be calibrated with standards which are water solutions of alcohol.

(A) Such alcohol solutions are secondary standards.

(B) Each forensic alcohol laboratory shall establish the concentration of each lot of secondary alcohol standards it uses, whether prepared or acquired, by an oxidimetric method which employs a primary standard, such as United States National Bureau of Standards potassium dichromate;

(2) The procedure shall include blank and secondary alcohol standard samples at least once each day that samples are subjected to forensic alcohol analysis.

(A) The blank and secondary alcohol standard samples shall be taken through all steps of the method used for forensic alcohol analysis of samples.

(3) The procedure shall also include analysis of quality control reference samples as described in Section 1220.3 and shall include at least duplicate analyses of samples for forensic alcohol analysis.

(A) A quality control reference sample shall not be taken from the same lot of alcohol solution which is used as a secondary alcohol standard.

(4) Alcohols or other volatile organic solvents shall not be used to wash or rinse glassware and instruments used for alcohol analysis;

(5) All instruments used for alcohol analysis shall be in good working order and routinely checked for accuracy and precision.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1220.3. Quality Control Program.

History

(a) Methods for forensic alcohol analysis shall be performed in accordance with the following quality control program:

(1) For each method of forensic alcohol analysis it performs, each forensic alcohol laboratory shall make or acquire a suitable quality control reference material containing alcohol, a sample of which it shall analyze along with each set of samples; the alcohol concentration in the reference material shall be between 0.10 and 0.20 grams per 100 milliliters of liquid;

(2) For each lot of quality control reference material, the laboratory shall determine a mean value of at least 20 replicate analyses, at a rate of no more than 2 analyses per day, with the method used for analysis of samples for forensic alcohol analysis;

(3) Acceptable limits of variation for the method shall be set as follows:

(A) The lower limit shall be calculated by subtracting, from the mean value, 0.01 grams per 100 milliliters;

(B) The higher limit shall be calculated by adding, to the mean value, 0.01 grams per 100 milliliters;

(4) At least one sample of the quality control reference material shall be analyzed with each set of samples analyzed for the purpose of forensic alcohol analysis;

(5) Whenever analysis of the quality control reference material is outside the acceptable limits, the method shall be regarded to be in error, and a forensic alcohol supervisor shall take remedial action to investigate and correct the source of error;

(6) Until such time as the error has been corrected, as shown by return of the analysis of the quality control reference material to values within the acceptable limits, no samples shall be analyzed for the purpose of forensic alcohol analysis.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1220.4. Expression of Analytical Results.

History

(a) With the exception of tissue analysis, all analytical results shall be expressed in terms of the alcohol concentration in blood, based on the number of grams of alcohol per 100 milliliters of blood.

(1) The symbols, grams %, %, and % (W/V), shall be regarded as acceptable abbreviations of the phrase, grams per 100 milliliters of liquid.

(b) Analytical results shall be reported to the second decimal place, deleting the digit in the third decimal place when it is present.

(d) Blood alcohol concentrations less than 0.02% on post-mortem blood samples may be reported as negative.

(e) A urine alcohol concentration shall be converted to an equivalent blood alcohol concentration by a calculation based on the relationship: the amount of alcohol in 1.3 milliliters of blood is equivalent to the amount of alcohol in 1 milliliter of urine.

(f) A breath alcohol concentration shall be converted to an equivalent blood alcohol concentration by a calculation based on the relationship: the amount of alcohol in 2,100 milliliters of alveolar breath is equivalent to the amount of alcohol in 1 milliliter of blood.

(g) Tissue analysis results shall be expressed in terms of a weight amount of alcohol in a unit weight of the specimen.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Editorial correction (Register 76, No. 24).

Article 7. Requirements for Breath Alcohol Analysis

§1221. General.

Note • History

Breath alcohol analysis shall be performed in accordance with standards set forth in this Article.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code.

HISTORY

1. New Article 7 (Sections 1221, 1221.1 through 1221.5) filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1221.1. Authorized Procedures.

Note • History

(a) Breath alcohol analysis shall be performed only with instruments and related accessories which meet the standards of performance set forth in these regulations.

(b) Such instruments may be used for the analysis of breath samples in places other than licensed forensic alcohol laboratories and by persons other than forensic alcohol supervisors, forensic alcohol analysts and forensic alcohol analyst trainees only if such places and persons are under the direct jurisdiction of a governmental agency or licensed forensic alcohol laboratory.

(1) Breath alcohol analysis by persons other than forensic alcohol supervisors, forensic alcohol analysts and forensic alcohol analyst trainees shall be restricted to the immediate analysis of breath samples collected by direct expiration by the subject into the instrument in which the measurement of alcohol concentration is performed.

(2) Except for the requirements of Section 1220.4, such immediate analysis shall not be subject to the requirements of Article 6.

NOTE

Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Repealer of subsection (c) filed 12-20-85 as an emergency; effective upon filing (Register 85, No. 52). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-21-86.

3. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19).

§1221.2. Standard of Performance.

Note • History

(a) Instruments for breath alcohol analysis shall meet the following standard:

(1) The instrument and any related accessories shall be capable of conforming to the “Model Specifications for Evidential Breath Testing Devices” of the National Highway Traffic Safety Administration of the U.S. Department of Transportation, which were published in the Federal Register, Vol. 49, No. 242, Pages 48854-48872, December 14, 1984, and are hereby adopted and incorporated.

(b) The ability of instruments and any related accessories to conform to the standard of performance set forth in this section shall be tested by the U.S. Department of Transportation.

NOTE

Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code.

HISTORY

1. Repealer of subsection (b) and relettering of (c), (d), (e), (f) and (g) to (b), (c), (d), (e) and (f) filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 15).

2. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

3. Amendment filed 12-20-85 as an emergency; effective upon filing (Register 85, No. 52). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-21-86.

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19).

§1221.3. Approved Instruments.

Note • History

(a) Only such types and models of instruments and related accessories as are named in the “Conforming Products List” published in the Federal Register by the National Highway Traffic and Safety Administration of the U.S. Department of Transportation shall be used for breath alcohol analysis in this State.

NOTE

Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Editorial correction (Register 76, No. 24).

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19).

§1221.4. Standards of Procedure.

Note • History

(a) Procedures for breath alcohol analysis shall meet the following standards:

(1) For each person tested, breath alcohol analysis shall include analysis of 2 separate breath samples which result in determinations of blood alcohol concentrations which do not differ from each other by more than 0.02 grams per 100 milliliters.

(2) The accuracy of instruments shall be determined.

(A) Such determination of accuracy shall consist, at a minimum, of periodic analysis of a reference sample of known alcohol concentration within accuracy and precision limits of plus or minus 0.01 grams % of the true value; these limits shall be applied to alcohol concentrations from 0.10 to 0.30 grams %. The reference sample shall be provided by a forensic alcohol laboratory.

1. Such analysis shall be performed by an operator as defined in Section 1221.4 (a)(5), and the results shall be used by a forensic alcohol laboratory to determine if the instrument continues to meet the accuracy set forth in Section 1221.4 (a)(2)(A).

(B) For the purposes of such determinations of accuracy, “periodic” means either a period of time not exceeding 10 days or following the testing of every 150 subjects, whichever comes sooner.

(3) Breath alcohol analysis shall be performed only with instruments for which the operators have received training, such training to include at minimum the following schedule of subjects:

(A) Theory of operation;

(B) Detailed procedure of operation;

(D) Precautionary checklist;

(E) Written and/or practical examination.

(4) Training in the procedures of breath alcohol analysis shall be under the supervision of persons who qualify as forensic alcohol supervisors, forensic alcohol analysts or forensic alcohol analyst trainees in a licensed forensic alcohol laboratory.

(A) After approval as set forth in Section 1218, the forensic alcohol laboratory is responsible for the training and qualifying of its instructors.

(5) An operator shall be a forensic alcohol supervisor, forensic alcohol analyst, forensic alcohol analyst trainee or a person who has completed successfully the training described under Section 1221.4 (a) (3) and who may be called upon to operate a breath testing instrument in the performance of his duties.

(6) Records shall be kept for each instrument to show the frequency of determination of accuracy and the identity of the person performing the determination of accuracy.

(A) Records shall be kept for each instrument at a licensed forensic alcohol laboratory showing compliance with this Section.

NOTE

Authority cited: Section 436.50, Health and Safety Code. Reference: Section 436.50, Health and Safety Code.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Amendment filed 12-20-85 as an emergency; effective upon filing (Register 85, No. 52). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-21-86.

3. Certificate of Compliance including amendment of subsection (a)(2)(A)1. transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19).

§1221.5. Expression of Analytical Results.

Results of breath alcohol analysis shall be expressed as set forth in Section 1220.4.

Article 8. Records

§1222. General.

Note • History

Forensic alcohol laboratories and law enforcement agencies shall maintain records which clearly represent their activities which are covered by these regulations. Such records shall be available for inspection by the Department on request.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code.

HISTORY

1. New Article 8 (§§ 1222, 1222.1, 1222.2) filed 10-9 -70; effective thirtieth day thereafter (Register 70, No. 41).

§1222.1. Forensic Alcohol Laboratory Records.

History

(a) Each laboratory which is licensed to perform forensic alcohol analysis shall keep the following records for a period of at least three years:

(1) An up-to-date record of persons in its employ who are qualified as forensic alcohol supervisors and forensic alcohol analysts; the record shall include the qualifications of each such person, including education, experience, training and performance in proficiency tests and examinations;

(2) A list of persons in its employ who are forensic alcohol analyst trainees, the date on which each such person began his training period and the number and results of analyses performed during the training period;

(3) Records of samples analyzed by that laboratory under these regulations, their results and the identity of persons performing the analyses;

(4) Records of the quality control program;

(5) Records of laboratory performance evaluation in alcohol analysis as shown by results of proficiency tests;

(6) Records of such determinations of accuracy of breath testing instruments as a laboratory may perform for law enforcement agencies;

(7) Records of such training as a laboratory may provide to persons who operate breath testing instruments for law enforcement agencies.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§1222.2. Breath Alcohol Analysis Records.

History

(a) Each agency shall keep the following records for breath testing instruments which are under its jurisdiction:

(1) Records of instrument determinations of accuracy;

(2) Records of analyses performed, results and identities of the persons performing analyses;

(3) At the location of each instrument, the precautionary checklist to be used by operators of the instrument.

HISTORY

1. Amendment filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Editorial correction (Register 76, No. 24).

Group 9. HIV Antibody Testing

Article 1. Approval of Laboratories

§1230. HIV Screening Testing by Laboratories.

Note • History

(a) All clinical laboratories that perform waived, moderate or high complexity tests or examinations to screen for human immunodeficiency virus (HIV) shall do all of the following:

(1) Utilize United States Food and Drug Administration (FDA) approved test systems in accordance with the manufacturers' instructions. Any laboratory that modifies a non-waived FDA-approved kit shall establish and verify the performance specifications pursuant to 42 Code of Federal Regulations Section 493.1253.

(2) Confirm all reactive or indeterminate HIV test results by following the HIV confirmation protocols recommended by the federal Centers for Disease Control and Prevention as published in the Mortality and Morbidity Weekly Report prior to reporting the result as positive.

(3) Establish and maintain a quality assurance program that includes all of the following:

(A) Evaluation and documentation of testing personnel by direct observation, training, and competency testing to ensure tests are accurately performed and reported. This shall be done prior to testing, six months later and then yearly as long as assessment of test performance is acceptable. If the testing personnel fail any assessment of test performance given in subpart (B), the testing personnel shall be removed from testing, retrained and their competency re-evaluated.

(B) Assessment and documentation of test performance by testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples at least twice yearly and monitored by the laboratory director.

(b) Failure to comply with all the requirements of this section shall subject the laboratory to sanctions pursuant to Business and Professions Code Section 1320.

NOTE

Authority cited: Sections 1603.1(f), 100275, 131050 and 131200, Health and Safety Code; and Section 1224, Business and Professions Code. Reference: Sections 1220 and 1265, Business and Professions Code; and Sections 1603.1, 101160, 120895, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 1-21-86 as an emergency; effective upon filing (Register 86, No. 6). A certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 5-21-86.

2. Change without regulatory effect of group 9 and article 1 heading filed 2-7-86; effective upon filing (Register 86, No. 6).

3. Certificate of Compliance as to 1-21-86 order including amendment of section heading and subsections (b) and (f) transmitted to OAL 5-15-86 and filed 6-12-86 (Register 86, No. 24).

4. Amendment filed 1-8-90 as an emergency; operative 1-8-90 (Register 90, No. 4). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 5-8-90.

5. Amendment filed 5-11-90 as an emergency; operative 5-11-90 (Register 90, No. 25). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 9-8-90.

6. Amendment filed 9-12-90 as an emergency; operative 9-12-90 (Register 90, No. 43). A Certificate of Compliance must be transmitted to OAL by 1-10-91 or the emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance including amendment transmitted to OAL 1-9-91 and filed 2-8-91 (Register 91, No. 11).

8. Repealer and new section filed 10-15-2009; operative 11-14-2009 (Register 2009, No. 42).

Chapter 3. Local Health Service

Subchapter 1. Standards for State Aid for Local Health Administration

(Originally Printed 11-1-47)

Article 1. Organization

§1250. Health Officer.

Note • History

The health department shall be under the direction of the health officer devoting full time to official duties and these duties shall constitute his primary responsibility and no other activities shall interfere with performance of his official duties.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 454 and 1130, Health and Safety Code.

HISTORY

1. New Sections 1250 to 1329, inclusive, filed 10-1-47 as an emergency (Register 10, No. 1).

2. Amendment filed 9-24-71; effective thirtieth day thereafter (Register 71, No. 39).

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1250 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 9-24-71 remains in effect uninterrupted (Register 85, No. 30).

4. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1251. Office.

Note • History

The health department shall maintain and operate a central office and headquarters on a full-time basis during the normal work week of the local government.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1251 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1252. Clerical Staff.

Note • History

There shall be a clerical staff under proper supervision, adequate to meet local needs.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1252 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1253. Public Health Nursing Staff.

Note • History

(a) There shall be a public health nursing staff under the supervision of a director of public health nursing, and such additional supervisors, who are necessary to provide effective service. Public health nurses shall be qualified and knowledgeable in matters pertaining to health, safety and sanitation within a local health jurisdiction which shall include but not be limited to:

(1) The control and prevention of communicable and chronic disease;

(2) The promotion of maternal, child and adolescent health;

(3) The prevention of abuse and neglect of children, spouses and elderly adults within the home environment;

(4) The case management of California Children Services or handicapped children;

(5) The assessment and prevention of accidents within the home environment;

(6) The provision of services for populations at risk; and,

(b) All members of the public health nursing staff who are employed as public health nurses including supervisory personnel shall be certified.

NOTE

Authority cited: Section 1130, Health and Safety Code. Reference: Sections 600-603, Health and Safety Code.

HISTORY

1. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 23).

2. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No. 11).

§1254. Environmental Health Staff.

Note • History

There shall be an adequate staff of Registered Sanitarians under the direction of a Director of Environmental Health. In addition, the staff shall include such other support personnel as are required to carry out the environmental health program.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1111 and 1130, Health and Safety Code.

HISTORY

1. Amendment filed 5-7-75; effective thirtieth day thereafter (Register 75, No. 19).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1254 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 5-7-75 remains in effect uninterrupted (Register 85, No. 30).

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1255. Public Health Laboratory.

Note • History

The principal public health laboratory shall be under the direction of a public health laboratory director. A branch public health laboratory shall be under the direction of a branch public health laboratory director who shall be directly responsible to the director of the principal public health laboratory.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1001, 1002, 1111 and 1130, Health and Safety Code.

HISTORY

1. Amendment filed 5-19-49 (Register 16, No. 4).

2. Repealer and new section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 3).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

4. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1255 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 30).

6. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1256. Provisional Approval of Health Departments.

Note • History

The Director of Health Services, after thorough investigation of geographic, transportation, economic, or other conditions, may grant provisional approval to health departments which serve all of the incorporated, as well as the unincorporated, area of the county and which are under the direction of a part-time county health officer; provided, however, that such counties shall have a population of less than 25,000, as determined pursuant to Section 1101, Chapter 8, Part 2, Division 1 of the Health and Safety Code. Such health departments, however, shall meet all standards established for local health departments by the Department except Section 1250 of this article. Such provisional approval shall terminate on June 30, 1948, but may be renewed annually at the discretion of the Director.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1101, 1102 and 1130, Health and Safety Code.

HISTORY

1. New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 3).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1256 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 1-28-59 remains in effect uninterrupted (Register 85, No. 30).

3. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

Article 2. Program

§1275. Duties and Functions.

Note • History

A local health department, in order to qualify for funds pursuant to Division 1, Part 2, Chapter 8, of the Health and Safety Code, shall perform all of the duties and functions imposed upon it by the Health and Safety Code and other statutes of the State of California, and by the rules, regulations and orders of the Department of Health Services.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130 and 1155, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1275 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1276. Basic Services.

Note • History

The health department shall offer at least the following basic services to the health jurisdiction which it serves:

(a) Collection, tabulation and analysis of all public health statistics, including population data, natality, mortality and morbidity records, as well as evaluation of service records.

(b) Health education programs including, but not necessarily limited to, staff education, consultation, community organization, public information, and individual and group teaching, such programs to be planned and coordinated within the department and with schools, public and voluntary agencies, professional societies, and civic groups and individuals.

(c) Communicable disease control, including availability of adequate isolation facilities, the control of the acute communicable diseases, and the control of tuberculosis and the venereal diseases, based on provision of diagnostic consultative services, epidemiologic investigation and appropriate preventive measures for the particular communicable disease hazards in the community.

(d) Medical, nursing, educational, and other services to promote maternal and child health, planned to provide a comprehensive program to meet community needs in these fields.

(e) Environmental health and sanitation services and programs in accordance with an annual plan and program outline as required in Title 17, Section 1328, and approved by the State Department of Health and the applicable services and program standards as specified in the State Department of Health “Services in a Local Environmental Health and Sanitation Program,” September 1976. The required services and programs shall be as follows:

(1) Food.

(2) Housing and institutions.

(3) Radiological health in local jurisdictions contracting with the State Department of Health to enforce the Radiation Control Law pursuant to Section 25600-25654 and Sections 25800-25876, Health and Safety Code.

(4) Milk and dairy products in local jurisdictions maintaining an approved milk inspection service pursuant to Section 32503, Food and Agricultural Code.

(5) Water oriented recreation.

(6) Safety.

(7) Vector control.

(8) Wastes management.

(9) Water supply.

(10) Air sanitation.

(11) Additional environmentally related services and programs as required by the County Board of Supervisors, City Council, or Health District Board.

(12) And may include land development and use.

(f) Laboratory services, provided by an approved public health laboratory in health departments serving a population of 50,000 or more. Such laboratories shall provide:

(1) Services necessary for the various programs of the health department.

(2) Consultation and reference services to further the development of improved procedures and practices in laboratories employing such procedures related to the prevention and control of human disease.

(g) Services in nutrition, including appropriate activities in education and consultation for the promotion of positive health, the prevention of ill health, and the dietary control of disease.

(h) Services in chronic disease, which may include case finding, community education, consultation, or rehabilitation, for the prevention or mitigation of any chronic disease.

(i) Services directed to the social factors affecting health, and which may include community planning, counseling, consultation, education, and special studies.

(j) Services in occupational health to promote the health of employed persons and a healthful work environment, including educational, consultative and other activities appropriate to local needs. Where the population of a health jurisdiction exceeds 500 thousand, the program in occupational health shall include a planned and organized service with trained staff.

(1) “Services in occupational health” shall mean, as a minimum, a program of industrial sanitation and surveillance of occupational health hazards to insure that places of employment are maintained in a healthful and sanitary condition. For the purpose of this section, “sanitary condition” is defined as equivalent to that described in the “Recommended Standards of Sanitation in Places of Employment” issued by the California State Department of Health Services. Such services shall be provided by at least one Occupational Health Sanitarian as defined in Section 1307, or any one of the occupational health disciplines in Section 1306, with medical, sanitation, and public health nursing support available.

(2) “Planned and organized service” shall include services in occupational health as defined above, and in addition the prevention of work-induced illness and disability by recognizing, evaluating and preventing unhealthful environmental conditions and practices in places of work.

(3) “Trained staff” shall be defined as follows:

(A) When the health jurisdiction includes a population of 500,000 to 1,000,000, at least 1, and after July 1, 1968, 2 full-time health professionals representing 1 or 2, respectively, of the disciplines listed in part (4) hereof shall be employed.

(B) When health jurisdictions include more than 1,000,000 population at least 2, and after July 1, 1968, 3 full-time health professionals representing 2 or 3, respectively, of the 5 disciplines listed in part (4) hereof shall be employed.

(C) When health jurisdictions include more than 5,000,000 population, at least 10 full-time health professionals including all 5 of the disciplines listed in part (4) hereof shall be employed.

(4) Occupational health disciplines include: Occupational Health Physician; Occupational Health Nursing Consultant; Industrial Hygiene Engineer; Industrial Hygienist (including sanitarians with appropriate training); and Industrial Hygiene Chemist as defined in Section 1306.

(k) Appropriate services in the field of family planning, which may include:

(1) Promotion of availability of program elements such as:

(A) Assembling knowledge about family planning, attitudes, values, and information held by population groups.

(B) Public and professional educational services about the health benefits of family planning and fertility control methods.

(C) Professional services for sterility correction,fertility control and genetic counseling for all segments of the population, making available methods acceptable to families of any religious persuasion.

(D) Evaluation of the adequacy of the community's family planning efforts.

(2) Provision of program elements which are not otherwise likely to be made available, including family planning services for those groups who cannot reasonably obtain them.

(l) Public health nursing services to provide for the preventive and therapeutic care of the population served.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1111, 1112, 1113, 1130, 1155, 1555.5 and 1155.6, Health and Safety Code.

HISTORY

1. Amendment of subsection (j)(1) filed 6-24-68; effective thirtieth day thereafter (Register 68, No. 24). For prior history, see Register 67, No. 50.

2. Amendment of subsection (f) filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

3. New subsection (l) filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 23).

4. Amendment of subsection (e) filed 12-9-77; effective thirtieth day thereafter (Register 77, No. 50).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1276 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 12-9-77 remains in effect uninterrupted (Register 85, No. 30).

6. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

Article 3. Personnel

§1300. Health Officer.

Note • History

The health officer shall be a graduate of a medical school of good standing and repute and shall be eligible for a license to practice medicine and surgery in the State of California; provided however that those health officers on a full-time basis as of September 19, 1947, shall be considered as meeting the requirements of this section.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 454 and 1130, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1300 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1301. Director of Public Health Nursing.

Note • History

(a) A director of public health nursing shall be a public health nurse who has:

(1) Completed a baccalaureate program of study in public health nursing accredited by the National League for Nursing and has had three years of progressively responsible experience in public health nursing or

(2) A Masters Degree with preparation in Nursing Administration, Supervision or Consultation from a program accredited by the National League for Nursing or the American Public Health Association and at least three years of progressively responsible experience in public health nursing.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 600, 601, 602, 603, 604 and 1130, Health and Safety Code.

HISTORY

1. Amendment filed 2-6-51 as an emergency; designated to be effective 3-1-51 (Register 23, No. 3).

2. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 23).

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1301 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 6-7-74 remains in effect uninterrupted (Register 85, No. 30).

4. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1302. Director of the Public Health Laboratory.

Note • History

The director of a principal public health laboratory shall be a certified Public Health Microbiologist whose qualifications conform with the specifications for this position as established by the Department, pursuant to the provisions of the Health and Safety Code. The director shall have had four or more years of experience in public health laboratory work. The quality, variety and currency of this experience shall be satisfactory to the Department.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1002 and 1130, Health and Safety Code.

HISTORY

1. New section filed 2-6-51 as an emergency; designated to be effective 3-1-51 (Register 23, No. 3).

2. Repealer and new section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 3).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

4. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1302 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 30).

6. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1302.1. Director of a Branch Public Health Laboratory.

Note • History

The director of a branch public health laboratory shall be a certified Public Health Microbiologist whose qualifications conform with the specifications for this position as established by the Department, pursuant to the provisions of the Health and Safety Code. The director shall have had two or more years experience in public health laboratory work. The quality, variety and currency of this experience shall be satisfactory to the Department.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1002 and 1130, Health and Safety Code.

HISTORY

1. New section filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 4).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1302.1 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 30).

3. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1303. Health Educator.

Note • History

A health educator shall hold a master's degree with specialization in public or community health education awarded upon completion of a program of study accredited by the American Public Health Association.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 3).

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

3. Amendment filed 8-10-70; effective thirtieth day thereafter (Register 70, No. 33).

4. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1303 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 8-10-70 remains in effect uninterrupted (Register 85, No. 30).

5. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1304. Director of Health Education.

Note • History

A director of health education appointed after November 1, 1962 who is responsible for the supervision of other professional staff shall have had, in addition to the professional training specified above, three or more years full-time paid experience in public health education, preferably in a local public health department.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1304 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-62 remains in effect uninterrupted (Register 85, No. 30).

3. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1305. Public Health Nurse.

Note • History

(a) A public health nurse shall be currently licensed to practice as a registered nurse in California and shall:

(1) Possess a California Public Health Nurse Certificate issued prior to March 5, 1954, or a Public Health Nurse Certificate issued under the provisions of Section 4500 et seq: and

(2) By October 1, 1987 acquire training in the detection, prevention, reporting requirements and treatment of child abuse and neglect in accordance with Section 4501 of this chapter of working for a local health jurisdiction on or after January 1, 1981.

(A) Directors of Public Health Nursing as defined in Section 1301 shall have the responsibility for verifying that all members of their Public Health Nursing Staff who have received Public Health Nurse Certificates prior to October 1, 1987, have received training which satisfies the requirement in Section 4501(a)(4).

(B) The Department of Health Services shall have the responsibility for verifying that all nurses who receive a Public Health Nurse Certificate after October 1, 1987 have received training which satisfies the requirements in Section 4501(a)(4).

NOTE

Authority cited: Sections 208, 600, 602 and 1130, Health and Safety Code. Reference: Section 600, 602, 605 and 1130, Health and Safety Code.

HISTORY

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

2. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

3. Repealer and new section filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 23).

4. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No. 11).

§1306. Occupational Health Trained Staff.

Note • History

Qualifications for each discipline included in the definition of trained staff shall conform to the following specifications:

(a) Occupational Health Physician. M.D. degree and license to practice medicine in California, and either:

(1) a master's degree in public health or occupational medicine and two years' experience in the full-time practice of occupational medicine, or

(2) four years' experience in the full-time practice of occupational medicine, at least one year of which shall have been in a public health program.

(b) Occupational Health Nursing Consultant. Baccalaureate degree and possession of a valid license as a registered nurse and a valid California Public Health Nurse certificate, and, either:

(1) a master's degree in public health and two years' experience in the full-time practice of occupational health nursing, or

(2) four years' experience in the full-time practice of occupational health nursing, and two years in a generalized public health nursing program.

(1) a master's degree in public health or industrial hygiene and two years' experience in the full-time practice of industrial hygiene engineering, or

(2) four years' experience in the full-time practice of industrial hygiene engineering, at least one year of which shall have been in a public health program.

(d) Industrial Hygienist. Baccalaureate degree with major in a physical or biological science, and, either:

(1) a master's degree in public health or industrial hygiene and two years' experience in the fill-time practice of industrial hygiene, or

(2) four years' experience in the full-time practice of industrial hygiene, at least one year of which shall have been in a public health program, or

(3) registration as a sanitarian in California with four years' experience in a local health department, three years of which shall have been in the full-time practice of industrial hygiene.

(e) Industrial Hygiene Chemist. Baccalaureate degree with major in chemistry or biochemistry, and, either:

(1) a master's degree in chemistry, biochemistry, or a related field of environmental chemistry and two years' experience as a professional chemist doing increasingly complex analytical procedures, or

(2) four years' experience as a professional chemist doing increasingly complex analytical procedures.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.

HISTORY

1. New section filed 12-15-67; effective thirtieth day thereafter. (Register 67, No. 50).

2. Amendment of subsection (d) filed 6-24-68; effective thirtieth day thereafter (Register 68, No. 24).

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1306 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 6-24-68 remains in effect uninterrupted (Register 85, No. 30).

4. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1307. Occupational Health Sanitarian.

Note • History

(a) Qualifications for an Occupational Health Sanitarian shall conform to the following specifications:

(1) Registration as a sanitarian in California;

(2) Three years' full-time experience in environmental sanitation;

(3) One year of experience in an occupational health program of a local health department under direct supervision of an Industrial Hygiene Engineer or Industrial Hygienist as defined in Section 1306, or satisfactory completion of a two-week intensive training course in the recognition of occupational health hazards conducted by the California State Department of Public Health, or the equivalent of such a course conducted by an institution acceptable to the Department.

(b) An Occupational Health Sanitarian with two years' full-time experience in that classification may qualify as an Industrial Hygienist for the purposes of Section 1276(j)(4) of this Code by completing two additional years of full-time experience in industrial hygiene under the direct supervision of an Industrial Hygiene Engineer or Industrial Hygienist qualified under Section 1306 above.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 519, 1111 and 1130, Health and Safety Code.

HISTORY

1. New section filed 6-24-68; effective thirtieth day thereafter (Register 68, No. 24).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1307 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 6-24-68 remains in effect uninterrupted (Register 85, No. 30).

3. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

§1308. Director of Environmental Health.

Note • History

A director of Environmental Health shall hold a valid certificate of registration as a Sanitarian in the State of California and shall have had three or more years' experience in an environmental health agency (a Master's Degree in Public Health, Health Science, Public Administration, or related field may be substituted for one year of the required experience).

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130 and 1155, Health and Safety Code.

HISTORY

1. New section filed 5-7-75; effective thirtieth day thereafter (Register 75, No. 19).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1308 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 5-7-75 remains in effect uninterrupted (Register 85, No. 30).

3. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

Article 4. Finance

§1325. Use of Funds.

Note • History

Funds available to local health departments under Chapter 8, Part 2, Division 1 of the Health and Safety Code may be expended for personnel, including but not limited to new or additional personnel and adjustments of salaries of existing personnel, maintenance and operation, equipment, and for capital expenditures. The funds may be used only to augment local appropriations provided for public health purposes, through the local public health department, including those functions listed in Article 2, but not including any of the following:

(a) Medical, hospital and therapeutic care of physically handicapped children.

(b) Maintenance of hospitals (including emergency hospitals and first aid stations), sanatoria and homes.

(d) Street cleaning.

(e) Inspection of building construction.

(f) Inspection of plumbing.

(g) Maintenance of dog or animal pounds.

(h) Inspection of cemeteries.

NOTE

Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1325 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1326. Restrictions on Matching Funds.

Note • History

For matching purposes as specified in Section 101255 of the Health and Safety Code, local health departments shall not include funds appropriated for functions listed under subsections (a) to (h), inclusive of Section 1325 above.

NOTE

Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1326 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34)

3. Change without regulatory effect amending section and Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1327. Deposit and Expenditure of Funds.

Note • History

The governing body of each local health department shall set up a special fund or account as approved by the State Department and all payments received from the State by the governing body shall be deposited in that fund or account. No money shall be expended from such fund or account except for public health purposes in accordance with Division 1, Part 2, Chapter 8, of the Health and Safety Code, and the rules and regulations adopted by the State Department of Health Services pursuant thereto.

NOTE

Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

HISTORY

1. Amendment filed 7-2-64; effective thirtieth day thereafter (Register 64, No. 14).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1327 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 7-2-64 remains in effect uninterrupted (Register 85, No. 30).

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

4. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1328. Budget and Program.

Note • History

Local health departments shall submit a budget each year, showing a total plan for the expenditure of public health funds during the year, together with an outline of the program contemplated. The appropriation made in support of such budget shall also be reported.

NOTE

Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1328 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34.)

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1329. Reports.

Note • History

Local health departments shall report their expenditures, and shall submit reports of services and operations, upon forms provided for that purpose, at such times as the State Department of Health Services may require.

NOTE

Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130, 1153 and 1154, Health and Safety Code.

HISTORY

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction of Section 1329 filed in error on 7-1-85 is null and void and text as filed with Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 30).

2. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

Subchapter 2. Standards for State Aid for Comprehensive Environmental Agencies

Article 1. Definitions

§1351. Comprehensive Environmental Agency.

Note • History

“Comprehensive Environmental Agency” means an agency responsible to the board of supervisors which has been assigned the total function of providing environmental health and sanitation services and programs and other related environmental management functions which the board of supervisors may choose to delegate to the agency.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Section 1155.5, Health and Safety Code.

HISTORY

1. New Subchapter 2 (Sections 1351-1375, not consecutive) filed 12-9-77; effective thirtieth day thereafter (Register 77, No. 50).

2. Editorial correction of NOTE filed 5-8-84 (Register 84, No. 19).

§1353. Environmental Health and Sanitation Services and Programs.

Note • History

“Environmental Health and Sanitation Services and Programs” means those agency provided services and programs which are required by the Director of the State Department of Health to meet local environmental health and sanitation needs. The term shall include additional environmentally related services and programs for which responsibility has been delegated to the agency by the county Board of Supervisors or Health District Board.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Section 1155.5, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

Article 2. Agency Personnel and Facilities

§1355. Director of Environmental Health.

Note • History

(a) There shall be a full-time Director of Environmental Health who shall be responsible for the administration of environmental health and sanitation services and programs.

(b) The Director shall meet the following minimum qualifications:

(1) Possession of a valid certificate of registration as a sanitarian in the State of California.

(2) Three or more years' experience in an environmental health agency. A Master's Degree in Public Health, Health Science, Public Administration, or a related field may be substituted for one year of the required experience.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1357. Environmental Health Staff.

Note • History

There shall be an adequate staff of Registered Sanitarians meeting the qualifications established by the State Department of Health pursuant to provisions of the Health and Safety Code and other support personnel necessary to implement agency services and programs. Staffing units shall be equal to or greater than those levels provided by the environmental health unit of the health department prior to the transfer.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1359. Clerical Staff.

Note • History

There shall be sufficient, properly supervised clerical staff to meet agency needs. Staffing levels shall be equal to or greater than those levels provided by the environmental health unit of the health department prior to the transfer.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1361. Office Facilities.

Note • History

There shall be provided publicly accessible office facilities which shall be in operation full time during the normal county government work week.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

Article 3. Organization

§1363. Conditions of Transfer.

Note • History

(a) Prior to transferring environmental health and sanitation services and programs from a local health department to an agency, the following shall be met:

(1) The county board of supervisors or health district board shall authorize the total environmental health and sanitation services and programs to be transferred and maintained as a single organizational unit.

(2) The Director of the State Department of Health shall give written approval for the transfer.

(3) The proposed agency shall have a State Department of Health approved annual program plan.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1365. Powers and Duties of the County Health Officer.

Note • History

The county health officer shall retain powers, duties, and responsibilities relating to the protection of public health as set forth in Section 452 of the Health and Safety Code.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 452, 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1367. Powers and Duties of the District Health Officer.

Note • History

The district health officer shall retain powers, duties, and responsibilities relating to the protection of public health as set forth in Division 1, Part 2, Chapter 6 (commencing with Section 880) of the Health and Safety Code.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Division 1, Part 2, Chapter 6 (commencing with Section 880) (Pursuant to the Savings Clause in Statutes 1959, Chapter 380, Page 2305, Section 3, as amended by Statutes 1961, Chapter 1362, Page 3137, Section 1; Statutes 1968, Chapter 468, Page 1099, Section 1) and Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1369. Powers and Duties of the Director of Environmental Health.

Note • History

(a) The Director of Environmental Health shall have powers and duties relating to environmental health and sanitation services and programs.

(b) The powers and duties shall be clearly delineated in writing and shall provide for well-defined, direct lines of communication with the county or district health officer to assure coordination of public health programs and environmental health and sanitation services and programs.

(c) These regulations shall not be deemed to diminish or impede any additional powers and duties of the Director of Environmental Health specified by statute, rule, regulation, resolution or order, or which may have been delegated to him by the county or district health officer.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

Article 4. Program

§1371. Basic Program.

Note • History

(a) Environmental health and sanitation services and programs shall be offered in accordance with an annual program plan approved by the State Department of Health and the applicable services and program standards an specified in the State Department of Health “Services in a Local Environmental Health and Sanitation Program,” September 1976. The required services and programs shall be as follows:

(1) Food.

(2) Housing and institutions.

(3) Radiological health in local jurisdictions contracting with the State Department of Health to enforce the Radiation Control Law pursuant to Sections 25600-25654 and Sections 25800-25876, Health and Safety Code.

(4) Land development and uses.

(5) Milk and dairy products in local jurisdictions maintaining an approved milk inspection service pursuant to Section 32503, Food and Agricultural Code.

(6) Occupational health.

(7) Water oriented recreation.

(8) Safety.

(9) Vector control.

(10) Wastes management.

(11) Water supply.

(12) Additional environmentally related services and programs as required by the County Board of Supervisors, City Council, or Health District Board.

(13) Air sanitation.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1373. Annual Program Plans.

Note • History

(a) Each county or district shall submit to the State Department of Health, annually for approval, program plans in each of the categories specified in Section 1371.

(b) The annual program plans shall contain information pertaining to community needs, authority, goals, objectives, activities, personnel, and program evaluation as may be required by the State Department of Health.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1375. State Financial Aid.

Note • History

County or district eligibility for funds pursuant to Division 1, Part 2, Chapter 8 (commencing with Section 1100) of the Health and Safety Code shall be contingent upon fulfillment by the agency of all environmental health and sanitation requirements imposed upon county or district health departments by state statutes, rules, regulations and orders, and by local ordinances.

NOTE

Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code.

HISTORY

1. New NOTE filed 5-8-84 (Register 84, No. 19).

Subchapter 3. Standards for Maintaining County Health Services

Article 1. Application

§1401. Application of Subchapter.

Note • History

Subchapter 3 shall apply to local jurisdictions that elect to apply for State funds under the provisions of Part 4.5 of Division 9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16702, Welfare and Institutions Code.

HISTORY

1. New Subchapter 3 (Sections 1401-1463, not consecutive) filed 10-18-78 as an emergency; effective upon filing (Register 78, No. 42).

2. Certificate of Compliance filed 2-6-79 (Register 79, No. 6).

3. Repealer of Subchapter 3 (Sections 1401-1463, not consecutive) and new Subchapter 3 (Sections 1401-1497, not consecutive) filed 8-29-80 as an emergency; designated effective 8-29-80 (Register 80, No. 35). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 12-29-80.

4. Certificate of Compliance transmitted to OAL 12-5-80 and filed 1-14-81 (Register 81, No. 3).

5. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

6. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1403. Section Headings.

Note

Section headings contained herein shall not be deemed to govern, limit, or modify the provisions of any section.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16712, Welfare and Institutions Code.

Article 2. Definitions

§1405. Addendum.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16990, Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1407. Agreement.

Note • History

“Agreement” means the Standard Agreement for County Health Services entered into and signed by the governing body of each local jurisdiction and the Director of the State Department of Health Services which specifies the conditions under which monies shall be transferred to each local jurisdiction from the County Health Services Fund pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704(b), Welfare and Institutions Code.

HISTORY

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1409. Allocation.

Note • History

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Sections 16702 and 16704, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of Section 1409 to Section 1418 filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1411. Annual Local Jurisdiction Budget.

Note • History

“Annual Local Jurisdiction Budget” means the official local jurisdiction budget adopted each year by the governing body of the local jurisdiction.

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1411.1. Benefits Chart.

Note • History

NOTE

Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code.

HISTORY

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending section heading and Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1413. Budget.

Note • History

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16700, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of Section 1413 to Section 1430.3 filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1415. City Health Services.

Note

“City health services” means public health services, outpatient health services, and inpatient health services provided directly by a city or financed or purchased by a city through grants, contracts, or agreements, but not including services provided pursuant to Division 5, Welfare and Institutions Code, or Division 10.5, Health and Safety Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16701(c), Welfare and Institutions Code.

§1417. County Health Services.

Note • History

“County health services” means public health services, outpatient health services, and inpatient health services provided directly by a local jurisdiction or financed or purchased by a local jurisdiction through grants, contracts, or agreements but not including services provided:

(1) Pursuant to Division 5, Welfare and Institutions Code.

(2) Pursuant to Division 10.5, Health and Safety Code.

(3) In Fiscal Year 1977-78 which are not part of the reported net county costs for Fiscal Year 1977-78.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16701(a), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1418. County Health Services Allocation.

Note • History

“County Health Services Allocation” means monies disbursed from the County Health Services Fund established pursuant to subdivision (a) of Section 16703, Welfare and Institutions Code, in an amount specified in the Standard Agreement for County Health Services entered into and signed by duly authorized local jurisdiction officials and the Director of Health Services. The “County Health Services Allocation” consists of an amount based on county population, in the case of a county, and may include an amount based on net costs budgeted by a local jurisdiction for the provision of health services.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16702 and 16704, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1419. County Health Services Fund.

Note • History

“County Health Services Fund” means the fund created by Section 16703, subdivision (a), Welfare and Institutions Code, for deposit of monies appropriated for distribution to the local jurisdictions pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16703, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1420.1. County Medical Services Program.

Note • History

NOTE

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1420.2. County Medical Services Program Account.

Note • History

NOTE

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1420.3. County Medical Services Program Contract.

Note • History

NOTE

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1420.4. Declaration of Intent to Enter into Contract.

Note • History

NOTE

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1420.5. County Medical Services Program Reserve Account.

Note • History

NOTE

Authority cited: Section 10725, Welfare and Institutions Code; and Section 100275, Health and Safety Code. Reference: Section 16709(g), Welfare and Institutions Code.

HISTORY

1. New section filed 4-4-86 effective thirtieth day thereafter (Register 86, No. 14).

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1421. Department.

Note

“Department” means the State Department of Health Services.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16702, Welfare and Institutions Code.

§1422. Director.

Note

“Director” means the Director of the State Department of Health Services.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16700, Welfare and Institutions Code.

§1422.1. Eligible Contract County.

Note • History

“Eligible Contract County” means a county which has requested the transfer of funding pursuant to Section 1157.5 of the Health and Safety Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16704, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1422.3. Eligibility Manual.

Note • History

NOTE

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1423. Expenditures.

Note • History

“Expenditures” means funds budgeted or expended to support health program operations and includes:

(1) Health services supplied or provided for through purchase or contract.

(2) Salaries and employee benefits.

(3) Operation and maintenance costs.

(4) Depreciation of facilities owned by a local jurisdiction.

(5) Administrative costs.

(6) Federal Revenue Sharing Funds budgeted or expended for these health activities.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16708, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1425. Fixed Assets, Fixtures, Structures and Improvements.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16708, Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1427. Inpatient/Outpatient Services.

Note • History

“Inpatient/outpatient services” means those medical care services provided directly by a local jurisdiction or purchased or provided through contracts with other providers which may include but not be limited to:

(1) General acute inpatient hospital services.

(2) Outpatient services administered by hospital staff, non-hospital based county clinics, and community clinics funded by a local jurisdiction.

(3) Skilled nursing facilities.

(4) Licensed home health agencies.

(5) Rehabilitation facility services.

(6) Inpatient/outpatient services for criminal justice inmates.

(7) Ambulance and related emergency services.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16701(a), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1428. Local Jurisdiction.

Note • History

“Local Jurisdiction” means a county, the San Joaquin Local Health District, a city which has not transferred to the county enforcement authority of applicable health statutes and regulations, or a city which provides public health services pursuant to a contract with a county through an organized health department recognized by the Department.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1429. Maximum Allocation.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1430. May, Shall, Should.

Note

“May” means permissible. “Shall” means mandatory. “Should” means desirable.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16712, Welfare and Institutions Code.

§1430.1. Medically Indigent Services Account.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803(b), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1430.2. Medically Indigent Services Allocation.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1430.3. Multi-Year Budget.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1430.4. Multi-Year Plan.

Note • History

“Multi-Year Plan” means the County Health Services three-year plan which describes proposed county health services in a format specified by the Department and submitted by a local jurisdiction pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of Section 1433 to Section 1430.4 filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1431. Net City Costs for Health Services.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16801(e), Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1432. Net County Costs for Health Services.

Note

“Net county costs for health services” means expenditures for county health services less revenues received for county health services plus Federal Revenue Sharing funds budgeted or expended for county health services.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16701(b), Welfare and Institutions Code.

§1433. Plan.

Note • History

NOTE

Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16700, Welfare and Institutions Code.

HISTORY

§1435. Public Health Services.

Note • History

“Public health services” means those health promotion, surveillance, and disease prevention services designed to protect the health of the public, population groups, and individuals.

NOTE

Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16801, Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1437. Reported Net County Costs for Fiscal Year 1977-78.

Note • History

“Reported net county costs for Fiscal Year 1977-78” means those net county costs for health services for Fiscal Year 1977-78 which were originally reported to the Department pursuant to Section 20 of Chapter 292 of the Statutes of 1978 or amended pursuant to County Health Services Bulletin #2-1979. These costs are those exact amounts listed below by county except that the amount listed for Alameda County does not include the net costs for Berkeley and the amount listed for San Joaquin County does not include the net costs for the San Joaquin Local Health District:

Alameda $22,649,584 Orange $21,552,624

Alpine $23,704 Placer $812,227

Amador $491,123 Plumas $115,890

Butte $1,179,463 Riverside $10,248,905

Calaveras $35,861 Sacramento $9,646,438

Colusa $273,457 San Benito $80,536

Contra Costa $11,924,448 San Bernardino $7,920,785

Del Norte $106,435 San Diego $10,797,538

El Dorado $1,015,867 San Francisco $40,124,175

Fresno $11,853,293 San Joaquin $3,006,398

Glenn $121,505 San Luis Obispo $1,889,127

Humboldt $1,238,729 San Mateo $8,280,966

Imperial $1,035,813 Santa Barbara $4,647,590

Inyo $593,006 Santa Clara $16,715,698

Kern $8,830,127 Santa Cruz $2,592,658

Kings $718,199 Shasta $563,682

Lake $64,719 Sierra $15,916

Lassen $401,705 Siskiyou $285,207

Los Angeles $177,838,404 Solano $1,006,584

Madera $311,721 Sonoma $1,439,658

Marin $1,760,674 Stanislaus $4,384,380

Mariposa $24,291 Sutter $999,607

Mendocino $547,607 Tehama $474,072

Merced $1,301,322 Trinity $318,281

Modoc $164,312 Tulare $2,317,423

Mono $424,737 Tuolumne $328,064

Monterey $4,200,837 Ventura $5,803,840

Napa $820,398 Yolo $1,419,400

Nevada $171,556 Yuba $334,214

NOTE

Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16990, Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1439. Revenues.

Note • History

“Revenues” means income budgeted or received for health services from fees, fines, grants, subventions, and/or monetary aid from government agencies but excluding property taxes, Federal Revenue Sharing, and monies provided pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1440. “Update.”

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16936, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

Article 3. County Health Services Multi--Year Plan and Budget

§1445. Multi-Year Plan and Budget Submission.

History

(a) Beginning in 1983, and each third subsequent year thereafter, the governing body of each county, the Cities of Berkeley, Long Beach, and Pasadena, and the San Joaquin Local Health District shall adopt and shall submit a Multi-Year Plan and Budget to the Director in the form and in accordance with procedures specified in this Article on or before September 15.

(b) Beginning in 1984, and each year thereafter, the governing body of each county, the Cities of Berkeley, Long Beach, and Pasadena, and the San Joaquin Local Health District shall adopt and shall submit an update of its adopted Multi-Year Plan and Budget to the Director in the form and in accordance with procedures specified in this Article on or before September 15.

(c) Copies of the Multi-Year Plan and Budget and Update shall be submitted to the appropriate area health planning agency simultaneously to submission to the Department.

(d) Submission of a Multi-Year Plan and Budget or Update shall not:

(1) Relieve any county of its indigent health care obligation under Section 17000, Welfare and Institutions Code.

(2) Restrict the ability of the State or any interested person or persons to obtain any judicial relief to which there is entitlement. NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16711, Welfare and Institutions Code.

HISTORY

1. Amendment of subsection (b) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

3. Certificate of Compliance including editorial correction transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Amendment of Article 3 heading and Section 1445 filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

§1451. Multi-Year Plan and Budget and Update Content.

Note • History

(a) The Multi-Year Plan and Budget submitted by each local jurisdiction shall contain but not be limited to a:

(1) Narrative section which provides a description of public health, and inpatient and outpatient services be provided or contracted for by the local jurisdiction.

(2) Budget section which details proposed expenditures, revenues and net county costs for county health services.

(3) Certification section containing signatures necessary for the formal transfer of State and/or Federal monies to the local jurisdiction pursuant to the Multi-Year Plan and Budget.

(b) The Multi-Year Plan and Budget shall include only health programs, services, and administrative support that are part of the reported net county costs for Fiscal Year 1977-78 and may include any new health programs which have been instituted since Fiscal Year 1977-78.

(c) Health programs and associated costs which existed during Fiscal Year 1977-78 and which are not part of the reported net county costs for Fiscal Year 1977-78 shall be excluded from the Multi-Year Plan and Budget, but may be in the Addendum identified in (d).

(d) The Multi-Year Plan and Budget may contain an Addendum which includes narrative descriptions and estimated expenditures, revenues, and net county costs for health services, exclusive of mental health, alcohol, and drug abuse treatment, not reported in the Plan and Budget.

(e) In those counties, except the County of Alameda, where the governing body of a city has not transferred to the county enforcement authority of applicable public health statutes and regulations or where public health services are provided b a city pursuant to a contract with a county, such a county shall, in the Multi-Year Plan and Budget, Update, and Agreement, provide for continuation and funding of such services.

(f) The Multi-Year Plan and Budget shall include only fiscal information which is consistent with the regulations on capital expenditures, depreciation, and administrative overhead as listed below:

(1) Capital expenditures for local jurisdiction structures and fixtures, and improvements to local jurisdiction structures and fixtures shall not be considered allowable costs.

(2) Depreciation for local jurisdiction structures and fixtures, and improvements to local jurisdiction structures and fixtures shall be an allowable expense for purposes of applying for monies pursuant to 1466. Depreciation also shall be an allowable expense for purposes of applying for monies pursuant to 1465(a) only if the:

(A) Reported net county costs for Fiscal Year 1977-78 included depreciation expenses for such local jurisdiction structures and fixtures, or improvements to local jurisdiction structures and fixtures; or,

(B) Reported net county costs for Fiscal Year 1977-78 included capital expenditures for such local jurisdiction structures and fixtures, or improvements to local jurisdiction structures and fixtures; or,

(C) Capital expense was incurred after June 30, 1978 and was for an allowable expense as determined by Department guidelines and regulations.

(3) Expenditures for fixed assets involving inpatient or outpatient health services for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code shall be depreciated and all other expenditures for fixed assets may be either expensed or depreciated, but not both.

(4) Administrative overhead shall be listed as a single line item or distributed across all programs, but not both.

(5) The Multi-Year Plan and Budget and Update shall include the Cost Allocation Summary presented annually to the State Controller's Office for the determination of indirect costs for Federal grants and contracts.

(g) The Multi-Year Plan and Budget and Update shall include information pertaining to medical services provided to indigent county residents. Specifically the Plan and Budget and Update shall include but not be limited to:

(1) The eligibility criteria the county uses to determine whether a person is certified as eligible for health services under Section 17000 of the Welfare and Institutions Code.

(2) A description of the county's eligibility process used to determine whether a person is eligible for services under Section 17000 of the Welfare and Institutions Code.

(3) A description of how county residents are notified or informed of the availability of county financed services pursuant to Section 17000 of the Welfare and Institutions Code.

(4) A listing of services or benefits which are provided.

(5) A listing of the location of services and how the county ensures reasonable accessibility of such services.

(6) A description of the county's fee collection policies, fee schedules, procedures and expected revenues for persons covered by Section 17000 of the Welfare and Institutions Code.

(7) An estimate of the Section 17000 target population size and an estimate of the number of persons who will use the services/benefits.

(8) A projection of the estimated costs of serving the medically indigent population under Section 17000 of the Welfare and Institutions Code.

(h) The annual Update of the Multi-Year Plan and Budget submitted by the local jurisdiction shall contain but not be limited to:

(1) The requirements specified in subdivisions (a) through (g), and any other instructions, forms, and guidelines developed by the Department pertaining to the annual Update.

(2) The Update shall not duplicate any of the material in the Multi-Year Plan and Budget.

(3) The Update also shall serve as a progress report evaluating what has been accomplished over the past year and shall provide specific time-limited measurable objectives in relation to each of the elements in the Multi-Year Plan and Budget during the applicable fiscal year.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16709, 16710 and 16711, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Amendment of Subsections (a)(1), (a)(2), (f)(5) and (g) filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

§1457. Plan and Budget Review.

Note • History

(a) The Department shall review the County Health Services Multi-Year Plan and Budget or Update submitted by each local jurisdiction to ensure as a minimum that the Multi-Year Plan and Budget or Update:

(1) Have been submitted in accordance with the procedures specified by the Director.

(2) Are in the format and cover the content specified by the Director.

(3) Contain the necessary signatures and certifications as specified by the Director.

(4) Contain budgeted financial data by budget unit as specified in the Annual County Budget and are presented in the format specified by the Department.

(5) Include copies of revenue and appropriations pages from the Annual County Budget for each budget unit listed pursuant to (4). Interim documentation may be submitted until an official Annual County Budget has been printed.

(6) Are in conformance with:

(A) Uniform accounting standards and procedures.

(B) Fiscal policies stated in these regulations.

(b) Based on the review of the Multi-Year Plan and Budget or Update, the Department may require a local jurisdiction to submit additional data or information in a format specified by the Department.

(1) The data or information shall be requested to augment an incomplete or inaccurate submission.

(2) Any local jurisdiction which does not comply with the request shall be considered as not having submitted a Multi-Year Plan and Budget or Update in conformance with Department guidelines and regulations and shall not receive per capita monies from the County Health Services Fund.

(c) All fiscal information submitted as part of the Multi-Year Budget or Update shall be verifiable and shall be subject to State audit.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

Article 4. Allocations, Agreement, Disbursement, Reporting and Recoupment Procedures

§1465. County Health Services Allocation.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16705, Welfare and Institutions Code.

HISTORY

1. Amendment of subsection (b)(3) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1466. Medically Indigent Services Allocation.

Note • History

(a) The Department shall compute each county's Medically Indigent Services Allocation in accordance with Subdivision (d) of Section 16703 of the Welfare and Institutions Code.

(b) A county may apply for all or a portion of its total allocation pursuant to 1473(c). If the County chooses to apply for these funds, it shall be bound by conditions and limitations contained in paragraph (1) of subdivision (c) of Section 16704 of the Welfare and Institutions Code on the use of such funds.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16703(b), 16704(c) and 16709(a), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1467. Medically Indigent Services Application.

Note • History

(a) In order to apply for the Medically Indigent Services Allocation, a county shall submit to the Department an Application adopted by the County Board of Supervisors prior to the disbursement of funds from the Medically Indigent Services Account. The Application shall be in a form and in accordance with procedures specified by the Director and shall contain but not be limited to the following:

(1) Unless a county has contracted with the Department pursuant to Article 6, an assurance by the County that it will incur no less in net costs of county funds for county health services in any fiscal year than the amount required to obtain the maximum allocation as specified in 1465(a).

(2) An assurance by the county that funds allocated pursuant to 1466 shall be expended only for health services included in Sections 14132 and 14021 of the Welfare and Institutions Code for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code. A county shall not be bound by utilization control provisions which are specified within Sections 14132 and 14021.

(3) An assurance by the county that funds allocated pursuant to 1466 shall not be expended for costs of services specified in county Short-Doyle plans which are in excess of the 125 percent limitation specified in Section 5705.1 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 16712, Welfare and Institution Code; and Statutes of 1982, Chapter 1594, Section 8(c). Reference: Sections 16704(c) and 16706, Welfare and Institutions Code.

HISTORY

1. New section filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

§1469. Agreement.

Note • History

(a) Upon completion of the Departmental review of a local jurisdiction's Multi-Year Plan and Budget or Update, the Department shall issue an Agreement for review and signature by appropriate officials representing the local jurisdiction. The agreement shall include, as appropriate, but shall not be limited to:

(1) The total funds to be allocated to the county based on population as specified in 1465(a)(1).

(2) The total funds to be allocated to the county based on budgeted allowable expenditures, revenues, and net costs as specified in 1465(a)(2).

(3) The total funds to be allocated to an Eligible Contract County solely for public health services as specified in 1465(a)(3).

(4) The total funds to be allocated to the City of Berkeley as specified in 1465 (a)(5).

(5) The total funds to be allocated to the San Joaquin Local Health District solely for public health services as specified in 1465(a)(6).

(6) The net costs of local jurisdiction funds for health services that must be incurred by the local jurisdiction in order to receive the total allocation specified in 1465(a).

(7) The sharing ratio of State funds as specified in (2), (3), (4) and (5) to the local jurisdiction funds as specified in (6). The sharing ratios shall not exceed those specified in 1465(h), as applicable.

(8) An assurance by the local jurisdiction that it agrees to expend local jurisdiction funds for net county costs for county health services in the amounts specified in 1465(c), (d), (e), and (f), as applicable.

(9) An assurance by the local jurisdiction that the health services provided by the Agreement will be in general accordance with the local jurisdiction's Multi-Year Plan and Budget or Update.

(10) An assurance by the local jurisdiction that monies provided by the State under the terms of this Agreement will be used to finance health services as described in the Multi-Year Plan and Budget or Update and for no other purpose.

(11) An assurance by the local jurisdiction that sufficient records, files and documentation will be maintained for State review concerning program activity and expenditures made under this Agreement and will be accessible for a period of at least four years from the expiration of this Agreement, or in the event of a State audit, until the audit has been resolved.

(12) An assurance by the local jurisdiction that access will be provided during normal working hours to authorize representatives of the Department and of other State agencies to all records, files, and documentation related to the Agreement.

(13) An assurance by the local jurisdiction that reports will be provided as required by the Department.

(b) The Agreement shall also include provisions pertaining to medically indigent services funds received pursuant to 1466. The provisions shall include but not be limited to:

(1) The total funds to be allocated to the county based on the allocation specified in 1466.

(2) The net costs for health services that must be incurred by the county in order to receive the allocation specified in 1466.

(3) An assurance by the county that it will incur no less in net costs of county funds for county health services in any fiscal year than the amount required to obtain the maximum allocation specified in 1465.

(4) An assurance by the county that funds allocated pursuant to 1466 shall be expended only for health services included in Sections 14132 and 14021 of the Welfare and Institutions Code for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code. A county shall not be bound by utilization control provisions which are specified within Sections 14132 and 14021.

(5) An assurance by the county that funds allocated pursuant to 1466 shall not be expended for costs of services specified in county Short-Doyle plans which are in excess of the 125 percent limitation specified in Section 5705.1 of the Welfare and Institutions Code.

(6) The total funds to be provided by the State as specified in (a) and in (b)(1) above, under the terms of the Agreement.

(d) A local jurisdiction that has not submitted a signed Agreement to the Department by the end of a current fiscal year shall be subject to recoupment of any funds disbursed pursuant to (b)(1).

(e) A local jurisdiction that does not conform with any or all of the terms of the Agreement may be subject to recoupment of funds disbursed to that local jurisdiction.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16706, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1473. Disbursement.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and Institutions Code.

HISTORY

1. Amendment of subsection (a)(2) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Amendment filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

5. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1475. Reports.

Note • History

(a) For Fiscal Year 1979-80 and annually thereafter, each local jurisdiction shall submit to the Department a report of estimated actual expenditures, revenues, and net county costs for services provided in accordance with the Multi-Year Plan and Budget or Update.

(1) The report shall be submitted in a form and in accordance with procedures specified by the Department.

(2) The report shall be due on November 15 in the year following the fiscal year for which data s being reported.

(b) For Fiscal Year 1979-80 and annually thereafter, each local jurisdiction shall submit to the Department a report of actual expenditures, revenues and net county costs for services provided in accordance with the Multi-Year Plan and Budget or Update.

(1) The report shall be submitted in accordance with the format and procedures as specified by the Department.

(2) The report shall be due on November 15 in the second year following the fiscal year for which data is being reported.

(c) Beginning on November 15, 1981, and annually thereafter each local jurisdiction shall prepare and submit to the Department a report describing health services provided by the local jurisdiction pursuant to Part 5 (commencing with Section 17000) of Division 9 of the Welfare and Institutions Code.

(1) The report shall be submitted in accordance with the procedures and timetable as established by the Department.

(2) The report shall include but not be limited to information covering the following:

(A) Eligibility standards

(B) Services provided

(D) Fees collected

(E) Target population size

(F) Costs

(d) The Director shall withhold part or all payment of County Health Services Funds to a local jurisdiction, unless the reports specified in (a) through (c) have been received by the Department.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16706 and 16716, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1477. Recoupment.

Note • History

(a) For Fiscal Year 1979-80 and annually thereafter, the Department shall review the report specified in 1475(a), which shall serve as the initial basis for the recovery of funds not expended in accordance with the Agreement described in 1469.

(1) The Department:

(A) Shall determine whether or not the county has reported only net costs specifically allowed pursuant to Department guidelines and regulations.

(B) May disallow reported costs that are inaccurate or are not allowable costs for county health services or for health services provided to persons eligible pursuant to Section 17000 of the Welfare and Institutions Code.

(2) The Department shall notify the local jurisdiction in writing of its determinations and allowances made pursuant to (1).

(3) Notification shall be sent to the local jurisdiction's governing body, Auditor-Controller, Administrative Officer, and the Health Agency Director, Health Officer, and Hospital Administrator, as applicable.

(4) The notification for the fiscal year shall list:

(A) Aggregate net county costs specified in the Agreement.

(B) Estimated actual net county costs as reported pursuant to 1475(a).

(5) If the estimated actual net county costs are less than the aggregate net county costs specified in the Agreement, the notification shall declare the Department's intent to do one or a combination of the following in order to recoup the State portion of the funds specified in (4)(C):

(A) Adjust subsequent payments to the local jurisdiction from the County Health Services Fund.

(B) Negotiate a repayment plan for the local jurisdiction.

(b) For Fiscal Year 1979-80 and annually thereafter, the Department shall review the report specified in 1475(b) which shall serve as the final basis for recoupment of funds not expended in accordance with the Agreement described in 1469, unless the report is modified by actual audit findings officially adopted by the State.

(1) The Department:

(A) Shall determine whether or not the local jurisdiction has reported only net costs specifically allowed pursuant to Department guidelines and regulations.

(B) May disallow reported costs that are inaccurate or are not allowable after verifying the information with the local jurisdiction and notifying them of the proposed disallowance.

(2) The Department shall notify the local jurisdiction in writing of its determinations and disallowances made pursuant to (1) and of any difference between the actual net county costs reported pursuant to 1475(b) and the estimated actual net county costs reported pursuant to 1475(a).

(4) The notification for the fiscal year shall list the:

(A) Actual net county costs as reported pursuant to 1475(b).

(B) Estimated actual net county costs as reported pursuant to 1475(a).

(5) If the actual net county costs are less than the estimated actual net county costs the notification shall declare the Department's intent to do one or a combination of the following in order to recoup the State portion of the funds specified in (4)(c):

(A) Adjust subsequent payments to the local jurisdiction from the County Health Services Fund.

(B) Negotiate a repayment plan for the local jurisdiction.

(c) The governing body of the local jurisdiction shall have twenty-one (21) working days, following receipt of notification pursuant to (a)(2) or (b)(2) to appeal the Department's decision. The appeal shall be in accordance with the format and procedures specified by the Department.

(d) The Department may adjust the monthly payments made to a county pursuant to an Agreement as specified in 1469(b) if the county fails to expend such funds as specified in the Agreement.

(e) The Department shall recover any unexpended funds disbursed to county as specified in 1473(b) for medically indigent services in accordance with the procedures specified in the Agreement.

(f) The Department shall recover any funds not expended pursuant to 1469(b) in accordance with the procedures specified in the Agreement.

NOTE

Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16706, Welfare and Institutions Code.

HISTORY

1. Amendment of subsections (d)(B) and (e) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1481. Special Needs and Priorities.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16707, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Amendment filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

Article 5. Public Hearing Procedures

§1485. Purpose.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1486. Conditions.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1487. Scheduling.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1489. Notification.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

1. Amendment of subsections (a)(1) and (a)(2) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1491. Conduct.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

1. Amendment of subsections (b) and (d) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1493. Findings.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and Institutions Code.

HISTORY

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1495. Transmittal.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

§1497. Determinations.

Note • History

NOTE

Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code.

HISTORY

1. Amendment of subsections (b) and (c) and new subsection (f) filed 5-21-81; effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed 10-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 42).

Article 6. County Medical Services Program

§1498. County Medical Services Program.

Note • History

NOTE

HISTORY

1. New Article 6 (Sections 1498-1498.9) filed 12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendments and editorial corrections transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Amendment of subsection (f) filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

4. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.1. Declaration of Intent to Contract.

Note • History

NOTE

Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16703 and 16709, Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment of subsections (a) and (c) filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.2. Small County Advisory Committee.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.3. Contract.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment of subsection (a)(1) and NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment of subsections (c), (d) and (e) filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.4. Eligibility.

Note • History

NOTE

Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 159, Section 87(c). Reference: Sections 16703, 16706 and 16709, Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment of subsections (b), (d), (e) and (f) filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.5. Benefits.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.6. Administration.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.7. Fiscal.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.8. Liabilities.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including editorial correction of NOTE transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

§1498.9. Reporting.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24)

2. Change without regulatory effect repealing section and amending Note filed 9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 36).

Chapter 3.1. Indian Health

Article 1. Definitions

§1500. Indian.

Note • History

“Indian” means any person who is:

(a) Identified as an Indian on the rolls maintained by the Bureau of Indian Affairs,

(b) Identified as an Indian on the rolls maintained by an Indian tribe, band, or other organized group of Indians, in any state,

(c) A descendant in the first or second degree of any person identified at any time on a roll referred to in subsection (a) or (b),

(d) Declared to be a member of a tribe or a descendant in the first or second degree of a member of a tribe by the tribal council of his or her tribe, or

(e) A descendant in any degree from a member of a tribe which has been declared to be terminated by the United States government. However, any person qualifying under this subsection must be at least one quarter Indian blood.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 429.30, 429.31 and 429.32, Article 14, Chapter 2, Part 1, Division 1, Health and Safety Code.

HISTORY

1. New Chapter 3.1, Articles 1-4 (Sections 1500-1541, not consecutive) filed 4-1-76 as an emergency; effective upon filing (Register 76, No. 14).

2. Certificate of Compliance filed 7-14-6 (Register 76, No. 29).

§1501. Indian Tribe.

“Indian Tribe” means any Indian tribe, band, nation or other organized group or community, which is determined to be eligible for the special programs and services provided by the United States or State of California, to Indians because of their status as Indians.

§1502. Existing Indian Health Programs.

“Existing Indian Health Programs” means any program which provided, as of September 8, 1975, direct health services as defined in Section 1503 under the supervision of a licensed physician and surgeon, dentist, optometrist, or nurse.

§1503. Direct Health Services.

“Direct Health Services” means one or more of the following services provided under the supervision of a licensed provider of health services acting within the scope of his or her license:

(a) Primary health care consisting of diagnostic, treatment and health maintenance services.

(b) Outreach, education, referral, follow-up services and assistance to the individual in obtaining services from other agencies to which he is entitled (health advocacy).

(1) Screening and disease detection services.

(2) Alcohol and drug abuse detoxification services.

(3) Dental health services.

(4) Services leading to the prevention of vision and hearing loss and the restoration of vision and hearing.

(5) Family planning services.

(6) Maternal and child health services.

(7) Medical care of chronic conditions.

§1504. Licensed Provider of Health Services.

“Licensed Provider of Health Services” for the purposes of Section 1503 means:

(a) A provider practicing in California licensed by the appropriate healing arts board.

(b) An individual employed by the Federal government in the practice of the healing arts on tribal lands.

§1505. Department.

Note • History

“Department” means the State Department of Health Services.

NOTE

Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code.

HISTORY

1. Editorial correction filed 12-7-84 (Register 84, No. 49.

§1506. Director.

Note • History

“Director” means the Director of the State Department of Health Services.

NOTE

Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code.

HISTORY

1. Editorial correction filed 12-7-84 (Register 84, No. 49).

§1507. Indian Medicine and Traditional Health Practices.

Note • History

“Indian Medicine and Traditional Health Practices” means traditional practices of Indian medicine which are native to an Indian community, which are accepted by that Indian community as handed down through the generations and which can be established through the collective knowledge of the elders of that Indian community.

NOTE

Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code.

HISTORY

1. New NOTE filed 12-7-84 (Register 84, No. 49).

Article 2. Indian Health Policy Panel

§1520. Indian Health Policy Panel.

An Indian Health Policy Panel established by the Director shall advise the Director regarding policy for Indian health.

§1521. Panel Membership.

Panel membership shall consist of four representatives of the California Rural Indian Health Board, four representatives of the California Urban Indian Health Council, and two individuals appointed by the Director. The representatives of the California Urban Indian Health Council and the California Rural Indian Health Board shall be appointed by the Council and the Board.

Article 3. Assistance to Indian Health Programs

§1530. Financial Assistance to Indian Health Programs.

Monies available under Chapter 606, Statutes of 1975, and any funds available to carry out provisions of Article 14 (commencing with Section 429.30) of Chapter 2 of Part 1 of Division 1 of the Health and Safety Code shall be allotted for the following purposes:

(a) Direct health services as defined under Section 1503 of these regulations.

(b) Technical assistance by individuals experienced in the delivery of health services including, but not limited to, health professionals, economists, sociologists, accountants, legal advisors, midwives (to the extent otherwise permitted by law), and other experts in Indian medicine and traditional health practices. Technical assistance may be provided by State staff, by consultants under contract with the State, or through contracts with local public and voluntary health organizations or existing Indian health programs.

(1) On the job training using workers in the program or individuals from other projects or agencies as instructors.

(2) Short term training sponsored by an educational facility not to exceed two weeks duration at any one time or one day per week over a three-month period.

(3) Tuition for the course work required by a staff member for the A.A., B.A. degree or advanced degree.

(d) Studies concerning the health needs, resources and practices of California Indians. Special emphasis shall be placed on the area of Indian medicine and traditional health practices.

§1531. Allocation of Financial Assistance to Indian Health Programs.

(a) Funds shall be allocated for health services which are supplemental to those available from the Federal or State government. State funds available for the purposes of the Indian Health Service Program (Article 14 (commencing with Section 429.30) of Chapter 2 of Part 1 of Division 1 of the Health and Safety Code) shall not duplicate or replace any commitment made by the Federal government.

(b) No funds shall be provided from those appropriated for the purposes of the Indian Health Service Program for types of services for which Indians are eligible under other programs and for which other funds are available, including but not limited to the following types of services:

(1) Family planning.

(2) Supplemental Feeding for Women, Infants and Children (WIC).

(3) Alcoholism or substance abuse services.

(4) Hospitalization other than for emergency services, if an individual is eligible for medical care under Title XVIII or XIX of the Federal Social Security Act, under the Workmen's Compensation Statutes of California, from the Veteran's Administration or other similar programs or when a public health service hospital is accessible or if an individual has private health insurance.

(5) Maternal and Child Health.

(6) Crippled Childrens Services.

(7) Community Mental Health Services Program (Short-Doyle).

(8) Developmental Disability Program (Regional Centers).

§1532. Allocation Formula.

(a) In the determination of the allocation of State funds the following factors shall be considered:

(1) Need as demonstrated by:

(A) The number of individuals to be served.

(B) The availability of other resources in the service area.

(D) Higher costs of providing health services in the areas served.

(2) The ability of the proposed program to meet that need, as determined by:

(A) Adequate personal services.

(B) Sufficient operating expenses.

(3) Compliance with statewide plan for Indian health services and existing priorities for services.

(4) Compliance with local Indian health plan.

(5) The demonstrated ability of the Indian health program to carry out the proposed services.

§1533. Reimbursement for Service.

(a) The programs shall maximize utilization of reimbursement from third-party payors.

(b) Where an Indian is eligible for health benefits from third-party payors and the service is provided by an existing Indian health program, the revenue collected from third-party payors shall be used to increase the services offered by the program.

§1534. To Qualify for Funding.

Note • History

(a) To qualify for funding an existing Indian health program shall be administered by a nonprofit corporation organized under the laws of this State or by an Indian tribe as defined in Section 1501. The board of directors or trustees of such corporation shall be composed of a majority of Indians as defined in Section 1500.

NOTE

Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Sections 1182 and 1182.2, Health and Safety Code.

HISTORY

1. New NOTE filed 12-7-84 (Register 84, No. 49).

§1535. Criteria for Reimbursement of Direct Services.

(a) Salaries, travel expenses, and per diem rates for employees of existing Indian health programs shall be no greater than the rate set for State employees in like circumstances. Exceptions shall be granted only when no provider of services is available to the program at the rate set for State employees.

(b) Rates for reimbursement of services provided on a fee-for-service basis shall be no greater than the prevailing rates in the community in which the provider of services offers services.

Article 4. Standards of Service

§1540. Confidentiality of Information.

(a) All patient files and information maintained or possessed by an existing Indian health program shall be treated as privileged communication, shall be held confidential, and shall not be divulged without the written consent of the individual or his personal representative, (or the parent or guardian, in the case of a minor), except as may be necessary to provide emergency services to the individual, to file a claim for benefits on behalf of the individual, or as required by the Department to administer this program. Information may be disclosed in summary, statistical, or other form which does not identify the particular individual.

(b) Services shall be provided in a manner that respects the privacy and dignity of the individual.

§1541. Informed Consent.

(a) No individual shall be denied benefits available under the Indian Health Service Program for failure to accept any form of offered treatment. In the case of any medical treatment offered or given to an individual under the Indian Health Services Program, a signed consent form shall be obtained indicating that the individual has been informed of all known risks, benefits, and alternatives to the proposed treatment. This requirement may be waived in the case of emergencies. In the case of minors, the consent form shall be signed by the parent or guardian.

Chapter 3.5. Joint Regulations for Handicapped Children

Subchapter 1. Interagency Responsibilities for Providing Services to Handicapped Children

§2000. Joint Regulations for Handicapped Children.

History

CROSS-REFERENCE: See Title 2, Division 9, Chapter 1, Articles 1-9, Sections 60000-60610, not consecutive.

HISTORY

1. New Chapter 3.5 (Subchapter 1, Section 2000) printed as cross-reference only (Register 86, No. 21).

Chapter 4. Preventive Medical Service

(Originally Printed 8-15-45)

Subchapter 1. Reportable Diseases and Conditions

Article 1. Reporting

§2500. Reporting to the Local Health Authority.

Note • History

(a) The following definitions shall govern the interpretation of this Subchapter.

(1) `CDC' means the Centers for Disease Control and Prevention, United States Department of Health and Human Services.

(2) `CSTE' means the Council of State and Territorial Epidemiologists.

(3) `MMWR' means the Morbidity and Mortality Weekly Report.

(4) `Case' means (A) a person who has been diagnosed by a health care provider, who is lawfully authorized to diagnose, using clinical judgment or laboratory evidence, to have a particular disease or condition listed in subsection (j); or (B) a person who meets the definition of a case in Section 2564 - Diarrhea of the Newborn, Section 2574 - Food Poisoning, Section 2612 Salmonella Infections (Other than Typhoid Fever), Section 2628 - Typhoid Fever, or Section 2636 - Venereal Disease; or (C) a person who is considered a case of a disease or condition that satisfies the most recent communicable disease surveillance case definitions established by the CDC and published in the Morbidity and Mortality Weekly Report (MMWR) or its supplements; or (D) an animal that has been determined, by a person authorized to do so, to have rabies or plague.

(5) `Clinical signs' means the objective evidence of disease.

(6) `Clinical symptoms' means the subjective sensation of disease felt by the patient.

(7) `Communicable disease' means an illness due to a specific microbiological or parasitic agent or its toxic products which arises through transmission of that agent or its products from an infected person, animal, or inanimate reservoir to a susceptible host, either directly or indirectly through an intermediate plant or animal host, vector, or the inanimate environment.

(8) `Director' means State Director of Public Health.

(9) `Drug susceptibility testing' means the process where at least one isolate from a culture of a patient's specimen is subjected to antimicrobial testing to determine if growth is inhibited by drugs commonly used to treat such infections.

(10) `Epidemiological risk factors' means those attributes, behaviors, exposures, or other factors that alter the probability of disease.

(11) `Epidemiologically linked case' means a case in which the patient has/has had contact with one or more persons who have/had the disease, and transmission of the agent by the usual modes of transmission is plausible.

(12) `Foodborne disease' means illness suspected by a health care provider to have resulted from consuming a contaminated food.

(13) `Foodborne disease outbreak' means an incident in which two or more persons experience a similar illness after ingestion of a common food, and epidemiologic analysis implicates the food as the source of the illness. There are two exceptions: even one case of botulism or chemical poisoning constitutes an outbreak if laboratory studies identify the causative agent in the food.

(14) `Health care provider' means a physician and surgeon, a veterinarian, a podiatrist, a nurse practitioner, a physician assistant, a registered nurse, a nurse midwife, a school nurse, an infection control practitioner, a medical examiner, a coroner, or a dentist.

(15) `Health officer' and `local health officer' as used in this subchapter includes county, city, and district health officers.

(16) `In attendance' means the existence of the relationship whereby a health care provider renders those services which are authorized by the health care provider's licensure or certification.

(17) `Infection control practitioner' means any person designated by a hospital, nursing home, clinic, or other health care facility as having responsibilities which include the detection, reporting, control and prevention of infections within the institution.

(18) `Laboratory findings' means (A) the results of a laboratory examination of any specimen derived from the human body which yields microscopical, cultural, immunological, serological, or other evidence suggestive of a disease or condition made reportable by these regulations; or (B) the results of a laboratory examination of any specimen derived from an animal which yields evidence of rabies or plague.

(19) `Multidrug-resistant Mycobacterium tuberculosis' means a laboratory culture or subculture of Mycobacterium tuberculosis which is determined by antimicrobial susceptibility testing to be resistant to at least isoniazid and rifampin.

(20) `Outbreak' means the occurrence of cases of a disease (illness) above the expected or baseline level, usually over a given period of time, in a geographic area or facility, or in a specific population group. The number of cases indicating the presence of an outbreak will vary according to the disease agent, size and type of population exposed, previous exposure to the agent, and the time and place of occurrence. Thus, the designation of an outbreak is relative to the usual frequency of the disease in the same facility or community, among the specified population, over a comparable period of time. A single case of a communicable disease long absent from a population or the first invasion by a disease not previously recognized requires immediate reporting and epidemiologic investigation.

(21) `Personal information' means any information that identifies or describes a person, including, but not limited to, his or her name, social security number, date of birth, physical description, home address, home telephone number, and medical or employment history.

(22) `Sexually Transmitted Diseases' means Chancroid, Lymphogranuloma Venereum, Granuloma Inguinale, Syphilis, Gonorrhea, Chlamydia, Pelvic Inflammatory Disease, and Nongonococcal Urethritis.

(23) `Suspected case' means (A) a person whom a health care provider believes, after weighing signs, symptoms, and/or laboratory evidence, to probably have a particular disease or condition listed in subsection (j); or (B) a person who is considered a probable case, or an epidemiologically-linked case, or who has supportive laboratory findings under the most recent communicable disease surveillance case definition established by CDC and published in the Morbidity and Mortality Weekly Report (MMWR) or its supplements; or (C) an animal which has been determined by a veterinarian to exhibit clinical signs or which has laboratory findings suggestive of rabies or plague.

(24) `Unusual disease' means a rare disease or a newly apparent or emerging disease or syndrome of uncertain etiology which a health care provider has reason to believe could possibly be caused by a transmissible infectious agent or microbial toxin.

(25) [Repealed]

(26) `Waterborne disease outbreak' means an incident in which two or more persons experienced a similar illness after consumption or use of the same water intended for drinking or after water contact such as by immersion, and epidemiologic investigation by public health authorities implicates the same water as the source of the waterborne illness. There is one exception: a single case of waterborne chemical poisoning constitutes an outbreak if laboratory studies indicate that the source water is contaminated by the chemical.

(b) It shall be the duty of every health care provider, knowing of or in attendance on a case or suspected case of any of the diseases or conditions listed in subsection (j) of this section, to report to the local health officer for the jurisdiction where the patient resides as required in subsection (h) of this section. Where no health care provider is in attendance, any individual having knowledge of a person who is suspected to be suffering from one of the diseases or conditions listed in subsection (j) of this section may make such a report to the local health officer for the jurisdiction where the patient resides.

(c) The administrator of each health facility, clinic or other setting where more than one health care provider may know of a case, a suspected case or an outbreak of disease within the facility shall establish and be responsible for administrative procedures to assure that reports are made to the local health officer.

(d) Each report made pursuant to subsection (b) shall include all of the following information if known:

(1) name of the disease or condition being reported; the date of onset; the date of diagnosis; the name, address, telephone number, occupation, race/ethnic group, Social Security number, sex, age, and date of birth for the case or suspected case; the date of death if death has occurred; and the name, address and telephone number of the person making the report.

(2) If the disease reported pursuant to subsection (b) is hepatitis, a sexually transmitted disease or tuberculosis, then the report shall include the following applicable information, if known: (A) hepatitis information as to the type of hepatitis, type-specific laboratory findings, and sources of exposure, (B) sexually transmitted disease information as to the specific causative agent, syphilis-specific laboratory findings, and any complications of gonorrhea or chlamydia infections, or (C) tuberculosis information on the diagnostic status of the case or suspected case, bacteriologic, radiologic and tuberculin skin test findings, information regarding the risk of transmission of the disease to other persons, and a list of the anti-tuberculosis medications administered to the patient.

(e) Confidential Morbidity Report forms, are available from the local health department for reporting as required by this section.

(f) Information reported pursuant to this section is acquired in confidence and shall not be disclosed by the local health officer except as authorized by these regulations, as required by state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual.

(g) Upon the State Department of Public Health's request, a local health department shall provide to the Department the information reported pursuant to this section. Absent the individual's written consent, no information that would directly or indirectly identify the case or suspected case as an individual who has applied for or been given services for alcohol or other drug abuse by a federally assisted drug or alcohol abuse treatment program (as defined in federal law at 42 C.F.R. Section 2.11) shall be included.

(h) The urgency of reporting is identified by symbols in the list of diseases and conditions in subsection (j) of this section. Those diseases with a diamond (τ) are considered emergencies and shall be reported immediately by telephone. Those diseases and conditions with a cross (+) shall be reported by mailing, telephoning or electronically transmitting a report within one (1) working day of identification of the case or suspected case. Those diseases and conditions not otherwise identified by a diamond or a cross shall be reported by mailing a written report, telephoning, or electronically transmitting a report within seven (7) calendar days of the time of identification.

(i) For foodborne disease, the bullet (•) symbol indicates that, when two (2) or more cases or suspected cases of foodborne disease from separate households are suspected to have the same source of illness, they shall be reported immediately by telephone.

(j) Health care providers shall submit reports for the following diseases or conditions.

NOTE

Authority cited: Sections 120130, 131050, 131051, 131052, 131080 and 131200, Health and Safety Code. Reference: Sections 1603.1, 100325, 103925, 113150, 113155, 120125, 120130, 120140, 120175, 120245, 120250, 131050, 131051 and 131080, Health and Safety Code; Sections 551, 554 and 555, Business and Professions Code; Section 1798.3, Civil Code; 42 C.F.R. Sections 2.11 and 2.12; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code.

HISTORY

1. Originally published 8-15-1945 (Title 17).

2. Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 52). For prior history, see Register 66, No. 39.

3. Amendment filed 12-14-79; effective thirtieth day thereafter (Register 79, No. 50).

4. Amendment of subsection (a) and new subsections (b)-(h) filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

5. Editorial correction of HISTORY No. 4 printing error (Register 89, No. 23).

6. Editorial correction of subsection (g)(1) printing error (Register 90, No. 4).

7. Editorial correction of printing errors in subsection (g) (Register 91, No. 46).

8. Amendment of section and Note filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

9. Amendment of section and Note, including amendment of subsection (j)(1) “Diphtheria”, refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 5-1-95 order, including amendment of section, transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

11. Editorial correction of subsections (j)(1) and (j)(2) (Register 97, No. 12).

12. Amendment of subsection (j), repealer of subsection (j)(1) designator and initial text, repealer of subsection (j)(2) and amendment of Note filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

13. Editorial correction restoring inadvertently deleted footnote (Register 2000, No. 33).

14. Amendment of subsection (j) and amendment of Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

15. Amendment of subsection (j) and amendment of Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

16. Certificate of Compliance as to 3-1-2002 order, including amendment of Note, transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

17. Amendment of subsection (j) filed 6-30-2005; operative 6-30-2005. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2005, No. 32).

18. Amendment of subsection (j) filed 10-26-2006; operative 10-26-2006. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2006, No. 43).

19. Amendment of subsection (j) filed 6-12-2007; operative 6-12-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

20. Amendment of subsection (j) filed 7-30-2007; operative 7-30-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

21. Amendment of subsections (a)(8), (g) and (j) and amendment of Note filed 2-13-2008; operative 2-13-2008. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2008, No. 7).

22. Amendment of subsection (j) and Note filed 9-22-2009; operative 9-22-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2009, No. 39).

23. Repealer of subsection (a)(25) and amendment of subsections (e) and (j) filed 6-30-2011; operative 6-30-2011. Submitted to OAL for printing only pursuant to Health and Safety Code sections 120130(a) and 120130(d) (Register 2011, No. 26).

§2501. Investigation of a Reported Case, Unusual Disease, or Outbreak of Disease.

Note • History

(a) Upon receiving a report made pursuant to Section 2500 or 2505, the local health officer shall take whatever steps deemed necessary for the investigation and control of the disease, condition or outbreak reported. If the health officer finds that the nature of the disease and the circumstances of the case, unusual disease, or outbreak warrant such action, the health officer shall make or cause to be made an examination of any person who or animal which has been reported pursuant to Sections 2500 or 2505 in order to verify the diagnosis, or the existence of an unusual disease, or outbreak, make an investigation to determine the source of infection, and take appropriate steps to prevent or control the spread of the disease. Whenever requested to do so by the Department, the health officer shall conduct a special morbidity and mortality study under Health and Safety Code Section 211 for any of the diseases made reportable by these regulations.

(b) If a disease is one in which the local health officer determines identification of the source of infection is important, and the source of infection is believed to be outside the local jurisdiction, the health officer shall notify the Director or the health officer under whose jurisdiction the infection was probably contracted if known. Similar notification shall be given if there are believed to be exposed persons, living outside the jurisdiction of the health officer, who should be quarantined or evaluated for evidence of the disease.

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code; and Section 555(b), Business and Professions Code. Reference: Sections 7, 200, 207, 211, 211.5, 304.5, 410, 1603.1, 3051, 3053, 3110, 3122, 3123, 3124, 3125, 3131 and 3132, Health and Safety Code; Sections 551, 554 and 555, Business and Professions Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

3. Amendment of section and Note, including renumbering and amendment of former section 2512 to subsection 2501(b)(1)-(2), filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section and Note refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 5-1-95 order, including repealer and new section heading, and amendment of section and Note transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§2502. Reports by Local Health Officer to State Department of Public Health.

Note • History

(a) Summary Reports: Each local health officer shall report at least weekly, on the Weekly Morbidity by Place of Report form to the Director the number of cases of those diseases, conditions, unusual diseases or outbreaks of disease reported pursuant to Section 2500. Copies of the form are available from the Department's Division of Communicable Disease Control.

(b) Individual Case and Outbreak Reports: For the diseases listed below, the local health officer shall prepare and send to the Department along with the summary report described in (a) above an individual case or outbreak report for each individual case/outbreak of those diseases which the Department has identified as requiring epidemiological analysis reported pursuant to Section 2500. At the discretion of the Director, the required individual case/outbreak report may be either a Confidential Morbidity Report, its electronic equivalent or a hard copy 8.5x11 inch individual case/outbreak report form. The Weekly Morbidity by Place of Report form indicates which format to use. Each individual case report shall include the following: (1) verification of information reported pursuant to Section 2500; (2) information on the probable source of infection, if known; (3) laboratory or radiologic findings, if any; (4) clinical signs and/or symptoms, if applicable; and (5) any known epidemiological risk factors. The Department or CDC has prepared forms that may be used for many of the diseases requiring individual case reports. Copies of these case report forms are available from the Department's Division of Communicable Disease Control. An individual case report is required for the following diseases:

Acquired Immune Deficiency Syndrome (AIDS)

Anthrax, human

Botulism (Infant, Foodborne, Wound, Other)

Brucellosis, human

Chickenpox (Varicella) deaths (separate reporting form required)

Chickenpox (Varicella) hospitalizations (separate reporting form

required)

Cholera

Creutzfeldt-Jakob Disease (CJD) and other Transmissible Spongiform Encephalopathies (TSE)

Cyclosporiasis

Cysticercosis

Diphtheria

Escherichia coli: shiga toxin producing (STEC) including

E. coli O157

Foodborne Disease Outbreak

Haemophilus influenzae, Invasive Disease

Hantavirus Infections

Hemolytic Uremic Syndrome

Hepatitis A, acute infection

Hepatitis B, acute only

Hepatitis C, acute only

Hepatitis D (Delta), acute infection

Hepatitis E, acute infection

Influenza, deaths in laboratory-confirmed cases for ages 0-64 years

Influenza, novel strains (human)

Legionellosis

Leprosy (Hansen Disease)

Leptospirosis

Listeriosis

Lyme Disease

Malaria

Measles (Rubeola)

Meningococcal Infections

Outbreak of Disease Report

Pelvic Inflammatory Disease

Pertussis (Whooping Cough)

Plague, human

Poliovirus Infection

Psittacosis

Q Fever

Rabies, human or animal (separate reporting forms required for

human and animal cases)

Relapsing Fever

Rickettsial Diseases (non-Rocky Mountain Spotted Fever), including Typhus and Typhus-like Illnesses)

Rocky Mountain Spotted Fever

Rubella (German Measles) (a separate form is used for Congenital Rubella)

Severe Acute Respiratory Infection (SARS)

Shiga toxin (detected in feces)

Smallpox

Staphylococcus aureus infection (only a case resulting in death or admission to an intensive care unit of a person who has not been hospitalized or had surgery, dialysis, or residency in a long-term care facility in the past year, and did not have an indwelling catheter or percutaneous medical device at the time of culture.)

Streptococcal Outbreaks and Individual Cases in Food Handlers and Dairy Workers Only

Syphilis

Tetanus

Toxic Shock Syndrome

Trichinosis

Tuberculosis

Tularemia, human

Typhoid Fever, Cases and Carriers (separate reporting forms required for cases and carriers)

Unusual Disease Report

Vibrio Infections

Viral Hemorrhagic Fevers, human (e.g., Crimean-Congo, Ebola, Lassa and Marburg viruses)

Waterborne Disease Outbreak

West Nile virus infection, acute

Yellow Fever

(c) Immediate Reports: Cases and suspect cases of anthrax (human or animal), botulism, brucellosis (human only), cholera, dengue, diphtheria, measles (rubeola), plague (human or animal), rabies (human only), smallpox (variola), tularemia (human only), varicella deaths, viral hemorrhagic fevers (human or animal), yellow fever, occurrence of any unusual diseases, and outbreaks of any disease are to be reported by the local health officer to the Director immediately by telephone.

(d) Upon request of the Department, the local health officer shall submit an individual case report for any disease not listed in subsection (b) above.

(e) During any special morbidity and mortality study requested under Section 2501, the local health officer shall be the Director's agent for purposes of carrying out the powers conferred under Government Code Section 11181.

(f) Confidentiality. Information reported pursuant to this section is acquired in confidence and shall not be disclosed by the local health officer except as authorized by these regulations, as required by state or federal law, or with the written consent of the individual to whom the information pertains or to the legal representative of that individual.

(1) A health officer shall disclose any information, including personal information, contained in an individual case report to state, federal or local public health officials in order to determine the existence of a disease, its likely cause or the measures necessary to stop its spread.

(2) A health officer may for purposes of his or her investigation disclose any information contained in an individual case report, including personal information, as may be necessary to prevent the spread of disease or occurrence of additional cases.

(3) A health officer may disclose any information contained in an individual case report to any person or entity if the disclosure may occur without linking the information disclosed to the individual to whom it pertains, and the purpose of the disclosure is to increase understanding of disease patterns, to develop prevention and control programs, to communicate new knowledge about a disease to the community, or for research.

(4) Notwithstanding subsections (1), (2), and (3) above, no information that would directly or indirectly identify an individual as one who has applied for or been given services for alcohol or other drug abuse by a federally assisted drug or alcohol abuse treatment program (as defined in 42 C.F.R. § 2.11) shall be included in an individual case report or otherwise disclosed absent the individual's written consent.

(g) Whenever the health officer collects personal information in order to prepare an individual case report required by subsection (b), the health officer shall notify the individual from whom the information is collected that: (1) supplying personal information related to the individual's disease is mandatory; (2) the only disclosure of personal information will be pursuant to subsections 2502(f(1) and 2502(f)(2); and (3) non-personal information may be disclosed pursuant to subsection 2502(f)(3).

NOTE

Authority cited: Sections 120130, 131050, 131051, 131052, 131080 and 131200, Health and Safety Code; and Section 555(b), Business and Professions Code. Reference: Sections 7, 1603.1, 100325, 100330, 103925, 113150, 113155, 120125, 120130, 120140, 120145, 120175, 120190, 120245, 120250, 131050, 131051 and 131080, Health and Safety Code; and Sections 551, 554 and 555, Business and Professions Code; Section 1798.3, Civil Code; Sections 11181 and 11182, Government Code; 42 C.F.R. Sections 2.11 and 2.12; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

3. Amendment filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 5-1-95 order, including repealer and new section heading, section and Note transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

6. Editorial correction of subsection (c) (Register 97, No. 12).

7. Amendment of subsections (b)-(c) and amendment of Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

8. Amendment of subsections (b)-(c) and amendment of Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

10. Amendment of subsection (b) filed 6-30-2005; operative 6-30-2005. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2005, No. 32).

11. Amendment of subsection (b) 6-12-2007; operative 6-12-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

12. Amendment of subsection (b) filed 7-30-2007; operative 7-30-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

13. Amendment of section heading, subsection (b) and Note filed 2-13-2008; operative 2-13-2008. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2008, No. 7).

14. Amendment of subsection (b) and Note filed 9-22-2009; operative 9-22-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2009, No. 39).

15. Amendment of subsections (a) and (b) filed 6-30-2011; operative 6-30-2011. Submitted to OAL for printing only pursuant to Health and Safety Code sections 120130(a) and 120130(d) (Register 2011, No. 26).

§2503. Reporting Occurrence of Unusual Diseases. [Repealed]

Note • History

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3053, 3110, 3123, 3124 and 3125, Health and Safety Code.

HISTORY

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

3. Amendment of section heading and section filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section heading and section refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 5-1-95 order, including repealer of section transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§2504. Report by Health Care Provider of Out-of-State Laboratory Findings.

Note • History

Whenever a health care provider's identification of a case or suspected case of tuberculosis includes laboratory findings from an out-of-state laboratory, the health care provider shall include those findings with the report made pursuant to Section 2500(b), and if the laboratory performed drug susceptibility testing, the results of such testing shall also be so reported.

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3053, 3110, 3123, 3125 and 3285, Health and Safety Code.

HISTORY

1. Amendment of section heading, repealer and new section, and new Note filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

2. Repealer and new section refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-1-95 order transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§2505. Notification by Laboratories.

Note • History

(a) To assist the local health officer, the laboratory director, or the laboratory director's designee, of a clinical laboratory, an approved public health laboratory or a veterinary laboratory in which a laboratory examination of any specimen derived from the human body (or from an animal, in the case of rabies or plague testing) yields microscopical, cultural, immunological, serological, or other evidence suggestive of those diseases listed in subsections (e)(1) and (e)(2) below, shall report such findings to the health officer of the local health jurisdiction where the health care provider who first submitted the specimen is located.

(1) For those diseases listed in subsection (e)(1), the report of such findings shall be made within one hour after the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction in which the health care provider is located within one hour from the time the laboratory notifies the referring laboratory that submitted the specimen.

(2) For those diseases listed in subsection (e)(2), the report of such findings shall be made within one working day from the time that the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction in which the health care provider is located within one working day from the time the laboratory notifies the referring laboratory that submitted the specimen.

(b) To permit local health officer follow-up of laboratory findings, all specimens submitted for laboratory tests or examinations related to a disease or condition listed in subsections 2505(e)(1) or 2502(e)(2) shall be accompanied by a test requisition which includes the name, gender, and age or date-of-birth of the person from whom the specimen was obtained and the name, address and telephone number of the health care provider or other authorized person who submitted the specimen. Whenever the specimen, or an isolate therefrom, is transferred between laboratories, a test requisition with the above patient and submitter information shall accompany the specimen. The laboratory that first receives a specimen shall be responsible for obtaining the patient and submitter information at the time the specimen is received by that laboratory.

(c) Each notification to the local health officer shall include the date the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the laboratory findings for the test performed, the date that any positive laboratory findings were identified, the name, gender, address, telephone number (if known) and age or date of birth of the person from whom the specimen was obtained, and the name, address, and telephone number of the health care provider for whom such examination or test was performed.

(d) The notification shall be submitted as specified in subsections (e)(1) and (e)(2) of this Section to the local health officer in the jurisdiction where the health care provider who submitted the specimen is located. When the specimen is from an out-of-state submitter, the state epidemiologist of the submitter shall be provided the same positive findings per subsections (e)(1) and (e)(2) of this Section. If the laboratory that finds evidence for any of those diseases listed in subsections (e)(1) and (e)(2) is an out-of-state laboratory, the California clinical laboratory that receives a report of such findings from the out-of-state laboratory shall notify the local health officer in the same way as if the finding had been made by the California laboratory.

(e) Laboratory reports to the local health officer shall include the information as specified in (c) of this Section and laboratories shall submit the reports within the following timeframes:

(1) The diseases or agents specified shall be reported within one hour after the health care provider or other person authorized to receive the report has been notified. Laboratories shall make the initial reports to the local health officer by telephone and follow the initial report within one working day by a report in writing submitted by electronic facsimile transmission or electronic mail to the local health officer. Within one year of the establishment of the state electronic reporting system, all List (e)(1) diseases, in addition to being reported by telephone within one hour, shall be reported electronically to the state electronic reporting system within one working day of identification. Reporting to the state electronic reporting system substitutes reporting by electronic facsimile transmission and electronic mail. Laboratory findings for these diseases are those that satisfy the most recent communicable disease surveillance case definitions established by the CDC (unless otherwise specified in this Section). The diseases or agents reported pursuant to this requirement are:

Anthrax, human (B. anthracis) (see section 2551 for additional reporting instructions)

Anthrax, animal (B. anthracis)

Botulism (see section 2552 for additional reporting instructions)

Brucellosis, human (all Brucella spp.) (see section 2553 for special reporting instructions)

Burkholderia pseudomallei and B. mallei (detection or isolation from a clinical specimen)

Influenza, novel strains (human) (see (i) for additional reporting requirements)

Plague, human (see section 2596 for additional reporting instructions)

Plague, animal

Smallpox (Variola) (see section 2614 for additional reporting instructions)

Tularemia, human (F. tularensis) (see section 2626 for additional reporting instructions)

Viral Hemorrhagic Fever agents, human (VHF), e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses (see section 2638 for additional reporting instructions)

Viral Hemorrhagic Fever agents, animal (VHF), e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses

(2) The diseases or agents specified shall be reported within one working day after the health care provider or other person authorized to receive the report has been notified. Laboratories shall transmit these reports to the local health officer by courier, mail, electronic facsimile or electronic mail. Within one year of the establishment of the state electronic reporting system, all List (e)(2) diseases shall be reported electronically to the state electronic reporting system within one working day of identification. Reporting to the state electronic reporting system substitutes reporting by courier, mail, electronic facsimile transmission or electronic mail. Laboratory findings for these diseases are those that satisfy the most recent communicable disease surveillance case definitions established by the CDC (unless otherwise specified in this Section). The diseases or agents reported pursuant to this requirement are:

Acid fast bacillus (AFB) (see (g) for additional reporting requirements)

Anaplasmosis/Ehrlichiosis

Bordetella pertussis acute infection, by culture or molecular identification

Borrelia burgdorferi infection

Brucellosis, animal (Brucella spp. except Brucella canis)

Campylobacteriosis (Campylobacter spp.) (detection or isolation a clinical specimen)

Chancroid (Haemophilus ducreyi)

Chlamydia trachomatis infections, including lymphogranuloma venereum (LGV)

Coccidioidomycosis

Cryptosporidiosis

Cyclosporiasis (Cyclospora cayetanensis)

Dengue (dengue virus)

Diphtheria

Encephalitis, arboviral

Escherichia coli: shiga toxin producing (STEC) including E. coli O157

Giardiasis (Giardia lamblia, intestinalis, or duodenalis)

Gonorrhea

Haemophilus influenzae (report an incident of less than 15 years of age, sterile site)

Hantavirus Infections

Hepatitis A, acute infection

Hepatitis B, acute or chronic infection (specify gender)

Hepatitis C, acute or chronic infection

Hepatitis D (Delta), acute or chronic infection

Hepatitis E, acute infection (detection of hepatitis E virus RNA from a clinical specimen or positive serology)

Legionellosis (Legionella spp.) (antigen or culture)

Leprosy (Hansen Disease) (Mycobacterium leprae)

Leptospirosis (Leptospira spp.)

Listeriosis (Listeria)

Malaria (see (h) for additional reporting requirements)

Measles (Rubeola), acute infection

Mumps (mumps virus), acute infection

Mycobacterium tuberculosis (see (f) for additional reporting requirements)

Neisseria meningitidis (sterile site isolate)

Poliovirus

Psittacosis (Chlamydophila psittaci)

Q Fever (Coxiella burnetii)

Rabies, animal or human

Relapsing Fever (Borrelia spp.) (identification of Borrelia spp. spirochetes on peripheral blood smear).

Rickettsia, any species, acute infection (detection from a clinical specimen or positive serology)

Rocky Mountain Spotted Fever (Rickettsia rickettsii)

Rubella, acute infection

Salmonellosis (Salmonella spp.)

Shiga toxin (detected in feces)

Shigellosis (Shigella spp.)

Syphilis

Trichinosis (Trichinella)

Tuberculosis

Tularemia, animal (F. tularensis)

Typhoid

Vibrio species infections

West Nile virus infection

Yellow Fever (yellow fever virus)

Yersiniosis (Yersinia spp., non-pestis) (isolation from a clinical specimen)

(f) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory or approved public health laboratory that isolates Mycobacterium tuberculosis from a patient specimen shall:

(1) Submit a culture as soon as available from the primary isolate on which a diagnosis of tuberculosis was established. Such a culture shall be submitted to the public health laboratory designated in Title 17 California Code of Regulations, Section 1075 for the local jurisdiction where the health care provider's office is located. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. The public health laboratory shall retain the culture received (one culture from each culture-positive patient) in a viable condition for at least six months.

(2) Unless drug susceptibility testing has been performed by the clinical laboratory on a strain obtained from the same patient within the previous three months or the health care provider who submitted the specimen for laboratory examination informs the laboratory that such drug susceptibility testing has been performed by another laboratory on a culture obtained from that patient within the previous three months, the clinical laboratory shall:

(A) Perform or refer for drug susceptibility testing on at least one isolate from each patient from whom Mycobacterium tuberculosis was isolated; and

(B) Report the results of drug susceptibility testing to the local health officer of the city or county where the submitting physician's office is located within one working day from the time the health care provider or other authorized person who submitted the specimen is notified; and

(C) If the drug susceptibility testing determines the culture to be resistant to at least isoniazid and rifampin, in addition, submit one culture or subculture from each patient from whom multidrug-resistant Mycobacterium tuberculosis was isolated to the official public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction in which the health care provider's office is located. The local public health laboratory shall forward such cultures to the Department's Microbial Diseases Laboratory. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed.

(g) Whenever a clinical laboratory finds that a specimen from a patient with known or suspected tuberculosis tests positive for acid fast bacillus (AFB) staining and the patient has not had a culture which identifies that acid fast organism within the past 30 days, the clinical laboratory shall culture and identify the acid fast bacteria or refer a subculture to another laboratory for those purposes.

(h) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory that makes a finding of malaria parasites in the blood film of a patient shall immediately submit one or more such blood film slides for confirmation to the public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction where the health care provider is located. When requested, all blood films shall be returned to the submitter.

(i) Whenever a laboratory receives a specimen for the laboratory diagnosis of influenza, novel strains in a human such laboratory shall communicate immediately by telephone with the Department's Viral and Rickettsial Disease Laboratory for instruction.

(j) All laboratory notifications herein required are acquired in confidence and shall not be disclosed by the local health officer except (1) as authorized by these regulations; (2) as required by state or federal law; or (3) with the written consent of the individual to whom the information pertains or the legal representative of that individual.

(k) The local health officer shall disclose any information, including personal information, contained in a laboratory notification to state, federal or local public health officials in order to determine the existence of the disease, its likely cause and the measures necessary to stop its spread.

NOTE

Authority cited: Sections 100180, 100275, 120130, 125095, 131050, 131051, 131052 and 131200, Health and Safety Code. Reference: Sections 100180, 120125, 120130, 120140, 120175, 120575, 121365 and 125100, Health and Safety Code; Sections 1209, 1246.5 and 1288, Business and Professions Code; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code.

HISTORY

1. New section filed 3-26-62; effective thirtieth day thereafter (Register 62, No.6).

2. Amendment of subsections (a) and (b) filed 6-25-72 as an emergency; effective upon filing (Register 72, No. 27).

3. Certificate of Compliance filed 10-24-72 (Register 72, No. 44).

4. Amendment of subsection (d) filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

5. Amendment of section and Note filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

6. Amendment of section and Note refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 5-1-95 order, including amendment of section, transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

8. Change without regulatory effect amending subsection (c) filed 7-15-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 29).

9. Amendment of subsections (a)-(d), repealer of subsection (e) and new subsections (e)-(e)(2) and amendment of Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

10. Amendment of subsections (a)-(d), repealer of subsection (e), new subsections (e)-(e)(2) and amendment of Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 3-1-2002 order, including further amendment of subsection (e)(1), transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

12. Amendment of subsection (e)(2) filed 6-30-2005; operative 6-30-2005. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2005, No. 32).

13. Amendment of subsection (e)(2) filed 10-26-2006; operative 10-26-2006. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2006, No. 43).

14. Amendment of subsections (e)(1)-(2), new subsections (i)-(j) and subsection relettering filed 6-12-2007; operative 6-12-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

15. Amendment of subsection (e)(2) filed 7-30-2007; operative 7-30-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).

16. Amendment of subsections (e)(1) and (e)(2) and amendment of Note filed 9-22-2009; operative 9-22-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2009, No. 39).

17. Amendment of subsections (e)(1)-(2), repealer of subsections (i)-(i)(4)(B), subsection relettering and amendment of newly designated subsection (i) filed 6-30-2011; operative 6-30-2011. Submitted to OAL for printing only pursuant to Health and Safety Code sections 120130(a) and 120130(d) (Register 2011, No. 26).

18. Amendment of subsection (e)(2) filed 9-27-2011; operative 10-27-2011. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2011, No. 39).

§2508. Reporting by Schools.

It shall be the duty of anyone in charge of a public or private school, kindergarten, boarding school, or day nursery to report at once to the local health officer the presence or suspected presence of any of the communicable diseases.

§2509. Records of Local Health Officer.

The local health officer shall maintain such records as he deems necessary in the performance of his duties, or as requested by the State Department of Health Services.

§2510. Outbreaks of Nonreportable Diseases. [Repealed]

History

HISTORY

1. Repealer filed 7-29-55; effective thirtieth day thereafter (Register 55, No. 11).

§2511. Determination of Morbidity Level.

History

It shall be the duty of the local health officer to determine the amount and kind of communicable disease occurring in his area by such methods as he deems necessary in order to obtain knowledge of the general level of morbidity in his jurisdiction.

HISTORY

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

Article 2. General Instructions

§2512. Investigation of the Case. [Renumbered]

History

HISTORY

1. Renumbering and amendment of former section 2512 to subsection 2501(b)(1)-(2) filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

2. Renumbering and amendment of former section 2512 to subsection 2501(b)(1)-(2) refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

§2514. Instructions to Household.

Note • History

It shall be the duty of the health care provider in attendance on a case or suspected case of any disease or condition listed in Sections 2500, or of any other disease considered to be communicable, to give detailed instructions to the members of the household in regard to precautionary measures to be taken for preventing the spread of the disease or condition. Such instructions shall conform to these regulations and local ordinances. It is the responsibility of each health care provider to be informed as to these regulations and the local ordinances which are in effect in the communities in which the health care provider practices.

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 207, 208, 3123 and 3285, Health and Safety Code.

HISTORY

1. Amendment of section and new Note filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.

2. Amendment of section and Note refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-1-95 order, including amendment of section, transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§2515. Definition of Isolation.

Isolation is defined as separation of infected persons from other persons for the period of communicability in such places and under such conditions as will prevent the transmission of the infectious agent. Isolation will be applied as instructed below.

§2516. Strict Isolation.

If the disease is one requiring strict isolation, the health officer shall insure that instructions are given to the patient and members of the household, defining the area within which the patient is to be isolated and stating the measures to be taken to prevent the spread of the disease.

Strict isolation shall include the following measures:

(a) The patient shall have a separate bed in a room protected against flies.

(b) All persons, except those caring for the patient, shall be excluded from the sick room.

(c) The persons caring for the patient shall avoid coming in contact with any other persons within the household or elsewhere until every precaution has been taken to prevent the spread of infectious material from the patient's room.

(d) The persons caring for the patient shall wear a washable outer garment and shall thoroughly wash their hands with soap and hot water after handling the patient or any object he may have contaminated. On leaving the room in which the patient is isolated, the attendant shall take off the washable outer garment and hang it in the room until disinfected.

(e) All discharges from the nose and mouth shall be burned or disinfected. The discharges should be received in pieces of soft tissue or cloth and dropped into a paper bag which can be burned.

(f) Objects which may have been contaminated by the patient shall be thoroughly cleansed before being removed from the contaminated area.

(g) The feces and urine of patients suffering from diseases in which the infectious agent appears in the feces or urine shall be disposed of according to instructions given be the local health officer.

§2518. Modified Isolation.

If the disease is one in which only a modified isolation is required, the local health officer shall issue appropriate instructions, prescribing the isolation technique to be followed. The isolation technique will depend upon the disease.

§2520. Quarantine.

Quarantine is defined as the limitation of freedom of movement of persons or animals that have been exposed to a communicable disease for a period of time equal to the longest usual incubation period of the disease, in such manner as to prevent effective contact with those not so exposed. If the disease is one requiring quarantine of the contacts in addition to isolation of the case, the local health officer shall determine the contacts who are subject to quarantine, specify the place to which they shall be quarantined, and issue instructions accordingly. He shall insure that provisions are made for the medical observation of such contacts as frequently as necessary during the quarantine period.

§2522. Observation.

For the purposes of definition, the term “observation,” as used in these regulations, shall refer to a frequent check upon the person under observation to determine whether such person is free of the disease for which he has been placed under observation, or has contracted the disease. Unless otherwise specified, it does not mean the isolation or quarantine of the individual.

§2524. Terminal Disinfection.

Each person released from quarantine or isolation shall bathe and wash his hair with soap and hot water and put on clean clothes. The area of isolation shall be disinfected according to the instructions of the local health officer.

§2526. Exclusion and Readmission by School Authorities.

Note • History

It shall be the duty of the principal or other person in charge of any public, private or Sunday School to exclude therefrom any child or other person affected with a disease presumably communicable, until the expiration of the prescribed period of isolation for the particular communicable disease. If the attending physician, school physician, or health officer finds upon examination that the person is not suffering from a communicable disease, he may submit a certificate to this effect to the school authority who shall readmit the person.

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3051, 3053, 3110, 3118 and 3123, Health and Safety Code.

HISTORY

1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

§2528. Contamination by Pathogenic Organisms of Milk, Milk Products or Products Resembling Milk Products.

Note • History

(a) The State Department of Health Services finds that the presence of any of the following pathogenic organisms in milk, milk product, or product resembling milk products make such product unsafe for human consumption: Mycobacterium tuberculosis; Brucella spp.; Streptococcus pyogenes, group A hemolytic; Corynebacterium diphtheria; Salmonella paratyphi; Salmonella schottmuelleri; Salmonella hirschfeldi; Salmonella typhi; Salmoneela dublin; Salmonella typhimurium; Shigella spp. Whenever a health officer finds that milk, milk product, or product resembling milk products, is unsafe for human consumption because it contains any of the above named organisms, he shall issue a written order to the producer or distributor of the product (1) summarizing the laboratory findings, and (2) prohibiting the sale or disposal of such milk, milk product, or product resembling milk products, except by a method approved by him, until such time as he finds the product or products to be safe for human consumption.

(b) Whenever a health officer has evidence that milk, milk product, or product resembling milk products has caused human illness or contains toxins which make such product unsafe for human consumption, he may issue a written order to the producer or distributor of the product (1) stating the facts upon which his conclusions are based, and (2) prohibiting the use, sale, or disposal of such milk, milk product, or product resembling milk products, except by a method approved by him, until such time as he finds it to be safe for human consumption.

(c) The health officer shall immediately forward a copy of any order issued pursuant to this section to the State Director of Health Services.

(d) Any producer or distributor of milk, milk product, or product resembling milk products, subject to an order of a health officer pursuant to this section may appeal to the State Department of Health Services solely upon the question of whether such products are, in fact, safe for human consumption. Such appeal shall be made in writing, stating which of the facts set forth in the order are admitted and denied. Upon receipt of the written appeal, the State Director of Health Services, after such investigation of the matter as he deems necessary, may amend or rescind the order, or set the matter for hearing before a hearing officer designated by him. In the event the order is not rescinded or amended to the satisfaction of the appellant, the matter shall be set for hearing. The hearing shall, if possible, be set within 14 days from the date of receipt of the appeal, unless additional time is required by the appellant. Insofar as is practicable, the procedures of the Administrative Procedure Act (Ch. 5, Pt. 1, Div. 3, Title 2, of the Government Code) shall apply. The hearing officer shall submit a proposed decision to the State Department of Health Services which shall issue its decision in accordance with Section 11517 of the Administrative Procedure Act. The decision shall be subject to judicial review.

(e) The procedures of this section authorize a health officer to take immediate action to protect the public health in the event he finds that milk, milk products, or products resembling milk products constitutes the applicability of other provisions of law pertaining to the regulation of such products, including but not limited to, the provisions of the Agricultural Code and the California Pure Foods Act (Ch. 3, Div. 21, Health and Safety Code).

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3110-3125, Health and Safety Code.

HISTORY

1. Repealer and new section filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 52).

§2530. Public Food Handlers.

Note • History

No person known to be infected with a communicable disease or suspected of being infected with a communicable disease shall engage in the commercial handling of food, or be employed on a dairy or on premises handling milk or milk products, until he is determined by the health officer to be free of such disease, or incapable of transmitting the infection. (See Chapter 7, Article 1, Section 28295, Health and Safety Code.)

NOTE

Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3051, 3053, 3110, 3123, 3131, 3132 and 28295, Health and Safety Code

HISTORY

1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

§2534. Laboratory Tests for the Release of Cases of Carriers of Communicable Diseases.

Whenever laboratory tests are required for the release of cases or carriers, the tests shall be taken by the health officer or his representatives and shall be submitted to a public health officer or his representatives and shall be submitted to a public health laboratory approved by the State Department of Health Services. Specimens may be sent to laboratories not so approved, provided the specimens are divided and a portion of the specimens are sent to an approved laboratory. Release shall be considered on the basis of the report of the approved laboratory only.

§2536. Transportation of Communicable Disease Cases.

History

No person with a communicable disease subject to isolation not any contact subject to quarantine shall travel or be transported from one place to another within the local health jurisdiction, without the permissions of the local health officer, and no such person shall travel or be transported outside the area of jurisdiction of the health officer until the permission of the health officer into whose jurisdiction the patient is to be brought is obtained. An exception may be made in instances where the patient is to be admitted directly to a hospital for the treatment of the communicable disease,provided that the health officer from whose jurisdiction the case to be transported shall insure that adequate precautions are taken to prevent dissemination of the disease by the patient or his contacts en route to the hospital.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2538. Funerals.

Funeral services for individuals who have died of a communicable disease shall be conducted in accordance with instructions of the health officer. In diseases requiring quarantine of contacts, a public funeral service may be permitted only if the casket remains closed and those contacts subject to quarantine who attend the funeral are adequately segregated from the public.

§2540. General Clause.

In addition to the requirements stipulated in these regulations, the local health officer shall, after suitable investigation, take such additional steps as he deems necessary to prevent the spread of communicable disease or a disease suspected of being communicable in order to protect the public health.

Article 3. Specific Diseases and Conditions

§2550. Amebiasis.

(a) Under ordinary circumstances, isolation of cases and quarantine of contacts are not required.

(b) Persons who are found to be excreting Endamoeba histolytica in the feces shall be prohibited from public food handling until three feces specimens, taken at intervals of not less than three days, shall be proved negative for the organism by a public health laboratory approved by the State Department of Health Services.

§2551. Anthrax. Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section 2518. Wound isolation precautions shall be instituted until lesions are free of anthrax bacilli. There are no restrictions on contacts.

(b) Laboratory. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human anthrax, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the State Department of Health Services for instruction.

NOTE

Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 120130, 120175, 120190, 120195 and 120215, Health and Safety Code.

HISTORY

1. Amendment of section heading and section and new Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

2. Amendment of section heading and section and new Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2552. Botulism. Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).) The health officer shall make an immediate investigation of every case or suspected case of botulism in an effort to establish the diagnosis and determine the source. In the event that a commercial food product is suspected as the source, special instructions will be given by the State Department of Health Services. The local health officer shall take all necessary steps to prevent distribution and consumption of the suspected food. There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human botulism, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the Department of Health Services for instruction.

NOTE

Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120175, 120185 and 120190, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment of section heading and section and new Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

3. Amendment of section heading and section and new Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2553. Brucellosis (Undulant Fever). Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).) There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human brucellosis, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the Department of Health Services for instruction.

NOTE

Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120185 and 120190, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2554. Chancroid.

(See Section 2636 on Venereal Diseases.)

§2555. Chickenpox.

History

HISTORY

1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2556. Cholera. Cases and Suspect Cases to Be Reported by Telephone or Telegraph.

History

(See Section 2501(c).) The case shall be isolated in accordance with Section 2516 and the intimate contacts quarantined pending receipt of instructions from the State Health Services Department.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2558. Coccidioidomycosis.

History

Report active cases only primary (including cavitary) or disseminated. There are no restrictions on case or contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2560. Conjunctivitis, Acute Infectious of the Newborn.

Note • History

(a) Acute infectious conjunctivitis of the newborn includes gonorrheal ophthalmia and ophthalmia neonatorum.

(b) Prophylaxis for acute infectious conjunctivitis of the newborn shall be administered to all infants within two hours after birth in accordance with Sections 551-556 of the Business and Professions Code.

(1) One percent silver nitrate in wax ampules administered without saline irrigation.

(2) Ophthalmic ointments or drops containing tetracycline or erythromycin.

(d) An infant with acute infectious conjunctivitis shall be isolated in accordance with Section 2516, Title 17, California Administrative Code, until clinical recovery occurs and negative laboratory tests are obtained.

NOTE

Authority cited: Section 555(b), Business and Professions Code. Reference: Sections 551 through 556, Business and Professions Code.

HISTORY

1. Amendment filed 5-28-53; effective thirtieth day thereafter (Register 53, No. 9).

2. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

3. Amendment filed 12-15-79; effective thirtieth day thereafter (Register 79, No. 50).

§2562. Dengue. Cases and Suspect Cases to Be Reported by Telephone or Telegraph.

History

(See Section 2501(c).) The case shall be confined during the clinical phase of the disease in a room or dwelling satisfactorily protected against mosquitos. There are no restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2564. Diarrhea of the Newborn.

History

(a) Any infant under 1 month of age in a hospital or institution, or any infant hospitalized because of prematurity, who has two or more watery or otherwise apparently abnormal stools within a 24-hour period, with or without other signs of illness, shall be considered a suspicious case of diarrhea of the newborn and immediately isolated. Any newborn, who within four days after discharge from a hospital has two or more watery or otherwise apparently abnormal stools within a 24-hour period, with or without other signs of illness, shall be considered a suspicious case and kept under close observation. If the diarrhea continues for more than two days the infant shall be immediately reported as a case of diarrhea of the newborn to the local health officer by telephone or other equally prompt means. An exception may be made in the case of entirely breastfed infants who show no signs of illness and are gaining weight.

(b) Isolation of Case. The case shall be placed in strict isolation until discharged from the hospital.

(c) Quarantine of Infants in Nursery. If two or more cases occur, all infants in the nursery shall be quarantined and no infants shall be admitted until all exposed infants have been discharged and the nursery thoroughly cleaned, and personnel, equipment, and procedures involved have been investigated by the health officer and found adequate.

(d) Care of Noncontacts. Infants born subsequent to quarantine of infants in the newborn nursery for diarrhea of the newborn shall be cared for in a separate clean newborn nursery by a separate nursing staff.

(e) Closure of Hospital to Maternity Admissions. If cases of diarrhea of the newborn as defined above occur also in the temporary clean nursery, the hospital shall be closed to maternity admissions until all cases and contacts are discharged and all nursery rooms and equipment thoroughly cleaned.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2566. Diphtheria.

History

(a) Isolation of Patient. The patient shall be isolated in accordance with Section 2516 until 2 cultures from the throat and 2 from the nose, taken not less than 24 hours apart, fail to show the presence of diphtheria bacilli, except that upon clinical recovery and where antibiotics have been used as therapy, isolation may be modified in accordance with Section 2518. Release cultures may not be taken less than seven days after discontinuance of such therapy. Isolation may be terminated if the bacilli cultured from the case are proved to be virulent.

(b) Control of Household Contacts. All household contacts shall be kept under daily medical observation for clinical evidence of diphtheria for seven days after last exposure. These contacts shall be isolated if they are found to have sore throat or nasal discharge until proved by culture not to have diphtheria. All household contacts under the age of 15 shall be quarantined for at least seven days after the last exposure to the case. Nose and throat cultures for diphtheria should then be taken and the contacts may be released from quarantine if such cultures are negative. If the contact has received an antibiotic, release cultures may not be taken less than seven days after discontinuation of such medication.

(c) Release of Carriers From Isolation. Convalescent or healthy carriers of diphtheria bacilli may be released from quarantine if the bacilli are shown to be avirulent by appropriate laboratory tests. Any person who has been free from the symptoms of diphtheria for four weeks or longer and who harbors virulent diphtheria bacilli is defined as a chronic carrier. Efforts should be made to eliminate the carrier state in such persons by appropriate medical or surgical measures. If these measures are unsuccessful or are refused the health officer may release the carrier from isolation when, in his judgment, such release is not detrimental to the public health, except that the carrier may not be permitted to engage in any occupation which involves handling of foods of close association with children outside his own family.

(d) Laboratory Tests for the Release of Cases or Carriers. Cultures or virulence tests for the release of diphtheria cases or carriers shall be taken not less than seven days after discontinuation of antibiotic therapy and examined in accordance with the provisions of Section 2534.

(e) Cases on Dairies. When a case of diphtheria occurs or is confined on the premises where milk or milk products are handled, the health officer shall prohibit the use, sale or disposal of such milk or milk product, except by a method approved by him, until he is satisfied that such products are safe for human consumption.

(f) Immunization. The health officer shall take appropriate measures to encourage and facilitate a continuing program of active immunization against diphtheria for all children within his jurisdiction.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2570. Encephalitis, Acute (Including Arthropod-Borne Viral, Post-Infectious, and Others).

History

The patient shall be isolated in accordance with Section 2518 for seven days from the onset of the infection. There are no restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2572. Disorders Characterized by Lapses of Consciousness, Alzheimer's Disease and Related Disorders.

Note • History

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Amendment filed 11-9-66; effective thirtieth day thereafter (Register 66, No. 39).

3. Amendment of subsection (a) and new subsections (b)-(d) filed 1-9-90; operative 1-9-90 pursuant to Government Code Section 11346.2(d) (Register 90, No. 4).

4. Repealer of section and amendment of Note filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2574. Food Poisoning.

(Excluding Botulism and Salmonella infections). A reportable case of food poisoning is defined as follows: any person with symptoms of acute gastroenteritis, vomiting, diarrhea, or neurologic symptoms whose illness occurs in association with a group of other persons who may have consumed a common food or beverage. The etiologic agents include:

(a) Organic poisons present in normal animal or plant tissues, including mushrooms, fish, and mussels.

(b) Mineral or organic poisons, including arsenic, lead, cadmium, and fluorine, introduced into food by accident, or with the intent to improve the appearance or as preservatives.

(c) Toxins preformed in food by the growth of microorganisms, including staphylococci. (Botulism is reported separately. See Section 2552.)

Upon receiving the report, the health officer shall make or cause to be made an investigation in an effort to determine the source and cause of the outbreak. If the responsible food is one distributed outside the area over which he has jurisdiction, he shall immediately report his findings to the Director of the State Department of Health Services and to those local health officers concerned. There are no restrictions on cases or contacts.

§2575. German Measles (Rubella).

History

The patient shall be isolated in accordance with Section 2518 until clinically recovered. There are no restrictions on contacts.

HISTORY

1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. New section filed 10-25-66; effective thirtieth day thereafter Register 66, No. 37). For history of former section see Register 55, No. 8.

§2577. Gonococcus Infection.

(See Section 2636 on Venereal Diseases.)

§2578. Granuloma Inguinale.

(See Section 2636 on Venereal Diseases.)

§2579. Hepatitis, Infectious.

History

(This term includes cases diagnosed as acute catarrhal jaundice, epidemic hepatitis and epidemic jaundice.) The patient shall be isolated in accordance with Section 2518 during the acute symptoms. There are no restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2580. Influenza, Epidemic.

History

HISTORY

1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2581. Hepatitis, Serum (Homologous Serum Jaundice).

History

The patient shall be isolated in accordance with Section 2518 during the acute symptoms. There are no restrictions on contacts.

HISTORY

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2582. Leprosy (Hansen's Disease).

History

The patient shall be isolated in accordance with Section 2518 if determined by clinical observation or by laboratory findings to be infectious. The degree of isolation shall be determined by the local health officer, who should, whenever possible, be advised by a physician specially qualified in this disease. If isolation of the patient is required and cannot be carried out at home or if adequate therapy is not available, the State Department of Public Health shall be notified and shall designate a hospital where the patient shall be isolated and treated. Apparently arrested or inactive cases, and persons who have been in close contact with a case for a prolonged period, shall be kept under observation as long as deemed necessary by the local health officer to determine if they have become infected or the disease reactivated.

All reports pertaining to cases of leprosy are confidential and the identity of patients shall not be divulged except as may be necessary for the protection of the public health.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 7-19-55, as an emergency; effective upon filing (Register 55, No. 10).

§2584. Leptospirosis (Including Weil's Disease).

History

There are no restrictions on case or contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2585. Lymphogranuloma Venereum.

(See Section 2636 on Venereal Diseases.)

§2586. Malaria.

The patient shall be confined during the clinical phases of the disease in a room or dwelling satisfactorily protected against mosquitoes.

§2588. Measles.

The patient shall be isolated in accordance with Section 2518 during the period of catarrhal symptoms and for seven days after the appearance of the rash. Restriction on contacts is not required, except at the discretion of the local health officer.

§2590. Meningitis, Meningococcal or Meningococcemia.

History

(a) The patient shall be isolated in accordance with Section 2518 until the end of the febrile period and until all acute symptoms have subsided.

(b) Contacts. Quarantine of contacts is not required, except at the discretion of the local health officer, but intimate contacts should be kept under frequent medical observation for a minimum of three days subsequent to diagnosis of the case. Prophylactic treatment of household contacts under medical supervision may be required by the health officer prior to release.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2592. Mumps.

History

The patient shall be isolated in accordance with Section 2518 until the swelling of the salivary glands has subsided. There are no restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2593. Neoplasm, Cancer.

Note • History

(a) Definitions.

(1) Department means Department of Health Services.

(2) Director means the Director of the Department of Health Services.

(3) Regional cancer registry means the organization authorized to receive and collect cancer data for a designated area of the state and which maintains the system by which the collected information is reported to the Department.

(4) Cancer means all malignant neoplasms, including carcinoa in situ, which are specified in Volume I of the 1986 California Cancer Reporting System Standards and as set forth in the International Classification of Diseases for Oncology Field Trial Edition 1986.

(5) Case means a cancer diagnosis for an individual who is either a resident of the designated area of the regional cancer registry, regardless of where the individual was treated or diagnosed, or seen at a cancer reporting facility, other facility or by a physician within the designated area of the regional cancer registry, regardless of where the individual resides.

(6) Active follow-up program means a system for determining the vital status of each reported case no later than twelve months after the date of the last reported contact. This date is defined in Volume I of the 1986 California Cancer Reporting System Standards.

(7) Cancer reporting facility means a hospital or other facility which treats or diagnoses cancer and is also one of the following:

(A) A facility currently licensed as a health facility under the provisions of Chapter 2, commencing with Section 1250, of Division 2 of the Health and Safety Code;

(B) A surgical clinic licensed under Chapter 1, Section 1204, of Division 2 of the Health and Safety Code;

(C) A facility covered by the provisions of Section 1206, except for subsection (f), of the Health and Safety Code which, while not licensed as a clinic, is operated for the predominant purpose of diagnosing or treating cancer or where a minimum of 100 or more cancer cases are diagnosed or treated in a year.

(8) Quality Control System means operational procedures by which the accuracy, completeness and timeliness of the information reported to the Department can be determined and verified. These criteria are defined in Volume I of the 1986 California Cancer Reporting System Standards.

(9) Certified Tumor Registrar (CTR) means the designation given to individuals who pass the certification examination given by the National Tumor Registrars Association (NTRA).

(10) Population-based means that all cases are drawn from a defined population of known size and characteristics, usually one within a defined geographic area.

(11) Cancer incidence data means information on new cases of cancer including the required data listed in the 1986 California Cancer Reporting System Standards and counts of these cases by their characteristics such as age, sex and ethnicity, and by anatomic site and morphology.

(12) Instance of cancer means case of cancer as defined in subsection (a)(5) above.

(13) Modeled after the Cancer Surveillance Program of Orange County means a population-based registry that collects treatment data, has a phased implementation, collects follow-up data, has a community advisory component and receives data in a machine-readable format from cancer reporting facilities as defined in subsection (a)(7) above.

(b) Reporting requirements. The Director shall designate cancer as a disease to be mandatorily reported for all counties within the State. All counties shall be assigned to a designated regional cancer registry. When the Director designates cancer as a disease to be mandatorily reported within an area, the Director shall designate the initial mandatory reporting period, which may be less than a full calendar year, for which the regional registry will submit cases to the Department.

(1) A regional cancer registry shall establish and maintain a cancer reporting system which is able to report 97 percent of the incident cases in the initial designated reporting period and each calendar year.

(2) The regional cancer registry shall have suitable arrangements to obtain data for reporting resident cases diagnosed or treated outside the designated area of the regional cancer registry.

(3) The regional cancer registry shall report to the Department all cases diagnosed or treated in a calendar year or initial reporting period within twelve months after the close of that calendar year or initial reporting period.

(4) The regional cancer registry shall submit, for each reportable case, the required data specified in Volume I, Section 13, of the 1986 California Cancer Reporting System Standards.

(5) The regional cancer registry shall report to the Department all follow-up information provided by cancer reporting facilities with an active follow-up program no later than six months after the cancer reporting facility provides the information to the regional registry. In addition, each regional registry shall implement within three years of the designation of mandatory cancer reporting for the region a program of active follow-up for all resident cases not otherwise being followed by a cancer reporting facility. The results of the active follow-up program of the regional registry shall be reported to the Department quarterly.

(6) Data submitted to the Department by the regional cancer registry shall be in machine-readable form. The format and codes used shall be as specified by the Department.

(7) The regional cancer registry shall maintain a system of quality control in accordance with procedures approved by the Department.

(8) Representatives of the Department shall have access to the source data and the stored data in the regional cancer registry for the purpose of quality control assessments. This includes access to all cancer records maintained by a reporting facility, physician, individual or agency providing diagnostic or treatment services to cancer patients within the region.

(9) The regional cancer registry shall maintain confidentiality of data as required in Section 211.5, Health and Safety Code, and shall maintain a security system for records which contain identifying data. This system shall be reviewed and approved by the Department.

(10) When cancer is designated a reportable disease in a region, the corresponding regional cancer registry shall inform the public that cancer has been designated as a disease required to be reported in that region and that each patient diagnosed or treated with a Reportable Neoplasm will be reported to the Department as required by law.

(11) Cancer reporting facilities within a reporting region shall report to the regional cancer registry the required data as listed in Volumes I and III of the 1986 California Cancer Reporting System Standards. These reports shall conform to Volumes I, II and III of the 1986 California Cancer Reporting System Standards. When a cancer reporting facility fails to produce reports meeting the standards cited above, the regional cancer registry may perform the data collection and collect compensation from the facility for the activity at cost.

(12) Cancer reporting facilities shall report to their regional cancer registry each reportable case within six months of the time the case comes under the care of, or is admitted to, the facility.

(13) Cancer reporting facilities with an active follow-up program shall report follow-up information to the regional cancer registry no less frequently than quarterly.

(14) A facility not already defined as a cancer reporting facility under these regulations which diagnoses or treats cancer and is a primary care clinic as defined in Section 1204, Health and Safety Code or an acute psychiatric hospital as defined in Section 1250, Health and Safety Code shall report each cancer case to its regional cancer registry, or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (Form PM-110), shown below, within 30 days of the date the patient is admitted to the facility or treated in the facility for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV.

(15) Physicians and surgeons caring for cancer patients not referred to a facility defined as a cancer reporting facility under these regulations shall report each cancer case to the regional cancer registry or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (PM-110), within 30 days of seeing the patient for the cancer for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV.

(16) Cancer reporting facilities shall submit their cancer cases and follow-up information to the regional cancer registry in machine-readable form. The format and codes used shall be as specified by the Department in the 1986 California Cancer Reporting System Standards Volume II.

(17) Cancer reporting facilities may elect to have the regional cancer registry staff do the cancer data collection. They may do so by a contract with the regional cancer registry to identify and report the cancer cases with the facility reimbursing the regional registry for that registry's expense.

(18) Cancer reporting facilities and physicians shall employ a mechanism to ensure that their patients are informed that cancer has been designated a reportable disease and that the facility will report each patient with cancer to the Department as required by law. Patient information sheets for this purpose will be supplied to physicians by the Department.

(c) Staffing. The identification and collection of cancer data in the regional cancer registries and cancer reporting facilities shall be performed by Certified Tumor Registrars (CTR) or staff eligible to take the certification examination.

(d) Training and Credentialing Period. Reporting facilities so requesting upon application to the regional registry, may be granted a credentialing period of up to 24 months for the purpose of obtaining training to meet the requirements set forth in subsection (c) above. No credentialing period may be granted to extend beyond 30 months from the effective date of mandatory cancer reporting for the region or beyond July 1, 1990. During a credentialing period the reporting facility must meet the quality and other reporting standards. It is the responsibility of the Department, which may be carried out by the regional cancer registries, to assure that adequate tumor registrar training resources are available for no less than 24 months following the initiation of mandatory reporting in a region.

(e) Designation of Agent. The Director may designate and contract with any agency to act as the Department's agent for the maintenance of the regional cancer registry. The designated agent shall comply with all regulations for the regional cancer registry.

(f) Revocation of Designation. The Director shall have the authority to revoke the designation as Departmental agent. Revocation shall be effective no sooner than 30 days after a written notice to revoke the designation has been served.

NOTE

Authority cited: Sections 208, 210 and 211.3, Health and Safety Code. Reference: Sections 210, 211.3 and 211.5, Health and Safety Code.

HISTORY

1. New section filed 3-20-81; effective thirtieth day thereafter (Register 81, No. 12).

2. Amendment filed 11-2-87; operative 12-2-87 (Register 87, No. 45).

§2594. Pertussis (Whooping Cough).

The patient shall be isolated in accordance with Section 2518 during the early catarrhal period and for 21 days after the appearance of the typical paroxysmal cough. The isolation provisions shall be adequate to prevent exposure of young children to the patient. Restrictions on contacts not required.

§2595. Physically Handicapped Children

(See subchapter 3).

§2596. Plague. Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).)

(a) All laboratory specimens submitted for the purpose of establishing a diagnosis shall be examined only in such laboratories as may be designated by the Director of the State Department of Health Services. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human plague, such laboratory shall communicate immediately by telephone with the State Department of Health Services Microbial Diseases Laboratory for instruction.

(b) Isolation. The patient shall be confined in a dwelling free from rodents and fleas and shall be isolated in accordance with Section 2516. The period of isolation shall not be terminated until two days after all symptoms have subsided. In cases of pneumonic plague, strict precautions against respiratory transmission of the disease shall be enforced.

(c) Contacts. Contacts of cases of plague shall be kept under quarantine until the health officer is satisfied that they have not contracted the infection, except that contacts of cases of pneumonic plague shall be kept in quarantine for a period of at least seven days after last exposure.

NOTE

Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 100180, 100275, 120145, 120190, 120215 and 120240, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment of section heading and subsection (a) and new Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

3. Amendment of section heading and subsection (a) and new Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2597. Q Fever.

History

No restrictions on cases or contacts.

HISTORY

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2598. Pneumonia, Infectious (Except Pneumonic Plague).

History

HISTORY

1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2600. Poliomyelitis, Acute Anterior.

The case shall be isolated in accordance with Section 2518 for a period of seven days from the onset of illness or for the duration of fever if longer. Restrictions on contacts is not required, except at the discretion of the local health officer.

§2602. Psittacosis.

The patient shall be isolated in accordance with Section 2518 during the acute stages. There are no restrictions on contacts.

§2603. Control of Pet Birds.

Note • History

(a) The department or local health officers may quarantine any species of pet birds imported into this State from states and countries where psittacosis or other diseases transmitted by pet birds to human beings have been reported by an official agency to be currently prevalent in pet birds. Such quarantine shall remain in effect until removed by the department, or local health officers, following proof that the quarantined birds are not infected with psittacosis or other diseases transmissible by pet birds to human beings.

(b) Whenever a pet bird or birds are suspected to be a source of human disease or a pet bird or birds are infected with a disease which is a potential source of human disease and, in the opinion of the department or local health officers, it is deemed necessary for the protection of the public, the pet bird or birds shall be quarantined. Such quarantine shall remain in effect until the quarantine authority has evidence that the quarantined bird or birds are not a hazard to the public's health. Such evidence may be obtained by the following actions:

(1) A sufficient number of birds, such numbers to be specified by the quarantine authority, are to be provided for laboratory testing in a laboratory approved by the department.

(2) If, upon completion of the necessary laboratory test no evidence is found that the birds are infected with a disease hazardous to human health, they may be released from quarantine. Such release shall be made only by the quarantine authority.

(3) If upon completion of the necessary laboratory test there is evidence that the bird or birds are infected with a disease hazardous to human health, the bird or birds shall remain under quarantine until the hazard has been eliminated to the satisfaction of the quarantine authority.

(4) If, following treatment methods or other methods which may be used to eliminate the hazard in the quarantined bird or birds, the quarantine authority finds that the hazard to humans no longer exists, it may release the bird or birds from quarantine.

(5) The owner of the quarantined bird or birds shall have the option to destroy the quarantined bird or birds if he so desires. In such case the quarantine will be lifted following evidence that the infected premises are thoroughly disinfected.

NOTE

Authority cited: Sections 100275 and 121745, Health and Safety Code. Reference: Section 121745, Health and Safety Code.

HISTORY

1. Amendment of subsections (a)(3), (a)(4), (d) and (k) filed 12-15-67; effective thirtieth day thereafter (Register 67, No. 50). For prior history, see Register 65, No. 22.

2. Amendments of subsection (d) filed 8-10-70; effective thirtieth day thereafter (Register 70, No. 33).

3. Amendment of subsections (a) and (f) filed 11-20-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 47).

4. Change without regulatory effect of NOTE (Register 86, No. 32).

5. Change without regulatory effect repealing subsections (a)-(l), relettering subsections, and amending Note filed 1-28-99 pursuant to section 100, title 1, California Code of Regulations (Register 99, No. 5).

§2603.5. Control of Psittacine Birds.

Note • History

NOTE

Authority cited: Sections 208 and 2100, Health and Safety Code.

HISTORY

1. New section filed 11-2-55 as an emergency; effective upon filing (Register 55,No. 16).

2. Repealer filed 12-19-55; effective thirtieth day thereafter (Register 55, No. 18).

§2604. Rabies, Human.

Note • History

The patient shall be isolated in accordance with Section 2518 during the course of the disease. There are no restrictions on contacts of a human case.

NOTE

Authority cited: Sections 102, 208 and 1900-2000, Health and Safety Code.

HISTORY

1. Amendment filed 12-19-57; effective thirtieth day thereafter (Register 57, No. 22).

§2606. Rabies, Animal.

Note • History

(a) Reporting. Any person having knowledge of the whereabouts of an animal known to have or suspected of having rabies shall report the facts immediately to the local health officer. The health officer shall likewise be notified of any person or animal bitten by a rabid or suspected rabid animal.

In those areas declared by the Director of the State Department of Health Services to be rabies areas (See Section 1901.2, California Health and Safety Code) the local health officer shall be notified when any person is bitten by an animal of a species subject to rabies, whether or not the animal is suspected of having rabies.

(b) Isolation. Any rabid animal, clinically suspected rabid animal, or biting animal shall be isolated in strict confinement as follows:

(1) Isolation of Rabid Animals or Clinically Suspected Rabid Animals. Any rabid animal or clinically suspected rabid animal shall be isolated in strict confinement under proper care and under the observation of a licensed veterinarian, in a pound, veterinary hospital, or other adequate facility in a manner approved by the local health officer, except where such responsibility has been delegated to a comparable officer by the governing body, and shall not be killed or released for at least 10 days after the onset of symptoms suggestive of rabies, with the exception that such animals may be sacrificed with permission of the local health officer for the purpose of laboratory examination for rabies using the fluorescent rabies antibody (FRA) test in an approved public health laboratory.

(2) Isolation of Biting Animals. At the discretion of the local health officer, any animal which bites or otherwise exposes a person shall be isolated in strict confinement in a place and manner approved by the local health officer and observed for at least 14 days (dogs and cats 10 days) after the day of infliction of the bite, with the exception that the following alternative to the 10 day isolation of dogs and cats is permitted--dogs or cats which have been isolated in strict confinement under proper care and under observation of a licensed veterinarian, in a pound, veterinary hospital, or other adequate facility in a manner approved by the local health officer, may be released from isolation by the local health officer after five days of veterinary observation if upon conducting a thorough physical examination on the fifth day or more after infliction of the bite, the observing veterinarian certifies that there are no clinical signs or symptoms of any disease. Notwithstanding the foregoing provisions, a local health officer may authorize, with permission of the owner and other legal restrictions permitting, the euthanasia of a biting animal for the purpose of laboratory examination for rabies using the fluorescent rabies antibody (FRA) test in an approved public health laboratory.

(3) Isolation of Biting Animals in Officially Declared Rabies Areas. In officially declared rabies areas (see Section 1901.2, California Health and Safety Code) the isolation described in paragraph (2) above shall be mandatory for any animal of a species subject to rabies that has bitten or otherwise exposed a person, with the exception of rodents (members of the order Rodentia) and rabbits and hares (members of the order Lagomorpha).

(4) Laboratory Examination of Rabid Animals, Clinically Suspected Rabid Animals or Biting Animals Which Die or Have Been Killed. If any rabid animal, clinically suspected rabid animal or biting animal dies or has been killed, adequate specimens shall be obtained and examined in a public health laboratory approved by the department. No person shall destroy or allow to be destroyed the brain of an animal of a species subject to rabies that has bitten or otherwise exposed a person before the destruction of such brain has been authorized by the local health department; provided, however, that the provisions of this paragraph (4) shall not apply to rodents (members of the order Rodentia ) and rabbits or hares (members of the order Lagomorpha ).

(c) Animal Contacts. Any animal of a species subject to rabies which has been bitten by a known rabid or suspected rabid animal or has been in intimate contact with a rabid or suspected rabid animal shall be quarantined in a place and manner approved by the local health officer, except where such responsibility has been delegated to a comparable officer by the local governing body, for a period of six months or destroyed, with the exception that the following alternatives are permitted in the case of dogs and cats as follows:

(1) If a dog over one year of age has been vaccinated against rabies within 36 months but not less than 30 days with a rabies vaccine of a type approved by the Department for a maximum immunity duration of at least 36 months, the dog may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by the local health officer for a period of 30 days following revaccination.

(2) If a dog under one year of age has been vaccinated against rabies within 12 months but not less than 30 days with a rabies vaccine of a type approved by the Department, the dog may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and a manner approved by the local health officer for a period of 30 days.

(3) If a cat has been vaccinated within one year but not less than 30 days with an annual type feline rabies vaccine or if a cat has been vaccinated under one year of age with a 36-month type of feline rabies vaccine within 12 months but not less than 30 days, the cat may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by the local health officer for a period of 30 days following revaccination.

(4) If a cat over one year of age has been vaccinated against rabies and has been vaccinated within 36 months and more than 30 days with a 36-month type feline rabies vaccine, the cat may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by a local health officer for a 30-day period following revaccination.

NOTE

Authority cited: Sections 208, 1905 and 3123, Health and Safety Code. Reference: Sections 1901, 1903, 1905, 1907 and 3123, Health and Safety Code.

HISTORY

1. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 19). For prior history see Register 65, No. 8.

2. Amendment of subsection (c) filed 5-20-77; effective thirtieth day thereafter (Register 77, No. 21).

3. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 5).

§2606.2. Rabies Quarantine.

Note • History

If rabies is known to exist within an area, the local health officer may establish a rabies quarantine and shall define the boundaries of the quarantine area and specify the animals subject to quarantine, and all such animals within the quarantined area shall be kept in strict confinement upon the private premises of the owner, keeper or harborer at all times until the quarantine is terminated by the local health officer.

NOTE

Authority cited: Sections 102, 208 and 1900-2000, Health and Safety Code.

HISTORY

1. New section filed 12-19-57; effective thirtieth day thereafter (Register 57, No. 22).

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 19).

§2606.4. Officially Declared Rabies Areas.

Note • History

(a) Administration and Enforcement. For purposes of administration and enforcement of Section 1920, California Health and Safety Code, in officially declared rabies areas, the following shall apply:

(1) Licensing and Vaccination Procedure. The vaccination of dogs four months of age or older as required by subdivision (b), Section 1920, California Health and Safety Code, shall be held a requisite to licensing as required under subdivision (a) therein. Completion of the licensing procedure consists of issuance of a license tag or a vaccination tag bearing the license data and shall be carried out only after presentation of a current valid official vaccination certificate. Current copies of the Compendium of Canine Rabies Vaccines approved by the Department, together with the maximum immunity duration periods prescribed by the Department for each type product, are available upon request from the Veterinary Public Health Unit, Infectious Disease Section, California Department of Health Services, 2151 Berkeley Way, Berkeley, California, 94704, telephone (415) 540-2391.

(2) Vaccination Certificates. Official vaccination certificates must show:

(A) the name, address and telephone number of the dog's owner;

(B) the description of the dog, including breed, color, age, and sex;

(D) the type of rabies vaccine administered;

(E) the name of the manufacturer; and

(F) the lot number of the vaccine used.

Such certificates shall bear the signature of the veterinarian administering the vaccine or a signature authorized by him, and in addition such certificate shall be stamped, printed, or typed with his name, address and telephone number for legibility, with the exception that at dog vaccination clinics conducted pursuant to Section 1920(f) of the Health and Safety Code, vaccination certificates approved by the local health officer may be used provided that the specific clinic is identified upon the vaccination certificate and records are maintained containing the information specified under items (E) and (F) above.

(3) Interval Permitted for Procurement of License. The vaccination of dogs four months of age against rabies as required under subdivision (b), Section 1920, California Health and Safety Code, and the license required by subdivision (a) of said section shall be procured not later than 30 days after the dog attains the age of four months. The license renewal shall be procured not later than 60 days after expiration of the previously issued license.

(4) Rabies Control Activities Reporting. During such time as a county is under official declaration as a rabies area, each local official responsible for the various phases of local dog or rabies control within each city, county and city or cities, or county shall make quarterly rabies control activities reports to and on forms furnished by the Department. Such reports shall be submitted to the Department by the local officials responsible for the various phases of local dog or rabies control through the local health officer so as to reach the Department not later than 30 days following each quarter.

(b) Vaccination of Dogs Against Rabies. Dogs shall be considered to be properly vaccinated for the purposes of Section 1920, California Health and Safety Code, when injected at four months of age or older with an approved canine rabies vaccine and revaccinated in accordance with the following conditions:

(1) Primary Immunization. Primary immunization shall be defined as the initial inoculation of an approved canine rabies vaccine administered to young dogs between the ages of 4 to 12 months.

(2) Minimum Age for Rabies Vaccination. The minimum age for which rabies immunization of dogs shall be accepted for purposes of dog-owner compliance with requirements for rabies vaccination and for purposes of issuance of dog licenses (See Section 2606.4(a)(1)) is 4 months.

(3) Revaccination Intervals. Dogs shall be revaccinated one year (12 months) after the primary immunization with an approved type of rabies vaccine. Dogs receiving vaccination after primary immunization or any dog receiving its initial rabies vaccination over 12 months of age shall be revaccinated thereafter at least once every three years (36 months) with an approved type rabies vaccine.

(c) Issuance of Dog Licenses. In no instances shall a dog license be issued for a period beyond the date upon which revaccination is due except, following primary immunization in a local jurisdiction which is on a fixed one-year licensing period, a license may be issued for a period beyond the revaccination date if early revaccination cannot be required in accordance with subdivision (d).

(d) Notwithstanding the rabies revaccination intervals specified in Section 2606.4(b)(3) above, local authorities may require revaccination prior to issuance of a license provided that revaccination against rabies in no instance shall be required sooner than one year (12 months) following a primary immunization or sooner than 2 years (24 months) following a vaccination of dogs vaccinated over one year (12 months) of age.

NOTE

Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Sections 1905 and 1920, Health and Safety Code.

HISTORY

1. New section filed 12-19-57; effective thirtieth day thereafter (Register 57, No. 22).

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 19).

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No. 21).

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 5).

§2606.6. Importation of Dogs.

Note • History

All dogs four months of age or older imported into this State for any purpose shall be accompanied by a certificate issued by a licensed veterinarian, stating that the dog or dogs have been vaccinated against rabies within 30 months of the date of importation for dogs vaccinated over 12 months of age or within 12 months for dogs vaccinated under 12 months of age with a canine rabies vaccine of a type approved by the Department for an immunity duration of at least 36 months.

NOTE

Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Sections 1905 and 1920(b), Health and Safety Code.

HISTORY

1. New Section filed 12-19-57; effective thirtieth day thereafter (Register 57, No. 22).

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 19).

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No. 21).

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 5).

§2606.8. Skunk Rabies.

Note • History

(a) Due to the presence of rabies in skunks in California and in many other states and the resultant hazard to the public health of rabies developing in skunks kept as pets, no person shall:

(1) trap or capture skunks for pets,

(2) trap, capture or hold skunks in captivity for sale, barter, exchange or gift,

(3) transport skunks from or into the state except as provided under (b) below.

(b) The importation of skunks into California or the exportation of skunks from the State is prohibited except by permit from the California State Department of Health Services to a recognized zoological garden or a research institution.

NOTE

Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Section 1905, Health and Safety Code.

HISTORY

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

2. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 5).

§2608. Relapsing Fever.

History

(a) (Tick-borne). There are no restrictions on case or contacts.

(b) (Louse-borne) Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents or lice. There are no restrictions on contacts. All lice and louse eggs on the patient's body, hair, or clothing shall be destroyed. Household contacts shall be louse-free.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2610. Rheumatic Fever, Acute.

History

There are no restrictions on case or contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2611. Rocky Mountain Spotted Fever.

History

There are no restrictions on case or contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2612. Salmonella Infections (Other Than Typhoid Fever).

Note • History

(a) Any illness in which organisms of the genus Salmonella (except the typhoid bacillus) have been isolated from feces, blood, urine or pathological material shall be reported as a Salmonella infection. A culture of the organisms on which the diagnosis is established shall be submitted first to a local public health laboratory and then to the State Microbial Diseases Laboratory for definitive identification. The period of isolation in accordance with Section 2518 shall be until clinical recovery. The patient shall be subject to supervision by the local health officer who may require, at his discretion, release specimens of feces for testing in a laboratory approved by the State Department of Health Services.

However, no patient shall be released from supervision to engage in any occupation involving the preparation, serving or handling of food, including milk, to be consumed by individuals other than his immediate family, nor to engage in any occupation involving the direct care of children or of the elderly or of patients in hospitals or other institutional settings until two successive authentic specimens of feces taken at intervals of not less than 24 hours, beginning at least 48 hours after cessation of specific therapy, if any was administered, have been determined, by a public health laboratory approved by the State Department of Health Services to be negative for Salmonella organisms. (See Section 2534.)

(b) Carriers. Any person who harbors Salmonella organisms three months after onset is defined as a convalescent carrier and may be restricted at the discretion of the local health officer.

Any person continuing to harbor Salmonella organisms one year after onset is a chronic carrier. Any person who gives no history of having had Salmonellosis or who had the illness more than one year previously who is found to harbor Salmonella organisms on two successive specimens taken not less than 48 hours apart is also considered to be a chronic carrier.

Chronic carriers of Salmonella, other than S. typhosa, shall be restricted at the discretion of the local health officer.

NOTE

Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No. 21).

3. Amendment filed 11-25-83; effective thirtieth day thereafter (Register 83, No. 48).

§2612.1. Turtle Salmonellosis.

Note • History

(a) Except as otherwise provided in this section, it shall be unlawful to import, sell or offer for sale or distribution to the public any live turtle(s) with a carapace length of less than 4 inches.

(b) The Department or any authorized representative thereof, or any local health officer or his representative may order the humane destruction of any turtle(s) that are unlawful to import, sell or offer for sale or distribution to the public under subsection (a) above.

(c) The Department or any authorized representative thereof, or any local health officer or his representative may quarantine turtles, take samples of tank water or any other appropriate samples of or from turtles offered for sale or distribution for the purpose of testing for Salmonella and Arizona organisms. The Department or any local health officer may order the immediate humane destruction of any lot of turtles found contaminated with Salmonella, Arizona, or other organisms which may cause or have caused disease in humans.

(d) Shipments of turtles under 4 inches in carapace length are permitted to a governmental agency, or to a recognized research or educational institution for research or teaching purposes or to a zoological garden for display.

(e) The following warning shall be posted conspicuously for buyer information at every display of turtles for retail sale or distribution or where the public may come in contact with turtles:

CAUTION: Turtles may transmit bacteria causing disease in humans. It is important to wash the hands thoroughly after handling turtles or material that had contact with turtles. Do not allow water or any other substance that had contact with turtles to come in contact with food or areas where food is prepared. Make sure that these precautions are followed by children and others handling turtles.

(f) For each sale of turtle(s) at retail, a sales slip shall be issued by the seller to the purchaser at time of the sale. The sales slip shall include the name, address and telephone number of the purchaser and the seller, and the date of sale. The sales slip shall have printed legibly on its front the warning statement contained in subsection (e) above. The seller shall keep a copy of the sales slip, which shall include the name, address and telephone number of the purchaser for not less than one year, and keep a complete record of all purchases, losses and other dispositions of turtles.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 205, 3051-3053, Health and Safety Code.

HISTORY

1. New section filed 10-5-72; effective thirtieth day thereafter (Register 72, No. 41).

2. Amendment filed 10-7-77; effective thirtieth day thereafter (Register 77, No. 41).

§2613. Shigella Infections (Dysentery, Bacillary).

Note • History

(a) The period of isolation in accordance with Section 2518 shall be until the acute symptoms have subsided.

The patient shall be subject to supervision by the local health officer who may require, at his discretion, release specimens of feces for testing in a laboratory approved by the State Department of Health Services. However, no patient shall be released from supervision to engage in any occupation involving the preparation, serving or handling of food, including milk, to be consumed by individuals other than his immediate family, nor to engage in any occupation involving the direct care of children or of the elderly or of patients in hospitals or other institutional settings until two successive authentic specimens of feces or of rectal swabs, taken at intervals of not less than 24 hours, beginning at least 48 hours after cessation of specific therapy, if any was administered, have been determined, by a public health laboratory approved by the State Department of Health Services, to be negative for Shigella organisms. (See Section 2534.)

(b) Contacts. Restrictions on contacts shall be at the discretion of the local health officer.

NOTE

Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No. 21).

3. Amendment filed 11-25-83; effective thirtieth day thereafter (Register 83, No. 48).

§2614. Smallpox (Variola). Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section 2516 until the scabs have separated and the scars have completely healed.

(b) Household Contacts. Household contacts shall be quarantined for at least 17 days after last exposure, except that the local health officer may, at his discretion, when the patient is properly isolated, release from quarantine persons who shall submit to vaccination against smallpox and prove to the satisfaction of the local health officer that the vaccination is successful. Such persons shall remain in quarantine until released by the local health officer.

(c) Casual Contacts. A person who has been exposed to the risk of contracting the disease by proximity to a case or to a suspected case of smallpox, shall be quarantined for a period not less than 17 days from the last date of exposure. Such persons may be released from quarantine if evidence of protection against smallpox is established to the satisfaction of the local health officer.

(d) Vaccination. The local health officer shall provide at public expense, as available, smallpox vaccination for persons who have been exposed to a case or suspected case of smallpox.

(e) Laboratory. Whenever a laboratory receives a specimen for the laboratory diagnosis of smallpox (variola), such laboratory shall communicate immediately by telephone with the State Department of Health Services Viral Rickettsial Disease Laboratory for instruction.

NOTE

Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120190, 120195 and 120215, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2616. Streptococcal Infections, Hemolytic (Including Scarlet Fever and Streptococcal Sore Throat).

History

(a) The patient shall be isolated in accordance with Section 2518 for not less than seven days from onset. Patients treated with an effective antibiotic may be released upon clinical recovery.

(b) Contacts. Household contacts should be kept under frequent medical observation for the development of streptococcal disease. Restriction on contacts is not required, except at the discretion of the local health officer.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2617. Syphilis.

(See Section 2636 on Venereal Diseases.)

§2618. Tetanus.

History

There are no restrictions on case or contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2620. Trachoma.

The patient shall be isolated in accordance with Section 2518 during the acute stages and when not under medical treatment satisfactory to the health officer. There are no restrictions on contacts.

§2622. Trichinosis.

The local health officer shall make an investigation to determine the source of infection. If the suspected source is a commercial food product, the health officer shall report the fact at once to the State Department of Public Health. There are no restrictions on case or contacts.

§2624. Tuberculosis.

History

A person having or suspected of having tuberculosis in a communicable stage shall be considered as fulfilling the requirements of modified isolation as long as he is under adequate medical supervision and observes the instructions issued by the local health officer. The isolation shall be adequate for the protection of persons residing within the household as well as the public.

A person having tuberculosis in a communicable stage, who refuses to observe the instructions of the local health officer and thereby needlessly exposes others to infection, shall be placed in strict isolation at home until such time as the local health officer feels that such isolation is no longer necessary for the protection of the public; and, in the event that such household isolation proves inadequate for the protection of members of the household or community, the patient shall be placed in isolation in quarters designated by the local health officer, until such time as such isolation is no longer necessary for the protection of the public.

The person officially in charge of a sanatorium or other place where tuberculosis patients are cared for shall be responsible for immediately notifying the health officer in whose territory a patient resides whenever such patient having tuberculosis in a communicable stage leaves the institution.

In every case in which a non-communicable tuberculous patient has been placed in a nursing home the local health officer or his deputy shall be responsible for the continued surveillance of such a patient to ensure that he remains non-communicable.

HISTORY

1. Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 52).

§2626. Tularemia. Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).)

There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human tularemia, such laboratory shall communicate immediately by telephone with the State Department of Health Services Microbial Diseases Laboratory for instruction.

NOTE

Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120130 and 120190, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2628. Typhoid Fever.

Note • History

(a) Case. A culture of the organism on which the diagnosis of typhoid fever is established shall be submitted first to a local public health laboratory and then to the State Microbial Diseases Laboratory for phage typing. The patient shall be isolated in accordance with Section 2518 until clinical recovery. The patient shall remain subject to supervision by the local health officer until three successive specimens of feces and urine taken at least 24 hours apart, beginning at least one week after discontinuation of specific therapy and not earlier than one month after onset of disease, have been found negative for typhoid bacilli at a public health laboratory approved by the State Department of Health Services. If any one of this series is positive, cultures of both urine and feces shall be repeated at intervals of 1 month during the 12-month period following onset, until at least three sets of negative cultures are obtained. The patient shall not take any part in the preparation, serving, or handling of milk or other food to be consumed by individuals other than his immediate family, or participate in the management of a dairy, milk distributing plant, boarding house, restaurant, food store, or any place where food is prepared or stored, or engage in any occupation involving the direct care of young children or the elderly or of patients in hospitals or other institutional settings until release specimens have been obtained, as described above, and are negative for typhoid organisms. (See Section 2534.)

(b) Contacts. There are no restrictions on contacts, except that any member of the patient's household shall not take part in the preparation, serving, or handling of milk or other food to be consumed by individuals, other than the immediate family except at the discretion and under the restrictions of the local health officer.

(c) Definition of Carriers. (1) Convalescent Carriers: Any person who harbors typhoid bacilli for three or more months after onset is defined as a convalescent carrier. Convalescent carriers may be released when three consecutive negative specimens of feces and urine taken at intervals of not less than one month, beginning at least one week after discontinuation of specific therapy are obtained. Such release may be granted at any time from 3-12 months after onset.

(2) Chronic Carriers: If the person continues to excrete typhoid bacilli for more than 12 months after onset of typhoid fever, he is defined as a chronic carrier. Any person who gives no history of having had typhoid fever or who had the disease more than one year previously, and whose feces or urine are found to contain typhoid bacilli on two separate examinations at least 48 hours apart, confirmed by State Microbial Diseases Laboratory, is also defined as a chronic carrier. All carriers shall be reported to the local health officer. Such reports shall be kept confidential and shall not be divulged to persons other than the carrier and his immediate family, except as may be required for the protection of the public health.

(3) Other Carriers: A person should be held under surveillance if typhoid bacilli are isolated from surgically removed tissues, organs, e.g., gallbladder, kidney, etc., or from draining lesions such as osteomyelitis. If the person continues to excrete typhoid bacilli for more than 12 months he is defined as a chronic carrier and may be released after satisfying the criteria for other chronic carriers.

(d) Carrier Restrictions and Supervision. When any known or suspected carrier of this disease is reported to the local health officer, he shall make an investigation and submit a report to the State Department of Health Services. He shall have performed laboratory work as defined in subsection (e) below. Any known or suspected carrier of this disease shall be subject to modified isolation and the provisions of this isolation shall be considered as fulfilled during such period as he complies with the instructions issued by the State Department of Health Services and the local health officer.

(1) Restrictions. Instructions shall be given to the carrier in writing by the local health officer.

(2) Supervision. The local health officer or his representative shall communicate with each carrier living within his jurisdiction at least twice a year to learn of any changes in the carrier's address, occupation or activities and to determine whether all instructions are being carried out. The local health officer shall submit a report to the State Department of Health Services every six months on each carrier in his jurisdiction. Any changes of address shall be reported immediately.

(e) Laboratory Tests. Whenever laboratory tests are required for the release of typhoid cases or carriers, the tests shall be taken by the local health officer or his representatives under such conditions that he can certify as to their being authentic specimens of the individual, and shall be submitted to a public health laboratory approved by the State Department of Health Services. Cultures from release specimens which are found positive by the approved laboratory shall be forwarded to the State Division of Laboratories for phage typing.

(f) Requirements for Release of Chronic Carriers. Authority for Release of Carriers. Any person ascertained to be a chronic typhoid carrier may be released from supervision by the Director of the State Department of Health Services or his designated representative provided the carrier applies for such release through his local health officer and fulfills the requirements specified by the Director of the State Health Department or his designated representative.

(1) Fecal Carriers. A person who has been determined to be a chronic fecal carrier may be released if six successive authentic stool and urine specimens taken at intervals of not less than one month are determined to be negative by a public health laboratory approved by the State Department of Health Services. If any one of these specimens is positive, he shall not be released unless the carrier condition has been cured by cholecystectomy, or by such other methods as are acceptable to the State Department of Health Services. The necessary requirements for such release will be submitted to the carrier and to the local health officer by the State Department of Health Services when application for the release is submitted.

(2) Cholecystectomy. The local health officer or, in areas not served by a local health department, the Director of the State Department of Health Services, shall be notified before a cholecystectomy is undertaken unless a specimen of duodenal contents, containing bile, has been found positive for typhoid bacilli, since in some cases the infection is not localized in the gall bladder. The patient shall be released under the same conditions as outlined for a fecal carrier.

(3) Urinary Carriers. A person who has been determined to be a chronic urinary carrier may be released if six successive authentic urine specimens taken at intervals of not less than one month are determined to be negative by a public health laboratory approved by the State Department of Health Services. If any one of these specimens is positive, he may be released following the surgical removal of the infected kidney or by such other methods as are acceptable to the State Department of Health Services. The necessary requirements for such release will be submitted to the carrier and to the local health officer by the State Department of Health Services when application for the release is submitted.

NOTE

Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No. 21).

3. Amendment filed 11-25-83; effective thirtieth day thereafter (Register 83, No. 48).

§2630. Typhus Fever (Flea-Borne, Endemic Type).

History

The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents, fleas or lice. There are no restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§2632. Typhus Fever (Louse-Borne, Epidemic Type). Cases and Suspect Cases to Be Reported by Telephone or Telegraph.

History

(See Section 2501(c).) The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents or lice. All lice and louse eggs on the patient's body, hair, or clothing shall be destroyed. Household contacts shall be louse-free. There are no other restrictions on contacts.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8.)

§2636. Venereal Diseases.

Note • History

(a) Sections 2636 to 2636(m) inclusive pertain to the venereal diseases and, unless otherwise specified, shall include syphilis, gonococcus infection, granuloma inguinale, lymphogranuloma venereum, and chancroid. (See Chapter 765, Statutes 1947; also Section 21100, Health and Safety Code.)

(b) Reports Confidential. Reports of examinations, cases, investigations and all records thereof made under the regulations for the control of venereal diseases shall be confidential and not open to public inspection and no part thereof divulged, except as may be necessary for the preservation of the public health.

(c) Report of Unusual Prevalence. When the local health officer, through investigation, becomes aware of unusual prevalence of venereal diseases, or of unusual local conditions favoring the spread of these diseases, he shall report the fact at once to the State Department of Health Services.

(d) Parents or Guardians Responsible for Compliance of Minors. The parents or guardians of minors suffering from a venereal disease shall be legally responsible for the compliance of such minors with the requirements of the regulations relating to the venereal diseases.

(e) Certification. Each local health officer shall take every proper means of repressing prostitution, inasmuch as it is the most prolific source of the venereal diseases. Health officers and physicians shall not issue certificates of freedom from venereal diseases to known prostitutes, as such certificates may be used for purposes of solicitation.

(f) Diagnosis. The local health officer may require the submission of such specimens as may be designated from cases of venereal disease for examination in a laboratory approved by the State Department of Health Services. The local health officer may require any physician in attendance on a person infected with a venereal disease or suspected of being infected with a venereal disease to submit such specimens as approved by the State Department of Health Services provided, however, nothing shall prevent the physician or individual from having additional examination made elsewhere.

(g) Instruction to the Patient. It shall be the duty of the physician in attendance on a person having a venereal disease, or suspected of having a venereal disease, to instruct such patient in precautionary measures for preventing the spread of the disease, the seriousness of the disease, and the necessity for treatment and prolonged medical supervision, and the physician shall, in addition, furnish approved literature on these subjects. Approved literature for distribution to patients may be secured from the State Department of Public Health and the local health departments free of charge.

(h) Investigation. All city, county and other local health officers are hereby directed to use every available means to ascertain the existence of, and immediately to investigate, all reported or suspected cases of venereal disease in the infectious stages within their several territorial jurisdictions, and to ascertain the sources of such infections. The attending physician, in every case of venereal disease coming to him for treatment, shall endeavor to discover the source of infection, as well as any sexual or other intimate contacts which the patient was in the communicable stage of the disease. The physician shall make an effort, through the cooperation of the patient, to bring these cases in for examination and, if necessary , treatment. If, within 10 days of identification, any such source of infection or any such contact has not given satisfactory evidence of being under the care of a physician, such person shall be reported to the health officer, the physician's name being kept confidential in any investigation by the health department. In cases in which prostitutes are named as sources of infection, all obtainable information as to name, description, residence, etc., shall be given to the health officer at once.

In carrying out such investigations, all health officers are hereby invested with full powers of inspection, examination and isolation of all persons known to be infected with a venereal disease in an infectious stage, or suspected of being infected with a venereal disease in an infectious stage and are hereby directed:

(1) To make such examinations as are deemed necessary of persons reasonably suspected of having a venereal disease in an infectious stage.

(2) When the individual to be examined is a woman, to provide the services of a woman physician if such physician is available, when so requested by the individual to be examined.

(3) To isolate such person, whenever deemed necessary for the protection of the public health. In establishing isolation the health officer shall proceed as provided in Sections 2636(i), 2636(j), 2636(l) and 2636(m).

(4) Pursuant to Section 3194.5 of the Health and Safety Code, a person employed by a Public Health Department shall meet the following training requirements as a prerequisite to the performance of venipuncture or skin puncture:

(A) Possess a statement signed by a licensed physician and surgeon stating that the individual named in such statement has received adequate training in the proper procedure to be employed in the performance of venipuncture and skin puncture.

(B) In order to receive such statement, the venereal disease case investigator shall be trained by a licensed physician and surgeon. The trainee shall observe and receive sufficient instruction and demonstration of the proper technique and procedure to be employed in the performance of venipunctures and skin punctures; in turn, the physician and surgeon shall then observe the procedure and technique of the trainee.

(C) When such training has been completed by the trainee to the satisfaction of the physician and surgeon, such physician and surgeon shall execute a statement that the venereal disease case investigator has received adequate training in the proper procedure to be employed in the performance of venipuncture and skin puncture.

Satisfaction of these training requirements shall be in addition to other requirements of Section 3194.5 of the Health and Safety Code.

(i) Isolation. Any person who presents himself (or herself) to any physician or person for treatment or diagnosis of any venereal disease except late syphilis shall be considered to be in modified isolation. The requirements of this isolation shall be considered fulfilled if the patient remains under adequate and proper treatment until the completion of the course of treatment, except in instances in which, because of occupation, suspicion of prostitution, or other reason, the health officer deems more strict isolation necessary to safeguard other persons.

(j) Violation of Isolation to be Reported. Whenever any person while in the infectious or potentially infectious stage of a venereal disease, lapses from treatment for a period of more than 10 days after the time appointed for such treatment, the said diseased person shall be deemed to have violated the requirements of isolation, and the physician or person in attendance upon such case shall report the same at once to the local health department, giving the person's name, address, and report number, together with such other information as requested on the card provided for this purpose, except that this shall not be required in instances in which a report has been received that the patient is under treatment elsewhere.

(k) If any person has knowledge that a person infected with a venereal disease is failing to observe adequate precautions to prevent spreading infection, he shall report the facts at once to the local health officer.

(l) Gonorrhea. A case of gonococcus infection of the genitourinary tract shall be regarded as subject to isolation until the local health officer is reasonable satisfied that the disease is no longer communicable.

(m) Syphilis. A case of syphilis shall be regarded as subject to isolation until, under treatment, all syphilitic lesions of the skin or mucous membrane are completely healed and a competent clinical examination fails to show the presence of any area from which infection may be spread. Any patient who refuses or otherwise fails to receive a full course of a currently accepted method of treatment, or who discontinues treatment prematurely, may be subjected to strict isolation if the health officer deems it necessary.

NOTE

Authority cited: Sections 102.208 and 3194.5, Health and Safety Code. Reference: Section 3194.5, Health and Safety Code.

HISTORY

1. New subsection (h)(4) filed 2-14-73; effective thirtieth day thereafter (Register 73, NO. 7).

§2638. Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa and Marburg Viruses). Cases and Suspect Cases to Be Reported by Telephone.

Note • History

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section 2516. Strict barrier isolation and patient blood, secretion and excreta precautions shall be enforced. The patient shall be instructed to refrain from unprotected sexual activity until secretions are free of virus or for 3 months after illness onset.

(b) Laboratory. Whenever a laboratory receives a specimen for laboratory diagnosis of suspected viral hemorrhagic fevers, such laboratory shall communicate immediately by telephone with the State Department of Health Services Viral and Rickettsial Disease Laboratory for instructions.

NOTE

Authority cited: Sections 100180, 100275, 120130, 120145 and 120175, Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120185, 120190, 120195, 120215 and 120240, Health and Safety Code.

HISTORY

1. New section filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).

§2640. Yellow Fever Cases and Suspect Cases to Be Reported by Telephone or Telegraph.

History

(See Section 2501(c).) The case shall be confined during the clinical phase of the disease in a room satisfactorily protected against mosquitoes. Contacts shall be kept under observation for a period of seven days after the date of last exposure.

HISTORY

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

Article 3.5. Reporting of Human Immunodeficiency Virus (HIV) Infection

Subarticle 1. Definitions

§2641.5. Alternative Testing Site.

Note • History

“Alternative Testing Site” means an anonymous HIV testing site funded by the California Department of Public Health, administered by a county health department and operated pursuant to Health and Safety Code, Sections 120890-120895.

NOTE

Authority cited: Sections 120125, 120130, 131080 and 131200, Health and Safety Code. Reference: Sections 120175, 120775, 120885-120895, 121025, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New article 3.5 (subarticles 1 and 4), subarticle 1 (sections 2641.5-2641.90) and section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 2-6-2008; operative 2-6-2008 (Register 2008, No. 6).

§2641.10. Anonymous Counseling and Testing Program.

Note • History

“Anonymous Counseling and Testing Program” means a program offering HIV counseling and testing while maintaining anonymity of the patient.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.15. Anonymous HIV Test.

Note • History

“Anonymous HIV Test” means an HIV test that maintains the anonymity of the patient.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.20. Biological Specimen.

Note • History

“Biological specimen” means any material that is derived from the human body.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Section 1206, Business and Professions Code; and Sections 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.25. Confidential HIV Test.

Note • History

“Confidential HIV Test” means an HIV test that links the test results to the patient in a restricted manner to protect against unauthorized disclosure of the identity of the patient.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.30. Confirmed HIV Test.

Note • History

“Confirmed HIV test” means:

(a) a procedure which verifies the presence of HIV infection as determined by any clinical laboratory test or HIV Test Algorithm or examination used to detect the presence of HIV, a component of HIV, or antibodies to or antigens of HIV, including the HIV antibody (HIV-Ab), HIV p-24 antigen, Western blot (Wb), and immunofluorescence antibody tests; or

(b) for the purpose of this Article, all tests used to monitor HIV infection, including HIV nucleic acid detection.

NOTE

Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1265 and 1281, Business and Professions Code; and Sections 101150, 101160, 120175, 120775, 120885-120895, 121025, 120917, 121022, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of subsection (a) and Note filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (a) and Note refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a) and Note refiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment of subsection (a), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.35. Department.

Note • History

“Department” means the California Department of Public Health, Office of AIDS.

NOTE

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 2-6-2008; operative 2-6-2008 (Register 2008, No. 6).

§2641.45. Health Care Provider.

Note • History

“Health care provider” means an individual who obtains the results of an HIV test or HIV test algorithm or submits a biological specimen to a laboratory for a test to detect the presence of HIV, a component of HIV or antibodies to or antigens of HIV, receives the test results and is;

(a) licensed under the provisions of Business and Professions Code, Division 2 (Healing Arts) and acting within his or her scope of practice, or;

(b) a designee of a physician and surgeon acting under the general supervision of that physician or surgeon, or;

(c) a person working in a publicly-funded confidential counseling and testing program acting under the general supervision of, and following the protocols approved by, the local Health Officer for the local health department.

NOTE

Authority cited: Sections 101160, 120125, 120130, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1281 and 1285, Business and Professions Code; and Sections 120175, 120775, 120885-120895, 120917, 121022, 121025, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of first paragraph and Note filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

3. Amendment of first paragraph and Note refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. Amendment of first paragraph and Note refiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment of first paragraph, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.50. Health Officer and Local Health Officer.

Note • History

“Health Officer and Local Health Officer” means the officer appointed by the local governing body (county, city, and district), as defined in Section 2500.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.55. HIV/AIDS Case Report.

Note • History

“HIV/AIDS Case Report” means California Department of Public Health HIV/AIDS Confidential Case Report form, Adult (CDPH 8641A (05/07)) or Pediatric (CDPH 8641P (05/07)), hereby incorporated by reference in this Article and available from the local health department or the Department.

NOTE

Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 120175, 120775, 120885-120895, 121022, 121025, 121035, 131019, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

3. Amendment of section and Note refiled with further amendments 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section and Note refiled with further amendment of Note 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.56. HIV/AIDS Confidentiality Agreement.

Note • History

“HIV/AIDS Confidentiality Agreement” means California Department of Public Health HIV/AIDS Confidentiality Agreement form (CDPH 8689 (05/07)), hereby incorporated by reference and available from the Department.

NOTE

Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 120175, 120775, 120820, 120885-120895, 120975, 120980, 121022, 121025, 121035, 121110, 131019, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

3. New section refiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-21-2007 order, including further amendment of section and Note, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.57. HIV Test Algorithm.

Note • History

“HIV test algorithm” means any multi-test procedure that determines the presence of HIV infection using confirmation protocols published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (MMWR).

NOTE

Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1206 and 1220, Business and Professions Code; and Sections 120917, 121022, 131051, 131052 and 131056, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 8-21-2007 order, including further amendment of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.60. Laboratory.

Note • History

“Laboratory” means a `clinical laboratory,' a `physician office laboratory,' or a `public health laboratory,' as defined in Business and Professions Code, Section 1206, that is authorized to perform clinical laboratory tests or examinations in California, or a clinical laboratory located outside of the State of California that is licensed pursuant to Business and Professions Code Section 1241(a) and that tests specimens originating in California.

NOTE

Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265 and 1281, Business and Professions Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.65. Laboratory Test.

Note • History

“Laboratory test” means a clinical laboratory test or examination as defined in Business and Professions Code, Section 1206(a)(4) and performed by a laboratory as defined in this Article.

NOTE

Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 1202.5 and 1206, Business and Professions Code; and Section 101160, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.70. Local Health Department.

Note • History

“Local health department” means the governing body providing public health services to cities and/or counties, as identified in Health and Safety Code, Section 101185.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.75. Non-Name Code. [Repealed]

Note • History

NOTE

Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Repealer filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

3. Repealer refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. Repealer refiled 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.77. Partial Non-Name Code. [Repealed]

Note • History

NOTE

Authority cited: Sections 100180, 100275, 120125, 120130 and 120140 Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2641.80. Personal Information.

Note • History

“Personal information” means an individual's complete Social Security Number, complete name or surname, home address, California driver's license or identification number, electronic mail address or telephone number.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.85. Publicly-Funded Confidential Counseling and Testing Program.

Note • History

“Publicly-funded Confidential Counseling and Testing Program” means a program financed by federal, state or local governmental agencies that provides confidential HIV tests to patients.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§2641.90. Soundex Code.

Note • History

“Soundex code” means a phonetic, alphanumerical formula which is used to convert the first letter and sequential consonants of an individual's surname into an algorithm. The Soundex code instructions are identified by the Department as form DHS 8641 SC (9/01), hereby incorporated by reference in this Article.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

Subarticle 4. Reporting Requirements

§2643.5. HIV Reporting by Health Care Providers.

Note • History

(a) Each health care provider that orders a laboratory test used to identify HIV, a component of HIV, or antibodies to or antigens of HIV shall submit to the laboratory performing the test a pre-printed laboratory requisition form which includes all documentation as specified in 42 CFR 493.1105 (57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993) and adopted in Business and Professions Code, Section 1220.

(b) The person authorized to order the laboratory test shall include the following when submitting information to the laboratory:

(1) Complete name of patient; and

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and

(3) Patient gender (male, female, transgender male-to-female, or transgender female-to-male); and

(4) Date biological specimen was collected; and

(5) Name, address, telephone number of the health care provider and the facility where services were rendered, if different.

(c) Each health care provider shall, within seven calendar days of receipt from a laboratory of a patient's confirmed HIV test or determination by the health care provider of a patient's confirmed HIV test, report the confirmed HIV test to the local Health Officer for the jurisdiction where the health care provider facility is located. The report shall consist of a completed copy of the HIV/AIDS Case Report form.

(1) All reports containing personal information, including HIV/AIDS Case Reports, shall be sent to the local Health Officer or his or her designee by:

(A) courier service, U.S. Postal Service Express or Registered mail, or other traceable mail; or

(B) person-to-person transfer with the local Health Officer or his or her designee.

(2) The health care provider shall not submit reports containing personal information to the local Health Officer or his or her designee by electronic facsimile transmission or by electronic mail or by non-traceable mail.

(d) HIV reporting by name to the local Health Officer, via submission of the HIV/AIDS Case Report, shall not supplant the reporting requirements in Article 1 of this Subchapter when a patient's medical condition progresses from HIV infection to an Acquired Immunodeficiency Syndrome (AIDS) diagnosis.

(e) A health care provider who receives notification from an out-of-state laboratory of a confirmed HIV test for a California patient shall report the findings to the local Health Officer for the jurisdiction where the health care provider facility is located.

(f) When a health care provider orders multiple HIV-related viral load tests for a patient, or receives multiple laboratory reports of a confirmed HIV test, the health care provider shall be required to submit only one HIV/AIDS Case Report, per patient, to the local Health Officer.

(g) Nothing in this Subchapter shall prohibit the local health department from assisting health care providers to report HIV cases.

(h) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the health care provider except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of that individual.

NOTE

Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1202.5, 1206, 1206.5, 1220, 1241, 1265 and 1281, Business and Professions Code; and Sections 1603.1, 101160, 120175, 120250, 120775, 120885-120895, 120917, 120975, 120980, 121015, 121022, 121025, 121035, 121085, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New subarticle 4 (sections 2643.5-2643.20) and section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

3. Amendment of section and Note refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 8-21-2007 with further amendment of Note as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including redesignation of former subsections (c)(1)A. and (c)(1)B. as subsections (c)(1)(A) and (c)(1)(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2643.10. HIV Reporting by Laboratories.

Note • History

(a) The laboratory director or authorized designee shall, within seven calendar days of determining a confirmed HIV test, report the confirmed HIV test to the Health Officer for the local health jurisdiction where the health care provider facility is located. The report shall include the:

(1) Complete name of patient; and

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and

(3) Patient gender (male, female, transgender male-to-female, or transgender female-to-male); and

(4) Name, address, and telephone number of the health care provider and the facility that submitted the biological specimen to the laboratory, if different; and

(5) Name, address, and telephone number of the laboratory; and

(6) Laboratory report number as assigned by the laboratory; and

(7) Laboratory results of the test performed; and

(8) Date the biological specimen was tested in the laboratory; and

(9) Laboratory Clinical Laboratory Improvement Amendments (CLIA) number.

(b)(1) All reports containing personal information, including laboratory reports, shall be sent to the local Health Officer or his or her designee by:

(A) courier service, U.S. Postal Service Express or Registered mail, or other traceable mail; or

(B) person-to-person transfer with the local Health Officer or his or her designee.

(2) The laboratory shall not submit reports containing personal information to the local Health Officer or his or her designee by electronic facsimile transmission or by electronic mail or by non-traceable mail.

(c) A laboratory that receives incomplete patient data from a health care provider for a biological specimen with a confirmed HIV test, shall contact the submitting health care provider to obtain the information required pursuant to Section 2643.5(b)(1)-(5), prior to reporting the confirmed HIV test to the local Health Officer.

(d) If a laboratory transfers a biological specimen to another laboratory for testing, the laboratory that first receives the biological specimen from the health care provider shall report confirmed HIV tests to the local Health Officer.

(e) Laboratories shall not submit reports to the local health department for confirmed HIV tests for patients of an Alternative Testing Site or other anonymous HIV testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked seroprevalence study.

(f) When a California laboratory receives a biological specimen for testing from an out-of-state laboratory or health care provider, the California director of the laboratory shall ensure that a confirmed HIV test is reported to the state health department in the state where the biological specimen originated.

(g) When a California laboratory receives a report from an out of state laboratory that indicates evidence of a confirmed HIV test for a California patient, the California laboratory shall notify the local Health Officer and health care provider in the same manner as if the findings had been made by the California laboratory.

(h) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the laboratory except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual.

NOTE

Authority cited: Section 1224, Business and Professions Code; and Sections 120125, 120130, 120140, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1265, 1281 and 1288, Business and Professions Code; and Sections 101150, 120175, 120775, 120885-120895, 120975, 120980, 121022, 121025, 121035, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

4. Amendment refiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including redesignation of former subsections (b)(1)A. and (b)(1)B. as subsections (b)(1)(A) and (b)(1)(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2643.15. HIV Reporting by Local Health Officers.

Note • History

(a) The local Health Officer or his or her authorized designee shall match and unduplicate laboratory reports of confirmed HIV tests with the local health department HIV/AIDS registry database and with HIV/AIDS Case Reports received from health care providers and not entered into the database.

(b) The Health Officer or his or her authorized designee shall, within 45 calendar days of receipt of a laboratory report of a confirmed HIV test, submit unduplicated HIV/AIDS Case Reports to the Department.

(1) HIV/AIDS Case Reports shall be sent by courier service, U.S. Postal Service Express or Registered mail, or other traceable mail to the California Department of Public Health, Office of AIDS, HIV/AIDS Case Registry.

(2) The local Health Officer or his or her authorized designee shall not report confirmed HIV tests for patients of an Alternative Testing Site or other anonymous counseling and testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked HIV seroprevalence study.

(c) The local Health Officer or his or her authorized designee shall not submit an HIV/AIDS Case Report to the Department for an infant under the age of 18 months, unless the infant's HIV infection is confirmed.

(d) All local health department employees and contractors shall sign the HIV/AIDS Confidentiality Agreement prior to accessing confidential HIV-related public health records. All HIV/AIDS Confidentiality Agreements shall be renewed at least once per year.

(e) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the local Health Officer or his or her authorized designee except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual.

NOTE

Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 120175, 120775, 120820, 120885-120895, 120975, 120980, 121015, 121022, 121025, 121035, 121085, 131019, 131051, 131052, 131056 and 131080, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. New subsection (d), subsection relettering and amendment of Note filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.

3. New subsection (d), subsection relettering and amendment of Note refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.

4. New subsection (d), subsection relettering and amendment of Note refiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment of subsection (b)(1), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§2643.20. HIV Reporting Exemptions.

Note • History

Alternative Testing Sites; other anonymous or unlinked HIV testing programs; blood banks; plasma centers; and blinded and/or unlinked seroprevalence studies are exempt from these HIV reporting regulations.

NOTE

Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.

HISTORY

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

Article 4. Approval Procedures for Canine Rabies Vaccines

§2650. Canine Rabies Vaccine Advisory Committee.

Note • History

The Director shall appoint a Canine Rabies Vaccine Advisory Committee consisting of 6 to 8 members. The Committee's responsibility shall be to assist the Department in evaluating the effectiveness of canine rabies vaccines. Membership shall include individuals with recognized professional expertise in at least one of the fields of immunology, virology, epidemiology, public health and veterinary medicine. Committee members shall serve without compensation but shall be reimbursed for actual and necessary expenses incurred during service on the committee. Canine rabies vaccines that have been approved by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, shall be evaluated for the degree of effectiveness by the Canine Rabies Vaccine Advisory Committee. In order to evaluate vaccine effectiveness the committee shall:

(a) Review test data submitted by canine rabies vaccine manufacturing firms, for approval of canine rabies vaccines.

(b) Make recommendations for Departmental approval or disapproval of canine rabies vaccines.

(c) Make recommendations concerning approval of any variances from the established standards for acceptance of canine rabies vaccines.

NOTE

Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.

HISTORY

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§2651. Approval of Canine Rabies Vaccines.

Note • History

(a) In order for a canine rabies vaccine to be approved for use in California, it shall adhere to the following requirements:

(1) Meet Animal and Plant Health Inspection Service (APHIS) standards for sterility and safety. Evidence of product conformance to APHIS Standards will be demonstrated by the United States Department of Agriculture (USDA) product licensing; and

(2) If an inactivated vaccine, it shall have a minimal relative potency (RP) at vaccination of at least 2.0 as determined by the National Institute of Health (NIH)Test for potency or if a modified live virus (MLV) vaccine it shall meet USDA potency Requirements; and

(3) Demonstrate an immunity duration of three or more years based on an immunity duration challenge study conducted in conformity with section 2652; and

(4) Comply with the origin and integrity of Rabies Vaccine Virus Requirements in section 2653.

NOTE

Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.

HISTORY

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§2652. Immunity Duration-Challenge Studies.

Note • History

(a) The demonstration of an acceptable immunity duration of three or more years, as shown by adequate challenge studies in dogs, shall be required. However, the above challenge study shall not suffice for acceptance of a subsequent multiple vaccine product that contains the same rabies vaccine as one of two or more component vaccines.

(b) Vaccine Trial Protocols. Vaccine trial protocols shall be submitted to the Department by vaccine manufacturers prior to beginning the immunity duration challenge study. The protocol shall include animals, materials, methods and procedures. The protocol shall include the identification number of each animal, its source and/or that of its mother, if applicable, sex, age, breed and the name, address, and telephone number of a contact person who can verify personal knowledge of the dog's vaccination history. Annual progress reports and a final report of the immunity-duration challenge study shall be submitted to the Department. The reports shall include by date for each dog its rabies antibody titers, other immunizations, medications, illnesses, unusual events and death, if applicable, as well as any changes or developments in reference to animals, materials, methods, and procedures. The Department shall supply firms with an outline to report the foregoing information. The outline will include the following items:

(1) “Protocol for Proposed Rabies Vaccine Immunity Duration Challenge Study”;

(2) “Procedures and Preliminary Data Attending Initiation of Canine Rabies Vaccine Immunity Duration Challenge Study”;

(3) “Progress Report: One Year Postvaccination”;

(4) “Progress Report: Two Years Postvaccination”;

(5) “Final Report”;

(6) “Results of Challenge”; and

(7) “Progress Report for Three Years Postvaccination.”

The Veterinary Public Health Unit, 714 P Street, Room 760, Sacramento, California 95814 will provide this outline upon request.

(c) Dogs Used in Studies. No pound dogs or other dogs of undeterminable rabies vaccination history shall be used in the study. Dogs shall be obtained from the original owner since birth or have verifiable histories. Groups of vaccinates and control dogs shall be of approximately equal composition, according to numbers, sex ratio (approximately 50:50), age, and origin. As much as is possible, dogs of uniform size or conformation shall be used. No dog shall be used which has had prior rabies immunization or which has detectable serum rabies neutralizing antibodies. Dogs under 8 months of age used in studies shall not originate from rabies-immunized mothers. No dog shall be over 1 1/2 years of age at vaccination or when set aside as a control.

(d) Size of Challenge Groups. Challenge groups, both vaccinates and nonimmunized controls, shall each consist of 30 or more dogs at challenge. Any additional (extra or back-up) dogs, intended to replace vaccinates or controls that die prior to challenge, shall be included in either the vaccinate or the control group prior to the initiation of the study and subsequently treated, sampled and reported on as either a vaccinate dog or as a control dog. The use of additional sets of vaccinate and/or control dogs to be challenged simultaneously, or at an earlier or later date, shall not be recognized as representative of separate trials. Instead, the serological results subsequent to vaccination and the reactions to challenge of all groups, sets, and individual dogs shall be included in the overall analysis on a cumulative basis. Failed antibody response or failed reaction to challenge at any time shall disqualify subsequent trial phases.

(e) Route and Site of Vaccination. MLV vaccines shall be inoculated intramuscularly at one site in the thigh. Inactivated vaccines may be inoculated by any single route and single site which provides the required protection against challenge at least 3 years post vaccination and is shown to be safe. The exact site and route of inoculation shall be described.

(f) New Route and/or Site of Vaccination. If a firm changes its recommended route and/or site of vaccination of a previously approved vaccine, the vaccine shall be tested as a new product, and the firm shall complete another satisfactory immunity duration-challenge study of 3 years or greater duration before the new route and/or site of vaccination shall be approved.

(g) Additional Vaccinations. Excepting food and water, no vaccinate or control dog shall be exposed to any vaccine, drug, or other substance by any route within three weeks prior to any bleeding for antibody test or within three weeks prior to or at any time after challenge with rabies virus except at euthanasia.

(h) Serology. Standard serum virus-neutralization tests done in mice (MSNT) or the rapid rabies fluorescent focus inhibition test (RFFIT) shall be used in comparing the immunogenicity of different products. No substitute test reagents or substitute tests shall be accepted.

(1) Test results shall be reported for the vaccinate group and controls. Serum virus-neutralization titrations shall be performed on sera of (1) all dogs prior to vaccination; (2) vaccinates at the end of post vaccination months 1, 3, 6, 9, 12, 18, 24, 30 and 36 just prior to challenge; (3) controls at the end of month 36 just prior to challenge; and (4) survivors just prior to euthanasia.

(2) At years post vaccination, all vaccinate dogs shall have demonstrable serum rabies antibody titers, the median titer being equal to, or greater than, 1:15 by the MSNT or an equivalent test.

(3) At 3 years post vaccination, at least 90 per cent of vaccinates shall have demonstrable titers by the MSNT, the median titer being equal to, or greater than, 1:10 by the MSNT or an equivalent test.

(i) Incidental Deaths or Deletions. There shall be a complete accounting for all dogs used in the study, including any that die or are killed after the start of the study or any withdrawn from participation for any reason. Each such dog shall be accounted for by dates and details of illness, treatment and death, the cause of death with supportive diagnostic test results, and rabies serology records. Each such dog shall be tested for rabies infection by Fluorescent Rabies Antibody (FRA) test followed by the mouse inoculation test if the FRA test is negative.

(j) Challenge Virus and Dose. The challenge virus inoculum shall be infective carnivore salivary gland suspension supernate of a North American carnivore “street” rabies virus. The dose of challenge virus given shall be estimated by titration prior to challenge and confirmed by titration of residual challenge inoculum. The dose of challenge virus shall be as low as possible while still achieving a mortality of 80 - 100 per cent in controls. The dose given each dog shall not exceed 200,000 mouse intracranial 50 percent lethal doses (MICLD50), or a demonstrably equivalent dose as determined by an alternate method of titration.

(k) Challenge Route and Procedure. Only challenge virus inoculum shall be inoculated into the masseter muscles of vaccinate dogs or control dogs at any time. Challenge virus shall be inoculated intramuscularly into the masseter muscles, the viral dose being divided into two equal parts for bilateral inoculation. Should a challenge route or site other than the intramasseter route be used, the firm employing the route or site shall demonstrate in a trial previously approved by the Department, the effectiveness and appropriateness of the post challenge holding period and compensate for any related increase in incubation period and decrease in susceptibility. All animals, vaccinates and controls, shall be challenged at the same time, either on an alternate basis (i.e., a vaccinate, followed by a control, followed by a vaccinate, etc.) or the vaccinates shall be challenged first and the controls challenged immediately afterwards. A separate needle and a separate syringe shall be used for each dog.

(l) Individual Enclosure for Each Challenged Dog. Each dog shall be kept in an individual enclosure, preventing its contact with any other animal.

(m) Post challenge Observation Period. Challenged dogs, retained in isolation, shall be observed for a minimum of 90 days prior to final bleeding, euthanasia, and rabies testing of their brains.

(n) Mortality in Challenged Animals. With rare exceptions, all vaccinates shall survive challenge. Eighty to one hundred percent of challenged controls shall die of rabies.

(o) Confirmatory Rabies Diagnostic Tests on Brains of Dogs that Die and on Brains of Survivors. Brains of dogs that die and brains of dogs that survive challenge shall be tested by fluorescent rabies antibody (FRA) test, followed by mouse-inoculation test if the former is negative; dead mice shall be confirmed as rabies-infected by FRA test on their brains. Dogs that die at any time following administration of a live virus vaccine shall be tested for possible rabies vaccine virus infection, using tests suitable to disclose, recover, and identify the strain of vaccine virus.

NOTE

Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.

HISTORY

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§2653. Origin and Integrity of Rabies Vaccine Virus.

Note • History

The Department shall be provided with comprehensive information on the origin, passage level, and sub-passage history of rabies viruses used in the development and production of rabies vaccines being submitted for approval. The integrity of the rabies virus used in the production of the vaccine shall be maintained without further modification once the vaccine is approved for use in the Department's rabies control program.

NOTE

Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.

HISTORY

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

Subchapter 2. Adult Health

HISTORY

1. Repealer of Subchapter 2 (Sections 2700, 2705, 2710 and 2711) filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 39). For prior history, see Register 58, No. 10.

Subchapter 2.5. Disorders Characterized by Lapses of Consciousness

Article 1. Definitions

§2800. Activities of Daily Living.

Note • History

“Activities of daily living” means bathing, dressing, feeding oneself, brushing one's teeth, and performing more complex tasks such as grocery shopping, cooking, management of personal finances, and operating a motor vehicle.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New subchapter 2.5 (articles 1-2, sections 2800-2812), article 1 (sections 2800-2808) and section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2802. Alzheimer's Disease and Related Disorders.

Note • History

“Alzheimer's disease and related disorders” means those illnesses that damage the brain causing irreversible, progressive confusion, disorientation, loss of memory and judgment.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2804. Diagnose.

Note • History

“Diagnose” means to identify the existence of a medical condition in a patient.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2806. Disorders Characterized by Lapses of Consciousness.

Note • History

(a) “Disorders characterized by lapses of consciousness” means those medical conditions that involve:

(1) a loss of consciousness or a marked reduction of alertness or responsiveness to external stimuli; and

(2) the inability to perform one or more activities of daily living; and

(3) the impairment of the sensory motor functions used to operate a motor vehicle.

(b) Examples of medical conditions that do not always, but may progress to the level of functional severity described in subsection (a) of this section include Alzheimer's disease and related disorders, seizure disorders, brain tumors, narcolepsy, sleep apnea, and abnormal metabolic states, including hypo- and hyperglycemia associated with diabetes.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2808. Sensory Motor Functions.

Note • History

“Sensory motor functions” means the ability to integrate seeing, hearing, smelling, feeling, and reacting with physical movement, such as depressing the brake pedal of the car to stop the car from entering an intersection with a green traffic light to avoid hitting a pedestrian crossing the street.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

Article 2. Reporting

§2810. Reporting Requirements.

Note • History

(a) Except as provided in Section 2812, a physician and surgeon shall notify the local health officer within seven (7) calendar days of every patient 14 years of age or older, when a physician and surgeon has diagnosed a disorder characterized by lapses of consciousness (as defined in Section 2806) in a patient.

(b) The report prepared pursuant to subsection (a) of this section shall include:

(1) The name, address, date of birth, and diagnosis of the patient; and

(2) The name, address, and phone number of the physician and surgeon making the report.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New article 2 (sections 2810-2812) and section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§2812. Exceptions to Reporting.

Note • History

A physician and surgeon shall not be required to notify the local health officer of a patient with a disorder characterized by lapses of consciousness if:

(a) The patient's sensory motor functions are impaired to the extent that the patient is unable to ever operate a motor vehicle, or

(b) The patient states that he or she does not drive and states that he or she never intends to drive, and the physician and surgeon believes these statements made by the patient are true, or

(c) The physician and surgeon previously reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle, or

(d) There is documentation in the patient's medical record that another physician and surgeon reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle.

NOTE

Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.

HISTORY

1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

Subchapter 3. Services for Physically Handicapped Children

Group 1. Minimum Standards for the Care of Physically Handicapped Children for Local Communities in California

Article 1. General

§2890. Confidential Nature of Crippled Children's Records.

Note • History

NOTE

Authority cited: Sections 208, 249, 268, and 271, Health and Safety Code.

HISTORY

1. New section filed 6-22-50 as an emergency; effective upon filing (Register 20, No. 6). For history of Group 1, see note to § 2900.

2. Change without regulatory effect pursuant to Section 100, Title 1, California Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED. NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not consecutive.)

§2900. Case Finding and Reporting.

Note • History

NOTE

Authority cited for § 2900 to 2904, inclusive: Sections 208 and 249, Health and Safety Code.

HISTORY

1. New Group 1 (§ 2900 to 2904, inclusive) filed 12-28-45; effective thirtieth day thereafter (Register 3).

2. Sections renumbered 2900 to 2905, inclusive, and new Section 2901 filed 3-4-47; effective thirtieth day thereafter (Register 7).

3. Amended Group 1 (§ 2900 to 2905, inclusive) filed 2-8-52; effective thirtieth day thereafter (Register 27, No. 3).

4. Change without regulatory effect pursuant to Section 100, Title 1, California Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED. NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not consecutive.)

§2901. Definition.

Note • History

NOTE

Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.

HISTORY

1. Amendment filed 9-18-52; effective thirtieth day thereafter (Register 29, No. 6).

2. Repealer and new section filed 5-7-75; effective thirtieth day thereafter (Register 75, No. 19).

3. Amendment of subsection (a)(20) and new subsection (a)(21) filed 5-10-79 as an emergency; effective upon filing (Register 79, No. 19).

4. Certificate of Compliance transmitted to OAH 9-7-79 and filed 9-12-79 (Register 79, No. 37).

5. Change without regulatory effect pursuant to Section 100, Title 1, California Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED. NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not consecutive.)

§2902. Records and Reports.

History

HISTORY

1. Change without regulatory effect pursuant to Section 100, Title 1, California Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED. NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not consecutive.)

§2903. Diagnostic Services.

Note • History

NOTE

Additional authority cited: Section 1509, Health and Safety Code.

HISTORY

1. Amendment filed 12-8-55; effective thirtieth day thereafter (Register 55, No. 18).

2. Amendment filed 2-9-67; effective thirtieth day thereafter (Register 67, No. 6).

3. Change without regulatory effect pursuant to Section 100, Title 1, California Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED. NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not consecutive.)

§2904. Treatment.

History

HISTORY

1. Amendment filed 12-8-55; effective thirtieth day thereafter (Register 55, No. 18).

2. Amendment filed 2-9-67; effective thirtieth day thereafter (Register 67, No. 6).

§2905. After-Care Services.

History

HISTORY

1. Amendment filed 4-29-53; effective thirtieth day thereafter (Register 53, No. 8).

§2906. Authorization for Services.

Note • History

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code, Reference: Art. 2, Ch. 2, Pt. 1, Div. 1, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

Article 2. Immunization Adverse Reaction Fund

§2907. Bone Marrow Transplantation for Cancer.

Note • History

NOTE

Authority cited: Section 208(a), Health and Safety Code. Reference: Section 273, Health and Safety Code.

HISTORY

1. New section filed 12-26-86; effective thirtieth day thereafter (Register 86, No. 52).

§2910. Program Administration.

Note • History

NOTE

Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.

HISTORY

1. New Article 2 (Sections 2910-2914, not consecutive) filed 5-10-79 as an emergency; effective upon filing (Register 79, No. 19).

2. Certificate of Compliance transmitted to OAH 9-7-79 and filed 9-12-79 (Register 79, No. 37).

§2912. Use of Fund.

Note • History

NOTE

Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.

HISTORY

§2914. Extensive Medical Care.

Note • History

NOTE

Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.

HISTORY

Article 3. Podiatrist and Family Practice Physician Services

§2920. California Children Services (CCS).

Note • History

NOTE

Authority cited: Section 208 (a), Health and Safety Code. Reference: Section 255.5 and 255.6, Health and Safety Code.

HISTORY

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

§2921. California Children Services (CCS) Panel.

Note • History

NOTE

Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 255.5 and 255.6, Health and Safety Code.

HISTORY

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

§2922. Expertise in the Care of Children.

Note • History

NOTE

Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.6, Health and Safety Code.

HISTORY

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

§2923. General Supervision.

Note • History

NOTE

Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.5, 262 and 268, Health and Safety Code.

HISTORY

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

Article 4. Genetically Handicapped Persons Program

§2930. Genetically Handicapped Persons Program.

Note • History

The Genetically Handicapped Persons Program (GHPP) is a health care program within the California Children Services (CCS) Branch which provides medical care and other related services for persons with the genetically handicapping conditions specified in Section 2932 of this chapter.

NOTE

Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Section 341, Health and Safety Code.

HISTORY

1. New section filed 12-28-87 as an emergency; operative 12-28-87 (Register 88, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-27-88.

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5-4-88 (Register 88, No. 19).

§2931. California Children Services/Genetically Handicapped Persons Program Special Care Center.

Note • History

(a) A California Children Services (CCS)/Genetically Handicapped Persons Program (GHPP) Special Care Center is a medical center which provides diagnostic and treatment services (inpatient, outpatient and home) to CCS clients under 21 years of age who have GHPP eligible conditions, and to GHPP clients over 21 years of age.

(b) California Children Services/Genetically Handicapped Persons Program Special Care Centers include the following:

(1) Hemophilia Center

(2) Cystic Fibrosis Center

(3) Sickle Cell Disease Center

(4) Specified Inherited Neurologic Disease Center

(5) Amniocentesis Center

(6) Metabolic Disease Center

NOTE

Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 340, 341 and 342, Health and Safety Code.

HISTORY

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5-4-88 (Register 88, No. 19).

§2932. Medical Eligibility--Conditions.

Note • History

(a) The following medical conditions are eligible for services through the GHPP program:

(1) Hemophilia, which includes any congenital hereditary hemorrhagic state due to a defect in the hemostatic mechanism resulting from a deficiency or abnormality in one of the plasma clotting factors or platelets including:

(A) Factor I deficiency

(B) Factor II deficiency

(D) Factor VII deficiency

(E) Factor VIII deficiency

(F) Factor IX deficiency

(G) Factor X deficiency

(H) Factor XI deficiency

(I) Factor XIII deficiency

(J) von Willebrand's Disease

(K) Congenital hereditary platelet deficiency diseases or dysfunction such as congenital thrombasthenia (Glanzman's thrombasthenia) and thrombocytopathia

(2) Cystic fibrosis

(3) Hemoglobinopathies with anemia including:

(A) Sickle Cell Disease, but not sickle cell trait

(B) Thalassemia

(4) Chronic degenerative neurological diseases:

(A) Huntington's Disease

(B) Joseph's Disease

1. Hereditary spastic paraplegia

2. Roussy-Levy Syndrome

3. Olivopontocerebellar degeneration

4. Refsum's disease

5. Charcot-Marie-Tooth Syndrome

(5) The following metabolic diseases:

(A) Disorder of amino-acid transport and metabolism

1. Phenylketonuria

2. Other disturbances of armoatic amino-acid metabolism

a. Tyrosinemia

3. Disturbances of branched chain amino-acid metabolism

a. Disturbances of metabolism of leucine, isoleucine, valine

b. Hypervalinemia

c. Intermittent branched-chain ketonuria

d. Leucine-induced hypoglycemia

e. Leucinosis

f. Maple syrup urine disease

g. Propionic and methylmalonic acidemias

h. Lactic and pyruvate metabolism disorders

i. Hereditary orotic (pyrimidine acidemia)

4. Disturbances of sulphur bearing amino-acid metabolism

a. Homocystinuria

b. Hypermethioninemia

5. Urea cycle disorders

a. Argininosuccinic aciduria

b. Citrullinemia

c. Disorders of metabolism of ornithine, citrulline, argininossuccinic acid, arginine, and ammonia

d. Hyperammonemia

e. Hyperornithinemia

(B) Disorders of carbohydrate transport and metabolism

1. Galactosemia

a. Galactose-1-phosphate uridyl transferase deficiency

b. Galactosuria

1. Wilson's disease

NOTE

Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 341 and 341.5, Health and Safety Code.

HISTORY

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5-4-88 (Register 88, No. 19).

Group 2. Registration as School Audiometrists

Article 1. General

§2950. Qualifications.

Note • History

The qualifications required for registration as school audiometrist shall be as follows:

(a) Satisfactory completion of required training in audiology, audiometry and hearing assessment at an accredited university or college. Such training must include a minimum of eight quarter hours, or equivalent, academic and practical preparation in audiology, identification audiometry and hearing assessment in courses approved by the Hearing Conservation Specialist of the State Department of Health Services. If the applicant completed the required training more than five years prior to the date of application for registration, the applicant must have had at least one year of verified supervised experience in the interim in the administration of hearing tests to school children in the public or parochial schools, or in other tax maintained educational institutions in this State. Verification will be documented in writing by the applicant's supervisor.

(b) Public health nurses and credentialed school nurses may either fulfill the requirements of subsection (a) or demonstrate satisfactory completion, at an accredited university or college, of a four quarter hours, or equivalent, hearing assessment course approved by the Hearing Conservation Specialist of the Department of Health Services.

(c) For purposes of subsections (a) and (b) accreditation of colleges or universities shall be by one of the following accrediting associations:

(1) New England Association of School and Colleges.

(2) Middle States Association of Colleges and Secondary Schools.

(3) North Central Association of Colleges and Secondary Schools.

(4) Northern Association of Schools and Colleges.

(5) Southern Association of Colleges and Schools.

(6) Western Association of Schools and Colleges.

(d) Applicants for registration as school audiometrists shall complete State Form Application for Registration as School Audiometrist PM 101 and submit the completed form to the State Department of Health Services, 714 P Street, Sacramento, CA 95814.

(e) A registration fee of $10.00 shall accompany each application.

(f) An applicant for registration as school audiometrist shall receive written notification informing the applicant that the application is complete and approved, or that the application is deficient and what specific information is required. Notification must occur within two weeks of receipt of the application by the State Department of Health Services. This two week time period is a median based on a minimum of one week and maximum of three weeks actual performance in 1985 and 1986.

(g) Within four weeks of receipt of an approved application, the State Department of Health Services shall issue a certification of registration to the applicant.

NOTE

Authority cited: Sections 208 and 1686, Health and Safety Code. Reference: Sections 1685 and 1686, Health and Safety Code; and Section 44879, Education Code, and Section 15374 et seq., Government Code.

HISTORY

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26). For prior history, see Register 69, No. 8.

2. Amendment of subsection (d) filed 6-25-86 as an emergency; effective upon filing (Register 86, No. 26). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 10-23-86.

3. Certificate of Compliance transmitted to OAL 10-17-86 and filed 11-17-86 (Register 86, No. 47).

4. Amendment filed 7-7-87; operative 8-6-87 (Register 87, No. 29).

§2951. Testing Standards.

Note • History

Schools conducting hearing testing shall comply with the following criteria:

(a) Equipment.

(1) Hearing threshold tests.

(A) Pure tone audiometers used for testing of hearing thresholds shall be those manufactured to meet or exceed specifications for wide range or limited range audiometers as defined by American National Standards Institute (ANSI) Specification Section 3.6-1969, Subsection 2.1.1 (published in 1969) and shall be maintained to meet such specifications. Such audiometers shall be designed to operate from alternating current supply voltages and meet the stability standards defined in Subsection 4.6 of American National Standards Institute (ANSI) Section 3.6-1969 Specifications.

(2) Hearing screening test.

(A) Pure tone audiometers used for hearing screening tests shall be those manufactured to meet or exceed specifications for wide range audiometers or limited range audiometers as defined by the American National Standards Institute (ANSI) Section 3.6-1969, Subsections 2.1.1 and 2.1.2 and shall be maintained to meet such specifications.

(B) Pure tone audiometers used for hearing screening tests shall not be battery powered. Audiometers in use on the effective date of the amendment to the regulations may be utilized until they no longer meet American National Standards Institute (ANSI) Section 3.6-1969 Specifications, Subsections 1 through 4.9.2.

(3) Care of equipment.

(A) Audiometric testing personnel shall be trained in the proper care of the testing equipment.

(B) Biological checks.

Audiometric testing personnel shall maintain continuous surveillance of the audiometer used, by performing biological checks as follows:

1. Daily. A brief biological check of the audiometer shall be made each day the audiometer is in use. The check shall consist of testing each earphone on a person with stable audiometric thresholds that do not exceed 25 decibel hearing level at any frequency tested between 500 Hertz and 4000 Hertz and comparing the test results with the subject's baseline audiogram. The subject may be the audiometrist.

2. Monthly. A detailed biological check of the audiometer which includes a careful listening test of earphones to insure that the audiometer displays no evidence of

a. Cross talk;

b. Signal distortion;

c. Transient clicks;

d. Abnormal noise; or,

e. Intermittent signal.

1. An electroacoustic calibration check of audiometers shall be made at least every 12 months, or more frequently if indicated by the biological checks, and meet or exceed the specifications outlined in Subsections 1 through 4.9.2., American National Standards for Audiometers, published by the American National Standards Institute (ANSI), Inc. (published in 1969).

2. A calibration chart, showing proof of performance, shall be kept with the audiometer.

(b) Test environment.

(1) For audiometric threshold testing and screening testing, the environmental noise level shall not exceed 41.5 decibel sound pressure level in the 500 Hertz band, 49.5 decibel sound pressure level in the 1000 Hertz band, and 54.5 decibel sound pressure level in the 2000 Hertz band, and 62 decibel sound pressure level in the 4000 Hertz band; or,

(2) The test environment shall be considered adequate if the noise levels do not cause a threshold shift greater than 10 decibels at those frequencies which must be included in a pure tone conduction threshold test. This procedure may be performed on the audiometris.

(1) Each pupil shall be given a hearing screening test in kindergarten or first grade and in second, fifth, eighth, tenth or eleventh grade and first entry into the California public school system.

(A) A school district may request a waiver of the hearing screening test for tenth and/or eleventh grade pupils once each school year. The request for a waiver must be in writing and addressed to the State Department of Health Services, Hearing Conservation Specialist. The waiver request must include the dates of the school year for which the waiver is requested and an alternative testing plan that will insure that each pupil at risk of hearing loss will receive testing services. Pupils at risk of hearing loss are: those exposed to loud noises, including loud music; pupils that have been referred for testing by a parent or teacher; repeat tests for those pupils for whom there was a previously documented problem, pupils who have not had a hearing test for three years; and any pupil who has enrolled for the first time in the school district. An approved waiver of the hearing screening test does not exempt a school district from reporting requirements contained in Section 2951, (e).

(B) Each pupil enrolled in a special education program (as described in Section 56001 of the Education Code), other than those pupils enrolled for a hearing problem, shall be given a hearing test when enrolled in the program and every third year thereafter. Hearing tests may be given more frequently as needed, based on the individual education program team's evaluation of each individual pupil.

(2) Pure tone audiometric screening tests shall be conducted at a level not to exceed 25 decibels and shall include the frequencies 1000, 2000 and 4000 Hertz. A pupil's failure to respond to any of the required frequencies constitutes a failure of the screening test. Individual tests may be used for pupils of all ages. Group tests may only be used for pupils who demonstrate reliable results.

(3) Pure tone air conduction threshold tests shall include the frequencies 500, 1000, 2000 and 4000 Hertz and shall be given to:

(A) All pupils who fail the screening tests;

(B) All pupils who are to be considered for further audiological or otological evaluation.

(d) Referral. The schools shall provide the parents or guardians of children who fail the hearing tests with a written notification of the test results and recommend that a medical and audiological evaluation be obtained whenever the test demonstrates:

(1) A hearing level of 30 decibels or greater for two or more frequencies in an ear at 500, 1000, 2000 or 4000 Hertz, or a hearing level of 40 decibels or greater for one of the frequencies tested, 500 through 4000 Hertz, on two threshold tests completed at an interval of at least two weeks; or

(2) There is evidence of pathology, such as an infection of the outer ear, chronic drainage, or a chronic earache.

(e) Reporting results.

(1) Dates and results of all screening hearing testing shall be recorded on each pupil's health record. Copies of all threshold tests shall be filed with the pupil's health records.

(2) Each school shall prepare an annual report of the school hearing testing program using Annual Report of Hearing Testing forms, PM 100, provided by the State Department of Health Services with copies to the district superintendent and the county superintendent of schools.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 1685 and 1686, Health and Safety Code; and Sections 44879 and 56001, Education Code.

HISTORY

1. New section filed 10-5-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

3. Repealer and new section filed 7-7-87; operative 8-6-87 (Register 87, No. 29).

4. New subsection (c)(1)(A) and newly designated subsection (c)(1)(B) filed 3-7-95; operative 4-6-95 (Register 95, No. 10).

Subchapter 4. The Infant Botulism Treatment and Prevention Program

Article 1. Definitions

§3000.2. Botulism Immune Globulin.

Note • History

“Botulism Immune Globulin” or “BIG” means the pharmaceutical product which consists of human-derived or human-gene-derived immunoglobulin (antibody) molecules or active fragments thereof and appropriate stabilizing agents that possesses the ability to neutralize botulinum or botulinum-like toxins.

NOTE

Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123700-123709, Health and Safety Code.

HISTORY

1. New subchapter 4 (articles 1-4), article 1 (sections 3000.2-3000.4) and section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and filed 11-4-98 (Register 98, No. 45).

§3000.4. Infant Botulism Treatment and Prevention Program.

Note • History

“Infant Botulism Treatment and Prevention Program” or “IBTPP” means the unit of the California Department of Health Services mandated by Health & Safety Code Section 123702.

NOTE

Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123700-123709, Health and Safety Code.

HISTORY

1. New section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and filed 11-4-98 (Register 98, No. 45).

Article 2. Distribution of Botulism Immune Globulin

§3010. Distribution of Botulism Immune Globulin.

Note • History

Only patients admitted to and treated in hospitals located in the United States, its territories and possessions, and the federal Centers for Disease Control and Prevention (CDC) shall be eligible recipients for the distribution of BIG.

NOTE

Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123702, 123704(b), (c), (g) and 123705, Health and Safety Code.

HISTORY

1. New article 2 (section 3010) and section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and filed 11-4-98 (Register 98, No. 45).

Article 3. Reporting Requirements for Hospitals Receiving BIG

§3020. Reporting Requirements for Hospitals.

Note • History

Within one week of discharge, the patient's hospital shall provide to the IBTPP the following information on the patient treated with BIG:

(a) Admission and discharge summaries, and

(b) A listing of hospital charges, costs, and reimbursements for the patient's hospital stay.

NOTE

Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123704(b), (c), (e), (f) and 123705, Health and Safety Code.

HISTORY

1. New article 3 (section 3020) and section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and filed 11-4-98 (Register 98, No. 45).

Article 4. Fees

§3030. Fee.

Note • History

The per patient fee for Botulism Immune Globulin shall be $45,300.

NOTE

Authority cited: Section 123707(d), Health and Safety Code. Reference: Sections 123702 and 123705, Health and Safety Code.

HISTORY

1. New article 4 (section 3030) and section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and filed 11-4-98 (Register 98, No. 45).

3. Amendment of section and Note filed 4-26-2005; operative 5-1-2004. Submitted to OAL for printing only pursuant to Health and Safety Code section 123702(d) (Register 2005, No. 17).

Subchapter 5. Public Health Nursing [Repealed]

Group 1. Public Health Nursing [Renumbered]

Article 1. Issuance of Public Health Nursing Certificates [Renumbered]

HISTORY

1. Renumbering of former title 17, group 1, article 1 (sections 4500-4504) to title 16, division 14, article 9 (sections 1490-1494) filed 1-26-96; operative 2-28-96. Submitted to OAL for printing only (Register 96, No. 5). For prior history, see Register 87, No. 11.

Group 2. Trained Attendants [Repealed]

HISTORY

1. Originally published 7-15-45 (Title 17).

2. Repealer of §4600 to 4722, inclusive, filed 6-29-48 (Register 13, No. 1).

Subchapter 6. Tuberculosis Hospitals and Sanatoria Receiving State Subsidy [Repealed]

(Originally Printed 8-15-45)

Note: Authority cited for Subchapter 6: Sections 102 and 208, Health and Safety Code. Reference: Sections 3279, 3294, 3298 and 3299, Health and Safety Code.

HISTORY

1. Sections 5100 to 5176, inclusive, 4-12-48.

2. New Sections 5100 to 5199, inclusive, filed 4-22-48 (Register 12, No. 4).

3. Repealer of Subchapter 6 (Sections 5100-5199 and Appendix) and new Subchapter 6 (Sections 5100, 5105, 5106, 5107, 5108, 5115, 5120, 5125, 5126 and 5127) filed 2-28-66; effective thirtieth day thereafter (Register 66, No. 6).

4. Repealer of Subchapter 6 (Sections 5100-5127, not consecutive) filed 9-23-85; effective thirtieth day thereafter (Register 85, No. 39).

Subchapter 7. Venereal Diseases

Cross Reference: Sections 2636 (a) to (m), Title 17, Subchapter 1.7, Reportable Diseases and Conditions.

§5151. Sexually Transmitted Diseases in Minors.

Note • History

(a) A minor 12 years of age or older may give consent to the furnishing of hospital, medical and surgical care related to the diagnosis and/or treatment of any of the following non-reportable sexually transmissible diseases:

(1) Candida genitalis.

(2) Chlamydia trachomatous.

(3) Condyloma acuminata.

(4) Hemophilus vaginalis (Gardnerella vaginale).

(5) Cytomegalovirus infection.

(6) Herpes genitalis.

(7) Molluscum contagiosum.

(8) Non-gonococcal urethritis, vaginitis and cervicitis.

(9) Pediculosis (Phthirus pubis).

(10) Scabies (Sarcoptes scabiei).

(11) Trichomoniasis.

NOTE

Authority cited: Section 208 (a), Health and Safety Code; and Section 34.7, Civil Code. Reference: Section 34.7, Civil Code.

HISTORY

1. New section filed 3-4-82; effective thirtieth day thereafter (Register 82, No. 10).

Subchapter 8. Immunization Against Poliomyelitis, Diphtheria, Pertussis, Tetanus, Measles (Rubeola), Rubella, Haemophilus Influenzae Type B (Hib), Mumps, and Hepatitis B

Article 1. Definitions

§6000. Admission.

Note • History

“Admission” means a pupil's first entry in a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. “Admission” also denotes a pupil's re-entry to one of these institutions after withdrawing from a previous enrollment.

(a) “Unconditional admission” is admission based upon documentation of receipt of all required immunizations or upon documentation of a permanent medical exemption or of a personal beliefs exemption to immunization in accordance with Section 6051.

(b) “Conditional admission” is admission based upon either documentation of having received some but not all required immunizations and of not being due for any vaccine dose at the time of entry or upon documentation of a temporary medical exemption to immunization in accordance with Section 6050. Continued attendance after conditional admission is contingent upon receipt of the remaining required immunizations in accordance with Sections 6020 and 6035.

NOTE

Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340, 120365, 120370 and 120375, Health and Safety Code.

HISTORY

1. Repealer and new Subchapter 8 (Sections 6000-6075) filed 3-22-78 as an emergency; effective upon filing (Register 78, No. 12). For history of former Subchapter 8, see Registers 61, No. 25; 62, No. 16; 63, No. 17; 66, No. 7; and 72, No. 11.

2. Repealer and new Subchapter 8 (Sections 6000-6075) filed 7-28-78; effective thirtieth day thereafter (Register 78, No. 30).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of subchapter 8 heading, section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

5. Editorial correction amending subchapter 8 heading (Register 97, No. 42).

§6010. Immunizing Agent. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code.

HISTORY

1. Amendment filed 4-15-80 as an emergency; effective upon filing (Register 80, No. 16). A Certificate of Compliance must be transmitted to OAH within 120 days or emergency language will be repealed on 8-14-80.

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

3. Repealer filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

§6015. Pupil.

Note • History

“Pupil” means a person under age 18 years admitted to or seeking admission to any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center.

NOTE

Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335) and 120360, Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

Article 2. Required Immunizations

§6020. Required Immunizations.

Note • History

(a) The required immunizations for admission to and attendance at a public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or developmental center shall be those set forth, according to age, in Table 1.

(b) In Table 1 of Section 6020 and in Table 2 of Section 6035, DTP (or DPT) means diphtheria and tetanus toxoids and pertussis vaccine, including DTaP vaccine. Tdap means tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine. DT (or TD) and Td (or dT) means diphtheria and tetanus toxoids.

(c) For pupils who have reached their seventh birthday, a history of any preparations containing diphtheria and tetanus toxoids and pertussis vaccine (DTP, DT, Td, Tdap, etc.) shall be acceptable as meeting the requirement for tetanus and diphtheria toxoids and pertussis vaccine that is set forth in Table 1.

(d) Pupils who have reached their seventh birthday shall be exempt from the mumps immunization requirements.

(e) Combination vaccines that include measles, mumps, and rubella components shall be acceptable as meeting the requirements for these vaccines that are set forth in Table 1.

(f) For pupils entering or advancing to the seventh grade, immunization requirements are set forth in Table 1.

(g) Pupils already admitted to California public and private schools at the Kindergarten level or above before July 1, 2001 are exempt from the Varicella (chickenpox) requirement as set forth in Table 1.

(h) For pupils entering or advancing into the eighth through twelfth grades, the immunization requirement is set forth in Table 1 of Section 6020.

Table 1: Immunization Requirements

Institution Age Vaccine Total Doses Received

Child care center, day Less than 2 months None

nursery, nursery school,

family day care home,

development center

Same as above 2-3 months 1. Polio1 1 dose

2. DTP 1 dose

3. Hib 1 dose

4. Hepatitis B 1 dose

Same as above 4-5 months 1. Polio1 2 doses

2. DTP, or combination of DTP and diphtheria-tetanus

toxoids 2 doses

3. Hib 2 doses

4. Hepatitis B 2 doses

Same as above 6-14 months 1. Polio1 2 doses

2. DTP, or combination of DTP and diphtheria-tetanus

toxoids 3 doses

3. Hib 2 doses

4. Hepatitis B 2 doses

Same as above 15-17 months 1. Polio1 3 doses

2. DTP, or combination of DTP and diphtheria-tetanus

toxoids 3 doses

3. Measles, rubella, and mumps 1 dose of each separately

or combined on or after the

1st birthday

4. Hib 1 dose on or after the

1st birthday

5. Hepatitis B 2 doses

Same as above 18 months-5 years 1. Polio1 3 doses

2. DTP, or combination of DTP and diphtheria-tetanus

toxoids 4 doses

3. Measles, rubella, and mumps 1 dose of each separately

or combined on or after the

1st birthday

4. Hib3 1 dose on or after the

1st birthday

5. Hepatitis B2 3 doses

6. Varicella 1 dose

Elementary school at 4-6 years 1. Polio1 4 doses, except that a total of

kindergarten level and 3 doses is acceptable if at

above least one dose was given on

or after the 4th birthday

2. DTP, or combination of DTP and diphtheria-tetanus

toxoids 5 doses, except that a total of

4 doses is acceptable if at

least one dose was given on

or after the 4th birthday.

3. Measles, rubella, and mumps 1 dose of each, separately

or combined, on or after the

1st birthday. Pupils entering

a kindergarten (or first grade

if kindergarten skipped) are

required to have 2 doses of

measles-containing

vaccine, both given on or

after the first birthday

4. Hepatitis B2 3 doses

5. Varicella 1 dose

Elementary school, 7-17 years 1. Polio1 4 doses, except that a total of

secondary school 3 doses is acceptable if at

least one dose was given on

or after the 2nd birthday

2. Diphtheria and tetanus toxoids and pertussis vaccine

given as DTP, DT, Td, or Tdap At least 3 doses. One more

dose is required if the

last dose was given before

the 2nd birthday.

3. Measles and rubella (mumps not required) 1 dose of each, separately

or combined, on or after the

1st birthday. (See below for

additional requirements for

7th grade enrollment,

effective 7/1/99.)

Institution Age Vaccine Total Doses Received

4. Varicella5 1 dose aged 7 through 12

years for students not

admitted to California

schools before July 1, 2001.

2 doses for students aged 13

through 17 years not

admitted to California

schools before July 1, 2001.

Seventh Grade Any 1. Tdap6,7 1 dose on or after the 7th

birthday

2. Measles4 2 doses of measles

-containing vaccine, both

given on or after the first

birthday.

Eighth through Twelfth Any pupil under 18 years 1. Tdap6,7 1 dose on or after the 7th

Grades8 birthday

Any 18 years and older None

1 Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable.

2 Applies only to children entering at kindergarten level (or at first grade level if kindergarten skipped) or below on or after August 1, 1997.

3 Required only for children who have not reached the age of 4 years 6 months.

4 Applies only to children (of any age) entering or advancing to the seventh grade on or after July 1, 1999.

5 Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement.

6Pupils must have received at least one dose of Tdap prior to admission or advancement into the 7th through 12th grades.

7If DTP was given on or after age 7 years instead of Tdap, this dose may also be counted as a valid dose for this requirement.

8This requirement is effective July 1, 2011, through June 30, 2012.

NOTE

Authority cited: Sections 120330, 120335 and 131200, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment filed 8-30-79; effective thirtieth day thereafter (Register 79, No. 35).

2. Amendment filed 4-15-80 as an emergency; effective upon filing (Register 80, No. 16). A Certificate of Compliance must be transmitted to OAH within 120 days or emergency language will be repealed on 8-14-80.

3. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

4. Amendment of subsections (c), (d), and (e) filed 10-3-80; effective thirtieth day thereafter (Register 80, No. 40).

5. Repealer and new section filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

6. Amendment of subsection (a), repealer of subsection (f) and subsection relettering, and amendment of Table 1 and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

7. Repealer of subsection (b), subsection relettering, amendment of newly designated subsection (b), and amendment of Table 1 and Note filed 5-22-97 as an emergency; operative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must be transmitted to OAL by 9-19-97 or emergency language will be repealed by operation of law on the following day.

8. Editorial correction of subsection (b) (Register 97, No. 37).

9. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and filed 9-26-97 (Register 97, No. 39).

10. New subsection (f), amendment of Table 1 and amendment of Note filed 2-18-99 as an emergency; operative 2-18-99 (Register 99, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-18-99 or emergency language will be repealed by operation of law on the following day.

11. Editorial correction of table (Register 99, No. 27).

12. Certificate of Compliance as to 2-18-99 order transmitted to OAL 5-26-99 and filed 6-30-99 (Register 99, No. 27).

13. New subsection (g), amendment of Table 1 and amendment of Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

15. Amendment of subsections (b)-(d), new subsection (h) and amendment of Table 1 and Note filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

16. Amendment of subsections (b)-(d), new subsection (h) and amendment of Table 1 and Note refiled 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

Article 3. Admission to School, Child Care Center, Day Nursery, Nursery School, Family Day Care Home, or Development Center

§6025. Unconditional Admission.

Note • History

Any pupil age 18 months or older who has received all the immunizations against poliomyelitis, diphtheria, tetanus, pertussis, measles (rubeola), rubella, Haemophilus influenzae type B, mumps, hepatitis B and varicella (chickenpox) required for his or her age, as defined in Table 1, Section 6020, or who has documented a permanent medical exemption or a personal beliefs exemption to immunization in accordance with Section 6051, shall be admitted unconditionally as a pupil to a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. However, for some pupils admitted unconditionally to a child care center, day nursery, nursery school, family day care home, or development center, an additional dose of DTP and/or polio vaccine will be required for admission to school at kindergarten level and above, as indicated in Table 1, Section 6020.

NOTE

Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of article 3 heading, section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

5. Amendment of section and Note filed 5-22-97 as an emergency; operative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must be transmitted to OAL by 9-19-97 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and filed 9-26-97 (Register 97, No. 39).

7. Amendment of section and Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§6030. Conditional Admission to Prekindergarten Level. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code.

HISTORY

1. Repealer filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

§6035. Conditional Admission.

Note • History

(a) Any pupil seeking admission to a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center who lacks documentation of having received all the required vaccine doses against poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, Haemophilus influenzae type B, mumps, hepatitis B and varicella (chickenpox) as specified in Table 1, Section 6020, and has not obtained a permanent medical exemption or a personal beliefs exemption to immunization in accordance with Section 6051, may be admitted conditionally if:

(1) he or she has not received all the immunizations required for his or her age group but has commenced receiving doses of all the vaccines in accordance with Table 2, is not currently due for any doses at the time of admission (if he or she is due for any doses at this time they must be obtained before admission), and the pupil's parent or guardian is notified of the date by which the pupil must complete all the required immunizations in accordance with Table 2; or

(2) he or she is under age 18 months and has received all the immunizations required for his or her age group but will require additional vaccine doses at an older age, and the pupil's parent or guardian is notified of the date by which the pupil must complete all the remaining doses when they become due in accordance with Table 1, Section 6020; or

(3) he or she has obtained a temporary medical exemption from immunization in accordance with Section 6050, and the pupil's parent or guardian is notified of the date by which the pupil must complete all the required immunizations when the temporary exemption terminates; or

(4) he or she is a pupil entering a child care center governed by Education Code Section 8263(c), where a different deadline for obtaining all required immunizations may apply.

(b) The public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center shall not allow the admission of any pupil seeking entry who does not meet the requirements for admission under Section 6025 or 6035. The principal or administrator shall advise the pupil, or the parent or guardian, to contact a physician or agency that provides immunizations.

Table 2: Conditional Admission Immunization Schedule

Vaccine Dose Time Intervals

Polio1 1st dose Before admission

2nd dose As early as 6 weeks but no later than 10 weeks after the 1st

dose. Before admission if 10 or more weeks have elapsed

since the 1st dose at the time of admission.

3rd dose As early as 6 weeks but no later than 12 months after the

2nd dose. Before admission if 12 or more months have

elapsed since the 2nd dose at the time of admission.

4th dose (Required only for

entry to kindergarten level

or above) Age 4-6 years: If the 3rd dose was given before the 4th

birthday one more dose is required before admission.

Age 7-17 years: If the 3rd dose was given before the

2nd birthday, one more dose is required before admission.

Diphtheria, Tetanus, and Pertussis

1st dose Before admission.

2nd dose As early as 4 weeks but no later than 8 weeks after the

FOR PUPILS UNDER AGE 7 YEARS: 1st dose. Before admission if 8 or more weeks have

elapsed since the 1st dose at the time of admission.

3rd dose As early as 4 weeks but no later than 8 weeks after the

Diphtheria-tetanus-pertussis (DTP) or combination 2nd dose. Before admission if 8 or more weeks have

of DTP and diphtheria-tetanus toxoids elapsed since the 2nd dose at the time of admission.

4th dose As early as 6 months but no later than 12 months after

the 3rd dose. Before admission if 12 or more months

have elapsed since the 3rd dose at the time of admission.

5th dose (Required only for

pupils ages 4-6 years

for entry to kindergarten

level and above) If the 4th dose was given before the 4th birthday, one

OR more dose is required before admission.

FOR PUPILS AGE 7 YEARS AND OLDER: 1st dose Before admission.

2nd dose As early as 4 weeks but no later than 8 weeks after the

1st dose. Before admission if 8 or more weeks have

Diphtheria-tetanus-pertussis (DTP, Tdap) elapsed since the 1st dose at the time of admission.

and diphtheria-tetanus toxoids 3rd dose As early as 6 months but no later than 12 months after the

2nd dose. Before admission if 12 or more months have

elapsed since the 2nd dose at the time of admission.

4th dose If the 3rd dose was given before the 2nd birthday, one

more dose is required before admission.

--------------------------- ---------------------------------------------

One Tdap dose Before 7th through 12th grade entry.

Measles One dose only Before admission. If the pupil is under age 15 months, this

dose is required when age 15 months is reached.

Note: For children entering kindergarten (or first grade 1st dose Before admission.

if kindergarten is skipped) on or after August 1, 1997, 2nd dose As early as 1 month but no later than 3 months after

two doses are required. For children entering 7th grade the 1st dose.

on or after July 1, 1999, the series shall be in process

or completed.

Rubella One dose only Before admission. If the pupil is under age 15 months, this

dose is required when age 15 months is reached.

Mumps (Not required for pupils age 7 years and older) One dose only Before admission. If the pupil is under age 15 months, this

dose is required when age 15 months is reached.

Hib

Children 2-14 months old Two doses 1st dose before admission. 2nd dose as early as 2 months

but no later than 3 months after the 1st dose.

Children 15 months-4 1/2 years old One dose Before admission.

Hepatitis B--For children entering at 1st dose Before admission.

kindergarten level (or first grade if kindergarten skipped) 2nd dose As early as 1 month but no later than 2 months after the first

or below on or after August 1, 1997. dose.

3rd dose Infants and children under age 18 months: As early as 2

months but no later than 12 months after the 2nd dose.

Also, no earlier than 4 months after the 1st dose.

Children age 18 months and older: As early as 2 months but

no later than 6 months after the 2nd dose. Also, no earlier

than 4 months after the 1st dose.

Varicella2 -- For children aged 13 through 17 years 1st dose Before admission

not admitted to California schools before July 1, 2001. 2nd dose As early as 4 weeks but no longer than 3 months after first

dose

1Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable.

2Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement.

NOTE

Authority cited: Sections 120330, 120335 and 131200, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment filed 8-30-79; effective thirtieth day thereafter (Register 79, No. 35).

2. Amendment of subsection (a) filed 4-15-80 as an emergency; effective upon filing (Register 80, No. 16). A Certificate of Compliance must be transmitted to OAH within 120 days or emergency language will be repealed on 8-14-80.

3. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

4. Repealer and new section filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

5. Amendment of subsections (a), (b), Table 2 and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

6. Amendment of subsection (a), Table 2 and Note filed 5-22-97 as an emergency; operative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must be transmitted to OAL by 9-19-97 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and filed 9-26-97 (Register 97, No. 39).

8. Amendment of Table 2 filed 2-18-99 as an emergency; operative 2-18-99 (Register 99, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-18-99 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 2-18-99 order transmitted to OAL 5-26-99 and filed 6-30-99 (Register 99, No. 27).

10. Editorial correction of Table 2 (Register 99, No. 39).

11. Amendment of subsection (a), Table 2 and Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

13. Amendment of Table 2 and Note filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

14. Editorial correction renumbering footnote reference (Register 2011, No. 28).

15. Amendment of Table 2 and Note refiled 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

§6040. Requirements for Continued Attendance.

Note • History

An already admitted pupil who is subsequently discovered not to have received all the immunizations which were required before admission or who is subsequently discovered not to have complied with the requirements for conditional admission specified in Section 6035 shall continue in attendance only if he or she receives all vaccine doses for which he or she is currently due and provides documentation of having received such doses no later than 10 school days after he or she or the parent or guardian is notified. The school, child care center, day nursery, nursery school, family day care home, or development center shall notify the pupil or the parent or guardian of the time period (no longer than 10 school days) within which the doses must be received.

NOTE

Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340 and 120375 (a) and (b), Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

§6045. Special Immunization Schedules.

Note • History

(a) Immunization schedules not conforming to those specified in Sections 6020 and 6035 may be approved by the State Department of Health Services when substantial medical or other conditions warrant, such as during an outbreak or epidemic of a particular disease.

NOTE

Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

§6050. Conditional Admission with Temporary Medical Exemption.

Note • History

A pupil who is temporarily exempt from immunization for medical reasons shall be admitted on condition that required immunizations are obtained at the termination of the exemption; the fact of the temporary medical exemption shall be recorded on the California School Immunization Record, PM 286 (1/02) as provided in Section 6070. A pupil with a temporary medical exemption may be subject to exclusion pursuant to Section 6060.

NOTE

Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120365, 120370 and 102375, Health and Safety Code.

HISTORY

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of section and Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§6051. Unconditional Admission with Permanent Medical Exemption or Personal Beliefs Exemption.

Note • History

A pupil with a permanent medical exemption or a personal beliefs exemption to immunization shall be admitted unconditionally. A pupil with an exemption which is not based on pre-existing immunity to disease may be subject to exclusion pursuant to Section 6060.

(a) A permanent medical exemption shall be granted upon the filing with the governing authority of a written statement from a licensed physician to the effect that the physical condition of the pupil or medical circumstances relating to the pupil are such that immunization is permanently not indicated. The fact of the permanent medical exemption shall be recorded on the California School Immunization Record, PM 286 (01/02) as provided in Section 6070. A permanent medical exemption may be provided for one or more vaccines. A physician may provide a written statement that the pupil is medically exempt from the measles (rubeola) and/or varicella (chickenpox) requirements as a result of having had measles (rubeola) and/or varicella (chickenpox) disease, respectively. A physician may provide a written statement that the pupil is medically exempt from the rubella and/or mumps requirement as a result of having had laboratory confirmed illness with the corresponding disease.

(b) A personal beliefs exemption shall be granted upon the filing with the governing authority of a letter or affidavit from the pupil's parent or guardian or adult who has assumed responsibility for his or her care and custody in the case of a minor, or the person seeking admission if an emancipated minor, that such immunization is contrary to his or her beliefs. The fact of the personal beliefs exemption shall be recorded on the California School Immunization Record, PM 286 (01/02). If a personal beliefs exemption letter or affidavit for some or all immunizations was filed with the governing authority prior to July 1, 2011, a personal beliefs exemption letter or affidavit for the pertussis booster immunization must be filed with the governing authority. The Personal Beliefs Exemption form, CDPH 8261 (03/11), hereby incorporated by reference, is to be made available at the school as a means for exercising a personal belief exemption to the pertussis booster immunization requirement in Section 120335(d), Health and Safety Code. The fact of a personal beliefs exemption for the pertussis booster immunization requirement in Section 120335(d), Health and Safety Code, shall be recorded on the Tdap (Pertussis Booster) Requirement sticker, PM 286 S (01/11).

NOTE

Authority cited: Sections 120330, 120335 and 131200, Health and Safety Code. Reference: Sections 120325, 120335, 120365, 120370 and 120375, Health and Safety Code.

HISTORY

1. Renumbering and amendment of a portion of former Section 6050 to Section 6051 filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

4. Amendment of section and Note filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section and Note refiled 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

Article 4. Exclusion

§6055. Conditions for Admission Not Fulfilled.

Note • History

The governing authority of the school, child care center, day nursery, nursery school, family day care home, or development center shall exclude from further attendance any pupil who fails to obtain the required immunizations within no more than 10 school days following receipt of the notice provided pursuant to Section 6040, unless the pupil is exempt for medical reasons or personal beliefs, until the pupil provides written evidence that he or she has received another dose of each required vaccine due at that time. Any pupil so excluded shall be reported to the attendance supervisor or to the building administrator.

NOTE

Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340, 120365, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

§6060. Pupil Not Completely Immunized and Exposed to Communicable Disease.

Note • History

Whenever the governing authority has good cause to believe that a pupil who is not completely immunized against a particular communicable disease may have been exposed to that disease, that information shall be reported by the governing authority immediately by telephone to the local health officer. The local health officer shall determine whether the pupil is at risk of developing the disease and, if so, may require the exclusion of the pupil from that school, child care center, day nursery, nursery school, family day care home, or development center until the completion of the incubation period and the period of communicability of the disease.

NOTE

Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335) and 120375(c), Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

Article 5. Records As Evidence of Immunization

§6065. Documentary Proof.

Note • History

(a) There shall be a written record given to the person immunized or to his or her parent or guardian, by the physician or agency performing the immunization which shall contain the following information:

(1) Name of the person.

(2) Birthdate.

(3) Type of vaccine administered.

(4) Month, day, and year of each immunization.

(5) Name of the physician or agency administering the vaccine.

(b) The written record shall be shown by the parent, guardian or person immunized to the governing authority of the school, child care center, day nursery, nursery school, family day care home, or development center at the time of the pupil's admission and at subsequent times when required by the governing authority to determine the pupil's immunization status. For the pupil to be admitted, the written record shall show at least the month and year of each required vaccine dose. For doses of measles, rubella and mumps vaccine given during the month of the first birthday the record shall also show the specific date (i.e., month, day and year) of immunization. For a dose of Tdap given during the month of the pupil's 7th birthday, the record shall also show the specific date (i.e., month, day and year) of immunization.

(c) When such written records are not available, the pupil shall not be admitted and the parent or guardian shall be referred to a physician or nurse for review of his or her immunization history and provision of immunizations as needed.

NOTE

Authority cited: Sections 120330, 120335 and 131200, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of subsection (b) and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

3. Amendment of section and Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

5. Amendment of subsection (b), repealer of subsection (d) and amendment of Note filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

6. Amendment of subsection (b), repealer of subsection (d) and amendment of Note refiled 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

§6070. School/Child Care Facility Immunization Record.

Note • History

(a) The governing authority of each school, child care center, day nursery, nursery school, family day care home, or development center shall record each pupil's immunizations on the California School Immunization Record, PM 286 (1/02) and is in its entirety, incorporated by reference which, at kindergarten level and above, shall be part of the mandatory permanent pupil record as defined in Section 430 of Title 5, California Code of Regulations.

(b) Each pupil's immunization record shall contain:

(1) Name of pupil.

(2) Birthdate (month, day and year).

(3) Date of unconditional or conditional admission (month, day, and year).

(4) Type of vaccine and date (month, day, and year) each dose was administered. Although month, day and year of vaccine administration should be recorded, a California Immunization Record, PM 286 (01/02), showing only month and year of vaccine dose(s) shall be allowed, except that for records showing measles, rubella, and/or mumps vaccine doses given during the month of the first birthday or Tdap dose given during the month of the 7th birthday, the date of immunization shall also be recorded.

(5) Date and type of exemption, if any.

(d) For pupils at kindergarten level and above transferring between school campuses within California or from a school in another state to a school in California, if the mandatory permanent pupil record or other immunization record has not been received at the time of entry to the new school, the governing authority of the school may admit the pupil for a period of up to 30 school days. If the mandatory permanent record or other immunization record has not arrived by the end of this period, the governing authority shall require the parent or guardian to present a written immunization record, as described in Section 6065, documenting that all currently due required immunizations have been received. If such a record is not presented, the pupil shall be excluded from further attendance until he or she comes into compliance with the immunization requirements, as outlined in Sections 6020, 6035, and 6065.

(e) The governing authority shall see that the immunization record of each pupil admitted conditionally is reviewed every 30 days until that pupil has received all the required immunizations. Any immunizations received subsequent to conditional admission shall be entered in the pupil's immunization record.

(f) For pupils who are being admitted or are advancing into the 7th through 12th grades beginning July 1, 2011, the governing authority shall record each pupil's Tdap dose, given or after the 7th birthday, on the supplemental sticker form Tdap (Pertussis Booster) Requirement [PM 286 S (01/11)]. This form is hereby incorporated by reference. The governing authority shall affix the PM 286 S (01/11) to the front of the pupil's California School Immunization Record, PM 286 (01/02).

NOTE

Authority cited: Sections 120330, 120335 and 131200, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section heading, subsection (a) and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

4. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

5. Amendment of subsection (b)(4), new subsection (f) and amendment of Note filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

6. Amendment of subsection (b)(4), new subsection (f) and amendment of Note refiled 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

§6075. Reporting.

Note • History

(a) The governing authority of each school, child care center, day nursery, nursery school, family day care home, or development center shall file a report with the state and local health departments on the immunization status of new entrants annually or when needed to determine immunization status such as during an epidemic or potential epidemic. The forms to be used for these reports are:

(1) Schools with kindergartens: IMMUNIZATION ASSESSMENT OF KINDERGARTEN STUDENTS--ANNUAL REPORT [PM 236 (3/01)] and this form in its entirety is incorporated by reference.

(2) Schools with seventh grades: PERTUSSIS BOOSTER IMMUNIZATION ASSESSMENT OF SEVENTH GRADE STUDENTS [CDPH 8259 (9/11)]. This form is hereby incorporated by reference.

(3) Child care centers, day nurseries, nursery schools and development centers: ANNUAL IMMUNIZATION REPORT ON CHILDREN ENROLLED IN CHILD CARE CENTERS [DHS 8018 (3/01)] and this form is in its entirety incorporated by reference or ANNUAL IMMUNIZATION ASSESSMENT REPORT OF CHILDREN ENROLLED IN CHILD CARE CENTERS--LINE LISTING [DHS 8387 (3/94)]. The Department of Health Services or the local health department will provide the appropriate reporting form.

(4) Family day care homes: ANNUAL FAMILY DAY CARE HOME IMMUNIZATION SURVEY [DHS 8529 (10/00)] and this form is in its entirety incorporated by reference.

(5) Schools with any grade from the 7th through 12th grade shall report data on Tdap immunization: PERTUSSIS (Tdap) ASSESSMENT OF 7-12th GRADE STUDENTS 2011-2012 SCHOOL SUMMARY SHEET [CDPH 8260 (01/11)]. This form is hereby incorporated by reference.

(b) The annual report shall contain at least the following information on new entrants in kindergarten or lower level classes only:

(1) Enrollment as of date of report.

(2) Number of new entrants admitted unconditionally specifying the number who have received all immunizations, the number who are medically exempt and the number who are exempt for personal beliefs.

(3) Number of new entrants admitted conditionally specifying the number of doses received of poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, Haemophilus influenza type b (Hib), mumps, hepatitis B, and varicella (chickenpox) vaccines.

(4) Other information requested by the State Department of Health Services.

(c) Additional reports which include new entrants in all grades may be requested during an epidemic or potential epidemic.

NOTE

Authority cited: Sections 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code.

HISTORY

1. Amendment of subsection (b)(3) filed 4-15-80 as an emergency; effective upon filing (Register 80, No. 16). A Certificate of Compliance must be transmitted to OAH within 120 days or emergency language will be repealed on 8-14-80.

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80 (Register 80, No. 34).

3. Amendment of subsection (a), new subsections (a)(1)-(3), and amendment of subsection (b)(3) and Note filed 3-29-96; operative 4-28-96 (Register 96, No. 13).

4. Editorial correction of subsection (b)(3) (Register 97, No. 12).

5. Amendment of subsection (b)(3) and Note filed 5-22-97 as an emergency; operative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must be transmitted to OAL by 9-19-97 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of Note (Register 97, No. 37).

7. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and filed 9-26-97 (Register 97, No. 39).

8. Amendment of subsection (a)(1), new subsection (a)(2) and subsection renumbering filed 2-18-99 as an emergency; operative 2-18-99 (Register 99, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-18-99 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 2-18-99 order transmitted to OAL 5-26-99 and filed 6-30-99 (Register 99, No. 27).

10. Amendment of subsections (a)(1), (a)(3)-(4) and (b)(3) and amendment of Note filed 9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 9-24-2002 order transmitted to OAL 1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

12. New subsection (a)(5) filed 6-30-2011 as an emergency; operative 7-1-2011 (Register 2011, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2011 or emergency language will be repealed by operation of law on the following day.

13. New subsection (a)(5) refiled with additional amendment of subsection (a)(2) and Note 12-15-2011 as an emergency; operative 12-28-2011 (Register 2011, No. 50). A Certificate of Compliance must be transmitted to OAL by 3-27-2012 or emergency language will be repealed by operation of law on the following day.

Subchapter 8.1. Immunization Against Measles (Rubeola) [Repealed]

HISTORY

1. Repealer filed 3-22-78 as an emergency; effective upon filing (Register 78, No. 12). For prior history, see Registers 67, No. 43; 67, No. 48; and 72, No. 11.

Subchapter 8.2. Immunization Against Diphtheria, Tetanus, and Pertussis [Repealed]

HISTORY

1. Repealer filed 3-22-78 as an emergency; effective upon filing (Register 78, No. 12). For prior history, see Register 72, No. 11.

Subchapter 9. Testing for Heritable Disorders

Group 3. Newborn Screening Program

Article 1. Definitions

§6500. Birth Attendant.

Note • History

“Birth attendant” means any person licensed or certified by the State to provide maternity care and to deliver pregnant women or to practice medicine.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. New subchapter 9 (section 6500) filed 12-1-65; designated effective 1-1-66 (Register 65, No. 23).

2. Amendment filed 10-5-66; effective thirtieth day thereafter (Register 66, No. 34)

3. Repealer filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).

4. Renumbering and amendment of former section 6500.5 to section 6500 filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

5. Amendment of subsection (r) and new subsections (s) and (t) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code section 309(g) (Register 90, No. 4).

6. Amendment of subsection (t) filed by the Department of Health Services with the Secretary of State on 5-30-90 as an emergency; operative 5-30-90. Submitted to OAL for printing only pursuant to Health and Safety Code section 309(g)(Register 90, No. 30).

7. Editorial correction of printing error in subsection (r) restoring History 5. and renumbering previous History 5. to 6. (Register 91, No. 32).

8. Change without regulatory effect amending subchapter heading, adding group 3 heading, and amending article heading, section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.1. Days of Age.

Note • History

“Days of age” means the measurement of the age of a newborn in 24-hour periods so that a newborn is one day of age 24 hours following the hour of birth.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41). For prior history, see Register 87, No. 47.

§6500.5. Discharge.

Note • History

“Discharge” means release of the newborn from care and custody of the perinatal licensed health facility to the parents or into the community.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

§6500.19. Inadequate Specimen.

Note • History

“Inadequate specimen” means a newborn's blood specimen which is not suitable in quality or quantity to perform newborn screening for one or more of the disorders covered by this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.25. Initial Positive Test.

Note • History

“Initial positive test” means a newborn's blood specimen which identified as positive for reporting purposes.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.28. Initial Specimen.

Note • History

“Initial specimen” means the first specimen collected subsequent to birth, pursuant to this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.31. Initial Test.

Note • History

“Initial test” means the first valid newborn screening test or combination of tests of a newborn for each disorder covered by this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.35. Newborn.

Note • History

“Newborn” means an infant 30 days of age and under.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.39. Newborn's Physician.

Note • History

“Newborn's physician” means the physician responsible for the care of the newborn after discharge from the hospital.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.45. Newborn Screening Area Service Center.

Note • History

“Newborn Screening Area Service Center” means an institution, corporation, hospital or university medical center:

(a) Having specialized expertise;

(b) Designated by the Department to serve a specific geographic area of the State: and

(c) Contracted with the Department to provide follow-up, referral and diagnosis of a preventable heritable or congenital disorder.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.46. Newborn Screening Laboratory.

Note • History

“Newborn screening laboratory” means a laboratory operated by the Department or a laboratory contracting with the Department to conduct tests required by this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.57. Perinatal Licensed Health Facility.

Note • History

“Perinatal licensed health facility” means any health facility licensed by the State and approved to provide perinatal, delivery, newborn intensive care, newborn nursery or pediatric services.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.59. Preventable Heritable or Congenital Disorder.

Note • History

“Preventable heritable or congenital disorder” means any disorder or abnormality present at birth which is detectable by testing a newborn and for which effective means of prevention or amelioration exists.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.65. Recall Specimen.

Note • History

“Recall specimen” means a specimen collected from a newborn because the initial test or combination of tests was positive for any of the disorders covered by this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.67. Recall Test.

Note • History

“Recall test” means a test ordered collected from a newborn because the initial test or combination of tests was positive for any of the disorders covered by this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.69. Repeat Specimen.

Note • History

“Repeat specimen” means a specimen collected from a newborn following the newborn screening laboratory's report that a previously collected specimen was either inadequate or that test results were inconclusive.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.70. Repeat Test.

Note • History

“Repeat test” means a test required by this Group to be repeated for a newborn because the previous specimen or test results were inadequate or test results were not complete.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6500.74. Sickle Cell Counselor.

Note • History

“Sickle cell counselor” means a person who:

(a) Is a physician, or has a master's degree in genetic counseling and is board eligible or board certified by the American Board of Genetic Counseling, or is certified by the Department of Public Health as having successfully completed an approved sickle cell counselor training program; and

(b) Provides face-to-face information on the medical, social, and genetic consequences of sickle cell disease and trait.

NOTE

Authority cited: Sections 124980, 125000 and 131200, Health and Safety Code. Reference: Sections 124980, 125000, 125025, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

2. Change without regulatory effect amending subsection (a) and Note filed 8-13-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 33).

§6500.77. Sickle Cell Education and Counseling Program.

Note • History

“Sickle cell education and counseling program” means an educational and counseling program in which the disease orientation is, in whole or in major part, sickle cell disease.

NOTE

Authority cited: Sections 124980, 125000 and 131200, Health and Safety Code. Reference: Sections 124980, 125000, 125025, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

2. Change without regulatory effect amending section and Note filed 8-13-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 33).

§6500.80. Transfer.

Note • History

“Transfer” means release of the newborn from care and custody of one perinatal licensed health facility to care and custody of another perinatal licensed health facility, or admission to another perinatal licensed health facility of a newborn from an out-of-state facility.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Article 2. Testing and Follow-Up Program Requirements

§6501. Scope of Newborn Testing.

Note • History

Each newborn born in California shall be tested for galactosemia, hereditary hemoglobinopathies, phenylketonuria and primary congenital hypothyroidism in accordance with procedures in this Group.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125000, 125001 and 125025, Health and Safety Code.

HISTORY

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).

2. Amendment filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

3. Amendment of subsections (a) and (c) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).

4. Change without regulatory effect adding article 2 heading and amending section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6501.2. Religious Objection.

Note • History

(a) The provisions of Section 6501 shall not apply if a parent or legally appointed guardian objects to a test on the ground that it conflicts with his or her religious beliefs or practices. If the parent or legal guardian refuses to allow the collection of a blood specimen, such refusal shall be: (1) made in writing, (2) signed by a parent or legally appointed guardian, and (3) included in the newborn's medical or hospital record.

(b) Birth attendants or physicians shall provide to parent(s) or legally appointed guardian(s) who object to the test on the basis it is in conflict with their religious beliefs or practices, a refusal form approved by the Department and shall obtain the appropriate signature(s) upon the form. If the parent(s) or legally appointed guardian(s) is unable to read such material, it shall be translated or read to such person(s) in a language understood by such persons.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6502. Fatal Condition.

Note • History

The provisions of Section 6501 shall not apply if the newborn has a condition almost certain to be fatal in the first 30 days of life. The prognosis shall be documented in the medical record.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Section 125000, Health and Safety Code.

HISTORY

§6502.1. Confidentiality.

Note • History

(a) All information, records of interview, written reports, statements, notes, memoranda, or other data procured by an individual, group or research team in the course of any testing under this Group shall be confidential and shall be used solely for the purposes of medical intervention, counseling, or specific research project approved by the Department.

(b) Except as provided by law, such information shall not be exhibited nor disclosed in any way, in whole or in part, by any individual, group, or research team except with the written consent of the person or his/her legally authorized representative unless such data can be made available in a manner which preserves anonymity of the persons tested.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services with the Secretary of State on 5-30-90 as an emergency; operative 5-30-90. Submitted to OAL for printing only pursuant to Health and Safety Code section 309(g) (Register 90, No. 30).

2. Change without regulatory effect amending subsection (a) and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6503. Newborn Screening Laboratory Requirements.

Note • History

(a) The Department shall designate laboratories and tests to be used for Department required newborn tests. Such laboratories shall be either laboratories operated by the Department for quality control confirmatory and emergency testing or contractor laboratories licensed as clinical laboratories under the Business and Professions Code.

(b) Perinatal licensed health facilities and birth attendants shall submit required specimens to the newborn screening laboratory designated by the Department.

(c) Contract newborn screening laboratories shall be limited to laboratories that shall have submitted a bid acceptable to the Department on a competitive contract to provide laboratory services in sufficient volume to cover all of the newborns born in a geographical area, as defined by the Department, plus an appropriate emergency capacity. The Department will define not more than six areas and may combine areas if necessary to reduce costs or assure statewide coverage.

(d) Notwithstanding (c) above a comprehensive prepaid group practice direct health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may have a laboratory serving a comprehensive prepaid group practice health care service plan designated a newborn screening laboratory under terms of a written agreement as defined in Section 6508(b) or may provide services in conformity with the terms of a mutually acceptable contract for services.

(e) Newborn screening laboratories shall participate in a proficiency testing program conducted by the Department's laboratory and shall maintain levels of performance acceptable to the Department.

(f) Newborn screening laboratories contracting with the Department shall be subject to on-site inspections and review of laboratory performance of tests and laboratory records.

NOTE

Authority cited: Sections 124980 and 125000 , Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

HISTORY

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).

2. Amendment filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).

4. Amendment filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

5. Amendment of subsections (d) and (e) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).

6. Change without regulatory effect amending section heading and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6504. Parent Education: Birth Attendants.

Note • History

All birth attendants engaged in providing perinatal care shall provide pregnant women, prior to the estimated date of delivery, with a copy of the informational material, entitled “Important Information for Parents,” provided by the Department.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

HISTORY

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).

2. Amendment of subsection (f) filed 8-29-80 as an emergency (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed on 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).

4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

5. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6504.2. Parent Education: Perinatal Licensed Health Facilities.

Note • History

Perinatal licensed health facilities shall provide each pregnant woman admitted for delivery with a copy of the informational material provided by the Department, entitled “Important Information for Parents” prior to collection of the blood specimen if such information has not been provided pursuant to Section 6504. If a woman is unable to read such material, it shall be translated or read to her in a language she understands.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6504.4. Specimen Collection Forms.

Note • History

(a) Department approved specimen collection forms shall not be copied, printed, reproduced, acquired, purchased or distributed other than as provided for in this Group.

(b) Such Department approved specimen collection forms shall be fully and accurately completed by birth attendants, perinatal licensed health facilities and laboratories; and a copy shall be filed in each newborn's medical record.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6504.6. Record Maintenance.

Note • History

Perinatal licensed health facilities shall maintain such records as are necessary to assure compliance with this Group and provide the Department with such data as may be periodically required including, but not limited to, information on all newborns discharged or transferred from the facility without collection of a blood specimen. All such information and records shall be confidential, but shall be open to examination by the Department personnel or its designated agents for any purpose directly connected with the administration of the newborn screening program.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6505. Collection of Specimens.

Note • History

(a) Birth attendants, laboratories and hospitals shall collect specimens using the technique for blood collection distributed by the Department.

(b) Physicians or birth attendants who are caring for newborns born in perinatal licensed health facilities shall have blood specimens collected using Department-approved specimen collection forms in accordance with criteria distributed by the Department including the following:

(1) A specimen must be collected from any untested infant prior to blood transfusion.

(2) For newborns discharged before six days of age, a blood specimen shall be obtained as close to the time of discharge from the perinatal licensed health facility as is practical regardless of age or feeding history, unless the newborn is transferred for continuing care to another perinatal licensed health facility on or before the sixth day of age. Perinatal licensed health facilities which discharge infants before 24 hours of age may request a waiver from this requirement documenting how such newborns will be tested on or before 6 days of age. Such alternative testing schedules must be approved in writing by the Department.

(3) For newborns remaining in perinatal licensed health facilities beyond five days of age, a blood specimen shall be obtained from the newborn on the sixth day of age regardless of feeding history.

(4) For newborns received by transfer on or before six days of age, the receiving hospital shall obtain a blood specimen as close to discharge as possible, and if not discharged by the sixth day, a blood specimen shall be obtained on the sixth day of life.

(c) For newborns not born in a perinatal licensed health facility but admitted to a perinatal licensed health facility within the first six days of age, a specimen shall be obtained as close to discharge as possible, and if not discharged by the sixth day of life, a blood specimen shall be obtained on the sixth day of life unless the newborn's physician has evidence that the specimen was previously obtained and records the results of the test in the newborn's medical record.

(d) For newborns not born in a perinatal licensed health facility but admitted to a perinatal licensed health facility after six days of age but within the first 30 days of age, a blood specimen shall be obtained within 48 hours after admission unless the newborn's physician has evidence that the specimen was previously obtained and records the results of the test in the newborn's medical record.

(e) Physicians attending sick newborns who exhibit symptoms suggestive of galactosemia, hypothyroidism or phenylketonuria (PKU), in addition to immediate diagnostic tests from local laboratory sources, shall have a blood specimen collected from the newborn and submitted to a newborn screening laboratory using forms purchased from the Department.

(f) Physicians attending critically ill newborns who require special care may postpone collection of a blood specimen until the newborn's emergency life threatening condition is stabilized.

(g) Birth attendants or physicians attending newborns not born in a perinatal licensed health facility and not subsequently admitted to a licensed health facility during the first six days of age, shall have a blood specimen collected from the newborn between the second and sixth days of age and submitted to a newborn screening laboratory using forms obtained from the Department.

(h) If a newborn is born outside of a perinatal licensed health facility and the birth is not attended by a birth attendant and the newborn is not subsequently admitted to a perinatal licensed health facility within the first ten days of age, the person required to register the birth shall arrange for a blood specimen to be collected and submitted to a newborn screening laboratory between the second and tenth day of age.

(i) Initial specimens shall be collected using a Department-approved form and shall be placed in the United States mail or other approved channel of transmittal to the assigned Department-approved laboratory as soon as possible, but not later than 12 hours after they are obtained.

(j) The blood specimen and information obtained during the testing process becomes the property of the State and may be used for program evaluation or research by the Department or Department-approved scientific researchers without identifying the person or persons from whom these results were obtained, unless the person or his/her legally authorized representative specifically prohibits such use in writing.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15). For history of former section, see Registers 78, No. 34 and 74, No. 18.

2. Amendment of subsection (i) filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed on 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).

4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

5. Amendment of subsections (b), (c), (f) and (i), and new subsection (j) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).

6. Change without regulatory effect amending Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506. Medical Record Review.

Note • History

(a) Perinatal licensed health facilities shall review each newborn's medical record within 14 days from the date of discharge to determine that the results of required tests are filed in the newborn's medical record, or that a parent's or legal guardian's signed refusal has been filed in the newborn's medical record.

(b) Whenever a perinatal licensed health facility determines that a specimen has been obtained, but there are no results available in the newborn's medical record the facility shall send written notification within five days to the Department.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. New Section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).

2. Repealer and new section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

3. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506.2. Newborns Discharged from a Perinatal Licensed Health Facility Without Testing.

Note • History

(a) Whenever a perinatal licensed health facility determines that a discharged newborn has not received the mandated tests, the facility shall contact the newborn's physician by telephone to inform him/her that a specimen must be obtained and immediately send written notification to the newborn's physician and the Department. If the newborn's physician cannot be contacted or will not obtain a specimen, the perinatal licensed health facility shall notify the Department-approved Newborn Screening Area Service Center by telephone and shall send written notification within five days to the Newborn Screening Area Service Center and the Department.

(b) When the newborn's physician is notified by telephone by the perinatal licensed health facility that a newborn was discharged from the perinatal licensed health facility before a specimen was taken, the newborn's physician shall make every reasonable effort to have a specimen obtained within five days of notification. If the newborn's physician cannot obtain the specimen, the Newborn Screening Area Service Center shall be notified by the newborn's physician by telephone. Such telephone notification shall be noted in the newborn's physician's records, specifying the date of notification, the person notified and the information provided.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506.6. Follow-Up to Reports of Inadequate Specimen.

Note • History

When the newborn's physician is notified by the laboratory by telephone that a specimen is inadequate, the physician so notified shall make every reasonable effort to have an adequate specimen obtained within five days of notification. If the newborn's physician so notified, cannot obtain the repeat specimen, the physician shall notify the Newborn Screening Area Service Center as soon as possible by telephone. Such telephone notification shall be noted in the newborn's physician's records specifying the date of notification, the person notified and the information provided.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506.8. Follow-Up to Reports of Initial Positive Result.

Note • History

When the newborn's physician is notified by telephone by the Department-approved Newborn Screening Area Service Center of an initial positive test result, the newborn's physician shall obtain an adequate recall blood specimen from the newborn and submit it to the designated laboratory within 48 hours. If the recall blood specimen cannot be obtained within 48 hours, the newborn's physician shall notify the Newborn Screening Area Service Center by telephone. Such telephone notification shall be noted in the newborn's physician's records, specifying the date of notification, the person notified and the information provided.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506.10. Repeat and Recall Specimen Collection and Transmittal.

Note • History

Repeat and recall specimens required by this Group shall be collected on Department approved forms, placed in appropriate containers, and shall be placed in the United States mail or other approved channel of transmittal to the assigned Department-approved laboratory as soon as possible, but not later than 12 hours after they have been obtained.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6506.12. Diagnosis Reporting.

Note • History

All physicians making an initial diagnosis of a preventable heritable disorder for which testing is required under this Group shall report such diagnosis and provide the information necessary for follow-up and investigation to the Department.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507. Failure to Comply.

Note • History

Willful or repeated failure to comply with this Group shall be referred by any person having knowledge of non-compliance to the appropriate licensing authority. Failure to report may constitute grounds for disciplinary action including revocation of license.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 124985 and 125000, Health and Safety Code.

HISTORY

§6507.1. Local Agency Responsibilities.

Note • History

(a) The county registrar of births shall provide a copy of the informational material prepared and provided by the Department to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility when the said newborn was not admitted to a perinatal licensed health facility within the first 30 days of age. The local health officer and the Department shall be notified of each such registration by the county registrar.

(b) Each local health department in the county where a newborn resides shall be responsible for making every reasonable effort to obtain specimens when requested by the Department-approved Newborn Screening Area Service Center or the Department. If after every reasonable effort a specimen cannot be obtained, the local health department may, after 30 days, with approval from the Department, terminate efforts.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980 and 125000, Health and Safety Code.

HISTORY

1. Renumbering of former Section 6507 to Section 6507.1 filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4). For prior history, see Register 86, No. 47.

2. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

3. Editorial correction of section heading (Register 2006, No. 44).

Article 3. Sickle Cell Programs

§6507.2. Sickle Cell Education and Counseling Program Requirements.

Note • History

(a) Each sickle cell education and counseling program shall apply for and obtain written approval from the Department of Health Services. Such approval shall be contingent upon compliance with all sections of this Group.

(b) Each sickle cell education and counseling program shall:

(1) Provide counseling services to the clients.

(2) Employ State-approved sickle cell counselors to perform all of the counseling following, or relating to, any abnormal hemoglobinopathy finding.

(3) Demonstrate, upon request by the Department of Health Services, that each of its counselors successfully participates in State-approved educational programs which serve to update the knowledge and enhance the proficiency of such counselors.

(4) Have a physician with special training and experience in pediatric hematology to serve as medical director or consultant to order and interpret laboratory tests used in counseling.

(5) Have written protocols to protect the confidentiality and security of all records containing personal information.

(6) Use only State-approved educational materials.

(7) Use any laboratory that meets the Department's standards for sickle cell hemoglobin testing.

NOTE

Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).

2. Change without regulatory effect adding article 3 heading and amending section heading, subsection (a) and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507.3. Certification of a Sickle Cell Counselor.

Note • History

(a) A sickle cell counselor shall obtain a certificate of approval from the Department of Health Services upon presentation of written evidence that he or she has:

(1) Completed a course at a sickle cell counselor training center approved by the Department with such center's endorsement of his or her ability to function as a sickle cell counselor, and/or

(2) Successfully completed an examination or examinations which demonstrate his or her knowledge or expertise in the field, and one or more personal interviews to demonstrate an understanding of, and ability to communicate with persons who have sickle cell disease or sickle cell trait.

(b) All sickle cell counselors must provide documentation of completion of State-approved training to update skills and knowledge on an annual basis.

NOTE

Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 125000, 125025 and 125030, Health and Safety Code.

HISTORY

2. Repealer of section 6507.3 and renumbering of section 6507.4 to section 6507.3 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending section heading and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507.4. Voluntary Participation.

Note • History

Participation by any person in a sickle cell education and counseling program in which medical information is obtained through interview, test or other ascertainment procedure shall be wholly voluntary and shall not be a prerequisite to eligibility for, or receipt of, any other services or assistance from, or to participation in any other program.

NOTE

Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

HISTORY

2. Renumbering of section 6507.4 to section 6507.3 and renumbering of section 6507.5 to section 6507.4 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507.5. Informed Consent.

Note • History

(a) A sickle cell education and counseling program shall obtain informed consent from each adult upon whom testing or any other screening procedure is to be performed. If the person is a minor other than a newborn, informed consent shall be obtained from such child's parent or guardian. An informed consent shall be obtained from an emancipated minor without the need for parent or guardian consent.

(b) The informed consent shall be in writing in format approved by the Department and shall be signed by the person, by his or her guardian or, except in the case of an emancipated minor, by his or her parent.

NOTE

Authority cited: Section 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

HISTORY

2. Renumbering of section 6507.5 to section 6507.4 and renumbering of section 6507.6 to section 6507.5 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

4. Editorial correction of History 2 (Register 95, No. 18).

5. Change without regulatory effect amending Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507.6. Approval of Hemoglobin Testing Laboratories.

Note • History

(a) All laboratories that accept specimens from an approved sickle cell counseling program shall be in compliance with the Business and Professions Code governing licensed clinical laboratory operations and personnel (commencing with Section 1200 of the Business and Professions Code) or be an approved public health laboratory operated in accordance with the California Health and Safety Code, Section 101150 et seq.

(b) All laboratories involved in sickle cell screening as specified in this Article shall use a test or combination of tests with demonstrated ability to distinguish hemoglobins including F, A, S, C, D, and E, as well as the thalassemias.

(c) The State Department of Health Services shall have the responsibility of monitoring sickle cell screening laboratories coming under the scope of this Article. Such monitoring may be accomplished by on-site inspections and proficiency testing, or any other effective method. The Department may deny, revoke, or suspend the approval of any laboratory which does not comply or continue to comply with the above qualifications.

NOTE

Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

HISTORY

2. Renumbering of section 6507.6 to section 6507.5 and renumbering of section 6507.7 to section 6507.6 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6507.7. Sickle Cell Trait Carrier Follow-Up Vendor.

Note • History

(a) A sickle cell trait follow-up vendor shall mean any sickle cell education and counseling program that:

(1) Is approved under this Group, and

(2) Signs a vendor agreement to provide services in accordance with Department policies, including a fee schedule provided by the Department. The Department may obtain and provide reimbursements for any or all follow-up services authorized as a result of newborn sickle cell screening from such approved vendors.

NOTE

Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

HISTORY

1. Renumbering of section 6507.7 to section 6507.6 and new section filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

3. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Article 4. Newborn Screening Participation Fee

§6508. Newborn Screening Fee Collection.

Note • History

(a) Perinatal licensed health facilities and birth attendants shall obtain from the Department a sufficient supply of specimen collection forms to permit collection of a blood specimen from each newborn required to be tested under this Group.

(b) The Department shall collect a fee for each specimen record form provided and a program participation fee for all services provided. The fee for a specimen form shall be $1 and for program services shall be $101.75 except for a comprehensive prepaid group practice direct health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available, which elects to provide testing, follow-up and/or counseling services to its members. The fee for such plans shall be equal to the Department's cost of administration of the newborn screening program, to be determined by reducing the $101.75 program service fee by the annual statewide average per infant contracted cost of laboratory testing, follow-up and/or counseling services rendered during the previous fiscal year. In order to qualify for this special fee a medical group serving a comprehensive prepaid group practice direct care service plan with 20,000 or more births shall sign a written agreement which contains the same standards and conditions, except as to payment or where specifically waived, as are applicable to the newborn screening laboratories and Newborn Screening Area Service Centers, adhere to the regulations governing the program, and to submit to monitoring and evaluation of compliance. Failure to comply with these conditions after being given written notification and 30 days to correct deviations shall result in loss of the option. In the event the option is lost the State shall designate appropriate contractors to provide services.

The provisions of this section shall apply even if the newborn is part of a State-approved demonstration project.

(c) Birth attendants and physicians attending newborns who are under six days of age and who were not born in perinatal licensed health facilities and not subsequently admitted to perinatal licensed health facilities shall obtain a sufficient supply of specimen record forms to permit collection or shall arrange for a collection of a blood specimen from each such newborn attended.

(d) Birth attendants and physicians attending newborns and perinatal licensed health facilities shall not charge parents or third parties responsible for medical care coverage fees for participation in the newborn screening program in addition to those specified in this section, except for reasonable fees for costs of blood specimen collection and handling which shall not exceed $6.

(e) The perinatal licensed health facility shall make available to the responsible physician, at no additional charge, specimen collection services or a specimen record form for obtaining either a repeat specimen for an inadequate specimen or a specimen on a newborn discharged without the test having been obtained.

(f) Birth attendants and physicians submitting a blood specimen for newborn screening on a form other than those approved by the Department shall be charged a handling fee of $5 in addition to the usual fee for program services and specimen record form specified in (b) above for each such specimen.

NOTE

Authority cited: Sections 124977, 124996, 125000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 124977, 124996, 125000 and 125001, Health and Safety Code.

HISTORY

1. New section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).

2. Amendment filed 12-6-90 as an emergency print only; operative 12-6-90 (Register 91, No. 14). A Certificate of Compliance must be transmitted to OAL by April 5, 1991, or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 12-6-90 order transmitted to OAL 3-19-91 and filed 4-8-91 (Register 91, No. 19).

4. Amendment filed 8-7-91 by the Department of Health Services with the Secretary of State, operative 8-7-91. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 309 (Register 91, No. 50).

5. Amendment of subsection (b) filed 6-30-92 with Secretary of State by the Department of Health Services; operative 7-1-92. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code sections 289.7(b) and 309(h) (Register 92, No. 27).

6. Certificate of Compliance as to 6-30-92 order transmitted to OAL 10-20-92 and filed 11-20-92 (Register 92, No. 47).

7. Editorial correction of History 5. (Register 92, No. 47).

8. Amendment of subsections (b) and (f) and amendment of Note filed 6-6-97 as an emergency; operative 6-6-97 (Register 97, No. 24). This regulatory action is deemed an emergency exempt from OAL review and was filed directly with the Secretary of State pursuant to Health and Safety Code section 125000(h). These amendments shall remain in effect until revised or repealed by DHS pursuant to Health and Safety Code section 125000(j).

9. Amendment of subsection (b) and Note filed 12-28-2001 as an emergency; operative 12-28-2001 (Register 2001, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-29-2002 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 12-28-2001 order transmitted to OAL 4-9-2002 and filed 5-16-2002 (Register 2002, No. 20).

11. Amendment of subsection (b) and amendment of Note filed 6-28-2002 as an emergency; operative 6-28-2002 (Register 2002, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-28-2002 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 6-28-2002 order transmitted to OAL 10-25-2002 and filed 12-2-2002 (Register 2002, No. 49).

13. Amendment of subsection (b) and Note filed by the Department of Health Services with the Secretary of State 12-31-2004 as an emergency; operative 12-31-2004 (Register 2005, No. 1). Compliance with Health and Safety Code section 124977 must be completed by 5-2-2005. Pursuant to Health and Safety Code section 124977, this amendment is exempt from OAL review and was submitted for printing only.

14. Compliance with Health and Safety Code section 124977(d)(1) as to 12-31-2004 order filed 4-29-2005. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing pursuant to Government Code section 11343.8 (Register 2005, No. 20).

15. Change without regulatory effect adding article 4 heading and amending section heading and section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

16. Amendment of subsection (b) and amendment of Note filed as an emergency by the Department 9-7-2007; operative 9-7-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 124977 (Register 2007, No. 42).

17. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 9-7-2007 order filed 4-2-2008. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing pursuant to Government Code section 11343.8 (Register 2008, No. 14).

18. Editorial correction of Histories 13 and 14 (Register 2008, No. 15).

§6510. Rhesus (Rh) Hemolytic Disease of the Newborn.

Note • History

NOTE

Authority cited: Sections 151, 208 and 306(b), Health and Safety Code. Reference: Sections 304, 305 and 306, Health and Safety Code.

HISTORY

1. New section filed 3-16-70; effective thirtieth day thereafter (Register 70, No. 12).

2. Amendment of subsection (a)(1) filed 2-2-71; effective thirtieth day thereafter (Register 71, No. 6).

3. Editorial correction filed 11-5-84 (Register 84, No. 45).

4. Change without regulatory effect renumbering former section 6510 to section 6529 filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Group 5. Prenatal (Multiple Marker) Testing Program

Article 1. Definitions

§6521. Alpha-Fetoprotein.

Note • History

“Alpha-fetoprotein” means the protein substance in maternal serum and amniotic fluid, the concentration of which is tested to determine the probability that the fetus has a neural tube defect. For the purpose of this Group, alpha-fetoprotein may be abbreviated and referred to as “AFP,” maternal serum alpha-fetoprotein may be abbreviated and referred to as “MS-AFP,” and amniotic fluid alpha-fetoprotein may be abbreviated and referred to as “AF-AFP.”

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050 and 125070, Health and Safety Code.

HISTORY

1. New article 2 (sections 6521-6529, not consecutive) filed by the Department of Health Services with the Secretary of State on 4-7-86 as an emergency; effective upon filing. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 86, No. 16).

2. Amendment of subsection (h) filed by the Department of Health Services with the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88 and filed 11-18-88 (Register 88, No. 48).

4. New subsections (n)-(n)(3) and amendment of Note filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).

6. Amendment of subsection (n)(1), new subsections (n)(2) and (n)(4), subsection renumbering and amendment of Note filed 10-1-92 as an emergency; operative 10-1-92 (Register 92, No. 40). Submitted to OAL for printing only pursuant to Government Code section 11343.8.

7. Certificate of Compliance as to 10-1-92 order filed 3-3-92 (Register 93, No. 10).

8. Amendment of section and Note filed 6-14-96 as an emergency; operative 6-14-96. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 96, No. 24).

9. Editorial correction of History 8 (Register 97, No. 12).

10. Amendment of subsection (p)(1) filed 3-14-97 by the Department of Health Services with the Secretary of State; operative 3-14-97. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 12).

11. Amendment of subsection (e) filed 9-25-97; operative 9-25-97. Submitted to OAL for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 39).

12. Change without regulatory effect adding group 5 heading, renumbering former article 2 to new article 1, and amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.3. Analyte.

Note • History

“Analyte” means any constituent or substance the concentration of which is related to the presence of a birth defect and is analyzed and reported by prenatal screening laboratories as part of a Departmentally provided or administered prenatal screening program including alpha-fetoprotein, human chorionic gonadotrophin and estriol.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.5. Birth Defect.

Note • History

“Birth defect” means any functional or structural defect caused by failure or error in the development of a fetus that is capable of being prenatally detected and for which the Department has provided a surveillance or screening program including neural tube defects, ventral wall defects, and chromosomal defects.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.7. Clinician.

Note • History

“Clinician” means physician, physician assistant, nurse midwife, nurse practitioner or any other person licensed or certified by the State to provide prenatal care to pregnant women or to practice medicine.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.9. Differential Diagnostic Screening Tests and Procedures.

Note • History

“Differential diagnostic screening tests and procedures” means those additional screening tests, methods, examinations or activities which are performed consequent to a positive blood screening test and which are used to distinguish between the presence of a birth defect of the fetus and other causes of positive blood screening tests.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.11. Expanded AFP Follow-Up Vendor.

Note • History

“Expanded AFP follow-up vendor” means any facility, clinic, institution, health maintenance organization, or physician that:

(a) Submits documentation verifying that it meets the standards published by the Department for approval as a comprehensive prenatal diagnosis center entitled: Prenatal Diagnosis Center Standards and Definitions 1997. This document in its entirety is hereby incorporated by reference in this section;

(b) Has had the documentation verified by a state visit; or

(c) Has had experience in the provision of follow-up of women with abnormal MS-AFP results as defined by California's MS-AFP Program prior to April 1, 1992; and

(d) Receives notification of approval as a Prenatal Diagnosis Center; and

(e) Signs a vendor agreement to provide such services in accordance with Department policies including a fee schedule published by the Department entitled: Vendor Agreement March 1, 1996, and incorporated by reference herein. The Department may obtain and provide reimbursement for any or all follow-up services authorized as the result of MS-AFP screening from any or all such approved vendors.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.13. Expanded AFP Prenatal Birth Defects Screening Laboratory.

Note • History

“Expanded AFP prenatal birth defects screening laboratory” means a laboratory approved by the Department to conduct prenatal screening laboratory tests to determine the concentration of analytes and perform other analysis related to birth defects specified as part of state administered testing.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.15. Expanded AFP Prenatal Screening for Birth Defects.

Note • History

“Expanded AFP prenatal screening for birth defects” means the sequence of screening tests of initial and repeat blood tests and, where medically indicated, differential diagnostic screening tests and procedures authorized by the Department and provided by Department-approved vendors.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.17. Gestational Age.

Note • History

“Gestational age” means the number of days elapsed since the first day of the last normal menstrual period. Gestational age may be calculated as the number of days from known or suspected conception plus 14 days or estimated by ultrasound examination and measurements.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.19. Inadequate Specimen.

Note • History

“Inadequate specimen” means a blood specimen collected from a pregnant woman which is not suitable in quality or quantity, was collected before the 105th or after the 140th day of gestation, or was not documented with the clinical information necessary for test result interpretation to perform valid prenatal screening for birth defects of the fetus.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.21. Initial Screening Positive Test.

Note • History

“Initial screening positive test” means an initial screening test of a specimen which gives a positive result for reporting purposes pursuant to this Group.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.23. Initial Specimen.

Note • History

“Initial specimen” means the first adequate specimen collected from a pregnant woman pursuant to this Group.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.25. Method.

Note • History

“Method” means the instruments, devices, reagents, steps and procedures used in a laboratory to measure the concentration of analytes in samples of maternal serum or amniotic fluid.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.27. Neural Tube Defect.

Note • History

“Neural tube defect” means any malformation caused by failure of the developing spine and skull to properly close. Examples are spina bifida and anencephaly.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.29. Prenatal Diagnosis Center.

Note • History

“Prenatal diagnosis center” means any facility in California which is approved by the Department to provide differential diagnostic tests and procedures for the prenatal evaluation or detection of genetic diseases, disorders, and birth defects of the fetus.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.31. Repeat Specimen.

Note • History

“Repeat specimen” means a blood specimen collected from a pregnant woman following the screening laboratory report that a previously collected blood specimen was either an inadequate specimen or that the screening test results were positive or inconclusive.

NOTE

Authority cited: Sections 124980, 125000 and 125070, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125065 and 125070, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Article 3. Testing and Follow Up Program Requirements

§6523. Expanded AFP Prenatal Birth Defects Screening Laboratories and Analytical Methods.

Note • History

(a) The Department shall approve Expanded AFP prenatal birth defects screening laboratories. Such laboratories shall be licensed as clinical laboratories under Division 2, Chapter 3 (commencing with Section 1200) of the Business and Professions Code.

(b) Approved Expanded AFP prenatal birth defects screening laboratories shall be limited to the following:

(1) A laboratory that shall have obtained a contract from the Department under applicable laws and regulations to provide laboratory services in sufficient volume to provide the prenatal birth defects screening test to all pregnant women in a designated geographic area defined by the Department, plus an emergency testing capacity that will be specified by contract. The Department will define not more than 6 geographic areas and may combine geographic areas if necessary to reduce costs or assure statewide coverage.

(2) A laboratory exclusively serving a comprehensive prepaid group practice or health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may be approved for testing consistent with the terms of a mutually acceptable contract for services.

(c) Expanded AFP prenatal birth defects screening laboratories approved by the Department shall comply with all laboratory standards for quality assurance issued by the Department and shall participate in a proficiency testing program approved and/or conducted by the Department and shall maintain levels of performance acceptable to the Department.

(d) Analytical methods to be used in the measurement of each analyte concentration in maternal serum shall be designated and/or approved by the Department.

(e) Analytical methods to be used in the measurement of the analyte concentration in amniotic fluid, and other adjunctive tests performed on amniotic fluid shall be designated and/or approved by the Department.

NOTE

Authority cited: Sections 125000(e) and 125070, Health and Safety Code. Reference: Sections 124980, 125000(e) and 125070, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services with the Secretary of State on 4-7-86 as an emergency; effective upon filing. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 86, No. 16).

2. Amendment of section heading, section and Note filed 6-14-96 as an emergency; operative 6-14-96. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 96, No. 24).

3. Editorial correction of History 2 (Register 97, No. 12).

4. Repeal of subsections (b)(3) and (f) filed 3-14-97 by the Department of Health Services with the Secretary of State; operative 3-14-97. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 12).

5. Amendment of subsection (b)(2) filed 9-25-97; operative 9-25-97. Submitted to OAL for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 39).

6. Change without regulatory effect adding article 3 heading filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6525. Prenatal Diagnosis Centers and Laboratories.

Note • History

The Department shall approve prenatal diagnosis centers and prenatal diagnosis methods and Expanded AFP Birth Defect Screening Laboratories and laboratory methods and shall institute such quality control and proficiency testing as is necessary to assure the accuracy of testing. No laboratory shall offer or provide prenatal birth defect screening diagnostic tests on California residents without having obtained prior approval from the Department.

NOTE

Authority cited: Sections 125050, 125055 and 125070, Health and Safety Code. Reference: Sections 124980, 125000 and 125070, Health and Safety Code.

HISTORY

3. Editorial correction of History 2 (Register 97, No. 12).

§6527. Clinician Requirements.

Note • History

(a) Clinicians shall provide or cause to be provided to all pregnant women in their care before the 140th day of gestation, or before the 126th day from conception, as estimated by medical history or clinical testing, information regarding the use and availability of prenatal screening for birth defects of the fetus. This information shall be in a format to be provided or approved by the Department and shall be given at the first prenatal visit and discussed with each pregnant woman.

(b) The provisions of subsection (a) shall not apply if the pregnant woman has completed more than 140 days of gestation or 126 days post conception, as estimated by medical history or clinical testing, and this fact is entered in the medical record.

(c) Clinicians shall cause to be provided to all pregnant women who, after being provided with the information pursuant to subsection (a), voluntarily request prenatal screening for birth defects of the fetus, the opportunity, the circumstances of which are to be documented in the medical record, to read and sign an informed consent document in a format provided or approved by the Department.

(d) If the pregnant woman consents to testing, the clinician shall arrange for prenatal screening directly or by referral to another clinician by:

(1) Fully and accurately completing all required specimen collection forms provided by the Department for this purpose;

(2) Collecting or arranging for the collection of an initial specimen following state directions for collection provided;

(3) As soon as possible, but within 24 hours of collection, place or cause to be placed all initial and repeat specimens in the channel of transmittal to the designated Expanded AFP prenatal birth defects screening laboratory.

(e) Blood collection forms and blood collection and mailing kits supplied by the Department shall not be copied, printed, reproduced, acquired, purchased, substituted or distributed other than as specified for use in the Expanded AFP Prenatal Birth Defects Screening Program administered by the Department.

(f) When notified that a blood specimen is inadequate for testing, the clinician shall make a reasonable effort to have an adequate specimen obtained as soon as possible but not more than five (5) days after such notification.

(g) For each woman in their care who was prenatally screened for birth defects of the fetus and who has an initial screening positive test, the clinician shall:

(1) Inform the woman that authorized follow-up services are available at Expanded AFP Follow-up Vendors, and that the program participation fees or laboratory test fee covers the authorized services.

(2) Report on the form provided by the Department for this purpose, within 30 calendar days of the end of the pregnancy, the outcome of pregnancy and status of each fetus, or infant resulting therefrom.

(h) The test results shall be confidential so that such information shall only be released with the knowledge and specific written consent of the woman tested. Persons authorized by the Department to conduct and monitor screening and/or to provide and monitor differential diagnostic follow-up services shall be provided information without necessity of specific written consent.

(i) Recognizing the strict gestational and time limits wherein prenatal detection of birth defects of the fetus is feasible, clinicians shall make every reasonable effort to schedule screening and differential diagnostic tests and procedures appropriately with respect to the gestational dates of the pregnant woman.

(j) Willful or repeated failure to comply with these regulations shall be referred by any person having knowledge of noncompliance to the appropriate licensing authority.

NOTE

Authority cited: Sections 125000 and 125070, Health and Safety Code. Reference: Sections 124980 (b), (c), (d), (h), (j) and 125070, Health Safety Code.

HISTORY

2. New subsection (j) filed by the Department of Health Services with the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88 and filed 11-18-88 (Register 88, No. 48).

5. Amendment of section and Note filed 6-14-96 as an emergency; operative 6-14-96. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 96, No. 24).

6. Editorial correction of History 5 (Register 97, No. 12).

7. Amendment of subsections (a), (c), (d)(1) and (d)(2), repealer of subsection (e), subsection relettering, and amendment of newly designated subsection (g)(1) filed 3-14-97 by the Department of Health Services with the Secretary of State; operative 3-14-97. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 12).

8. Editorial correction of subsection (g) and Note (Register 97, No. 41).

9. Change without regulatory effect amending section heading filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6529. Rhesus (Rh) Hemolytic Disease.

Note • History

(a) Medical staffs of hospitals and physicians thereof shall in providing for the care of pregnant women determine that a blood specimen has been obtained for the determination of rhesus (Rh) blood type or shall obtain or cause to be obtained a blood specimen within 24 hours of termination of pregnancy whether by delivery or by spontaneous or therapeutic abortion for this purpose.

(b) All cases, or suspected cases of rhesus (Rh) hemolytic disease of the newborn, shall be reported to the Department of Health Services. Every patient diagnosed in any licensed hospital as having such condition shall be reported by the hospital on the form provided by the Department for this purpose. The hospital shall notify the physician making the diagnosis that such a report has been filed.

NOTE

Authority cited: Sections 124980 and 125000, Health and Safety Code. Reference: Sections 124980, 125075 and 125085, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services on 4-7-86 as an emergency; effective upon filing. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 86, No. 16).

2. Amendment of subsection (a) filed by the Department of Health Services with the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88 and filed 11-18-88 (Register 88, No. 48).

4. Amendment filed 8-7-91 by the Department of Health Services with the Secretary of State; operative 8-7-91. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 309 (Register 91, No. 50).

5. Amendment of subsection (a) filed 6-30-92 with Secretary of State by the Department of Health Services; operative 7-1-92. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code sections 289.7(b) and 309(h) (Register 92, No. 27).

6. Certificate of Compliance as to 6-30-92 order transmitted to OAL 10-20-92 and filed 11-20-92 (Register 92, No. 47).

7. Editorial correction of History 5. (Register 92, No. 47).

8. Amendment of subsections (a) and (b) and amendment of Note filed 6-6-97 as an emergency; operative 6-6-97 (Register 97, No. 24). This regulatory action is deemed an emergency exempt from OAL review and was filed directly with the Secretary of State pursuant to Health and Safety Code sections 125000(h) and 125070(b). These amendments shall remain in effect until revised or repealed by DHS pursuant to Health and Safety Code sections 125000(j) and 125070(c).

9. Amendment of subsection (a) and amendment of Note filed 2-26-98 as an emergency; operative 2-26-98 (Register 98, No. 10). Submitted to OAL for printing only pursuant to Health and Safety Code section 125000.

10. Change without regulatory effect repealing former section 6529 and renumbering former section 6510 to new section 6529, including amendment of section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6531. Reporting of Neural Tube Defects.

Note • History

(a) All cases of neural tube defect in a fetus or an infant under one year of age shall be reported to the Department.

(b) This report shall be made:

(1) By the health facility in which the case is initially diagnosed;

(2) By the physician making the initial diagnosis if the case is not diagnosed in a health facility;

(3) Within 30 calendar days of the initial diagnosis;

(4) On the form to be provided by the Department for this purpose.

NOTE

Authority cited: Section 125070, Health and Safety Code. Reference: Section 125070, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services with the Secretary of State on 10-9-85 as an emergency; effective upon filing. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 85, No. 45).

2. Change without regulatory effect amending subsection (a) and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6532. Reporting of Chromosomal Disorders.

Note • History

(a) All cases of Down's syndrome or other chromosomal defects in a fetus or an infant under one year of age shall be reported to the Department. Chromosomal defects shall mean any abnormality in structure or number of chromosomes.

(b) This report shall be made:

(1) by the cytogenic laboratory performing the chromosomal analysis or by the physician making the diagnosis;

(2) within 30 calendar days of the initial diagnosis;

(3) on a form to be provided by the Department for this purpose.

NOTE

Authority cited: Section 125000, Health and Safety Code. Reference: Section 125000, Health and Safety Code.

HISTORY

1. New section filed by the Department of Health Services with the Secretary of State on 2-24-89 as an emergency; operative on 3-1-89. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 89, No. 10).

2. Change without regulatory effect amending Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Article 4. Prenatal Screening Fee Collection

§6540. Program Participation Fee.

Note • History

The all-inclusive program participation fee for maternal serum alpha fetoprotein, used as a single marker to screen neural tube defects only, shall be $57. The all-inclusive program participation fee for maternal serum alpha fetoprotein and one or more additional markers used for screening for NTD and Down Syndrome, shall be $162. The fee shall be paid to the Department by the woman being tested or by any third party which is legally responsible for her care including any health care service plan, managed health care plan, managed care plan, prepaid health plan or prepaid group practice health care service plan as defined in or licensed in accordance with Health and Safety Code Section 1340 et seq.

NOTE

Authority cited: Sections 124977, 124996, 125000(h), 125055, 125070 and 131200, Health and Safety Code. Reference: Sections 124996, 125000(b) and (f), 125001, 125050, 125060, 125065 and 131052, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting article 4 (sections 6540-6540.1) and section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

2. Change without regulatory effect amending section and Note filed 2-16-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 7).

3. Amendment of section and Note filed 9-23-2011 as an emergency; operative 9-23-2011 (Register 2011, No. 38). Pursuant to Health and Safety Code section 124977(d)(1), this regulation was submitted to OAL as a file and print only and was not subject to OAL review. Health and Safety Code section 124977(d)(2) provides this emergency amendment shall not be repealed by OAL and shall remain in effect until revised or repealed by the Department.

4. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 9-23-2011 order filed 1-26-2012. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing pursuant to Government Code section 11343.8 (Register 2012, No. 4).

§6540.1. Prepaid Group Practice Plan.

Note • History

Health care providers which contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership may provide, without contracting with the Department, any or all of the testing and counseling services required to be provided under this Group, if the services meet quality standards established by the Department and the plan pays that portion of a fee established under Section 6540 which is directly attributable to the Department's cost of administering the testing or counseling service and any required testing or counseling services provided by the state for plan members during the previous fiscal year. This option must be executed under terms of a written agreement. Payment by the plan shall be deemed to fulfill any obligation the provider or the provider's patient may have to the Department to pay a fee in connection with the testing or counseling service.

NOTE

Authority cited: Sections 124996, 125070 and 125000(h) and (j), Health and Safety Code. Reference: Sections 124996, 125000(b) and (f), 125001, 125050, 125055, 125060 and 125065, Health and Safety Code.

HISTORY

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Subchapter 10. Tuberculosis Screening of Employees and Volunteers in Private, Parochial and Nursery Schools

Article 1. Definitions

§6600. Employee.

Note • History

An employee of the school is a person on the school's payroll, part time or full time.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3450-3455, Health and Safety Code.

HISTORY

1. New Subchapter 10 (Sections 6600 through 6608) filed 4-3-68; effective thirtieth day thereafter (Register 68, No. 14).

§6601. Volunteer.

A volunteer is a person not on the school's payroll who meets the following criteria: (a) contributes time and services in support of the school's operation, (b) whose work is regularly scheduled by the school on a continuing basis at least once monthly, and (c) who works on the school premises during school hours.

§6602. Private and Parochial Schools.

Private and parochial schools are schools offering elementary and secondary daily education in any of the grades, kindergarten through twelfth.

§6603. Nursery School.

Nursery school is any school receiving and caring for one or more children of preschool age on a partial or full time basis.

§6604. Elementary School.

Elementary school is any school offering instruction in any of the grades kindergarten through eighth.

§6605. Secondary School.

Secondary school is any school offering instruction in any of the grades, ninth through twelfth.

§6606. Minimum Examination.

Minimum examination required is a chest X-ray or the approved skin test. If the tuberculin test is positive (10 mm. or over), it must be followed by a chest X-ray. Private physicians, local health departments or local Tuberculosis and Health Associations may provide these tests and X-rays.

§6607. Approved Skin Test.

Approved skin test is the intradermal Mantoux 5 TU (.0001 mgm) PPD.

Article 2. Records as Evidence of Compliance

§6608. Records as Evidence of Compliance.

A school will have satisfactorily complied with the requirements of the law if by two weeks after the opening of the school year the school administrator provides the local health officer with a statement certifying (a) the number of persons employed, (b) the number of volunteers, and (c) that the required certificate for each, signed by a physician licensed to practice medicine in California, or a notice from a public health agency or unit of the Tuberculosis and Health Association indicating freedom from active tuberculosis is on file and available for verification. Thereafter, the legal requirements will be met by obtaining the certificate prior to or within two weeks of date of employment, or acceptance of a volunteer, and repeating every two years.

Subchapter 11. First Aid and Cardiopulmonary Resuscitation Training Standards for Public Safety Personnel [Repealed]

HISTORY

1. Change without regulatory effect repealing subchapter 11 (articles 1-4, sections 6701-6722) filed 6-21-90 pursuant to section 100, title 1, California Code of Regulations (Register 90, No. 34).

Subchapter 12. Ambulance Personnel* [Repealed]

NOTE

Authority cited: Sections 208 and 1760, Health and Safety Code. Additional authority cited: Section 1760.5, Health and Safety Code. Reference: Sections 1760 and 1760.5, Health and Safety Code.

HISTORY

1. New subsection (c) filed 8-19-76 as an emergency; effective upon filing (Register 76, No. 34). For prior history, see Register 74, No. 52.

2. Certificate of Compliance filed 12-15-76 (Register 76, No. 51).

3. Repealer of Article 1 (Sections 6750-6752) and new Article 1 (Sections 6750-6752) filed 2-17-78; effective thirtieth day thereafter (Register 78, No. 7).

4. Repealer of Subchapter 12 (Sections 6750-6760, not consecutive) filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 39). For prior history, see Registers 78, No. 7, and 74, No. 52.

* Renumbered from Subchapter 11 (Register 74, No. 52).

Subchapter 13. Child Health and Disability Prevention Program

Article 1. Definitions

§6800. Health Assessment.

Note • History

(a) “Health assessment” means the following:

(1) A comprehensive health and developmental history, and a physical examination.

(2) Appropriate health screening procedures and immunizations.

(3) Evaluation of results in terms of needed diagnosis and treatment.

(4) Providing the person screened with a copy of the results and an explanation of their meaning.

(5) Health education appropriate to the person's age and health status, including anti-tobacco use education.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321.2, 324 and 24165.3, Health and Safety Code.

HISTORY

1. Repealer of Subchapter 13 (Sections 6800-6984, not consecutive) and new Subchapter 13 (Sections 6800-6874, not consecutive) filed 3-29-79; designated effective 5-1-79 (Register 79, No. 15). For history of prior subchapter, see Registers 75, No. 9; 75, No. 14; 75, No. 15; 75, No. 31; 76, No. 11; 76, No. 14; 76, No. 21; 76, No. 29; 76, No. 44; 76, No. 46; 76, No. 49.

2. Repealer and new section filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsection (a)(2) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

5. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

§6801. Community.

Note • History

“Community” means an individual county, or a city and county, or counties acting jointly, or a city which operates an independent health agency. In the instance of a city providing the services described in this subchapter, the powers granted a governing body of a county to operate a child health and disability prevention program shall be vested in the governing body of that city.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. New section filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6802. Community Child Health and Disability Prevention Program.

Note • History

(a) “Community child health and disability prevention (CHDP) program” means a community based and operated program of activities, approved and funded by the Department, necessary to comply with federal and state legislation and regulations that require:

(1) CHDP services to be made available to Medi-Cal beneficiaries from birth to 21 years of age, and to be reimbursed by the State.

(2) Health assessment and referral to diagnosis and treatment services to be made available to (1) children who are not Medi-Cal beneficiaries from birth until 90 days after entrance into the first grade, and (2) all persons under 19 years of age whose family income is not more than 200% of the federal poverty level. State reimbursement of the costs of health assessment and referral to diagnostic and treatment services for these children is limited by the amount of funds appropriated by the Legislature, and is made available only for those children who meet the age and family income criteria defined by the State Department of Health Services' Child Health and Disability Prevention Program.

(3) Children entering first grade to present a certificate within 90 days after entrance that they have received health assessment within the prior 18 months. A waiver signed by the child's parent or guardian indicating that they do not want or are unable to obtain such health assessment and evaluation services for their children shall be accepted in lieu of the certificate.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 320 and 24165.3, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (a)(2) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

§6804. Contract Counties.

Note

“Contract counties” means those counties which contract with the Department for health services and which have not elected to provide the services themselves. The Department is responsible for the child health and disability prevention programs in those counties.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

§6806. Department.

Note

“Department” means the State Department of Health Services.

NOTE

Authority cited: Sections 208, 320.2 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

§6808. Diagnosis.

Note • History

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. Repealer filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6810. Director.

Note

“Director” means the Director of the State Department of Health Services, unless otherwise specified.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

§6812. Governing Body.

Note

“Governing Body” means, except where indicated otherwise in this subchapter, the county board of supervisors, or boards of supervisors in the case of counties acting jointly or the city council in the case of a city.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320 et seq., Health and Safety Code.

§6813. Initiation of Treatment.

Note • History

“Initiation of treatment” means the first encounter for treatment of the medical and the dental problems disclosed during the health assessment.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.7, Health and Safety Code.

HISTORY

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6814. Medi-Cal Beneficiary.

Note • History

(a) “Medi-Cal beneficiary” means an individual under 21 years of age who is eligible for and certified to receive services under provisions of the California Medical Assistance Program (Chapter 7 of Part 3 of Division 9 of the Welfare and Institutions Code, beginning with Section 14000). Medi-Cal beneficiaries include:

(1) Persons who are certified eligible to receive cash grants under one of the public assistance programs.

(2) Persons who are certified eligible to receive medically needy or medically indigent Medi-Cal benefits.

(3) Other persons who are certified eligible to receive noncash grant Medi-Cal benefits. Other persons include the following:

(A) Children not in school and not in training.

(B) Persons receiving in-home supportive services.

(C) Persons who have lost AFDC eligibility, but are continuing to receive Medi-Cal benefits for four months from the date of lost eligibility.

(D) Persons who were discontinued from cash grants solely due to a 20 percent Social Security increase in 1977.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (a)(3)(C) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

§6816. Person.

Note

“Person” means anyone from birth to 21 years of age eligible to receive services specified in this subchapter. Persons include newborns, infants, children, youth, emancipated minors, young adults and adults. In those instances where the person is not an adult or an emancipated minor, “person” means the person, or his/her parent(s) or guardian(s).

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

§6817. Clinical Laboratory.

Note • History

“Clinical Laboratory” means a facility for examining and testing specimens for the purpose of obtaining scientific data which may be used to ascertain the presence, progress, and source of disease in human beings.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; Section 14105, Welfare and Institutions Code. Reference: Section 320, Health and Safety Code; Section 14132, Welfare and Institutions Code; and Section 655.6, Business and Professions Code.

HISTORY

1. New section filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

§6818. Screening.

Note • History

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. Repealer filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6819. Child Health and Disability Prevention Services in Contract Counties.

Note • History

The organizational unit within the Department which is responsible for health services in contract counties shall develop annual plans and budgets, and shall conduct a program which is acceptable to the Child Health and Disability Prevention Program, and which is in accordance with the provisions of this subchapter.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321.2, Health and Safety Code.

HISTORY

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

Article 2. Program Administration

§6820. Advisory Boards.

Note

(a) Membership. Membership in an advisory board shall be as follows:

(1) Members appointed to the local advisory board by the local governing body shall include, but not be limited to, individuals who, at the time of their appointment, are representatives of health professions concerned with child health, school health personnel and parents of children eligible to receive services under provisions of this subchapter, whether or not the services are eligible for state reimbursement.

(2) The governing body may recognize individuals as alternates who have professional or parent qualifications equivalent to that of the member.

(3) The governing body shall not appoint any employee of the local health department to the advisory board, except that the director and deputy director of the community child health and disability prevention program shall be ex officio, nonvoting members of the board.

(4) Individuals appointed to the advisory board as parents of children eligible to receive services shall neither be employed by an individual or an agency providing health services to the public for fee, nor be a provider of health services to the public for fee.

(b) Responsibilities. The local advisory board shall be responsible for the reviewing, advising and reporting functions related to the community child health and disability prevention program as specified in Section 321.7, Health and Safety Code. The advisory board may also advise the local governing body and appropriate governmental agencies on health matters additional to the community child health and disability prevention program, such as maternal and child health in general.

(c) Tenure. Members of the advisory board shall serve at the pleasure of the appointing authority for a term of three years, except that one-third of the members first appointed in each jurisdiction shall serve for three years, one-third of the members for two years and one-third of the members for one year.

(d) Meetings. The advisory board shall meet at least twice each year, once before March 1, and once after March 1 but before September 1. In addition, the board shall meet on the call of the chairperson of the board or on the call of one-third of its members. Public notice shall be given of the date, time and location of each meeting in advance of the meeting. Meetings shall be open to the public.

(e) Reimbursement. Advisory board members and alternates shall serve without compensation, except that members, and alternates when acting in lieu of members, shall be reimbursed under the approved community plan for actual and necessary expenses incurred in connection with the performance of their duties. Parent members may additionally be reimbursed for their actual and necessary costs of child care and lost wages.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321.7, Health and Safety Code.

§6822. Director and Deputy Director.

Note • History

(a) Designation. Each governing body, except those in contract counties whose programs are administered by the Department, shall appoint a physician, licensed to practice medicine in California, as Director, Child Health and Disability Prevention Program. The director shall have administrative responsibility for the organizational unit concerned with child health in the local health department as defined in Section 1102, Health and Safety Code. If the director is an existing health official, the director or local appointing authority shall also appoint a Deputy Director, Child Health and Disability Prevention Program, with experience in the delivery of health services to children and youth who is assigned to the organizational unit for which the Director, Child Health and Disability Prevention Program, has direct administrative responsibility.

(b) Responsibilities. The responsibilities of the director shall include, but not be limited to:

(1) Developing and implementing the community child health and disability prevention program plan and assuring its compliance with federal and state regulations. To the extent possible, this plan should relate to all community health services for children and youth, and to the integration and coordination of these services with the community's child health and disability prevention program.

(2) Managing funds granted under the state-approved community plan.

(3) Completing all reports and maintaining all records required by the Department.

(4) Providing support staff and services to the community child health and disability prevention advisory board.

(5) Preparing an annual report to the governing body.

(c) Reimbursement. The salary and necessary expenses of the community child health and disability prevention program director or deputy director may be reimbursed by the State under the approved community plan to the extent that the services are directly related to the community child health and disability prevention program. However, if the director is a health officer as defined in Sections 451, 502 or 940 of the Health and Safety Code, no funds from this program shall be used directly or indirectly for reimbursement of the health officer's services rendered to the program. If the director is an existing health official other than the health officer, the official's salary may be reimbursed to the extent the official renders services to the program as indicated in the program's approved annual plan and budget.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321(a) and 322, Health and Safety Code.

HISTORY

1. Amendment of subsections (a) and (c) filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6824. State and Local Responsibilities.

Note • History

(a) Annual plan and budget. On or before March 15 of each year, each governing body shall submit to the Department's Child Health and Disability Prevention Program the following:

(1) A summary of the previous fiscal year's activity ending the previous June 30.

(2) A summary of the current fiscal year's activity from the previous July 1 to the date of the revised budget submittal. A projection of activities from the date of the revised budget submittal through June 30 of the current fiscal year is desirable, but optional.

(3) A description of the community program to be offered the next fiscal year, including expected program performance goals and activities. Descriptive material submitted as part of a previously state-approved plan need not be repeated. If the community child health and disability prevention program plan is part of the community's more comprehensive child health plan, the more comprehensive plan may be submitted in lieu of a separate community child health and disability prevention program plan.

(4) A budget for the next fiscal year beginning July 1.

(A) The community child health and disability prevention program budget for the budget year shall be limited to those items, including equipment and remodeling, required to implement the plan approved by the Department's Child Health and Disability Prevention Program.

(B) If the amount appropriated in the State Budget Act and enacted into law for the budget year differs from the amount in the budget submitted by the Governor, each local governing body shall submit to the Department's Child Health and Disability Prevention Program an additional revised plan and budget that reflects the share of the reduction determined by the Director to be applicable to that community child health and disability prevention plan.

(5) A preliminary budget estimate for the following fiscal year beginning the following July 1.

(6) A current agreement between the community child health and disability prevention program and the county welfare department relating to the provision and documentation of child health and disability prevention services to Medi-Cal beneficiaries and setting forth the responsibilities of the community program and the county welfare department to assure adequate informing, outreach, referral and follow-up.

(7) Other information which may be required by the Department's Child Health and Disability Prevention Program.

(b) Informing Medi-Cal beneficiaries. Medi-Cal beneficiaries shall be informed as follows:

(1) No later than 60 days following the date of a family's initial Medi-Cal eligibility determination or of determination after a period of ineligibility, the family must be informed of the availability of CHDP services including dental services. This must be done in writing and using face-to-face contact by a person who can explain these services and benefits. A family who loses and regains eligibility more than twice within a twelve-month period need not be informed more than twice in that twelve-month period. Informing includes the offer of services, assistance with scheduling appointments and transportation, and documenting responses.

(2) If no member of an eligible family participates in the program, the family must be informed in writing at least once each year beginning October 1, 1980. Informing includes offering CHDP services, offering assistance with transportation and scheduling appointments, and documenting responses.

(3) Each of the following must be used to inform an eligible family:

(A) Clear, nontechnical materials for those families who are to be informed in writing.

(B) Procedures suitable for informing persons who are illiterate, blind, deaf, or cannot understand the English language.

(4) A family being informed about the program must be given the following information:

(A) The benefits of preventive health and dental services.

(B) How medical and dental services can be obtained.

(D) The health assessment and dental services that are offered.

(E) A summary of the State's periodicity schedule.

(F) That recipients can receive both initial and periodic health assessments and dental services according to the State's periodicity schedule.

(G) That treatment services shall be provided for problems disclosed during screening.

(H) That assistance in referral shall be provided.

(I) That assistance with transportation shall be provided if the person requests it.

(J) That assistance in scheduling appointments shall be provided if the person requests this assistance.

(K) That as long as the person remains eligible for Medi-Cal, he or she may request these services at any time in the future if the decision is postponed at the time of initial informing.

(L) That the person may choose to receive CHDP services from a provider of the person's choice, and that if the provider does not offer the full range of CHDP services specified in this subchapter, the person can receive the services not offered if the person makes a request to the community CHDP program or welfare department. If such request is made, assistance in scheduling appointments and transportation shall be offered, and the responses documented.

(M) That these CHDP services are available from approved providers at no cost to the family.

(c) Information and training for county welfare employees. Information and training for county welfare department personnel shall be as follows:

(1) The State Departments of Health Services and Social Services shall provide information, training and materials necessary to ensure that county social services and welfare eligibility personnel, and other appropriate welfare department employees, are fully informed as to the purpose, nature, scope and benefits of CHDP services.

(2) Such employees shall be trained in methods of information dissemination that will encourage and motivate eligible individuals to make use of such preventive medical programs.

(3) The provision of such training shall be verified in appropriate sections of the annual plans submitted to the Department's Child Health and Disability Prevention Program by community child health and disability prevention programs.

(d) Information and training for local health department personnel. Information and training for local health department personnel shall be as follows:

(1) The Department shall provide such information, training and materials necessary to ensure that appropriate local health department personnel and other appropriate county and municipal employees are informed as to the purpose, nature, scope and benefits of CHDP services.

(2) Such employees shall be trained in methods of information dissemination that will encourage and motivate eligible individuals to make use of such preventive medical programs.

(e) Required services. Each community child health and disability prevention program shall provide, in accordance with this subchapter, at least the following services:

(1) Outreach and health education, including anti-tobacco use education.

(2) Referral to dentist.

(3) Referral to a health assessment.

(4) Health assessment.

(5) Certification for school entry.

(6) Referral to diagnosis and treatment.

(7) Diagnosis and treatment.

(f) Records and information. Each community child health and disability prevention program shall keep records and provide information on the results of health assessments and follow-up to diagnosis and treatment, and other data about the persons served as may be required by the Department's Child Health and Disability Prevention Program.

(g) Other responsibilities. The Department shall provide the following:

(1) Regulations and minimum standards for quality preventive health services for children and youth, including anti-tobacco use education guidelines.

(2) Consultation services on all aspects of community program development.

(3) Appropriate data collection and reporting forms.

(4) Documentation and data, made available at the state or local level, on all aspects of the program including:

(A) The results of informing services.

(B) The results of screening services.

(D) The results of anti-tobacco education services.

(5) Management reports for state and local program use.

(6) Reports required by the federal Early Periodic Screening Diagnosis and Treatment Program.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 320, 321.2, 322.5, 324 and 24165.3, Health and Safety Code.

HISTORY

1. Repealer and new section filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (b)(1) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

4. Amendment of subsections (e)(1) and (g) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

5. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

§6826. State and Local Information and Training Responsibilities.

Note • History

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. Repealer filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6828. Sanctions for Noncompliance.

Note

(a) If the Chief of the State Child Health and Disability Prevention Program determines that a reasonable period of technical consultation and assistance has been provided or arranged for by the State Child Health and Disability Prevention Program, and further determines that a community child health and disability prevention program director fails to comply with any state or federal law or regulation governing child health and disability prevention services, or with the approved community plan, the Chief of the State Child Health and Disability Prevention Program shall notify the local governing body in writing of the specific areas of noncompliance. A copy of the notice shall be sent to the community program director, the county welfare department director, and to the local child health and disability prevention program advisory board.

(b) If the local governing body fails to provide substantial evidence to the Chief of the State Child Health and Disability Prevention Program within 30 days that the community program director is complying and shall continue to comply with the laws, regulations and the approved community plan, the Director shall convene a hearing for the community program to show cause why the Director should not take action to secure compliance. The Director shall invite the community child health and disability prevention program's advisory board and other persons or organizations interested in the community's child health and disability prevention program to present comments at such hearing. The Department shall give the community program, concerned individuals and organizations, and the general public at least 15 days notice of such hearing.

(c) The Director shall consider the case on the record established at the hearing and render findings and decision on the issues within 30 days following the hearing. The findings and decision shall be submitted in writing by the Director to the local governing body. A copy of the notice shall be sent to the community program director, the county welfare department director, and to the local child health and disability prevention program advisory board.

(d) If the Director determines that there is a failure on the part of the community child health and disability prevention program to comply with any state or federal law or regulation governing child health and disability prevention services, or the approved community plan, the Department may invoke any of the following sanctions:

(1) Consistent with federal and state law, withhold part or all of state and federal funds from such community until the local governing body provides written documentation of compliance to the Director.

(2) Bring an action in mandamus or such other action in court as may be appropriate to compel compliance.

(e) Nothing in this section shall be construed as relieving the local governing body of the responsibility to provide funds necessary to continue the child health and disability prevention services required by Sections 320, et seq., Health and Safety Code.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

Article 3. Eligibility for Services and Reimbursement

§6830. Eligibility for Services.

Note • History

(a) Medi-Cal beneficiaries shall be eligible for periodic health assessments, and for diagnosis and treatment, if necessary, in accordance with the provisions of this subchapter.

(b) Any child

(1) between birth and 90 days after entrance into the first grade who is not a Medi-Cal beneficiary and

(2) all persons under 19 years of age whose family income is not more than 200 percent of the federal poverty level shall be eligible for health assessments in accordance with the provisions of this subchapter. Availability of services and reimbursement for these services shall depend on the amount of funds appropriated by the Legislature for the services as specified in section 6832(b).

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 322.5, 323.7 and 24165.3, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (b) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

§6832. Eligibility for Reimbursement.

Note • History

(a) The costs of periodic health assessments provided to Medi-Cal beneficiaries shall be reimbursed by the State in accordance with the schedule of maximum allowances specified in section 6868.

(b) If the amount of funds appropriated in the State Budget Act are sufficient, the costs of health assessments provided to (1) children between birth and 90 days after entrance into the first grade, who are not Medi-Cal beneficiaries, and (2) all persons under 19 years of age whose family income is not more than 200 percent of federal poverty level shall be reimbursed by the State. To the extent that funds are not sufficient, these costs shall be reimbursed only for those children who meet the age and family income criteria defined by the Department's Child Health and Disability Prevention Program.

(c) The costs of diagnosis and treatment services provided to Medi-Cal beneficiaries as a result of health assessments shall be reimbursed by the State in accordance with the Medi-Cal fee schedules, subject to any applicable Medi-Cal program limitations.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 322.5, 323.2 and 24165.3, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

Article 4. Required Services

§6840. Required Services.

Note • History

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (a)-(e), Health and Safety Code.

HISTORY

1. Repealer filed 12-1-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6842. Outreach and Health Education.

Note • History

(a) Plan. Each community child health and disability prevention program shall develop, plan and implement community outreach and health education activities which are related to the community's needs and resources. Activities may include, but are not limited to, community organization, staff training, consultation with children and families, staff services to community child health and disability prevention program advisory boards, and the development and dissemination of informational and educational material for the public, potential users and providers of the program's services, advisory board members, local agencies and community groups.

(b) Outreach. An outreach program shall be as follows:

(1) Community child health and disability prevention programs shall develop outreach programs to involve persons in the use of preventive health services. Outreach and health education services shall be designed to ensure that the only reason eligible persons do not participate in the health assessment and referral for diagnosis and treatment portions of the program is because they intelligently and knowingly decline such participation for reasons unrelated to availability and accessibility of the health assessment, diagnosis and treatment services.

(2) In cooperation with the community child health and disability prevention program, the governing body of every school district or private school which has children enrolled in kindergarten shall, at the time the parent or guardian registers a child in kindergarten, inform the parents or guardians as follows:

(A) It is statutorily required that children provide, within 90 days after entrance into the first grade, either a certificate to the school documenting that within the prior 18 months the child has received the appropriate health assessment required by law, or a waiver signed by the parent or guardian indicating that they do not want or are unable to obtain such health assessments for their children.

(B) The health assessment that is required is available from the child's usual source of health care, the local health department, some schools and other places in the community.

(C) Rather than wait until the child actually enters first grade, it is advisable to get the health assessment as early as possible, preferably within six months prior to kindergarten entrance, at which time it is also required that the child's immunizations (a part of the total health assessment) be brought up to date.

(3) The parents or guardians of children entering the first grade who do not have documentation that the appropriate health assessment has been done or waived shall be informed by the school at that time as follows:

(B) The health assessment that is required is available from the child's usual source of health care, the local health department, some schools and other places in the community.

(c) Informing. Persons eligible to receive CHDP services shall be informed, using effective methods to involve them and in a language understandable to them, about the following:

(1) The value of preventive health services.

(2) Health assessments.

(3) The need for prompt diagnosis and appropriate treatment of suspected disabilities.

(4) The nature, scope and benefits of the Child Health and Disability Prevention Program.

(d) Health Education. Health education, including anti-tobacco use education, shall be an integral part of the health assessment.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321.2, 323.5, 324.2 and 24165.3, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (d) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

§6843. Referral to Dentist.

Note • History

(a) Availability.

(1) A direct referral to a dentist shall be made for eligible Medi-Cal beneficiaries three years of age and older unless dental services have been declined. The dental referral is for the purpose of diagnosis and treatment. Dental treatment consists of dental care needed for relief of pain and infections, restoration of teeth and maintenance of dental health.

(2) An inspection of the teeth, gums and mouth is part of the health assessment, and referral to a dentist shall be made if appropriate.

(b) Informing and training responsibilities. The provisions of Section 6824 also apply to the information and training responsibilities of the state and community child health and disability prevention programs regarding informing Medi-Cal beneficiaries of the availability of dental services, how the services may be obtained, and of the assistance available with transportation and scheduling appointments.

(c) Frequency. An annual referral to a dentist for dental services shall be offered each eligible Medi-Cal recipient three years of age and older. Dental providers, approved for participation in the Medi-Cal program, shall be reimbursed for diagnosis resulting from this annual referral, and for dental care needed for relief of pain and infections, restoration of teeth and maintenance of dental health.

(d) Offer of assistance with transportation and scheduling appointments. Medi-Cal beneficiaries shall be offered assistance with transportation and scheduling appointments for initial and periodic dental examinations. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary.

(e) Completion of referral. All reasonable steps shall be taken to ensure that Medi-Cal beneficiaries eligible to receive an initial or a periodic dental examination, and who request a referral, complete the referral. An initial dental examination shall normally be completed within 120 days from either the date the beneficiary requests the referral, or the date the beneficiary was certified eligible to receive Medi-Cal benefits, whichever occurs later. A periodic dental examination shall normally be completed within 120 days from either the date the beneficiary requests the referral, or the last day of the month in which the annual dental examination was due, whichever occurs earlier.

(f) Referral sources. The first source of referral for dental services shall be the person's usual source of licensed dental care. If no usual source of licensed dental care can be identified, the person shall be given, without prejudice for or against any one source, the names and locations of at least three sources of dental care, when available, which have been approved as providers of dental services by the California Medical Assistance Program. Although the family or recipient may choose to receive dental diagnostic and treatment services from a provider of its choice, to be eligible for state reimbursement, these services shall be provided by Medi-Cal approved providers and in accordance with the provisions of the California Administrative Code, Title 22, Division 3 and subject to any applicable Medi-Cal program limitations.

(g) Documentation. If initial or periodic dental services were not provided to a Medi-Cal beneficiary who had requested such services and who also had requested assistance with transportation or scheduling appointments for services, documentation must exist showing that the family or person lost eligibility, could not be located despite a good faith effort to do so, or the person's failure to receive the services was due to an action or decision by the family or person, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2, 322.7 and 323.7, Health and Safety Code.

HISTORY

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13). 3. Amendment of subsection (a)(1) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

3. Amendment of subsection (a) (1) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

§6844. Referral to Health Assessment.

Note • History

(a) The following shall apply to all persons eligible to receive health assessments under the provisions of this subchapter:

(1) All reasonable steps, including assistance in scheduling and completing appointments if requested, and in following up initial efforts, shall be taken to ensure that persons eligible to receive health assessments, and who request a health assessment, receive it.

(2) Appointments for requested health assessments shall be completed in a reasonable period of time, normally not to exceed 60 days.

(3) The first source of referral for a health assessment shall be the person's usual source of health care. Preference should be given to the comprehensive care provider. If no usual source of health care can be identified, the person shall be given, without prejudice for or against any one provider, the names and locations of at least three providers, when available, who have been approved as providers of health assessments by the community child health and disability prevention program director. The availability of health assessments directly from the clinic operated by the community program may also be made known to the person.

(4) Although a person may choose to receive a health assessment from a provider of the person's choice, to be eligible for state reimbursement, the health assessment shall be provided by providers who have been approved to bill the Department for these services.

(b) Additional to (a), above, the following shall apply to Medi-Cal beneficiaries who request health assessments:

(1) Medi-Cal beneficiaries shall be offered assistance with transportation and scheduling health assessment appointments. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary.

(2) If a person chooses to receive a health assessment from a provider that does not furnish the full range of services as specified in this subchapter, the community child health and disability prevention program shall, if requested, provide or arrange for provision of all such services that are not offered by that provider. At the time of the request, the person must be offered assistance with transportation and scheduling appointments. The response to this offer shall be recorded, and this assistance shall be provided if requested.

(3) If an initial or a periodic health assessment is not provided to a Medi-Cal beneficiary who requests such services and who also requests assistance with transportation or scheduling appointments for services, documentation must exist showing that the family or person lost eligibility, could not be located despite a good faith effort to do so, or the person's failure to receive the services was due to an action or decision by the family or person, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (d) and 323.7, Health and Safety Code.

HISTORY

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6846. Health Assessment.

Note • History

(a) Conditions. The following conditions apply to health assessments provided to eligible persons:

(1) A health assessment shall not be provided without the voluntary consent of the patient.

(2) A health assessment shall not be provided to minors without the prior and written consent of the minor's parent or guardian unless one or more of the following circumstances exist:

(A) The minor is emancipated.

(B) The minor is married.

(D) Provision of the service is exempted from parental consent by federal or state statute or regulation.

(b) Required screening procedures. Unless medically contraindicated or deemed inappropriate by the health assessment provider, or refused by the person, health assessments shall include the following procedures:

(1) Health and developmental history.

(2) Unclothed physical examination including assessment of physical growth.

(3) Assessment of nutritional status.

(4) Inspection of ears, nose, mouth, throat, teeth and gums.

(5) Vision screening.

(6) Hearing screening.

(7) Tuberculin testing and laboratory tests appropriate to age and sex, including tests for anemia, diabetes and urinary tract infections.

(8) Testing for sickle cell trait and lead poisoning where appropriate.

(9) Immunizations appropriate to age and health history necessary to make status current. (Patient shall also receive, subsequent to the health assessment, any immunizations which could not be given during the assessment, and any immunizations necessary to complete a series which could not be completed during the assessment.)

(10) Health education and anticipatory guidance appropriate to age and health status.

(c) Additional screening procedures. A community child health and disability prevention program may include screening procedures in its program, additional to the ones included in this section, if these procedures are approved by the Department and the State Child Health Board.

(d) Rechecks. In those instances where a person is eligible for state reimbursement of health assessment costs, reimbursement may be made for one recheck of those screening procedures (excluding the Health History and Physical Examination) and laboratory tests where such a recheck is medically indicated because questionable or marginal results were obtained during the prior screening.

(e) Results of health assessment. The results of the health assessment shall be handled as follows:

(1) Health assessment providers shall provide the person with a copy of the results of the screening tests, with an appropriate explanation of the results. Such notification and discussion of screening test results, unless provided by a licensed or certified practitioner of the healing arts, shall be free of diagnostic statements or suggestions that the person needs any particular treatment. Specifically, no medical care or special education plan shall be instituted solely on the basis of the health screening results.

(2) The results of the health assessment shall be recorded on forms provided by the Department.

(f) Concurrent diagnosis and treatment. Nothing in these regulations shall be interpreted to mean that a licensed or certified practitioner of the healing arts may not provide diagnosis and treatment, in conjunction with the health assessment, if medically indicated.

(g) Nonspecified procedures. Health screening procedures that are approved for reimbursement by the Department are specified, together with their maximum allowable reimbursements, in Section 6868. Reimbursement for procedures not specified in Section 6868 shall not be made without written approval of the Department.

NOTE

Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Reference: Sections 321.2 and 324, Health and Safety Code.

HISTORY

1. New NOTE filed 4-16-79, correcting inadvertent omission from 3-29-79 filing of Subchapter 3 (Register 79, No. 15).

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6847. Periodicity of Health Assessments.

Note • History

(a) Eligibility. Medi-Cal beneficiaries who have received an initial health assessment are also eligible for subsequent, periodic health assessments.

(b) Notifying and Offering Assistance. Persons eligible for periodic assessments shall be notified before each assessment is due of their entitlement to the assessment, and of the availability of assistance with transportation and scheduling appointments. The informing may be in writing. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary.

(c) Frequency. Persons eligible for periodic health assessments shall receive one assessment during each age period listed below. The first age at which the next health assessment is due is the age of the person at the previous assessment plus the interval indicated in the parenthesis after that age period in the table shown in this subsection. However, a periodic assessment may be done at any time from the beginning to the end of each age period. Persons will be considered overdue for an assessment on the first day he or she enters a new age period without assessment having been performed in the previous age period.

For example, a child receiving an assessment at two and one-half years of age is first due for the next assessment at three and one-half years of age (the age at the time of previous assessment, two and one-half plus the time interval between assessments for that age group, one year). The assessment is overdue when the child is four years old. There is no time interval in the 17-20 age period because no additional assessments will be given after that assessment. Initial and periodic assessments, and the initiation of any needed treatment, shall normally be completed within 120 days from either the last day the person is eligible for assessment in any age period or the day the person is notified that the next assessment is due, whichever occurs first.

The following table is a guide for the minimum frequency at which health assessments shall be provided to persons eligible for periodic assessments:

Under 1 month old (1 month)

1 through 2 months old (2 months)

3 through 4 months old (2 months)

5 through 6 months old (2 months)

7 through 9 months old (3 months)

10 through 12 months old (3 months)

13 through 17 months old (5 months)

18 through 23 months old (6 months)

2 years old (1 year)

3 years old (1 year)

4 through 5 years old (2 years)

6 through 8 years old (3 years)

9 through 12 years old (4 years)

13 through 16 years old (4 years)

17 through 20 years old

(d) Additional Health Assessments. The frequency indicated in this section is considered a minimum for preventive health care. More frequent health assessments will be reimbursed when the additional assessment is deemed appropriate by the health assessment provider. Circumstances which may indicate the need for more frequent assessments include the following:

(1) The parents have or the person has a particular need for education and guidance.

(2) There is the presence or possibility of perinatal disorders (such as low birth weight, low Apgar scores at birth, prolonged labor).

(3) The person is or will be exposed to a potentially stressful environment--for example, camp or contact sports--before the next periodic health assessment indicated by the periodicity schedule is due.

(e) Limitations. Reimbursement at more frequent intervals will not be made for a health assessment of an individual for the purpose of monitoring or treating a specific disease or disorder previously diagnosed, or for a person whose overall health status requires ongoing treatment care. Such individuals are still eligible for regular assessments if they are otherwise eligible for CHDP services.

NOTE

Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Reference: Sections 320 and 323.7, Health and Safety Code.

HISTORY

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsections (c) and (d)(2) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

§6848. Certification for School Entry.

Note • History

(a) If a child receives a health assessment under provisions of this subchapter, and must present documentation to the school in which the child is to enroll that the appropriate health screening procedures specified in Section 6846 have been performed, the physician, certified pediatric nurse practitioner or certified family nurse practitioner providing or supervising such screening shall give the child or parent or guardian a certificate documenting that the child has received the appropriate health screening procedures. The certificate shall be provided whether the cost of the health assessment is reimbursed by the State or paid on behalf of the child.

(b) A child may be certified for school entry by the child's personal physician, certified pediatric nurse practitioner or certified family nurse practitioner without receiving a further health assessment if the child has received a physical examination and ongoing comprehensive medical care from that physician, certified pediatric nurse practitioner or certified family nurse practitioner during the 18 months preceding entry into the first grade, or within 90 days thereafter, and that care has included all the applicable health screening procedures outlined in Section 6846.

(c) The health certification for school entry shall be on the form provided by the Department, Report of Health Examination For School Entry, PM171A(6/84).

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.5, Health and Safety Code; Section 14132.41, Welfare and Institutions Code; and Sections 2834, 2835, 2835.5 and 2836, Business and Professions Code.

HISTORY

1. New section filed 4-16-79, correcting inadvertent omission of section 6848 from 3-29-79 filing of subchapter 3; effective 5-16-79 (Register 79, No. 15).

2. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsections (a), (b), and Note filed 10-27-93 as an emergency; operative 10-27-93 (Register 93, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-25-94 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 10-27-93 order with amendment of subsection (c) transmitted to OAL 2-23-94 and filed 4-6-94 (Register 94, No. 14).

§6850. Referral to Diagnosis and Treatment.

Note • History

(a) The following shall apply to all persons for whom diagnosis and treatment is indicated as a result of initial or periodic health assessments received under the provisions of this subchapter:

(1) All reasonable steps, including assistance in scheduling and completing appointments shall be taken to ensure that persons receive needed diagnosis and treatment services. This referral assistance shall include giving the family or person the names, address and telephone numbers of providers who have expressed a willingness to furnish, at little or no expense to the family, those treatment services which are not reimbursable by the Department.

(2) Appointments for diagnostic and treatment services shall be completed in a reasonable period of time, normally not to exceed 60 days from the time of the health assessment.

(3) The health assessment provider shall be responsible for assisting the person in completing diagnosis and treatment. Such assistance may be rendered directly by the provider or through the provider's agreements with the community child health and disability prevention program, appropriate agency or individual.

(4) The first source of referral for diagnosis and treatment shall be the person's usual source of licensed or certified health care. If a referral is required and no regular source of licensed or certified health care can be identified, the provider shall provide a list of at least three appropriate sources of care, when available, without prejudice for or against any specific source or licensed profession. One of the referral sources may be the health assessment provider. State reimbursement for diagnostic and treatment services provided to Medi-Cal beneficiaries can be made only to providers who have been approved for participation in the Medi-Cal program.

(5) The community child health and disability prevention program shall:

(A) Identify those persons eligible for CHDP services who can obtain needed medical or remedial services through a grantee under Title V of the Social Security Act (Maternal and Child Health and Crippled Children's Services).

(B) Ensure that persons eligible for Title V services are informed of available services, and referred, if they desire, to Title V grantees that offer services appropriate to the persons' needs.

(6) The source of health care selected by the person shall be indicated on the CHDP assessment form. If that source is other than the assessment provider, a copy of the CHDP referral form or equivalent shall be provided, with the person's written permission, to the identified source of healthcare.

(b) Additional to (a), above, the following shall apply to Medi-Cal beneficiaries for whom diagnosis and treatment is indicated as a result of initial or periodic health assessments:

(1) Medi-Cal beneficiaries, who requested assistance with transportation or scheduling the appointment for the health assessment, shall be offered assistance with transportation and scheduling appointments for diagnosis and treatment. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary.

(2) Medi-Cal beneficiaries, who did not request assistance with transportation or scheduling the appointment for the health assessment, may request assistance with transportation and scheduling appointments for diagnosis and treatment. If the beneficiary requests such assistance, the request shall be documented and the assistance shall be provided.

(3) Treatment needed as a result of an initial health assessment shall normally be initiated within 120 days from either the date the beneficiary requested the health assessment, or the date the beneficiary was certified eligible to receive Medi-Cal benefits, whichever occurs later. Treatment needed as a result of a periodic health assessment shall normally be initiated within 120 days from either the date the beneficiary requested the health assessment, or the last day of the month in which the beneficiary's age exceeds the oldest allowable age for the health assessment according to the periodicity schedule specified in Section 6847, whichever occurs earlier.

(4) If diagnostic and treatment services are not provided to a Medi-Cal beneficiary who requests such services and who also requests assistance with transportation or scheduling appointments for such services, documentation must exist showing that the family or recipient declined the services, lost eligibility, could not be located despite a good faith effort to do so, or the recipient's failure to receive the services was due to an action or decision by the family or recipient, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services.

(c) Each community child health and disability prevention program shall be responsible for developing and maintaining a referral and follow-up system for diagnosis and treatment, and for ensuring that referral is carried out. The referral and follow-up system shall be specified in the community's child health and disability prevention program plan. Agreements between the community program and providers, and between the community program and other appropriate individuals and agencies participating in the community program, may be part of the referral and follow-up system.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2, 323.7 and 324, Health and Safety Code.

HISTORY

1. New section filed 4-16-79, correcting inadvertent omission of Section 6850 from 3-29-79 filing of Subchapter 3; effective 5-16-79 (Register 79, No. 15).

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsections (a)(4) and (6) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

§6852. Diagnosis and Treatment.

Note • History

(a) To be eligible for state reimbursement, diagnostic and treatment services, which may be required by Medi-Cal beneficiaries as a result of a health assessment received, shall be provided by providers approved for participation in the California Medical Assistance Program. The diagnostic and treatment services shall be in accordance with the provisions of the California Administrative Code, Title 22, Division 3 and subject to any applicable Medi-Cal program limitations.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

Article 5. Providers of Health Screening and Evaluation Services

§6860. Conditions of Participation.

Note • History

(a) Dental diagnostic and treatment services shall be provided by or under the supervision of a dentist licensed to practice dentistry in California. To be eligible for state reimbursement, billing for dental services shall be in accordance with the regulations governing the California Medical Assistance Program.

(b) Health assessments shall be performed in accordance with the provisions of this subchapter as follows:

(1) By, or under the supervision and/or responsibility of, a physician licensed to practice medicine in California.

(2) By a certified family nurse practitioner or certified pediatric nurse practitioner, as defined in Title 22, Section 51170.3(b) and (c), respectively.

(c) Each individual, partnership, clinic, group, association, institution, or public or private agency desiring to participate in a community child health and disability prevention program as a provider of health assessments only, or as a provider of comprehensive health care, shall notify the director of that program of such intent. Notification shall be made to the director of each community child health and disability prevention program in which it is desired to provide service. Notification shall be in the manner established by the community program director.

(d) Physicians, medical clinics, medical groups, certified pediatric nurse practitioners or certified family nurse practitioners may be approved for participation as providers in the community program by the community program director on receipt by the director of written notification stating the following:

(1) The physician, certified pediatric nurse practitioner, certified family nurse practitioner, medical clinic, or medical group understands the requirements of the Child Health and Disability Prevention Program, and desires to participate in it as either a comprehensive care provider or as a provider of health assessments only.

(2) If parts of the required health assessment are not available through the physician, certified pediatric nurse practitioner or certified family nurse practitioner, the physician or certified family nurse practitioner or certified pediatric nurse practitioner shall refer the person to other providers approved by the community program for completion of those parts.

(e) Agencies and organizations (other than physicians and physician groups) desiring to participate in the community program, where physicians or other persons under physician supervision will be employed to do parts of the health assessment, shall state in writing the qualifications of the screening personnel when notifying the community program director of their intent to participate as providers. Participation of such agencies and organizations shall require the written approval of the community program director, and compliance with the provisions of this subchapter and with any standards that may be established by the community program director.

(f) If the community child health and disability prevention program director determines that a provider, previously approved for participation in the community program, is not providing services in accordance with provisions of this subchapter or the standards established by the community program, the community program director may withdraw the approval.

(g) Prepaid health plans, their subcontractors or sub-subcontractors, under contract to the Department to provide medical care to Medi-Cal enrollees are exempted from the provisions of this section only for CHDP services that are provided to their Medi-Cal enrollees. If such a prepaid health plan wishes to provide CHDP services to persons other than their Medi-Cal enrollees, full compliance with this section is required.

(h) Health assessments may be conducted in public and private school facilities provided that, with respect to private school facilities, no services provided thereon pursuant to this subchapter and financed by public funds shall result in any material benefit to, or be conducted in a manner which furthers any educational or other mission of, such a school or any person or entity maintaining the school.

(i) Health assessments shall be made available to eligible persons as defined in this subchapter without regard to race, religion, sex, national origin, citizenship, marital status, parenthood or source of payment.

(j) Clinical laboratories, may be approved for participation as providers in the community program by the community program director on receipt by the director of written notification stating that the clinical laboratory understands the requirements of the Child Health and Disability Prevention Program, and desires to participate in it as a provider of laboratory services.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321(c), Health and Safety Code; Sections 655.6, 2834, 2835, 2835.5 and 2836, Business and Professions Code; Section 14132.41, Welfare and Institutions Code; and 42 U.S.C. Section 1396d(a).

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. New subsection (a) filed and existing subsections (a) through (h) relettered to (b) through (i) filed 5-22-80; effective thirtieth day thereafter (Register 80, No. 21).

4. New subsection (j) and amendment of Note filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

5. New subsections (b)(1)-(3), amendment of subsection (b) and (d)-(d)(2) and Note filed 10-27-93 as an emergency; operative 10-27-93 (Register 93, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-25-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-27-93 order with amendment of subsections (b)-(b)(2) transmitted to OAL 2-23-94 and filed 4-6-94 (Register 94, No. 14).

§6862. Types of Providers.

Note • History

(a) A health assessment provider shall be a physician, physician group, certified family nurse practitioner, certified pediatric nurse practitioner, or public or private agency or organization that provides the services specified in this subchapter to persons eligible to receive those services.

(b) A provider may agree to provide health assessments only, or may agree to be a comprehensive care provider, that is, to provide health assessments and diagnosis and follow-up services.

(c) A health assessment-only provider shall meet the following conditions unless failure to meet any of them is due to circumstances other than the provider's inaction:

(1) Assure completion of the full range of health assessment services appropriate to the individual as defined in section 6846, including anti-tobacco use education and the completion of immunizations and immunization series which could not be given during the health assessment, but which are necessary to make the immunization status current.

(2) Provide referral for diagnosis and treatment, as specified in section 6850, for all persons identified as needing such services as a result of health assessments.

(d) A comprehensive care provider shall be certified by the Department for participation in the California Medical Assistance program and shall meet the following conditions unless failure to meet any of them is due to circumstances other than the provider's inaction:

(1) Assure completion of the full range of health assessment services appropriate to the person as defined in section 6846, including anti-tobacco use education and the completion of immunizations and immunization series which could not be given during the health assessment, but which are necessary to make the immunization status current.

(2) Initiate diagnosis and treatment, or referral for diagnosis and treatment, for all persons identified as needing such services as a result of the health assessment.

(3) Assume overall case management of the person in the event of subsequent referrals which may be part of the needed diagnosis and treatment program.

(4) Assure the provision of subsequent, periodic health assessment at the frequency indicated in section 6847.

(5) Be available as a source of primary care on a continuing basis to the person in the event subsequent medical services are requested.

(6) Maintain a health record for each person.

(e) A clinical laboratory provider shall be a clinical laboratory that meets the definition of the Medi-Cal program in Title 22, California Code of Regulations (CCR), Section 51211.2.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321, 323 and 24165.3, Health and Safety Code; Sections 655.6, 2834, 2835, 2835.5 and 2836, Business and Professions Code; Section 14132.41, Welfare and Institutions Code; and 42 U.S.C. Section 1396d(a).

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsections (c) and (d) filed 2-27-90 as an emergency pursuant to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and filed 7-18-90 (Register 90, No. 38).

5. New subsection (e) and amendment of Note filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

6. Amendment of subsection (a) and Note filed 10-27-93 as an emergency; operative 10-27-93 (Register 93, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-25-94 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 10-27-93 order transmitted to OAL 2-23-94 and filed 4-6-94 (Register 94, No. 14).

Article 6. Claiming for Services

§6866. Procedures.

Note • History

(a) The health assessment provider shall inquire of all persons receiving health assessments under provisions of this subchapter as to the person's entitlement to third-party reimbursement for such services. Where such entitlement exists, it shall be billed as follows:

(1) Insurance carriers shall be billed where such entitlement exists.

(2) The Department's Child Health and Disability Prevention Program shall be billed, in the manner specified by the program, for health assessments provided to the following persons:

(A) Medi-Cal beneficiaries if those services are not reimbursable under (1), above.

(B) Persons who are not Medi-Cal beneficiaries and for whom services are not reimbursable under (1), above, but who meet the age and family income criteria specified by the Department's Child Health and Disability Prevention Program.

(3) Persons enrolled in prepaid health plans that contract with the Department shall receive CHDP services from the prepaid health plan in which they are enrolled in accordance with the contract existing between the prepaid health plan and the Department.

(4) Persons may be billed directly for health assessments which are not reimbursable under (1) or (2), above, or the services may be provided at no cost to the person if the provider chooses.

(b) Eligibility for state-subvened health assessments shall be determined by the screening provider prior to the provision of such services.

(c) Each provider who bills the Department's Child Health and Disability Prevention Program for health assessments rendered pursuant to the provisions of this subchapter shall accept as total reimbursement for those services the amount reimbursed by the Department, and shall make no additional charges to any individual or to the Department's Child Health and Disability Prevention Program for such services.

(d) Providers' reimbursement claims for health assessments rendered under the provisions of this subchapter shall be subject to audit by the State anytime within three years beginning with the year in which the claim was filed.

(e) A clinical laboratory may bill the Department's Child Health and Disability Prevention Program for cytologic examinations of gynecologic slides taken during the course of a CHDP health assessment, or other laboratory services resulting from a CHDP health assessment as follows:

(1) The clinical laboratory shall accept as total reimbursement for the services rendered the amount reimbursed by the Department, and shall make no additional charge to any individual, provider, or to the Department's Child Health and Disability Prevention Program.

(2) Each claim for reimbursement must be accompanied by a legible copy of the CHDP health assessment provider's claim form, the Confidential Screening/Billing Report (PM 160) (revision 10/91), which indicates the name, address, and CHDP provider number of the clinical laboratory that will bill the CHDP program for the examination of gynecologic slides or other laboratory services.

(3) Clinical laboratories claims for reimbursement will not be processed for payment without the cross-reference information required in (2) above.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.2 (a), Health and Safety Code; and Section 655.6, Business and Professions Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. New subsections (e)-(e)(3) and amendment of Note filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

§6868. Schedule of Maximum Allowances.

Note • History

(a) Health screening procedures. Reimbursement for the procedures listed in this subsection, when billed in accordance with this subchapter, shall be the amount billed by the provider for the procedures performed, up to the maximum allowances specified in this subsection. For purposes of this subsection: new patient means a person who has not previously received a health assessment from the examiner, and there is no health assessment record for the person established with the provider; extended visit means a visit in which the patient requires as much or more time to be given a health assessment as does a new patient; routine visit means a visit in which the patient requires less time than ordinarily needed with a new patient or an extended visit.

MAXIMUM

HEALTH SCREENING PROCEDURE ALLOWANCE

History and Physical Examination by Comprehensive Care Provider

New Patient or Extended Visit

Adolescent (age 12 through 20 years) $49.51

Late childhood (age 5 through 11 years) 43.32

Early childhood (age 1 through 4 years) 40.84

Infant (birth through 11 months) 38.37

Routine Visit

Adolescent (age 12 through 20 years) 39.60

Late childhood (age 5 through 11 years) 33.43

Early childhood (age 1 through 4 years) 30.95

Infant (birth through 11 months) 28.46

By Health Assessment--Only Provider

New Patient or Extended Visit

Adolescent (age 12 through 20 years) 43.32

Late childhood (age 5 through 11 years) 37.13

Early childhood (age 1 through 4 years) 34.65

Infant (birth through 11 months) 32.18

Routine Visit

Adolescent (age 12 through 20 years) 37.13

Late childhood (age 5 through 11 years) 30.95

Early childhood (age 1 through 4 years) 28.46

Infant (birth through 11 months) 25.99

Pelvic Exam 10.00

Vision Screening

MAXIMUM

HEALTH SCREENING PROCEDURE ALLOWANCE

Snellen eye test or equivalent visual acuity test

Age 7 years and older $ 2.02

Age 3 through 6 years 4.00

Hearing Screening

Pure Tone Audiometry 9.21

Tuberculin Testing

Multiple Puncture 4.54

Mantoux (intracutaneous) 7.53

(b) Laboratory Tests. For laboratory tests listed in this subsection that the provider performs, reimbursement shall be either the provider's usual charge to the general public for the test or the maximum allowance specified in this subsection, whichever is less. If a laboratory test is performed by other than the screening provider, for instance by an outside laboratory, the screening provider may bill the Department's Child Health and Disability Prevention Program for the charge made to the provider by the laboratory (except for cytologic examination of a gynecologic slide as described below), plus a charge not to exceed $4.63 for the provider's collection and handling of the specimen. The total shall not exceed the maximum allowance specified in this subsection for the laboratory test.

If a clinical laboratory performs a cytologic examination of a gynecologic slide taken during the course of a CHDP health assessment, or other laboratory services resulting from a CHDP health assessment, the clinical laboratory may bill the Department's Child Health and Disability Prevention Program the clinical laboratory's usual charge to the general public not to exceed the maximum allowance specified in this subsection. The health assessment provider may bill the program a charge not to exceed $4.63 for the provider's collection and handling of the specimen. The total charge from the clinical laboratory and the health assessment provider shall not exceed the maximum allowance specified in this subsection for cytologic tests. Clinical laboratory tests shall be performed in the manner and by persons and laboratories that meet the relevant standards established in the Health and Safety Code, the Business and Professions Code and Title 17 of the California Code of Regulations.

MAXIMUM

LABORATORY TEST ALLOWANCE

Blood Tests

Hematocrit $3.01

Hemoglobin 3.01

Sickle Cell Status (Electrophoresis) 30.11

Blood Lead Screening

Blood Lead Level Determination 22.45

Phenylalanine (PKU) Blood 4.54

Urine Tests

Urinalysis, routine, complete 4.54

Urine “Dipstick” 2.87

Tests for Microorganisms

Culture for Neisseria Gonorrhea 6.02

Cytologic Tests

Papanicolaou (Pap) Smear 11.22

Ova and Parasites, direct smears, concentration and identification 12.39

VDRL, RPR or ART 4.56

Chlamydia Test 19.25

(c) Immunizations. Reimbursement for the immunizations listed in this subsection, when billed in accordance with this subchapter, shall be the amount billed by the provider for the immunizations given, up to the maximum allowances specified in this subsection. However, if the provider uses vaccine supplied at no cost to the provider by the Department's Immunization Assistance Program, the maximum reimbursement for administration of the vaccine shall be the amount determined by the Department rather than the amount specified in this subsection. The maximum reimbursement rate for the professional component of administering an immunization under this subsection shall be $4.52. The maximum allowable reimbursement for the ingredient component of an immunization shall be based on prevailing market acquisition costs as determined by the Department's fiscal intermediary.

IMMUNIZATION

DPT (diphtheria and tetanus toxoids with pertussis vaccine) First, second, third of series; booster.

Td (combined tetanus and diphtheria toxoids, adult type)

Dd (combined tetanus and diphtheria toxoids, pediatric type)

Hib (Haemophillus Influenza Type b) vaccine

Hib (Haemophillus Influenza Type b) conjugate vaccine

HibTITER

Polio: IPV (inactivated trivalent poliovirus vaccine) First, second, third of series, or booster

TOPV (trivalent oral polio virus vaccine) First, second, third of series; booster.

Measles vaccine

Rubella vaccine

Mumps vaccine

MR (measles, rubella) vaccine

MMR (measles, mumps, rubella) vaccine

MuR (mumps, rubella) vaccine

HBVAC (hepatitis B vaccine) (Pre-exposure)

HBIG (hepatitis B immune globulin) (Post exposure)

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code, and Sections 14105 and 14124.5, Welfare and Institutions Code. Reference: Sections 323 and 323.2 (a), Health and Safety Code; and Section 14105, Welfare and Institutions Code; Items 4260-111-001, Chapter 258, Statutes of 1984, and Statutes of 1985, Chapter 111, Items 4260-111-001 and 890; and Section 655.6, Business and Professions Code.

HISTORY

1. Amendment filed 8-1-84 as an emergency; effective upon filing (Register 84, No. 31). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-84. For prior history, see Register 81, No. 52.

2. Certificate of Compliance transmitted to OAL 11-27-84 and filed 12-27-84 (Register 84, No. 52).

3. Amendment filed 8-1-85 as an emergency; effective on filing (Register 85, No. 32). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-85.

4. Certificate of Compliance transmitted to OAL 11-20-85 and filed 12-27-85 (Register 85, No. 52).

5. Amendment of section and Note filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

Article 7. Records, Reporting and Confidentiality

§6870. Records.

Note

Records shall be maintained by the community child health and disability prevention program, and those participating in it, for the purposes and in the manner specified by the Department's Child Health and Disability Prevention Program.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (c) and 321.2 (h), Health and Safety Code.

§6872. Reporting.

Note • History

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code.

HISTORY

1. Repealer filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6874. Confidentiality.

Note • History

(a) All information and results of the health assessments of each person shall be confidential and shall not be released without the informed consent of the person or parent or guardian.

(b) The results of the health assessment shall not be released to any public or private agency, even with the consent of the person or parent or guardian, unless accompanied by a professional interpretation of what the results mean.

NOTE

Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 324.5, Health and Safety Code.

HISTORY

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register 79, No. 48). A Certificate of Compliance must be filed within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

Subchapter 14. Stop Tobacco Access to Kids Enforcement (STAKE) Act Program

§6901. Definitions.

Note • History

(a) “Decoy” means a 15 or 16 year old individual participating in an inspection carried out by the Department to determine compliance with California law prohibiting the sale of a tobacco product to a minor.

(b) “Department” means the Department of Health Services or a local law enforcement agency that has entered into an enforcement delegation contract with the Department of Health Services.

(c) “Inspection” means a law enforcement activity conducted by the Department in which a decoy, under the direct supervision of a regularly employed peace officer, attempts to purchase a tobacco product at a retail site.

(d) “Minor” means any individual under 18 years of age.

(e) “Person” means any individual, partnership, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within the state, and any representative agent, or agency of any of the foregoing.

(f) “Retail site” means any outlet that provides tobacco products for sale to consumers including, but not limited to, an establishment, vending machine, vehicle, mobile unit, stationary mobile unit, booth, stand, or concession.

(g) “Sale” means the transfer or exchange for consideration or otherwise furnishing of a tobacco product to a consumer for the purpose of consumption or use, and not for re-sale.

(h) “Seller” means the owner of any retail business or any employee of the retail business authorized to make sales of tobacco products to consumers.

(i) “Tobacco product” means any substance containing tobacco leaf, including, but not limited to, cigarettes, cigars, pipe tobacco, snuff, chewing tobacco, or dipping tobacco.

(j) “Valid identification” means a document issued by a federal, state, county, or municipal government, or subdivision or agency thereof, including, but not limited to, a motor vehicle operator's license or an identification card issued to a member of the Armed Forces, which contains the name, date of birth, description, and photograph of the individual.

(k) “Vending machine” means any mechanical device, the operation of which depends upon the insertion of money, trade checks, tokens or other things representative of value and which dispenses or vends tobacco products.

NOTE

Authority cited: Sections 22952(b) and 22952(d), Business and Professions Code; and Section 208, Health and Safety Code. Reference: Sections 22951, 22952(b), 22952(c), 22952(d)(1)-(7), 22954, 22956, 22957 and 22958 Business and Professions Code.

HISTORY

1. New section filed 12-20-89 as an emergency; operative 12-20-89 (Register 89, No. 52). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 4-19-90.

2. Repealed by operation of Government Code 11346.1(g) filed 1-22-91 (Register 91, No. 19).

3. Amendment of subchapter 14 heading, deletion of article 1 heading and new section filed 12-22-95 as an emergency; operative 12-22-95 (Register 95, No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subchapter 14 heading, deletion of article 1 heading and new section refiled 4-17-96 as an emergency, including amendment of Note; operative 4-17-96 (Register 96, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-19-96 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subchapter 14 heading, deletion of article 1 heading and new section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of Note and of History 4 and History 5 (Register 96, No. 50).

7. Amendment of subchapter 14 heading, deletion of article 1 heading and new section refiled 12-10-96 as an emergency, including amendment of Note; operative 12-10-96 (Register 96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 12-10-96 order, including amendment of subchapter heading and subsection (b), transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

§6902. Warning Sign; Identification.

Note • History

(a) At each retail site that sells or furnishes tobacco products a sign shall be conspicuously posted so that it is likely to be read by a consumer during a sale at each cash register, vending machine or any other point at which sales occur. The sign shall meet the following specifications:

(1) Contain the following words with initial letters capitalized in the following manner: The Sale of Tobacco Products to Persons Under 18 Years of Age Is Prohibited by Law and Subject to Penalties. Valid Identification May Be Required. To Report an Unlawful Tobacco Sale Call 1-800-5ASK-4-ID. Business and Professions Code Section 22952.

(2) Be square in shape and no smaller than 5.5 inches high by 5.5 inches wide (30.25 square inches) or be rectangular in shape and no smaller than 3.66 inches high by 8.5 inches wide (31.11 square inches). A sign may be larger; however, the sign shall be proportionate to one set of the dimensions set forth in this subdivision.

(3) Be printed in ink that is of high contrast from the color of the background material. (Examples are black ink on white paper or dark blue ink on yellow paper.)

(4) Located at least one-third inch from the top and sides, the following required words shall be no smaller than 20 point medium or bold Helvetica or Futura type face: “The Sale of Tobacco Products to Persons Under 18 Years of Age Is Prohibited by Law and Subject to Penalties. Valid Identification May Be Required.” Located at least one-third inch from the sides, the following required words shall be no smaller than 30 point medium or bold Helvetica or Futura type face and in all cases 6 point size larger than all other text: “To Report an Unlawful Tobacco Sale Call 1-800-5ASK-4-ID.” Located at least one-quarter inch from the sides and bottom, the required legal citation “Business and Professions Code Section 22952” shall be no smaller than 12 point medium or bold Helvetica or Futura type face.

(b) The seller shall request valid identification from any individual who attempts to purchase a tobacco product if that individual reasonably appears to the seller to be under 18 years of age.

NOTE

Authority cited: Section 22952(b), Business and Professions Code. Reference: Sections 22952(b) and 22956, Business and Professions Code.

HISTORY

1. New section filed 12-22-95 as an emergency; operative 12-22-95 (Register 95, No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 4-17-96 as an emergency; operative 4-20-96 (Register 96, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-19-96 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96 or emergency language will be repealed by operation of law on the following day.

4. Editorial correction of subsection (a)(1) (Register 96, No. 50).

5. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register 96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 12-10-96 order transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

§6903. Inspections; Decoys.

Note • History

(a) The Department shall conduct inspections using decoys who shall present the appearance of an individual under 18 years of age. For purposes of verifying that a decoy appears to be under 18 years of age at the time of the inspection, a photograph or video recording of the decoy shall be taken prior to and on the same day as the inspection and shall be retained by the Department.

(b) A decoy, if requested, shall present valid identification.

(d) Within 2 working days of a sale of tobacco to a decoy during an inspection, the peace officer who originally accompanied and supervised the decoy during the inspection, shall return to the retail site, advise the seller of the inspection and violation, and identify the decoy to the seller by means of a photograph taken the same day as the inspection.

(e) The Department may use video recording equipment, including video, audio, photographic and other audio/visual recording equipment, to record and document an inspection.

(f) Inspections of retail sites may be conducted: (1) on the basis of random selection in a given geographic area; or (2) in response to reports of violations of Penal Code section 308 subsection (a) or of Business and Professions Code section 22958; or (3) in response to reports of unlawful sales over the toll-free telephone number authorized by subdivision (b) of section 22952 of the Business and Professions Code.

NOTE

Authority cited: Section 22952(d), Business and Professions Code. Reference: Sections 22952(b), 22952(c), 22952(d)(1)-(7) and 22958, Business and Professions Code; and Section 308, Penal Code.

HISTORY

2. Editorial correction of subsection (f) (Register 96, No. 16).

3. New section refiled 4-17-96 as an emergency; operative 4-20-96 (Register 96, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-19-96 or emergency language will be repealed by operation of law on the following day.

4. New section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96 or emergency language will be repealed by operation of law on the following day.

5. Editorial correction of subsection (e) (Register 96, No. 50).

6. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register 96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 12-10-96 order, including amendment of subsection (d), transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

8. Change without regulatory effect amending subsection (b) filed 2-25-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 9).

§6904. Defenses.

Note • History

Failure to comply with the procedures set forth in Subdivision (d) of Section 22952 of the Business and Professions Code and Title 17, California Code of Regulations, Section 6903 shall be a defense to any action brought pursuant to the STAKE Act (Division 8.5 of the Business and Professions Code).

NOTE

Authority cited: Section 22952(d), Business and Professions Code. Reference: Sections 22952(d)(1)-(8), Business and Professions Code.

HISTORY

4. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register 96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 12-10-96 order, including amendment of section, transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

§6905. Annual Report of Tobacco Retail Sites.

Note • History

(a) Each cigarette or tobacco products distributor or wholesaler and each cigarette vending machine operator as required in Business and Professions Code section 22954 shall, within 45 days after the end of the calendar year, annually file a report listing the retail sites, including dealers as defined in Revenue and Taxation Code section 30012, to which it provided tobacco products during the calendar year just ended. This report of retail sites shall be filed with the Department of Health Services, Tobacco Control Section, 601 North 7th Street, M.S. 555, P.O. Box 942732, Sacramento, CA 94234-7320. The first report shall be submitted for the calendar year beginning January 1, 1995. The annual report shall contain the following:

(1) The name of the cigarette or tobacco products distributor or wholesaler or cigarette vending machine operator company.

(2) The address and telephone number of the company's principal executive office.

(3) The name, title, and address of the representative of the company to whom correspondence regarding this report should be addressed.

(4) The name, title and signature of the official authorized to sign the report on behalf of the company.

(5) A certification made pursuant to Code of Civil Procedure Section 2015.5 by the authorized person whose signature appears on the report as follows:

“I certify under penalty of perjury under the laws of the State of California that the information contained in the report is true and correct:

”

(Date) (Signature)

(6) A list of each retail site's name and the physical location of the retail site to which the company supplied tobacco products or vending machines for the preceding calendar year. The list shall include, on separate lines, the full name, street address, city and zip code of each retail site. For those companies with computer capability, the list of the retail sites is also required to be submitted on a computer diskette as a flat ASCII file, or other format to be specified by the Department of Health Services, on one or more 3 1/2 inch or 5 1/4 inch floppy diskette(s). For those companies without computer capability, submission of the list on a computer diskette is not required. For the second and subsequent year that the company files this report, the company is required to either submit the information required by this subsection or report only changes to the first report. Where a company opts in the second or subsequent year to report only changes to the first or previous report, such second or subsequent report shall include and clearly identify name or address changes of the retail sites, additional retail sites to which it supplies tobacco products or vending machines and retail sites to which it no longer supplies tobacco products or a vending machine.

NOTE

Authority cited: Section 100275, Health and Safety Code. Reference: Section 22954, Business and Professions Code; Section 30012, Revenue and Taxation Code; and Section 2015.5, Code of Civil Procedure.

HISTORY

2. New section refiled 4-17-96 as an emergency, including amendment of Note; operative 4-17-96 (Register 96, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-19-96 or emergency language will be repealed by operation of law on the following day.

4. Editorial correction of History 2 and History 3 (Register 96, No. 50).

6. Certificate of Compliance as to 12-10-96 order transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

Chapter 5. Sanitation (Environmental)

(Originally Printed 8-15-45)

Subchapter 1. Engineering (Sanitary)

Group 1. Domestic Water Supplies Quality and Monitoring [Repealed]

NOTE

Authority cited: Section 4026, Health and Safety Code. Reference: Sections 4010-4037, Health and Safety Code.

HISTORY

1. Repealer of Group I (Articles 1-5, Sections 7001-7025, not consecutive) filed 11-4-77; effective thirtieth day thereafter (Register 77, No. 45).

Group 1.1. Waterworks Standards [Repealed]

NOTE

Authority cited: Sections 208 and 4010.1(h), Health and Safety Code. Reference: Sections 4010.1(h), 4012, 4013, and 4019, Health and Safety Code.

HISTORY

1. New Group 1.1 (Sections 7050-7081, not consecutive) filed 2-1-74; effective thirtieth day thereafter (Register 74, No. 5).

2. Repealer of Group 1.1 (Sections 7050-7081, not consecutive) filed 12-6-79; effective thirtieth day thereafter (Register 79, No. 49).

Group 2. Certification of Water Treatment Facility Operators [Repealed]

HISTORY

1. Certificate of Compliance as to 4-25-2001 order repealing group 2 (articles 1-8, sections 7100-7134) transmitted to OAL 7-12-2001 and filed 8-13-2001 (Register 2001, No. 33). For prior history of group 2, see Register 2001, No. 17.

Group 3. Drain Wells [Repealed]

HISTORY

1. Repealer of group 3 (article 1, section 7557) filed 2-21-85; effective on filing pursuant to Government Code section 11346.2(d) (Register 85, No. 8).

Group 4. Drinking Water Supplies

Article 1. General

§7583. Definitions.

Note • History

In addition to the definitions in Section 116275 of the Health and Safety Code, the following terms are defined for the purpose of this Chapter:

(a) “Approved Water Supply” is a water supply whose potability is regulated by a State of local health agency.

(b) “Auxiliary Water Supply” is any water supply other than that received from a public water system.

(d) “AWWA Standard” is an official standard developed and approved by the American Water Works Association (AWWA).

(e) “Cross-Connection” is an unprotected actual or potential connection between a potable water system used to supply water for drinking purposes and any source or system containing unapproved water or a substance that is not or cannot be approved as safe, wholesome, and potable. By-pass arrangements, jumper connections, removable sections, swivel or changeover devices, or other devices through which backflow could occur, shall be considered to be cross-connections.

(f) “Double Check Valve Assembly (DC)” is an assembly of at least two independently acting check valves including tightly closing shut-off valves on each side of the check valve assembly and test cocks available for testing the watertightness of each check valve.

(g) “Health Agency” means the California Department of Health Services, or the local health officer with respect to a small water system.

(h) “Local Health Agency” means the county or city health authority.

(i) “Reclaimed Water” is a wastewater which as a result of treatment is suitable for uses other than potable use.

(j) “Reduced Pressure Principle Backflow Prevention Device (RP)” is a backflow preventer incorporating not less than two check valves, an automatically operated differential relief valve located between the two check valves, a tightly closing shut-off valve on each side of the check valve assembly, and equipped with necessary test cocks for testing.

(k) “User Connection” is the point of connection of a user's piping to the water supplier's facilities.

(l) “Water Supplier” is the person who owns or operates the public water system.

(m) “Water User” is any person obtaining water from a public water supply.

NOTE

Authority cited: Sections 116350, 116375, 116555 and 131200, Health and Safety Code. Reference: Sections 116325, 116350 and 116555, Health and Safety Code.

HISTORY

1. Repealer of Articles 1 through 10 and New Articles 1 through 4 (Sections 7583, 7588 through 7594, 7603 through 7605, and 7615 through 7622) filed 5-8-53; effective thirtieth day thereafter (Register 53, no. 8).

2. New section filed 5-26-87; operative 6-25-87 (register 87, No. 23).

3. Change without regulatory effect amending first paragraph and Note filed 4-21-2011 pursuant to section 100, title 1, California Code of Regulations (Register 2011, No. 16).

§T17-7583. Purpose. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7584. Responsibility and Scope of Program.

Note • History

The water supplier shall protect the public water supply from contamination by implementation of a cross-connection control program. The program, or any portion thereof, may be implemented directly by the water supplier or by means of a contract with the local health agency, or with another agency approved by the health agency. The water supplier's cross-connection control program shall for the purpose of addressing the requirements of Sections 7585 through 7605 include, but not be limited to, the following elements:

(a) The adoption of operating rules or ordinances to implement the cross-connection program.

(b) The conducting of surveys to identify water user premises where cross-connections are likely to occur,

(c) The provisions of backflow protection by the water user at the user's connection or within the user's premises or both,

(d) The provision of at least one person trained in cross-connection control to carry out the cross-connection program,

(e) The establishment of a procedure or system for testing backflow preventers, and

(f) The maintenance of records of locations, tests, and repairs of backflow preventers.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7585. Evaluation of Hazard.

Note • History

The water supplier shall evaluate the degree of potential health hazard to the public water supply which may be created as a result of conditions existing on a user's premises. The water supplier, however, shall not be responsible for abatement of cross-connections which may exist within a user's premises. As a minimum, the evaluation should consider: the existence of cross-connections, the nature of materials handled on the property, the probability of a backflow occurring, the degree of piping system complexity and the potential for piping system modification. Special consideration shall be given to the premises of the following types of water users:

(a) Premises where substances harmful to health are handled under pressure in a manner which could permit their entry into the public water system. This includes chemical or biological process waters and water from public water supplies which have deteriorated in sanitary quality.

(b) Premises having an auxiliary water supply, unless the auxiliary supply is accepted as an additional source by the water supplier and is approved by the health agency.

(c) Premises that have internal cross-connections that are not abated to the satisfaction of the water supplier or the health agency

(d) Premises where cross-connections are likely to occur and entry is restricted so that cross-connection inspections cannot be made with sufficient frequency or at sufficiently short notice to assure that cross-connections do not exist.

(e) Premises having a repeated history of cross-connections being established or re-established.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7586. User Supervisor.

Note • History

The health agency and water supplier may, at their discretion, require an industrial water user to designate a user supervisor when the water user's premises has a multipiping system that convey various types of fluids, some of which may be hazardous and where changes in the piping system are frequently made. The user supervisor shall be responsible for the avoidance of cross-connections during the installation, operation and maintenance of the water user's pipelines and equipment.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7588. Cross-Connection. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7589. Approved Water Supply. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7590. Auxiliary Supply. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7591. Approved Check Valve. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7592. Approved Double Check Valve Assembly. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7593. Air-Gap Separation. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7594. Approved Reduced Pressure Principle Backflow Prevention Device. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 2. Protection of Water System

§7601. Approval of Backflow Preventers.

Note • History

Backflow preventers required by this Chapter shall have passed laboratory and field evaluation tests performed by a recognized testing organization which has demonstrated their competency to perform such tests to the Department.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7602. Construction of Backflow Preventers.

Note • History

(a) Air-gap Separation. An Air-gap separation (AG) shall be at least double the diameter of the supply pipe, measured vertically from the flood rim of the receiving vessel to the supply pipe; however, in no case shall this separation be less than one inch.

(b) Double Check Valve Assembly. A required double check valve assembly (DC) shall, as a minimum, conform to the AWWA Standard C506-78 (R83) adopted on January 28, 1978 for Double Check Valve Type Backflow Preventive Devices which is herein incorporated by reference.

(c) Reduced Pressure Principle Backflow Prevention Device. A required reduced pressure principle backflow prevention device (RP) shall, as a minimum, conform to the AWWA Standard C506-78 (R83) adopted on January 28, 1978 for Reduced Pressure Principle Type Backflow Prevention Devices which is herein incorporated by reference.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7603. Location of Backflow Preventers.

Note • History

(a) Air-gap Separation. An air-gap separation shall be located as close as practical to the user's connection and all piping between the user's connection and the receiving tank shall be entirely visible unless otherwise approved in writing by the water supplier and the health agency.

(b) Double Check Valve Assembly. A double check valve assembly shall be located as close as practical to the user's connection and shall be installed above grade, if possible, and in a manner where it is readily accessible for testing and maintenance.

(c) Reduced Pressure Principle Backflow Prevention Device. A reduced pressure principle backflow prevention device shall be located as close as practical to the user's connection and shall be installed a minimum of twelve inches (12”) above grade and not more than thirty-six inches (36”) above grade measured from the bottom of the device and with a minimum of twelve inches (12”) side clearance.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§7604. Type of Protection Required.

Note • History

The type of protection that shall be provided to prevent backflow into the public water supply shall be commensurate with the degree of hazard that exists on the consumer's premises. The type of protective device that may be required (listed in an increasing level of protection) includes: Double Check Valve Assembly-(DC), Reduced Pressure Principle Backflow Prevention Device-(RP), and an Air-gap Separation-(AG). The water user may choose a higher level of protection than required by the water supplier. The minimum types of backflow protection required to protect the public water supply, at the water user's connection to premises with various degrees of hazard are given in Table 1. Situations which are not covered in Table 1 shall be evaluated on a case-by-case basis and the appropriate backflow protection shall be determined by the water supplier or health agency.

TABLE 1

TYPE OF BACKFLOW PROTECTION REQUIRED

Minimum Type

of Backflow

Degree of Hazard Prevention

(a) Sewage and Hazardous Substances

(1) Premises where there are waste water pumping and/or AG

treatment plants and there is no interconnection

with the potable water system. This does not include a

single-family residence that has a sewage lift pump. A RP may

be provided in lieu of an AG if approved by the health

agency and water supplier.

(2) Premises where hazardous substances are handled in any manner AG

in which the substances may enter the potable water system.

This does not include a single-family residence that has a sewage

lift pump. A RP may be provided in lieu of an AG if approved by the

health agency and water supplier.

(3) Premises where there are irrigation systems into which fertilizers, RP

herbicides, or pesticides are, or can be, injected.

(b) Auxiliary Water Supplies

(1) Premises where there is an unapproved auxiliary water supply AG

which is interconnected with the public water system. A RP or DC

may be provided in lieu of an AG if approved by the health agency and

water supplier.

(2) Premises where there is an unapproved auxiliary water supply and RP

there are no interconnections with the public water system. A DC may

be provided in lieu of a RP if approved by the health agency and

water supplier.

(1) Premises where the public water system is used to AG

supplement the recycled water supply.

(2) Premises where recycled water is used, other than as allowed in RP

paragraph (3), and there is no interconnection with the potable water

system.

(3) Residences using recycled water for landscape irrigation as DC

part of an approved dual plumbed use area established pursuant to

sections 60313 through 60316 unless the recycled water supplier

obtains approval of the local public water supplier, or the Department

if the water supplier is also the supplier of the recycled water, to utilize

an alternative backflow protection plan that includes an annual

inspection and annual shutdown test of the recycled water and potable

water systems pursuant to subsection 60316(a).

(d) Fire Protection Systems

(1) Premises where the fire system is directly supplied from the DC

public water system and there is an unapproved auxiliary water supply

on or to the premises (not interconnected).

(2) Premises where the fire system is supplied from the public water AG

system and interconnected with an unapproved auxiliary water supply.

A RP may be provided in lieu of an AG if approved by the health agency

and water supplier.

(3) Premises where the fire system is supplied from the public water DC

system and where either elevated storage tanks or fire pumps which take

suction from private reservoirs or tanks are used.

(4) Buildings where the fire system is supplied from the public water DC

system and where recycled water is used in a separate piping system

within the same building.

(e) Dockside Watering Points and Marine Facilities

(1) Pier hydrants for supplying water to vessels for any purpose. RP

(2) Premises where there are marine facilities. RP

(f) Premises where entry is restricted so that inspections for RP

cross-connections cannot be made with sufficient frequency or at

sufficiently short notice to assure that they do not exist.

(g) Premises where there is a repeated history of cross-connections RP

being established or re-established.

NOTE

Authority cited: Section 116375, Health and Safety Code; and Section 13521, Water Code. Reference: Section 116375, Health and Safety Code; and Sections 13520, 13521 and 13554(a)(3), Water Code.

HISTORY

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

2. Editorial correction of first paragraph and Table 1, subsection (d)(1) (Register 95, No. 49).

3. Amendment of section and Note filed 11-2-2000; operative 12-2-2000 (Register 2000, No. 44).

§7605. Testing and Maintenance of Backflow Preventers.

Note • History

(a) The water supplier shall assure that adequate maintenance and periodic testing are provided by the water user to ensure their proper operation.

(b) Backflow preventers shall be tested by persons who have demonstrated their competency in testing of these devices to the water supplier or health agency.

(c) Backflow preventers shall be tested at least annually or more frequently if determined to be necessary by the health agency or water supplier. When devices are found to be defective, they shall be repaired or replaced in accordance with the provisions of this Chapter.

(d) Backflow preventers shall be tested immediately after they are installed, relocated or repaired and not placed in service unless they are functioning as required.

(e) The water supplier shall notify the water user when testing of backflow preventers is needed. The notice shall contain the date when the test must be completed.

(f) Reports of testing and maintenance shall be maintained by the water supplier for a minimum of three years.

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer and new section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 3. Protection of Public Water System at Service Connection

§T17-7603. Where Protection Is Required.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7604. Type of Protection.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 4. Protection of Potable Water System Within Premises

§T17-7615. Separate Drinking Water Systems.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7616. Fire System.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7617. Process Waters.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7618. Sewage Treatment Plants and Pumping Stations.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7619. Plumbing Connections.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7620. Pier and Dock Hydrants.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7621. Marking Safe and Unsafe Water Lines.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§T17-7622. Water Supervisor.

Note • History

NOTE

Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code.

HISTORY

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 5. Domestic Water Supply Reservoirs

§7623. Intent of Regulations.

Note • History

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. New Article 5 (7623 through 7630) filed 12-14-56; effective thirtieth day thereafter (Register 56, No. 22).

2. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7624. Application of Regulations.

Note • History

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7625. Definitions.

Note • History

(a) “Domestic water supply reservoir” as used herein means a reservoir used to impound or store water intended solely or primarily for domestic purposes.

(b) “Distribution reservoir” as used herein means a reservoir, directly connected with the distribution system of the domestic water supply project, used primarily to care for fluctuations in demand which occur over short periods of from several hours to several days, or as local storage in case of emergency such as a break in a main supply line or failure of pumping plant.

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4050, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. Amendment filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7626. Application for Permit.

Note • History

(a) Recreational use on and around a domestic water supply reservoir is prohibited unless specifically authorized in a water supply permit.

(b) Within 30 calendar days of receipt of an application for a permit or petition for permit modification pursuant to Section 4011 or 4019, Health and Safety Code, the Department shall inform the applicant in writing that it is either complete and accepted for filing or that it is deficient and what specific information or documentation is required to complete the application. An application is considered complete if it is in compliance with the requirements of Section 4012, Health and Safety Code. For proposed water system improvements, new water systems or a “project” as defined in Section 15378, Title 14, California Administrative Code where environmental documentation is required, a copy of such documentation shall be included in the application.

(c) Within 90 calendar days from the date of filing of a completed application, the Department shall inform the applicant in writing of its decision regarding an application.

(d) The Department's time periods for processing an application from the receipt of the initial application to the final decision regarding issuance or denial of a water permit based on the Department's actual performance during the two years preceding the proposal of this section, were as follows:

(1) The median time was--7.5 months

(2) The minimum time was--1.5 months

(3) The maximum time was--85.5 months

NOTE

Authority cited: Sections 208, 4011, 4012, 4019 and 4051, Health and Safety Code; and Section 15376, Government Code. Reference: Sections 4012, 4019, 4050, 4051, 4463 and 4470.1, Health and Safety Code; Section 15376, Government Code; and Sections 21000-21176, Public Resources Code.

HISTORY

1. Amendment filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7627. Data to Accompany Application.

Note • History

(a) The application for a permit to allow recreational use shall be accompanied by detailed information, including but not limited to, the following:

(1) Maps showing the reservoir area, including location of water works facilities, area to be open for recreational use and location of sanitary facilities to be provided for the public.

(2) Data on the size of the reservoir, length of time of water storage in the reservoir, topography of the reservoir site, prevalence of wind-induced currents and other factors that may affect the quality of the stored water and movement of possible contaminants to the water intake.

(3) Data on the size of the protective zone to be provided between the area of recreational use and point of water withdrawal for the water supply.

(4) A statement describing the type of recreational use proposed and the maximum number of persons, cars, vehicles and boats allowed in the area.

(5) A description of the water supplier's program, personnel and financing to control the recreational use, including maintenance and operations of recreational and sanitary facilities, and supervision of the people permitted in the area.

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012, 4019, 4050, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. Amendment filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7628. Guides to Evaluating Application.

Note • History

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§7629. Reservoirs for Which Permits May Be Granted.

When the department finds that the intended recreational use will not render the water supply as delivered to the consumers impure, unwholesome or unpotable, permit for such use will be issued. Subject to the department findings the following types of domestic water supply reservoirs may be used for recreational purposes:

(1) Reservoirs from which water is continuously and reliably treated by filtration and chlorination; provided that for smaller water systems, under special circumstances satisfactory to the State Department of Public Health, approved dual chlorination may be acceptable;

(2) Reservoirs from which water is withdrawn by open channels or other conduits and subsequently stored again in reservoirs falling in the category of Section 7629(1) before reaching a distribution reservoir, or before entering the distribution system or a consumer's premises.

§7630. Kinds of Recreational Use Allowed or Prohibited.

Note • History

NOTE

Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

HISTORY

1. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

Article 11. Delegation of Authority Pursuant to Section 4025 of the Health and Safety Code (Permits for Small Water Systems)

NOTE

Authority cited: Sections 208 and 4025, Health and Safety Code. Reference: Sections 4010-4035, Health and Safety Code.

HISTORY

1. New Article 11 (Sections 7690, 7691 and 7692) filed 4-19-50 (Register 20, No. 1).

2. Repealer of Article 11(Sections 7690-7692) filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 34).

Article 12. Production and Distribution of Bottled Water

HISTORY

1. Repealer of Article 12 (Sections 7695-7701) filed 1-31-74; effective thirtieth day thereafter (Register 74, No. 5). For history of prior Article, see Register 53, No. 10.

Group 5. Sanitary Control of Shellfish

Introduction

All regulations in this group with section numbers preceded by T17- contain building standards which appear in the California Administrative Code, Title 24, Part 6, Division T17 and, to the extent that they are building standards, are included here for convenience and continuity.

Article 1. Shellfish Certificates

§7706. Shellfish Bed Certificate Issuable by the State Board of Public Health.

Note • History

Any person, firm, or corporation engaged in the cultivating or harvesting of oysters, clams, or mussels for sale to the public for human consumption shall possess a valid certificate issued by the State Board of Public Health.

NOTE

Authority cited: Section 208, Health and Safety Code.

HISTORY

1. Repealer of Group 5 (Sections 7706 through 7749) and new Group 5 (Sections 7706 through 7714, 7719, 7720, 7725, 7730 through 7733, 7738 through 7762) filed 12-19-55; effective thirtieth day thereafter (Register 55, No. 18).

§7707. Shellfish Plant Certificate Issuable by the State Board of Public Health.

Any person, firm, or corporation operating a plant engaged in culling, shucking, packing or repacking fresh oysters, clams or mussels for sale to the public for human consumption shall hold a valid certificate issued by the State Board of Public Health.

§7708. Authority of State Board of Public Health to Revoke or Suspend Certificate.

Each certificate so issued shall be revocable or subject to suspension by the State Board of Public Health if for any reason the safety of the shellfish as an article of food is not assured or if the standards set forth herewith are not maintained at all times.

§7709. Expiration and Renewal of Certificates.

A certificate issued under these regulations shall be valid for a period not to exceed one year and shall expire on February 15th of each year. An application for renewal of a certificate shall be made by January 1st of each year if an applicant desires to continue to hold a certificate. No certificate can be transferred.

§7710. Definition.

For purpose of these regulations, the term “shellfish” is hereby declared to mean and include all varieties of oysters, clams, and mussels.

§7711. Types of Certificates.

Shellfish certificates issued hereunder shall be of the following classifications:

A. Shellfish beds and shellfish stock derived therefrom for human consumption.

B. Shellfish culling, shucking, packing, and repacking plants and shucked shellfish produced therefrom for human consumption.

C. A “limited” certificate may be granted as provided under Section 7744.

§7712. Application for Certificate.

The applicant for a certificate to operate in either of the classifications described above shall file with the State Department of Public Health a written request accompanied by a detailed description of the shellfish beds or shellfish handling plants and a map showing the location of the beds or facilities. With the application shall be filed a description of the proposed source or sources of shell or shucked stock. He shall also file with the State Department of Public Health an agreement to comply with each and all of these regulations.

§7713. No Shellfish Grown in the State of California to Be Sold or Distributed Unless Certified.

No shellfish grown in the State of California shall be sold or distributed except from growing areas that have been approved and have been granted a valid certificate by the State Board of Public Health under these regulations. Shellfish shall not be sold or distributed from growing areas in other states unless each lot of shellfish obtained therefrom bears a certificate number designating a certificate of cleanliness and safety issued by the State Department of Health of the state in which the shipment originates acceptable to the California State Department of Public Health.

§7714. No Shucked Shellfish to Be Sold or Distributed Unless Certified.

No shucked shellfish shall be sold or distributed except where such shellfish have been handled in plants for which a certificate has been issued by the State Board of Public Health under these regulations. Shucked shellfish from other states shall not be sold or distributed unless each lot of shucked shellfish obtained therefrom bears a certificate number designating a certificate of cleanliness and safety issued by the State Department of Health of the state in which the shipment originates acceptable to the California State Department of Public Health.

Article 2. Safety of Shellfish and Health of Employees

§7719. Safety of Shellfish for Human Consumption.

No shellfish shall be sold or distributed for human consumption unless it is safe as an article of food and is free from filth.

§7720. Persons Infected With Communicable Diseases.

Persons who are infected with or are carriers of organisms of typhoid fever, dysentery, septic sore throat, or certain other communicable diseases which might be transmitted through shellfish or who have infected wounds or open lesions on exposed portions of the body shall not be employed in the growing beds or shucking, packing, or repacking plant. If the owner or manager has reason to suspect that any employee has contracted such a communicable disease, he shall immediately exclude said employee from the growing beds or plant.

Article 3. Records

§7725. Record of Operations.

A daily record of shellfish received and shipped shall be kept showing kinds of shellfish, designation of the beds from which derived, name of grower, name of shipper, and name of consignee. These records shall be available for inspection by the State Department of Public Health or its agents during all reasonable hours. Upon request these records shall be submitted to the State Department of Public Health.

Article 4. Shellfish Beds

§7730. Cleanliness of Shellfish Growing Areas.

Shellfish beds shall be located in growing areas not adversely affected by sewage, other wastes, or human and recreational activity. All operation of the beds shall be such as not to adversely affect the cleanliness of the growing area.

§7731. Boat Sanitation.

All boats, scows, and appurtenances thereto used in the taking of shellfish or used in the transportation of shellfish from the beds to plants or used in the water over the shellfish beds shall be kept in such a state of cleanliness and repair that shellfish growing on the bed and handled and stored thereon shall not be subject to contamination. Decks, holds, or bins used for storage and/or transporting of shellfish on boats shall not be washed with polluted water. Persons in boats over the shellfish beds shall not discharge human wastes to the waters. Adequate facilities shall be provided for disposal of human wastes from persons working on the shellfish beds.

§7732. Shellfish from Uncertified Areas Brought into Certified Beds.

Shellfish growing in uncertified areas may not be brought into a bed for which a certificate has been issued unless special approval is first granted by the State Department of Public Health. Such approval shall be in writing and granted only on condition that the method of transplanting and timing of arrival of the shellfish will insure that the transplanted shellfish remain in the approved growing area at least 30 days before harvesting for sale for human consumption. This translating area must be in separate portions of the bed and one in which no other shellfish are held.

§7733. Water Quality.

Shell stock shall not be cleaned, stored, floated, or conditioned in water, the standard of which is not as rigid as that required at certified shellfish beds.

Article 5. Plants and Operations

§T17-7738. Culling Plants.

Culling plants shall be located in areas free from insanitary conditions and faulty sewage disposal. They shall be provided with an ample supply of water under adequate pressure from a source approved by the State Department of Public Health for the purpose of hosing down floor and benches and cleaning the shellfish. Floors and premises shall be kept in a clean and sanitary condition.

§7739. Storage.

Shellstock in storage shall be adequately protected from contamination at all times. Dry shellstock shall not be stored on floors. Storage areas must be kept clean at all times. Containers shall be clean and in good condition.

§7740. Cleanliness of Shellstock.

Only shellstock that is reasonably clean and reasonably free of mud shall be shipped or marketed. Oysters, clams, or mussels which are dead or do not have tight shells shall not be shipped or marketed.

§7741. Shipping.

Shellstock shall be handled and shipped under such temperature as will keep them alive. Each lot of shellstock shall be shipped in clean containers such as bags, boxes, or barrels so as to prevent spoilage or contamination during shipping. Each lot shall be plainly marked with the name and address of the shipper, the certificate number of the bed from which the oysters, clams, or mussels were obtained, and the date of harvest.

§7742. Shucking and Packing Plants and Equipment.

Shellfish shall be shucked and packed in such a manner that they are not subject to contamination. Shellstock shall be free of mud when they are shucked. Only live shellfish shall be shucked. Shucked shellfish shall not remain on the shucking table for more than one hour unless refrigerated at .50 degrees Fahrenheit or less.

§7743. Washing.

History

All shucked shellfish shall be properly washed and shall be free of sand, mud and other foreign material. Methods and equipment used for washing the shucked shellfish shall be adequate to accomplish this purpose and shall be approved by the State Health Department. All water used for washing the shellfish shall meet the requirements of Section T17-7753 of these regulations.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

§T17-7744. Plant Arrangement.

Unless shellfish are shucked directly into packing containers with no further processing, the shucking and packing processes shall be done in separate rooms. There shall be installed in the partition between the two rooms a delivery window through which the shucked stock is passed to the packing room. Provision shall be made for storing the employees' outer garments, aprons, gloves, etc., in a separate room.

* In special instances where shucking is done on a small scale for local retail sales, shucking and packing may be permitted in a single room if approved by the State Department of Public Health. This single room and all operations shall conform to all requirements of these regulations except that of separate shucking and packing rooms. “Limited” certificates shall be issued in these instances and all containers of shucked shellfish shall be clearly labeled or marked with the words “limited certificate” and the appropriate certificate number.

* Not a building standard.

§7745. Floors.

The floors of all rooms in which shellfish are stored, shucked, washed, packed, or otherwise processed shall be constructed of concrete or other equally impervious material, graded to drain quickly, free from cracks or uneven surfaces that might interfere with proper cleaning or drainage, and maintained in a clean and satisfactory condition.

§T17-7746. Walls and Ceilings.

Walls and ceilings shall be maintained in a smooth, clean, washable, light-colored condition. They shall be impervious to moisture and shall be kept in good repair. Walls contiguous to benches shall, to a height of two feet above the bench top, be of smooth concrete, metal or equally nonabsorbent material.

§T17-7747. Screening.

The plant shall have all openings effectively screened with not less than 16-mesh screening, unless other effective means are provided to prevent the entrance of flies and other insects.

§T17-7748. Light.

Ample light to work by shall be provided in all working rooms. A light intensity of not less than 10 foot-candles shall be maintained on all working surfaces when workers are at their working positions.

§T17-7749. Ventilation.

Adequate ventilation shall be provided to prevent condensation on ceilings or other surfaces.

§T17-7750. Toilet Facilities.

Every shellfish culling, shucking, packing, or repacking plant shall be provided with clean and adequate toilet facilities conveniently located.* No toilet room shall be used for the storage of garments, food products, containers, or equipment. Construction and maintenance of toilets shall comply with all local and state regulations.

* Not a building standard.

§T17-7751. Handwashing Facilities.

An adequate number of lavatories shall be provided at locations conveniently to toilet rooms and shellfish handling operations, including running hot and cold water, soap, and individual disposal towels. The use of a common towel is prohibited.

All employees shall wash their hands thoroughly with running water and soap on beginning work and after each visit to the toilet. Signs to this effect shall be posted in conspicuous places in the plant and in the toilet rooms.

§T17-7752. Sewers and Drains.

Sewage and other liquid wastes shall be discharged into public sewers wherever possible. Where private sewage or waste disposal systems must be utilized they shall be constructed in accordance with state and local regulations pertaining thereto. Plant waste systems shall be properly trapped and vented. Waste liquids shall be disposed of in a manner that will not adversely affect the quality of the water in which shellfish are grown or stored. Waste lines from washing machines shall have suitable protection against the possibility of sewage or wastes entering these machines.

§7753. Water Supply.

Shucking, packing, or repacking plants shall be provided with an ample supply of water under adequate pressure from a source approved by the State Department of Public Health. The supply shall be accessible to all parts of the plant, adequate in quantity, and of a safe sanitary quality. No cross-connections with unapproved supplies or other possible sources of contamination shall be permitted.

§7754. Benches and Stands.

All benches and stands shall be of smooth concrete, metal, or other nonabsorbent material, free from cracks or crevices, and so constructed that drainage is complete and rapid. Shucking blocks shall be removable unless an integral part of the bench and shall be of solid one-piece construction.

§7755. Construction of Utensils and Equipment.

All shucking pails, opening knives, blowers, skimmers, tanks, tubs, trays, measures, colanders, paddles, or other equipment or utensils which may come in contact with shucked shellfish shall be made of not readily corrodible, smooth, impervious material and shall be constructed in such a manner as to eliminate grooves, seams, and cracks where foreign particles, dirt, and slime might collect. Perforations in the skimmers, colanders, and blower trays shall be smooth to facilitate cleaning. Skimmers, ladles, and colanders of wire-mesh construction are not permitted. The top rim of every tank, tub, and tray shall be at least 30 inches above the floor.

§7756. Aprons and Finger Cots.

All persons who handle shucked shellfish shall wear clean aprons and coats of washable and waterproof material. If finger cots or similar shields for protecting the palm of the hand are worn, they shall be of clean, washable and waterproof material.

§7757. Refrigeration.

Unless shellfish are delivered to the consumer immediately upon completion of shucking, refrigeration facilities shall be provided capable of cooling the shucked shellfish to a temperature below 50 degrees Fahrenheit within two hours after the shellfish are shucked, and keeping them at this temperature until delivered to the consumer. If shucked shellfish are frozen, they shall be kept in a frozen condition until delivered to the consumer. The refrigerator or icebox shall have an impervious lining. The floor shall be graded to drain quickly. An accurate thermometer shall be kept in the refrigerator or icebox. Refrigerators shall be kept clean and sanitary at all times.

§7758. Ice.

Ice used for the processing of shucked shellfish shall be obtained from an approved source and shall be stored and handled in a sanitary manner. No ice shall be allowed to come in contact with shucked shellfish.

§7759. Cleaning.

The floors, walls, and, if necessary, ceilings in the plant shall be cleaned at the end of each day's operations and flushed with water. All equipment, utensils, benches, etc., which come in contact with shucked shellfish shall be thoroughly scoured at the end of each day's operations. The premises shall be kept clean and free of litter and rubbish. Equipment and articles not required in the processing of the shellfish shall be excluded from the plant.

§7760. Sterilization of Equipment.

All utensils, equipment, or working surfaces coming in contact with shucked shellfish after being thoroughly cleansed shall be sterilized by methods approved by the State Department of Public Health. Sterilized equipment shall be protected from recontamination between usages.

§7761. Packing and Shipping.

Note • History

Shucked shellfish shall be packed and shipped either in single-service containers made of clean impervious materials or in properly designed, returnable containers* which have received adequate cleansing and bactericidal treatment. All containers shall be stored in a manner that will protect them from contamination. Containers holding one gallon or more must be positively sealed or so sealed that tampering with the container can easily be detected. Each can, container, or package shall bear the name of the shipper, certificate number of the shucking, packing, or repacking plant, and date packed. The date may be in code if the code is registered with the State Department of Public Health.

NOTE

Authority cited: Sections 202, 205(d) and 208, Health and Safety Code. Reference: Sections 26542, 28312-28315 and 28440, Health and Safety Code.

HISTORY

1. Amendment filed 5-3-67; effective thirtieth day thereafter (Register 67, No. 18).

* Returnable containers will be accepted only for interplant shipment of shucked shellfish.

§7762. Repacking Shucked Stock.

Repacking of shucked shellfish shall only be done if contamination of the shellfish will not occur. Repacking of shucked stock shall be in conformance with all sections of these regulations dealing with shucking and packing of shellfish.

Group 6. Public Swimming Pools

NOTE

Authority cited for Group 6: Sections 102 and 208, Health and Safety Code. Reference: Sections 24100 through 24109, Health and Safety Code.

HISTORY

1. Originally printed 8-15-45 (Title 17).

2. Repealer of Group 6 (Sections 7774 through 7872) and new Group 6 (Sections 7774, 7775, 7780 through 7810, 7820 through 7833) filed 9-30-60; effective thirtieth day thereafter (Register 60, No. 21).

3. Group 6 repealer and adoption refiled 11-15-60; effective thirtieth day thereafter (Register 60, No. 23).

4. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 23).

5. Repealer of Group 6 (Articles 1, 2-2.1 and 3, Sections 7774-T17-7833) filed 10-16-80; designated effective 10-1-81 (Register 80, No. 42).

6. Editorial correction of effective date of History Note No. 5 (Register 80, No. 52).

7. Editorial change filed 9-4-81 redesignating effective date of 10-16-80 order from 10-1-81 to 12-30-81 (Register 81, No. 36).

8. Deletion of Group 6 text (Sections 7774-T17-7833) which was repealed effective 12-30-81 (Register 89, No. 37).

Group 7. Bottled Water and Water Vending Machines

Article 1. Water Bottler and Water Vendor Responsibilities

§7861. General.

Note • History

(a) Each water bottler shall:

(1) Exercise due care and diligence to protect water sources under his control;

(2) Provide and effectively operate and maintain water treatment, bottling, capping, bottle washing and product storage facilities;

(3) Maintain adequate water quality monitoring;

(4) Take whatever investigative or corrective action is necessary to assure that a pure, wholesome and potable water is supplied to consumers.

(b) Each water vending machine operator shall:

(1) Operate and maintain all water vending machines under his control in a sanitary manner;

(2) Maintain adequate water quality monitoring;

(3) Take whatever investigative or corrective action is necessary to assure that a pure, wholesome and potable water is supplied to consumers.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, inclusive, Health and Safety Code.

HISTORY

1. New Group 7 (Sections 7861-7883) filed 1-31-74; effective thirtieth day thereafter (Register 74, No. 5). For history of former Group 7, see Register 68, No. 49.

2. Amendment filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

Article 2. Definitions

§7862. Definitions.

Note • History

(a) “Department” means the California Department of Health.

(b) “Approved” means approved in writing by the Department.

(c) “Bottler” means a person, firm, partnership, or corporation, or other business organization owning and/or operating a water bottling plant.

(d) “Vended Water” means water dispensed by way of a water vending machine.

(e) “Water-vending machine” means any self-service device which upon insertion of a coin, coins, or token, or upon receipt of payment by other means, dispenses unit servings of water in bulk into a customer's container, without the necessity of refilling the machine between each operation.

(f) “Mineral Water” means bottled drinking water containing more than 500 milligrams per liter of total dissolved solids and/or one or more chemical constituents in excess of the concentrations listed in the Federal Bottled Water Quality Standards, 21 CFR, Section 103.35 (d).

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Amendment filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

2. Editorial correction of NOTE (Register 97, No. 37).

Article 3. Water Quality

§7863. Bottled and Vending Machine Water Quality.

Note • History

(a) Quality standards for bottled water withdrawn from sealed bottles, and water from vending machines at point of discharge to customer's container, shall conform to Federal Water Quality Standards for Bottled Water, 21 CFR, Section 103.35 except:

(1) Mineral water shall be exempt from chemical quality standards of 21 CFR, Section 103.35 (d);

(2) Bottled fluoridated water shall contain 1.0 + 0.1 milligrams per liter fluoride ion.

NOTE

Authority cited: Sections 208 and 4041, Health and Safety Code. Reference: Section 4041, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

2. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

Article 4. Good Manufacturing Practices

§7864. Water Bottling Plants.

Note • History

(a) Bottlers shall comply with the following Good Manufacturing Practices:

(1) Federal standards relating to Processing and Bottling of Bottled Drinking Water, 21 CFR, Section 129.

(2) Federal Standards Relating to Human Foods; Current Good Manufacturing Practice in manufacture, processing, packing or holding, 21 CFR, Section 110.

(3) Regulations for Sanitation in Food Plants, 17 CAC 12235-12285.

(b) Prior to bottling, bottled water shall be subject to effective treatment by ozonation, ultraviolet or other treatment approved by the Department.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043 Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7865. Water Vending Machines.

Note • History

(a) Products from each water vending machine shall be sampled by the vending machine operator once every six months or coliform organisms.

(b) Prior to discharge to the customer's container, water vended by machine shall be subject to effective treatment by ultraviolet or other treatment approved by the Department.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7866. Cleaning and Sanitizing of Containers.

Note • History

(a) Bottler shall utilize at least one of the following cleaning/sanitizing processes for multi-use bottles or containers:

(1) Any of the federal sanitizing procedures listed in 21 CFR, Section 129.80 (d).

(2) Exposing all interior surfaces to not less than two and one-half percent caustic solution at a minimum temperature of 120F for not less than one minute where high velocity jets are used or for not less than three minutes where soaker type bottle washers are used.

A final rinsing of the bottle inside, using operations or product water shall be used to remove traces of any caustic sanitizing agent.

(3) Any other method approved in writing by the Department.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7867. Water Dispensers.

Note • History

(a) Dispensers for bottled water, furnished by the water bottler or distributor, shall be delivered to the consumer's premise in a clean, sanitary condition, protected from dust, dirt or other contamination.

(b) Ollas or other water-holding dispensers, both refrigerated and nonrefrigerated, shall be checked for cleanliness each time the dispenser is serviced by the bottler or distributor's representative and when necessary returned to the bottler or distributor for cleaning and sanitizing before reuse.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7868. Labels and Advertising.

Note • History

(a) Mineral water shall be plainly labeled “Mineral Water,” and the label shall show amounts of any mineral substance which exceed bottled water standards, 21 CFR, Section 103.35, and the source of the water.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

Article 5. Out-of-State Bottler or Distributor

§7869. Applications.

Note • History

Application for a license by an out-of-state bottler or by a distributor of water bottled out of state shall be submitted with sufficient information to demonstrate that the water is pure, wholesome and potable. This information shall be included in a report prepared by the agency having authority over bottled water in the state where the water is bottled. If no agency has specific authority over bottled water, the report shall be prepared by a registered civil engineer with recognized experience and competence in the field of water sanitation and/or food production. The applicant may contract with the Department for out-of-state inspections and preparation of the report necessary to support issuance of the license. The report shall include, but not be limited to, the following:

(a) Where applicable, a copy of the out-of-state laws and regulations on bottled water and the license issued.

(b) A report on compliance or noncompliance with all water quality and sampling and water bottling requirements specified in this chapter.

(c) A statement from the out-of-state regulatory agency and the applicant that they will inform the Department of contamination or illness associated with the bottled water shipped into the State.

(d) Information on type and quantity of bottled water shipped into the State and how the bottled water is packaged, transported and stored upon arrival before distribution in the State.

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

Article 6. Licenses and Fees

§7870. Licenses.

Note • History

a) Water Bottling Plants.

The owners or operators of each water bottling plant shall make application for license on forms provided by the Department. The application and license fee shall be submitted for a calendar year. License fees payable are due on or before January 1 and shall be in accordance with Table 1. For new bottling operations, the fee shall be $500.00 for the first calendar year's operation. For water bottled out of state, license fees shall be in accordance with Table 1. Average weekly production shall be determined by dividing the number of gallons shipped into California during the previous year by 52.

TABLE 1

WATER BOTTLING PLANT LICENSE FEE SCHEDULE

Last Year's Average Current

Weekly Production Annual

Bottled Water (in Gallons) License Fee

2,500 or less $100

2,501 to 10,000 $200

10,001 to 25,000 $300

25,001 to 50,000 $400

Over 50,000 $500

(b) Water Vending Machines.

Each water vending machine owner or operator shall make application and obtain a license for each machine operated under his control. The annual license fee for each approved machine shall be $5 per calendar year. A decal or seal provided by the Department indicating a license fee has been paid shall be affixed in a prominent place to each vending machine in service.

Each model of a water vending machine shall be approved by the Department. For newly designed machines or existing machines with modifications, adequate data shall be submitted regarding ability of the machine to comply with the standards of design and to continuously and reliably deliver water complying with water quality standards prescribed in Section 7863. The evaluation fee for each model of a new machine and existing machines with modifications affecting the quality of the water produced shall be in accordance with Table 2. The Department may accept, without payment of a fee, the evaluation of a new or modified model by a recognized independent laboratory.

TABLE 2

WATER VENDING MACHINE EVALUATION FEE SCHEDULE

New machine $500

Existing machine with major modifications $200

Existing machine with minor modifications $50

NOTE

Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code.

HISTORY

1. Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7871. Doors and Windows.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7872. Toilet--Handwashing Facilities.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7873. Plant Maintenance.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7874. Personnel--Cleanliness.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7875. Cleaning and Sanitizing of Containers.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7876. Filling and Closures.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7877. Dry Storage.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7878. Water Dispensers.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7879. Water Vending Machines.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7880. Records.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7881. Labels and Signs.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7882. Applications.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§7883. Licenses.

History

HISTORY

1. Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

Group 8. Sanitary Inspections

Article 1. Sale of Rat Exterminators

§7925. Sale of Rat Exterminators.

The sale or exposure for sale of alleged rodent exterminators, the manufacture of which is based upon the use of cultures of bacteria which may contaminate human food supplies, is hereby prohibited.

Article 2. Capture, Holding, Shipment and Sale of Wild Rodents

§7933. Definitions.

History

(a) Vector Management Unit.

“Vector management unit” means the organizational entity within the Department of Health with primary responsibility for the surveillance, prevention and control of insects and other animals of public health significance.

(b) Wild Rodent.

“Wild rodent” means wild ground squirrels, chipmunks, rats, mice or any other members of the order Rodentia occurring in nature in California except muskrats and beavers.

HISTORY

1. New section filed 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

§7934. Registration.

Note • History

(a) Each person holding a valid scientific collecting permit issued by the Department of Fish and Game pursuant to Fish and Game Code Section 2576, who captures or holds in quarantine wild rodents with the intent to sell them shall register annually with the health officer of each jurisdiction in which the wild rodents are captured or quarantined.

(b) The local health officer shall notify the vector management unit, within seven days, of each person registered.

NOTE

Authority cited for Article 2: Sections 102 and 208, Health and Safety Code. Reference: Sections 205, 3053 and 3114, Health and Safety Code.

HISTORY

1. Amendment of Article 2 ( 7934 added, 7935-7937 amended) filed 7-1-66 as an emergency; effective upon filing (Register 66, No. 20). 2. Certificate of Compliance--Section 11422.1, Government Code, filed 10-25-66 (Register 66, No. 37).

3. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

§7935. Disinfestation, Quarantine and Shipment of Wild Rodents.

History

(a) No person shall sell any wild rodent which has not been disinfected of ectoparasites and quarantined pursuant to the provisions of this Section.

(b) Disinfestation of rodents shall be as follows:

(1) Any person capturing wild rodents with the intent to sell shall, in the locality of capture, disinfest each rodent of ectoparasites using the 1977 “Specifications for disinfestation of wild rodents captured and held for sale” issued by the vector management unit.

(2) Upon release from quarantine and prior to shipment, each rodent shall again be disinfected using the 1977 “Specifications for disinfestation of wild rodents captured and held for sale” issued by the vector management unit.

(1) The rodents shall be segregated and confined in cages by species, and date and locality of capture, with the date and specific locality of capture clearly designated on the cages.

(2) The rodents shall be held in quarantine for a period of two weeks prior to the date of shipment.

(3) If a rodent dies, the quarantine of all remaining rodents in that cage shall be extended two weeks from the date of that death or any later death.

(4) Each rodent death shall be reported to the local health officer within two working days of the rodent's death.

(5) Rodent carcasses shall be promptly frozen pending collection by the local health officer.

(d) Shipment of rodents shall be as follows:

(1) A statement shall accompany the shipment and shall bear the names and addresses of the shipper and receiver, the date of shipment, the location and dates of capture, and certification that the rodents have been quarantined and disinfested of ectoparasites.

(2) Such statement shall be retained by the receiver for a period of one year.

(3) On the date of shipment, the shipper shall submit two copies of the shipment statement to the local health officer, who shall forward, within seven days, one copy to the vector management unit.

HISTORY

1. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

§7936. Reports.

History

The local health officer shall report all deaths of wild rodents held in quarantine to the vector management unit and ship the carcasses of such rodents to the State laboratory for examination as directed by the vector management unit.

HISTORY

1. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

§7937. Disposition of Trapped Wild Rodents.

History

All wild rodents trapped in the same general area within which a rodent or other animal has been found to be infected with plague or other disease communicable to man shall be subjected to such quarantine, isolation, disinfestation or other procedure which the vector management unit finds necessary for the protection of the public health.

HISTORY

1. Amendment file 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

Group 9. Registered Sanitarians GTP

Article 1. Internship Program

§7941.1. Internship Program.

Note • History

An internship program shall include field training equivalent to 600 hours of supervised field experience or completion of six months of supervised field experience in a local environmental health jurisdiction during the formal undergraduate or graduate course studies for the degree in environmental health and shall include experience in at least six environmental program areas. Three of the areas of field experience shall be selected from the following six basic environmental program areas: food protection, waste management (liquid, solid, and hazardous), water sanitation, housing and institutions, recreational swimming areas and waters, and vector control. Experience in the three remaining environmental program areas shall be selected from the following: air sanitation, safety and accident prevention, land development and use, disaster sanitation, electromagnetic radiation, milk and dairy products sanitation, noise control, occupational health, rabies and animal disease control, and any of those from the six basic program areas above not previously selected.

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code.

HISTORY

1. Repealer of former Article 1 (Sections 7941 and 7941.5) and new Article 1 (Section 7941.1) filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18). For prior history, see Register 73, No. 26.

2. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections 7941.1--7941.6 and 7942-7946) pursuant to Section 100, Title 1, California Code of Regulations filed 10-20-89 (Register 89, No. 49).

Article 2. Approval of Educational Institutions

§7941.2. Approved Educational Institution.

Note • History

In order to be approved by the Department, an institution shall be on the list of accredited colleges or universities maintained by the U.S. Office of Education and shall meet the curriculum requirements specified in Section 7941.5(b) if providing course work leading to a degree in environmental health.

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code.

HISTORY

1. Repealer of former Article 2 (Section 7942) and new Article 2 (Sections 7941.2 and 7941.3) filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18). For prior history, see Register 68, No. 29.

§7941.3. Review of Curriculum.

Note • History

Institutions requesting approval of their environmental health degree program shall first submit their curriculum to the Sanitarian Registration Certification Committee for review and if it meets the prescribed curricula as specified in Section 7941.5(b) it shall be submitted to the Department for approval.

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code.

HISTORY

1. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections 7941.1--7941.6 and 7942-7946) pursuant to Section 100, Title 1, California Code of Regulations filed 10-20-89 (Register 89, No. 49).

Article 3. Registration Procedures

§7941.4. Certification of Registration.

Note • History

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 522, Health and Safety Code.

HISTORY

1. New Article 3 (Section 7941.4) filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18). For prior history, see Register 58, Nos. 5 and 11 and No. 4.

Article 4. Minimum Educational and Experience Qualifications for Admission to the Examination for Registered Sanitarians

§7941.5. Educational and Experience Requirements.

Note • History

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code.

HISTORY

1. Renumbering of former Section 7941.5 to Section 7942 and new Article 4 (Sections 7941.5, 7941.6 and 7942) filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18). For prior history, see Register 73, No. 26.

§7941.6. Cross-Certification with Department of Food and Agriculture.

Note • History

NOTE

Authority cited: Section 520, Health and Safety Code. Reference: Section 517, Health and Safety Code.

HISTORY

§7942. Exceptions.

Note • History

NOTE

Authority cited: Section 542(b), Health and Safety Code.

HISTORY

1. Repealer of former Section 7492 and renumbering of former Section 7941.5 to Section 7942 filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18).

Article 5. Application Procedures for Sanitarian Registration

§7943. Application Submission, Completion and Notification.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code.

HISTORY

1. New Article 5 (Sections 7943-7946) filed 5-3-85; effective thirtieth day thereafter (Register 85, No. 18). For history of former Section 7944, see Register 58, No. 5.

2. Change without regulatory effect repeating Group 9 (Articles 1-5, Sections 7941.1--7941.6 and 7942-7946) pursuant to Section 100, Title 1, California Code of Regulations filed 10-20-89 (Register 89, No. 49).

§7944. Application Review Period.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code.

HISTORY

§7945. Application Decision Period.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code.

HISTORY

§7946. Median, Minimum, and Maximum Application Processing Times.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code.

HISTORY

Group 10. Sanitation, Healthfulness and Safety of Ocean Water-Contact Sports Areas

Article 1. Intent of Regulations

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code.

HISTORY

1. New Group 10 (§ 7950 through 7961) filed 2-18-58; effective thirtieth day thereafter (Register 58, No. 3).

2. Repealer of Article 1 (Sections 7950 and 7951) filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

Article 2. Definitions

§7952. Public Water-Contact Sports Area Defined.

Note • History

Public water-contact sports area means any area so designated (1) by a regional water pollution control board, or (2) by any other authorized and responsible public agency.

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. New NOTE filed 3-20-84 (Register 84, No. 12).

§7953. Public Beach Defined.

Note • History

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§7954. Safety Program Defined.

Note • History

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§7955. Refuse Defined.

Note • History

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§7956. Storm Drain.

Note • History

“Storm drain” means a conveyance through which water flows onto or adjacent to a public beach and includes rivers, creeks, and streams, whether in natural or in man-made channels.

NOTE

Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code.

HISTORY

1. New section filed 7-26-99 as an emergency; operative 7-26-99 (Register 99, No. 31). A Certificate of Compliance must be transmitted to OAL by 11-23-99 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99 and filed 11-30-99 (Register 99, No. 49).

Article 3. Sanitation

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. Repealer of Article 3 (Section 7956) filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

Article 4. Healthfulness

§7957. Physical Standard.

Note • History

No sewage, sludge, grease, or other physical evidence of sewage discharge shall be visible at any time on any public beaches or water-contact sports areas.

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. New NOTE filed 3-20-84 (Register 84, No. 12).

§7958. Bacteriological Standards.

Note • History

(a) The minimum protective bacteriological standards for waters adjacent to public beaches and public water-contact sports areas shall be as follows:

(1) Based on a single sample, the density of bacteria in water from each sampling station at a public beach or public water contact sports area shall not exceed:

(A) 1,000 total coliform bacteria per 100 milliliters, if the ratio of fecal/total coliform bacteria exceeds 0.1; or

(B) 10,000 total coliform bacteria per 100 milliliters; or

(D) 104 enterococcus bacteria per 100 milliliters.

(2) Based on the mean of the logarithms of the results of at least five weekly samples during any 30-day sampling period, the density of bacteria in water from any sampling station at a public beach or public water contact sports area, shall not exceed:

(A) 1,000 total coliform bacteria per 100 milliliters; or

(B) 200 fecal coliform bacteria per 100 milliliters; or

(b) Water samples shall be submitted for bacteriological analyses to a laboratory certified by the Environmental Laboratory Accreditation Program, California Department of Health Services in microbiology for methods for the analysis of the sample type.

NOTE

Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code.

HISTORY

1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

2. Repealer and new section and amendment of Note filed 7-26-99 as an emergency; operative 7-26-99 (Register 99, No. 31). A Certificate of Compliance must be transmitted to OAL by 11-23-99 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99 and filed 11-30-99 (Register 99, No. 49).

§7959. Bacteriological Sampling.

Note • History

(a) In order to determine that the bacteriological standards specified in 7958 above are being met in a water-contact sports area designated by a Regional Water Quality Control Board in waters affected by a waste discharge, water samples shall be collected at such sampling stations and at such frequencies as may be specified by said board in its waste discharge requirements.

(b) In waters of a public beach or water-contact sports area that has not been so designated by a Regional Water Quality Control Board, water samples shall be collected at such sampling stations and at such frequencies as may be determined by the local health officer or the Department. Local health officers shall be responsible for the proper collection and analysis of water samples in such areas.

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code.

HISTORY

1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§7960. Corrective Action.

Note • History

When a public beach or public water-contact sports area fails to meet the standards as set forth in 7957 or 7958 above, the local health officer or the Department, after taking into consideration the causes therefor, may at his or its discretion close, post with warning signs, or otherwise restrict use of said public beach or public water-contact sports area until such time as corrective action has been taken and the standards as set forth in 7957 and 7958 above are met.

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code.

HISTORY

1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§7961. Public Beaches Visited by More Than 50,000 People Annually and Adjacent to Storm Drains.

Note • History

(a) Waters adjacent to a public beach shall be tested for bacteria identified in Section 7958 on at least a weekly basis from April 1 to October 31, inclusive, if the beach is

(1) Visited by more than 50,000 people annually, and

(2) Located adjacent to a storm drain that flows in the summer.

(b) Water samples shall be taken from locations that include areas affected by storm drains. Samples shall be taken in ankle- to knee-deep water, approximately 4 to 24 inches below the water surface.

(c) When testing reveals that the waters adjacent to a public beach fail to meet any of the standards set forth in Section 7958(a)(1) the local health officer shall post the beach pursuant to Health and Safety Code Section 115915, and shall use the standards of Section 7958(a)(1) and (2) in determining the necessity to restrict the use of or close the public beach or portion thereof.

(d) In the event of a known release of untreated sewage into waters adjacent to a public beach, the local health officer shall:

(1) Immediately post and close the beach or a portion thereof, or otherwise restrict its use until the source of the sewage release is eliminated;

(2) Sample the affected waters; and

(3) Continue closure or restriction of the beach or a portion thereof and posting the beach until testing results establish that the standards of Section 7958(a)(1) are satisfied.

NOTE

Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99 and filed 11-30-99 (Register 99, No. 49).

§7962. Duties Imposed on a Local Public Officer or Agency.

Note • History

Pursuant to Health and Safety Code Sections 115880(h), 115885(g), and 115915(c), any duty imposed upon a local public officer or agency by Section 7961 shall be mandatory only during a fiscal year in which the Legislature has appropriated sufficient funds, as determined by the State Director of Health Services, in the annual Budget Act or otherwise for local agencies to cover the costs to those agencies associated with performance of these duties.

NOTE

Authority cited: Section 100275, Health and Safety Code. Reference: Sections 115880, 115885 and 115915, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99 and filed 11-30-99 (Register 99, No. 49).

Article 5. Safety

NOTE

Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code.

HISTORY

1. Repealer of Article 5 (Section 7961) filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

Group 10.1. Sanitation of Public Beaches

Article 1. Intent of Regulations

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, 427.5, 427.6 and 427.9, Health and Safety Code.

HISTORY

1. New Group 10.1 (Sections 7970 through 7994) filed 8-30-72; effective thirtieth day thereafter (Register 72, No. 36). Sections 7982, 7990 and 7993 approved by Buildings Standards Commission 7-28-72.

2. Repealer of Article 1 (Section 7970) filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

Article 2. Definitions and Exemptions

§7971. Beach.

Note • History

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, 427.5, 427.6 and 427.9, Health and Safety Code.

HISTORY

1. Repealer filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

§7972. Saltwater Body.

Note • History

Saltwater Body means the ocean, a marine bay, estuary or lagoon.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-9-84 (Register 84, No. 32).

§7973. Freshwater Body.

Note • History

Freshwater Body means a natural or artificial lake, river, reservoir, stream or canal.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7974. Refuse.

Note • History

Refuse means domestic or industrial garbage, rubbish, or other debris adversely affecting public health and safety as specified by the Health Officer.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7975. Sanitation.

Note • History

Sanitation means the maintenance of a safe and healthful environment by means of removal of refuse; provision of sanitary toilet and handwashing facilities; disposal of sewage and liquid wastes; protection of bathing water quality; provision of pure, wholesome and potable drinking water; and control of harmful insects, rodents and animals.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7976. Recreational Purposes.

Note • History

Recreational purposes include but are not limited to, swimming, camping, scenic enjoyment, fishing, shellfish gathering, surfing, scuba or snorkel diving, boating, equestrianship, use of recreational vehicles, jogging, walking, and beachcombing.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7977. Public Health and Safety.

Note • History

Public health and safety means the maintenance of an environment that contributes to human well being, and in which there is an absence of human disease, ill health or injury.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7978. Health Officer.

Note • History

Health Officer means the legally appointed Health Officer of the county or city having jurisdiction of the area in which a public beach is located.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.5, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7979. Exemption.

Note • History

Sections 7981 through 7991 of Title 17 shall not apply when the Health Officer determines that the beach is maintained primarily as an open space. The criteria, among others, that may be evidence of open space is lack of developed access, lack of parking facilities, lack of lifeguard services, or where casual use normally does not exceed 50 people per mile of shoreline.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

§7980. Review by Health Officer.

Note • History

No persons shall begin construction, reconstruction or alteration of any public beach sanitation facility without first submitting plans, specifications and other such information, as may be required, to the Health Officer for his review and written approval. If no action is taken within fifteen (15) days of submission of plans, the project shall be deemed approved. If the Health Officer disapproves, the reason shall be so stated in writing.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

Article 3. Day Use Beaches

§7981. Application.

Note • History

The provisions of this article shall be applicable to public beaches where overnight camping is not permitted.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7982. Toilets.

Note • History

Toilets shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code. Portable toilets may be substituted for plumbed toilets.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, Health and Safety Code.

HISTORY

1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

§7983. Water Supply.

Note • History

Water when provided for drinking, showers, or handwashing shall be from a source approved by the Health Officer.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7984. Maintenance.

Note • History

Toilets shall be available to the public at all times the beach is officially open for use. All facilities must be maintained in a clean and sanitary condition at all times.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7985. Refuse Handling.

Note • History

(a) Refuse containers approved by the Health Officer shall be provided at all public beaches.

(b) All refuse shall be stored in the container in a manner which will not create a nuisance.

(c) Containers shall be emptied at frequencies sufficient to prevent overflow and to be maintained in a sanitary condition.

(d) Every public beach shall be maintained in a clean condition free of refuse.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7985.1. Animals.

Note • History

No person shall bring onto or allow any animal, except guide dogs used by the blind, to remain on any beach which has been designated a public swimming beach by the state, or any city, county, or city and county and where lifeguards are provided, except that horses may be ridden on designated equestrian trails and areas.

This regulation is not intended to prohibit or supersede any local ordinance now in effect or which may be enacted.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New section filed 8-3-73; effective thirtieth day thereafter (Register 73, No. 31).

2. Editorial correction of NOTE filed 8-9-84 (Register 84, No. 32).

§7986. Implementation.

Note • History

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. Repealer filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

Article 4. Beaches Allowing Overnight Camping

§7987. Application.

Note • History

The provisions of this article shall be applicable to public beaches used for overnight camping.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7988. Refuse Handling.

Note • History

(a) Refuse containers approved by the Health Officer shall be provided in every camping area.

(b) All refuse shall be stored and removed in a manner that will not create a nuisance.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7988.1. Animals.

Note • History

This regulation is not intended to prohibit or supersede any local ordinance now in effect or which may be enacted.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New section filed 8-3-73; effective thirtieth day thereafter (Register 73, No. 31).

2. Editorial correction of NOTE filed 8-9-84 (Register 84, No. 32).

§7989. Campsites.

Note • History

(a) No travel trailer, camp car, recreational vehicle or tent shall be located closer than six feet from any building or other travel trailer, camp car, recreational vehicle or tent on an adjacent lot or campsite.

(b) Each vehicular lot or campsite in a camping area shall have direct access.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. Editorial correction of NOTE filed 8-9-84 (Register 84, No. 32).

§7990. Sanitary Facilities.

Note • History

(a) Toilets shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code.

(b) Shower baths or other bathing facilities are not required; however, when provided, they shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

§7991. Maintenance.

Note • History

All sanitary facilities shall be maintained in a clean and safe condition.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7992. Disposal of Sewage Wastes.

Note • History

(a) Wastewater or material from plumbing fixtures shall not be permitted to be deposited upon the ground.

(b) Campsites not provided with a drain inlet shall not be occupied by a travel trailer, camp car, or recreational vehicle equipped with plumbing unless the drain outlet of the vehicle is capped or as otherwise provided by part (c) of this section. Each campsite for use by vehicles equipped with toilets, unless self-contained shall be provided with a three-inch drain inlet.

(d) Trailer sanitation stations approved by the Health Officer and designed to receive the discharge of sewage holding tanks of self-contained vehicles shall be installed or available in an accessible location to every public beach campground area in which there are campsites not provided with drain inlets designed to receive the discharge of sewage wastes. Trailer sanitation stations shall be provided on the basis of one station for each 100 such campsites or portion thereof.

(e) Trailer sanitation stations shall be designed and constructed as required by Sections 5570 through 5580, Title 25, California Administrative Code.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7993. Laundry Facilities.

Note • History

Laundry facilities are not required; however, when provided they shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

§7994. Water Supply.

Note • History

When provided, potable water shall be from a source approved by the Health Officer and obtainable from faucets installed not more than 400 feet from each campsite. Potable water shall be adequate for all the requirements of the camping area.

NOTE

Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

Group 11. Food Crop Growing and Harvesting Sanitation

Article 1. Intent of Regulations

§T17-8000. Intent of Regulations.

Note • History

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.20, Health and Safety Code.

HISTORY

1. New Group 11 (Sections 8000 through 8013) filed 4-13-66; effective thirtieth day thereafter (Register 66, No. 9).

2. Repealer of Article 1 (Section T17-8000) filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 2. Definitions

§T17-8001. Food Crop.

Note • History

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.21, Health and Safety Code.

HISTORY

1. Amendment filed 6-12-70; effective thirtieth day thereafter (Register 70, No. 24).

2. Repealer filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§T17-8002. Privacy.

Note • History

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. Repealer filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§8003. Toilet Facilities.

Note • History

Toilet facilities include water flush toilets, chemical toilets, or sanitary privies where lawful, in portable or fixed form.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.23, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

2. Editorial renumbering of former Section T17-8003 to Section 8003 (Register 85, No. 32).

Article 3. Toilet Facilities

§8004. General Standards.

Note • History

Toilet facilities shall meet the following standards:

(a) Toilet facilities shall provide a minimum area of eight (8) square feet, with a minimum width of two and one-half (2 1/2) feet for each toilet seat. A minimum area of ten (10) square feet, with a minimum width of two and one-half (2 1/2) feet, shall be required when a urinal is included. Sufficient additional space shall be included if handwashing facilities are within the facility.

(b) Units housing toilet and handwashing facilities shall be rigidly constructed and their inside surfaces shall be of nonabsorbent material, smooth, readily cleanable, and finished in a light color.

(c) Units housing toilet and handwashing facilities shall be ventilated and provided with self-closing doors, lockable from the inside.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section T17-8004 to Section 8004 filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§8005. Chemical Toilet Standards.

Note • History

The wastewater tank on chemical toilets shall be constructed of durable, easily cleanable material and have a minimum tank capacity of forty gallons. Construction shall be such as to prevent splashing on the occupant, field, or road.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Sections 5474.23 and 547.29, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section T17-8005 to Section 8005 filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 4. Servicing of Units

§8006. Suitable Chemicals.

Note • History

Odor control and solid liquefying chemicals that are effective at all times shall be used in chemical toilet waste holding tanks.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.29, Health and Safety Code.

HISTORY

1. Amendment filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32.)

§8007. Disposal of Contents of Chemical Tanks.

Note • History

Contents of chemical tanks shall be disposed of by draining or pumping into a sanitary sewer, an approved septic tank of sufficient capacity to handle the wastes, a suitably sized and constructed holding tank, approved by the local health department, or by any other method approved by the local health department.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§8008. Standards.

Note • History

Handwashing facilities shall meet the following standards:

(a) Pure, wholesome, and potable water shall be available for handwashing.

(b) Signs shall be posted, indicating that the water is only for handwashing purposes.

(d) Handwashing facilities shall be provided at the unit or in the immediate vicinity.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.26, Health and Safety Code.

HISTORY

1. Repealer of former Section 8008, and renumbering and amendment of former Section 8012 to Section 8008 filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§8009. Privies.

Note • History

Privies shall be moved to a new site or taken out of service when the pit is filled to within two feet of the adjacent ground surface. The pit contents shall be covered with at least two feet of well-compacted dirt when the privy is moved.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§8010. Toilets.

Note • History

It shall be the responsibility of the employer to insure that toilets are serviced and maintained in a clean, sanitary condition and kept in good repair at all times.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. New NOTE filed 8-9-84 (Register 84, No. 32).

Article 5. Supplies

§8011. Toilet Paperholder.

Note • History

Toilet paper shall be provided in a suitable holder in each toilet unit.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. Amendment filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 6. Handwashing Facilities

§8012. Standards.

Note • History

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.26, Health and Safety Code.

HISTORY

1. Renumbering and amendment of Section T17-8012 to Section 8008 filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 7. Waste Wash Water Disposal

§8013. Water Flush Toilets and Handwashing Facilities.

Note • History

Water flush toilets and handwashing facilities shall conform to the (Compiled) State Building Standards Code, Part 5, Title 24, California Administrative Code.

NOTE

Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code.

HISTORY

1. Repealer and new section filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Group 12. Reclaimed Waste Water

§8025. Intent.

Note • History

NOTE

Authority cited for Group 12: Section 102, Health and Safety Code. Reference: Section 13521, Water Code.

HISTORY

1. New Group 12 (Sections 8025 through 8050) filed 5-20-68; effective thirtieth day thereafter (Register 68, No. 20).

2. Repealer of Group 12 (Sections 8025-8050) filed 4-2-75; effective thirtieth day thereafter (Register 75, No. 14).

Subchapter 1.5. Regulations for Implementation of the California Environmental Quality Act of 1970

(Originally Printed 7-21-73)

NOTE

Authority cited: Section 208, Health and Safety Code, and Section 21082, Public Resources Code. Reference: Section 21000 et seq., Public Resources Code.

HISTORY

1. New Subchapter 1.5 (Sections 8100-8113.5) filed 7-20-73; effective thirtieth day thereafter (Register 73, No. 29).

2. Amendment filed 11-21-79; effective thirtieth day thereafter (Register 79, No. 47).

3. Repealer of Subchapter 1.5 (Sections 8100-8113.5) filed 10-12-83; effective thirtieth day thereafter (Register 83, No. 42).

Subchapter 2. Foods and Drugs

Group 1. Rules and Regulations

§10101. Order Promulgating Regulations.

Note • History

Under the authority of Sections 200 through 208, 26321, 26542, 28013, 28153, 28182, 28243, 28339, 28440, 28508, 28663.5 and 28709 of the Health and Safety Code, and Section 1147 of the Agricultural Code, the following regulations for the enforcement of Division 21 of the Health and Safety Code are hereby promulgated.

These regulations shall take effect on September 1, 1954.

The regulations now in force are hereby repealed as of the date the new regulations herein promulgated shall become effective.

NOTE

Authority cited for subchapter 2 filed 7-29-54: Sections 200 through 208, 26321, 26542, 28013, 28153, 28182, 28243, 28339, 28440, 28508, 28663.5, 28709, Health and Safety Code, and Section 1147, Agricultural Code.

HISTORY

1. Originally printed August 15, 1945 (Title 17).

2. For repealers, added sections, amendments and revisions of former subchapter 2, refer to Registers 8, No. 3; 10, No. 6; 13, No. 2; 16, No. 5; 17, No. 2; 18, No. 4; 19, No. 2; 20, No. 1; and 26, No. 3.

3. Repealer and new subchapter 2 filed 7-29-54; designated effective 9-1-54 (Register 54, No. 16).

§10102. General Regulations.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10103. Constitutionality.

If any section, subsection, clause, sentence, or phrase of these regulations or standards is for any reason held to be invalid or unconstitutional, such decision shall not affect the remaining portions of these regulations or standards. The State Board of Public Health hereby declares that it would have adopted the remaining portions of these regulations or standards irrespective of the fact, that any such section, subsection, clause, sentence, or phrase of these regulations or standards be declared invalid or unconstitutional.

§10150. Cosmetic Regulations.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Article 1. Definitions

§10200. Dietary Supplement.

Note • History

(a) “Dietary supplement”

(1) Means an article (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) A vitamin,

(B) A mineral,

(D) An amino acid,

(E) A dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or

(F) A concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) Means a product that

(A) Is labeled as a dietary supplement and

(B) Is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or if not intended for ingestion in such a form

(3) Does

(A) Include an article that is approved as a new drug in compliance with Health and Safety Code section 111550, subdivision (a) or (b), certified as an antibiotic under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 357, and/or licensed as a biologic under the Public Health and Safety Act, 42 U.S.C. section 262 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food, unless the article, when used as or in a dietary supplement under the conditions of use set forth in the labeling for such dietary supplement is adulterated under California Health and Safety Code section 110545, and

(B) Not include

1. An article that is approved as a new drug in compliance with Health and Safety Code section 111550, subdivision (a) or (b), certified as an antibiotic under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 357, and/or licensed as a biologic under the Public Health and Safety Act, 42 U.S.C., section 262, or

2. An article authorized for investigation as a new drug, antibiotic, or biologic for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, and which was not, before its approval, certification, licensing, or authorization, marketed as a dietary supplement.

(b) A dietary supplement may be a food or a drug, or both a food and a drug, as these terms are defined in Health and Safety code sections 109935 and 109925.

NOTE

Authority cited: Sections 100275, 110065 and 110100, Health and Safety Code. Reference: Sections 110175, 110290, 110545, 110620, 110625, 110630, 110660, 110705, 110760, 110765 and 110770, Health and Safety Code.

HISTORY

1. New article 1 (section 10200) and section filed 10-15-96; operative 1-1-97 (Register 96, No. 42). A Certificate of Compliance must be transmitted to OAL by 5-1-97 or emergency language will be repealed by operation of law on the following day.

2. New article 1 (section 10200) and section refiled 4-29-97 as an emergency; operative 5-2-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-2-97 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-29-97 order transmitted to OAL 8-28-97 and filed 10-9-97 (Register 97, No. 41).

Article 2. Drugs and Devices Regulations

DRUGS AND DEVICES

§10350. Labeling Defined (26207).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10355. Truth of Labeling (26208).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10360. New Drugs--Definition.

Note • History

Newness of a drug may arise by reason (among other reasons) of:

(a) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component;

(b) The newness for drug use of a combination of two or more substances, none of which is a new drug;

(c) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug;

(d) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body; or

(e) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26021, Health and Safety Code.

HISTORY

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No. 15).

2. Amendment of section heading and repealer of subsection (f) filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10365. Drugs--Name (26230).

History

HISTORY

1. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10370. Poisonous Insecticides and Rodenticides, Use of (26234(2)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10371. Drugs: Current Good Manufacturing Practice in Manufacture, Processing, Packaging, Labeling or Holding (26234(3)).

Note • History

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 26234(3), Health and Safety Code.

HISTORY

1. New section filed 1-3-66; effective thirtieth day thereafter (Register 66, No. 1).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10375. Blending of Certified Coal Tar Colors (26235 (2)).

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10376. Drug and Device Manufacturing Licenses.

Note • History

(a) The fee for a manufacturer's license as required by Sections 26685 and 26688 of the Health and Safety Code is $200.00 and will cover a period of 12 months. The license is not transferable and will not be prorated.

(b) Manufacturers of human prescription drugs shall pay an additional license fee of $100.00 per year, plus the fingerprint processing fee charged by the California Department of Justice.

(c) Application for Drug Manufacturing License shall be made on State Department of Health form #EH-52 (Rev. 4/93). Applications for a Device Manufacturing License shall be made on State Department of Health form #EH-72.

(d) Applications for a Drug Manufacturing License shall include the following information on or attached to the application form:

(1) The name of the license applicant, and the full business address and telephone number of the manufacturing facility;

(2) All trade or business names used by the license applicant;

(3) Name(s) of the person(s) in charge of manufacturing;

(4) Name, address and telephone number of the person responsible for correspondence;

(5) The type of ownership or operation (for example, partnership, association, corporation, or individual/sole proprietorship);

(6) The name(s) of the owner and/or operator of the license applicant, including:

(A) If an individual, the name of the individual; if a sole proprietorship, the name of the sole proprietor and the name of the business entity;

(B) If a partnership or other unincorporated association, the name of each partner or member, and name of the partnership or association;

(C) If a corporation, the corporate name, and the state of incorporation, the name and title of each corporate officer and director; and

(D) The name of each person holding more than 5 percent equity, or debt liability of the applicant.

(7) Types of products to be manufactured;

(8) Type of processing to be utilized;

(9) Signature of license applicant under penalty of perjury affirming that the information in the application is true and accurate;

(10) Printed name and title of the individual signing the application;

(11) Date application was signed; and

(12) For human prescription drug manufacturers only:

(A) properly completed Disclosure Statement (form #EH-53 (rev. 4/93)), two properly completed fingerprint cards, and fingerprint processing fee for each person in charge of manufacturing and each person whose name is required to be included in the license application under Paragraphs (d)(6)(A) through (d)(6)(C). However, where the license applicant is a corporation, partnership, or other business association and the total number of partners, members, or corporate officers, directors, and shareholders (as the case may be) exceeds five, the application shall so state, and the documents and fee described in this Paragraph shall only be submitted for each person in charge of manufacturing, and

1. For corporations: of the corporate officers who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five highest ranking officers in this group, and

2. For partnerships, joint ventures, and similar business association: of the partners or members who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five persons in this group who own the largest interests in the applicant entity.

(B) Fingerprint cards and fingerprint processing fee shall only be submitted once for each person. If there is a change of any person in charge of manufacturing or any person occupying a position listed in Paragraphs (d)(6)(A) through (d)(6)(C), fingerprint cards and processing fee shall be submitted for each new or additional person.

(C) Other persons listed in Paragraph (d)(6) may be required by the Department to submit the documents described in this Paragraph as necessary to determine the qualifications of the applicant.

(e) Within 30 calendar days of receipt of a drug manufacturing license application, the Department shall inform the applicant in writing that it is either complete and accepted for filing or that the application is deficient and what specific information or documentation is required to complete the application. An application is considered complete when all information, documents, and fees required in this Section have been received by the Department.

(f) Within 240 calendar days from the date of filing of a completed drug manufacturing license application, the Department shall inform the applicant in writing of its decision regarding a drug manufacturing license application. The median time for the Department to process a drug manufacturing license application from acceptance of the initial application to the final license decision has been 29 calendar days; the minimum time was one calendar day; the maximum time was 919 calendar days.

NOTE

Authority cited: Section 15376, Government Code and Sections 102, 208, 26202, 26209 and 26688, Health and Safety Code. Reference: Sections 26685, 26687, 26688 and 26689, Health and Safety Code.

HISTORY

1. New section filed 5-16-69 as an emergency; designated effective 7-1-69 (Register 69, No. 20).

2. Certificate of Compliance--section 11422.1, Gov. Code, filed 7-29-69 (Register 69, No. 31).

3. Amendment filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

4. Amendment of section heading, new subsection (b) and renumbering and amendment of following paragraph and repealer of subsections (c)-(d) and new subsections (d)-(f) and amendment of Note filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.

5. Amendment refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of History 5. (Register 93, No. 20).

7. Certificate of Compliance as to 1-20-93 order including amendment of subsections (c) and (d)(12)(A), and repealer and new subsections (d)(12)(A)1.-2. transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377. Definitions.

Note • History

(a) The definitions set forth in this Section apply to Sections 10376 through 10377.8 only.

(b) Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(d) Controlled Substance means, unless otherwise specified, a drug, substance, or immediate precursor which is listed in any schedule in Health and Safety Code Sections 11054, 11055, 11056, 11057, or 11058, or which is regulated as a controlled substance under the Controlled Substances Act (21 U.S.C. § 801 et seq.) or the Controlled Substances Import and Export Act (21 U.S.C. § 951 et seq.).

(e) Drug sample means a unit of a human prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

(f) Human prescription drug means any drug intended for human use required by State law to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 26660 of the Health and Safety Code.

(g) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man, including those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

(h) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the drug product.

(i) Manufacturer means any person who prepares, compounds, propagates, processes, or fabricates any drug. The term manufacturer includes anyone who repackages or otherwise changes the container, wrapper, or labeling of any drug in furtherance of the distribution of the drug. The term manufacturer does not include:

(1) A retailer who repackages from a bulk container at the time of sale to its ultimate consumer; or

(2) Anyone who sells, purchases, or trades blood or blood components intended for transfusion, provided that the blood or blood components are prepared using physical or mechanical means, not chemical processes.

(j) Transfusion means a use of blood or blood components in which the blood or blood components are administered into a vein of a human being for treatment of disease, including physical injury.

NOTE

Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Sections 26209, 26685, 26686 and 26688, Health and Safety Code.

HISTORY

1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93, No. 20).

4. Editorial correction of printing error in subsection (e) (Register 93, No. 28).

5. Certificate of Compliance as to 1-20-93 order including amendment of subsection (d) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.1. Qualifications.

Note • History

(a) A license to manufacture human prescription drugs may be denied on the ground that the license applicant is not qualified by reason of the applicant's experience to manufacture and distribute human prescription drugs in a safe manner and in compliance with federal, state, and local drug laws. In the case of a partnership, association, or corporation, an applicant's experience includes the experience of each person whose name is required to be included in the license application. An applicant's experience includes, but is not limited to, the following factors:

(1) Any conviction of the applicant under any federal, state, or local laws relating to drugs, including drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

(2) Any felony conviction of the applicant under federal, state, or local laws which is substantially or rationally related to the qualifications, functions, and duties of a licensed human prescription drug manufacturer; a crime shall be considered substantially or rationally related to qualifications, functions, or duties of human prescription drug manufacturer if, reasonably or to a substantial degree, it evidences present or potential unfitness of a licensee to perform the functions authorized by the license in a manner consistent with the public health, safety, or welfare.

(3) The applicant's past experience in the manufacture or distribution of drugs, including controlled substances;

(4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(5) Suspension or revocation by federal, state, or local government of any license or permit currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

(6) Compliance with licensing requirements under drug or device licenses previously granted by the Department, if any;

(7) Compliance with requirements to maintain and/or make available to the Department those records required under the Sherman Food, Drug, and Cosmetic Law (Health and Saf. Code § 26000 et seq.) and the regulations adopted pursuant to that law;

(8) Compliance with requirements to make available to federal, state, or local law enforcement officials those records described in 21 Code of Federal Regulations section 205.50 (55 Fed. Reg. 38025-38026 (Sept. 14, 1990)); and

(9) History of addiction or habitual use of any controlled substance, narcotic, prescription drug, or alcoholic beverage.

(b) As used in subsection (a), “conviction” includes a plea, verdict, or finding of guilt regardless of whether sentence has been imposed, but does not include:

(1) any conviction for an offense specified in subdivision (a) or (b) of Health and Safety Code Section 11361.5 which became final more than two years prior to the date of the license application, or

(2) any conviction under Health and Safety Code Section 11557 or its successor Section 11366 when that conviction was stipulated or designated to be a lesser included offense of the offense of possession of marijuana;

(c) The Department may deny a license to a license applicant if it determines that the granting of such a license would not be in the public interest, based on factors which are substantially or rationally related to protecting the public from adulterated or misbranded human prescription drugs.

NOTE

Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612, 26689 and 26691, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Editorial correction of printing error in subsection (a)(6) (Register 93, No. 28).

5. Certificate of Compliance as to 1-20-93 order including new subsections (b)-(b)(2) and subsection relettering, transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.2. Revocation and Suspension.

Note • History

(a) Any conviction of any violation of federal, state, or local drug laws shall be grounds for suspending or revoking a license to manufacture human prescription drugs.

(b) Any action or conduct which would have warranted denial of a license to manufacture human prescription drugs shall be grounds for suspending or revoking a license to manufacture human prescription drugs.

NOTE

Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Sections 26688, 26689, 26691 and 26801, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.3. Compliance.

Note • History

Human prescription drug manufacturers and their officers, agents, representatives, and employees shall comply with the requirements of Sections 10377.4, 10377.5, 10377.6, 10377.7, and 10377.8 relating to human prescription drugs.

NOTE

Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.4. Requirements for the Storage and Handling of Human Prescription Drugs.

Note • History

(a) All facilities at which human prescription manufacturers manufacture, store, warehouse, handle, offer, market, display, or otherwise hold human prescription drugs shall be secure from unauthorized entry and shall have adequate security conditions, as follows:

(1) Access from outside the premises shall be kept to a minimum and be well-controlled;

(2) The outside perimeter of the premises shall be well-lighted; and

(3) Entry into areas where human prescription drugs are held shall be limited to authorized personnel.

(b) All such facilities shall be equipped with an alarm system to detect entry after hours.

(c) All such facilities shall be equipped with an alarm system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(d) Each outgoing shipment of human prescription drugs shall be carefully inspected for identity of the human prescription drugs and to ensure that there is no delivery of human prescription drugs that have been damaged in storage or held under improper conditions. Records of nonconforming drugs and their disposition shall be established and maintained, and shall include the name and label potency of the drug product, dosage form, lot number, quantity, reason for nonconformance, name of the inspector, date of inspection, and disposition.

(e) Human prescription drugs manufactured by the licensee, which are outdated, damaged, deteriorated, misbranded, or adulterated, shall be quarantined and physically separated from other prescription drugs until they are destroyed or brought into compliance with all applicable laws by reprocessing or relabeling. Records of drugs quarantined shall be established and maintained, and shall include the name and label potency of the quarantined drug product, dosage form, lot number, reason for the quarantine, name of the person responsible for the quarantine, location of quarantined drug product, date of disposition, and ultimate disposition of the quarantined drug product.

NOTE

Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of subsection (a) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.5. Requirements for the Establishment and Maintenance of Human Prescription Drug Records.

Note • History

(a) Human prescription drug manufacturers shall establish and maintain inventories and records of all transactions regarding the disposal of human prescription drugs. These records shall include the following information:

(1) The identity and quantity of the human prescription drugs disposed of; and

(2) The dates of disposal of the human prescription drugs.

(b) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), shall be made available for inspection and photocopying by the Department or any authorized federal, state, or local law enforcement agency officials for a period of at least three years following distribution, disposal, or other disposition.

(c) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection as soon as possible, but no later than two working days after a request by an authorized official of a federal, state, or local law enforcement agency.

(d) Human prescription drug manufacturers shall establish and maintain lists of officers, directors, managers, and other persons in charge of human prescription drug manufacturing, distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

NOTE

Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.6. Written Policies and Procedures for the Handling of Human Prescription Drugs.

Note • History

(a) Human prescription drug manufacturers shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the security and disposition of human prescription drugs including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

(b) Human prescription drug manufacturers shall include in their written policies and procedures the following:

(1) A procedure to be followed for handling recalls and withdrawals of human prescription drugs. This procedure shall be adequate to deal with recalls and withdrawals due to:

(A) Any action initiated at the request of the Department, the federal Food and Drug Administration or other federal, state, or local law enforcement or other government agency;

(B) Any voluntary action by the manufacturer to remove defective or potentially defective human prescription drugs from the market; or

(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(2) A procedure to ensure that the manufacturer is prepared for, protected against, and is ready to handle any crisis that affects security or operation of any facility in the event of fire, flood, or other natural disaster, or strike or other situations of local, state or national emergency; and

(3) A procedure to ensure that any outdated human prescription drugs shall be segregated from other drugs and destroyed. This procedure shall provide for written documentation of the disposition of outdated human prescription drugs. This documentation shall be maintained for at least three years after disposition of the outdated human prescription drugs.

NOTE

Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.7. Inspection by Federal, State, and Local Law Enforcement Officials.

Note • History

Human prescription drug manufacturers shall permit authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, during business hours or any other reasonable times and in a reasonable manner, to the extent authorized by law.

NOTE

Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Section 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10377.8. Manufacturers of Active Ingredient Components of Human Prescription Drugs.

Note • History

(a) In addition to the regulations in this article, manufacturers of any active ingredient component of a human prescription drug shall comply with the following sections of Code of Federal Regulations, title 21, part 211 (revised as of April 1, 1992), except that all references to “drug product” shall apply to active ingredient components: sections 211.25 (Personnel qualifications), 211.28 (Personnel responsibilities), 211.42 (Design and construction features), 211.44 (Lighting), 211.46 (Ventilation, air filtration, air heating and cooling), 211.48(a) [first sentence] and (b) (Plumbing), 211.50 (Sewage and refuse), 211.52 (Washing and toilet facilities), 211.56 (Sanitation), 211.58(Maintenance), 211.63 (Equipment design, size, and location), 211.65 (Equipment construction), 211.67 (Equipment cleaning and maintenance), 211.68 (Automatic, mechanical, and electronic equipment), 211.142 (Warehousing procedures), 211.150 (Distribution procedures), 211.180(a), (c), (d), and (f) (General requirements), 211.182 (Equipment cleaning and use logs), 211.196 (Distribution records), 211.204 (Returned drug products), and 211.208 (Drug product salvaging).

(b) In the event that it is impossible for a manufacturer of a biological drug to comply with both this section and the federal regulations for the manufacture of biologic drugs, this section shall not apply to the extent that it conflicts with a federal regulation specifically applicable to the biological drug product in question.

NOTE

Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

HISTORY

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of newly designated subsection (a) and new subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§10380. Labeling, Misbranding (26240).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10381. Label Non-Prescription Drugs. Pregnancy/Nursing.

Note • History

(a) Any drug not subject to Section 26660 of the Health and Safety Code which is intended for systemic absorption into the human body shall include on the label the following statement:

“Caution: If pregnant or nursing a baby, consult your physician or pharmacist before using this product.”

(b) Section 10381(a) shall not apply if such drug:

(1) Is intended for poison control purposes.

(2) Is labeled with information regarding use in pregnancy and nursing which is substantially similar to the statement required by Section 10381(a).

(3) Meets both of the following:

(A) It is intended to benefit the embryo, fetus or nursing infant during the period of pregnancy or lactation.

(B) It is labeled with specific directions for use during the period of pregnancy or lactation pursuant to federal or state requirements.

(4) Is not intended to be systemically absorbed.

(5) Is oxygen intended for emergency use.

(c) Any drug manufactured and labeled after 11-18-82 shall be misbranded if the information required by this section is not disclosed on the label.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400, 26630 and 26638, Health and Safety Code.

HISTORY

1. New section filed 10-19-81; effective thirtieth day thereafter (Register 81, No. 43).

2. Editorial correction of subsection (c) (Register 82, No. 3).

§10385. Labeling Requirements (26241).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10386. Manufacturer of Finished Dosage Form.

Note • History

The intent of this section is to assure that the advertising and labeling required by Section 26636(c) of the code provides sufficient useful information to pharmacists, physicians, and other purchasers of prescription drugs that they may identify certain persons participating in the manufacturing of the finished dosage form of such drug(s). These regulations are in addition to the regulations of other sections of the Sherman Food, Drug, and Cosmetic Law regarding labeling and advertising requirements for drugs.

(a) For the purpose of this section the finished dosage form of a prescription drug is defined as that form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling.

(b) For the purpose of this section only, the term “drug” shall include only those articles as defined in Section 26010 of the Act which achieve their principal intended purposes through chemical action within or on the body of man or other animals or which are metabolized in the achievement of these purposes.

(c) For the purpose of this section the term “manufacturer” means persons who “manufacture” as that term is defined by Section 26019 of the Health and Safety Code.

(d) For the purpose of this section the term advertisement shall have the same definition as Section 26002 of the Health and Safety Code.

(e) The labeling and advertising for any prescription drug, including those whose label states “distributed by . . .” or similar language, must contain the name and place of business of the manufacturer who mixed the final ingredients, and the manufacturer who encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form, qualified by such phrases as “final ingredients mixed by . . .,” “encapsulated by . . .,” “tableted by . . .,” or words of similar or like meaning that express the facts. The presence of the name and address of only one manufacturer shall mean that only the named firm mixed the final ingredients and encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form.

(f) The requirement for declaration of the name of the manufacturer of the finished dosage form shall be deemed to be satisfied in the case of a corporation only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

(g) For the purposes of this section, all products subject to this section will be deemed to be misbranded if the name and place of business of each manufacturer as described in the foregoing subsections of this regulation is not included in the labeling on, or within the package from which the drug is dispensed and in all advertising of such product intended primarily for dissemination to California practitioners.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26636, Health and Safety Code.

HISTORY

1. New section filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10390. Forms of Making Required Statements (26242).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10395. Statements of Ingredients and Proportions (26243).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§10400. Hoxsey Method for Treatment of Cancer.

Note • History

(a) The Hoxsey method is a cancer treatment system which employs the use of the substances potassium iodide, lactated pepsin, red clover blossoms, cascara sagrada, licorice, burdock root, stillingia root, berberis root, poke root, echinacea root, prickly ash bark, and buckthorn bark, either singly or in combination with each other.

(b) The prescription, administration, sale or other distribution of Hoxsey agents, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes he or she has or who may have cancer is prohibited, except as provided by Section 1708 of the Health and Safety Code.

(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all ingredients of the Hoxsey formula, make any representation that said Hoxsey method for the treatment of cancer, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination or in any guise whatever, has any value in arresting or curing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.1. Beta-Cyanogenetic Glucosides (“Laetriles”) Agent for Treatment of Cancer.

Note • History

(a) The Department of Public Health has carefully considered a document entitled “A Report on the Treatment of Cancer with Beta-Cyanogenetic Glucosides (`Laetriles')” dated May 20, 1963, and is satisfied beyond a reasonable doubt that the findings therein are true. The Department hereby ratifies and adopts said report as its own and a copy of same is on file with the California State Department of Public Health and is available for public inspection at its office located at 2151 Berkeley Way, Berkeley, California.

(b) The Department of Public Health hereby finds that beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide), and prunasin, commonly known as “Laetriles,” are of no value in the diagnosis, treatment, alleviation or cure of cancer and that the use of one or more of these agents in early cancer to the exclusion of conventional treatment might well be dangerous since treatment with acceptable, modern, curative methods (surgery or radiation) would thereby be delayed potentially until such time as metastases had occurred and the cancer therefore might no longer be curable. In late disease palliative effect is lacking. The Department recommends that the public refrain from using any of the said agents or any agent, drug, medicine, compound or device substantially similar thereto in the diagnosis, alleviation, treatment or cure of cancer.

(c) Except as otherwise provided in Section 1708 of the California Health and Safety Code the prescription, administration, sale or other distribution of beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) and prunasin, commonly known as “Laetriles” or, any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes that he has or may have cancer is prohibited; and the Department shall upon learning of such prescription, administration, sale or other distribution take appropriate steps to cause such persons so doing to cease and desist therefrom.

(d) No person shall for the purpose of prescribing, administering, selling or otherwise distributing beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) or prunasin, commonly known as “Laetriles,” make any representation that said agents have any value in arresting, alleviating or curing cancer; and the Department shall upon learning of such representation take appropriate steps to cause such person to cease and desist from such representation and shall take such other and further steps as may be appropriate to cause such representation to be discontinued.

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

§10400.2. Bolen Test for Diagnosis of Cancer.

Note • History

(a) As used in this section, the Bolen test means the determination of malignancy by the clotting patterns of a drop of blood as described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to the DIAGNOSIS OF CANCER WITH THE BOLEN TEST dated April 17, 1963.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the administration of the Bolen test or any substantially similar test for the diagnosis of cancer in any patient who has or who believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of administering the Bolen test make any representation that it has any value in diagnosing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference, Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.3. Koch Agents for Treatment of Cancer.

Note • History

(a) As used in this section, the Koch agents mean those agents described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH THE KOCH SYNTHETIC ANTITOXINS --(Malonide, Glyoxylide and Parabenzoquinone) dated April 17, 1963, which agents are commonly known as Malonide, Glyoxylide and Parabenzoquinone and are further commonly collectively known as the Koch agents.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of the three Koch agents, as defined in subsection (a) of this section, or any agents substantially similar thereto, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all of the Koch agents, make any representation that the Koch agents, whether singly or in any combination or in any guise whatever, have any value in arresting, alleviating, or curing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.4. Lincoln Staphage Lysate Agent for Treatment of Cancer.

Note • History

(a) As used in this section, Lincoln Staphage Lysate means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH LINCOLN STAPHAGE LYSATE, dated April 17, 1963, which agent consists of staphylococcus bacteriophage lysates, alpha and beta is commonly known as Lincoln Staphage Lysate.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Lincoln Staphage Lysate, as defined in subsection (a) of this section, or any agent substantially similar thereto, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Lincoln Staphage Lysate, make any representation that it has any value in arresting, alleviating or curing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.5. Mucorhicin Agent for Treatment of Cancer.

Note • History

(a) As used in this section, Mucorhicin means that agent, consisting of a mold substrate containing generic forms of Mucor, Rhizopus and various strains of penicillium, as described and defined in the report entitled REPORT, FINDINGS, AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH MUCORHICIN, dated April 17, 1963.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Mucorhicin, as defined in subsection (a) of this section, or any agent substantially similar thereto, in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Mucorhicin, make any representation that Mucorhicin in any dosage or in any guise whatever, has any value in arresting, alleviating or curing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No. 17).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.6. Anthrone Test for Diagnosis of Cancer.

Note • History

(a) As used in this section, the Anthrone test means the determination of the presence or degree of malignancy by the purported determination of the 24 hour level of chorionic gonadotropin excretion in urine as such method is described and defined in the report entitled in part REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL with respect to the DIAGNOSIS OF CANCER WITH THE ANTHRONE TEST dated August 17, 1964.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the use of the Anthrone test, as described in subsection (a) of this section, or any test substantially similar thereto for the diagnosis of cancer in any patient who has or who believes that he has or who may have cancer is prohibited.

(c) No person shall, for the purpose of using the Anthrone test in any guise whatever, make any representation that it has any value in diagnosing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 7-28-65; effective thirtieth day thereafter (Register 65, No. 13).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10400.7. Krebiozen for Treatment of Cancer.

Note • History

(a) As used in this section Krebiozen means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS OF THE CANCER ADVISORY COUNCIL with respect to THE TREATMENT OF CANCER WITH KREBIOZEN dated May 27, 1964 and the supplementary report of said Council dated September 12, 1967.

(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the prescription, administration, sale or other distribution of Krebiozen, as defined in subsection (a) of this section, or any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Krebiozen, make any representation that said agent has any value in arresting, alleviating or curing cancer.

NOTE

Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.

HISTORY

1. New section filed 10-27-67; effective thirtieth day thereafter (Register 67, No. 43).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10401. Drugs for Use in the Diagnosis, Treatment, Alleviation or Cure of Cancer in Human Beings.

Note • History

NOTE

Authority cited: Sections 102, 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1-1707.7, Health and Safety Code.

HISTORY

1. New section filed 3-8-68 as an emergency; effective upon filing (Register 68, No. 10).

2. Amendment filed 4-3-68 as an emergency; effective upon filing. Certificate of Compliance included (Register 68, No. 14).

3. Amendment of 1st paragraph filed 6-24-68; effective thirtieth day thereafter (Register 68, No. 24).

4. Amendment of 1st paragraph filed 3-19-70; effective thirtieth day thereafter (Register 70, No. 12).

5. Repealer filed 12-1785; effective thirtieth day thereafter (Register 85, No. 51).

§10401.1. Investigation of Various Agents for the Diagnosis or Treatment of Cancer.

Note • History

Experts wishing to investigate the value of drugs, medicines, compounds or devices in the diagnosis or treatment of cancer under the exemption provisions of Section 1708 of the Health and Safety Code shall provide the following information, in 20 copies, to the Department for approval prior to initiating the investigation.

(a) A sample of the labeling of the drug, medicine, compound or device which shall include the name, quantity, lot number of the agent and name of manufacturer and also a statement “Caution: New drug (or medicine or compound or device). Use in the diagnosis, treatment, alleviation or cure of cancer limited by law to investigational use.”

(b) If the animal testing required by subsection (b) of 1708 has been done by or under the auspices of a person other than the applicant and the latter wishes to use the results of such testing as a part of his request for approval of the investigation, a signed authorization for use of the results from the person or persons responsible for such testing shall be provided.

(c) The written statement signed by the expert shall show what facilities the expert will use for the investigation to be conducted by him; that the drug, medicine, compound or device will be used solely by him or under his direction for the investigation; and shall contain information identifying any assistant or agent of the expert who uses the drug, medicine, compound or device under the direction of the expert. It shall also include a study plan for the investigation to show that a significant number of cases and controls are to be studied, the duration of the study and all other details of the plan; a sworn statement that the agent is to be used solely for investigational purposes without compensation or profit; and a detailed outline of the training and experience of the expert, this latter requirement being met by submission of a curriculum vitae and a list of publications. Criteria for evaluation of effect shall be those adopted by the Cancer Advisory Council on April 12, 1967.

(d) A copy of the consent form required by subsection (f) of 1708.

(e) An acknowledgment that complete records will be kept.

NOTE

Authority cited: Sections 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1 through 1707.5, Health and Safety Code.

HISTORY

1. New section filed 7-30-69; effective thirtieth day thereafter (Register 69, No. 31).

2. Amendment of first paragraph filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10401.2. American Board of Oncology.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 1708.5, Health and Safety Code (Chapter 1130, Statutes of 1980).

HISTORY

1. New section filed 2-11-81 as an emergency; effective upon filing (Register 81, No. 7).

2. Order of Repeal of 2-11-81 emergency order filed 2-11-81 by OAL pursuant to Government Code Section 11349.6 (Register 81, No. 7).

§10405. Directions for Use--Exemptions Thereto.

Note • History

(a) Adequate Directions for Use. “Adequate directions for use” means directions under which a layperson can use drug or device safely and for the purposes for which it is intended. Directions for use may be inadequate because (among other reasons) of omission, in whole or in part, or incorrect specification of:

(1) Statements of all conditions, purposes, or uses for which such drug or device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug or device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug or device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(2) Quantity of dose (including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions).

(3) Frequency of administration or application.

(4) Duration of administration or application.

(5) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factors).

(6) Route or method of administration or application.

(7) Preparation for use (shaking, dilution, adjustment of temperature, or other manipulation or process).

(8) Methods of application or use.

(b) Exemptions From Directions for Use. Drugs and devices subject to Section 26638 of the code, shall be exempt from the requirements under the following conditions:

(1) Exemptions for Drugs and Devices Shipped Directly to Licensed Practitioners, Hospitals, Clinics, or Public Health Agencies for Professional Use. Except as provided in subparagraph (3) of paragraph (b) of this section, a drug or device shipped directly to or in the possession of a practitioner licensed by law to administer the drug or to use or direct the use of the device, or shipped directly to or in the possession of a hospital, clinic, or public health agency, for use in the course of the professional practice of such a licensed practitioner, shall be exempt from Section 26638 of the code if its meets the conditions of Section 10410 (b) and (c), Section 10415 (a) (2) and (3) or Section 10415 (b) (2) and (3) of these regulations.

(2) Retail Exemption for Veterinary Drugs and Prescription Devices. A drug or device subject to Section 10410 or Section 10415 (b) of these regulations shall be exempt at the time of delivery to the ultimate purchaser or user from Section 26638 of the code if it is delivered by a licensed practitioner in the course of the practitioner's professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.

(3) Exemption for New Drugs or Devices. A new drug or device shall be exempt from Section 26638 of the code:

(A) To the extent to which such exemption is claimed in an effective application with respect to such drug or device under Section 26670 of the code; or

(B) If no application under Section 26670 of the code is effective with respect to such drug but it complies with Section 26679 of the code and Section 10440 of the regulations thereunder. No exemptions shall apply to any other drug or device which would be a new drug or device if its labeling bore representation for its intended uses.

(4) Exemption for Drugs or Devices When Directions Are Commonly Known. A drug or device shall be exempt from Section 26638 of the code insofar as adequate directions for common uses thereof are known to the ordinary individual.

(5) Exemptions for Inactive Ingredients. A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from Section 26638 of the code. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an effective new drug application provides for such use.

(6) Exemption for Diagnostic Reagents. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product shall be exempt from Section 26638 of the code if it meets the requirements of Section 809.10 of Title 21 of the Code of Federal Regulations.

(7) Exemption for Prescription Chemicals and Other Prescription Components. For use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from Section 26638 of the code if all the following conditions are met:

(A) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form; and

(B) The label of the drug bears:

1. The statement “For prescription compounding”; and

2. If in substantially all dosage forms in which it may be dispensed it is subject to Section 26662 of the code, the statement “Caution: Federal law prohibits dispensing without prescription,” or “Caution: Not to be dispensed without a prescription”; or,

3. If it is not subject to Section 26662 of the code and is by custom among retail pharmacists sold in or from the intrastate package for use by consumers, “Adequate directions for use” in the conditions for which it is so sold. Provided, however, that the information referred to in subdivision 3 of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.

(C) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an effective new drug application covers such use of the drug in compounding prescriptions.

(8) Exemption for Processing, Repacking, or Manufacture. A drug in a bulk package (except tablets, capsules, or other dosage unit forms) or a device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from Section 26638 of the code if its label bears the statement “Caution: For manufacturing, processing, or repacking”; and, if in substantially all dosage forms in which it may be dispensed it is subject to Section 26662, the statement “Caution: Federal law prohibits dispensing without prescription,” or “Caution: Not to be dispensed without a prescription.” This exemption and the exemption under paragraph (7) of this section may be claimed for the same article. But the exemption shall not apply to a substance, material, or device intended for use in manufacture, processing, or repacking which causes the finished article to be a new drug, unless:

(A) An effective new drug application held by the person preparing the dosage form or drug for dispensing covers the production and delivery to that person of such substance; or

(B) If no application is effective with respect to such new drug, the label statement “Caution: For manufacturing, processing, or repacking” is immediately supplemented by the words “in the preparation of a new drug limited by state law to investigational use,” and the delivery is made for use only in the manufacture of such new drug limited to investigational use as provided in Section 10560 of these regulations.

(9) Exemption for Drugs and Devices for Use in Teaching, Research, and Analysis. A drug or device subject to Sections 10410 and 10415 (a) and (b) of these regulations shall be exempt from Section 26638 of the code if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or research not involving clinical use, or in clinical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

(10) Expiration of Exemptions.

(A) If a shipment or delivery or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug or device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

(B) The exemptions conferred by paragraphs (5), (6), (7), (8), and (9) of this section shall continue until the drugs or devices are used, for the purposes for which they are exempted, or until they are relabeled to comply with Section 26638 of the code. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by Section 26662 of the code and Sections 10410 and 10415 (a) and (b) of these regulations.

(c) Intended Uses. The words “intended uses” or words of similar import in paragraphs (a) and (b) of this section refer to the objective intent of the persons legally responsible for the labeling of drugs and devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representative, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into intrastate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom the packer distributor, or seller received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give one notice, that a drug or device introduced into intrastate commerce by said manufacturer is to be used for conditions, purposes or uses other than the ones for which it is offered, the manufacturer is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26662, Health and Safety Code.

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10409. Prescription Ophthalmic Devices.

Note • History

The quality standards for prescription ophthalmic devices shall be the 1972 standards of the American National Standards Institute Z80.1 and Z80.2.

NOTE

Authority cited: Section 2541.3, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 2541.3, Business and Professions Code.

HISTORY

1. New section filed 10-8-76; effective thirtieth day thereafter (Register 76, No. 41).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

§10410. Exemption for Prescription Devices.

Note • History

A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met:

(a) The device is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device and is to be sold only to or on the prescription or other order of such practitioner for use in the course of the practitioner's professional practice.

(b) The label of the device (other than surgical instruments) bears:

(1) The statement “Caution: Federal law restricts this device to sale by or on the order of a ________,” or “Caution sale of this device is restricted to sale by or on the order of a ________.” The blanks to be filled with the word “physician,” “dentist,” “veterinarian,” or with the descriptive designation of any other practitioner licensed by the law of the State of California; and

(2) The method of its application or use.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26643, Health and Safety Code.

HISTORY

1. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10415. Exemption for Prescription Drugs and Veterinary Drugs.

Note • History

(a) Exemption for Prescription Drugs. A drug subject to the requirements of Section 26660 of the code, shall be exempt from Section 26638 if all the following conditions are met:

(1) The drug is:

(A) In the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription drugs; or

(B) In the possession of a pharmacy or a public health agency, regularly and lawfully engaged in dispensing prescription drugs; and is to be dispensed in accordance with Section 26662.

(2) The label of the drug bears:

(A) The statement “Caution: Federal law prohibits dispensing without prescription,” or “Caution: Not to be dispensed without a prescription”; and

(B) The recommended or usual dosage; and

(D) If it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium the quantity or proportion of each active ingredient and if it is not for oral use the names of all other ingredients. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed, and, in the case of ampuls, too small or otherwise unable to accommodate a label but which are packaged in a container from which they are withdrawn for dispensing or use, the information referred to in subdivision (A) of this subparagraph may be placed on the outside container only.

(3) The labeling of the drug (which may include brochures readily available to licensed practitioners) bears information as to the use of the drug by practitioners licensed by law to administer it: provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among practitioners licensed by law to administer the drug.

(b) Exemption for Veterinary Drugs. A drug intended solely for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met:

(1) The drug is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of veterinary drugs and is to be sold only to or on the prescription or other order of a licensed veterinarian for use in the course of the veterinarian's professional practice.

(2) The label of a drug bears:

(A) The statement “Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian,” or “Caution: To be sold only by or on the order of a licensed veterinarian”; and

(B) The recommended or usual dosage; and

(D) The quantity or proportion of each active ingredient if it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.

(3) The labeling of the drug (which may include brochures readily available to licensed veterinarians) bears information as to use of the drug by licensed veterinarians; provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among veterinarians licensed by law to administer such drug.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26660 and 26662, Health and Safety Code.

HISTORY

1. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10416. Exemptions for Drugs Dispensed by Licensed Practitioners.

Note • History

NOTE

Authority cited: Sections 102, 208 and 26202, Health and Safety Code.

HISTORY

1. New section filed 8-2-72; effective thirtieth day thereafter (Register 72, No. 32).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10417. Formulary of Inequivalent Generic Drug Types and Drug Products for Which Substitution Poses a Threat to Health and Safety.

Note • History

(a) The generic drug types or drug products listed in the formulary below have been determined, pursuant to Business and Professions Code Section 4047.7, to have demonstrated clinically significant biological or therapeutic inequivalence and which, if substituted in accordance with Business and Professions Code Section 4047.6, would pose a threat to the health and safety of patients receiving such medications.

FORMULARY

(1) Generic Drug Types

(2) Drug Products

(b) Any person requesting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall submit such request to the Department of Health Services in accordance with the following:

(1) Submissions supporting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall consist of evidence of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience, on the basis of which it could be fairly and responsibly determined by the Director that a generic drug type or drug product demonstrates, or does not demonstrate, clinically significant biological or therapeutic inequivalence and which, if substituted for another drug product under the provisions of Section 4047.6 of the Business and Professions Code would pose a threat to the health and safety of patients receiving prescription medication.

(2) Submissions shall adequately identify all drug products involved by name of manufacturer, lot number(s), and dosage form(s) and should demonstrate the condition(s) of use (e.g., duration, frequency, etc.) of any such drug product where substitution poses a threat to the health and safety of the patient.

(3) Submissions shall be made in triplicate to Food and Drug Branch, Department of Health Services, Sacramento, CA 95814.

(4) Any information submitted shall be considered to be public information.

NOTE

Authority cited: Section 4047.7, Business and Professions Code. Reference: Sections 4047.6 and 4047.7, Business and Professions Code.

HISTORY

1. New section filed 5-14-76 as an emergency; effective upon filing (Register 76, No. 20).

2. Certificate of Compliance filed 9-8-76 (Register 76, No. 37).

3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10420. Label Requirements (26254).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

NEW DRUGS

§10425. Applications.

Note • History

(a) Each new drug application submitted for filing with the Department shall be in duplicate. If any part of the application is in a foreign language, an accurate and complete English translation shall be appended to that part.

(b) An application shall not be accepted for filing if only one copy is submitted or if it is incomplete on its face in that:

(1) It does not contain all the matter required by clauses (1), (2), (3), (4) and (6), of Section 26670 of the code.

(2) It does not state the conditions under which the drug or device is to be used; or

(3) The specimen of labeling proposed for use upon or within the retail package does not expressly or by reference to a brochure or other printed matter prescribe, recommend, or suggest the use of the drug or device under such conditions.

(c) The date on which an application is received by the Department shall be considered to be the date on which the application is filed, and the Department shall notify the applicant of such date. If the applicant withdraws the application, it shall be considered as not having been filed.

(d) The applicant may file an amendment to an application which has been filed and is pending before the Department, but in that case the unamended application shall be considered as having been withdrawn and the amended application shall be considered as having been filed on the date on which the amendment is received by the Department. The Department shall notify the applicant of such date.

(e) After an application has become effective with respect to a drug or device the applicant may file a supplemental application with respect thereto setting forth any proposed change in the conditions under which the drug or device is to be used in the labeling thereof, in any circumstance relating to its production, or in any other information contained in the effective application. Such supplemental application may omit statements in the effective application concerning which no change is proposed.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26670, Health and Safety Code.

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10430. Notification of Applicant (26289).

History

HISTORY

1. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10435. Insufficient Information in Application (26290).

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

3. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10437. Suspension of Effective Application (26290.5).

History

HISTORY

1. New section filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10438. Untrue Statements in Applications (26290) (e) and 26290.5 (2).

History

HISTORY

1. New section filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10440. Exemptions from Section 26670.

Note • History

A shipment or other delivery of a new drug or device is exempt from the operation of Section 26670 of the code if:

(a) The exemption is claimed pursuant to Section 26679 of the code, and

(b) The conditions of Title 21, Code of Federal Regulations, Part 312 are satisfied for drugs or the conditions of Title 21, Code of Federal Regulations, Part 812 are satisfied for devices, or the conditions of Title 21, Code of Federal Regulations, Part 813 are satisfied for devices which are intraocular lenses.

NOTE

Authority cited: Sections 208, 26202 and 26679, Health and Safety Code. Reference: Section 26679(e), Health and Safety Code.

HISTORY

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No. 15).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10445. Exemptions from Section 26288 of the Code (26292 (2) (3)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10446. Exemptions for Dental Laboratories.

Note • History

(a) Dental laboratories which manufacture dental prostheses shall be exempt from the licensing provisions of Section 26685 of the Health and Safety Code until such time that the health hazards, if any, have been identified and effective procedures for their prevention have been established by the Department after consultation with the California State Board of Dental Examiners, the dental profession and the dental laboratory industry.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26693(g), Health and Safety Code.

HISTORY

1. New section filed 6-12-70; effective thirtieth day thereafter (Register 70, No. 24).

2. Editorial correction filed 8-22-84 (Register 84, No. 34).

§10450. Form of Guaranty (26297).

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10455. Expiration of Guaranty (26301).

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

§10460. Presentation (26341).

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Article 3. Food Regulations

§10750. Label Requirements for Foods and Dietary Supplements.

Note • History

(a) Any food or dietary supplement, as defined in Title 17, California Code of Regulations, Division 1, section 10200, that contains any amount of a substance listed in Table 10750 A shall comply with the following:

(1) The label of foods and dietary supplements that have a total surface area available to bear labeling of 12 square inches or more shall bear the following notice in the manner prescribed in paragraph (a)(2) of this section:

NOTICE: This product contains (name of substance(s) and common name(s) if different). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition.

(2) The notice required by paragraph (a)(1) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice,

(B) Utilize at least one point leading,

(D) Be all black or one color type, printed on a white or other neutral contrasting background,

(E) Utilize single easy to read type style such as Helvetica Regular and upper and lower case letters,

(F) Be in type size no smaller than 8 point,

(G) The word “NOTICE” shall be in all upper case letters, and

(H) The sentence “Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health.” shall be underlined and highlighted by bold or extra bold type, such as Helvetica Black.

(3) Foods and dietary supplements in small packages that have a total surface area available to bear labeling of less than 12 square inches shall include the notice required by paragraph (a)(1) in the format specified in (a)(2) in a package insert or a tag attached to the package and bear the following label notice in the manner prescribed in paragraph (a)(4) of this section:

NOTICE: Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. See package insert (or attached tag) for additional information.

(4) The notice required by paragraph (a)(3) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice,

(B) Utilize at least one point leading,

(D) Be all black or one color type, printed on a white or other neutral contrasting background,

(E) Utilize single easy to read type style as Helvetica Regular and upper and lower case letters,

(F) Be in type size no smaller than 6 point,

(G) The word “NOTICE” shall be in all upper case letters, and

(b) This section does not apply to foods and dietary supplements containing the leaf gel or leaf juice of aloe (Aloe ferox Mill. or Aloe vera (L.) N.L. Burm.) or concentrations thereof, providing that the food or dietary supplement does not contain another substance listed in Table 10750 A.

Table 10750 A-Listed Substances

Common Name Plant Part Botanical Name

aloe also known as latex Aloe ferox Mill.

cape aloe

aloe also known as latex Aloe vera (L.) N.L.Burm.,

aloe vera also known as Aloe

barbadensis Mill. or Aloe

vulgaris Lamk.

buckthorn berry Rhamnus catharticus L.

cascara also known as bark Rhamnus purshianus DC.

cascara sagrada also known as Rhamnus

purshiana DC. or Frangula

purshiana (DC.) JG Cooper

frangula also known as bark Rhamnus frangula L. also

buckthorn known as Frangula alnus

Mill.

rhubarb root also known as root Rheum officinale Baill.,

as Chinese rhubarb Rheum palmatum L., Rheum

rhaponticum L., or Rheum

tanguticum, Maxim. ex

Balf.

senna also known as leaf Senna alexandrina P. Mill.

Alexandria senna or or pod also known as Cassia senna

Tinnevelly senna L., Cassia angustifolia

Vahl. Cassia acutifolia

Del., or Senna

angustifolia (Vahl) Batka

senna also known as leaf Senna obtusifolia (L.) Irwin

sicklepod senna or pod and Barneby also known as

Cassia obtusifolia (L.)

senna leaf Senna tora (L.) Roxb. also

or pod known as Cassia tora (L.)

NOTE

Authority cited: Sections 100275, 110065 and 110100, Health and Safety Code. Reference: Sections 110175, 110290, 110660, 110705, 110760, 110765 and 110770, Health and Safety Code.

HISTORY

1. New section filed 10-15-96; operative 1-1-97 (Register 96, No. 42). A Certificate of Compliance must be transmitted to OAL by 5-1-97 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 78. No. 35.

2. Editorial correction of subsection (b) and Table 10750 A (Register 97, No. 18).

3. New section refiled 4-29-97 as an emergency; operative 5-2-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-2-97 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 4-29-97 order, including amendments, transmitted to OAL 8-28-97 and filed 10-9-97 with changes in label “Notice” effective 3-1-98 (Register 97, No. 41).

5. Editorial correction of subsection (a)(2)(E) and Table (Register 98, No. 9).

§10755. Truth of Labeling (26456).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

ADULTERATION

§10760. Metal Coated Dragees and Ornaments (26470 (2)).

History

HISTORY

1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§10765. Toxic Substances--Use of (26470 (2)).

History

HISTORY

1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§10770. Secondhand Use of Barrels.

Note • History

(a) No wooden barrel or keg that has ever been used as a container for other than food products may be re-used for the storage and/or conveyance of any food product.

(b) Barrels or kegs that have been used as containers for food products may be re-used for storage and/or conveyance of other food products. Provided: they are thoroughly cleaned and are in a sanitary condition at the time of re-use.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26524, Health and Safety Code.

HISTORY

1. Editorial correction of section heading and new NOTE filed 8-22-84 (Register 84, No. 34).

§10775. Custard Fillings for Pastry (26470 (4)).

History

HISTORY

1. Repealer filed 6-23-72; effective thirtieth day thereafter (Register 72, No. 26).

§10780. Containers, Cadmium Plated (26470 (6)).

History

HISTORY

1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§10785. Packing Materials (26470 (6)).

History

HISTORY

1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§10786. Apricot Kernels.

Note • History

(a) Apricot kernels sold or distributed into food channels are misbranded unless the package or container is conspicuously labeled: “Apricot kernels may be toxic; very low quantities may cause reactions.”

(b) Subsection (a) does not apply to:

(1) Firms selling bulk apricot kernels for processing into macaroon paste or marzipan where the firms furnish to the Department upon its request, documentation acceptable to the Department, of its intended use as macaroon paste or marzipan, and the apricot kernels are clearly labeled:

“Not suitable for food use without further processing.”

(2) Fresh apricots or to apricot kernels added to canned apricots as an optional flavor agent.

NOTE

Authority cited: Section 26202, Health and Safety Code. Reference: Sections 26400 and 26520, Health and Safety Code.

HISTORY

1. New section filed 6-23-77; effective thirtieth day thereafter (Register 77, No. 26).

2. Amendment filed 9-24-85; effective thirtieth day thereafter (Register 85, No. 39).

§10790. Candy, Trinkets in, Prohibited (26472 (b)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10795. Blending and Dilution of Certified Coal Tar Colors (26472 (c)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

LABELING, MISBRANDING

§10800. Labeling, Misbranding (26490 (1)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10805. Required Statements, When Exempt (26491).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§10810. Prominence of Required Statements (26492).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§10815. Prepackaged Candy and Cookies, Retail Sale of Food from Bulk Containers (Label Exemptions) (26492).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10820. Exemption upon Proper Labeling.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10825. Conformity to Definitions and Standards of Identity (26493).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10826. Temporary Permits for Intrastate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity.

Note • History

(a) To obtain a temporary permit for intrastate shipment of experimental packs of food varying from the requirements of definitions and standards of identity, a person shall file with the Department a written application in triplicate containing the following:

(1) Name and address of the applicant.

(2) A statement of whether or not the applicant is regularly engaged in producing the food involved.

(3) A reference to the applicable definition and standard of identity (citing applicable section of regulations).

(4) A full description of the proposed variation from the standard.

(5) The basis upon which the food so varying is believed to be wholesome and nondeleterious.

(6) The amount of any new ingredient to be added; the amount of any ingredient, required by the standard, to be eliminated; any change of concentration not contemplated by the standard; or any change in name that would more appropriately describe the new product under test. If such new ingredient is not a commonly known food ingredient, a description of its properties and basis for concluding that it is not a deleterious substance.

(7) The purpose of effecting the variation.

(8) A statement of how the variation is of potential advantage to consumers.

(9) The labeling proposed to be used for the food so varying.

(10) The period during which the applicant desires to introduce such foods into intrastate commerce, with a statement of the reasons supporting the need for such period.

(11) The probable amount of such food that will be distributed.

(12) The areas of distribution.

(13) The address at which such food will be manufactured.

(b) The applicant for a permit described in (a) shall provide the Department, upon request, with samples of the food varying from the standard and any additional information deemed necessary by the Department.

(c) If the Department concludes that the variation may be advantageous to consumers and will not result in failure of the food to conform to any provision of the act except Section 26556, a permit shall be issued to the applicant for intrastate shipment of such food. The terms and conditions of the permit shall be those set forth in the application with such modifications, restrictions, or qualifications as the Department may deem necessary and state in the permit.

(d) The terms and conditions of the permit may be modified at the discretion of the Department or upon application of the permittee during the effective period of the permit.

(e) The Department may revoke a permit for cause, which shall include but not be limited to the following:

(1) That the permittee has introduced a food into intrastate commerce contrary to the terms and conditions of the permit.

(2) That the application for a permit contains an untrue statement of a material fact.

(3) That the need therefor no longer exists.

(f) During the period within which any permit is effective, it shall be deemed to be included within the terms of any guaranty or undertaking otherwise effective pursuant to the provisions of Section 26300 of the act.

(g) If an application is made for an extension of the permit, it shall be accompanied by a description of experiments conducted under the permit, tentative conclusions reached, and reasons why further experimental shipments are considered necessary.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26513, Health and Safety Code.

HISTORY

1. New section filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Amendment filed 9-24-85; effective thirtieth day thereafter (Register 85, No. 39).

§10830. Designation of Ingredients (26495).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§10835. Listing Ingredients in Order of Predominance (26495 (2)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10840. Dietary Food Labeling (26496 (1)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 60, No. 15.

§10841. Label Statements Relating to Emergency Food Packs.

Note • History

NOTE

Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 26467, Health and Safety Code.

HISTORY

1. New section filed 11-22-61; effective thirtieth day thereafter (Register 61, No. 23).

2. Repealer filed 9-24-85; effective thirtieth day thereafter (Register 85, No. 39).

§10842. Saccharin Warning Labeling.

Note • History

(a) The saccharin warning labeling requirements of the Federal Saccharin Study and Labeling Act, Public Law 95-203, 1977, and the compliance guidelines promulgated under authority of that act, shall be applicable to all saccharin containing products in intrastate commerce in this State.

(b) These labeling requirements and guidelines shall apply only to products introduced into intrastate commerce after the effective date of this section.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26206, Health and Safety Code.

HISTORY

1. New section filed 6-15-78; effective thirtieth day thereafter (Register 78, No. 24).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

§10845. Artificial Flavoring or Coloring, Chemical Preservatives (26496 (2)).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10850. Form of Guaranty (26521).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10855. Expiration of Guaranty (26525).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10860. Exemptions from Labeling Requirements (26542).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§10862. Adoption of Federal Requirements.

Note • History

Subchapter B, Title 21, Code of Federal Regulations and amendments thereto shall be included as the requirements of this Department.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26203, 26205-26209, 26438, 26510 and 26559, Health and Safety Code.

HISTORY

1. New section filed 7-12-78; effective thirtieth day thereafter (Register 78, No. 28).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

§10865. Presentation (26565).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Article 3.1. Food Additives Regulations

HISTORY

1. Repealer of Article 3.1 (Sections 11000.1 through 11025.1, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 62, No. 15.

Article 3.5. Foods Under Agricultural Code Regulations

HISTORY

1. Repealer of Article 3.5 (Sections 11350 through 11367, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 66, No. 20; and 67, Nos. 20, 40, 43, 46 and 48.

Article 3.6. Poultry Meat and Poultry Products

§11375. Sources of Poultry Meat.

Note • History

NOTE

Authority cited: Section 26540, Health and Safety Code. Reference: Sections 26540 and 26541, Health and Safety Code.

HISTORY

1. New Article 3.6 (Sections 11375 through 11378) filed 6-24-68; effective thirtieth day thereafter (Register 68, No. 24).

2. Editorial correction renumbering former Section 11375 to new Section 19043 filed 4-13-84 (Register 84, No. 15).

§11376. Conditions for Use.

Note • History

NOTE

Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code.

HISTORY

1. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§11377. Methods for Treating.

Note • History

NOTE

Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code.

HISTORY

1. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§11378. Disposal of Unfit Poultry Meats.

Note • History

NOTE

Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code.

HISTORY

1. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

Article 3.7. Raw Milk and Raw Milk Products

§11380. Required Health Warning on Labels of Raw Milk and Raw Milk Products.

Note • History

(a) Raw Milk and raw milk products shall bear the following warning on the principal display panel or panels of the label:

WARNING

Raw (unpasturized) milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity.

(b) The warning shall appear within a heavy borderline in a color sharply contrasting to that of the background. The signal word “WARNING” shall appear in capital letters of ten point type or greater. The remaining text of the warning shall be printed in capital letters of six point type or greater. All characters in the warning message shall be in a sans serif type style.

(1) “[R]aw” means unpasteurized;

(2) “[R]aw milk product” means any food which contains raw milk, and shall include, but not be limited to, cheese (except when ripened or cured at least 60 days pursuant to sections 37975 and 38001 of the Food and Agricultural Code), cream, butter and kefir.

(d) Raw milk or raw milk products packaged in recyclable glass containers which are sold only at the location where the raw milk or raw milk product is produced (including containers which are delivered directly from the point of production to a retail customer by agents or employees of the production facility), and which have a principal display panel only on the container cap, may instead have attached to the container a tag containing the warning message set forth in subsection (a), provided that the tag will stay attached to the container and remain readable under customary conditions of storage and transportation, excluding intentional removal after purchase by, or delivery to, the retail customer. The tag shall be attached in a conspicuous location on the container. The warning message portion of the tag shall be subject to all other requirements of this section. The tag may, to the extent authorized by law, contain any other information desired by the production facility. For purposes of this subsection, a “tag” can be of any shape, material, and design, so long as the warning message is conspicuous and easily readable.

(e) Any raw milk or raw milk product which does not bear a label meeting the requirements of this section is misbranded.

(f) This section does not apply to raw milk and raw milk products produced and packaged before February 21, 1991.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400 and 26550, Health and Safety Code.

HISTORY

1. New section filed 2-11-91 as an emergency; operative 2-11-91 (Register 91, No. 12). A Certificate of Compliance must be transmitted to OAL by 6-11-91 or emergency language will be repealed by operation of law on the following day.

2. Repealer of 2-11-91 order and adoption of new section filed 5-9-91 as an emergency; operative 5-9-91 (Register 91, No. 25). A Certificate of Compliance must be transmitted to OAL by 9-6-91 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-9-91 order transmitted to OAL 9-3-91 and filed 9-30-91 (Register 92, No. 4).

Article 4. Horse Meat Regulations

HISTORY

1. Repealer of Article 4 (Section 11400) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Article 5. Cold Storage Regulations

§11600. Cold Storage Regulations.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Repealer filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

§11601. Cold Storage Licenses.

Note • History

(a) Cold Storage licenses shall be valid for a two-year period from date of issue and are not transferable. The fee for the license is $100.00.

(b) Application for a Cold Storage license shall be made on State Department of Health form #EH-7.

(d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application.

NOTE

Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code.

HISTORY

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

Article 5.5. Low Acid Frozen Foods in Hermetically Sealed Containers, Regulations

NOTE

Authority cited: Sections 208 and 28182, Health and Safety Code. Reference: Sections 28165-28186, Health and Safety Code.

HISTORY

1. Repealer and new Article 5.5 (Sections 11800, 11810, 11820, 11830, 11840, 11850, 11860, and 11870) filed 12-20-55; effective thirtieth day thereafter (Register 55, No. 18).

2. Repealer of Article 5.5 (Sections 11800-11870, not consecutive) filed 3-21-84; effective thirtieth day thereafter (Register 84, No. 12).

Article 6. Bakery Sanitary Regulations

§12001. Custard and Cream Fillings for Pastry (28208).

Note • History

(a) Perishable bakery products shall include, but are not limited to, products such as cream-filled pies, pumpkin pies, cakes, pastries, custard, meringues and cheese cake, which consist in whole or in part of milk or milk products, eggs, synthetic fillings or any ingredients capable of supporting rapid and progressive growth of infectious or toxicogenic microorganisms.

(b) Perishable bakery products shall be kept, displayed, transported or maintained at or below 45o Fahrenheit. This Section shall not apply to products during reasonable periods of preparation or handling not to exceed two hours.

(d) Uncut pumpkin, sweet potato, yam and squash pies baked in the shell or so prepared that the filling reaches a temperature of at least 140 F, for 5 minutes and which are packaged individually at the point of production to prevent contamination, may be considered not to be a perishable product and refrigeration is not required. When packaged, the above pies shall be labeled “Refrigerate after opening.”

(e) Uncut citrus meringue pies having a filling of 4.5 pH or lower, and packaged individually at the point of production to prevent contamination may be considered not to be a perishable product and refrigerator is not required. When packaged, citrus meringue pie shall be labeled “Refrigerate after opening.”

(f) Marshmallow topping, or other filling or topping products, with a sugar-water ratio of at least 2.1 to 1 are not perishable and do not require refrigeration.

NOTE

Authority cited: Sections 102, 208 and 28214, Health and Safety Code. Reference Section 28208, Health and Safety Code.

HISTORY

1. New section filed 6-23-76; effective thirtieth day thereafter (Register 72, No. 26).

2. Amendment of subsections (d) and (e) filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

3. Amendment of subsection (b) filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

4. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

5. Repealer of Section 12000 (number and section heading only) filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

Article 6.1. Local Enforcement of the Sherman Food, Drug and Cosmetic Law As It Relates to Retail Food Establishments

§12100. Definitions.

Note • History

(a) Retail food establishment means any room, building, vehicle, place, or portion thereof, maintained, used, or operated for or in conjunction with, the retail sale of food or preparation of food and includes, but is not limited to:

(1) “Retail Food Production and Marketing Establishment” as defined in Section 28802 of the Health and Safety Code.

(2) “Bakery” as defined in Section 28190 of the Health and Safety Code.

(3) “Roadside Stand” as defined in the California Administrative Code, Title 17, Section 13650.

(4) “Restaurant” as defined in Sections 26595(c) and 28522 of the Health and Safety Code.

(5) “Itinerant Restaurant” as defined in Sections 26595(c) and 28523 of the Health and Safety Code.(6) “Vehicle” as defined in Sections 26595(c) and 28524 of the Health and Safety Code.

(7) “Mobile Food Preparation Units” as defined in the California Administrative Code, Title 17, Section 13601.

(8) “Vending Machines” as defined in Section 28525 of the Health and Safety Code.

(b) Menu misrepresentation means any false statement on a menu.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26460, 26581 and 26590, Health and Safety Code.

HISTORY

1. New Article 6.1 (Sections 12101-12110) filed 4-21-78; effective thirtieth day thereafter (Register 78, No. 16).

2. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

§12101. Application for Participation.

Note • History

Application for participation shall be made by letter from the local health department to the Director of the Department of Health.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26581, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12102. Local Enforcement Authorization.

Note • History

(a) A local department authorized as a local retail food enforcement program by the Department shall enforce Department regulations and the following chapters, articles and sections of Division 21 of the Health and Safety Code pertaining to the preparation, handling and sale of foods in retail food establishments.

(1) Definitions and General Provision (Chapter 1).

(A) Short title and definitions (Article 1) Sections 26000, 26001, 26002, 26004, 26006, 26007, 26008, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26019, 26023, 26024,26025, 26026, 26028 and 26029.

(B) General provisions (Article 2) Sections 26050 through 26052.

(2) Administration (Chapter 2).

(A) Generally (Article 1) Section 26214.

(B) Inspection and sampling (Article 3) Sections 26230 through 26235.

(3) Guarantees (Chapter 3) Sections 26300 through 26307.

(4) Packaging, labeling and advertising (Chapter 4).

(A) Generally (Article 1) Sections 26400, 26401, 26402, 26405, 26406, 26407 and 26408.

(B) Fair packaging and labeling (Article 2) Sections 26430, 26431, 26432, 26436 and 26439.

(5) Food (Chapter 5).

(A) Generally (Article 1) Section 26500.

(B) Enrichment of food and food products (Article 2.5) Sections 26516, 26517 and 26518.

(D) Misbranded food (Article 4) Sections 26550 through 26569.7.

(E) Potentially hazardous foods (Article 5) Section 26570.

(F) Frozen products (Article 5.5) Section 26575.

(G) Local enforcement (Article 6) Sections 26580 through 26590.

(H) Hamburger and imitation hamburger (Article 7) Sections 26595 through 26599.

(6) Penalties and Remedies (Chapter 8)

(A) Penalties (Article 1) Sections 26801 and 26802.

(B) Proceedings (Article 2) Sections 26811, 26812 and 26813.

(D) Injunctions (Article 4) Sections 26850 and 26851.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26583 and 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12103. Laboratory Examinations.

Note • History

(a) A local health department shall be able to make the following laboratory examinations in order to qualify for local enforcement of retail food establishments.

(1) Examination of Fresh Meats shall be in accord with the methods of analysis of the Association of Official Analytical Chemists (AOAC) and supplements thereto for the following:

(A) Fat content of ground and chopped beef and pork sausage.

(B) Presence of preservatives including sulfite, borates, nitrite and nitrate.

(D) Presence of vegetable protein or other extenders.

(2) Examination of Alcoholic Beverages.

(A) Determine alcoholic proof by AOAC methods.

(B) Micro analytical examination to determine and identify insects and other filth adulteration.

(3) Filth Examination of Various Foods.

(A) Presence of insects by macro or micro analytical methods.

(B) Presence of rodent urine by the AOAC method of analysis.

(D) Verification of foreign material by microscopic and macroscopic examination.

(b) Laboratory examinations shall be performed in a Public Health Laboratory or a laboratory designated by the local health department and approved by the Department.

(c) Laboratory examinations shall be performed by the professional staff employed in the laboratory designated by the local health department and approved by the Department.

(d) The laboratory personnel shall complete Department approved training.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26583, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12104. Personnel Training.

Note • History

(a) Local health department personnel shall complete state approved training in the following areas:

(1) Enforcement of statutes and regulations relating to mislabeling, false advertising and adulteration of foods in retail food establishments.

(2) Observation and recording of violative conditions in narrative reports that can be used for legal actions.

(3) Determining alcoholic proof of liquor products for mislabeling and candling of full or partly filled liquor bottles to determine adulteration.

(4) Procedures for voluntary condemnation and destruction of violative food products.

(5) Procedures for the embargo of violative food products and the release of an embargo.

(6) Collection of representative official samples of violative food and potential adulterants.

(7) Completing official sample receipt forms and memorandum of instruction for laboratory examinations.

(8) Procedures for the forfeiture, condemnation and destruction of food found to be adulterated or misbranded.

(9) Preparation of statements of facts for referrals of violative conditions to the district attorney.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12105. Staff Qualifications.

Note • History

The minimum qualifications for professional staffing by local health departments to carry out the local enforcement of the Sherman Food, Drug, and Cosmetic Law and Department regulations relative to retail food establishments shall be a registered sanitarian.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12106. Reporting Requirements.

Note • History

Each local health department shall submit quarterly reports to the Department that summarize enforcement activities for retail food establishments.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12107. Enforcement Authority for Menu Misrepresentation.

Note • History

(a) Menu is a form of advertising. A local health department authorized by the Department to enforce only menu misrepresentation shall enforce the following sections of the Health and Safety Code:

(1) Advertising (Chapter 4, Article 3) Sections 26460 and 26461.

(2) Penalties (Chapter 8, Article 1) Sections 26801 and 26802.

(3) Proceedings (Chapter 8, Article 2) Sections 26811 and 26812.

(4) Injunctions (Chapter 8, Article 4) Sections 26850 and 26851.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26460, 26461 and 26581, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12108. Personnel Training.

Note • History

(a) Personnel from local health departments who are assigned to enforce the Sherman Food, Drug, and Cosmetic Law as it relates only to menu misrepresentation in retail food establishments shall participate and complete state approved training as required in Section 12104 or meet the following training requirements:

(1) Enforcements of statutes and regulations relating to false advertising in food menus that are used in retail food establishments.

(2) Recording violative conditions in narrative reports of observation that can be used for legal action.

(3) Preparation of statements of facts for referrals or violative conditions to the district attorney.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26583 and 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12109. Staff Qualifications.

Note • History

The minimum qualifications for staffing by local health departments to enforce the Sherman Food, Drug, and Cosmetic Law as it relates to menu misrepresentation shall be at the level of a registered sanitarian.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12110. Reporting Requirements.

Note • History

A local health department authorized by the Department to enforce only menu misrepresentation shall submit semiannual reports to the Department that summarize enforcement activities.

NOTE

Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

Article 7. Food Sanitation Regulations

§12200. Vegetable Juice, Preparation and Sale of Fresh (28281-28282).

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12205. Premises.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12210. Materials.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12215. Extracting Machines.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12220. Storage and Sale.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12225. Employees.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12230. Revocation of Permit.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

SANITATION IN FOOD PLANTS

§T17-12235. Light, Ventilation, and Plumbing (28281).

Note • History

NOTE

Authority cited: Sections 208 and 28281, Health and Safety Code. Reference: Section 28281, Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12240. Water Supply.

Note • History

NOTE

Authority cited: Sections 208 and 28281, Health and Safety Code. Reference: Section 28281, Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§T17-12245. General Plant Sanitation; Floors, Walls, Ceilings, Etc.

Note • History

The floors, walls, ceilings, partitions, posts, doors and other parts of all preparation and processing areas shall be of such materials, construction and finish that they may be readily and thoroughly cleaned. The floors in all areas where water is used in the operation are to be so constructed and of such material as to be watertight and they shall be maintained in such condition as to stay watertight. All areas used for edible products shall be separate and distinct from those used for inedible products, such as fish meal reduction plants.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code.

HISTORY

1. Editorial correction of section heading and new NOTE filed 7-3-84 (Register 84, No. 27).

§12250. Areas, Equipment, and Operations to Be Sanitary.

Note • History

(a) Areas, equipment and utensils used for preparing, storing or otherwise handling any food product and all other parts of the establishment shall be kept clean and in a sanitary condition. Areas in which any food product is prepared, processed, stored or handled, including walls, ceilings, and overhead structures of such areas, shall be kept as reasonably free from moisture as is practicable. In such areas there shall be no dripping from any source, including ceilings and overhead structures, that may contaminate the product.

(b) Equipment and utensils used for preparing, processing or otherwise handling any food product shall be of such materials and construction that they can be readily and thoroughly cleaned. Pipelines used to convey fluid or semi-fluid products shall be so constructed that they can be readily and thoroughly cleaned.

(c) Operations and procedures involving the preparation, storing or handling of any food product shall be strictly in accord with good sanitary practice.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§12255. Use of Poisonous Insecticides and Rodenticides.

Note • History

(a) Every practical precaution shall be taken to keep establishments free from flies, rats, mice and other vermin. If necessary, rodent-proof rooms shall be provided for materials which might become contaminated by these pests.

(b) The use of insecticides, or rodenticides, toxic to humans, in areas where any food products, not adequately protected, is being stored or handled is prohibited.

(c) Poisonous insecticides and rodenticides may be used under buildings, wharves, outbuildings, or similar places, or where adequately protected packaged products are stored; only, if adequate precautions are taken to eliminate the possibility of said poisons being accidentally spilled, or carried, by any means, to areas where these poisons are prohibited. These poisons are to be adequately protected from possible contact by children, or domestic animals, and are to be plainly and distinctly labeled for identification by adults.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 28282(a), Health and Safety Code.

HISTORY

1. Editorial correction of section heading and new NOTE filed 7-3-84 (Register 84, No. 27).

§12260. Empty Container Storage.

Note • History

Empty cans, jars, lids, covers, barrels, drums, etc., must be clean when filled with food products.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§12265. Bactericidal Treatment of Utensils and Equipment in Food Processing Establishments (28282(c)).

Note • History

NOTE

Authority cited: Sections 208 and 28282, Health and Safety Code. Reference: Section 28282(c), Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12270. Tagging Insanitary Equipment.

Note • History

NOTE

Authority cited: Sections 208 and 28282, Health and Safety Code. Reference: Section 28282, Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12275. Personal Hygiene.

Note • History

(a) The employees of the establishment who handle any food product shall keep their hands clean; and, after visiting the toilet room or urinals, shall wash their hands before handling any food product or implement used in the preparation of the product.

(b) Outer clothing and gloves worn by persons who handle any food product shall be clean and of material that can be readily cleaned.

(c) Such practices as spitting on the floor and using empty cans, jars, or other containers as drinking cups, or for purposes other than those originally intended, are forbidden.

(d) Care shall be taken to prevent the contamination of food products with perspiration, hair, cosmetics, medicaments and the like. Adequate head coverings must be worn by all men and women while engaged in the preparation or handling of any food product.

(e) Smoking by any person shall not be permitted while preparing or handling any food product or while handling empty cans, jars, lids, barrels, drums or other receptacles used for food products.

(f) The use of fingernail polish by any person preparing, processing, or handling any food product without gloves whereby the product might become contaminated, is prohibited.

(g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any area where any food product is prepared, processed, or handled; except, in or on facilities specifically provided for this purpose.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 28282(d), 28291 and 28293, Health and Safety Code.

HISTORY

1. Editorial correction of section heading and new NOTE filed 7-3-84 (Register 84, No. 27).

§12280. Sanitary Facilities.

Note • History

Adequate sanitary facilities and accommodations shall be furnished by every food packing establishment. Of these the following are specifically required:

(a) Dressing rooms, and toilet and urinal rooms shall be sufficient in number and conveniently located. These rooms shall be well lighted, sufficiently ventilated to insure sanitary conditions, vented to the outside, and meet all requirements as to sanitary construction and equipment. All doors entering such rooms shall be self-closing. All windows shall be screened. Such rooms shall be separate from areas in which food products are prepared, stored, or handled. The walls, ceiling, partitions, and other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal rooms shall be of light color and of such construction as to be easily and adequately cleaned. Where five or more persons of both sexes are employed, separate facilities shall be provided for each sex.

(b) Sanitary washing facilities, including running hot and cold water, soap and individual towels, shall be provided, and shall be placed in or near toilet and urinal rooms and also at other places in the establishment as may be essential to insure cleanliness of all persons handling any food product.

(d) Toilet soil lines shall be kept separate from industrial waste lines to a point outside the buildings. Drainage from toilet bowls and urinals shall not be discharged into grease salvage basins, or into open disposal systems.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 28287, 28288, 28289 and 28290, Health and Safety Code.

HISTORY

1. Editorial correction of section heading and new NOTE filed 7-3-84 (Register 84, No. 27).

§12285. Surroundings of Food Packing Establishments (28298).

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12290. Labeling Exemption (28322).

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12295. Form of Affidavit.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

WALNUT SHELLING

§12300. Purchase of Walnut Meats from Producers, Etc. (28336).

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12302. Walnut Shelling Licenses.

Note • History

NOTE

Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code.

HISTORY

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

2. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12305. Production Record Specifications.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12310. Bill of Sale Specification.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12315. Condition of Walnut Meats.

History

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

Article 8. Cannery Inspection Regulations

ACIDIFIED FOOD PRODUCTS PACKED IN HERMETICALLY SEALED CONTAINERS SUBJECT

TO pH CONTROL

§12400. Applicability.

Low acid (high pH) foods or acid foods containing low acid ingredients to an extent where a food poisoning hazard may exist when placed in hermetically sealed containers, and which are not processed by steam under pressure must be packed under the supervision of the Department of Public Health. This includes several types or classes of food products, among which are the following: vegetables in acidified brine or oil, vegetable juice cocktails, and various formulated products.

§12405. Acid Requirements.

(a) All products subject to Section 12400 found to have a pH greater than 4.6 will be restrained.

(b) The pH of low-acid foods may be lowered by the addition of any edible organic food acid such as citric or acetic. Allowance must be made for the fact that certain acids, such as acetic, are quite volatile and rapidly lose their strength when heated in open containers. The Department of Public Health must be consulted to determine the strength and amount of acid to be used for each type of pack and the control measures that are necessary.

For illustration purposes only, the following examples are cited: On the basis of 60 percent solids in a final acidified artichoke pack, the following brines are found to furnish the required pH of less than 4.6:

(1) Unblanched, 0.6 percent citric acid (80 ounces per 100 gallons)

(2) Water blanched, 0.53 percent citric acid (71 ounces per 100 gallons)

(3) Acid blanched in a 1 percent citric acid solution for six minutes, 0.24 percent citric acid (32 ounces per 100 gallons)

(c) Acidified vegetables from a batch previously inspected and released by the Department of Public Health may be repacked in a packing medium of an edible vegetable oil without official reinspection only when adequate records are maintained clearly showing the batch number of the original batch and the date of release thereof and the batch number of the repacked vegetable.

§12410. Titration by Inspectors.

(a) Samples of the acid blanching solutions and brining solution shall be collected, one sample of each to be taken at the beginning of each day's run subsequently at about two-hour intervals during the day. These samples are to be titrated daily by the state cannery inspector.

(b) When the blanching or brining solution is changed, or more acid added, the batch number must be changed. A batch is understood to mean all material blanched at one time in a given solution.

§12415. Low Acid Ingredients in Acid Foods.

Some foods such as vegetable juice cocktails are made by mixing portions of low acid vegetables with products possessing a safe level of acidity, with a resulting potential food poisoning hazard. The control of acidity for this type of product is based on the examination of the finished product, and is determined directly as pH, which must be below 4.6. Samples of the finished product are to be submitted to the laboratory as requested.

§12420. Formulated Products.

By “formulated products” is meant the class of foods that is compounded from a number of ingredients according to a definite formula, and these ingredients when so compounded do not have a pH low enough to render them commercially sterile when processed without steam under pressure. The control of acidity for this type of product is based on the examination of the finished product, and is determined directly as pH, which must be below 4.6. Samples of the finished product are to be submitted to the laboratory as requested.

§12425. Test Equipment.

All plants packing food products regulated under Sections 12415 and 12420 shall have and maintain in proper working condition for the use of the state cannery inspector pH determination equipment of the glass electrode type. All plants packing vegetables in acidified brine shall have complete titrating equipment, consisting of burette, standardized alkaline solution, indicator solution, pipettes, and titrating flasks or beakers. All of the above must be kept in clean workable condition at all times.

§12430. Samples to Laboratory.

(a) Samples of the finished product, whether brine packed or oil packed from an acid blanch, are to be submitted to the laboratory as requested.

(b) Cans should be labeled to show the following: product, date of pack and code number.

§12435. Production Records.

Production records shall be kept and a coding system inaugurated as specified by the inspection service. The production record shall show the cooking time and temperature for each batch, also number of containers per batch.

§12440. Inspectors' Reports.

A daily report is to be submitted to the Department of Public Health covering the results of the state cannery inspector's titrations on all blanching solutions and/or bines; also a report of his pH determinations to be certain that the acidification procedures are in order.

§12445. Releases.

Batches of foods subject to pH control are not to be released by the state cannery inspector until authorization is received from the San Francisco Office.

CONDUCT OF CANNERIES

§12450. Responsibility of Canners.

It is the responsibility of every person, group, or organization engaged in the commercial, semicommercial, cooperative, or noncommercial community (church, school, or otherwise) canning or preservation of low-acid foods in hermetically sealed containers, among other things, to achieve commercial sterility in all units packed.

§12451. Cannery Licenses.

Note • History

(a) Cannery licenses will be valid for a two-year period from date of issue and are not transferable. The fee for the license is $100.00.

(b) Application for a Cannery license shall be made on State Department of Health form #EH-153.

(d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application.

NOTE

Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code.

HISTORY

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

§12455. Official Sterilization Processes.

All products except those under pH control as defined in Section 12400 through 12445 must meet specific requirements as to initial temperature, process time and temperature, as determined for each product. The Department of Public Health shall be contacted for the latest official sterilization requirements. (See Sections 12790 through 12975.)

§12460. Initial Temperature.

The term “initial temperature” as used herein designates the average temperature of the can contents at the time steam is turned on for the process. Just prior to the start of the process, the contents of the container used for checking the initial temperatures should be shaken or stirred and the temperature determined. This container should be representative of the coldest cans in the retort load and should have an initial temperature equal to or greater than the initial temperature specified under “Official Sterilization Process.” “Initial temperature” should not be confused with “closing temperature.”

§12465. Cleanliness of Materials.

All raw material must meet full requirements as to purity, wholesomeness, cleanliness and suitability for canning purposes. To this end the packer must supply any and all necessary equipment, and additional help and measures designed to insure the quality of the product.

§12470. Record of Cooks.

Each licensed retort operator shall keep a record of the cooks as required by the State Board of Public Health.

(a) The original and a duplicate of the production record must be kept by filling in accurately in complete detail the form approved by the Department of Public Health. Each entry in the record must be made by the operator at the time the specific retort operation is observed and not copied afterward. It must be in legible handwriting and be signed by the operator or operators.

(b) Chart of recording thermometer must show full time and temperature as required, otherwise the product will be restrained.

(c) Each production record and recording thermometer chart shall be stamped, initialed and numbered by a state cannery inspector before use and must be accounted for.

(d) The cook or batch number and size of cans involved must be recorded by the canner in each respective curve of all temperature charts.

(e) Production records and charts must be scrutinized and checked by a state cannery inspector before product is released for shipment.

§12475. Coding.

History

(a) Each plant must submit and have approved a code to appear legibly on the cover of each container. This code will show the plant where packed, year packed, the product contained therein, day code, and period code. The period shall be changed every two and one half hours or less. This time interval may be extended to three hours if a petition is filed with the Department demonstrating that adequate consumer protection is provided under those conditions when potentially hazardous products are required to be removed from retail market. If a container such as a glass bottle be used and the cap or cover be too small to permit the coding to be embossed or ink-stamped thereon, it shall be permissible to legibly perforate or ink-stamp the required code on the label, provided the label is securely affixed to the container.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

§12480. Requirements.

(a) All products must be free from adulteration and misbranding in accordance with Chapter 3 of Division 21 of the Health and Safety Code, and the United States Food, Drug and Cosmetic Act. The product must not be in violation of any state or county law. The net weight or other information as required by law must appear correctly upon labels.

(b) Any number of cans deemed necessary shall be cut and examined at any time by representatives of the Department of Public Health.

(c) Plants and equipment must comply with necessary requirements as to cleanliness and sanitation and conform to any and all state requirements.

(d) Officials of plants must insure the cooperation of all plant personnel.

(e) Packers must realize and faithfully fulfill their own responsibilities and obligations to produce a sound, wholesome, and safe product.

(f) All packers must fulfill their obligations with respect to maintenance of cannery inspection service according to Article 2 of Chapter 8 of Division 21 of the Health and Safety Code.

§12481. Examination of Can Closures and Can Closure Machines.

Note • History

(a) Visual Examination. During regular production runs, a constant watch shall be maintained for gross maladjustments such as deadheads, cut-overs, and other similar double seam defects. Maintaining this constant check may be accomplished in several ways, depending on the type of closing machine, line speeds, and general equipment layout. It may best be performed by training the closing machine operator to recognize irregularities by visual examination. However, an adequate check program can be maintained through use of other trained personnel.

The operator, can closure supervisor, or other qualified personnel shall visually examine, at intervals of not more than thirty minutes, the top seam of a randomly selected can from each seaming station, and shall record his observations. Additional visual seam inspections shall be made immediately after a can-jam in a closing machine, or after start-up of a machine following a prolonged shut-down. All pertinent observations shall be recorded. If irregularities are found, the action taken shall be noted.

(b) Tear-down Examination. Tear-down examinations shall be made at a frequency of at least one can per seaming station every four hours or each major fraction thereof. Such examinations shall be made as soon as possible after starting up following a shut-down, waiting only long enough for the machine to “warm up.” Cans for visual inspection shall be taken during this warm-up period. The results of the tear-down examinations shall be recorded.

(c) General Observations. Following are some of the various factors which influence double seam quality and which shall be examined in the course of the can seam examination:

(1) Condition of the seaming equipment--whether or not the mechanical operation and adjustment of the closing machine give the proper seam contours.

(2) Can material--variations in tinplate thickness.

(3) Can size--roll contours change with can size to accommodate variations in plate thickness.

Other pertinent observations shall also be recorded indicating the presence or absence of such defects as cut-overs, droops, etc.

NOTE

Authority cited: Section 28440, Health and Safety Code. Reference: Sections 28310-28322, Health and Safety Code.

HISTORY

1. New section filed 3-13-67; effective thirtieth day thereafter (Register 67, No. 11).

§12482. Required and Optional Seam Measurements.

Note • History

(a) Optical System (use of seam scope or projector)

Required Optional

Body hook Width (length, height)

Overlap Cover hook

Tightness (observation for wrinkle) Countersink

Thickness

(b) Micrometer Measurement System

Required Optional

Cover hook Overlap (by calculation)

Body hook Countersink

Width (length, height) Thickness

Tightness (observation for wrinkle)

Regardless of whether or not a seam scope or seam projector is used, the double seam shall be torn down for examination.

(c) Two measurements shall be made for each double seam characteristic if a seam scope or seam projector is used. If a micrometer is used, three measurements shall be made at points approximately 120 apart, excluding the side seam. The high and low measurements must fall within limits considered to be normal for the conditions.

With regard to measurement limits, the canner shall follow the working limits recommended by the can supplier.

Overlap length can be calculated by the following formula:

The theoretical overlap length = CH+BH+T = W

where CH = coverhook

BH = body hook

*T = cover thickness, and

W = seam width (height, length)

*In general practice, 0.010 may be used for the tinplate thickness.

(d) Records shall be kept on all seam examinations. The form of such records shall be the choice of the canning company, but the records must show the frequency of visual and tear-down inspections, and the measurements made. It is suggested that sample forms be obtained from the can supplier.

For the purposes of State inspection, records of seam examinations must be filed and held for inspection by the State Department of Public Health.

NOTE

Authority cited: Section 28440, Health and Safety Code. Reference: Sections 28310-28322, Health and Safety Code.

HISTORY

1. New section filed 3-13-67; effective thirtieth day thereafter (Register 67, No. 11).

§12485. Standards for Water Used in Fish Canneries.

Waters used in fish canning operations within canneries shall conform to the following standards:

(a) Water satisfactory without treatment.

(1) For whole fish handling operations:

(A) Not subject to contamination with human fecal discharges.

(B) Maximum of 7 E. coli organisms per cc.

(2) For cut fish handling operations:

(A) Not subject to contamination with human fecal discharges.

(B) Maximum of 7 E. coli organisms per cc.

(b) Waters satisfactory after treatment:

(1) For whole fish handling operations:

(A) Not subject to gross contamination with human fecal discharges before treatment.

(B) Maximum of 3 E. coli organisms per cc. after treatment.

(2) For cut fish handling operations:

(A) Not subject to gross contamination with human fecal discharges before treatment.

(B) Maximum of 3 E. coli organisms per cc. after treatment.

(D) The treatment shall include filtration or the equivalent as one of the steps of the treatment process.

Samples for bacteriological analysis shall be analyzed by an approved method set forth in the latest edition of the APHA manual entitled “Standard Methods for the Examination of Water and Sewage.” Those methods shall be employed which give the most specific reliable means of measuring organisms having their origin in the intestines of man and other warm-blooded animals.

GENERAL SANITARY REQUIREMENTS FOR FOOD

PACKING ESTABLISHMENTS

§12490. Establishments and Premises in or on Which Food Products Are Prepared, Handled, Stored, or Packed Shall Be Maintained in a Sanitary Condition.

The following general requirements shall be complied with:

(a) Light.

There shall be light of good quality and well distributed wherever the food product may become contaminated.

(b) Ventilation.

There shall be ventilation sufficient to insure sanitary conditions.

There shall be efficient drainage and plumbing systems for the premises. All closed drains shall be properly installed with approved traps and vents.

§12495. Water Supply.

Potable water supply for plant use shall be clean, and bacterially suitable with adequate facilities for its distribution in the plant and its protection against contamination and pollution. In those cases where ocean water is used in the handling of a food product, such as in fish canneries, the ocean water must meet the bacteriological and quality standards for such water as set forth in Section 12485 of these regulations.

In cases where nonpotable water is used, there shall be no cross connection between the nonpotable supply line system and the potable water supply line system. Any nonpotable supply line system shall be painted a color to distinguish it from any potable water supply line system.

§12500. Floors, Walls, Ceilings, Etc.

The floors, walls, ceiling, partitions, posts, doors, and other parts of all preparation and processing areas shall be of such materials, construction and finish that they may be readily and thoroughly cleaned. The floors in all areas where water is used in the operation are to be so constructed and of such material as to be water tight and they shall be maintained in such condition as to stay water tight. All areas used for edible products shall be separate and distinct from those used for inedible products, such as fish meal reduction plants.

§12505. Use of Poisonous Insecticides and Rodenticides in Food Processing Establishments.

(b) The use of insecticides or rodenticides, toxic to humans, in areas where any food product, not adequately protected, is being stored or handled is prohibited.

§12510. Animals in Plant.

Every practical precaution shall be taken to exclude dogs, cats, birds, or other animals and fowl from food establishments.

§12515. Sanitary Facilities.

Adequate sanitary facilities and accommodations shall be furnished by every food packing establishment. Of these, the following are specifically required:

(a) Dressing rooms, and toilet and urinal rooms shall be sufficient in number and conveniently located. These rooms shall be well lighted, sufficiently ventilated to insure sanitary conditions, vented to the outside, and meet all requirements as to sanitary construction and equipment. All doors entering such rooms shall be self-closing. All windows shall be screened. Such rooms shall be separate from areas in which food products are prepared, stored, or handled. The walls, ceilings, partitions, and other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal rooms shall be of light color and of such construction as to be easily and adequately cleaned. Where five or more persons of both sexes are employed, separate facilities shall be provided for each sex.

(b) Sanitary washing facilities, including running hot and cold water, soap, and individual towels, shall be provided, and shall be placed in or near toilet and urinal rooms and also at other places in the establishment as may be essential to insure cleanliness of all persons handling any food product.

(d) Toilet soil lines shall be kept separate from industrial waste lines to a point outside the buildings. Drainage from toilet bowls and urinal shall not be discharged into grease salvage basins, or into open disposal systems.

§12520. Areas, Equipment, and Operations to Be Sanitary.

(a) Areas, equipment, and utensils used for preparing, storing or otherwise handling any food product and all other parts of the establishment shall be kept clean and in sanitary condition.

Areas in which any food product is prepared, processed, stored or handled, including walls, ceilings, and overhead structures of such areas shall be kept as reasonably free from moisture as is practicable. In such areas there shall be no drippings from any source including ceilings and overhead structures that may contaminate the product.

(b) Equipment and utensils used for preparing, processing, or otherwise handling any food product shall be of such materials and construction that they can be readily and thoroughly cleaned. Pipe lines used to convey fluid or semifluid products shall be so constructed that they can be readily and thoroughly cleaned.

(c) Operations and procedures involving the preparation, storing, or handling of any food product shall be strictly in accord with good sanitary practice.

§12525. Personal Hygiene.

(a) The employees of the establishment who handle any food product shall keep their hands clean and, after visiting the toilet room or urinals, shall wash their hands before handling any food product or implement used in the preparation of the product.

(b) Outer clothing and gloves worn by persons who handle any food product shall be clean and of material that can be readily cleaned.

(c) Such practices as spitting on the floor and using empty cans, jars, or other containers as drinking cups, or for purposes other than those originally intended, are forbidden.

(d) Care shall be taken to prevent the contamination of food products with perspiration, hair, cosmetics, medicaments, and the like. Adequate head coverings must be worn by all men and women, while engaged in the preparation or handling of any food product.

(e) Smoking by any person shall not be permitted while preparing or handling any food product or while handling empty cans, jars, lids, barrels, drums or other receptacles used for food products.

(f) The use of fingernail polish by any person preparing, processing, or handling any food product without gloves whereby the product might become contaminated, is prohibited.

(g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any area where any food product is prepared, processed, or handled, except in or on facilities specifically provided for this purpose.

§12530. Surroundings.

The outer premises of every food handling establishment embracing docks, storage areas, and areas where cars and vehicles are loaded and unloaded, and the driveways, approaches, yards, etc. shall be properly drained and kept in a clean and orderly condition. The accumulation of any material in which flies or other insects or vermin may breed or which will afford rodent harborage is forbidden. No nuisance which might contribute to insanitation shall be allowed on the premises of any food packing establishment.

§12535. Employment of Diseased Persons.

No food packing establishment shall knowingly employ in any department where any food product is prepared or handled, any person affected with a communicable disease.

§12540. Empty Container Storage.

Empty cans, jars, covers, lids, barrels, drums, etc. must be clean when filled with food products.

§12545. Tagging Insanitary Equipment.

When the use of any equipment, which is unclean or insanitary, would lead to contamination of the food product, an inspector may attach a quarantine tag to it. No equipment or utensils so tagged shall again be used until made acceptable. Such tag so placed shall not be removed by any person other than an employee of the Department of Public Health.

RECANNING OF FOOD PRODUCTS

§12550. Recanning.

It is not permissible to recan for sale any low acid canned food product for which the State Board of Public Health requires a specific retort process, without first obtaining written permission from the Department of Public Health. Such recanning must be done under the supervision of a duly authorized Inspector of the Department of Public Health.

SPOILAGE IN CANNED FOOD PRODUCTS

§12555. Reporting Spoilage.

Spoilage in any canned products packed under inspection must be reported in writing to the nearest office of the Department of Public Health, or to any Cannery Inspector in person.

All swells, springers and flippers found in the warehouse must be included in the report.

§12560. Segregation.

When swells or other evidence of spoilage in excess of one-half of one percent, (5 cans per 1,000), are found in any warehouse lot, such spoilage must be segregated from the normal cans, and the entire lot, including flat cans, held pending immediate notification of the Department of Public Health. No samples of such material shall be drawn for any purpose until authorization has been granted by the Department of Public Health.

§12565. Examination.

All of the above must be held in a safe and separate place in the warehouse pending examination and recommendation by a representative of the Department of Public Health as to the disposition thereof.

§12570. Monthly Reports.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12575. Sale to Salvage Company.

A report must be made to the Department of Public Health before any canned products packed under the supervision of the Department of Public Health are sold to a salvage company. The material must be inspected and released by a representative of the Department of Public Health before the shipment is made.

§12580. Application.

This regulation is applicable only to warehouse stocks of low acid canned foods which are packed under supervision of the Department of Public Health, and does not apply to material from the cook room damaged or spoiled because of mechanical defects.

VENTING OF CANNED FOOD PRODUCTS

§12585. Venting of Canned Food Products.

It is not permissible to vent and reprocess for sale any low acid canned food for which the State Board of Public Health requires a specified retort process.

BUCKLED CANS

§12590. Tolerance per Batch.

(a) Wherein 10 percent or more of a particular batch is found to be in buckled condition, the entire batch (both buckled and normal appearing cans) shall be restrained.

By “buckled condition” is meant those cans with strained ends caused by excessive internal pressure during processing or cooling, resulting in one or both ends having elevated or wavy areas such that they have become unsatisfactory for retail trade.

(b) Batches wherein less than 10 percent of the number of cans are buckled, only that material showing buckled condition shall be restrained and the normal appearing cans may be released.

(c) Buckled cans shall be reformed as soon as possible after the cans have been restrained. The reforming of the cans must be done before any arrangements can be made to submit the material to a flip vacuum test.

The reforming consists of forcing the distorted top or bottom back to its normal position. Ends slightly distorted may be reformed by thumb pressure whereas ends more severely distorted or strained may be reformed with the closing machine chuck or other suitable tool. Reforming the ends might have some effect upon the vacuum of the cans and as a consequence flip testing should not follow the reforming operation until approximately 30 days have elapsed.

(d) If swells develop during the holding period, they are not to be destroyed, but submitted to the laboratory for examination.

§12595. Supervision of Flip Testing.

Flip testing shall be done in the presence of a State Cannery Inspector. Workable zero, or the minimum external vacuum is to be at such a point that cans with 1 1/2” internal vacuum, or more, are segregated from cans with less than 1 1/2” internal vacuum.

§12600. Segregation of Flip-Tested Cans.

The segregation of flip-tested cans shall be into three lots, namely:

(a) Normal appearing cans

(b) Cans showing 1 1/2” or more internal vacuum

(1) All swells which do not show obvious cause of spoilage shall be submitted to the laboratory for examination immediately upon instructions from the State Cannery Inspector.

(2) All leaks and cans punctured at the time of flip test shall be destroyed.

§12605. Holding After Flip Test.

All material, including normal appearing and buckled cans, not destroyed or submitted to the laboratory must remain under the original restraining order until official release has been authorized in writing.

(a) Such restrained material shall be segregated and marked to distinguish: (1) normal appearing cans, (2) cans with 1 1/2” or more internal vacuum, (3) cans with less than 1 1/2” internal vacuum.

§12610. Cans Having Less Than 1 1/2 ” Internal Vacuum.

After the flip test representative samples of cans having less than 1 1/2” internal vacuum shall be submitted for laboratory examination.

(a) If laboratory findings on samples containing less than 1 1/2” internal vacuum indicate no spoilage, the remainder of the cans in the batch restrained containing less than 1 1/2” vacuum may be released for manufacturing purposes or disposed of directly through channels such as hotels or restaurants for immediate consumption. The canner must notify the Department of Public Health to whom this lot is sold. The material flip testing 1 1/2” or more vacuum and the normal cans may be released for retail trade.

(b) If laboratory findings on samples containing less than 1 1/2” internal vacuum indicate the product not to be commercially sterile, all such cans are to be destroyed in the presence of the State Cannery Inspector.

§12615. Cans Having 1 1/2 ” or More Internal Vacuum.

In the event no cans in the lot are found with internal vacuum less than 1 1/2,” representative samples of the lot having 1 1/2” or more of internal vacuum shall be submitted for laboratory examination.

(a) If laboratory findings on samples containing 1 1/2” or more internal vacuum indicate no spoilage, the remainder of the cans having flip tested 1 1/2” or more internal vacuum may be released for retail distribution. Normal cans restrained in such lots may also then be released for shipment through retail trade channels.

(b) If laboratory findings on samples having 1 1/2” or more internal vacuum indicate the product not to be commercially sterile, all such cans shall be destroyed in the presence of the State Cannery Inspector. In this event, samples will then be taken from the lot of normal appearing cans to be submitted for laboratory examination.

§12620. Normal Cans; No Spoilage.

Note • History

If laboratory findings on samples of normal appearing cans indicate no spoilage, the remainder of the normal appearing cans may then be released for retail trade distribution.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Sections 28432 and 28440, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

§12625. Normal Cans; Spoilage.

If laboratory findings on samples of normal appearing cans indicate the product not to be commercially sterile, all such cans are to be destroyed in the presence of the State Cannery Inspector.

§12630. Overfills and Hydrogen Swells.

That material found to be abnormal due to overfilling or due to the accumulation of hydrogen from chemical action may be recanned under the inspection of the Department of Public Health, based on laboratory examinations of representative samples. See Sections 12550 and 12585 of these regulations.

§12635. Sampling.

All samples submitted to the laboratory must be selected by the State Cannery Inspector.

§12640. Decision to Flip Test.

The Department of Public Health shall determine for each restrained lot whether both normal appearing cans and buckled cans must be flip tested.

DISPOSAL OF UNFIT CANNED FOODS

§12645. Prevention of Salvage of Unfit Canned Foods.

All unfit food products in hermetically sealed containers that are destroyed in public or private dumps must be destroyed by any method suitable to the Department of Public Health; thus preventing the salvage of food unfit for human consumption.

EXPERIMENTAL AND TRIAL PACKS

§12650. Applications.

Applications must be made to the Department of Public Health, in writing, for permission to put up experimental trial packs of any low acid food products. Applications must include complete details of the prospective pack: formula, product, size of pack, size of cans, number of cans, packing medium, initial temperature, time and temperature of process, pH of pack, processing equipment, proposed labels, proposed use of the finished pack. Experimental packs not so authorized will be restrained.

§12652. Exemption.

The above does not apply to a commercial cannery equipped with or having access to a qualified research department if no commodities packed on an experimental basis will be distributed in commerce.

FISH--DELIVERY, HANDLING, AND INSPECTION OF

§12655. General Rules.

(a) The term “decomposed” as used herein shall mean fish that are “in whole or in part diseased, contaminated, filthy, putrid, or decomposed or otherwise unfit for food.”

(b) The Department of Public Health shall require the seller of raw fish and the canning organization involved in each sale to comply with the provisions of Chapter 3 of Division 21 of the Health and Safety Code prohibiting the manufacture, production, preparation, compounding, packing, selling, offering for sale or keeping for sale of any decomposed fish. The responsibility for maintaining an effective inspection service and of eliminating decomposed fish from the canned product shall rest upon the Department of Public Health, Bureau of Food and Drug Inspections, and the executive head of each canning organization.

(c) The inspector in charge at the plant shall require that all cannery operations be carried on under clean and sanitary conditions and require the immediate disposal of decomposed fish, fish offal and bait chum.

(d) The term “inspector” as used in these regulations shall mean a duly authorized “state cannery inspector.”

§12660. Standards for Inspection of Raw Fish.

History

(a) Inspection of raw fish shall be strict and uniform and shall be designed and carried out to the end that fish unsuitable for canning shall be rejected in the raw state insofar as possible.

(b) The standards to be used in the examination and judging of fish shall be such as will make the resultant product conform to the Food, Drug and Cosmetic Act of the United States and to the California Health and Safety Code, Chapter 3 of Division 21.

The Department will not reject cooked fish because of its color or quality, unless such color or quality indicates decomposition as defined in subsection (a) hereof.

(d) Split, mashed, or broken fish shall be condemned if deemed by the inspector to be necessary for the prevention of acceptance of decomposed fish.

(e) The canner shall, promptly on arrival of each boat-load of fish, notify the Department of Public Health, and no canner shall receive fish into its plant until authorization is given by the inspector.

(f) Raw tuna in the round, shall be inspected by the examination of each raw, defrosted fish at the time they are eviscerated. “Defrosted” shall mean that each fish is thawed out to the point that odors are readily detectable. Raw tuna, not in the round, received dressed, eviscerated, gilled, headed or loins or pieces received frozen, shall be inspected in a manner satisfactory to the Department of Public Health at such places and times as may be directed by the inspector to prevent the canning of decomposed fish. Cooked fish, frozen cooked fish or fish pieces, shall be inspected at such places and times as may be directed by the inspector to insure compliance with the law and these regulations.

(g) Raw sardines and mackerel shall, when offered for delivery, be inspected in the boat or at the hoist or at any other point selected by the inspector in charge of the district in order to insure the most effective inspection at each plant. There may be more than one place of inspection.

HISTORY

1. Amendment filed 9-30-60; effective thirtieth day thereafter (Register 60, No. 21).

§12665. Inspection Service--Tuna.

(a) The inspection of all fish for canning purposes shall be under the direction of the Chief of the Bureau of Food and Drug Inspections of the Department of Public Health. The inspector on duty at each plant shall observe that all operations are carried out in a sanitary manner and in a manner to prevent the canning of decomposed fish, and shall immediately report to his superior any unusual or objectionable practice.

(b) In order to facilitate and expedite the administration and enforcement of the aforementioned acts and these regulations each canner may select sufficient personnel from his own employees who shall be trained by an inspector of the bureau to examine fish. The supervising inspector shall notify each canner in writing the names of employees of each company who are approved by the bureau as fish examiners.

(c) The detailed examination of the fish shall be made by an inspector or an approved cannery fish examiner under the supervision of an inspector. The inspector shall specify the number of cannery fish examiners required, in accordance with the condition of fish in process from time to time, and the canner immediately shall supply the number so specified, referring any difference of opinion in this regard to the inspector in charge of the district. The approved cannery fish examiners shall at all times be under the direction of the inspector in charge at the plant while they are performing the duty of examining fish. The inspector in charge at the plant may call upon the cannery management for an approved substitute whenever any authorized cannery fish examiner is, in the opinion of the inspector, doing his work unsatisfactorily. In the event such substitution is not immediately made, an inspector shall be assigned to replace him until an approved substitute is available. The canner involved shall not receive or pack any fish until a proper substitute or an inspector is available. All costs shall be assessed against the canner involved.

(d) The inspector in charge of the district shall have full authority over the activities of his subordinates while assigned to the respective canneries.

§12670. Raw Fish Reports.

(a) The inspector shall make a written record of each boat load on a printed form. The records shall state total quantity of fish and include such evidence as the inspector may be able to obtain as to the method of handling.

(b) The bureau shall have free access to the records of each cannery which bear directly on the problem of fish and cannery inspection.

(c) Condemned tuna shall be weighed by the canner in the presence of the inspector and the inspector's report shall show accurately the weight of condemned fish. The inspector shall keep separate weight records of fish rejected by the canner because of quality or condition other than decomposition.

§12675. Fishing Vessels.

(a) Decks and holds of all boats and vessels catching tuna, mackerel, or sardines and transporting them to a cannery shall be kept in a clean and sanitary condition. The requirement for cleaning vessels and boats shall be enforced regardless of the size or type of the vessel or boat and shall be uniform throughout the State.

(b) Each vessel shall keep a written log which shall be available to the inspection service. Records of net boats shall show the time of each set.

(c) No decomposed chum may be used for bait or in taking mackerel. All bait or chum used must be fresh (not over 24 hours old) unless it be salted or frozen.

(d) High seas fishing boats, whether net or bait, shall keep a record of their catch and their methods of handling fish, including hold and water temperature.

(e) The Department of Public Health or its authorized agent may require interested parties, including members of the laboratory staff, to appear when undue quantities of fish have been condemned. Inquiry shall be made of the fishermen to determine the methods used in fishing and handling. An endeavor shall be made to explain to the fishermen the proper method of handling raw fish to prevent the recurrence of the loss. Representatives of the United States Food and Drug Administration and other interested parties may be admitted to the inquiry.

§12680. Disposal of Condemned Fish.

(a) When a boat load of tuna or mackerel has been condemned as unfit for canning, the inspector shall notify the supervising inspector who shall take such action as is necessary to prevent delivery of the rejected fish to any other plant.

(b) When a boat load of sardines has been condemned and the canner to whom delivery was offered can not receive the fish for reduction purposes, the inspector shall take the necessary steps to prevent the canning of these fish by any other canner.

(c) In all cases the inspector shall serve notice upon the captain of the boat whose fish are condemned that they shall not be used or sold for canning purposes.

(d) The inspector shall take such action as may be necessary to insure that fish which are condemned for canning purposes shall not be used for canning.

§12685. Sampling Canned Tuna.

(a) The supervising cannery inspector in charge of the district shall determine whether or not sample cans of the final product shall be taken for examination. He shall base his decision upon the condition of the boat load and the report of the inspector. If the boat load of fish is in a prime state of preservation at the time of packing, confirmed by inspection in the plant, no samples need be taken.

(b) Sampling shall be carried out according to rules promulgated by the Department of Public Health and the minimum quantities of samples shall be as follows:

A lot of less than 200 cases 48 cans

200 to 1,000 cases 96 cans

1,000 to 2,000 cases 192 cans

2,000 to 5,000 cases 288 cans

5,000 to 10,000 cases 576 cans

Over 10,000 cases 960 cans

Not more than one can should be taken from any one case in sampling.

MACKEREL, HORSE, LABELING EXEMPTION

§12690. Horse Mackerel.

(Treacherous symmetricus) may be labeled as “Jack mackerel” providing that the word “jack” shall be prominently printed in the same size, style and color letters as the word “mackerel” which it modifies; and in addition, that the scientific name Treacherous symmetricus be included on the label; also no written or oral representation on the label or in connection with the sale of the product in invoicing or elsewhere implying that this fish is California mackerel or Pacific mackerel (Pneumatophorus diego) or any fish other than Treacherous symmetricus.

§12695. Sanitary Boat Certificates.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12700. Supervision of Cleaning.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12705. Method of Cleaning.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

INSPECTION LEGEND

§12710. Application.

Any packer desiring to use the inspection legend on labels for products packed under the provisions of Chapter 8 of Division 21 of the Health and Safety Code shall make a formal written application therefor to the Board of Public Health.

§12715. Permission.

Upon receipt of written permission from the Board of Public Health the following statement may be placed on the labels of only those products packed in compliance with the provisions of the Laws Relating to Cannery Inspection.

§12720. Official Wording.

The official wording of the legend is as follows: Sterilized under the supervision of and according to the regulations of the California State Department of Public Health.

RETORT EQUIPMENT AND OPERATION

§12725. Notification of Intention to Install Retorts.

Every person, firm, company, organization, association, or corporation in the State of California desiring to install a retort to be used for the sterilization of low-acid food products in accordance with the provisions of Sections 28410 and 28411 of the Health and Safety Code, prior to installation of such equipment, shall notify the Department of Public Health.

§12730. Obtaining Approval.

Approval shall be obtained from the Department of Public Health before any retort equipment is installed or before previously installed equipment may be used for processing commercial products under inspection.

Upon request diagrams of minimum installations for discontinuous retorts may be obtained from the Department of Public Health.

§12735. Types of Retorts.

(a) Horizontal. Still and rotary retorts

(b) Vertical. Still retorts

Installations and operations of continuous pressure cookers are not sufficiently standardized at the present time to permit making regulations governing their installations and operation. However, such installations shall be subject to the approval of the Department of Public Health.

§12740. Definition of Terms.

Note • History

(a) Inspector. “Inspector” means a duly authorized representative of the Department.

(b) Vent. A “vent” is a valve-controlled opening into a retort, used for the elimination of air during the coming-up time.

(c) Retort Bleeder. A “retort bleeder” is an opening of at least one-eighth inch into a retort which is open during the entire process for the removal of air that may enter the retort with the steam or through a leaky air valve.

(d) Thermometer Bleeder. A “thermometer bleeder” is a one-sixteenth inch or larger opening into a thermometer well or pocket. This bleeder is open during the entire process to ensure a continuous flow of steam from the retort past the thermometer bulb in order that the temperature shown will be the same as that in the retort.

(e) Coming-Up Time (Lag). The “coming-up time” is the time which elapses between the turning on of the steam and the time when the retort reaches the processing temperature.

(f) Process. The term “process” designates the heat treatment expressed in terms of temperature and time given the product after the container is permanently sealed, in order to destroy spoilage microorganisms.

(g) Plug-Cock Valves. An approved type of “plug-cock valve” is one which permits an unrestricted flow of air through the valve.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction of subsection (a) and new NOTE filed 8-1-84 (Register 84, No. 31).

§12745. Required Equipment for All Types of Retorts When Sterilizing Food in Tin or in Glass Jars with Closures Such That They May Be Processed in Steam.

Note • History

(a) Recording Thermometer.

(1) The temperature chart shall be easily readable to 1 degree F and shall be graduated in not to exceed 2 degrees F divisions within the range of plus and minus 10 degrees F of the official process to be used. All charts shall have a working scale of not less than three inches. Written permission from the Department shall be obtained for the use of old equipment with charts having a working scale of less than three inches. All replacements or new installations shall conform to a minimum three-inch working scale.

(2) No temperature chart shall be used in a recording thermometer unless it is a chart manufactured specifically for use in the recording thermometer installed on the retort.

(3) It shall be unlawful to use charts with the temperature indicated in code.

(4) Every recording thermometer shall bear the name plate of the original manufacturer having the serial number assigned by the manufacturer, and the manufacturer's chart number die stamped thereon.

(5) Any recording thermometer found by a cannery employee or Inspector to be faulty in its operation shall be promptly adjusted or replaced by a properly functioning instrument.

(6) Any recording thermometer requiring repair of the thermal system shall be repaired by the manufacturer or a servicing organization accredited by the manufacturer.

(7) Documentary evidence of proper calibration may be required for any repaired recording thermometer when returned by the manufacturer or accredited servicing organization.

(8) All recording thermometers shall be so placed with respect to light that they are conveniently readable.

(b) Indicating Mercury Thermometer.

(1) The divisions shall be easily readable to 1 degree F and shall not exceed 20 degrees F per inch of graduated scale. It shall be unlawful to use mercury thermometers with the temperatures indicated in code.

(2) All mercury thermometers shall be placed in respect to light so that they are conveniently readable.

(1) Every retort shall have a pressure gauge of the Bourdon type in which the operating mechanism is a complete unit independent of the case. Every gauge shall be equipped with a compensating hair spring.

(2) The minimum diameter of the dial shall be four inches.

(3) The range of the pressure scale shall preferably be 0 to 30 pounds, but a range of 0 to 60 pounds may be used.

(4) Any retort pressure gauge found to be inaccurate either by a cannery employee or by an Inspector shall be replaced by a properly functioning instrument.

(d) Valves for Removal of Condensate.

(1) Condensate shall not be allowed to accumulate in horizontal retorts.

This may be prevented by the installation of a one-half inch or larger valve in the bottom of the retort to be left open sufficiently to remove the condensate.

(2) To assure that condensate will not accumulate in a retort during the process, a one-eighth inch or larger petcock or valve shall be installed or a hole drilled in the drain or bottom of the retort and it shall remain open during the entire processing time.

(e) By-Pass Around Diaphragm Control Valve on Steam Inlet.

Each diaphragm control valve shall be equipped with a by-pass to allow for hand control in case of an emergency.

(f) Steam Inlet.

(1) Horizontal Retorts:

(A) For retorts more than 20 feet in length, the steam shall enter the spreader pipe near the center of the retort. For retorts less than 20 feet in length, the steam may enter the spreader pipe either at the center or at the end. If steam enters at the end, the spreader pipe shall be no smaller than the steam inlet.

(B) The retort shall be equipped with an adequately perforated pipe extending throughout the entire length of the bottom of the retort with perforations arranged so that the steam is directed up and into the load of cans. The ends of the steam spreader shall be closed.

(2) Vertical Retorts:

(A) If steam is admitted into the bottom of the retort, it shall be directed up into the load of cans. Any other position of the steam inlet must be approved by the department.

The recommended number of holes to be used in steam spreaders is given in the following table:

Size of Steam Supply Inlet

Size 3/4 1 1 1/4 1 1/2 2 2 1/2

Holes Inch Inch Inch Inch Inch Inch

Inches Pipe Pipe Pipe Pipe Pipe Pipe

3/16 25 45 70 112 185 265

7/32 18 35 50 82 135 195

1/4 14 25 38 62 105 145

(g) Retort Bleeders.

(1) For Horizontal Retort:

(A) A horizontal retort shall be equipped with bleeders along the top of the retort not more than eight feet apart and there shall be one within approximately one foot of each end of the retort. These bleeders shall be kept wide open during the entire process.

(B) Any bleeder at least one-eighth inch in size on a thermometer well may be considered to comply with this requirement when the well is in the top of the retort and located at the proper place.

(2) For Vertical Retort:

(A) A vertical retort shall be equipped with a bleeder at the end of the retort opposite the steam inlet. This bleeder shall be wide open during the entire process. In the case of very small retorts (less than 30-inch diameter and less than four feet in depth) a three-thirty-second inch bleeder may be used.

(h) Thermometer Bleeders. Bleeders for All Thermometers on All Types of Retorts. A one-sixteenth-inch or larger bleeder hole shall be kept open for the free escape of steam on all thermometer fittings unless thermometer bulbs are set wholly within the shell of retort proper. The bleeders shall be so located as to provide a full flow of steam past the sensitive part of the thermometer bulb.

(i) Vents for Removal of Air From Retorts During Coming-Up Period. Vents shall be installed and operated in such a way that all the air is removed from the retort before timing of the process is started.

See the venting systems described under Sections 12760 and 12765 of these regulations.

(j) Stacking Equipment for Use in Horizontal and Vertical Retorts.

(1) Stacking equipment (baskets, trays, gondolas, etc.) for all types of containers in discontinuous retorts, when cans or jars are stacked in a vertical position, shall be preferably of strap iron. When perforated sheet metal baskets are used, the perforations in the bottoms shall be at least one-inch holes on one-and-three-fourths-inch centers or their equivalent, unless other equipment has been approved.

(2) If dividers are used, they shall be of wide mesh material, such as fish nets or onion sacks, or of strap iron or sheet metal having perforations at least the equivalent of one-inch holes on one-and-three-fourths-inch centers. Close meshed cloth dividers are not permitted.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code.

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Editorial correction of subsections (a)(1), (a)(5) and (c)(4) filed 8-1-84 (Register 84, No. 31).

§12750. Additional Equipment Suggested but Not Required by the Department of Public Health.

(a) The use of an additional thermometer on each retort is advised to serve primarily as a check instrument, preferably located adjacent to the temperature recorder bulb.

(b) An automatic temperature controller is recommended.

(c) A safety valve of such size and capacity that it meets with the requirements of any board of mechanical engineers or any safety code in the State of California, and/or the California Industrial Accident Commission. It is recommended that the safety valve discharge be equal to or greater in capacity, than the retort steam supply line.

§12755. Venting of Retorts for Removal of Air, General Considerations.

(a) Vents (except drains when used as vents) shall be in the opposite side or end of the retort from that at which the steam is admitted.

(b) Vent valves shall be of the gate or plug cock type, preferably quick acting, except where otherwise specified.

A globe valve of one pipe size larger than the minimum vent requirement may be substituted for a gate valve.

(c) for the most efficient operation of a retort, cans shall be so stacked, and the stacking equipment shall be of a type such that the air can be removed rapidly enough to permit a uniform distribution of heat throughout the retort at the time processing temperature is attained. Anything which interferes with the free flow of steam through any part of a retort load makes this requirement more difficult to meet.

Use of the drain as a vent in conjunction with venting from the top of the retort is permissible and several combinations of top and bottom vents are described. However, it is more desirable to use venting systems which do not involve the use of the drain.Various arrangements of vents may be used to obtain uniform heat distribution throughout a retort. The following vent arrangements and cycles of operation have been found to give satisfactory heat distribution. Every retort shall be equipped with one of these installations or some other arrangement of vents which is equally satisfactory. If venting systems other than those described here are desired, or if shorter coming-up times are to be used, the approval of the Department of Public Health shall first be obtained. A special investigation may be required in order to determine the conditions under which such equipment may be used. If equipment now in use approximates, but does not exactly conform to one of the prescribed venting systems, the Department of Public Health should be consulted before any expensive change of equipment is undertaken. Full details concerning the present installation should be furnished to the department.Conditions such as boiler capacity and size of steam inlets vary in different plants and modifications of the venting procedure may be necessary in some instances to permit reaching the temperature specified within the recommended time. When this seems necessary, an investigation will be made by the Department of Public Health and modifications of the equipment or venting procedure will be suggested in accordance with conditions found. When a change in procedure is suggested, this new procedure will then become the approved method of venting the retorts in question at that plant.

§12760. Venting of Horizontal Retorts for Removal of Air.

The following venting specifications are for discontinuous horizontal retorts not exceeding five and one-half feet inside diameter, and are based on data from tests made with round cans in strap iron trays. There is evidence to indicate that the use of perforated sheet metal trays may necessitate supplementary retort venting or modifications in the stacking of cans.

(a) System A. Venting Through Multiple One-Inch Vents Discharging Directly to the Atmosphere.

(2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F, or at least seven minutes to at least 220 degrees F.

(3) If vent pipes are to be extended beyond the valves, the extensions shall be of at least one pipe size larger than the vent pipes entering the retort.

(b) System B. Venting Through the Drain Valve and Through Multiple One-Inch Vents Discharging Directly to the Atmosphere.

(2) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size for retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length.

The drain valve may be either globe or gate type.

(3) Operation. The vent valves and the drain valve shall be wide open when steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F.

(5) The one-inch vent valves shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F.

(6) If vent pipes are to be extended beyond the valves, the extensions shall be of at least one pipe size larger than the vent pipes entering the retort.

The drain may be extended beyond the valve with pipe the same size as the valve.

(1) Equipment. A retort shall be equipped with unrestricted one-inch pipes, approximately one foot in length, one for each five feet--or fraction thereof--of retort length, approximately symmetrically placed along the top of the shell, uniformly separated, not more than seven feet apart, and connected into a manifold. There shall be one of the above vents within two and one-half feet of each end of the shell. The manifold shall be of 2 1/2-inch pipe size for retorts up to 15 feet in length, and of three-inch pipe size for retorts over 15 feet in length. Venting shall be controlled by a vent valve in a pipe leading from, and of a size not smaller than that of the manifold.

(2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least six minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F or at least eight minutes to at least 220 degrees F.

(3) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

(d) System D. Venting Through the Drain Valve and Through Multiple One-Inch Vents Discharging Through a Manifold.

(1) Equipment. A retort shall be equipped with unrestricted one-inch pipes approximately one foot in length, one for each five feet--or fraction thereof--of retort length, approximately symmetrically placed along the top of the shell, uniformly separated, not more than seven feet apart and connected into a manifold. There shall be one of the above vents within two and one-half feet of each end of the shell. The manifold shall be of 2 1/2-inch pipe size for retorts up to 15 feet in length, and of three-inch pipe size for retorts over 15 feet in length. Venting shall be controlled by a vent valve in a pipe leading from, and of a size not smaller than that of the manifold.

(2) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size or retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length.

The drain valves may be either gate or globe type.

(3) Operation. The vent valve and drain valve shall be wide open when steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least three minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F.

(5) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F.

(6) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

(e) System E. Venting Through the Water Spreader.

(1) Equipment. The water spreader shall be of not less than 1 1/2-inch pipe size for retorts less than 15 feet in length, with the water inlet connected through the shell so that the spreader pipes extend in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than two-inch pipe size. The vent pipe shall be of at least two-inch pipe size and shall be connected into the water inlet without any restriction in pipe size.

The water spreader shall be of not less than two-inch pipe size for retorts from 15 to 30 feet in length with the water inlet connected through the shell so that the spreader pipes extend in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than 2 1/2-inch pipe size. The vent pipe shall be of at least 2 1/2-inch pipe size and shall be connected into the water inlet without any restrictions in pipe size.

If the water enters at or near one end of the retort the water spreader shall be at least as large as the water inlet.

For retorts over 30 feet in length, the Bureau of Food and Drug Inspections, Cannery Inspection Section, shall be consulted for the proper venting requirements.

(2) The water spreader shall have holes of not less than three-sixteenths-inch diameter distributed uniformly along the length of the spreader pipe, and of sufficient number so that their aggregate area is not less than that of a two-inch pipe (3.34 square inches) for retorts up to 15 feet in length, or not less than that of a 2 1/2-inch pipe (4.75 square inches) for retorts having lengths of 15 to 30 feet.

(3) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F; or the vent valve shall remain wide open for at least seven minutes to at least 220 degrees F.

(4) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

(5) The following table indicates the minimum number of holes permissible in water spreaders when used for venting:

Number of Holes in Spreader Pipe

Drill For 1 1/2-Inch For 2-Inch For 2 1/2-Inch

Size Pipe Outlet Pipe Outlet Pipe Outlet

Inches (2.02 Sq. In.) (3.34 Sq. In.) (4.75 Sq. In.)

3/16 74 121 173

7/3 54 89 127

1/4 42 69 97

(f) System F. Venting Through the Drain Valve and Through the Water Spreader.

(1) Equipment. The water spreader shall be of not less than 1 1/2-inch pipe size for retorts less than 15 feet in length, with the water inlet connected through the shell so that the spreader pipe extends in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than two-inch pipe size. The vent pipe shall be of at least two-inch pipe size and shall be connected into the water inlet without any restriction in pipe size.

The water spreader shall be of not less then two-inch pipe size for retorts from 15 feet to 30 feet in length with the water inlet connected through the shell so that the spreader pipe extends in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than 2 1/2-inch pipe size. The vent pipe shall be of at least 2 1/2-inch pipe size and shall be connected into the water inlet without any restrictions in pipe size.

If the water enters at or near one end of the retort the water spreader shall be of at least the same size as the water inlet.

For retorts over 30 feet in length, the Department of Public Health shall be consulted for the proper venting requirements.

(2) The water spreader shall have holes of not less than three-sixteenths-inch diameter distributed uniformly along the length of the spreader pipe, and of sufficient number so that their aggregate area is not less than that of two-inch pipe (3.34 square inches) for retorts up to 15 feet in length, or not less than that of a 2 1/2-inch pipe (4.75 square inches) for retorts having lengths of 15 to 30 feet.

See table in subsection (e)(5) for number and size of holes required.

(3) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size for retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length. The drain valve may be either globe or gate type.

(4) Operation. The vent valve and the drain valve shall be wide open when steam is admitted to the retort.

(5) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F.

(6) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F.

(7) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

(g) System G. Venting Through a Single 2 1/2-Inch Top Center Vent--for Retorts Less Than 15 Feet Long.

(1) Venting may be accomplished by the use of a single 2 1/2-inch unrestricted vent located at the top of the shell, provided this vent is within two feet of the center of the retort.

(2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least four minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F.

If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

(h) System H. Venting Through the Drain Valve and Through a Single 1 1/2-Inch Top Center Vent for Retorts Less Than 15 Feet Long.

(1) Venting may be accomplished by the use of the drain valve in conjunction with a single unrestricted 1 1/2-inch vent located at the top of the shell, provided the vent is within two feet of the center of the retort.

(2) In addition, the retort shall be equipped with a drain of not less than four-inch pipe size.

(3) Operation. The vent valve and the drain valve shall be wide open when steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F.

(5) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F.

(6) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired.

§12765. Venting of Vertical Retorts for Removal of Air.

Note • History

(a) The following specifications apply for venting vertical retorts not larger than approximately 42 inches diameter by 96 inches high, when the following equipment is used:

(1) Strap-iron or adequately perforated metal baskets.

(2) Vents located in or near the top of the retort.

(3) At least a one-inch steam line into the bottom of the retort and arranged so that steam is directed up into the load of cans.

(4) Raised supports for retort baskets so constructed that no baffling effect occurs. Baffle plates are not permitted.

If dividers are used, they shall be of wide mesh material, such as fish nets or onion sacks, or of strap iron or sheet metal having perforations at least the equivalent of one-inch holes on one and three-fourths-inch centers. Close meshed cloth dividers are not permitted .

(b) System I. Venting Through a Single 1 1/2-Inch Overflow Pipe.

(1) Venting of a vertical retort may be accomplished through a 1 1/2-inch overflow pipe if it is connected to the retort within at least 10 inches of the top of the shell. The overflow pipe shall have not more than eight feet of 1 1/2-inch pipe beyond the valve. If the vent pipe discharges into a manifold, the manifold shall be sufficiently large so that venting will not be impaired.

(2) Operation. The vent valve shall be wide open when steam is turned on, and it shall remain wide open for at least four minutes after steam is turned on and also until the mercury thermometer reaches a temperature of at least 218 degrees F or for at least five minutes to at least 215 degrees F.

(1) Venting of a vertical retort may be accomplished through a single unrestricted one-inch vent located in the lid of the retort. This vent shall be equipped with a one-inch gate valve and shall discharge into the atmosphere, with not more than four feet of one-inch pipe beyond the valve.

(2) The vent valve shall be wide open when steam is turned on, and it shall remain wide open for at least five minutes after steam is turned on and also until the mercury thermometer reaches a temperature of at least 230 degrees F or for at least seven minutes to at least 220 degrees F.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

§12767. Diagrams of Venting Systems.

Note • History

Diagrams Reprinted from “Food Industries” Vol. 16, Page 93, February, 1944

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

RETORTS, FOR FOODS IN GLASS

§12770. Notification of Intention to Install Retorts.

Every plant desiring to install a retort to be used for the sterilization of low acid food products in accordance with the provisions of Sections 28410 and 28411 of the Health and Safety Code, prior to installation of such equipment, shall notify the Department of Public Health.

§12775. Obtaining Approval.

Approval shall be obtained from the Department of Public Health before any retort equipment is installed, or before previously installed retort equipment may be used for processing commercial products under inspection. Every plant must be properly equipped to satisfy all requirements of the department.

§12780. Equipment Required.

Note • History

Every horizontal steam operated discontinuous retort to be used for the sterilization of food products packed in glass containers must have the following as minimum equipment:

(a) Gauge water glass or series of petcock water level indicators. (Gauge water glass is recommended.)

Automatic pressure control is recommended to prevent waste of compressed air.

(b) Pressure regulating valve in the overflow line. It shall be the same size as, or larger than, the water supply line.

(d) Recording thermometer

(2) No temperature chart shall be used in a recording thermometer unless it is a chart manufactured specifically for use in the recording thermometer installed on the retort.

(3) It shall be unlawful to use charts with temperature indicated in code.

(4) Every recording thermometer shall bear the name plate of the original manufacturer having the serial number assigned by the manufacturer, and the manufacturer's chart number die stamped thereon.

(5) Any recording thermometer found by a cannery employee or State Cannery Inspector to be faulty in its operation shall be promptly adjusted or replaced by a properly functioning instrument.

(6) Any recording thermometer requiring repair of the thermal system shall be repaired by the manufacturer or a servicing organization accredited by the manufacturer.

(7) Documentary evidence of proper calibration may be required for any repaired recording thermometer when returned by the manufacturer or accredited servicing organization.

(8) All recording thermometers shall be so placed with respect to light that they are conveniently readable.

(e) Indicating mercury thermometer.

(1) The divisions shall be easily readable to 1 degree F and shall not exceed 20 degrees F. per inch of graduated scale. It shall be unlawful to use mercury thermometers with the temperature indicated in code.

(2) All mercury thermometers shall be placed in respect to light so that they are conveniently readable.

(f) Pressure gauge.

(2) The minimum diameter of the dial shall be four inches.

(3) The range of the pressure scale shall preferably be 0 to 30 pounds but a range of 0 to 60 pounds may be used.

(4) Any retort pressure gauge found to be inaccurate either by a cannery employee or by an Inspector shall be replaced by a properly functioning instrument.

(g) Proper circulating equipment to insure agitation of the water during come-up and process time. In horizontal retorts this may be accomplished with a recirculating pump. In vertical retorts this may be accomplished by providing for a continuous supply of compressed air through the steam distributor cross during these periods. The bypass line around the air control valve, providing a continuous supply of air, shall be at least one-eighth inch inside diameter.

(h) Adequately perforated steam distributor pipe extending the length of horizontal retorts or forming a cross throughout the width of the bottom of vertical retorts or any other approved methods.

(i) Bottom drain.

(j) A safety valve of such size and capacity that it meets with the requirements of any Board of Mechanical Engineers or any Safety Code in the State of California, and/or the California Industrial Accident Commission. It is recommended that the safety valve discharge be equal to or greater in capacity than the retort steam supply line.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code.

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Editorial correction of subsections (d)(1), (f)(4) and new NOTE filed 8-1-84 (Register 84, No. 31).

§12785. Installation of Equipment.

Note • History

(a) The gauge water glass or series of petcocks shall be installed in such a position as to determine the water level during the process. If a gauge water glass is used, a mark indicating the height of the top row of jars shall be placed on the gauge water glass. If a series of petcocks is used, the petcock above the level of the top row of jars must be open at all times during the process and the free flow of water shall be visible to the retort operator.

(b) Steam and air shall be admitted at the bottom of the retort. Water may be admitted at the top, or bottom, or both.

It is recommended that all pipe connections be equipped with check valves where there is a common entrance for steam, water, and air.

(c) Steam and air shall be admitted into the bottom center of the retort through a perforated pipe or cross extending the length of the horizontal retort or throughout the width of a vertical retort, and in which the perforations are so arranged as to produce equal turbulence and distribution throughout the length of the pipe or cross. The extreme ends of the perforated steam distributor pipe or cross shall be closed; other methods of producing turbulence and proper distribution of heat are subject to approval.

(d) Each diaphragm control valve shall be equipped with a bypass to allow for hand control in case of an emergency.

(e) In horizontal retorts a suction manifold shall be installed in the bottom of the retort to remove the water for circulation. The number of water inlets to the suction manifold shall be dependent upon the length of the retort with a minimum of one for each eight linear feet of retort length. The inlets shall be spaced at approximately equal intervals. The combined area of the inlets shall equal the area of the manifold. The manifold shall be connected to a recirculating pump operating at a sufficient rate to completely recirculate the water in not more than seven minutes. The water shall re-enter the top of the retort through the perforated water spreader.

Any other type of manifold or suction installation will be subject to the approval of the Department.

It is recommended that the switch operating the pump be equipped with a signal light, preferably red, or other warning device, so that the operator can see at all times that the pump is properly functioning.

(f) In horizontal retorts the mercury thermometer bulb, recording thermometer bulb and temperature controller bulb shall be located within the shell of the retort, and in such a position that they are beneath the surface of the water throughout the process.

(g) In vertical retorts the recording thermometer bulb and temperature controller bulb shall be installed at the bottom of the retort beneath and away from the steam inlet.

(h) In vertical retorts the mercury thermometer shall be so installed as to permit continuous circulation of the heating medium past the bulb during the process.

This may be accomplished by inserting the thermometer in a gradually sloped shallow and closed extension of the retort.

(i) The bottom of the overflow outlet shall be above the level of the top of the jars in the retort.

(j) All recording thermometers, mercury thermometers, pressure gauges and gauge water glasses must be so placed in respect to light that they are easily readable.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code.

HISTORY

1. Editorial correction of subsection (e) and new NOTE filed 8-1-84 (Register 84, No. 31).

§12790. General.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12795. Animal Food Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12800. Asparagus Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12805. Beans, Dry: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12810. Beans, Green and Wax, Whole or Cut: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12815. Beans, Lima and Soy: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12820. Bean Sprouts: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12825. Beets: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12830. Broccoli: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12835. Brussels Sprouts: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12840. Cabbage: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12845. Carrots: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12850. Carrot Juice: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12855. Carrots and Peas: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12860. Cauliflower: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12865. Celery: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12870. Chili Products: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12875. Corn: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12880. Corn Meal Mush: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12885. Fish Products: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12890. Hominy: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12895. Lentils in Unthickened Sauce: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12900. Mushrooms: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12905. Mushroom Sauce--Spaghetti Sauce: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12910. Olives: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12915. Parsnips: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12920. Peas: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12925. Potatoes: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12930. Potatoes, Sweet: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12935. Poultry Meat--Turkey: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12940. Pumpkin: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12945. Ravioli: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12950. Spaghetti: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12955. Spinach, Packing and Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12960. Tamales, Cup: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12965. Vegetables, Chopped: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12970. Vegetables for Salad: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12975. Vegetables, Strained: Sterilization Processes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12976. Cookroom Personnel.

Note • History

In order to facilitate and expedite the administration and enforcement of these regulations, each canner shall select sufficient qualified personnel from his own employees who, to the satisfaction of the State Cannery Inspector, shall see that these regulations are followed.

NOTE

Authority cited: Sections 102, 208, 26202, 26501 and 28440, Health and Safety Code.

HISTORY

1. New Sections 12976 through 12984 filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

§12977. Posting of Cooks

Note • History

Official cooks for all low acid products being packed must be conspicuously posted near the retorts.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

§12978. Marking Containers.

Note • History

Each can, glass jar, or other food container, basket, truck, car or crate containing unretorted material to be processed in still retorts shall be plainly and conspicuously marked with a heat sensitive indicator which will visually indicate to all cookroom personnel whether or not each unit has been retorted. The marking of each individual food container with an indicator to indicate process status is desirable.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

§12979. Time Limits.

Note • History

Not more than two hours shall elapse between the time the first can is closed, and the time steam is admitted to the retort containing that batch or cook, except

(a) tuna which may be held for a maximum of three hours after closing, and

(b) canned ripe olives and acidified food products packed under pH control for which the time limitation does not apply. In the event this time limit is exceeded, the cans or jars may be processed but shall be quarantined by the inspector until the Department has determined they are free from spoilage.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§12980. Double Door Retorts.

Note • History

No uncooked containers may be placed in a double door retort before the rear door has been closed. Deviations will be allowed only if prior approval has been obtained from the Department.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§12981. Retort Markers.

Note • History

A distinctive marker must be hung over the still retort opening when the retort contains unprocessed containers. It must be placed so that the door or lid cannot be locked before the marker is removed. A retort must not be locked until the operator indicates that it is ready for the process to start. Deviations will be allowed only if prior approval has been obtained from the Department.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§12982. Care of Containers.

Note • History

Any container which falls on the floor must be immediately picked up. Any container removed for inspection must be promptly returned. Any container of unproven status with regard to processing must be punctured.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§12983. Blanching.

Note • History

In the canning of leafy vegetables, all of the product which has been blanched must be canned and the containers closed within thirty minutes after shut down in order to prevent incipient spoilage before processing. If this period is exceeded, the product may be canned, but must be quarantined by the inspector until the Department has determined they are free from spoilage. All such material shall be carefully segregated so representative samples may be sent to the laboratory.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§12984. Posting Regulations.

Note • History

These regulations covering operation procedures must be conspicuously posted in all cookroom areas where they can be read and understood.

NOTE

Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

Article 9. Olive Oil Regulations

§13500. Olive Oil Regulations.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Repealer filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

Article 10. Mobile Food Preparation Units

§13600. Order Promulgating Standards.

Note • History

Under the authority of Section 28694.5 of the Health and Safety Code, the following regulations establishing definitions and minimum standards of operation and construction for mobile food preparation units and commissaries which service mobile food preparation units are hereby promulgated.

NOTE

Authority cited for Article 10: Section 28694.5, Health and Safety Code. Reference: Sections 28590-28650, Health and Safety Code.

HISTORY

1. Repealer and new Article 10 (Sections 13600-13609) filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 52).

§13601. Definitions.

History

(a) “Mobile food preparation unit” means any wheeled vehicle upon which ready-to-eat food is cooked, wrapped, packaged, processed, or portioned for service, sale or distribution. This section does not apply to a “bakery delivery vehicle” as defined in Section 28524 of the Health and Safety Code or a vehicle used only for the sale or delivery of fresh meat, fish, poultry, or produce.

(b) “Mechanical refrigeration” means a unit which extracts heat from an area by means of liquefication and evaporation of a fluid by means of compressor or flame, or by means of a thermoelectric device. Acceptable mechanical refrigeration shall also include cold plates.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission 11-10-72. (Register 72, No. 49).

§13602. Exterior Requirements.

History

(a) The name and address of the person operating the mobile food preparation unit shall be plainly indicated on each side of the exterior of the vehicle in letters of contrasting colors at least three inches high with a minimum 3/8 inch-wide stroke. Any of the following three methods are acceptable:

(1) The name, street address, and city of the person in whose name the license is issued. Listing of the phone number is optional with the owner or operator of the vehicle.

(2) The name of the owner or operator, or his business name and city, providing they are listed in the telephone directory.

(3) The name of the operator or owner of the vehicle, or his business name, and the address of the commissary from which the vehicle is serviced.

(b) Entrance doors to food preparation areas shall be self-closing and kept closed when not being used.

(c) Compressor units that are not an integral part of equipment, auxiliary engines, generators, etc., shall be installed in an area that is completely separated from food preparation and food storage and which is accessible from outside the unit for proper cleaning and maintenance. The food preparation and storage area shall be so constructed so as to be rodent proof.

(d) The exterior of the mobile food preparation unit and the surrounding area, as relating to the operation of the unit, shall be maintained in a sanitary condition by the operator of the unit. No attachment (such as a can opener) shall be mounted on the exterior of the mobile food preparation unit. Adequate waste containers shall be furnished for the use of customers. These containers shall be of easily cleanable construction and furnished with a tight-fitting cover and shall be kept clean.

HISTORY

1. Amendment of subsections (a) and (d) filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13603. Interior Requirements.

History

(a) At least a two-compartment metal sink equipped with hot and cold running water with dual integral metal drainboards, installed with at least 1/8 inch per foot slope toward the sink, and fabricated with a minimum of 1/2 inch lip or rim to prevent the draining liquid from spilling onto the floor shall be provided. The dimensions of each compartment shall be at least 12 inches wide, 12 inches long, and 10 inches deep. Each drainboard shall be at least the size of one of the sink compartments.

If multi-use eating and drinking utensils are used, the sink shall have three compartments; each compartment with a minimum size of 12” x 12” x 10.” The drainboards shall be at least 12” x 12.” Drainboards for a three-compartment sink shall comply with the requirements of drainboards for a two-compartment sink.

The sink shall be equipped with a mixing faucet and shall be provided with a swivel spigot capable of servicing any sink compartment individually as desired.

(b) Hand washing facilities, including a lavatory supplied with hot and cold running water with a mixing type faucet, hand washing detergent or soap and single-service sanitary towels in permanently installed dispensing devices shall be provided and maintained in each mobile food preparation unit. The hand washing facilities shall be separate from the utensil washing sinks. The lavatory basin must have a minimum dimension of 9” x 9” in width and 5 inches in depth. The hand washing facilities shall be separated from the utensil washing sinks by a metal guard with a height of at least three inches, and extending from the back edge of the drainboard to the front edge of the drainboard, the corners of the barrier to be rounded. No separation barrier is required if the distance between the hand washing sink and the utensil drainboards is two or more feet. Mobile food preparation vehicles in operation and built before the effective date of the regulations adopted December 5, 1969, may be accepted without separate hand wash basins until January 1, 1975, at which time they must comply with the regulations or discontinue operation.

(c) Floors, walls, and ceilings shall be constructed so that the surfaces are impervious, smooth and cleanable. Floor surfaces shall provide employee safety from slipping. The juncture of the floors and walls shall be covered with the floor surface extending up the wall at least four inches. In all mobile food preparation units constructed after the effective date of these regulations there shall be a clear, unobstructed height over the aisle-way portion of the unit of at least 76 inches from floor to ceiling, and a minimum of 30 inches of unobstructed horizontal aisle space.

(d) Construction joints and seams shall be sealed to provide smooth, easily cleanable surfaces. Soldered joints and seams shall be smooth to the touch. Silicone sealant or equivalent waterproof compounds shall be acceptable, providing they prevent the entrance of liquid waste or vermin.

(e) All equipment shall be so installed as to be easily cleaned, prevent vermin harborage and provide adequate access for service and maintenance. Equipment shall be spaced apart for easy cleaning or shall be sealed together. Food equipment and machinery set apart from adjacent equipment or machinery, or the clearance between the top of the counter, or the bottom of a piece of equipment with a rigid utility connection, shall provide a minimum width of three inches of unobstructed space for sanitary maintenance beneath the counter equipment or the sides of adjacent equipment. Food equipment or machinery of a size and weight that can be easily picked up and moved by one person, and with a flex connection need not comply with minimum leg height requirement. No threads, nuts, or rivets shall be exposed where they interfere with cleaning. Should such threads, nuts, or rivets interfere with cleaning they shall be capped.

On existing mobile food preparation units and equipment with exposed threads, nuts, screws, or rivets that can be cleaned with the usual, easily available cleaning equipment such as brushes, brooms, mops, cleaning cloths, or with steam, or flushing with water, shall be acceptable if maintained in a clean and sanitary condition.

(f) All equipment shall be sealed to the floor to prevent moisture from getting under the equipment or it shall be raised at least six inches off the floor by means of an easily cleanable leg and foot.

(g) Equipment, including the interior of cabinet units or compartments, shall be constructed so as to have smooth, easily accessible, and easily cleanable surfaces (free from channels, crevices, flanges, ledges, or other cleaning obstructions). Unfinished wooden surfaces are not permitted. Food contact surfaces shall be constructed of metal, high pressure laminated plastics, or laminated hardwood. These surfaces must be kept free of cracks, cuts, and other obstructions which would interfere with proper cleaning.

(h) All utensils shall be designed and constructed so as to be easily cleanable and shall be made of nontoxic materials.

(i) Space around pipes, conduits, or hoses that extend through cabinets, floors, or outer walls shall be sealed. The closure shall be smooth and easily cleanable.

(j) Light bulbs, tubes, etc., shall be covered with a completely enclosed plastic safety shield or its equivalent. Light fixtures shall be installed so as to not constitute a hazard to personnel or food materials.

(k) Waste receptacles shall be provided inside of the vehicle. They shall be constructed so as to be smooth, nonabsorbent and easily cleanable, and kept clean.

(l) No smoking signs and signs directing proper hand washing shall be posted in the food preparation area.

(m) The interior of the mobile food preparation unit and all equipment and utensils in the unit shall be kept clean and in good repair and free of vermin.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13604. Temperature Requirements.

History

(a) Adequate mechanical refrigeration space shall be provided and each refrigerator shall be equipped with an easily readable thermometer. Wooden shelves are not permitted in the refrigerator. Readily perishable food shall be kept at 45 Fahrenheit, or below, at all times (except as provided in Subsection (b)). Readily perishable packaged food arranged for display and self-service may be held on an ice bed. Mobile units manufactured prior to the effective date of this Section are not required to have mechanical refrigeration space provided adequate nonmechanical refrigeration has been installed.

(b) Adequate space shall be provided to maintain readily perishable food which is kept hot at a temperature of 140 Fahrenheit, or higher, and a suitable thermometer to test the internal temperature of food, accurate to plus or minus 2 Fahrenheit, must be available for measuring the temperature of the hot food. All readily perishable food which is not refrigerated shall be kept at 140 Fahrenheit, or higher, at all times.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

2. Amendment of subsection (a) filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

§13605. Ventilation.

History

Mechanical exhaust ventilation equipment shall be provided over all cooking equipment as required to effectively remove cooking odors, smoke, steam, grease and vapors. The ventilation shall be adequate to provide a reasonable condition of comfort for employees. Grease filters or other means of grease extraction are required and shall be of steel construction, or other approved material, and shall be readily accessible for cleaning. Every joint and seam shall be substantially tight. No solder shall be used, except for sealing a joint or seam. Every hood shall be so designed and installed to provide for thorough cleaning of the entire hood. When grease gutters are provided they shall drain to a collecting receptacle fabricated, designed, and installed to be readily accessible for cleaning. All ducts in the exhaust system shall have a slope of at least two inches per lineal foot. All seams in this duct work shall be substantially tight to prevent the accumulation of grease. The ducts shall have sufficient clean-outs to make the ducts readily accessible for cleaning. Make-up air shall be provided at the rate of that exhausted. It may be accomplished from screened service openings, vents in the ceiling, or mechanically through an air-conditioning system, but not through open doors or openable windows.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13606. Storage.

History

(a) Spare tires, related automotive equipment, or special tools relating to the mechanical operation of the mobile food preparation unit shall not be stored in the food preparation or food storage areas.

(b) A separate cabinet or drawer shall be installed for the storage of insecticides or other poisonous substances, if such substances are used. All poisonous chemicals shall be kept in this cabinet, or drawer in their original containers, and in a manner that offers no contamination hazard to food or utensils.

(c) Suitable facilities shall be provided for the storage of linens, uniforms, and other related linens. Suitable facilities such as a cabinet or drawer shall be provided for the storage of personal belongings. All personal belongings shall be kept in the space provided.

(d) All pressure cylinders shall be securely fastened to a rigid structure of the vehicle. All liquefied petroleum equipment shall be installed to meet fire department standards and other laws that are applicable. A minimum 5 B.C.-rated fire extinguisher to combat grease fires shall be installed on the interior of each mobile food preparation unit in a readily accessible place.

(e) Adequate and suitable space shall be provided for the orderly storage of food and food service materials.

(f) Single-service utensils shall be stored in their original enclosed package, in a clean, dry area. They shall be kept in an approved, enclosed dispenser for customer use. Straws shall be wrapped or dispensed from approved, enclosed dispensers. An enclosed dispenser shall protect the lip-contact portion of the eating and drinking utensil from contamination.

HISTORY

1. Amendment of subsections (b), (d) and (f) filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13607. Service Openings.

History

(a) Service openings shall be limited to 216 square inches each. The service openings may not be closer together than 18 inches. They shall be self-closing with a screen of not less than 16 mesh per inch, or a solid closing device. With the exception of the service openings the entire food preparation and food storage area shall be enclosed with a solid, easily cleanable material. The counter surface of the service openings shall be smooth and easily cleanable.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13608. Power Supply.

History

Whenever the vehicle is in service, adequate electrical power shall be provided to operate the approved exhaust, lighting, and refrigeration systems, or any other accessories and appliances that may be installed on a mobile food preparation unit.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13609. Water Supply, Plumbing.

History

(a) A water supply tank of sufficient capacity to furnish an adequate quantity of potable water for food preparation, cleaning, and hand washing purposes shall be provided (minimum 30 gallons). Hose connection valves shall be at least five feet above the ground and be kept covered with a protective screw-type cap, which is attached to the vehicle. The water supply shall meet health department requirements of potability as specified in Chapter 7 (commencing with Section 4010) of Part 1, Division 5 of the Health and Safety Code. The water system shall be of such materials and designed and constructed so water or air can be introduced without the water becoming contaminated. The water system shall deliver at least one gallon per minute to each sink basin in the unit.

(b) A hot water heater with a minimum capacity of three gallons, or an instantaneous heater capable of producing water of 120 Fahrenheit interconnected with the potable water supply, shall be provided and shall operate independently of the vehicle engine and/or generator. Hot and cold water, under pressure, shall be provided at hand washing and utensil sinks units from mixing faucets.

(c) The liquid waste tank shall have a capacity at least 50 percent greater than the fresh water tank, and shall receive and be adequate to hold melting ice water resulting from one day's operation.

(d) All tanks, lines, couplings, valves, or any other plumbing shall be designed, installed, maintained, and constructed of materials that will not contaminate the water supply, food, utensils, or equipment.

(e) Water and waste storage tanks shall be installed so as to be easily drained, flushed, and cleaned with an easily accessible outlet. Breather tubes or overflow pipe openings shall be protected from the entrance of dust, insects, and other contamination. All waste lines shall be connected to the waste tank with watertight seals.

(f) The water supply tank shall be filled and the waste storage tank shall be emptied only at the commissary or other facilities approved by the health officer.

(g) Toilet facilities for the use of the food service personnel shall be available within 100 feet of the vehicle whenever it is stopped to conduct business for more than a one-hour period.

(h) Mobile food preparation units may be connected to an approved water supply and sewerage disposal system. Such units shall be equipped with a hose or other approved connection to attach to the water system. This connection shall be used for no other purpose and shall be protected from contamination at all times. In order to avoid confusion, all water connections shall be green in color. Waste lines shall be a color other than green.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

Article 10.1. Commissaries Servicing Mobile Food Preparation Units

§T17-13611. General Requirements.

Note • History

(a) The requirements of this article shall be the minimum requirements for commissaries which service mobile food preparation units in the State of California.

NOTE

Authority cited for Article 10.1: Section 28694.5, Health and Safety Code. Reference: Sections 28590 through 28650, Health and Safety Code.

HISTORY

1. New Article 10.1 ( T17-13611 through T17-13616) filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 52).

2. Approved by State Building Standards Commission 2-13-70 nunc pro tunc (12-22-69) (Register 70, No. 8).

§13612. Waste Handling and Disposal.

(a) Each commissary which services mobile food preparation units, shall have on the premises adequate facilities for:

(1) Handling liquid waste from the mobile unit being serviced. Such facility shall be constructed so that waste can be handled in a safe and sanitary manner.

(2) Handling and disposing of garbage and rubbish which originates on the mobile unit. The waste receptacles shall be constructed so as to be easily cleaned and securely covered.

§13613. Water Supply and Plumbing.

History

(a) Each commissary which services mobile food preparation units shall have potable water available for filling the water tanks of mobile units. Such watering facilities shall be constructed so as to minimize the possibility of contaminating the water being loaded.

(b) The hose used for filling water tanks shall be constructed of a nontoxic material (NSF approval recommended). It shall be green in color and shall be used for no other purpose. At all times the hose shall be kept at least four feet above the ground.

(d) Potable water supply shall at all times be protected from potential backflow.

HISTORY

1. Amendment of subsections (b) and (d) filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§T17-13614. Electrical Hook-Up Facilities.

(a) Each commissary which services mobile food preparation units shall have available sufficient, suitable electrical outlets for mobile units which require electrical service. These outlets shall be constructed to comply with the applicable provisions of Part , Title 24, California Administrative Code.

§T17-13615. Toilet and Lavatory.

History

(a) Each commissary which services mobile food preparation units shall have available suitable toilet and lavatory facilities for the use of the operators of the mobile units. These facilities shall be provided with hot and cold running water with mixing faucets, or tempered (110o-115oF) running water, soap and sanitary towels in permanently installed dispensing devices. Toilet facilities shall be kept clean and in good repair.

(b) If toilet facilities are used by five or more people of different sex, separate facilities for each sex shall be provided. The ratio of toilets to employees shall be as required in Section B-1105, Part 2, Title 24, California Administrative Code, and one additional toilet and lavatory facility shall be provided for each additional 60 mobile unit operators of the same sex on the premises at any one time.

HISTORY

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

§T17-13616. Facilities for Food Storage.

History

(a) Each commissary which services mobile food preparation units shall have adequate facilities for storing all food and supplies which are loaded on the mobile units. No food or food in a container shall be stored directly on the floor. They shall be stored at least six inches above the floor, or under such other conditions as are approved by the State Health Department. “Other conditions” that may be acceptable are storage of foods on moveable pallets with a minimum height of five inches.

(b) Perishable food shall be stored in devices which maintain the temperature of the food at 45 Fahrenheit, or below, or 140 Fahrenheit, or above, at all times. These devices shall be equipped with thermometers which are located so as to be easily read.

HISTORY

1. Amendment of subsection (a) filed 11-28-72; effective thirtieth day thereafter. Approved by Building Standards Commission November 10, 1972 (Register 72, No. 49).

2. Amendment of subsection (b) filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

Article 10.2. Requirements for the Sale of Imitation Hamburger in Restaurants

§13620. Definitions.

Note • History

(a) “Wallboard” means any permanent sign used to display or describe food items for sale in a restaurant.

(b) “Placard” means any non-permanent sign used to display or describe food items for sale in a restaurant.

NOTE

Authority cited: Sections 208, 26202 and 26596, Health and Safety Code. Reference: Section 26596, Health and Safety Code.

HISTORY

1. New Article 10.2 (Sections 13620 and 13621) filed 10-11-74; effective thirtieth day thereafter (Register 74, No. 41).

2. Editorial correction of NOTE filed 8-1-84 (Register 84, No. 31).

§13621. Wallboard and Placard Requirements in Restaurants Without Menus.

Note • History

Restaurants serving imitation hamburger containing more than 10 percent added protein and water or other extenders or binders shall post an ingredient statement on a wallboard or placard.

(a) The ingredients shall be listed in descending order of predominance by weight.

(b) The term “imitation hamburger,” or any other term which accurately informs the customer of the nature of the product and its ingredients, shall be stated in letters at least one (1) inch in height (72 point letters) in bold-face type in colors which contrast with the wallboard or placard.

(c) The wallboard or placard shall be posted in a permanent place, conspicuous to the customers, in each room or area where food is served.

NOTE

Authority cited: Sections 208, 26202 and 26596, Health and Safety Code. Reference: Section 26596, Health and Safety Code.

HISTORY

1. New NOTE filed 8-1-84 (Register 84, No. 31).

Article 10.3. Requirements for Roadside Stands, Food Establishments Open to the Outside Air, and Retail Dairies

§13650. Definitions.

Note • History

(a) “Roadside Stand” means a food establishment which has one or more sides open to the outside air during hours of business, which sells produce or shell eggs or both, and where no more than ten percent of the floor space of the food sales and storage area is devoted to packaged foods.

(b) “Food Establishment Open to the Outside Air” means a food establishment which has one or more sides open to the outside air during hours of business, and where over ten percent of the floor space is devoted to the storage and sale of packaged foods to consumers.

(c) “Retail Dairy” means a food establishment of which milk or milk products to be sold directly to the consumer constitute over 50 percent of the volume of sales. Processing and packaging facilities as defined in Sections 32505 and 32513 of the California Food and Agricultural Code shall not be considered part of the retail dairy.

(d) “Retail Sales Area of Grower-Seller Premises” means the retail sales area operated by a grower or producer only for the sale of his own produce or shell eggs or both directly to the consumer. These products must be grown or produced on property owned, rented, or leased by the grower or producer, and on which the sales area is located.

(e) “Employee” means any person working in an establishment governed by the provisions of this Article.

(f) “Food Preparation” means any operation by which the form, flavor, or consistency of food is changed. It includes, but is not limited to, cooking, seasoning, cutting, and grinding.

(g) “Milk and Milk Products” means those food items which are defined in Sections 32510-32512 of the California Food and Agricultural Code, Division 15, Part 1, Chapter 1. Milk and milk products will be considered to be packaged foods.

(h) “Packaged Foods” means foods in a package, as defined in Section 26023 of the California Health and Safety Code. The package shall conform to the applicable provisions of Chapter 4 of Division 21 (commencing with Section 26400) of the California Health and Safety Code. The packaging of such products shall be done at a facility approved by the local health officer. Processing and packaging facilities as defined in Sections 32505 and32513 of the California Food and Agricultural Code shall be exempt from this requirement.

(i) “Potentially Hazardous Food” means any food which consists in whole or in part of ingredients capable of supporting rapid and progressive growth of infectious or toxicogenic microorganisms, including, but not limited to, milk or milk products, eggs, meat, poultry, fish or shellfish. It does not include food that has been processed and packaged so as to prevent the growth of pathogenic microorganisms, or any uncracked shell eggs.

(j) “Produce” means any fruit or vegetable in its raw or natural state.

(k) “Produce Preparation” means any operation by which the form, flavor or consistency of the produce is changed. It includes, but is not limited to, cooking, seasoning, cutting, trimming, and grinding.

(l) “Trimming” means the removal of part of the produce, such as outer leaves, stems, stalks, roots, and tops.

(m) “Utensil” means any kitchenware, cutlery, container, implement, wrapper or other equipment with which food comes in contact during storage, display, preparation, sale, or through use by an employee or consumer.

NOTE

Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5 Health and Safety Code.

HISTORY

1. New Article 10.3 (Sections 13650 through 13653) filed 8-1-75; effective thirtieth day thereafter (Register 75, No. 31).

2. Editorial correction relettering subsections (a) and (c)-(k) filed 7-3-84 (Register 84, No. 27).

§13651. Structural and Operational Requirements.

Note • History

NOTE

Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§13652. Health Requirements.

Note • History

(a) All employees shall wear clean washable outer garments and shall keep their hands clean at all times while engaged in handling food, beverages, or utensils. All employees shall wash their hands and arms with soap or detergent and water before commencing work after using toilet facilities, before returning to work, and at such other times as are necessary to prevent contamination of food. Legible signs shall be posted in each toilet room directing attention to this requirement.

(b) When information as to the possibility of disease transmission is presented to the local health officer, he shall investigate conditions and take appropriate action. The health officer may, after investigation and for reasonable cause, require any or all of the following measures to be taken:

(1) The immediate exclusion of such employee or owner from the affected food establishment;

(2) The immediate closing of the establishment until in the opinion of the health officer no further danger exists;

(3) Medical examination of the owner and employees, with such laboratory examination as may be indicated, or should such examination or examinations be refused, the immediate exclusion of the refusing owner or employee from that or any other food establishment operation until a medical or laboratory examination shows that he is not affected with, or a carrier of, any disease in a communicable form.

NOTE

Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§13653. Enforcement and Inspection.

Note • History

NOTE

Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code.

HISTORY

1. Repealer filed 11-20-85; effective thirtieth day thereafter (Register 85, No. 47).

Article 10.4. Ventilation Standards for Retail Food Establishments

§13670. Adoption of the 1976 Uniform Mechanical Code.

Note • History

Chapter 4-20 of Title 24, California Administrative Code, shall be the commercial hood and kitchen ventilation standards for retail food establishments as defined in Title 17, California Administrative Code, Section 12100(a).

NOTE

Authority cited: Sections 208, 28694, 28694.5 and 28863, Health and Safety Code. Reference: Sections 28196, 28545 and 28826, Health and Safety Code.

HISTORY

1. New Article 10.4 (Sections 13670-13671) filed 9-18-80; effective thirtieth day thereafter (Register 80, No. 38).

§13671. Building Plan Approval.

Note

(a) Building plans for new construction or remodeling of kitchen ventilation systems in retail food establishments shall be submitted for review and approval to either the local health officer or a duly authorized registered sanitarian.

(b) Construction or installation shall not begin without prior written approval that the building plan complies with the requirements of Section 13670.

NOTE

Authority cited: Sections 208, 28694, 28694.5 and 28863, Health and Safety Code. Reference: Sections 28196, 28545, 28826 and 28865, Health and Safety Code.

Article 10.5. Raw Oysters

§13675. Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements.

Note • History

(a) For purposes of this article, the following definitions shall apply:

(1) “Dealer” means a person who shucks, packs, re-packs, processes, labels, re-labels, ships, re-ships, holds or otherwise sells shellfish. “Dealer” does not include persons solely engaged in retail activities as defined in the Health and Safety Code, Section 113875.

(2) “Gulf oyster” means any oyster harvested from the states of Alabama, Florida, Louisiana, Mississippi, or Texas.

(3) “Half-shell oyster” means any oyster from which one shell has been removed.

(4) “MPN” (Most Probable Number) means a statistical estimate of the number of bacteria per unit volume determined from the number of positive results in a series of fermentation tubes.

(5) “Non-detectable level” means that the MPN of Vibrio vulnificus bacteria is less than 3 MPN per gram of product as determined by the Vibrio vulnificus testing method in the U.S. Food and Drug Administration Bacteriological Analytical Manual, 8th Edition, 1995, pages 9.01-9.27, hereby incorporated by reference.

(6) “Offers” means making raw oysters available to any person, whether the raw oysters are subject to purchase, exchange, or transfer, or are provided without charge.

(7) “Orders” means requesting or selecting raw oysters for consumption on the premises of a retail food facility, or requesting or selecting raw oysters for consumption off the premises.

(8) “Oyster treatment process” means a process that has been determined by the state shellfish control authority having jurisdiction, the U.S. Food and Drug Administration, or a recognized process authority to consistently reduce the level of Vibrio vulnificus to a non-detectable level.

(9) “Recognized process authority” means the person(s) or organization(s) recognized by the state shellfish control authority or the U.S. Food and Drug Administration as having expert knowledge of oyster treatment processes, and having adequate facilities for making such determinations.

(10) “Retail food facility” means “retail” as defined in section 113875 of the Health and Safety Code and “food facility” as defined in section 113785 of the Health and Safety Code.

(11) “Shellfish Control Authority” means the State, or other regulatory authority, or its designated agents responsible for the enforcement of laws or regulations governing shellfish growing and harvesting areas, shellfish handling facilities and dealer activities including harvesting, transporting, storing, handling, processing, packing, and repacking of shellfish.

(12) “Shellstock oyster” means any oyster in both shells.

(13) “Shucked oyster” means any oyster from which both shells have been removed and which has been packed in a container by a dealer.

(14) “Tent cards” means free-standing print displays or a printed display in a supporting stand designed for placement on dining tables or food service counters.

(b) Every retail food facility that offers raw Gulf oysters shall provide a written warning to any person who orders raw oysters, as provided in this section.

(1) The written warning shall be worded in English and Spanish as follows:

WARNING

THIS FACILITY OFFERS RAW OYSTERS FROM THE GULF OF MEXICO. EATING THESE OYSTERS MAY CAUSE SEVERE ILLNESS AND EVEN DEATH IN PERSONS WHO HAVE LIVER DISEASE (FOR EXAMPLE ALCOHOLIC CIRRHOSIS), CANCER OR OTHER CHRONIC ILLNESSES THAT WEAKEN THE IMMUNE SYSTEM. If you eat raw oysters and become ill, you should seek immediate medical attention. If you are unsure if you are at risk, you should consult your physician.

AVISO IMPORTANTE

ESTA FACILIDAD OFRECE OSTRAS CRUDAS DEL GOLFO DE MÈXICO. A COMER ESTAS OSTRAS CRUDAS PUEDEN CAUSAR UNA ENFERMEDAD GRAVE Y HASTA LA MUERTA EN LAS PERSONAS QUE PADECEN DE ENFERMEDADES DEL HÌGADO (POR EJEMPLO, CIRROSIS ALCOHÒLICA), CANCER U OTRAS ENFERMEDADES CRÒNICAS QUE DEBILITAN EL SISTEMA INMUNOLÒGICO. Si usted come ostras crudas y se enferma, debe buscar atenciòn medica inmediatamente. Si usted cree estar en peligro, debe consultar a un mèdico.

(2) Where raw oysters are purchased by a consumer over a counter, or where they are offered for sale by a sign, tag, or menu board, the sign bearing the warning set forth in subsection (b)(1) shall be prominently placed so that it is likely to be read by consumers prior to ordering raw oysters. The warning signs shall meet the following specifications:

(A) Be square in shape and no smaller than 10 inches on a side (100 square inches) or be rectangular in shape and no smaller than 11 inches high by 8.5 inches wide (93.5 square inches).

(B) Be printed in black ink on a white background, dark blue ink on a yellow background or other ink that is of high contrast from the color of the background material.

(D) The word “Warning” and the words “Aviso Importante” shall be in all bold, upper case letters and underlined and be no smaller than 35 point type face.

(E) The first two sentences of the English and the Spanish version shall be in bold letters and be no smaller than 30 point type face. The remaining sentences of the English and the Spanish version shall be no smaller than 25 point type face.

(3) Where raw oysters are ordered directly from a server, at a dining table, or where a warning sign posted pursuant to subsection (b)(2) is not clearly legible from any location where the consumer orders raw oysters, the warnings shall be printed on all menus in which raw oysters are listed, or on tent cards located on each dining table. For menus, the warning may be shortened to contain the headers and the first two sentences of the English and Spanish statements as set forth in subsection (b)(1) and shall be prominently placed on the menu so that it is likely to be read by consumers prior to ordering raw oysters. Tent cards shall contain the complete warning statements as set forth in subsection (b)(1) and be prominently placed on the dining tables so that they are likely to be read by consumers prior to ordering raw oysters. Both menu warning statements and tent card warning statements shall meet the following specifications:

(A) Be printed in black ink on a white background, dark blue ink on a yellow background or other ink that is of high contrast from the color of the background material.

(B) The word “Warning” and the words “Aviso Importante” shall be in all bold, upper case letters and underlined.

(4) Menu warning statements shall meet the following additional specifications:

(A) Be no smaller than 10 point type face.

(B) Be enclosed by a box rule with no less than 1/8” of space around the notice.

(5) Tent card warning statements shall meet the following additional specifications:

(A) Be square in shape and no smaller than 4 inches on a side (16 square inches) or be rectangular in shape and no smaller than 3 inches high by 5 inches wide (15 square inches).

(B) The word “Warning” and the words “Aviso Importante” and the first two sentences of the English and Spanish version shall be in no smaller than 12 point medium or bold type face, and the remaining sentences shall be no smaller than 10 point type face.

(1) Refuse to accept any container of raw shellstock oysters, half-shell oysters, or shucked oysters, if the container does not have a tag or label affixed that prominently and clearly bears the statement “Harvested in ______________________________”, “Product of ______________________________”, or words of similar meaning (to be filled in with the name of the state or foreign country in which the raw oysters were harvested). For containers of raw oysters that have any oyster harvested from a state bordering on the Gulf of Mexico, this paragraph is satisfied when the container bears a tag or label affixed that prominently and clearly bears the statement “Harvested from the Gulf of Mexico”, or “Product of the Gulf of Mexico”.

(2) Refuse to accept raw shellstock oysters unless each container contains a tag or label that prominently and clearly bears all of the following:

(A) The harvest date of the oysters.

(B) The bed name or lease number assigned by the shellfish control authority to the harvest area.

(C) The state abbreviation and certification number assigned by the shellfish control authority to the harvester, or original dealer.

(3) Refuse to accept raw shucked oysters unless each container of oysters bears a label that prominently and clearly states all the following:

(A) The sell-by-date, date-shucked, date-packed, or similar date of the shucked oysters.

(B) The state abbreviation and certification number assigned by the shellfish control authority of the state or foreign country to the harvester or original dealer.

(C) The harvest date of raw Gulf oysters. This requirement is satisfied when each shipment of raw oysters is accompanied by an invoice that specifies the harvest date of the oysters.

(D) That raw Gulf oysters, which have not been subjected to an oyster treatment process, be cooked before eating.

(4) Refuse to accept any container of raw half-shell oysters unless each container of oysters bears a tag or label that prominently and clearly states the information required in subparagraphs (c)(3)(A), (B), and (C).

(5) Refuse to accept any container of raw shellstock, half-shell, or shucked Gulf oysters harvested during April through October, and such oysters shall be deemed adulterated, unless:

(A) The oysters have been subjected to an oyster treatment process and are prominently and clearly tagged or otherwise labeled with the information required by subsection (i); and

(B) The dealer or retail food facility has on file a current copy of the letter from the department verifying the use of an oyster treatment process in accordance with subsection (h).

(d) Warnings under subsection (b) are not required for raw shellstock, half-shell or shucked Gulf oysters whenever the retailer has received a copy of a current verification letter from the dealer pursuant to subsection (h) and tags or labels as required by subsection (i) demonstrating that the oysters have been subjected to an oyster treatment process.

(e) In order to be eligible to receive verification by the department that oysters supplied by the dealer are subjected to an oyster treatment process, a dealer shall submit a written request for verification pursuant to Section 13676. A verification issued by the department shall be valid for two years from the date of issue unless revoked or suspended.

(f) A dealer who has received a verification pursuant to Section 13676 shall notify the department in writing prior to making any changes to the oyster treatment process, or any changes to the Hazard Analysis and Critical Control Point (HACCP) plan required by Title 21, Code of Federal Regulations, Part 123.

(g) A dealer who has received a verification pursuant to Section 13676 shall notify the department, within seven days, of any new information known to the dealer pertaining to the effectiveness of the oyster treatment process.

(h) A dealer who has received verification pursuant to Section 13676 shall provide a copy of the letter from the department granting the current verification to every dealer and retail food facility in California to whom the dealer sells or provides shellstock, half-shell, or shucked raw Gulf oysters. Every dealer and retail food facility that offers shellstock, half-shell, or shucked raw Gulf oysters for which verification pursuant to Section 13676 has been granted, shall retain and make available for inspection by the department and local health agencies a copy of the current verification letter provided by the dealer. A retail food facility shall retain the copy of the verification for one year after the date that the verification expires.

(i) A dealer who has received verification pursuant to Section 13676 shall affix to each container of raw Gulf oysters processed to reduce Vibrio vulnificus to a non-detectable level, a tag or label pursuant to subsections (c)(2), (c)(3), and (c)(4), as required. In addition to requirements of subsections (c)(2), (c)(3), and (c)(4), such tag or label shall clearly and prominently bear the phrase “PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS”, followed by a lot number traceable to the dealer's processing records. Use of the phrase “PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS”, or words of similar meaning on tags or labels of raw unprocessed oysters, or on tags or labels of processed raw oysters from other than a dealer who has a current verification from the department is unlawful, and causes the oysters to be misbranded.

NOTE

Authority cited: Sections 100275, 110065, 110105, 110430, 112165 and 113710, Health and Safety Code. Reference: Sections 110175, 110545, 112165(c), 112195, 112200 and 113980, Health and Safety Code.

HISTORY

1. New section filed 12-31-90 as an emergency; effective 12-31-90 operative 3-1-91 pursuant to subsection (g) (Register 91, No. 8). A Certificate of Compliance must be transmitted to OAL by 4-30-91 or emergency language will be repealed by operation of law on the following day.

2. Repealer and new section filed 3-1-91 as an emergency, operative 3-1-91 (Register 91, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-1-91 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-1-91 order including amendment of section transmitted to OAL 7-1-91 and filed 7-23-91 (Register 91, No. 45).

4. Editorial correction of printing errors in section (Register 91, No. 45).

5. Amendment of section heading, section and Note filed 6-6-97 as an emergency; operative 6-6-97 (Register 97, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-6-97 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of History 3 (Register 97, No. 46).

7. Certificate of Compliance as to 6-6-97 order, including amendment of subsection (g)(1), transmitted to OAL 10-1-97 and filed 11-13-97 (Register 97, No. 46).

8. Amendment of section heading, section and Note filed 4-14-2003 as an emergency; operative 4-14-2003 (Register 2003, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-12-2003 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 4-14-2003 order transmitted to OAL 8-11-2003 and filed 9-23-2003 (Register 2003, No. 39).

§13676. Request for Verification.

Note • History

(a) A request for verification by the department that oysters supplied by a dealer are subjected to an oyster treatment process shall include all of the following:

(1) The name and address of the dealer;

(2) A copy of the shellfish certificate or license issued by the Shellfish Control Authority having jurisdiction;

(3) A description of the process used to treat the oysters and the procedures used to ensure that oysters harvested during April through October and shipped to California are subjected to the treatment.

(4) A report by the Shellfish Control Authority or a recognized process authority, accompanied by the concurrence of the U.S. Food and Drug Administration verifying that the process used consistently reduces the level of Vibrio vulnificus to a non-detectable level.

(5) Signature, under penalty of perjury, of the individual requesting verification attesting to the accuracy of the information provided in the request for verification.

(b) Requests for verification shall be deemed complete when the information specified in subsection (a) has been received in writing by the department. Initial requests for verification may be submitted at any time to the department. Requests for renewals shall be submitted to the department no later than 60 days prior to the expiration date. Requests for verification shall state whether the dealer is requesting an initial verification or renewal of an existing verification.

(c) The department shall notify the dealer in writing within 15 days of receipt of a request for verification of one of the following:

(1) The request for verification is complete and shall be evaluated by the department, or

(2) The request for verification is incomplete and not accepted for evaluation. The department's written notification shall describe the specific information or documentation that is deficient.

(d) Within 60 days of the receipt of a complete request for verification, the department shall notify the dealer of one of the following:

(1) That the oyster treatment process has been verified, or

(2) That the request has been reviewed and denied for failure to establish that each oyster harvested during April through October and sold or distributed in California will be subjected to an oyster treatment process. The department shall provide a written description in the notification of the basis for the denial.

(e) Written notification by the department to dealers requesting verification shall be deemed to occur on the date that the notification is postmarked.

(f) The department shall deem a request for verification abandoned by a dealer requesting verification who fails to respond or to supply information or documents within 30 days of notification by the department.

(g) The time periods for processing a request for verification from the date of receipt by the department are as follows:

(1) The median time for processing a request is 45 days.

(2) The minimum time for processing a request is 20 days.

(3) The maximum time for processing a request is 60 days.

(h) The department may revoke or suspend a verification granted pursuant to Section 13675(e) and this section for any failure of the dealer to ensure the use of the oyster treatment process as described in the request for verification, for any failure of the oyster treatment process to reduce Vibrio vulnificus to non-detectable levels, or for any violation by the dealer of this article. The department shall inform the person of any denial, revocation, or suspension in writing, stating the reasons for the denial, revocation, or suspension.

NOTE

Authority cited: Section 15376, Government Code; and Sections 100275, 110065, 110105, 110430 and 112165(a), Health and Safety Code. Reference: Sections 110435, 110545, 110660, 112165(c), 112195, 112200 and 113980, Health and Safety Code.

HISTORY

1. New section filed 4-14-2003 as an emergency; operative 4-14-2003 (Register 2003, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-12-2003 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 4-14-2003 order transmitted to OAL 8-11-2003 and filed 9-23-2003 (Register 2003, No. 39).

Article 11. Frozen Food Locker Regulations

§13700. Frozen Food Locker Regulations.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code.

HISTORY

1. Repealer filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

§13701. Licenses for Frozen Food Locker Plants.

Note • History

(a) Licenses for Frozen Food Locker Plants will be valid for a two-year period from date of issue and are not transferable. The fee for the license is $50.00.

(b) Application for a Frozen Food Locker Plant license shall be made on State Department of Health form #EH-6.

(d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application.

NOTE

Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code.

HISTORY

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

Article 12. Hazardous Substances Regulations

NOTE

Authority cited for Article 12: Sections 102 and 208, Health and Safety Code. Reference: Sections 28740 through 28755, 28778 and 28779, Health and Safety Code.

HISTORY

1. New Article 12 (Sections 14001-14003, 14010-1401, 14061-14063, 14101-14103, 14105, 14107 and 14108) filed 7-23-62; effective thirtieth day thereafter (Register 62, No. 15).

2. Repealer of Article 12 (Sections 14001-14108, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). Group 2. Definitions and Standards

Group 2. Definitions and Standards

Article 13. Food Standards

§15200. Order Promulgating Standards.

Note • History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15205. General Regulations.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15210. Examinations and Investigations--Samples.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15215. General Methods for Water Capacity and Fill of Containers.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15220. General Statements of Substandard Quality and Substandard Fill of Container.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

FLOURS AND RELATED PRODUCTS

Subarticle 1. Flour and Cereal Products

HISTORY

1. Repealer of Part 1 (Sections 15225-15300, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 67, No. 40, and 56, No. 16.

Subarticle 2. Corn Flour and Related Products

HISTORY

1. Repealer of Part 2 (Sections 15305-15375, not consecutive) filed 9-1-78; effective thirtieth day thereafter. (Register 78, No. 35) For prior history, see Registers 78, No. 10; 77, No. 48; 67, No. 40; and 56, No. 16.

Subarticle 2 A. Rice and Related Products

HISTORY

1. Repealer of Part 2A (Section 15376) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 60, No. 15.

Subarticle 3. Bakery and Bakery Products

HISTORY

1. Repealer of Part 3 (Sections 15380-15403, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 78, No. 10; 77, No. 48; 67, No. 40; 61, No. 23; 60, No. 15; and 56, No. 16.

Subarticle 4. Alimentary Pastes

§15405. Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 67, No. 40.

§15410. Enriched Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15415. Milk Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15420. Whole Wheat Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15425. Wheat and Soy Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15430. Vegetable Macaroni Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15435. Noodle Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 67, No. 40.

§15440. Enriched Noodle Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15445. Wheat and Soy Noodle Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15450. Vegetable Noodle Products: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15455. Oriental Style Noodles, Chinese Style Noodles, Japanese Style Noodles, Korean Style Noodles: Identity; Label Statement of Ingredients.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No. 15).

2. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15460. Tagliarini: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15465. Use of Secondhand Boxes for Alimentary Pastes.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

PROCESSED VEGETABLE PRODUCTS

Subarticle 1. Canned Vegetables

HISTORY

1. Repealer of Part 1 (Sections 15470-15525, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 68, No. 14; 60, No. 15; and 56, No. 16.

Subarticle 2. Canned Vegetable Other Than Those Specifically Regulated

HISTORY

1. Repealer of Part 2 (Sections 15530 and 15531) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 68, No. 4; 60, No. 15; and 56, No. 16.

PROCESSED TOMATO PRODUCTS

Subarticle 3. Canned Tomatoes

HISTORY

1. Repealer of Part 1 (Sections 15535-15545, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 68, No. 14.

Subarticle 4. Tomato Products

HISTORY

1. Repealer of Part 2 (Sections 15550-15570, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 60, No. 15; and 56, No. 16.

Subarticle 5. Tomato Products, Mold Filament Tolerance

§15575. Tomato Catsup, Puree, and Paste.

Note • History

A mold tolerance of 40 percent of the microscopic fields is not to be exceeded in cases of tomato catsup, puree, and paste.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§15580. Tomato Juice.

Note • History

The mold tolerance in case of tomato juice should not exceed 20 percent of the microscopic fields.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§15585. Comminuted Tomato Products.

Note • History

Comminuted tomato products exceeding mold count tolerances specified in Section 15575 and Section 15580 cannot be used as ingredients of manufactured foods such as tomato soup, spaghetti sauce, etc.

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code.

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. New NOTE filed 7-3-84 (Register 84, No. 27).

PROCESSED FRUIT PRODUCTS

Subarticle 1. Canned Fruit

HISTORY

1. Repealer of Part 1 (Sections 15590-15713, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 67, No. 23; 60, No. 15; and 56, No. 16.

Subarticle 2. Fruit Preserves and Jellies

HISTORY

1. Repealer of Part 2 (Sections 15715 and 15716) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 67, No. 23; 60, No. 15; 57, No. 11; and 56, No. 16.

Subarticle 3. Fruit Butters

HISTORY

1. Repealer of Part 3 (Sections 15717, 15718 and 15719) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 67, No. 23; and 56, No. 16.

Subarticle 3.5. Citrus Products

HISTORY

1. Repealer of Part 3.5 (Sections 15721-15723, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 68, No. 43.

Subarticle 4. Carbonated Beverages

HISTORY

1. Repealer of Part 4 (Section 15726) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 68, No. 20.

DRESSINGS FOR FOODS

Subarticle 1. Dressings for Salads

HISTORY

1. Repealer of Part 1 (Sections 15735-15750, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 68, No. 36; 60, No. 15; and 56, No. 16.

SEA FOODS AND SEA FOOD PRODUCTS

Subarticle 1. Canned Shrimp

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 1 (Sections 15755-15757) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Register 66, No. 20.

Subarticle 2. Canned Oysters

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 2 (Sections 15760 and 15765) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Registers 66, No. 37 and 54, No. 16.

Subarticle 3. Raw Oysters

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 3 (Sections 15770-15820, not consecutive) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Register 56, No. 16.

Subarticle 4. Sea Food Cocktails

§15825. Sea Food Cocktails.

Note • History

Sea food cocktails are the food products prepared by immersing the clean, cooked, edible portions of sea food ingredients in a suitable acidified sauce.

(a) Sauce. A suitable cocktail sauce may be made from catsup or other acidulated tomato product with or without the addition of pieces and/or sodium benzoate. A sufficient amount of vinegar or other food acid shall be added to bring the pH of the sauce to 3.70 or lower. This pH shall be checked by the packer for every batch of sauce.

(b) “Meat” Ingredient.

(1) The sea food ingredient of sea food cocktails must represent not less than 30 percent of the weight of the finished product.

(2) If such ingredient consists wholly of the “meat” of one type of sea food such as crab meat, shrimp, oyster, etc., the product may be named after that ingredient.

(3) If a mixture of two sea food ingredients are used the product may be so named to indicate this fact, stating first the name of the sea food ingredient present in greatest quantity.

(4) If a mixture of more than two sea food ingredients is used in substantial quantities the product may be labeled “mixed sea food cocktail” or the names of the three or more sea food ingredients may be stated in the order of their predominance by weight.

NOTE

Authority cited: Sections 208 and 25610, Health and Safety Code. Reference: Sections 25610 and 25612, Health and Safety Code.

HISTORY

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).

2. Amendment filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

Subarticle 5. Canned Tuna Fish

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 5 (Sections 15826 and 15827) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Register 60, No. 15. Subarticle 1.

EGGS AND EGG PRODUCTS

§15830. Eggs.

Note • History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15835. Liquid Eggs, Mixed Eggs, Liquid Whole Eggs, Mixed Whole Eggs: Identity.

History

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15840. Frozen Eggs, Frozen Whole Eggs, Frozen Mixed Eggs: Identity.

History

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15845. Dried Eggs, Dried Whole Eggs; Identity.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 66, No. 20.

§15850. Egg Yolks, Liquid Egg Yolks, Yolks, Liquid Yolks:

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

3. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15855. Frozen Yolks, Frozen Egg Yolks: Identity.

History

HISTORY

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15856. Egg Whites, Liquid Egg Whites, Liquid Egg Albumen; Identity.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 66, No. 20.

§15857. Frozen Egg Whites, Frozen Egg Albumen; Identity.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15860. Dried Egg Yolks, Dried Yolks; Identity.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 66, No. 20.

§15861. Dried Egg Whites, Egg White Solids, Dried Egg Albumen, Egg Albumen Solids; Identity.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 66, No. 20.

COCOA PRODUCTS

§15865. Cacao Nibs, Cocoa Nibs, Cracked Cocoa: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15870. Chocolate Liquor, Chocolate, Baking Chocolate, Bitter Chocolate, Cooking Chocolate, Chocolate Coating, Bitter Chocolate Coating; Identity: Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15875. Breakfast Cocoa, High Fat Cocoa: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15880. Cocoa, Medium Fat Cocoa: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15885. Low-Fat Cocoa: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15890. Sweet Chocolate, Sweet Chocolate Coating: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15895. Milk Chocolate, Sweet Milk Chocolate, Milk Chocolate Coating, Sweet Milk Chocolate Coating: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 56, No. 16.

§15900. Skim Milk Chocolate, Sweet Skim Milk Chocolate, Skim Milk Chocolate Coating, Sweet Skim Milk Chocolate Coating: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15905. Buttermilk Chocolate, Buttermilk Chocolate Coating: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15910. Mixed Dairy Product Chocolate, Mixed Dairy Product Chocolate Coating: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15915. Sweet Chocolate and Vegetable Fat (Other Than Cacao Fat) Coatings: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§15920. Sweet Cocoa and Vegetable Fat (Other Than Cacao Fat) Coatings: Identity; Label Statement of Optional Ingredients.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

FLAVORING EXTRACTS

§15925. Distinction Between “Extract” and “Flavor.”

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

Subarticle 1. Extracts

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 1 (Section 15930) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Registers 78, No. 35 and 54, No. 16.

Subarticle 2. Flavors

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer of Part 2 (Sections 15935-15970, not consecutive) filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12). For prior history, see Register 54, No. 16.

Subarticle 3. Labeling

§15975. Labeling Defined.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15980. Where Label Statements Must Appear.

All required information shall appear on the main display panel of the bottle and carton. If more than one panel is used for display, the required information shall appear on each. This statement applies to the name of the product, list of ingredients when required, declaration of artificial color, added preservative, name and address of the manufacturer, distributor or packer, and the statement of the quantity of contents.

§15985. Name and Address of Manufacturer or Distributor.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15990. Quantity of Contents Statement.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15995. Listing of Ingredients.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16000. Artificial Coloring.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16005. Artificial Flavoring.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16010. Chemical Preservatives.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16015. Guaranty Statements.

Note • History

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code.

HISTORY

1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16020. Misleading Containers.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

SIRUP STANDARDS

§16025. Definitions.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16030. Sirup.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16035. Sugar-Cane Sirup.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16040. Sorghum Sirup.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16045. Maple Sirup.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16050. Sugar Sirup.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16055. Imitation Sirups.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16060. Labeling of Sirups.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

VINEGAR STANDARDS

§16065. Vinegar, Cider Vinegar, Apple Vinegar.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16070. Distilled Vinegar, Spirit Vinegar, Grain Vinegar.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16075. Wine Vinegar, Grape Vinegar.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16080. Malt Vinegar, Beer Vinegar.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16085. Spices.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16090. Labeling of Vinegars.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16095. Adulteration.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16100. Imitation Vinegar.

History

HISTORY

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

MISCELLANEOUS FOOD PRODUCTS

Subarticle 1. Olives, Ripe, Sold in Bulk

§16105. Manner of Holding Bulk Ripe Olives.

Note • History

All bulk ripe olives shall be held in kegs or barrels in a brine solution containing as a minimum 2 1/2 percent salt (10 degrees salometer).

NOTE

Authority cited: Sections 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26050, 26209 and 26520, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§16110. Label Stipulations of Bulk Ripe Olives.

Note • History

All barrels or kegs containing ripe olives shall have a label affixed thereto bearing the following statement:

The Contents of This Keg or Barrel

Shall Not be Held or Preserved in Closed or

Sealed Glass Jars or Tins

NOTE

Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26050 and 26520, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

Subarticle 2. Canned Whole and Pitted Ripe Olives

§16112. Definitions.

Note • History

(a) The term “Canned Ripe Olives” refers to olives of the “ripe type” or the “green-ripe type.”

(1) “Ripe type” olives are those which have been treated and oxidized in processing to produce a typical dark brown to black color.

(2) “Green-ripe type” olives are those which have not been oxidized in processing and which range in color from yellow-green; green-yellow or other greenish casts; and which may be mottled.

NOTE

Authority cited: Sections 208, 26202 and 26510, Health and Safety Code. Reference: Section 26510, Health and Safety Code.

HISTORY

1. New Part 2 (Sections 16112, 16113 and Table 1) filed 12-15-83; effective thirtieth day thereafter (Register 83, No. 51).

2. Editorial correction of subsection (a)(2) printing error (Register 84, No. 8).

§16113. Labeling.

Note

(a) Cans of Ripe Olives shall bear a label which meets all of the labeling requirements set forth in Article 4, Sections 26550 thru 26562 of the California Health and Safety Code and in addition, shall bear all of the following information:

(1) A statement of the drained weight.

(2) A size designation according to one of the seven sizes set forth in Table 1.

(3) A cut or imprint which represents the approximate size of the fruit designated as set forth in Table 1.

(b) Cans of Ripe Olives with counts per pound between two size ranges shall be labeled as the lesser or smaller size.

NOTE

Authority cited: Sections 208, 26202 and 26510, Health and Safety Code. Reference: Sections 26556 and 26557, Health and Safety Code.

Illustration has been reduced for printing purposes.

Article 13.1. Actionable Defect Levels for Processed Foods

§16200. General Provisions.

Note • History

A manufacturer shall not mix a lot of a food containing defects exceeding the actionable level with another lot of food containing fewer defects than the actionable level. Such mixing renders the food actionable regardless of the defect level of the final food.

NOTE

Authority cited: Sections 208, 26202 and 26203, Health and Safety Code. Reference: Sections 26203, 26520 and 26523, Health and Safety Code.

HISTORY

1. New Article 13.1 (Sections 16200-16201) filed 5-30-78; effective thirtieth day thereafter (Register 78, No. 22).

2. Amendment filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§16201. Heat Processed Canned Peaches: Actionable Defect Levels for Insects.

Note • History

(a) Definitions.

(1) Standard Peach Unit means:

(A) A single whole peach, or

(B) A peach half, or

(C) A number of pieces smaller than halves which taken together are equal in weight to a fraction of the drained weight according to can size as follows:

Drained Weight

or Drained

Weight Fraction

Equivalent to

One Standard

Can Size Peach Unit

8 oz. - 211x304 1/3

No. 300 - 300x407 1/6

No. 303 - 303x406 1/6

No. 2 - 307x409... 1/8

No. 2 1/2 - 401x411 1/10

No. 10 - 603x700 1/40

No. 10 - 603x700 solid pack or preheated pie pack 1.5 oz.

Larger than above sizes 1.5 oz.

1. The method of ascertaining drained weight shall be the method used for the USDA Quality Grade Standards for canned foods.

(2) Insect infested means a standard peach unit having embedded or clinging insects or insect fragments.

(b) Actionable levels for peaches which are principally peeled by hand, such as white peaches, are reached at any time when:

(1) More than five percent of standard peach units by count are insect infested, or

(2) More than twenty percent of the cans contain one or more free floating whole insect larvae, or the larval parts equivalent to a whole larva, or any free floating part of any adult insect.

(1) More than one percent of standard peach units by count are insect infested, or

(2) More than two percent of the cans contain one or more free floating whole insect larvae, or the larval parts equivalent to a whole larva, or any free floating part of any adult insect.

(d)Sampling Requirements.

(1) The minimum number of standard peach units and the minimum number of cans selected from a single manufacturer's lot for evaluation of compliance shall be determined according to can size as follows:

Minimum

Number of Minimum

Standard Number

Can Size Peach Units of Cans

8 oz. - 211/304 100 50

No. 300 - 200x407 100 25

No. 303 - 303x406 100 25

No. 2 - 307x409 125 25

No. 2 1/2 - 401x411 200 25

No. 10 - 603x700 200 8

All Larger Cans 200 2

NOTE

Authority cited: Sections 208, 26202 and 26203, Health and Safety Code. Reference: Sections 26523 and 26524, Health and Safety Code.

HISTORY

1. New NOTE filed 7-3-84 (Register 84, No. 27).

Article 14. Wine Standards and Prohibited Practices

§17000. Order Promulgating Regulations and Standards.

Note • History

NOTE

Authority cited for Article 14: Sections 26540 and 26540.2, Health and Safety Code. Reference: Secs. 26540.2 and 26542.1, Health and Safety Code.

HISTORY

1. Repealer of Article 14 (Sections 17000 through 17105) and new Article 14 (17000, 17001, 17005, 17010, 17015, 17075, 17076, 17090, 17100, 17105 and 17116) filed 9-23-69; effective thirtieth day thereafter (Register 69, No. 39). For prior history, see Register 66, No. 20.

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§17001. Adoption and Application of Regulations and Standards.

Note • History

(a) Application. The Treasury Department regulations adopted and the exceptions and additional provisions in this Article shall be applicable to all the wine produced, imported, bottled, offered for sale or sold within the state for beverage use, or any other purpose, except as hereinafter provided. The production, the importation, or sale within this state of any product as, or under the designation of wine, which fails to conform to the applicable standard described herein, except for distillation into wine spirits or industrial or nonbeverage purposes is hereby prohibited.

(b) Except as otherwise provided in this Article, the definitions and standards of identity and quality for wine and their amendments, now or hereafter promulgated by the U. S. Treasury Department, Internal Revenue Service, in Title 27 C.F.R., Part 4, Subparts B and C, Part 19, Subpart N, Part 231, Subpart F and Part 240, Subparts O, P, Q, R, S, T, V, W, X, Z, and ZZ, are the definitions and standards of identity and quality for wine in the State of California.

NOTE

Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code.

HISTORY

1. Amendment filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17005. Standards of Identity and Quality for Wine Produced in California or Elsewhere.

Note • History

(a) The standards herein established are minimum standards for wine of the several classes and types defined.

(b) Prohibited Wine. Wine derived from raisins, dried grapes, dried berries, and other dried fruit, and imitation or substandard wine, shall not be produced, imported, or sold in this state except for distillation into wine spirits or for industrial or nonbeverage purposes.

(c) Cellar Treatment. Cellar treatment shall conform to the methods and materials authorized for treatment of wine by the Alcohol, Tobacco and Firearms Division of the Internal Revenue Service as well as the California Pure Foods Act and the Federal Food, Drug, and Cosmetic Act and the regulations adopted thereunder. In case of conflict between Federal and State laws or regulations the California law or regulation shall take precedence.

NOTE

Authority cited: Sections 208, 26202 and 26215, Health and Safety Code. Reference: Section 26515, Health and Safety Code.

HISTORY

1. Repealer of subsection (d) filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17010. Provisions Applicable to Wine Produced in California.

Note • History

The following provisions shall apply to wines produced in California:

(a) Sugar Use. No sugar, or material containing sugar, other than pure condensed grape must, and no water in excess of the minimum amount necessary to facilitate normal fermentation, may be used in the production or cellar treatment of any grape wine except:

(1) In the production of sparkling wine (where sugar or liquid sugar may only be used in the traditional secondary fermentation and dosage),

(2) Carbonated and special natural wine; provided, however, that sparkling and carbonated wine or the residuum thereof may be reconverted into still wine, and such wine and special natural wine or the residuum thereof may be distilled into wine spirits if the unfermented sugar has not been refermented.

(3) Natural grape wine produced outside of the State of California with the use of sugar pursuant to applicable federal regulations may be blended with grape wine produced in California pursuant to these regulations only for the purpose of producing sparkling wine and carbonated wine. The resultant blend shall not be entitled to the appellation of origin “California” or any geographical subdivision thereof.

(b) Sweetness Limitation.

(1) The Brix saccharometer test, using a saccharometer calibrated at 20o C and made in the presence of the alcohol content provided herein shall be:

(A) Not less than 5.5 degrees for Angelica, Muscatel, Port and White Port.

(B) Not less than 3.5 degrees for Tokay (as a dessert wine).

(2) The reducing sugar content (per 100 milliliters at 20o C and calculated as dextrose) for sherries shall be as follows:

Minimum Maximum

Dry Sherry 0.0 gram 2.5 grams

Sherry 2.5 grams 4.0 grams

Sweet, Golden, Cream or

Mellow Sherry 4.0 grams

(c) Fixed Acidity. The minimum titratable fixed acidity per 100 milliliters at 20o C for grape wine (except wine used solely for blending, medicinal or industrial purposes) calculated as tartaric acid, shall be as follows:

red table wine 0.4 gram

white table wine 0.3 gram

all other wine 0.25 gram

NOTE

Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code.

HISTORY

1. Amendment of subsection (b) (1) (C) and (D) filed 6-12-70; effective thirtieth day thereafter (Register 70, No. 24).

2. Amendment filed 11-29-79; effective thirtieth day thereafter (Register 79, No. 48).

3. Amendment of NOTE filed 3-21-84 (Register 84, No. 12).

§17015. Wines Bearing the Appellation of Origin “California” or a Geographical Subdivision Thereof.

Note • History

(a) A grape wine shall be entitled to the appellation of origin “California” or a geographical subdivision thereof only if:

(1) 100 percent of its volume is derived from fermented juice of fruit grown within California; except that wine spirits produced in California from residues of wines, which contain grapes grown outside of California, may be used in the production of wines bearing the appellation of origin “California” or subdivisions thereof, subject to all of the following limitations:

(A) The wine shall not derive more than 1 percent of its volume from fruit grown outside California.

(B) The non-California portion shall be derived solely from residue wine spirits.

(C) Grapes, juice, concentrate, wine or other distilling material shall not be imported into California for distilling of wine spirits for use under this Section, and

(2) It has been fully produced and finished within the State of California, and

(3) It conforms to the requirements of these regulations; provided, that no wine shall be entitled to an appellation of origin in violation of Section 25236 or Section 25237 of the California Alcoholic Beverage Control Act.

NOTE

Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code.

HISTORY

1. Amendment filed 8-10-78; effective thirtieth day thereafter (Register 78, No. 32).

2. New NOTE filed 3-21-84 (Register 84, No. 12).

§17075. Labeling.

Note • History

(a) Certificate. The permittee responsible for labeling shall, upon request of the Department, furnish adequate proof that a valid certificate of label approval for all labels has been obtained from the U. S. Treasury Department and that such certificate is unrevoked at the time the wine is offered for sale; provided a wine shall not be deemed to be mislabeled, if its label fails to conform to the federal requirements only in those particular respects which are specifically authorized in this Article.

(b) Service Containers. The prescribed mandatory information requirement shall not apply to containers used solely for service purposes, where such containers are filled on retail premises just before sale and for immediate use thereon.

NOTE

Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code.

HISTORY

1. Amendment filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17076. Combination Wines.

History

HISTORY

1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17090. Advertising of Wine.

History

HISTORY

1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17100. Sanitation.

History

HISTORY

1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17105. Enforcement.

History

HISTORY

1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17116. Constitutionality.

History

HISTORY

1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

Article 15. Distilled Spirits Standards

§18000. California Brandy.

Note • History

(a) A grape brandy shall be entitled to the appellation “California” only if:

(1) 100% of its volume is derived at the time of distillation from grapes grown within the State of California or from California wine and

(2) It has been fully distilled within the State of California.

NOTE

Authority cited: Sections 208 and 26514, Health and Safety Code. Reference: Section 26514, Health and Safety Code.

HISTORY

1. Repealer of Article 15 (Sections 18000-18135, not consecutive) filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior history, see Register 75, No. 19.

2. New Article 15 (Section 18000) filed 11-29-79; effective thirtieth day thereafter (Register 79, No. 48).

3. Amendment filed 8-14-81; effective thirtieth day thereafter (Register 81, No. 33).

Article 16. Processed Pet Food Regulations

§19000. Order Promulgating Standards.

Note • History

NOTE

Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code.

HISTORY

1. Repealer and new Article 16 (Sections 19000 through 19040, not consecutive) filed 8-10-70; effective thirtieth day thereafter (Register 70, No. 33). For prior history, see Registers 60, No. 3, and 64, No. 11.

2. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§19001. Intent of Regulations.

Note • History

NOTE

Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code.

HISTORY

1. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§19005. Definitions.

Note • History

(a) “Complete food” means a nutritionally adequate pet food compounded by a specific formula to be fed as the sole ration and capable of maintaining life and/or promoting normal reproduction in healthy pets without any additional substance being consumed except water, based upon the recommendations of recognized authority in the field of animal nutrition.

(b) “Balanced food” means a pet food having all known required nutrients in a proper amount and proportion based upon the recommendations of recognized authority in the field of animal nutrition for a given set of physiological animal requirements.

(c) “Edible” as used in this article is to be construed as food fit to be eaten by dogs, cats, or other domestic animals.

(d) “Meat” means the clean, wholesome flesh derived from slaughtered mammals and is limited to that part of the striated muscle which is skeletal or that which is found in the tongue, in the diaphragm, in the heart, or in the esophagus; with or without the accompanying and overlying fat, and the portions of skin, sinew, nerve and blood vessels which normally accompany the flesh. The term “meat” when applied to the corresponding portions of mammals other than cattle, swine, sheep and goats shall be used in qualified form, for example, “horsemeat.”

(e) “Meat by-products” is the non-rendered, clean, wholesome parts of the carcass of slaughtered mammals such as lungs, spleens, kidneys, brains, liver, stomach, bone, blood, and intestines free of their contents. It does not include skin, horns, teeth and hoofs. The term “meat by-products” when applied to the corresponding portions of mammals other than cattle, swine, sheep and goats shall be used in qualified form, as, for example, “horsemeat by-products.”

(f) “Poultry” means the eviscerated carcass of slaughtered poultry, exclusive of the head, feet and feathers.

(g) “Poultry parts” means the clean, wholesome parts of dressed poultry characterized by large portions of bone such as necks, backs, and wings exclusive of feet, heads, viscera and feathers.

(h) “Poultry by-products” means the non-rendered, clean parts of carcasses of slaughtered poultry such as heads, feet, and viscera free from fecal content and foreign matter, except in such trace amounts as might occur unavoidably in good factory practice.

(i) “Giblet” means the edible heart, liver, and gizzard of poultry.

(j) “Fish” means the fish and/or any part of fish used as a pet food ingredient with or without removal of entrails, head, tail and fins, except as provided in paragraph (k) of this section.

(k) “Fish by-products” means the heads, fins, tail ends, bones, skin and viscera of fish.

(l) “Fish meal” means the dried ground whole fish or fish cuttings, either or both, with or without extraction of part of the oil.

(m) The common names and definitions of other ingredients used in the processing of pet foods shall be those recognized in the Official Publication of Feed Control by the Association of American Feed Control Officials (AAFCO) Incorporated and/or the U.S. Department of Agriculture.

NOTE

Authority cited: Sections 208 and 27040, Health and Safety Code. Reference: Section 27040, Health and Safety Code.

HISTORY

1. Amendment filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§19010. Chemical Analysis.

Note • History

(a) All canned pet food shall comply with the following analysis:

(1) Crude protein content--a minimum of 7 1/2 percent

(2) Crude fat content--a minimum of 2 percent

(3) Crude fiber content--a maximum of 1 1/2 percent

(4) Moisture content--a maximum of 78 percent or the natural moisture content of the constituent ingredients of the product, whichever is greater.

(b) All semi-moist pet food shall comply with the following analysis:

(1) Crude protein content--a minimum of 12 percent

(2) Crude fat content--a minimum of 5 percent

(3) Crude fiber content--a maximum of 5 percent

(4) Moisture content--a maximum of 65 percent

(1) Crude protein content--a minimum of 18 percent

(2) Crude fat content--a minimum of 4 percent

(3) Crude fiber content--a maximum of 10 percent

(4) Moisture content--a maximum of 18 percent

NOTE

Authority cited: Sections 208 and 27040(a), Health and Safety Code. Reference: Sections 27033 and 27040, Health and Safety Code.

HISTORY

1. Editorial correction adding NOTE filed 4-13-84 (Register 84, No. 15).

§19015. Exemptions.

Note • History

(a) Treats, candy and special diet for pets are exempt from the minimum and maximum requirements of the chemical analysis but shall comply with Section 19025, of this Article.

(b) A processed pet food consisting entirely of gravy, sauce, broth or juice, when so labeled, is exempt from the requirements of paragraphs (a), (b), and (c) of Section 19010 and paragraph (b) of Section 19025 of this Article.

NOTE

Authority cited: Sections 208 and 27040(a), Health and Safety Code. Reference: Sections 27033 and 27040(a), Health and Safety Code.

HISTORY

1. Editorial correction filed 4-13-84 (Register 84, No. 15).

§19020. Required Verifications.

Note • History

(a) Prior to offering a processed pet food for sale in California, each pet food manufacturer shall submit in triplicate to the Department, the following:

(1) A complete list of the pet food ingredients by their common or usual name, and in order of their predominance by weight. The percentage of each ingredient derived from mammals, poultry, or fish shall be stated for each formula when the product is as defined in Section 19025, paragraphs (i), (j), (k), and (l) of this Article.

(2) copies of each label for all processed pet foods.

(b) Manufacturers of processed pet foods shall, upon request, supply verification of formulas, and/or flavor ingredients or claims to the State Department of Public Health.

NOTE

Authority cited: Sections 208 and 27040, Health and Safety Code. Reference: Sections 27031, 27032, 27033, 27034 and 27040(a) and (d), Health and Safety Code.

HISTORY

1. Editorial correction filed 4-13-84 (Register 84, No. 15).

§19025. Labeling and Restrictions.

Note • History

(a) The words “dog food,” “cat food,” or similar designations shall appear conspicuously upon the principal display panels of the pet food labels.

(b) The following shall appear on the label:

“Guaranteed Analysis”

Crude protein --minimum %

Crude fat --minimum %

Crude fiber --maximum %

Moisture --maximum %

Additional guarantees, if any, shall follow crude fiber.

(c) The ingredients used in the manufacture of the processed pet food shall be listed in the ingredient statement on the label by their common or usual name as defined in Section 19005 of this Article in their descending order of predominance by weight. When water is added in the preparation of a processed pet food, a statement of that fact, for example, “sufficient water has been added for processing,” may appear at the conclusion of the ingredient list.

(d) No product or any of its wrappers, packaging or other containers shall bear any false or misleading marking, label or other labeling, and no statement, word, picture, design, or device which gives a false indication of origin, quality or flavor. No product shall be wholly or partly enclosed in any wrapper, packaging or other container that is so made, formed, or filled as to be misleading.

(e) All labels shall also comply with the provisions of Sections 27031, 27032, 27033, and 27034 of the California Health and Safety Code and the U.S. Fair Packaging and Labeling Act.

(f) A processed pet food shall not be labeled a specific flavor unless a sufficient amount of that ingredient is used to impart such characteristic flavor and/or odor to the finished product which is detectable by a recognized test method, or is one the presence of which provides a characteristic distinguishable by the pet. Any flavor designation on a pet food label must either conform to the name of its source as shown in the ingredient statement or the ingredient statement shall show the source of the flavor.

(g) The terms “fit for human food,” “fit for human consumption,” or any similar terms are prohibited on the labels or in advertisements of a processed pet food.

(h) The name of the processed pet food shall not be derived from one or more ingredients of a mixture to the exclusion of other ingredients and shall not be one representing any components of a mixture of a pet food product unless all components or ingredients are included in the name except as specified in paragraphs (f), (i), (j), (k) and ( l) of this section; provided, that if any ingredient or combination of ingredients is intended to impart a distinctive characteristic to the product which is significant to the purchaser, the name of that ingredient or combination of ingredients may be used as a part of the name of the pet food if:

(1) the ingredient or combination of ingredients is present in sufficient quantity to impart a distinctive characteristic to the product;

(2) it does not constitute a representation that the ingredient or combination of ingredients is present to the exclusion of other ingredients; and

(3) it is not otherwise false or misleading.

(i) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish constitutes 95% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient(s) may form a part of the product name of the pet food, provided that where more than one such ingredient is part of the product name, then all such ingredient names shall be in the same size, style, and color print on the front panel of the label, in their descending order of predominance by weight.

(j) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish constitutes 50% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient(s) may form a part of the product name of the pet food, when the product name also includes a descriptive term “with gravy,” “with sauce,” or similar connotation which will fully describe the contents of the pet food mixture. All such ingredient name(s) shall be in descending order of predominance by weight. The ingredient name(s) shall be in the same size, style, and color print on the front panel of the label and the descriptive term shall follow immediately after or below the ingredient name(s) in conspicuous size lettering in the same style and color print.

(k) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish, constitutes 25% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient or ingredients may form a part of the product name of the pet food only if the product name also includes a primary descriptive term such as “balls,” “cakes,” “loaf,” “croquettes,” or “stew,” so that the product name describes the contents of the product in accordance with an established law, custom, or usage, or so that the product name is not misleading. All such ingredient names and the primary descriptive term shall be in the same size, style and color print.

(l) A product shall not be described on the label or in advertising as “all meat” or “100% meat” or “all tuna” or “all chicken” or otherwise represented as being composed wholly of a named ingredient if it contains other added ingredients such as the by-products of meat, poultry, or fish. However, for the purpose of this provision, water sufficient for processing, required denaturing agents, and trace amounts of preservatives and condiments shall not be considered ingredients.

(m) Terms such as “burger,” “chunk,” “patty,” “cube,” “loaf,” “croquette” and other of similar import, shall not be used to describe a product or an ingredient thereof which does not have substantially the shape or form so represented when it is sold to the retail purchaser.

(n) The names of ingredients shall not be used in advertising, labeling, brand or trade name, or otherwise, so as to misrepresent directly or by implications the identity of an ingredient or the composition of a processed pet food.

(o) A vignette, graphic, or pictorial representation of a product on a processed pet food label shall not misrepresent the contents of the package.

(p) Inspection Legend. Upon receipt of written permission from the Department, the following statement may be placed on the labels or can end of pet food packed in compliance with the provisions of the Laws Relating to Cannery Inspection: “STERILIZED UNDER THE SUPERVISION OF AND ACCORDING TO THE REGULATIONS OF THE CALIFORNIA STATE DEPARTMENT OF HEALTH SERVICES.”

NOTE

Authority cited: Sections 208 and 27040(a), and (d), Health and Safety Code. Reference: Sections 27031, 27032, 27034 and 27040, Health and Safety Code.

HISTORY

1. Editorial correction filed 4-13-84 (Register 84, No. 15).

§19030. Manufacturing Requirements.

Note • History

(a) Pet food ingredients used to manufacture a processed pet food shall be sound, clean, and wholesome and shall conform to the provisions of the California Pure Pet Food Act of 1969.

(b) All stomachs, intestines, and/or other such by-products, which are used in the manufacture of processed pet food, shall be thoroughly washed and inspected for fecal or foreign contamination.

(c) Meat meal, meat and bone meal, meat scraps, and other similar meat products may be used only if they have been produced in a plant approved by a federal, state, or municipal inspection agency.

(d) All processed pet food packed in hermetically sealed containers shall be processed in such a manner as to achieve commercial sterility in all units packed.

(e) All processed pet food not packed in hermetically sealed containers shall be processed so as to render the product free of salmonella, or other pathogenic microorganisms which are transmissible to man or animal.

NOTE

Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code.

HISTORY

1. Editorial correction adding NOTE filed 4-13-84 (Register 84, No. 15).

§19035. Magnet to Remove Ferrous Material.

Note • History

(a) All pet food processors are hereby required to install between the cooker and the filling machine a magnetic separator with a holding power of not less than 125 pounds per square inch to remove ferrous material. The magnetic exposure area shall be not less than 6 inches by 10 inches.

(1) The magnet shall be so installed that the material to be processed shall pass the magnet in a relatively thin stream.

(2) If an electro-magnet is used it shall be fitted with a trap to prevent any material already removed from passing to the filler, in the event of a power failure. The switch operating an electro-magnet shall be equipped with a red signal light.

(b) A magnetic separator specified in Section 19035(a) is not required if it is demonstrated to the Department's satisfaction that equivalent protection is being provided by the use of other methods or devices.

NOTE

Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code.

HISTORY

1. Editorial correction adding NOTE filed 4-13-84 (Register 84, No. 15).

§19040. Arsenic and Lead Tolerance in Animal Food.

Note • History

The tolerance for arsenic in processed pet food is established at 1/20 (0.05) grain per pound and for lead at 1/60 (0.0167) grain per pound.

NOTE

Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code.

HISTORY

1. Editorial correction adding NOTE filed 4-13-84 (Register 84, No. 15).

§19041. Pet Food Licenses and Certificates.

Note • History

(a) Licenses and certificates for pet food processors will be valid for a two-year period from date of issue and are not transferable. The fee for the license or certificate is $200.00.

(b) Application for a Processed Pet Food license or certificate shall be made on State Department of Health form #446-129 or #446-130 respectively.

(d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license or certificate application.

NOTE

Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code.

HISTORY

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).

§19043. Sources of Poultry Meat.

Note • History

Only poultry meat or poultry product from state or federally inspected poultry processing plants may be used in animal foods.

NOTE

Authority cited: Sections 208, 26202, 26510 and 27040, Health and Safety Code. Reference: Sections 27033, 27040 and 27041, Health and Safety Code.

HISTORY

1. Editorial correction renumbering former Section 11375 to new Section 19043 filed 4-13-84 (Register 84, No. 15).

Subchapter 3. Vector Control

(Originally Printed 5-14-49)

Group 1. Standards Governing State Aid to Local Mosquito Control Agencies

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code.

HISTORY

1. New § 30001-30053, inclusive, filed 5-3-49 (Register 16, No. 3).

2. Repealer of Group 1 (Articles 1-7, Sections 30001-30053, not consecutive) filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

Group 2. Standards Governing Certification of Local Vector Control Agency Personnel

Article 1. Definitions

§30001. Certified Technician.

Note • History

“Certified Technician” means any employee of a vector control agency who has passed the Department's certification examination as specified in section 30055 and is required by section 30061 to obtain continuing education units in order to independently handle, apply, or supervise the application of any pesticide as part of such employee's official duties.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

1. New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30003. Certified Technician (Limited).

Note • History

“Certified Technician (Limited)” means any employee of a vector control agency who has passed the Department's certification examination as specified in section 30055, but who is exempt under section 30061 from continuing education requirements. A Certified Technician (Limited) may not handle or apply a pesticide as part of his or her official duties except under the direct supervision of a Certified Technician, or as permitted under section 30061(d).

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30005. Continuing Education Unit.

Note • History

“Continuing Education Unit (CEU)” means a unit value assigned to educational activities approved by the Department equal to one unit for each 50 to 60 minute segment of instruction as determined by the Department.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30007. In-Service Training.

Note • History

“In-Service Training” means training given within an agency on subjects directly related to vector control duties.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30009. Pesticide Label.

Note • History

“Pesticide Label” means the written, printed or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30011. Relevant Vectors.

Note • History

“Relevant Vectors” means those vectors normally included within a group of vectors falling within the category of each vector control certificate and which employee of a vector control agency may be expected to control when working within a particular certificate specialty.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30013. Under the Direct Supervision of.

Note • History

“Under the Direct Supervision of” means the act or process whereby a pesticide is applied by a Certified Technician (Limited) or a Vector Control Aide acting under the instructions and control of a Certified Technician who is responsible for the actions of that person and who is available if and when needed even though such certified technician is not physically present at the time the pesticide is applied. A Certified Technician shall be physically present during the application of a pesticide when required by the pesticide label.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-1-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30015. Vector.

Note • History

“Vector” means any animal that meets the definition of section 402.1 of the Health and Safety Code.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30017. Vector Control Aide.

Note • History

“Vector Control Aide” means a person who is employed by a vector control agency but is not certified under Section 30055 and may not handle or apply a pesticide as part of his or her official duties except under the direct supervision of a Certified Technician or as permitted under section 30061(d).

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30019. Vector Control Agency.

Note • History

“Vector Control Agency” means any government agency, including but not limited to a mosquito abatement district, vector control district, pest abatement district, environmental health department, or public health department, which conducts an ongoing program within its jurisdiction to reduce vector populations in order to protect the public health and well-being.

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

HISTORY

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30054. Definitions.

Note • History

NOTE

Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d) and 402.1, Health and Safety Code.

HISTORY

1. Repealer and new article 1 (section 30054) filed 12-19-78; effective thirtieth day thereafter (Register 78, No. 51). For history of prior section, see Register 74, No. 5.

2. Amendment filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

3. Repealer filed 9-25-89 as an emergency; operative 9-25-89 (Register 89, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 1-23-90.

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer filed 11-16-90; operative 11-16-90 pursuant to Government Code 11346.1(d) (Register 90, No. 52).

Article 2. Certification Examination

§30055. Examination Requirements.

Note • History

Any person employed by a vector control agency as a Certified Technician or Certified Technician (Limited) shall pass, with a score of 70 percent or higher, the Public Health Pest Control Certified Technician Examination administered by the Department.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 402(d), 403, 2202 and 2805, Health and Safety Code.

HISTORY

1. Repealer of article 2 (sections 30060-30061) and new article 2 (sections 30055-30059) filed 12-19-78; effective thirtieth day thereafter (Register 78, No. 51). For history of prior Article, see Register 74, No. 5.

2. Repealer and new section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 1-23-90.

3. Editorial correction of printing error of NOTE (Register 89, No. 49).

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer and new section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30056. Examination Content.

Note

(a) The written examination for certification of vector control agency personnel shall consist of questions covering the following areas:

(1) Label and labeling comprehension--factors including:

(A) The general format and terminology of pesticide labels and labeling;

(B) The understanding of instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels;

(D) Necessity for use consistent with the label.

(2) Safety--factors including:

(A) Pesticide toxicity and hazard to man;

(B) Common exposure routes;

(D) Precautions necessary to guard against injury to applicators and other individuals in or near treated areas, including medical supervision;

(E) Need for and use of protection clothing and equipment;

(F) Symptoms of pesticide poisoning;

(G) First aid and other procedures to be followed in case of a pesticide accident; and

(H) Safe and proper procedures for identification, storage, transport, handling, mixing of pesticides and disposal of pesticides and used pesticide containers, including precautions to prevent access by children.

(3) Environment--The potential environmental consequences of the use and misuse of pesticides as may be influenced by such factors as climate and weather, non-target organisms, and drainage patterns.

(4) Vectors--factors such as:

(A) A knowledge of relevant vectors and their distribution;

(B) Recognition of relevant vectors by distinguishing features of the vector organisms and/or characteristics of damage or other signs;

(D) Public health importance of relevant vectors, including a practical knowledge of vector-borne disease transmission, as it relates to and influences control programs; and

(E) Habitats where relevant vectors occur, including a practical knowledge of those environments.

(5) Pesticides--factors such as:

(A) Types of pesticides;

(B) Types of formulations;

(C) Characteristics of pesticides and formulations, including compatibility, synergism, persistence, and animal and plant toxicity;

(D) Hazards and residues associated with use, including applicable laws and regulations;

(E) Factors which influence effectiveness or lead to such problems as resistance to pesticides; and

(F) Dilution procedures.

(6) Pesticide application equipment and techniques--factors including:

(A) Types of equipment and their uses, advantages, and limitations;

(B) Maintenance of equipment;

(D) Operating procedures and techniques used to apply various formulations of pesticides;

(E) A knowledge of the most effective equipment and technique of application to use in a given situation;

(F) Relationship of discharge and placement of pesticides to proper use, unnecessary use, and misuse; and

(G) Prevention of drift and pesticide loss into the environment.

(7) Non-chemical control methods--A practical knowledge of the importance and use of such methods as sanitation, waste management, drainage, exclusion, trapping, public education, and legal abatement.

(8) Record Keeping--A familiarity with the principles and practices of biological and operational documentation.

(9) Supervisory Requirements--A practical knowledge of State and Federal supervisory requirements, including labeling, regarding the application of restricted materials by a technician's aide.

(10) Laws and Regulations--A basic knowledge of applicable State and Federal laws and regulations.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 1800-1813 and 2200-2910, Health and Safety Code.

§30056.1. Interpretation of Dates.

Note • History

For purposes of this Article:

(a) Submission of an application shall be deemed to occur on the date the application form is received by the Department.

(b) Filing of a completed application shall be deemed to occur when all information required to be submitted on an application form has been received by the Department.

(c) Written notifications by the Department to applicants shall be deemed to occur on the date the notifications are postmarked.

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code; and Sections 15376 and 15378, Government Code. Reference: Sections 15376 and 15378, Government Code.

HISTORY

1. New section filed 4-11-85; effective thirtieth day thereafter (Register 85, No. 15).

§30056.2. Applications.

Note • History

(a) To apply for admission to the Public Health Pest Control Certified Technician Examination, the applicant shall complete an Application for Admission to the Public Health Pest Control Certified Technician Examination, FORM EH 173 (2/88). The application form shall include the applicant's name and job title, the employing agency's name and address, and the signatures of the applicant and the agency administrator. The form shall be completed, signed, and submitted in accordance with directions printed on or provided with the form.

(b) Within 14 calendar days after submission of an application for admission to the examination, the Department shall notify the applicant in writing, through the vector control agency where the applicant is employed, that the application is complete and accepted for filing, or that the application is deficient, and what specific information is required to complete the application. Notification of acceptance shall be in the form of a copy of the application form, marked “approved,” which shall be returned to the applicant. If deficient, the entire application shall be returned to the applicant.

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code.

HISTORY

1. New section filed 4-11-85; effective thirtieth day thereafter (Register 85, No. 15).

2. Amendment filed 9-25-89 as an emergency; operative 9-25-89 (Register 89, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 1-23-90.

3. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

4. Amendment filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

§30056.3. Admission to Examination.

Note • History

Admission to an examination shall be permitted upon presentation by the applicant of an approved copy of the application form, as provided pursuant to Section 30056.2(b).

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code.

HISTORY

1. New section filed 4-11-85; effective thirtieth day thereafter (Register 85, No. 15).

§30056.4. Notification of Examination Results.

Note • History

The Department shall notify the applicant in writing, through the vector control agency where the applicant is employed, of the examination result and decision on the certification, within 118 calendar days after the filing of a completed application.

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code; and Section 15376, Government Code. Reference: Section 15376, Government Code.

HISTORY

1. New section filed 4-11-85; effective thirtieth day thereafter (Register 85, No. 15).

§30056.5. Processing Times.

Note • History

The Department's minimum, maximum, and median time periods for processing a certificate, from the receipt of the initial applications to notification of the final certification decision regarding results of the examination for certification, based on the Department's actual performance during the two years immediately preceding the proposal of this regulation, were as follows:

(a) The median time was 54 calendar days.

(b) The minimum time was 50 calendar days.

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code; and Section 15376, Government Code. Reference: Section 15376, Government Code.

HISTORY

1. New section filed 4-11-85; effective thirtieth day thereafter (Register 85, No. 15).

§30057. Expiration.

Note • History

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code.

HISTORY

1. Repealer filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

§30058. Denial, Suspension, or Revocation.

Note

(a) The Director may deny, suspend, or revoke any certificate for any of the following reasons:

(1) Failure to adequately supervise the use of a restricted material.

(2) Failure to obtain a restricted material permit when required.

(3) Failure to comply with any applicable provision of Divisions 6 or 7 of the Food and Agricultural Code or regulations adopted pursuant to such provisions.

(4) Failure to record each restricted material use and submit such record as required by law or regulations.

(5) Making any false or fraudulent record.

(6) Operating in a faulty, careless, or negligent manner.

(7) Failure to qualify by examination.

(b) Any action to deny, suspend or revoke such certificate shall be heard under the Administrative Procedure Act, Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code; provided, however, if the Director finds that the protection of the public welfare or safety requires immediate action, he or she may, without hearing, temporarily suspend or condition the certificate and shall forthwith schedule the matter for hearing. The Director may terminate such temporary suspension or condition upon corrective action as he or she deems satisfactory to assure compliance with the requirements of the law and the regulations.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 1800-1813 and 2200-2910, Health and Safety Code.

§30059. Records.

Note • History

NOTE

Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code.

HISTORY

1. Repealer filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

Article 3. Continuing Education

§30061. Continuing Education Requirements.

Note • History

(a) Except as provided in (d), any employee of a vector control agency who independently handles, applies, or supervises the application of any pesticide as part of his or her official duties shall obtain the following continuing education units (CEU) within each two year period following initial date of certification:

(1) Minimum Prerequisite CEU for all specialty certificates:

(A) Pesticide use and safety--ten CEU.

(B) Animal biology and ecology--two CEU.

(2) Additional minimum CEU for each specialty certificate:

(A) Mosquito Control--six CEU on mosquitoes and two CEU on other aquatic invertebrates and their control.

(B) Terrestrial Invertebrate Control--six CEU on domestic flies, fleas, and ticks; two CEU on other terrestrialinvertebrate vectors, and their control.

(b) Failure to attain minimum CEU in any specialty area shall result in the down-grading of certification in the specialty in which the Certified Technician is delinquent, to the Certified Technician (Limited) status.

(c) Reinstatement to Certified Technician status shall be subject to the approval of the Department upon proofof minimum CEU and proof of payment of all current fees.

(d) The foregoing continuing education requirements are not applicable to the following:

(1) Employees who use insignificant amounts of compounds commonly used for pest detection during inspections.

(2) Persons who do not handle, apply, or supervise the application of any pesticides for public health purposes.

(3) Employees involved only in research and development of public health pesticides.

NOTE

Authority cited: Sections 208, 2202 and 2805, Health and Safety Code. Reference: Sections 402(d), 403, 2202 and 2805, Health and Safety Code.

HISTORY

1. Repealer of section, and new Article 3 (section 30061) filed 12-19-78; effective thirtieth day thereafter (Register 78, No. 51). For history of former section, see Register 74, No. 5.

2. Amendment filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

3. Repealer and new section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 1-23-90.

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer and new section filed 11-16-90; operative 11-16-90 pursuant to Government Code section 11346.2(d) (Register 90, No. 52).

Subchapter 3.1. Implementation of the Emergency Mosquito Abatement Funding Act of 1983

Article 1. General Provisions

§30062. Definitions.

Note • History

The following definitions shall apply to this subchapter:

(a) “Local agency” means a county which has established an emergency mosquito abatement trust account pursuant to Article 4 (commencing with Section 25850) of Chapter 8 of Part 2 of Division 2 of Title 3 of the Government Code; or a mosquito abatement district or vector control district which has established an emergency mosquito abatement trust fund pursuant to Article 5.1 (commencing with Section 2315) of Chapter 5 of Division 3 of the Health and Safety Code; or a pest abatement district which has established an emergency mosquito abatement trust fund pursuant to Article 4.1 (commencing with Section 2877) of Chapter 8 of Division 3 of the Health and Safety Code.

(b) “Threat to the public health and safety” means the actual or scientifically predictable presence of mosquitoes in such numbers that, in the judgment of the Department, there is a strong probability that:

(1) Mosquitoborne pathogens will be transmitted to humans; or

(2) There will be substantial interference with the normal enjoyment of life or property by an entire community or neighborhood, or by any considerable number of persons.

NOTE

Authority cited: Section 25852(e), Government Code; and Sections 208 and 2317(e), Health and Safety Code. Reference: Section 2317(d), Health and Safety Code; and Section 25852(d), Government Code.

HISTORY

1. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter 3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 7-27-84 as an emergency; effective upon filing (Register 84, No. 31). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-26-84.

2. Repealed by operation of Government Code Section 11346.1(g) (Register 84, No. 48).

3. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter 3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 11-26-84 as an emergency; effective upon filing (Register 84, No. 48). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 3-26-85.

4. Certificate of Compliance filed 3-21-85 (Register 85, No. 12).

Article 2. Conditions Governing Expenditure of the Emergency Mosquito Abatement Trust Account or Fund

§30064. Application for Expenditure.

Note

(a) When a local agency applies to the Department for authority to expend any portion of the principal of the emergency mosquito abatement trust account (if the local agency is a county) or emergency mosquito abatement trust fund (if the local agency is a mosquito abatement district, vector control district, or pest abatement district) it shall apply for the expenditure in writing, by telephone, or other rapid means, but shall confirm in writing within 3 working days.

(b) The application for expenditure shall include the following:

(1) Whether the imminent threat to the public health and safety is due to either an actual outbreak or to an expected outbreak of mosquitoes, or both;

(2) The mosquito species involved;

(3) Other areas involved;

(4) The specific control actions proposed;

(5) The approximate dates of the proposed actions;

(6) The name of the person who will supervise the proposed actions and the vector control certificates or licenses possessed by that person; and

(7) The amount of the principal proposed to be expended.

NOTE

Authority cited: Section 25852(e), Government Code; and Sections 208 and 2317(e), Health and Safety Code. Reference: Section 2317(d), Health and Safety Code; and Section 25852(d), Government Code.

Article 3. Criteria for Determining If a Local Agency Has Established Adequate Emergency Mosquito Abatement Procedures

§30066. Criteria for Emergency Mosquito Abatement Procedures.

Note

The emergency mosquito abatement procedures shall be adequate if: (a) The local agency's program is under the direct supervision of:

(1) A technician certified in mosquito control pursuant to Section 402 of the Health and Safety Code; or

(2) Any person who is licensed in health-related pest control pursuant to Chapter 1 (commencing with Section 11401) and Chapter 2 (commencing with Section 11501) of Division 6 of the Food and Agricultural Code; and

(b) The Department finds that the proposed emergency mosquito abatement procedures are proven effective in the reduction of the imminent threat to the public health and safety.

NOTE

Authority cited: Sections 208 and 2317(e), Health and Safety Code; and Section 25852(e), Government Code. Reference: Section 2317(e), Health and Safety Code; and Section 25852(e), Government Code.

Subchapter 3.2. Importation of Wild Animals

Article 1. General

§30070. Purpose and Scope.

Note • History

These regulations are intended to provide safeguards for the protection of persons in the State of California from disease hazards associated with imported wild animals. The regulations apply to all persons, including but not limited to the following: educational and research institutions, zoological gardens, schools, colleges, universities, pet stores, animal care facilities, and laboratories, who import, hold, sell, purchase or possess any wild animal for which an import permit is required under the provisions of Chapter 14, Division 20, California Health and Safety Code.

NOTE

Authority cited: Sections 102, 208 and 25990.5, Health and Safety Code. Reference: Sections 25990 through 25994.8, Health and Safety Code.

HISTORY

1. New Subchapter 3.1 ( 30070 through 30086) filed 10-8-70; effective thirtieth day thereafter (Register 70, No. 41).

2. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter 3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 7-24-84 as an emergency; effective upon filing (Register 84, No. 31). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-26-84. 3. Repealed by operation of Government Code Section 11346.1(g) (Register 84, No. 48).

4. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter 3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 11-26-84 as an emergency; effective upon filing (Register 84, No. 48). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 3-26-85.

5. Editorial correction of HISTORY NOTE Nos. 2-4 (Register 84, No. 48).

§30071. Definitions.

Note • History

For the purposes of these regulations:

(a) “Person” means any person, firm, association, organization, partnership, business trust, corporation, or company.

(b) “Department” means the State Department of Health Services.

(c) “Animal” means any wild animal or bird specified by the Department under provisions of Chapter 14, Division 20, of the Health and Safety Code.

(d) “Veterinarian” means a person authorized to practice veterinary medicine under provisions of Chapter 11, Division 2, California Business and Professions Code.

(e)“Standards” means the requirements with respect to the quarantine housing, handling, care, treatment, and transportation of imported animals.

(f) “Primate” means a nonhuman member of the highest order of mammals, including prosimians, monkeys, and apes as specified in Section 30072.

(g) “Euthanasia” means the humane destruction of an animal accomplished by a method that involves instantaneous unconsciousness and immediate death or by a method that involves anesthesia, produced by an agent which causes painless loss of consciousness, and death during such loss of consciousness.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Section 25990.5, Health and Safety Code.

HISTORY

1. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

Article 2. Import Permits

§30072. Wildlife Admitted by Permit.

Note • History

No person shall import into or receive in this State any animals of the following orders, families, and genera specified herein without first obtaining a permit and paying to the Department such fees as required under these regulations.

(a) Birds (Class Aves). Admissible without permit from the department.

(b) Mammals (Class Mammalia)

(1) Primates (Order Primates)--Members of the following families, all genera therein:

Family Lorisidae, Genus Loris (Slender Loris), Genus Nycticebus (Slow Loris), Genus Arctocebus (Golden Potto), Genus Perdicticus (Potto), Genus Galago (Galago), and Genus Euoticus (Needle-clawed Galago).

Family Callithricidae, Genus Callithrix (Short-tusked Marmoset), Genus Cebuella (Pygmay Marmoset), Genus Saguinus (Long-tusked Marmoset), and Genus Leontideus (Lion-headed Marmoset).

Family Cebidae, Genus Aotus (Douroucoulis), Genus Callicebus (Titi Monkey), Genus Cacajao (Ukari), Genus Pithecia (Saki), Genus Chiropotes (Red-backed Saki), Genus Alouatta (Howler Monkey), Genus Cebus (Capuchin), Genus Saimiri (Squirrel Monkey), Genus Ateles (Spider Monkey), Genus Brachyteles (Woolly Spider Monkey), Genus Lagothrix (Woolly Monkey), and Genus Callimico (Goeldi's Marmoset).

Family Cercopithecidae, Genus Macaca (Macaque), Genus Cynomacaca (Celebes Macaque), Genus Cynopithcus (Celebes Crested Macaque), Genus Cercocebus (Mangabey), Genus Chaeropithecus (Baboon), Genus Comopithecus (Hamadryas Baboon), Genus Mandrillus (Mandrill), Genus Theropithecus (Gelada Baboon), Genus Cercopithecus (Guenon), Genus Miopithecus (Talapoin Monkey), Genus Allenopithecus (Allen's Monkey), Genus Erythrocebus (Patas Monkey), Genus Presbytis (Langur), Genus Pygathrix (Douc Langur), Genus Rhinopithecus (Snub-nosed Langur), Genus Simias (Mentawi Islands Snub-nosed Langur), Genus Nasalis (Proboscis Monkey), and Genus Colobus (Colobus Monkey).

Family Pongidae, Genus Hylobates (Gibbon), Genus Symphalangus (Siamang Gibbon), Genus Pongo (Orangutan), Genus Pan (Chimpanzee), and Genus Gorilla (Gorilla).

(2) Carnivores (Order Carnivora)--Members of the following families, all genera therein unless otherwise noted:

(A) Family Felidae, genus Felis and genus Panthera, consisting of New World species: F. pardalis (Ocelot), F. wiedii (Margay), F. tigrina (Little Spotted Cat), F. colocolo (Pampas Cat), F. geoffroyi (Geoffroy's Cat), F. guigna (Kodkod), F. jacobita (Gato Andina), F. yagouaroundi (Jaguarundi), and P. onca (Jaguar).

All other members of the family Felidae are admissible without permit from the Department.

(B) Family Canidae, genus Aopex (Arctic Fox), genus Vulpes (Red or Kit Fox), genus Urocyon (Gray Fox), and genus Canis, including all species other than Canis familiaris (the domestic dog).

All other members of the family Canidae are admissible without permit from the Department.

All other members of the family Procyinidae are admissible without permit from the Department.

(D) Family Musteldae, genus Mephitis (Striped Skunk) and genus Spilogale (Spotted Skunk).

All other members of the family Musteldae are admissible without permit from the Department.

(3) Bats (Order Chiroptera)--Members of all families, all genera therein.

NOTE

Reference should also be made to statutory provisions of the California Fish and Game Code and the joint regulations of the Fish and Game Commission and the California Department of Agriculture. Where question exists regarding the importation into and the keeping of live wild birds, mammals, amphibians, reptiles, crustaceans and fish in California, representatives of the Department of Fish and Game should be consulted.

NOTE

Authority cited: Sections 208, 25990.3 and 25990.5, Health and Safety Code. Reference: Sections 25990.3 and 25990.5, Health and Safety Code.

HISTORY

1. Amendment of subsection (b)(2), designation of (b)(2)(A) and new subsections (b)(2)(B)-(b)(3) and Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30073. Application for Import Permits.

Note • History

Import permits for animals listed under Section 30072 shall be issued only upon written application from the person desiring to import them. The application shall include but not be limited to the following:

(a) The number, common name, and true scientific name of each species (Example reference: Walker, E. P., and others. Mammals of the World. Baltimore, Johns Hopkins Press, 1975. Volumes I and II).

(b) The carrier and probable point of first arrival in this state of each shipment.

(d) The name and address of the consignee.

(e) The name and address of the consignor.

(f) The place or premise where the animals shall be held in quarantine pending the completion of such tests, veterinary examinations, and observation period as may be specified by the department in issuance of import permit. Adequate quarantine facilities must be available and approved by the department before issuance of the import permit can be made (See Sections 30077 and 30077.1).

(g) The name and address of the veterinarian who shall conduct the tests and examinations specified by the department.

(h) For personal pets only, the date of acquisition and name and address of supplier.

NOTE

Authority cited: Sections 208, 25990.5 and 25992.3, Health and Safety Code. Reference: Sections 25992 and 25992.3, Health and Safety Code.

HISTORY

1. Amendment of subsection (a) and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30073.1. Determination of Application Completeness and Notification.

Note • History

(a) Within 15 calendar days of receipt of an application for a wild animal importation permit, or a request for permit modification, the Department shall inform the applicant in writing either that the application is complete and accepted for filing, or that it is deficient and identify the additional specific information necessary for the application to be complete.

(b) The date on which the application is determined complete for filing, or on which the application is determined deficient shall be the date on which the Department's written notification to the applicant is postmarked.

NOTE

Authority cited: Section 15376, Government Code; and Sections 208 and 25992, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25992, Health and Safety Code.

HISTORY

1. New section filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30073.2. Application Time Periods for Processing a Permit Based on Actual Performance.

Note • History

(a) The Department's time periods for processing a wild animal importation permit application, or a wild animal quarantine facility approval application, from the receipt of the initial application to the final decision regarding the permit or approval, are as follows:

(1) The median time for processing is:

(A) 10 calendar days for an importation permit application.

(B) 90 calendar days for a quarantine facility approval application.

(2) The minimum time for processing is:

(A) 5 calendar days for an importation permit application.

(B) 60 calendar days for a quarantine facility approval application.

(3) The maximum time for processing is:

(A) 15 calendar days for an importation permit application.

(B) 180 calendar days for a quarantine facility approval application.

NOTE

Authority cited: Section 15376, Government Code; and Sections 208 and 25992, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25992, Health and Safety Code.

HISTORY

1. New section filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30074. Issuance of Import Permits.

Note • History

Issuance of import permits for animals listed under Section 30072 may be made by the Department upon:

(a) Submission of written application providing the information enumerated under Section 30073 not less than seven (7) days preceding the probable date of shipment, and

(b) if necessary, submission of a written application for Department approval of the wild animal quarantine facility, completion of an on-site inspection, and final approval of the quarantine facility or premise designated in the permit application, and

(c) payment of the necessary permit fees required under Section 25992.8 of the Health and Safety Code and set forth under Section 30076 of these regulations, and

(d) determination by the Department that the public health and safety is not endangered, and

(e) approval of the probable point of first arrival into this State.

NOTE

Authority cited: Sections 208, 25990.5, 25992.3 and 25992.8, Health and Safety Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.8, Health and Safety Code.

HISTORY

1. Amendment of first paragraph, subsections (b) and (d) and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30074.1. Importation of Animals Under Special Permit.

Note • History

Permits not requiring the quarantine of imported wild animals may be issued by the Department under the following special conditions:

(a) Short-Term Exhibition of Captive Born and Raised Nonhuman Primates Having No Contact With the Public. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for short-term nonresident exhibition purposes (e.g., circuses) under a short-term exhibition permit issued by the Department upon application for the permit and payment of a $10.00 permit fee per animal. Persons wishing to import or receive nonhuman primates for short-term exhibition purposes under this subsection shall provide the Department with documentation of the following:

(1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive born and raised, and

(3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with the public, and

(4) A veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases.

(b) Short-Term Exhibition of Captive Born and Raised Nonhuman Primates Having Direct Contact With the Public. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for nonresident exhibition purposes under a short-term exhibition permit issued by the Department upon application for a permit and payment of a $10.00 permit fee per animal. Persons wishing to import or receive short-term exhibition nonhuman primates into the State where the animal(s) will have direct contact with the public shall provide the Department with documentation of the following:

(1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive born and raised, and

(3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with the public at all times except when being exhibited, and

(5) A negative tuberculin skin test performed on the animal(s) not more than 30 days before importation.

(c) Short-Term Exhibition of Captive Born and Raised Carnivores. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for short-term nonresident exhibition purposes (e.g., circuses) under a short-term exhibition permit issued by the Department upon application for the permit and payment of a $10.00 permit fee per animal. Persons wishing to bring short-term exhibition carnivores into the State shall provide the Department with documentation of the following:

(1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive born and raised, and

(3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with other animals or the public, and

(d) Zoological exhibition of specified wild animals.

(1) Animals subject to these provisions as specified under Section 30072 may be brought into the State for exhibition in a zoological collection accredited by the American Association of Zoological Parks and Aquariums (AAZPA) under a zoological exhibition permit issued by the Department upon payment of a $10.00 permit fee per animal. AAZPA accredited organizations wishing to import or receive specified wild animals for zoological exhibition purposes under this subsection shall provide the Department with documentation of the following:

(A) The animal(s) are captive born and raised, or have been in the possession of the consignee for at least 180 days prior to importation, and

(B) the animal(s) are being imported from an AAZPA-accredited zoological collection, and

(C) a health history on the animal or the parents of the animals less than six months of age, for the 180 days prior to importation, and

(D) a veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases.

(E) A negative tuberculin skin test performed on all nonhuman primates not more than 30 days before importation.

(2) Nonhuman primates imported under this subsection shall be kept in isolation for 30 days immediately following importation. The animal(s) shall be tested if necessary for enteric pathogens during isolation. If at the end of the 30 days, the animal(s) are tuberculin skin tested with negative results, are examined and issued a health certificate by an accredited veterinarian certifying that the animal(s) are healthly and free of signs of contagious or infectious diseases, the animal(s) may be released by the Department upon review of isolation records.

(3) Carnivores or Chiroptera specified in Section 30072 imported under this subsection shall be kept in isolation for 90 days immediately following importation. If at the end of the 90 days, the animal(s) are examined and issued a health certificate by an accredited veterinarian certifying that the animal(s) are healthy and free of signs of contagious or infectious diseases, the animal(s) may be released by the Department upon review of isolation records.

(e) Animal Breeding. Animals being moved for breeding purposes as part of a recognized animal colony established for experimental breeding of animals in captivity, may be moved for this purpose upon issuance of a fee exempt permit provided that the conditions specified by the Department in the permit are adhered to in full.

(f) Animal(s) permitted entry under subsection 30074.1(a) through (e) shall not be sold, traded, or given away during the permit period without notification and prior approval by the Department. The duration of the permit will be determined by the Department at the time of permit issue and shall not exceed the duration of an exhibitor's itinerary submitted to the Department at the time of permit application. The duration of the permit may be extended at the discretion of the Department.

NOTE

Authority cited: Sections 208, 25990.5, 25992.3, 25992.5 and 25992.8, Health and Safety Code. Reference: Sections 25990.5, 25992.3, 25992.5 and 25992.8, Health and Safety Code.

HISTORY

1. Amendment of section and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30075. Conditions of Quarantine for Personal Pets.

Note • History

NOTE

Authority cited: Sections 208, 25990.5 and 25992, Health and Safety Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.5, Health and Safety Code.

HISTORY

1. Repealer and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30076. Permit Fees.

Note • History

(a) Each application for an import permit shall be accompanied by payment of an import permit fee to the Department. Except as provided in Section 30074.1(e), the permit fee charged shall be at the rate of $10.00 per animal.

(b) If the actual number of animals received in the shipment exceeds the number enumerated in the application, payment of an additional fee, for the unpaid animal(s), shall be due at the rate of $10.00 per animal plus a charge of $10.00 for amending the original permit issued.

(c) If the actual number of animals received is less than the number enumerated on the application, the person may apply for a refund subject to such verification and documentation as may be required by the department.

(d) No refund shall be allowed for animals found dead on arrival (DOA), but credit may be allowed for animals DOA against future imports within the following 12 month period. No credit or refund shall be allowed for animals which die during quarantine or are found diseased and not fit for release from quarantine.

(e) A previously issued import permit may be amended by the Department where necessary upon written request by the permittee provided the purpose of the amendment does not in the opinion of the Department jeopardize the intent and purpose of the required quarantine procedure or the public health. A fee of $10.00 must accompany the written request for amendment.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Section 25992.8, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

2. Subsection redesignation and amendment of subsections (a), (b) and (e) filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

Article 3. Quarantine Facilities and Operating Standards

§30077. Animal Holding Facility.

Note • History

(a) Structural. The housing facilities used for quarantine of imported animals shall be constructed in accordance with the compiled State Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regulations. All quarantine structures, fixtures, equipment and facilities shall be maintained so as to be clean, sanitary and in good repair. All quarantined animals shall be contained within the facility.

(b) Storage. Supplies of food and bedding shall be adequately protected against contamination with zoonotic disease causing organisms. Refrigeration shall be provided for supplies of perishable food.

(c) Medical Waste Disposal. Animal and food wastes, bedding, debris and any items present in the quarantine facility while a wild animal quarantine is in effect shall be disposed of as medical waste in accordance with Health and Safety Code, Section 25020, et seq. Disposal facilities shall be provided and operated as to prevent vermin infestation and minimize orders and diseases hazards.

(d) Handwashing Facilities. Handwashing facilities, such as basins or sinks, shall be provided to maintain cleanliness among caretakers. Handwashing facilities shall include hot and cold running water, soap, paper towels, and a waste container. Handwashing facilities shall conform to the State Building Code, Part 5, Title 24, California Code of Regulations.

(e) Drainage. A suitable method shall be provided to rapidly eliminate excessive water from housing facilities. If drains are used, they shall be properly constructed and shall be kept in good repair to avoid disease transmission within the facility. Draining facilities to rapidly eliminate excessive water from housing facilities shall conform to the State Building Code, Part 5, Basic Plumbing Regulations, Title 24, California Code of Regulations.

(f) Local Building Codes, Zoning Codes, Use and Business Permits. Notwithstanding the provisions of these regulations, the provisions of local building codes, zoning codes, and applicable use and business permits shall be complied with by the owner or operator of quarantine facilities as a condition to approval by the Department, provided such provisions are at least equal to these regulations. Construction shall be in accordance with Title 24, California Code of Regulations.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

3. Amendment of section heading and subsection (c) filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30077.1. Alternative Housing Facilities.

Note • History

The use of alternative housing quarantine facilities for special purpose conditions may be approved by the Department upon written application provided the public health and safety shall not be endangered. These facilities shall be constructed in accordance with the State Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regulations.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

3. Amendment of section heading and text filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§30078. Primary Enclosures.

Note • History

Primary enclosures shall conform to the following requirements:

(a) They shall be maintained so as to be clean and dry.

(b) They shall provide convenient access to clean food and water.

(c) Primary enclosures shall conform to the State Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regulations.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

§30079. Animal Health and Husbandry Standards.

Note • History

(a) Food.

(1) The food shall be free from contamination, wholesome, and of sufficient quality and nutritive value to meet the known normal daily requirements for the condition and size of the animal.

(2) Food, and food receptacles if used, shall be accessible to all animals and shall be placed so as to minimize contamination by excreta. Food receptacles, except self feeders, shall be kept clean and sanitized at least once a week.

(b) Watering.

(1) All watering receptacles shall be kept clean and shall be sanitized at least once a week.

(2) Automatic watering devices shall be maintained in accordance with good husbandry practices. They shall be sanitized when occupancy in the primary enclosure is changed and at the end of quarantine period.

(1) Cleaning of Primary Enclosures. Excreta shall be removed from the primary enclosures at least daily, or as often as necessary to prevent contamination of the animals contained therein and to reduce disease hazards and odors. When hosing or flushing methods are used for this purpose, measures shall be taken to prevent animals confined in such enclosures from being wetted or contaminated involuntarily.

(2) Sanitization of Primary Enclosures.

(A) Prior to the introduction of animals into primary enclosures previously occupied by other animals, such enclosures shall be sanitized in the manner provided in subparagraph (c)(3) of this subdivision.(B) Primary enclosures shall be sanitized often enough to prevent an accumulation of debris or excreta, or a disease hazard: Provided, however, that such enclosures shall be sanitized at least once every two weeks in the manner provided in subparagraph (c)(3) of this subdivision.

(3) Sanitizing Procedures. Cages, rooms, vehicles and hard surfaced pens or runs shall be sanitized either by washing them with hot water (180 F.) and soap or detergent, as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam.

(d) Housekeeping. Premises (buildings and grounds) shall be kept clean and in good repair in order to protect the animals from injury and to facilitate the prescribed husbandry practices set forth in this section. Premises shall remain free of accumulations of trash.

(e) Pest Control. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained.

(f) Employees. A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth herein. Persons well trained and competent in retrieving, restraining and releasing animals in a humane manner for testing and examination procedures during quarantine must be provided. Such practices shall be carried out by or under the supervision of an animal caretaker who has a background in animal husbandry or care. Proper safeguards and precautions shall be practiced by employees so as not to endanger themselves, other persons, or animals. Outer work clothing, gloves, boots, etc., used in caring for animals in quarantine shall not be worn outside the quarantine area.

(g) Classification and Separation.

(1) Animals housed in the same primary enclosure shall be maintained in compatible groups and shall not be housed in the same primary enclosure with other animal species.

(2) Animals entering quarantine on different dates shall not be housed in the same room, unless the quarantine periods commence with the date of the last animal(s) admitted to the room (See Section 30081).

(h) Veterinary Care.

(1) Programs of disease control and prevention, euthanasia, and adequate veterinary care shall be established and maintained under the supervision and assistance of a veterinarian.

(2) Each animal shall be observed daily by the animal caretaker in charge or by someone working under his direct supervision. Sick or diseased, injured, lame, or blind animals shall be provided with veterinary care or humanely disposed of unless such action is inconsistent with the purposes for which the animals are being imported.

(i) Vehicles.

(1) Vehicles used in transporting animals shall be mechanically sound and equipped to provide fresh air to all animals being transported, without injurious drafts. The vehicles shall contain the animals and restrict the entry of other animals and unauthorized persons.

(2) The ability to view the interior of the cargo space is necessary to observe any animals that may have escaped from their primary enclosures.

(3) The interior of the animal cargo space shall be kept clean.

(4) The animal cargo space and all primary enclosures used in transport shall be cleaned and sanitized in the manner provided in subsection (c)(3) of this section after each shipment has been transported from the point of arrival to the quarantine facility. Animals entering quarantine and those having completed the quarantine shall not be transported concurrently in the same vehicle.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

§30080. Approved Quarantine Facilities.

Note • History

(a) Approval. Quarantine facilities used to house imported animals are subject to inspection and approval by representatives of the Department for such periods of time as the Department deems indicated. Such facilities may be used for housing imported animals only as long as they are maintained and operated in conformance with standards prescribed in Sections 30070 through 30086; in Title 42 of the Code of Federal Regulations, Section 71.53; and in “Biosafety in Microbiological and Biomedical Laboratories”, U.S. Department of Health and Human Services, Public Health Service, Centers fro Disease Control and National Institutes of Health, 2nd edition, 1988; which are hereby incorporated by reference.

(b) Inspection. The department may make such inspection of approved facilities as it deems necessary to insure compliance with prescribed standards. Such inspections shall be carried out by department representatives at any time, normally during but not restricted to working hours.

(c) Notification of Change in Name or Ownership. The department shall be notified of any change in name, address, management or substantial control or ownership of any approved facility.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25992.5, Health and Safety Code.

HISTORY

1. Amendment of subsection (a) and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

Article 4. Quarantine Provisions

§30081. Quarantine.

Note • History

All imported animals must be maintained for such period of quarantine as may be required by the Department and under such conditions as prescribed herein:

(a) Quarantine Period and Conditions for Release Therefrom.

(1) Primates. The normal quarantine period required for primates is that which provides for a physical examination, administration of a tuberculin test by a veterinarian upon entry and a repeat physical examination and tuberculin test 30 days later. Primates may be released from quarantine by the department upon completion of the second tuberculin test provided that in the judgment of the attending veterinarian:

(A) Both tuberculin tests are negative.

(B) The animals exhibit no visible oral ulcers at the end of quarantine period.

(C) The animals show no clinical evidence of dysentery or diarrhea, emesis, emaciation, contagious skin lesions, central nervous system disturbances, jaundice, or abnormal respiratory signs at the end of quarantine period.

(D) There is no evidence of a zoonotic disease traced back to the quarantined animals.

(E) In the opinion of the attending veterinarian the animals are healthy. A summary report by the attending veterinarian, in writing over his signature, shall be made to the department incorporating 1) the results of all tests, physical examinations, etc., performed and 2) his opinion that the animals are healthy (See Section 30084).

(2) Carnivores. Carnivores shall be confined in a place and manner approved by the Department for a 90 day period. A primary enclosure as defined under Section 2-9302 and set forth under Section 2-9305, Title 24, California Code of Regulations, or an equivalent approved by the Department, is acceptable for confinement. If at the end of quarantine, the animals are examined and found healthy by a veterinarian, they may be released by the Department upon receipt of such certification in writing by the attending veterinarian without further restriction.

(b) Imported animals refused release from quarantine shall be handled in such manner as approved and specified by the department.

(c) Where the quarantine procedures specified herein are not compatible with the objective of a specific research project, the department may authorize variations from the requirements specified herein provided that no public health hazard will result from the variations allowed.

(d) Any person importing animals for purposes of sale to any educational and research institution, zoological garden, laboratory, college or university, may satisfy the requirements of this section and Sections 30081.1-30084 by contract with such institution. Such quarantine shall meet all of the requirements herein with regard to period, observation, reporting and other conditions of quarantine.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code.

HISTORY

1. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

§30081.1. Tuberculin Test.

The method of tuberculin testing used shall be subject to approval by the department. Normal variations in site of administration and type and dilution of tuberculin used for intradermal injection may be accepted by the department. The use of such testing methods as the patch and multiple puncture tests will not be accepted.

Article 5. Quarantine Records

§30082. Record Keeping.

Note • History

Adequate records shall be kept by permit number showing daily health status of each animal in the shipment, together with notation, under veterinary supervision, of signs of any illness, deaths, any treatment given, results of any tests or examinations performed, etc., on all animals in the shipment.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

§30083. Animal Identification.

Note • History

Identification of animals shall be maintained through use of cage numbers, tags on individual animals, or by means of tattoo.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code.

HISTORY

1. New NOTE filed 12-26-84 (Register 84, No. 52).

Article 6. Quarantine Reporting

§30084. Reporting of Tests Results, Physical Examinations, Illnesses, Deaths.

Note • History

(a) A written summary report by the attending veterinarian of the results of all tests, physical examinations, etc., performed shall be made to the department in writing over a signature of the attending veterinarian.

(b) Deaths or illnesses in quarantined animals shall be immediately reported to the attending veterinarian and then to the Department without delay. Dead animals shall be handled as biohazardous medical waste and kept under refrigeration pending necropsy instructions by the attending veterinarian. A necropsy shall be conducted under strict infection control precautions by the attending veterinarian or otherwise qualified pathologist, and adequate specimens shall be obtained for diagnostic laboratory examination to determine the cause of illness or death. Following necropsy, the carcass shall be handled and disposed of as biohazardous waste.

(c) Records shall be maintained by the quarantine facility for a two-year period and shall be available for department examination upon request.

NOTE

Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994.3 and 25994.5, Health and Safety Code.

HISTORY

1. Repealer and new subsection (b) and new Note filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

Article 7. Cooperation with Other Governmental Agencies

§30085. Cooperating Agencies.

It is the intent of the department to maintain liaison and to cooperate fully with other governmental agencies having jurisdiction with regard to the import, holding, or regulation of animals into the United States and California as well as within the State. These agencies include:

(a) Foreign Quarantine Program, Center for Disease Control, U.S. Department of Health, Education and Welfare.

(b) Animal Resources Branch, Division of Research Facilities and Resources, National Institutes of Health, U.S. Department of Health, Education and Welfare.

(d) Bureau of Customs, U.S. Treasury Department.

(e) Animal Health Division, Agricultural Research Service, U.S. Department of Agriculture.

(f) U.S. Department of Defense.

(g) California Department of Fish and Game.

(h) California Department of Agriculture.

(i) County and city government, including local public health agencies, within the State of California.

Any importation or other acquisition of wild animals under these regulations does not relieve the importer's responsibility for complying with any applicable health, quarantine, agriculture, customs, license, permit or any other requirements imposed by the laws or regulations of other duly authorized federal or State agency or county, city and county, or city government in California.

Article 8. Exceptions

§30086. Exceptions.

The department upon application may grant variances from the requirements of these regulations as it determines are authorized by law and will not result in hazard to the public health. Such applications, and variances made thereon, shall be in writing; any variances granted under this section shall set forth conditions designed to protect the public health, and shall be granted only for a specified period, not to exceed 6 months.

Subchapter 4. Radiation

Group 1. General

Article 1. Definitions

§30100. General Definitions.

Note • History

As used in subchapter 4:

(a) “Act” means the “Radiation Control Law,” Health and Safety Code, Division 104, Part 9, chapter 8, sections 114960 et seq.

(b) “Agreement State” means any state with which the United States Atomic Energy Commission or Nuclear Regulatory Commission has entered into an effective agreement under section 274b of the Atomic Energy Act of 1954, Title 42, United States Code, section 2021(b) (formerly section 274(b)).

(c) “Decommission” means to remove safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license.

(d) “Department” means the California Department of Public Health.

(e) “Depleted uranium” means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

(f) “Hazardous radioactive material,” as used in section 33000 of the California Vehicle Code and 114820(d) of the Health and Safety Code means any “highway route controlled quantity” of radioactive material as such material is defined in title 49, Code of Federal Regulations, section173.403.

(g) “Human use” means the internal or external administration of radiation or radioactive materials to human beings.

(h) “Installation” means the location where one or more reportable sources of radiation are possessed.

(i) “License,” except where otherwise specified, means a license issued pursuant to group 2, Licensing of Radioactive Material.

(j) “Other official agency specifically designated by the Department” means an agency with which the Department has entered into an agreement pursuant to section 114990 of the Health and Safety Code.

(k) “Person” means any individual, corporation, partnership, limited liability company, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, other than the United States Nuclear Regulatory Commission, the United States Department of Energy, or any successor thereto, and other than Federal Government agencies licensed by the United States Nuclear Regulatory Commission, under prime contract to the United States Department of Energy, or any successor thereto.

(l) “Personnel monitoring equipment” means devices designed to be worn or carried by an individual for the purpose of measuring the dose received by that individual (e.g., film badges, pocket chambers, pocket dosimeters, film rings, etc.).

(m) “Possess” means to receive, possess, use, transfer or dispose of radioactive material pursuant to this regulation.

(n) “Possessing a reportable source of radiation” means having physical possession of, or otherwise having control of, a reportable source of radiation in the State of California.

(o) “Radiation” (ionizing radiation) means gamma rays and X-rays; alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles; but not sound or radio waves, or visible, infrared, or ultraviolet light.

(p) “Radiation machine” means any device capable of producing radiation when the associated control devices are operated, but excluding devices which produce radiation only by the use of radioactive material.

(q) “Radioactive material” means any material which emits radiation spontaneously.

(r) “Registrant” means any person who is registering or who has registered with the Department pursuant to group 1.5, Registration of Sources of Radiation.

(s) “Reportable sources of radiation” means either of the following:

(1) Radiation machines, when installed in such manner as to be capable of producing radiation.

(2) Radioactive material contained in devices possessed pursuant to a general license under provisions of sections 30192.1 and 30192.6.

(t) “Research and development” means theoretical analysis, exploration, experimentation or the extension of investigative findings and scientific or technical theories into practical application for experimental or demonstration purposes, including the experimental production and testing of models, prototype devices, materials and processes; but shall not include human use.

(u) “Sealed source” means any radioactive material that is permanently encapsulated in such manner that the radioactive material will not be released under the most severe conditions likely to be encountered by the source.

(v) “Source of radiation” means a discrete or separate quantity of radioactive material or a single radiation machine.

(w) “Special nuclear material” means:

(1) Plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Department declares by rule to be special nuclear material after the United States Nuclear Regulatory Commission, or any successor thereto, has determined the material to be such, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing, but does not include source material.

(x) “Specific license” means a license or the equivalent document issued to a named person by the Department or by the Nuclear Regulatory Commission or by any other Agreement State.

(y) “This regulation” means: California Code of Regulations, Title 17, Division 1, Chapter 5, Subchapter 4.

(z) “User” means any person who is licensed to possess radioactive material or who has registered as possessing a reportable source of radiation pursuant to groups 1.5 and 2 of this subchapter, or who otherwise possesses a source of radiation which is subject to such licensure or registration.

(aa) “Worker” means any individual engaged in activities subject to this regulation and controlled by a user, but does not include the user.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985, 115060, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer of group 1 and new group 1 (sections 30100 through 30146) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior histories, see Registers 62, No. 1 and 62, No. 8.

2. Repealer and new section filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

3. Change without regulatory effect of subsection (ac)(2) (Register 88, No. 6).

4. Amendment of subsection (j), relettering of former subsections (p)-(ap) to subsections (q)-(aq), and new subsection (p) filed 9-5-89; operative 10-5-89 (Register 89, No. 36).

5. New subsection (k) and redesignation of former sections (k) through (aq) to subsections (l) through (ar) filed 4-19-91; operative 5-19-91 (Register 91, No. 20).

6. Editorial correction of printing error in subsections (q)-(ar) (Register 91, No. 30).

7. Change without regulatory effect amending subsection (an) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

8. Amendment of section and Note filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

10. Amendment of subsection (a), new subsection (c) and subsection relettering filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 10-16-95 order, including amendment of subsections (a), (f) and (k) and of Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

12. Amendment of subsection (q) and NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

14. Amendment of subsection (a) filed 7-20-2006; operative 8-19-2006 (Register 2006, No. 29).

15. Amendment of subsections (d) and (f) and Note filed 4-24-2009; operative 5-24-2009 (Register 2009, No. 17).

16. Repealer of subsections (j)-(j)(6), subsection relettering, amendment of newly designated subsections (k), (s)(2), (y) and (aa) and amendment of Note filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).

§30102. Registration Requirement. [Repealed]

History

HISTORY

1. Renumbering and amendment of former Section 30102 to Section 30108 filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30103. Communications. [Repealed]

History

HISTORY

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

2. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 2. Exemptions and Enforcement

§30104. Exemptions.

Note • History

(a) The Department may, upon application by any user, or upon its own initiative, grant such exemptions from the requirements of this regulation as it determines are authorized by law and will not result in undue hazard to health, life or property. Applications for exemptions shall specify why such exemption is necessary.

(b) Before granting an exemption, the Department shall determine that there is reasonable and adequate assurance that:

(1) the doses to any individual in any controlled area will not exceed those specified in Section 30265;

(2) the dose to the whole body of any individual in an uncontrolled area will not exceed 0.5 rem in a year;

(3) The deposition of radioactive material in the body of any individual will not likely result in a greater risk to the individual than would be expected from the dose specified in Section 30104 (b)(1) or (2), as appropriate, based on guidance from such bodies as the International Commission on Radiological Protection, and the National Council on Radiation Protection and Measurements; and

(4) there is no significant hazard to life or property.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25815 and 25876, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former section 30345 to article 2 (section 30104) filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

2. Change without regulatory effect of subsection (b)(3) (Register 87, No. 4).

3. Change without regulatory effect amending subsections (b) and (b)(3) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

§30105. Deliberate Misconduct.

Note • History

(a) A user, applicant for a license or registration, employee of a user or applicant, or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any user or applicant for a license or registration, who knowingly provides to any user, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a user's or applicant's activities subject to this regulation, shall not:

(1) Engage in deliberate misconduct, as defined in subsection (c), that causes or would have caused, if not detected, a user or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Department; or

(2) Deliberately submit to the Department, a user, an applicant, or a user's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Department.

(b) A person who violates subsection (a) shall be subject to enforcement action in accordance with the Act.

(c) For the purposes of subsection (a), deliberate misconduct by a person means an intentional act or omission that the person knows:

(1) Would cause a user or applicant to be in violation of any rule, regulation, or order, or any term, condition, or limitation, or any license or registration issued by the Department; or

(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a user, applicant, contractor, or subcontractor.

NOTE

Authority cited: Sections 100170, 100275, 115000, 115230 and 115235, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115215, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 12-29-2005; operative 1-28-2006 (Register 2005, No. 52). For prior history of former article 2 (section 30105), see Register 85, No. 48.

Group 1.5. Registration of Sources of Radiation

Article 1. Registration Procedure

§30108. Registration Requirement.

Note • History

Every person possessing a reportable source of radiation shall register with the Department in accordance with the provisions of this Group.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115060, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30102 to Section 30108 and designation of new Group 1.5 (Sections 30108-30146, not consecutive) filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

2. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30108.1. Registration and General Provisions for Persons Possessing Devices Under Sections 30192.1 and 30192.6.

Note • History

(a) A person required to register pursuant to sections 30192.1(d)(1) or 30192.6(b)(1) shall, within 30 calendar days of taking possession of a device or product, submit to the Department the following:

(1) Legal name, mailing address, and telephone number of the registering person. If renewing registration, the registration number previously issued to the registrant shall also be included;

(2) For each device subject to section 30192.1:

(A) The manufacturer's name, serial number, model number, the radioisotope, and the radioisotope's activity (as indicated on the device's label). For devices used in a fixed location, the physical address of each location where a device is used and the total number of devices at each location shall be submitted. For portable devices, the physical address of each primary place of storage and the total number of devices stored at each location shall be submitted. If renewing registration and there has been no change in the previously indicated devices, indicate that no change has occurred;

(B) Name, title, and telephone number, if different than the number specified in subsection (a)(1), of the individual appointed pursuant to section 30192.1(d)(15);

(D) Signature and date of signature of the individual identified in subsection (a)(2)(B), attesting to the following statement:

“I [insert name as it appears in response to subsection (a)(2)(B)] attest that I am aware of the requirements of the general license specified in section 30192.1 of title 17, California Code of Regulations, and that the information provided concerning the device or product has been verified through a physical inventory and checking of label information.”

(3) For persons possessing devices subject to section 30192.6:

(A) A statement that the registrant has, pursuant to section 30192.6(b)(3), developed, implemented, and will continue to maintain procedures designed to establish physical control over the depleted uranium described in section 30192.6(a), and designed also so as to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

(B) Name, title, and telephone number, if different than the number specified in subsection (a)(1), of the individual appointed pursuant to section 30192.6(b)(4);

(4) Except for persons possessing devices pursuant to section 30192.6, the registration fee specified in section 30145.

(b) Each person shall renew registration annually on or before the current registration's expiration date, by submitting to the Department all required items in subsection (a).

(c) In lieu of the requirements in section 30115, within 30 calendar days of the occurrence of the event, each person registered pursuant to this section shall notify the Department of any change in the information submitted in response to subsection (a), including discontinuance of use of a device or product.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115000, 115060, 115065, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30110. Initial Registration.

Note • History

(a) Every person not already registered who acquires a reportable source of radiation shall register with and pay the fee as specified in Section 30145 to the Department within 30 days of the date of acquisition.

(b) Every person who intends to acquire a radiation machine capable of operating at a potential in excess of 500 kVp shall notify the Department at least 60 days prior to his/her possession of the machine or at least 60 days prior to the commencement of construction or reconstruction of the room which will house the machine, whichever occurs first. This equipment shall not be used to treat patients until written approval of provisions for radiation safety has been obtained by the user from the Department.

(c) Every person who registers or renews a registration shall complete a separate registration form furnished by the Department for each separate installation.

NOTE

Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code.

HISTORY

1. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

3. Amendment of subsection (a) filed 11-1-93 as an emergency; operative 11-1-93 (Register 93, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 11-1-93 order transmitted to OAL 2-24-94; disapproved by OAL 4-7-94 (Register 94, No. 27).

5. Amendment of subsection (a) refiled 7-6-94 as an emergency; operative 7-6-94 (Register 94, No. 27). A Certificate of Compliance must be transmitted to OAL by 11-3-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and filed 7-20-94 (Register 94, No. 29).

§30111. Renewal of Registration.

Note • History

Every person already registered pursuant to 30110 shall renew such registration annually and pay the fee as specified in Section 30145 to the Department on or before the registration renewal date.

NOTE

Authority cited: Sections 100275 and 115000(c), Health and Safety Code. Reference: Section 115060(b), Health and Safety Code.

HISTORY

1. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

2. Repealer and new section and amendment of Note filed 1-20-99; operative 2-19-99 (Register 99, No. 4).

§30112. Registration Form. [Repealed]

History

HISTORY

1. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30113. Separate Installations. [Repealed]

History

HISTORY

1. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30115. Report of Change.

Note • History

Except for persons subject to section 30108.1, the registrant shall report in writing to the Department, within 30 days, any change in: registrant's name, registrant's address, location of the installation, or receipt, sale, transfer, disposal, or discontinuance of use of any reportable source of radiation.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115060, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30116. Report of Discontinuance. [Repealed]

History

HISTORY

1. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30117. Registration Shall Not Imply Approval. [Repealed]

History

HISTORY

1. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30118. Vendor Obligation.

Note • History

(a) Any manufacturer, distributor, retailer, agent, or any other person who sells, leases, transfers or lends a radiation machine to any person who may be required to register such machine shall notify the Department on a form approved by the Department no later than 30 days after the end of each calendar quarter of:

(1) The names and addresses of persons who have received such machines.

(2) The manufacturer and model of each such machine.

(3) The date of transfer of each radiation machine.

(4) Other related information as may be required by the Department.

(b) The vendor shall inform the receiver of each machine of the registration requirements of Section 30108 of these regulations.

NOTE

Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code.

HISTORY

1. New section filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

4. Change without regulatory effect of subsection (b) (Register 88, No. 6).

§30120. Reportable Sources of Radiation. [Repealed]

History

HISTORY

1. Repealer of Article 4 (Section 30120) filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 2. Exclusions from Registration

§30125. Excluded Material and Devices.

Note • History

The following devices and materials do not require registration:

(a) Electrical equipment that produces radiation incidental to its operation for other purposes, but which does not produce radiation in any area accessible to individuals such that there is a reasonable likelihood that any individual will receive a radiation dose to the whole body, head and trunk, gonads, or lens of the eye or active blood-forming organs in excess of 0.5 rem in a year.

(b) All radioactive materials except as specified in sections 30192.1 and 30192.6.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115060(c), 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

2. Editorial renumbering of former article 5 to article 2 (Register 85, No. 48).

3. Change without regulatory effect amending subsection (b) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

4. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30126. Exempt Possessors.

Note • History

Common and contract carriers are exempt from the requirement to register to the extent that they transport or store reportable sources of radiation in the regular course of their carriage for another or storage incident thereto.

NOTE

Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code.

HISTORY

1. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 3. Records

§30130. Radiation Protection Standards. [Repealed]

History

HISTORY

1. Repealer of Section 30130 and renumbering of Article 6 to Article 3 filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30131. Records to be Maintained. [Repealed]

Note • History

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

1. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

2. Repealer of section and amendment of Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

§30140. Violations. [Repealed]

History

HISTORY

1. Repealer of Article 7 (Section 30140) filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30140. Violations.

History

HISTORY

1. Repealer of Article 7 (Section 30140) filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 4. Fees

§30145. Registration Fees.

Note • History

(a) Each radiation machine that is a reportable source of radiation as defined in section 30100(t), is classified as one of the following:

(1) “High priority radiation machine,” a radiation machine, which has high potential for exposing humans by means of heavy use, high radiation exposure, specialized use for radiosensitive areas of the human body, or misadjustment or malfunction of radiation safety features. A high priority radiation machine is further defined as one of the following machine types, or a machine that is used by any of the following categories of users:

(A) Orthopedist.

(B) Radiologist or roentgenogoloist.

(D) Hospital.

(E) Medical clinic.

(F) Portable X-ray service (human use).

(G) Fluoroscope used on humans.

(H) Chest photofluorography (minifilm unit).

(I) Non-human use particle accelerator with maximum energy capable of equaling or exceeding 10 MeV.

(J) Non-human use radiation machine used in field radiography, as defined in Section 30336(c).

(2) “Medium priority radiation machine,” a radiation machine not covered by subsections (a)(1), (a)(3) or (a)(4).

(3) “Dental priority radiation machine,” a radiation machine used exclusively in dental radiography of human beings.

(4) “Special priority radiation machine,” a radiation machine used for mammography.

(b) When a radiation machine is equipped with two or more tubes that can be used separately, each tube shall be considered as a single radiation machine.

(c) For registration or renewal of registration as a general licensee pursuant to section 30192.1, the fee shall be $70.00 for each device in possession, except that persons possessing such devices under a specific license shall be exempt from this fee.

(d) Except as provided in subsection (e), initial registration shall be valid for a period of one year.

(e) The initial registration period for a reportable source of radiation being registered by a person who has a reportable source of radiation already registered with the Department shall be coterminous with the existing registration.

(f) Any fees collected for a radiation machine or a device for any registration period shall be transferred to any replacement radiation machine or device for the remainder of the registration period.

(g) For initial registration or renewal of registration, the fees shall be $214.00 annually for each high priority radiation machine, $172.00 annually for each medium priority radiation machine, $79.00 annually for each dental priority radiation machine and, except as provided in section 30145.1, $475.00 annually for each special priority radiation machine. Where the initial registration period is less than one year pursuant to subsection (e), the initial registration fee shall be prorated, based on the priority classification and number of full months in the initial registration period in accordance with the following formula:

Initial Registration Fee = A x [B/ (12 Months)]

Where:

A = Annual fee as specified above, dollars per year

B = Number of full months remaining in coterminous period

(h) The total registration fee paid by a registrant for high priority, medium priority, special priority, and dental priority radiation machines, which are at the same installation, shall not exceed $6,000.00 per year.

(i) A late fee of 25% of the annual fee shall be charged for any registration fee which is 30 days past due.

(j) Fees required by this section shall be nonrefundable.

NOTE

Authority cited: Sections 114975, 115000, 115060, 115065, 115080, 115085 and 131200, Health and Safety Code. Reference: Sections 114980, 115065, 115080, 115085, 115165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment of subsection (a) filed 7-1-75; effective thirtieth day thereafter (Register 75, No. 27).

2. Amendment filed 4-30-76; effective thirtieth day thereafter (Register 76, No. 18).

3. Amendment filed 7-3-79 as an emergency; effective upon filing (Register 79, No. 27).

4. Certificate of Compliance transmitted to OAL 10-26-79 and filed 11-2-79 (Register 79, No. 44).

5. Amendment filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

6. Change without regulatory effect of subsections (a) and (a)(1)(k) (Register 88, No. 6).

7. Amendment of subsection (a) filed 4-19-91; operative 5-19-91 (Register 91, No. 20).

8. Amendment of subsection (a) and Note, and adoption of subsections (d)-(f) filed 11-1-93 as an emergency; operative 11-1-93 (Register 93, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-1-94 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 11-1-93 order transmitted to OAL 2-24-94; disapproved by OAL 4-7-94 (Register 94, No. 27).

10. Amendment of subsection (a) and Note and new subsections (d)-(f) refiled 7-6-94 as an emergency; operative 7-6-94 (Register 94, No. 27). A Certificate of Compliance must be transmitted to OAL by 11-3-94 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and filed 7-20-94 (Register 94, No. 29).

12. Amendment of section and Note filed 1-20-99; operative 2-19-99 (Register 99, No. 4).

13. Amendment of section heading, section and NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

15. New subsection (c), subsection relettering, amendment of newly designated subsections (d), (f) and (g) and amendment of Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30145.1. Registration Fee, Mammography Exception.

Note • History

The fee shall be $282.00 annually for each special priority radiation machine accredited by an independent accrediting agency recognized under the federal Mammography Quality Standards Act [42 U.S.C. 263(b)].

NOTE

Authority cited: Sections 100275, 115000(c), 115065, 115080 and 115085, Health and Safety Code. Reference: Sections 115080 and 115085, Health and Safety Code.

HISTORY

1. New section filed 1-20-99; operative 2-19-99 (Register 99, No. 4).

2. Amendment filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30146. Payment of Fee.

Note • History

Each registration or registration renewal which reports possession of a radiation machine, and each report of change reporting the receipt of an additional radiation machine, shall be accompanied by an amount to pay the fee for the period to the next regularly scheduled registration renewal date.

NOTE

Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25817, Health and Safety Code.

HISTORY

1. Amendment filed 7-1-75; effective thirtieth day thereafter (Register 75, No. 27).

2. Amendment filed 4-30-76; effective thirtieth day thereafter (Register 76, No. 18).

3. New NOTE filed 7-12-84 (Register 84, No. 28).

Group 2. Licensing of Radioactive Materials

Article 1. General [Repealed]

HISTORY

1. Repealer of Article 1 (Sections 30170 through 30173) and new Article 1 (Sections 30170, 30172 and 30173) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Registers 62, No. 1 and 62, No. 8.

2. Repealer of article 1 (Sections 30170-30173) filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 2. Definitions [Repealed]

HISTORY

1. Repealer and new section filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Registers 62, No. 1 and 62, No. 8.

2. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

3. Repealer of article 2 (section 30175) filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 3. Exemptions

§30180. Exempt Persons, Products, Concentrations and Quantities.

Note • History

(a) Any person is exempt from this regulation if such person:

(1) Is a common and contract carrier transporting radioactive material in the regular course of their carriage for another or storage incident thereto. Such carriers are subject to the provisions of Group 4, Transportation of Radioactive Material.

(2) Is licensed by the United States Nuclear Regulatory Commission under Title 10, Code of Federal Regulations, Part 150, Section 150.15, Continued Commission Regulatory Authority in Agreement States, or otherwise agreed upon by the Department and the Commission.

(3) Is under a prime contract with the United States Nuclear Regulatory Commission or the United States Department of Energy at a U.S. Government-owned or controlled site, including the transporting of radioactive material to or from such site, the performance of contract services during temporary interruptions of such transportation; for research in or development, manufacture, storage, testing or transportation of atomic weapons or components thereof; or for the use of nuclear devices in U.S. Government-owned vehicle or vessel; or under a subcontract when it is jointly determined by the Department and the United States Nuclear Regulatory Commission that an exemption is appropriate.

(b) The following products are exempt from this regulation:

(1) Timepieces, hands or dials therefor, containing any radioactive luminous material provided these have been distributed as exempt products in accordance with a United States Nuclear Regulatory Commission license: and any timepieces, hands or dials therefore containing radium activated luminous material.

(2) Automobile lock illuminators containing up to 15 millicuries of tritium or 2 millicuries of promethium 147 per lock.

(3) Compounds or mixtures with rare earth elements containing up to 0.25% by weight of source material.

(4) Glazed ceramic tableware containing up to 20% by weight of source material in the glaze.

(5) Glassware containing not more than 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction;

(6) Glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983.

(7) Photographic film, negatives, and prints containing source material.

(8) Incandescent gas mantles, vacuum tubes, electric lamps, and welding rods containing thorium.

(9) Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys; provided that the thorium content of the alloy does not exceed 4% by weight.

(10) Finished optical lenses containing up to 30% by weight of thorium, but not including spectacles, contact lenses, or eyepieces of optical instruments and subject to not altering the finished product by any process such as shaping, grinding, or polishing.

(11) Fire detector heads containing up to 0.005 microcuries of uranium per head.

(12) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium.

(13) Germicidal lamps, sun lamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium.

(14) Personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium.

(15) Shipping containers utilizing natural or depleted uranium metal as shielding, if such container is and remains:

(A) Conspicuously impressed with the legend: “CAUTION--RADIOACTIVE SHIELDING--URANIUM” and;

(B) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one eight inch (3.2 mm).

(16) Counterweights of uranium installed in, or store or handled in connection with installation in or removal from, aircraft, rockets, projectiles, or missiles, if each such counterweight has been manufactured pursuant to an appropriate specific license; and

(A) each counterweight manufactured prior to December 31, 1969 has been, and remains, impressed, labeled and marked in accordance with the provisions of that specific license at the time of manufacture;

(B) each counterweight manufactured on or after December 31, 1969 has been impressed with the following legend clearly legible through any plating or other covering: “DEPLETED URANIUM”; and is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: “UNAUTHORIZED ALTERATIONS PROHIBITED.”

(17) Precision balances or parts therefor, provided that no such balance contains more than 1.0 millicurie of tritium and no balance part contains more than 0.5 millicurie of tritium.

(18) Automobile shift quadrants containing not more than 25 millicuries of tritium.

(19) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas.

(20) Thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat.

(21) Thorium contained in any finished aircraft engine part containing nickel-thoria mixture, provided that:

(A) The thorium is dispersed in the nickel-thorium mixture in the form of finely divided thorium dioxide; and

(B) The thorium content of the mixture does not exceed 4% by weight.

(22) Electron tubes: Provided that each tube does not contain more than one of the following specified quantities of radioactive material:

(A) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

(B) 1 microcurie of cobalt 60;

(D) 30 microcuries of krypton 85;

(E) 5 microcuries of cesium 137;

(F) 30 microcuries of promethium 147;

and provided further, that these have been manufactured and distributed pursuant to an appropriate specific license.

Note: Electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.)

(23) Synthetic plastic resins containing scandium 46 and designed for sand consolidation in oil wells provided such resins shall have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products.

(24) Intact meters containing radium activated luminous material.

(25) Piezoelectric ceramic containing not more than 2 percent by weight source material.

(26) Gas and aerosol detectors containing radioactive material and designed to protect life or property from fires and airborne hazards provided such detectors have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products.

(27) Self-luminous products containing tritium, krypton 85, or promethium 147 provided such products have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products, and provided further that such products are not used primarily for frivolous purposes or as toys or adornments.

(28) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(A) Each source contains no more than one exempt quantity set forth in section 30235, Schedule A, and

(B) Each instrument contains no more than ten exempt quantities. For purposes of subsection (b)(28)(A) and (B), an instrument's source(s) may contain either one type or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in section 30235, Schedule A, provided that the sum of such fractions shall not exceed unity.

(C) For purposes of subsection (b)(28)(B), 0.05 microcurie of americium- 241 is considered an exempt quantity under section 30235, Schedule A.

(29) Spark gap irradiators containing not more than one microcurie of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three gallons per hour (11.4 liters per hour).

(30) Capsules containing one microcurie of carbon-14 urea each, for in vivo diagnostic use for humans. Persons who use the capsules for research involving human subjects shall possess a specific license issued pursuant to section 30195.

(1) Any naturally-occurring radioactive material, except source material, in concentrations which occur naturally. Unprocessed ore in its natural form containing source material is exempt. Refining and processing are not exempt.

(2) Any chemical mixture, compound, solution or alloy containing up to one-twentieth of one percent (0.05 percent) by weight of source material.

(3) Any radioactive material in concentration not exceeding those specified in section 30237, Schedule C, except that a specific license shall be required by any person to transfer possession or control of any product or material into which radioactive material has been introduced in such concentrations except for transfers to appropriately licensed persons for analytical test or waste disposal purposes.

(4) Radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in section 30235, Schedule A, if not more than 10 such scheduled quantities are possessed at any one time.

(d) The exemptions contained in subsection (b) shall not authorize any of the following:

(1) The manufacture of any product listed.

(2) The application or removal of radioactive luminous material to or from meters and timepieces, or hands and dials therefor.

(3) The installation into automobile locks of illuminators containing tritium or promethium 147 or the application of tritium to balances of precision or parts therefor.

(4) The chemical, physical, or metallurgical treatment or processing of thorium-metal alloys.

(5) Human use, or the use in any device or article, except time pieces and the product specified in subsection (b)(30), which is intended to be placed on or in the human body.

(6) The chemical, physical, or metallurgical treatment or processing of uranium counterweights other than repair or restoration of any plating or other covering.

(e) The exemptions specified in subsections (b)(30), (c)(3) or (c)(4) shall not authorize the production, packaging, repackaging or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115165 and 115235, Health and Safety Code.

HISTORY

1. Amendment of subsection (c)(1) and new subsection (d)(7) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42). For prior history, see Register 71, No. 30.

2. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

3. Change without regulatory effect of subsections (b)(15) and (c)(2)-(4) (Register 88, No. 6).

4. Change without regulatory effect amending subsections (b)(1), (b)(17), (b)(28), and (d)(2) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

5. Editorial correction reinserting inadvertently omitted subsections (c)-(c)(4) (Register 92, No. 44).

6. Editorial correction of subsection (b)(28)(B) (Register 2003, No. 29).

7. Amendment of section and repealer and new Note filed 7-28-2006; operative 8-27-2006 (Register 2006, No. 30).

§30181. Persons Exempt. [Repealed]

History

HISTORY

1. Amendment of subsection (b)(1) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

2. Repealer filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

§30182. Other Exemptions. [Repealed]

History

HISTORY

1. Repealer filed 11-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 4. Licenses

§30190. Types of Licenses.

Note • History

(a) Department licenses for radioactive material are of two types: general and specific.

(b) General licenses provided in this regulation are effective without the filing of an application with the Department or the issuance of licensing documents to particular persons, except that any person to whom a general license is issued pursuant to sections 30192.1 and 30192.6 shall be subject to the registration requirements specified in section 30108.1.

(c) Specific licenses are issued to named persons upon approval of an application filed pursuant to this regulation. A specific license issued by the Department is required by any person to possess any radioactive material in this state, except as otherwise provided in sections 30180, 30191, 30192, 30192.1, 30192.2, 30192.3, 30192.4, 30192.5, 30192.6, 30225, or 30226.

(d) Every specific and general license is subject to all applicable provisions of this regulation and, except as otherwise specified, to the provisions of Group 3 of this subchapter (Standards for Protection Against Radiation).

NOTE

Authority cited: Sections 114970, 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114970, 115060, 115165, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer of Article 4 (Sections 30190 through 30205) and new Article 4 (Sections 30190 through 30198 and 30205) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Register 62, No. 1.

2. Amendment of subsections (b) and (c) and new Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30191. General Licenses-Source Material.

Note • History

(a) A general license is hereby issued to commercial firms, educational institutions, and medical institutions and government agencies, authorizing the possession, use, and transfer of not more than 15 pounds of source material at any one time, for research, development, educational, commercial or operational purposes. Persons authorized to possess, use, or transfer source material pursuant to this general license may not receive more than a total of 150 pounds of source material in any one calendar year. With respect to such source material, any person shall be exempt from the provisions of Group 3 of this subchapter, except for sections 30254 and 30293(a), unless such person also possesses source material under a specific license.

(b) A general license described in subsection (a) shall not authorize human use, or the use in any device or article which is intended to be placed on or in the human body, or the use of any instrument or apparatus (including component parts and accessories thereto) intended for human use.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New NOTE filed 8-22-84 (Register 84, No. 34).

2. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

3. Change without regulatory effect inserting (a) to first paragraph filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

4. Amendment of subsection (a) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

5. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192. General Licenses--Static Elimination or Ion Generation Devices.

Note • History

(a) A general license is hereby issued to any person, authorizing possession, transference, receipt, acquisition, use and ownership of radioactive material incorporated in any of the following items when manufactured, tested, and labeled pursuant to a specific license, which authorizes distribution to general licensees:

(1) Static eliminators containing sealed sources of up to 500 microcuries of polonium-210 per device.

(2) Air ionization devices containing, as sealed sources, up to 500 microcuries of polonium-210 or 50 millicuries of tritium per device.

(b) Possession of radioactive material listed in this section is exempt from the requirements of Group 3 of this subchapter, except for sections 30254 and 30293(a) of this subchapter and sections 20.2201 and 20.2202 of title 10, Code of Federal Regulations, Part 20, incorporated by reference in section 30253.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment of subsection (c) and new subsection (f) filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

2. Amendment of subsection (c)(1) filed 5-13-66; effective thirtieth day thereafter (Register 69, No. 20).

3. Repealer of subsections (a)(1)(B) and (a)(1)(C), renumbering of (a)(1)(D) to (a)(1)(B), new subsection (a)(3) and amendment of subsection (b) filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

4. Repealer of subsections (a)(2) and (b)(2) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

5. Amendment of subsection (a)(3) filed 10-11-74; effective thirtieth day thereafter (Register 74, No. 41).

6. Repealer and new section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

7. Amendment of subsection (b) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

8. Editorial correction restoring inadvertently deleted Histories (Register 97, No. 45).

9. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192.1. General Licenses--Gauging and Controlling.

Note • History

(a) A general license is hereby issued to commercial and industrial firms, research, educational and medical institutions, individuals in the conduct of their business, and government agencies, to acquire, receive, possess, use or transfer, in accordance with this section, radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(b) The general license issued pursuant to subsection (a) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the provisions of:

(1) A specific license, which authorizes distribution of the device, issued by the Department pursuant to section 30195(d);

(2) An equivalent specific license issued by an Agreement State other than this State; or

(3) A specific license issued by the United States Nuclear Regulatory Commission (NRC) under section 32.51 of title 10, Code of Federal Regulations (10 CFR), Part 32.

(c) Devices described in subsection (a) shall have been received from one of the specific licensees described in subsection (b), or through a transfer made pursuant to subsection (d)(12).

(d) Persons who acquire, receive, possess, use or transfer a device under the general license issued pursuant to subsection (a) shall:

(1) Register and renew registration pursuant to section 30108.1 any devices containing at least 10 millicuries (mCi) of cesium-137, 0.1 mCi of strontium-90, 1 mCi of cobalt-60, 0.1 mCi of radium-226, or 1 mCi of americium-241 or any other transuranic (i.e., an element with atomic number greater than uranium (92)), based on the activity indicated on the label. The licensee shall be subject to the reporting requirement in section 30108.1(c) for such devices;

(2) Ensure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon, and comply with all instructions and precautions provided by such labels;

(3) Ensure that the device is tested for leakage of radioactive material and that the on-off mechanism and indicator, if any, operate as designed. These tests shall be performed at intervals no longer than six months or at such other intervals as are specified in the device's label. However:

(A) Devices containing only krypton need not be tested for leakage; and

(B) Devices containing only tritium, or not more than 100 microcuries (uCi) of other beta and/or gamma emitting material or 10 uCi of alpha emitting material, and devices held in storage in the original shipping container prior to initial installation, need not be tested for any purpose;

(4) Ensure that the tests required by subsection (d)(3) and any testing, installation, servicing, and removal from installation involving the radioactive material, its shielding, or containment, are performed:

(A) In accordance with the instructions provided by the device's labels; or

(B) By a person holding a specific license issued by the Department or an Agreement State other than this State, authorizing the licensee to perform those activities;

(5) Maintain records showing compliance with the requirements of subsections (d)(3) and (d)(4), to include the results of tests, the dates of performance of tests, and the names of the persons performing testing, installing, servicing, and removing from the installation radioactive material, its shielding, or containment. The licensee shall retain records of tests required by:

(A) Subsection (d)(3) for three years after the next required test for leakage and test of the on-off mechanism and indicator is performed, or until the sealed source is transferred or disposed of; and

(B) Subsection (d)(4) for three years from the date of the recorded event or other test, or until the device is transferred or disposed of;

(6) Immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 uCi or more of removable radioactive material. The device shall not be operated until it has been repaired by the manufacturer or a person holding a specific license issued by the Department, the NRC, or an Agreement State other than this State, authorizing the licensee to repair the device. The device, and any radioactive material from the device, may only be disposed of in accordance with subsection (d)(10);

(7) Within 30 calendar days of an event specified in subsection (d)(6), submit a report to the Department containing:

(A) A brief description of the event and the remedial action taken; and

(B) If removable radioactive material greater than or equal to 0.005 uCi has been detected, or failure of or damage to a sealed source is likely to result in contamination of the premises or the environs, a plan to ensure that the premises and environs are acceptable for unrestricted use;

(8) Not abandon the device;

(9) Not export the device except in accordance with an export license issued by the NRC pursuant to 10 CFR, Part 110. This provision shall not be construed to incorporate by reference 10 CFR, Part 110;

(10) Transfer or dispose of the device only:

(A) By export as provided by subsection (d)(9);

(B) By transfer to a specific licensee authorized to receive such device or another general licensee as authorized in subsection (d)(12); or

(C) After obtaining written Department approval authorizing transfer or disposal to any other specific licensee not specifically identified in subsection (d)(10)(A) or (B), except that a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if the holder:

1. Verifies that the specific license authorizes the possession and use, or pursuant to section 30194.2 applies for and obtains an amendment to the license authorizing the possession and use;

2. Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subsection (d)(2)), so that the device is labeled in compliance with section 20.1904 of 10 CFR, Part 20, incorporated by reference in section 30253; however, the manufacturer, model number, and serial number shall be retained;

3. Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

4. Reports the transfer under subsection (d)(11);

(11) Within 30 calendar days after transfer of a device pursuant to subsection (d)(10), submit a report to the Department containing the:

(A) Identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(B) Name, address, and license number of the person receiving the device (license number not applicable if exported); and

(12) Transfer the device to another general licensee only if:

(A) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section, sections 30108.1, 30254, 30257 and 30293(a) of this subchapter, sections 20.2201 and 20.2202 of 10 CFR, Part 20, incorporated by reference in section 30253, and any safety documents identified in the label of the device. Within 30 calendar days of the transfer, the transferor shall submit a report to the Department containing:

1. The manufacturer's (or initial transferor's) name;

2. The model number and the serial number of the device transferred;

3. The transferee's name and mailing address for the location of use; and

4. The name, title, and phone number of the responsible individual identified by the transferee pursuant to subsection (d)(15); or

(B) The device is held in storage by an intermediate person in the original shipping container at its intended location of use, prior to initial use by a general licensee;

(13) Comply with sections 20.2201 and 20.2202 of 10 CFR, Part 20, incorporated by reference in section 30253, for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from other requirements in Group 3 of this subchapter, except for sections 30257 and 30293(a);

(14) Upon Department request, provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee is unable to provide the requested information within the allotted time, a request for extending that time shall be submitted prior to the end of the allotted time, and the request for an extension of time shall include a written justification as to why the allotted time should be extended;

(15) Appoint an individual responsible for having knowledge of required actions and authority for taking required actions, so as to comply with this section and all sections cited or referenced within this section. Appointment of the responsible individual does not relieve the general licensee of any of its own responsibility for complying with the Act and this subchapter; and

(16) Not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by subsection (d)(3) need not be performed during the period of storage. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they shall be tested for leakage before use or transfer, and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(e) The general license issued pursuant to this section does not authorize the manufacture or import of devices containing radioactive material.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of subsection (b)(5) (Register 88, No. 6).

3. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

4. Repealer and new section and amendment of Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192.2. General Licenses--Aircraft Safety Devices.

Note • History

(a) A general license is hereby issued to any person to possess, own, receive, acquire and use tritium or promethium-147 contained within luminous safety devices designed for use in aircraft, provided that each such device contains not more than 10 curies of tritium or 300 millicuries of promethium-147 and provided further that each such device has been manufactured, assembled, initially transferred or imported in accordance with a specific license authorizing distribution to general licensees.

(b) The general license issued pursuant to subsection (a) does not authorize:

(1) The manufacture, assembly, disassembly, repair, import or disposal of such devices;

(2) The export of luminous safety devices containing tritium or promethium-147;

(3) The use of such devices other than in aircraft; and

(4) The possession, ownership, receipt, acquisition, or use of promethium-147 contained in instrument dials.

(c) Persons who possess a device under the general license issued pursuant to subsection (a) shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter except for sections 30254 and 30293(a) of this subchapter and sections 20.2201 and 20.2202 of title 10, Code of Federal Regulations, Part 20, incorporated by reference in section 30253.

NOTE

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192.3. General Licenses--Calibration or Reference Sources.

Note • History

(a) A general license is hereby issued to persons who hold either a specific license issued by the Department for any radioactive material, or a specific license issued by the United States Nuclear Regulatory Commission for any radioactive material, to possess americium-241, plutonium, or radium-226 in the form of calibration or reference sources. Calibration or reference sources shall be manufactured in accordance with the specifications contained in an appropriate specific license, which authorizes distribution under a general license. Each source possessed pursuant to the general license or its storage container shall bear a label, which includes the information required in the following statement:

“The receipt, possession, use and transfer of this source, Model ____, Serial No. ____, are subject to a general license or its equivalent, and are further subject to the regulations of the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Removal of this label is prohibited.

CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS (AMERICIUM-241, PLUTONIUM, OR RADIUM-226, whichever is appropriate). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. _______________________________________” (Name of Manufacturer or Importer)

(b) Persons who possess a source under the general license issued pursuant to subsection (a) shall:

(1) Not have, at any one time, at any one location of storage or use, more than 5 microcuries of americium-241, 5 microcuries of plutonium, or 5 microcuries of radium-226 contained in such sources.

(2) Not transfer, abandon or dispose of such sources, except by transfer to a person authorized by a license to receive the source.

(3) With respect to each such source when not in use, store the source in a closed container adequately designed and constructed to contain any of the radioactive material in the event the source is ruptured or leaks.

(4) Not use such source for any purpose other than calibration of radiation detectors or standardization of other sources.

(c) Persons who possess a source under the general license issued pursuant to subsection (a) shall, with respect thereto, be exempt from the requirement of Group 3 of this subchapter, except for sections 30253, 30254, 30255, 30275(a) and (b), 30293, and 30295.

(d) The general license issued pursuant to subsection (a) does not authorize the manufacture, import, or export of calibration or reference sources containing americium-241, plutonium, or radium-226 or the introduction of americium-241, plutonium, or radium-226 into any product or material.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192.4. General Licenses--Ice Detection Devices.

Note • History

(a) A general license is hereby issued to any person to possess, own, receive, acquire, use, or transfer strontium-90 contained in ice detection devices, provided that each device contains not more than 50 microcuries of strontium-90, and provided further that each device has been manufactured or imported in accordance with a specific license which authorizes distribution under a general license.

(b) Persons who possess, own, receive, acquire, use or transfer a device under the general license issued pursuant to subsection (a) shall:

(1) Assure that all labels affixed to the device at the time of receipt, and which bear a statement that prohibits removal of the labels, are maintained thereon; and

(2) Immediately upon occurrence of damage, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license authorizing such testing or repair; or dispose of the device pursuant to section 20.2001 of title 10, Code of Federal Regulations, Part 20 (10 CFR 20), incorporated by reference in section 30253.

(c) Persons who possess, own, receive, acquire, use, or transfer a device under the general license issued pursuant to subsection (a) shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter, except for sections 30254 and 30293(a) of this subchapter and sections 20.2001, 20.2201 and 20.2202 of 10 CFR 20, incorporated by reference in section 30253.

(d) This general license does not authorize the manufacture, assembly, disassembly, repair, or import of ice detection devices containing strontium-90.

NOTE

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30192.5. General Licenses--In Vitro Testing.

Note • History

(a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to possess and use radioactive material in prepackaged units for in vitro clinical testing, not exceeding the following:

Radionuclide Maximum Maximum

uCi* per unit uCi total

Tritium 50 2,000

Carbon-14 10 2,000

Iron-59 20 200

Selenium-75 10 200

Cobalt-57 10 200

Iodine-125 or Iodine-131 10 200

Mock Iodine-125

Reference Source

Iodine-129 0.05 -

Americium-241 0.005 -

* microcurie (uCi)

(b) The general licensee shall not possess or use radioactive material under the general license issued pursuant to subsection (a):

(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority; and

(2) Unless the prepackaged unit bears a label or is accompanied by a package insert containing the following or a substantially similar statement:

“This radioactive material may be received and used only by physicians, veterinarians, clinical laboratories or hospitals, and only for in vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom to human beings or animals. The receipt, possession, use and transfer of this material is subject to the regulations and general license of the United States Nuclear Regulatory Commission or a state with which the Commission has entered into an agreement for the exercise of regulatory authority.”

(c) Persons who possess radioactive material under the general license issued pursuant to subsection (a), shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter, except that persons using Mock Iodine-125 shall comply with sections 20.2001, 20.2201 and 20.2202 of title 10, Code of Federal Regulations, Part 20, incorporated by reference in section 30253.

NOTE

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

4. Editorial correction amending column heading in subsection (a) (Register 2011, No. 24).

§30192.6. General Licenses--Depleted Uranium.

Note • History

(a) A general license is hereby issued to any person to receive, acquire, transfer, possess or use depleted uranium contained in industrial products or devices, for the purpose of providing a concentrated mass of the product or device, when such products or devices are manufactured pursuant to a specific license authorizing distribution to general licensees.

(b) Persons who receive, acquire, use, transfer or possess depleted uranium under the general license issued pursuant to subsection (a) shall:

(1) Register in accordance with section 30108.1;

(2) Not introduce such depleted uranium into any chemical, physical or metallurgical treatment or process, other than a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;

(3) Develop, implement and maintain procedures designed to establish physical control over such depleted uranium in order to prevent its unauthorized use or transfer in any form, including metal scrap;

(4) Appoint an individual responsible for having knowledge of required actions and authority for taking required actions, so as to comply with this section and all sections cited or referenced within this section. Appointment of the responsible individual does not relieve the general licensee of any of its own responsibility for complying with the Act and this subchapter;

(5) Not abandon such depleted uranium;

(6) Transfer or dispose of such depleted uranium only by transfer in accordance with sections 30210 and 30210.1.

(7) Within 30 calendar days of any transfer, report in writing to the Department the transferee's name and address.

(c) Persons who possess, receive, acquire, transfer or use depleted uranium under the general license issued pursuant to subsection (a) shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter.

NOTE

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30193. Application for Specific Licenses and Amendments. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30194. Approval of Applications and Specific Terms and Conditions for Licenses.

Note • History

(a) An application for a new specific license or for renewal or amendment of an existing license will be approved if the Department determines that:

(1) the applicant or his specified personnel are qualified by reason of training and experience to use radioactive material of the kinds and quantities and for the purposes requested, in such a manner as to provide reasonable and adequate assurance of protection to health, life, and property;

(2) the applicant's equipment, facilities, proposed uses and procedures are such as to provide reasonable and adequate assurance of protection to health, life, and property;

(3) the issuance of the license will not jeopardize the health and safety of the public;

(4) the applicant satisfies all applicable requirements of the Act and regulations thereunder.

(b) Prior to issuing, amending or renewing a license pursuant to the provisions of this subchapter, the Department may inspect at any reasonable time the place of business, or premises and facilities of any applicant in order to verify information contained in the application or to obtain additional information for the purpose of completing the application.

(c) No license or any right under a license shall be assigned or otherwise transferred unless approved in advance by the Department.

(d) Each licensee shall restrict possession of licensed material to the locations and conditions of the use authorized in the license.

(e) Each specific license shall expire on the expiration date specified as a condition of the license. However, the license shall continue to be valid if a timely application for renewal is filed. An application for renewal shall be timely if filed at least 30 days prior to the expiration date. The existing license shall not expire until the department has taken final action on the timely filed application for renewal.

(f) Applications and documents submitted shall be made available for public inspection except where the applicant identifies portions of the application as “trade secret” and the Department finds that the information is “trade secret” pursuant to provisions of the Public Records Act and Evidence Code Section 1060.

(g) As provided by Section 30195.1, certain applications for specific licenses filed under Group 2 shall contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted before January 1, 1996, the submittal of a proposed decommissioning funding plan or a certification of financial assurance for decommissioning may follow the renewal application but shall be submitted on or before January 1, 1996.

NOTE

Authority cited: Sections 100110, 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165, 115230 and 115235, Health and Safety Code.

HISTORY

1. Amendment filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

2. New subsection (g) filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-16-95 order, including amendment of Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

§30194.1. Criteria for Authorizing Multiple Locations of Use.

Note • History

Criteria for authorizing more than one location of use on a specific license shall be as follows:

(a) All locations shall be under the same business entity.

(b) The radiation protection program required by section 20.1101 of Title 10, Code of Federal Regulations, Part 20 as incorporated by reference in section 30253 shall demonstrate that use of radioactive materials at each location shall be in accordance with this regulation.

(c) A single location where licensing and compliance records will be maintained for Department review shall be designated.

(d) The nature of radioactive materials use and the operations shall be the same at all locations.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115165, Health and Safety Code.

HISTORY

1. New section filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30194.2. Amendment Requests.

Note • History

To amend an existing license, a licensee shall submit a written request to the Department containing:

(a) The licensee's name and license number as shown on the specific license.

(b) The nature and scope of the request.

(d) If the request proposes to increase the maximum possession limit specified on the license, the request shall include the fee specified in section 30231(c).

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115165, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30195. Special Requirements for Issuance of Specific Licenses.

Note • History

In addition to the requirements set forth in Section 30194, specific licenses for certain specialized uses will be issued only if the following conditions are met:

(a) For human use of radioactive material limited to medical purposes, the applicant submits documentation demonstrating that they are capable of complying with the regulations governing the medical use of radioactive material in title 10, Code of Federal Regulations, Part 35 (10 CFR 35) (January 1, 2008), which is hereby incorporated by reference with the exceptions listed at subsections (a)(1) through (a)(15) below, and upon issuance of a license maintains compliance with said regulations:

(1) Title 10, Code of Federal Regulations, sections 35.1, 35.5, 35.7, 35.8, 35.10, 35.11(c), 35.12, 35.13, 35.14, 35.15, 35.18, 35.19, 35.26, 35.65, 35.4001, and 35.4002 are not incorporated by reference.

(2) Any references to the United States Nuclear Regulatory Commission (NRC) or any component thereof shall be deemed to be a reference to the “Department” as defined in section 30100 of this regulation.

(3) Any reference to 10 CFR 35, section 35.5 shall be deemed to be a reference to section 30293 of this regulation.

(4) Any reference to “Person” in 10 CFR 35 shall be deemed to be a reference to the term “Person” as defined in section 114985(c) of the Health and Safety Code.

(5) Any reference to “Licensee” in 10 CFR 35 shall be deemed to be a reference to the term “User” as defined in section 30100 of this regulation.

(6) Any reference to “Byproduct material” in 10 CFR 35 is replaced by the term “Radioactive Material” as defined in section 30100 of this regulation.

(7) The definition of the term “Agreement State” in 10 CFR 35, section 35.2 is replaced by the definition of the term “Agreement State” as defined in section 30100 of this regulation.

(8) The definition of the term “Sealed source” in 10 CFR 35, section 35.2 is replaced by the definition of the term “Sealed source” as defined in section 30100 of this regulation.

(9) The definition of the term “Dentist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a dentist pursuant to the California Dental Practice Act specified in Business and Professions Code Section 1600 et seq.

(10) The definition of the term “Pharmacist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a pharmacist pursuant to the California Pharmacy Law specified in Business and Professions Code Section 4000 et seq.

(11) The definition of the term “Podiatrist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a podiatrist pursuant to California Business and Professions Code sections 2460 et seq.

(12) The definition of the term “Physician” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a physician and surgeon or as an osteopathic physician and surgeon pursuant to the California Medical Practice Act specified in Business and Professions Code Section 2000 et seq.

(13) The reference to section 19.12 found in 10 CFR 35, section 35.27(b)(1) shall be deemed to be a reference to section 30255 of this regulation.

(14) The date January 1, 2011 is substituted for the date October 24, 2002 found in 10 CFR 35, section 35.57(a)(1) and (b)(1). Subdivisions (a)(2) and (b)(2) of 10 CFR 35, section 35.57 are substituted with the following:

(A) “An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist, or an authorized medical physicist, or an authorized nuclear pharmacist, and physicians, dentists, or podiatrists identified as authorized users for the medical use of radioactive material on a license or an NRC or Agreement State license or a permit issued by a Department, NRC or Agreement State broad scope licensee or NRC master material license permit or by an NRC master material license permittee of broad scope before January 1, 2011 need not comply with the training requirements of 10 CFR 35, sections 35.50, 35.51, or 35.55, and subparts D through H of 10 CFR 35, respectively.”

(15) Nothing in this incorporation by reference shall be construed to authorize the Department to approve of specialty boards or medical specialty boards for meeting training requirements specified in 10 CFR 35.

(b) For use of multiple quantities of types of radioactive material for research and development or for processing for distribution:

(1) The applicant has a radiation safety committee of at least three members which must evaluate all proposals for, and maintain surveillance over, all uses of radioactive material. Committee members shall be knowledgeable and experienced in pertinent kinds of radioactive material use and in radiation safety.

(2) The applicant has a radiation safety officer, who is a member of the radiation safety committee, and who is supported by a staff of a size and degree of competence appropriate to deal with radiation safety problems that might be encountered.

(3) The applicant furnishes a detailed statement of the qualifications, duties, authority, and responsibilities of the radiation safety committee and of the staff radiation safety group.

(1) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling, proposed uses and conditions of use, and potential radiation hazards of each device to provide reasonable assurance that:

(A) the radioactive material contained in the device will not be lost;

(B) no individual will receive a radiation dose to the whole body or major portion thereof, head and trunk, lens of the eye, gonads, or active blood-forming organs in excess of 0.5 rem in a year, under ordinary circumstances of use;

(D) the radioactive material within the device would not be accessible to unauthorized individuals.

(2) The applicant submits a sample of the labels to be affixed to the device which include instructions and precautions for safe operation, and indicates the manner in which the labels will be affixed and their location on the device. Each such label shall bear the statement, “Removal of this label is prohibited.”

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer and new subsection (e) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

2. Repealer of subsection (e) filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

3. Change without regulatory effect amending subsection (d) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

4. Repealer of subsections (a)-(b)(2), new subsections (a)-(a)(15), subsection relettering and amendment of Note filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).

5. Editorial correction of subsection (a)(14) (Register 2010, No. 45).

§30195.1. Special Requirements for Issuance of Specific Licenses--Financial Surety for Decommissioning.

Note • History

(a) The regulations governing financial assurance for decommissioning in Title 10, Code of Federal Regulations (10 CFR), section 30.35 (January 1, 2007) and Appendices A through E of 10 CFR Part 30 referenced in section 30.35, are hereby incorporated by reference with the following exceptions:

(1) Subsection 30.35(g) is not incorporated by reference.

(2) The phrase “byproduct material” shall include all “radioactive material” as defined in Title 17, California Code of Regulations, section 30100, except source material which shall be governed by subsection (b).

(3) The date “January 1, 1996” is substituted for the date “July 27, 1990.”

(4) Any reference to the United States Nuclear Regulatory Commission (NRC) or any component thereof shall be deemed to be a reference to the Department.

(5) Any reference to 10 CFR section 30.37 shall be deemed to be a reference to Section 30194.

(6) The date “January 1, 1998” is substituted for the date “November 24, 1995.”

(7) The date “January 1, 2010” is substituted for the date “December 2, 2004.”

(8) The date “July 1, 2010” is substituted for the date “June 2, 2005.”

(9) The date “January 1, 2011” is substituted for the date “December 2, 2005.”

(10) The reference to 10 CFR section 20.303 found in the Note of Appendix B of 10 CFR Part 30 shall be deemed a reference to 10 CFR section 20.2003.

(11) Provisions relating only to power reactor licensees found in the following appendices are not incorporated:

(A) Appendix A, II.A.1.(ii);

(B) Appendix A, II.A.1.(iv);

(D) Appendix A, II.A.2.(iv);

(E) Appendix C, II.A(1); and

(F) Appendix C, II.A(2).

(b) The regulations governing financial assurance for decommissioning in 10 CFR section 40.36 (January 1, 2007) are hereby incorporated by reference with the following exceptions:

(1) Subsection 40.36(f) is not incorporated by reference.

(2) The date “January 1, 1996” is substituted for the date “July 27, 1990.”

(3) Any reference to the NRC or any component thereof shall be deemed to be a reference to the Department.

(4) Any reference to 10 CFR section 40.43 shall be deemed to be a reference to Section 30194.

(5) The date “January 1, 1998” is substituted for the date “November 24, 1995.”

(6) The date “January 1, 2009” is substituted for the date “December 2, 2004.”

(7) The date “July 1, 2009” is substituted for the date “June 2, 2005.”

(8) Appendix A referenced in section 40.36 is not incorporated by reference.

(1) Persons authorized to possess no more than 1,000 times the quantity specified for each licensed material specified in Appendix B to Part 30 of Title 10, Code of Federal Regulations;

(2) Persons authorized to possess hydrogen-3 contained in hydrogen gas in a sealed source;

(3) Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than 30 days; or

(4) Persons authorized to possess no more than 10 mCi of source material in any form and source material in any quantity in a non-dispersible form.

NOTE

Authority cited: Sections 115000, 115091, 131055 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115091, 115092 and 115235, Health and Safety Code.

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Amendment of subsection (c) filed 7-12-89; operative 8-11-89 (Register 89, No. 28).

3. Renumbering of former section 30195.1 to new section 30195.3 and new section filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-16-95 order, including amendment of subsection (c)(1) and Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

5. Amendment of subsections (a) and (b), new subsections (a)(5), (a)(6), (b)(4) and (b)(5), and amendment of Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

6. Amendment of subsections (a), (a)(2), (a)(4)-(5), (b) and (b)(3)-(4), new subsections (a)(7)-(11)(F) and (b)(6)-(8) and amendment of Note filed 12-30-2008; operative 1-29-2009 (Register 2009, No. 1).

§30195.2. Special Requirements for Issuance of Specific Licenses--Emergency Plans.

Note • History

(a) The regulations governing application for specific licenses in Title 10, Code of Federal Regulations, Section 30.32, Subsection (i), as revised January 1, 1994, including section 30.72 of Title 10, Code of Federal Regulations, referenced in such Subsection (i), are hereby adopted by reference with the following exceptions:

(1) The phrase “radioactive material” as defined in Title 17, California Code of Regulations, Section 30100 is substituted for the phrase “byproduct material.”

(2) Any reference to the Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department.

(b) In addition to the requirements set forth in §§ 30194, 30195, 30195.1 and 30195.3, specific licenses shall be issued only if the requirements specified in Subsection (a) are met.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230, and 115235, Health and Safety Code.

HISTORY

1. New section filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 10-16-95 order, including amendment of Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

§30195.3. Special Requirements for Issuance of Specific Licenses for Use of Sealed Sources in Industrial Radiography.

Note • History

(a) The definitions of sections 30100 and 30330 apply to this section.

(b) An applicant for a specific license for the use of sealed sources in industrial radiography shall submit:

(1) A description of the applicant's training program that meets the requirements of section 30333(a) and (b). Copies of typical examinations and correct answers shall be submitted. Instructors shall, at a minimum, meet the requirements of section 30333.05(a)(1). Instructor qualifications shall be submitted;

(2) If the applicant proposes to be a radiation safety training provider, the information required by section 30331(a)(3) through (a)(5) and the fee required by section 30331(a)(6) in addition to any fee required by section 30230. This information shall be clearly identified as being submitted for compliance with section 30331;

(3) Procedures for verifying and documenting the certification status of radiographers and ensuring that the certification of each radiographer remains valid;

(4) A description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in radiography using sealed sources, including specified delegation of authority and responsibility;

(5) Operating and emergency procedures that meet the requirements of section 30333.1;

(6) A description of the internal inspection system used to assure that radiographers and radiographer's assistants comply with Department regulations and license conditions and the applicant's operating and emergency procedures as required by section 30333(e);

(7) The name(s) and qualification(s) of the individual(s) designated as the radiation safety officer (RSO) and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with Department regulations and license conditions and the applicant's operating and emergency procedures. The designated RSO shall, at a minimum, meet the requirements specified in section 30333.07. Potential designees shall, at a minimum, meet the requirements specified in section 30333.05; and

(8) The location and a description of the location of each field station and permanent radiographic installation.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165 and 115235, Health and Safety Code.

HISTORY

1. Renumbering of former section 30195.1 to new section 30195.3 filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 10-16-95 order, including amendment of Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

3. Amendment of section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30196. Issuance of Specific Licenses. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30197. Specific Terms and Conditions of Licenses. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30198. Expiration of Licenses. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30205. Modification, Suspension, Revocation and Termination of Licenses.

Note • History

(a) All licenses shall be subject to modification, suspension, or revocation by regulations or orders issued by the department.

(b) Any license may be modified, suspended, or revoked by the department:

(1) for any material false statement in the application or in any required report;

(2) because of conditions revealed by any means which would warrant refusal to grant such a license on an original application; or

(3) for violation of any terms and conditions of the Act, of the license, or of any relevant regulation or order of the department, including non-payment of license fee pursuant to Sections 30230-30232 of this regulation.

(c) Prior to the institution of proceedings to modify, suspend, or revoke a license, facts or conduct which may warrant such action shall be called to the attention of the licensee in writing and the licensee shall be accorded reasonable opportunity to demonstrate or achieve compliance, except in cases of willful violation or those in which the public health or safety requires otherwise.

(d) A specific license may be terminated by mutual consent between the licensee and the department.

NOTE

Authority cited: Sections 208 and 25811(d), Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment of subsection (b)(3) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

2. New NOTE filed 8-22-84 (Register 84, No. 34).

Article 5. Transfer of Material

§30210. Authorization for Transfer.

Note • History

(a) A licensee may transfer radioactive material only to persons listed below and only following acceptance of such transfer:

(1) the Department;

(2) any person who is exempt from this regulation to the extent permitted under such exemption; or

(3) any person licensed or authorized to receive the material by the United States Nuclear Regulatory Commission, the Department, or any other Agreement State.

(b) This section does not authorize the commercial distribution of radioactive material other than those items listed in Section 30192 through 30192.6, except when such distribution is authorized by a specific license.

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of Article 5 (Section 30210 and 30211) and new Article 5 (Section 30210) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Register 62, No. 1.

2. Amendment filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

3. Amendment filed 5-13-69; effective thirtieth day thereafter (Register 69, No. 20).

4. Amendment filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30210.1. Verification Required.

Note • History

(a) Before transferring radioactive material to a licensee, the licensee transferring the material shall verify license authorization for the receipt of the type, form and quantity of radioactive material to be transferred.

(b) The transferrer shall utilize methods of verification and maintain records of verification required by subsection (a) as specified in 10CFR30.41 (38FR33968).

NOTE

(1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25855, 25875 and 25876, Health and Safety Code.

(2) Copies of Title 10, Code of Federal Regulations --Energy, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of NOTE (Register 88, No. 6).

§30210.2. Labeling Requirements for the Manufacture, Preparation or Transfer for Commercial Distribution of Drugs Containing Radioactive Material for Human Use as Authorized by a Specific License.

Note • History

(a) A person applying for a specific license to manufacture, prepare or transfer for commercial distribution radioactive drugs for human use shall satisfy the following labeling requirements:

(1) A label shall be affixed to each transport radiation shield of a radioactive drug to be transferred for commercial distribution. The label shall include:

(A) The radiation symbol and the words, “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”;

(B) The name of the radioactive drug or its abbreviation; and

(C) The quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(2) A label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include:

(A) The radiation symbol and the words, “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”, and

(B) An identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165 and 115235, Health and Safety Code.

HISTORY

1. New section filed 10-13-99; operative 11-12-99 (Register 99, No. 42).

Article 6. Enforcement

§30220. Violations. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of Article 6 (Sections 30215 through 30217) and new Article 6 (Section 30220) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Register 62, No. 21.

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 7. Reciprocal Recognition of Licenses

§30225. Persons Specifically Licensed by Other Agencies.

Note • History

(a) Any person who holds a specific license issued by the United States Nuclear Regulatory Commission (NRC), by any other Agreement State, or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), other than this State, may conduct activities of the kind therein authorized within this State for a period not in excess of 180 days in any calendar year without obtaining a specific license from the Department, provided that:

(1) The person maintains an office for directing the licensed activity, at which radiation safety records are normally maintained, in a location under jurisdiction of the agency which issued the specific license;

(2) The license does not limit the authorized activity to specified installations or locations;

(3) The person provides written notice to the Department at least three days prior to engaging in such activity. Such notice shall indicate the location, specific time period, and type of proposed possession and use within this state, and shall be accompanied by a copy of the pertinent license. If, for a specific case, the 3-day period would impose an undue hardship on the person, the person may make application to the Department to proceed sooner;

(4) The person complies with all applicable regulations of the Department and with all the terms and conditions of the license, except such terms and conditions as may be inconsistent with said regulations;

(5) The person supplies such other information as the Department may request; and

(6) The person pays a fee in accordance with section 30230(f) to the Department, prior to the engagement of activities within the state.

(b) Any person who holds a specific license issued by the NRC, by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the CRCPD, other than this State, authorizing the holder to manufacture, install or service a device described in section 30192.1(a), is hereby issued a general license to install or service such device in this State, provided that:

(1) The person files a report with the Department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State, identifying each device recipient by name and address, identifying the type of device transferred or installed, and identifying the quantity and type of radioactive material contained in each device;

(2) The device has been manufactured and labeled and is installed and serviced in accordance with applicable provisions of the specific license;

(3) The person assures that any labels required to be affixed to the device, under regulations of the authority which licensed manufacture of the device, are affixed and bear a statement that “Removal of this label is prohibited;” and

(4) The person furnishes to each device recipient in this State to whom he or she transfers such a device, or on whose premises he or she installs the device, a copy of the regulations contained in Group 1.5 of this subchapter and sections 30192.1, 30254, 30257, 30293(a)(2) and 30295 of Group 3 of this subchapter, and sections 20.2201 and 20.2202 of title 10, Code of Federal Regulations, Part 20, incorporated by reference in section 30253.

(c) The Department may withdraw, limit, or qualify its acceptance of any license specified in subsection (a) or (b) upon determining that such action is necessary to protect health or to minimize danger to life or property.

(d) Authorization granted pursuant to this section does not authorize a person to conduct activities in areas within this State that are under exclusive federal jurisdiction.

NOTE

Authority cited: Sections 114975, 115000, 115060 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985, 114990, 115060, 115065, 115090, 115093, 115105, 115110, 115120, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer of article 7 (section 30220) and new article 7 (section 30225) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Register 62, No. 21.

2. Amendment of subsection (a) filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

3. Amendment of subsection (a) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

4. New NOTE filed 8-22-84 (Register 84, No. 34).

5. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

6. New subsection (a)(6) and amendment of Note filed 10-23-91; operative 11-22-91 (Register 92, No. 5).

7. Amendment of section and Note filed 10-15-2001; operative 11-14-2001 (Register 2001, No. 42).

8. Amendment of subsection (a)(6) filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

10. Amendment of section heading, section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30226. Persons Generally Licensed by Other Agencies.

Note • History

(a) A person generally licensed by the United States Nuclear Regulatory Commission (NRC), or an Agreement State other than this State, is not subject to the registration requirements specified in section 30192.1(d)(1) if the device is used in areas subject to the Department's jurisdiction for a period less than 180 days in any calendar year.

(b) Authorization granted pursuant to this section shall not authorize a person to conduct activities in areas within this State that are under exclusive federal jurisdiction within this State.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115060, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

Article 8. License Fees

§30230. License Fees.

Note • History

(a) Except as provided in subsection (b), each applicant for a specific license pursuant to the provisions of this group shall include with the application a nonrefundable fee, which is equal to the annual fee as set forth in section 30231, and if the specific license is granted, the application fee shall constitute the annual fee for the first year of the license.

(b) Each applicant for a specific license for commercial distribution of sealed sources or devices containing sealed sources, who requests evaluation of the information submitted pursuant to section 30195(d)(1) and (d)(2), shall include with the application, a nonrefundable fee, which is equal to the annual fee, and a nonrefundable evaluation fee as set forth in section 30231. If the specific license is granted, the fee equal to the annual fee shall constitute the annual fee for the first year of the license.

(c) Each licensee shall pay an annual fee, as set forth in section 30231, on or before the anniversary of the effective date of the license.

(d) Each licensee, who applies for an amendment to a specific license that increases the maximum possession limits of the license shall include with the request submitted pursuant to section 30194.2, an additional fee for each such amendment, as set forth in section 30231(c).

(e) Each licensee authorized pursuant to section 30195(d) to commercially distribute sealed sources or devices containing sealed sources shall, in addition to the annual fee specified in section 30231(a), pay:

(1) The evaluation fees specified in section 30231(f)(1) through (3), specific to the type of evaluation, when a request for evaluation is submitted to the Department; and

(2) The annual fee specified in section 30231(f)(4).

(f) Each person authorized to conduct activities within the state pursuant to section 30225(a) shall pay a fee as specified in section 30231(e).

NOTE

Authority cited: Sections 100275, 115000, 115060 and 115065, Health and Safety Code. Reference: Sections 114965, 114970, 114980 and 115165, Health and Safety Code.

HISTORY

1. Amendment filed 8-1-62; effective thirtieth day thereafter (Register 62, No. 16).

2. Renumbering from article 9 to article 8, filed 11-29-65 (Register 65, No. 23).

3. New NOTE filed 8-22-84 (Register 84, No. 34).

4. New subsection (d) and amendment of Note filed 10-23-91; operative 11-22-91 (Register 92, No. 5).

5. Amendment of section and NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30231. Fee Schedule.

Note • History

(a) The annual fee shall be calculated in accordance with the following formula and shall not exceed $25,000.00 for any one license:

Annual fee (rounded to the nearest dollar) = A + (A x B x C)

Where:

A = [Sum of the license fee specified in subsection (b)(1), the fee for unsealed sources specified in subsection (b)(2) and the fee for sealed sources specified in subsection (b)(3)]

B = [Number of authorized use locations minus one as specified in subsection (b)(4)]

C = [0.2 as specified in subsection (b)(4)].

(b) The annual fee for each specific license shall consist of the following components:

(1) A fee of $1,112.00 for each license;

(2) A fee for the unsealed sources authorized to be possessed at any one time by the license provided such unsealed sources have a combined total strength of over 10 millicuries (mCi), as follows:

Over 10 mCi, but not over 100 mCi $636.00

Over 100 mCi, but not over 500 mCi $1,271.00

Over 500 mCi, but not over 1 curie (Ci) $2,543.00

Over 1 Ci, but not over 10 Ci $3,814.00

Over 10 Ci, but not over 100 Ci $5,085.00

Over 100 Ci $6,375.00;

(3) A fee for the sealed sources authorized to be possessed at any one time by the license provided such sealed sources have a combined total strength of over 100 mCi, as follows:

Over 100 mCi, but not over 1 Ci $636.00

Over 1 Ci, but not over 5 Ci $1,271.00

Over 5 Ci, but not over 10 Ci $2,543.00

Over 10 Ci, but not over 100 Ci $3,814.00

Over 100 Ci, but not over 1,000 Ci $5,085.00

Over 1,000 Ci $6,357.00; and

(4) A fee for each location of use greater than one, authorized in a specific license pursuant to section 30194.1, which is determined by multiplying the number of authorized use locations minus one by the sum of the values of subsections (b)(1) through (3) and by 0.2.

(c) The amount of additional fee required pursuant section 30230(d), except as limited by this section, shall be the difference between the current annual fee and the total annual fees required for the new limits requested.

(d) Any licensee who fails to pay the annual fee by the anniversary of the effective date of the license shall immediately cease use of all sources of radiation by placing the sources in storage until such time as the annual fee and a late fee of 25 percent of the annual fee has been paid.

(e) The fee for persons authorized to operate under section 30225(a) shall be equal to the annual fee as specified in subsection (a) for the combined total strength of radioactive material that will be possessed while in this state. The fees shall be effective for the period in which reciprocity is granted under section 30225.

(f) The fees required by subsections (b) and (e) of section 30230 shall be as follows:

(1) $4,270.00 for evaluation of each device and sealed source;

(2) $3,270.00 for evaluation of each device only;

(3) $1,000.00 for evaluation of each sealed source only; and

(4) $400.00, annually, for each registry certificate maintained by the Department indicating that the sealed source or device is commercially manufactured and/or distributed and includes evaluations of modifications of the source or device identified on the certificate.

(g) Fees required by this section shall be nonrefundable.

NOTE

Authority cited: Sections 100275, 115000, 115060 and 115065, Health and Safety Code. Reference: Sections 114965, 114970, 114980 and 115165, Health and Safety Code.

HISTORY

1. Amendment filed 8-1-62; effective thirtieth day thereafter (Register 62, No. 16).

2. Amendment filed 7-2-82; effective thirtieth day thereafter (Register 82, No. 27).

3. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

4. Amendment filed 7-7-86 as an emergency; effective upon filing (Register 86, No. 28). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-4-86.

5. Certificate of Compliance transmitted to OAL 10-9-86 and filed 11-7-86 (Register 86, No. 45).

6. Amendment filed 3-6-89 as an emergency; operative 3-6-89 (Register 89, No. 10). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 7-5-89.

7. Certificate of Compliance transmitted to OAL 6-12-89 and filed 6-28-89 (Register 89, No. 26).

8. New subsection (e) and amendment of Note filed 10-23-91; operative 11-22-91 (Register 92, No. 5).

9. Amendment of subsections (a)-(c) and (e) and Note filed 3-1-94 as an emergency; operative 3-1-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 6-28-94 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 3-1-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

11. Repealer and new section and amendment of NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30232. Fee Limitations. [Repealed]

Note • History

NOTE

Authority cited: Sections 208, 25811 and 25816, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25816, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 7-2-82; effective thirtieth day thereafter (Register 82, No. 27).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

3. Amendment filed 7-7-86 as an emergency; effective upon filing (Register 86, No. 28). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-4-86.

4. Certificate of Compliance transmitted to OAL 10-9-86 and filed 11-7-86 (Register 86, No. 45).

5. Amendment filed 3-6-89 as an emergency; operative 3-6-89 (Register 89, No. 10). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 7-5-89.

6. Certificate of Compliance transmitted to OAL 6-12-89 and filed 6-28-89 (Register 89, No. 26).

7. Amendment of subsections (a), (c)-(f) and Note filed 3-1-94 as an emergency; operative 3-1-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 6-28-94 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 3-1-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

9. Repealer filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

Article 9. Schedules

§30235. Schedule A. Exempt Quantities.

Note • History

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and 115235, Health and Safety Code.

HISTORY

1. New Schedule A filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30). For history of former section, see Register 62, No. 16.

2. Amendment filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

3. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

4. Amendment of Note filed 7-28-2006; operative 8-27-2006 (Register 2006, No. 30).

§30236. Schedule B, Table I, In Vitro Clinical Tests. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25855, 25875 and 25876, Health and Safety Code.

HISTORY

1. New Schedule B filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For history of former Schedule B, see Registers 72, No. 42, and 67, No. 46.

2. Repealer filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30237. Schedule C.

Note • History

Column I Column II

Gas Liquid and solid

concentration concentration

Element (atomic number) Isotope (mCi/ml1) (mCi/ml2)

Antimony (51) Sb122 3 x 10-4

Sb124 2 x 10-4

Sb125 1 x 10-3

Argon (18) Ar37 1 x 10-3

Ar41 4 x 10-7

Arsenic (33) As73 5 x 10-3

As74 5 x 10-4

As76 2 x 10-4

As77 8 x 10-4

Barium (56) Ba131 2 x 10-3

Ba140 3 x 10-4

Beryllium (4) Be7 2 x 10-2

Bismuth (83) Bi206 4 x 10-4

Bromine (35) Br42 4 x 10-7 3 x 10-2

Cadmium (48) Cd109 2 x 10-2

Cd115m 3 x 10-4

Cd113 3 x 10-4

Calcium (20) Ca45 9 x 10-3

Ca47 5 x 10-4

Carbon (6) C14 1 x 10-6 8 x 10-3

Cerium (58) Ce141 9 x 10-4

Ce143 4 x 10-4

Ce144 1 x 10-4

Cesium (55) Cs131 2 x 10-2

Cs134m 6 x 10-2

Cs134 9 x 10-3

Chlorine (17) Cl36 9 x 10-7 4 x 10-3

Chromium (24) Cr51 2 x 10-2

Cobalt (27) Co57 5 x 10-3

Co58 1 x 10-3

Co60 5 x 10-4

Copper (29) Cu64 3 x 10-3

Dysprosium (66) Dy165 4 x 10-3

Dy166 4 x 10-4

Erbium (68) Er169 9 x 10-4

Er171 1 x 10-3

Europium (63) Eu162 6 x 10-4

(T/2=9.2 Hrs.)

Eu158 2 x 10-3

Fluorine (9) F18 2 x 10-6 8 x 10-3

Gadolinium (64) Gd153 2 x 10-3

Gd159 8 x 10-4

Gallium (31) Ga72 4 x 10-4

Germanium (32) Ge71 2 x 10-2

Gold (79) Au196 2 x 10-2

Au198 5 x 10-4

Au199 2 x 10-2

Hafnium (72) Hf181 7 x 10-4

Hydrogen (1) H3 5 x 10-6 3 x 10-2

Indium (49) In113m 1 x 10-2

In114m 2 x 10-4

Iodine (53) I126 3 x 10-9 2 x 10-5

I131 3 x 10-9 2 x 10-3

I132 8 x 10-8 6 x 10-4

I133 1 x 10-8 7 x 10-3

I134 2 x 10-7 1 x 10-3

Iridium (77) Ir190 2 x 10-3

Ir192 4 x 10-4

Ir194 3 x 10-4

Iron (26) Fe53 8 x 10-2

Fe59 6 x 10-4

Krypton (36) Kr86m 1 x 10-6

Kr88 3 x 10-6

Lanthanum (57) La140 2 x 10-4

Lead (82) Pb203 4 x 10-3

Lutetium (71) Lu177 1 x 10-3

Manganese (25) Mn52 3 x 10-4

Mn54 1 x 10-3

Mn56 1 x 10-3

Mercury (80) Hg197m 2 x 10-3

Hg197 3 x 10-3

Hg203 2 x 10-4

Molybdenum (42) Mo99 2 x 10-3

Neodymium (60) Nd147 6 x 10-4

Nd149 3 x 10-3

Nickel (28) Ni66 1 x 10-3

Niobium (columbium)(41) Nb95 1 x 10-3

Nb97 9 x 10-3

Osmium (76) Os185 7 x 10-4

Os191m 3 x 10-2

Os191 2 x 10-3

Os193 6 x 10-4

Palladium (46) Pd103 3 x 10-3

Pd109 9 x 10-4

Phosphorus (15) P32 2 x 10-4

Platinum (78) Pt191 1 x 10-3

Pt193m 1 x 10-2

Pt197m 1 x 10-2

Pt197 1 x 10-3

Polonium (84) Po210 7 x 10-4

Potassium (19) K42 3 x 10-3

Praseodymium (59) Pr142 3 x 10-4

Pr143 5 x 10-4

Promethium (61) Pm147 2 x 10-3

Pm149 4 x 10-4

Radium (88) Ra223 1 x 10-7

Radon (86) Rn230 1 x 10-7

Rn222 1 x 10-8

Rhenium (75) Re183 6 x 10-3

Re185 9 x 10-4

Re188 6 x 10-4

Rhodium (45) Rh103m 1 x 10-1

Rh105 1 x 10-3

Rubidium (37) Rb85 7 x 10-4

Ruthenium (44) Ru97 4 x 10-3

Ru103 8 x 10-4

Ru105 1 x 10-3

Ru106 1 x 10-4

Samarium (62) Sm133 8 x 10-4

Scandium (21) Sc45 4 x 10-4

Sc47 9 x 10-4

Sc48 3 x 10-4

Selenium (34) Se73 3 x 10-2

Silicon (14) Si31 9 x 10-2

Silver (47) Ag105 1 x 10-3

Ag110m 3 x 10-4

Ag111 4 x 10-4

Sodium (11) Na24 2 x 10-3

Strontium (38) Sr85 1 x 10-3

Sr89 1 x 10-4

Sr91 7 x 10-4

Sr92 7 x 10-4

Sulfur (16) S35 9 x 10-8 6 x 10-8

Tantalum (73) Ta182 4 x 10-4

Technetium (43) Tc99m 1 x 10-1

Tc98 1 x 10-3

Tellurium (52) Te125m 2 x 10-3

Te127m 6 x 10-4

Te127 3 x 10-3

Te129m 3 x 10-4

Te131m 6 x 10-4

Te132 3 x 10-4

Terbium (65) Tb169 4 x 10-4

Thallium (81) Tl200 4 x 10-3

Tl201 5 x 10-2

Tl202 1 x 10-3

Tl204 1 x 10-3

Thulium (69) Tm170 5 x 10-4

Tm171 5 x 10-3

Tin (50) Sn113 9 x 10-4

Sn123 2 x 10-4

Tungsten (wolfram)(74) W181 4 x 10-3

W187 7 x 10-4

Vanadium (23) V48 3 x 10-4

Xenon (54) Xe131m 4 x 10-6

Xe133 3 x 10-6

Xe135 1 x 10-6

Ytterbium (70) Yb173 1 x 10-3

Yttrium (39) Y90 2 x 10-4

Y91m 3 x 10-3

Y91 3 x 10-4

Y92 6 x 10-4

Y93 3 x 10-4

Zinc (30) Zn65 1 x 10-3

Zn69m 7 x 10-4

Zn69 2 x 10-2

Zirconium (40) Zr95 6 x 10-4

Zr97 2 x 10-4

Beta and/or gamma emitting

radioactive material not

listed above with half-life

less than 3 years 1 x 10-10 1 x 10-6

Note: 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule C, the activity stated is that of the parent isotope and takes into account the daughters.

Note: 2: Where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule C for the specific isotope when not in combination. The sum of such ratios may not exceed “1” (i.e. unity).

Example:

1 Values are given only for those materials normally used as gases.

2 mCi/gm for solids.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and 115235, Health and Safety Code.

HISTORY

1. Amendment filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

2. Change without regulatory effect amending Arsenic and Beryllium and adoption of NOTE filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

3. Amendment of listings for argon and platinum and amendment of footnote 2 and Note filed 7-28-2006; operative 8-27-2006 (Register 2006, No. 30).

Group 3. Standards for Protection Against Radiation

Article 1. General

§30250. Authority. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of Article 1 and new Article 1 (30250 through 30255) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former Article 1, see Register 62, No. 1.

2. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30251. Purpose. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30252. Scope and Purpose.

Note • History

(a) Group 3 regulations apply to all persons who possess sources of radiation, except as exempt from the licensing and registration requirements or otherwise specifically exempted by the provisions of Group 1 and Group 2 of this subchapter.

(b) The limits in Group 3 do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Repealer and new subsection (b) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 87, No. 28.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

3. Editorial correction deleting History 1 and amending and redesignating History 2 (Register 94, No. 28).

§30253. Standards for Protection Against Radiation.

Note • History

(a) The regulations governing standards for protection against radiation in title 10, Code of Federal Regulations, part 20, (10 CFR 20) sections 20.1001 through 20.2402 and Appendices A through G, (January 1, 2008) are hereby incorporated by reference with the following exceptions:

(1) Title 10, Code of Federal Regulations, sections 20.1001, 20.1002, 20.1006, 20.1007, 20.1008, 20.1009, 20.1401, 20.1402, 20.1403, 20.1404, 20.1405, 20.1406, 20.1905(g), 20.2106(d), 20.2203(c), 20.2206, 20.2302, 20.2401, and 20.2402, and Appendix D are not incorporated by reference.

(2) Any references to the United States Nuclear Regulatory Commission (NRC) or any component thereof shall be deemed to be a reference to the California Department of Public Health.

(3) The definition of the term “Byproduct material” in 10 CFR 20, section 20.1003 is replaced by the definition of the term “radioactive material” as defined in section 30100 of this regulation.

(4) The definition of the term “License” in 10 CFR 20, section 20.1003 is replaced by the definition of the term “License” as defined in section 30100 of this regulation.

(5) The definition of the term “Licensed material” in 10 CFR 20, section 20.1003 is modified to mean any radioactive material (including source material, special nuclear material, or byproduct material) received, possessed, used, transferred or disposed of under a general or specific license issued by the NRC, or by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control Program Directors, Inc. With respect to dose limits and reporting requirements, the term “Licensed material” is to be construed broadly in context to include any source of ionizing radiation subject to the requirements of this regulation.

(6) The definition of the term “Licensee” as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term “User” as set forth in section 30100 of this regulation.

(7) The definition of the term “Person” as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term “Person” as set forth in section 114985(c) of the Health and Safety Code.

(8) The definition of the term “Radiation (ionizing radiation)” as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term “Ionizing radiation” as set forth in section 114985(b) of the Health and Safety Code.

(9) The definition of the term “Special nuclear materials” as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term “Special nuclear material” as set forth in section 114985(f) of the Health and Safety Code.

(10) Reports of transactions and inventories required in 10 CFR 20, section 20.2207 shall be submitted to the National Source Tracking System maintained by NRC as specified in section 20.2207. Methods of reporting specified in section 20.2207(f) are identified on NRC's form, referenced in section 20.2207(f)(4).

(b) The terms defined in 10 CFR 20, section 20.1003, as incorporated by reference, shall apply to this regulation, except that:

(1) The term “Act” as defined in 10 CFR 20, section 20.1003 is limited to the textual material incorporated by reference in subsection (a) above. The meaning of the term “Act” elsewhere in this regulation, is as defined in section 30100 of this regulation.

(2) The term “Department” as defined in 10 CFR 20, section 20.1003 is limited to the provisions incorporated by reference in subsection (a). The meaning of the term “Department” elsewhere in this regulation, is as defined in section 30100 of this regulation.

NOTE

Authority cited: Sections 114975, 115000, 131051, 131052, 131055 and 131200, Health and Safety Code. Reference: Sections 114960, 114965, 114970, 114985, 114990, 115060, 115105, 115110, 115120, 115165, 115230 and 115235, Health and Safety Code.

HISTORY

1. Repealer and new section filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 86, No. 28.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

3. Editorial correction deleting History 1 and amending and redesignating History 3 (Register 94, No. 28).

4. Editorial correction of section heading (Register 99, No. 8).

5. Amendment of section and Note filed 10-15-2001; operative 11-14-2001 (Register 2001, No. 42).

6. Change without regulatory effect amending subsection (a)(1) and repealing subsections (a)(10)-(12) filed 8-8-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 32).

7. Amendment filed 7-20-2006; operative 8-19-2006 (Register 2006, No. 29).

8. Amendment of subsections (a)-(a)(3) and (a)(5), new subsection (a)(10), amendment of subsections (b)(1)-(2) and amendment of Note filed 11-9-2010; operative 12-9-2010 (Register 2010, No. 46).

Article 2. Notices, Instructions, and Reports to Workers; Inspections and Investigations

§30254. Inspection.

Note • History

(a) Each user shall afford to the Department or other official agency specifically designated by the Department, at all reasonable times, opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to these regulations.

(b) During an inspection, inspectors may consult privately with workers as specified below. The user may accompany inspectors during other phases of an inspection.

(1) Inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of Department regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.

(2) During the course of an inspection any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which he has reason to believe may have contributed to or caused any violation of the Radiation Control Law, these regulations, or license condition, or any unnecessary exposure of an individual to radiation from licensed radioactive material or a registered radiation machine under the user's control. Any such notice in writing shall comply with the requirements of subsection (h) hereof.

(3) The provision of paragraph (b)(2) of this section shall not be interpreted as authorization to disregard instructions pursuant to Section 30255(b)(1).

(c) If, at the time of inspection, an individual has been authorized by the workers to represent them during inspections, the user shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.

(d) Each worker's representative shall be routinely engaged in work under control of the user and shall have received instructions as specified in Section 30280(b)(1).

(e) Different representatives of users and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.

(f) With the approval of the user and the workers' representative, an individual who is not routinely engaged in work under control of the user, for example, a consultant to the user or to the workers' representative, shall be afforded the opportunity to accompany inspectors during the inspection of physical working conditions.

(g) Notwithstanding the other provisions of this section, inspectors are authorized to refuse to permit accompaniment by an individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the user to enter that area.

(h) Any worker or representative of workers who believes that a violation of the Radiation Control Law, these regulations or license conditions exists, or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Department or other official agency specifically designated by the Department. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the user by the Department no later than at the time of inspection except that, upon the request of the worker giving such notice, his name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Department except for good cause shown.

(i) If, upon receipt of such notice, the Chief, Radiologic Health Branch, of the Department, determines that the complaint meets the requirements set forth in subsection (h) hereof, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, he shall cause an inspection to be made as soon as practicable, to determine if such alleged violation exists or has occurred. Inspections pursuant to this section need not be limited to matters referred to in the complaint.

(j) No user shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of himself or others of any option afforded by this section.

(k) If the Chief, Radiologic Health Branch, of the Department, determines with respect to a complaint under subsection (h) hereof that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the complainant shall be notified in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position to the Director of the Department, who will provide the user with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The user may submit an opposing written statement of position with the Director of the Department who will provide the complainant with a copy of such statement by certified mail. Upon the request of the complainant, the Director of the Department, or his designee, may hold an informal conference in which the complainant and the user may orally present their views. An informal conference may also be held at the request of the user, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written or oral views presented, the Director of the Department shall affirm, modify, or reverse the determination of the Chief, Radiologic Health Branch, of the Department, and furnish the complainant and the user a written notification of his decision and the reason therefor.

(l) If the Department determines that an inspection is not warranted because the requirements of subsection (h) hereof have not been met, it shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of subsection (h) hereof.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Repealer and new section filed 8-19-75 as an emergency; effective upon filing (Register 75, No. 34). Approved by CAL/OSHA Standards Board 12-16-75.

2. Certificate of Compliance filed 11-28-75 (Register 75, No. 48).

3. Amendment of subsections (b)(3) and (d) filed 8-23-76; effective thirtieth day thereafter (Register 76, No. 35).

4. Amendment of subsections (h), (i) and (k) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

5. New article 2 heading and amendment of subsection (b)(3) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30255. Notices, Instructions, and Reports to Personnel.

Note • History

(a) This section establishes requirements for notices, instructions, and reports by users to individuals engaged in work under a license or registration and options available to such individuals in connection with Department inspections of licensees or registrants to ascertain compliance with the provisions of the Radiation Control Law and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The requirements in this section apply to all persons who receive, possess, use, own or transfer material licensed by or registered with the Department.

(b) Each user shall:

(1) Inform all individuals working in or frequenting any portion of a controlled area of the storage, transfer, or use of radioactive materials or of radiation in such portions of the controlled area; instruct such individuals in the health protection problems associated with exposure to such radioactive materials or radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; instruct such individuals in, and instruct them to observe, to the extent within their control, the applicable provisions of Department regulations and license conditions for the protection of personnel from exposures to radiation or radioactive materials occurring in such areas; instruct such individuals of their responsibility to report promptly to the licensee or registrant any condition which may lead to or cause a violation of department regulations or license conditions or unnecessary exposure to radiation or radioactive material, and of the inspection provisions of Section 30254; instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive materials; and advise such individuals as to the radiation exposure reports which they may request pursuant to this section. The extent of these instructions shall be commensurate with potential radiological health protection problems in the controlled area.

(2) Conspicuously post a current copy of this regulation, a copy of applicable licenses for radioactive material, and a copy of operating and emergency procedures applicable to work with sources of radiation. If posting of documents specified in this paragraph is not practicable the user may post a notice which describes the document and states where it may be examined.

(3) Conspicuously post a current copy of Department Form RH-2364 (Notice to Employees) in a sufficient number of places to permit individuals working in or frequenting any portion of a controlled area to observe a copy on the way to or from such area.

(4) Conspicuously post any notice of violation involving radiological working conditions or any order issued pursuant to the Radiation Control Law and any required response from the user. Department documents posted pursuant to this paragraph shall be posted within two working days after receipt of the documents from the Department; the user's response, if any, shall be posted within two working days after dispatch by the user. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(5) Assure that documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(6) Provide reports to any individual of their radiation exposure data and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of that individual as specified in this section. The information reported shall include data and results obtained pursuant to Department regulations, orders, or license conditions, as shown in records maintained by the user pursuant to Department regulations. Each notification and report shall: be in writing; include appropriate identifying data such as the name of the user, the name of the individual, the individual's Social Security number; include the individual's exposure information; and contain the following statement:

“This report is furnished to you under the provisions of the California State Department of Public Health Regulations: Standards for Protection Against Radiation. You should preserve this report for future reference.”

These reports shall be provided as follows:

(A) Each user shall advise each worker annually of the worker's dose as shown in records maintained by the user pursuant to title 10, Code of Federal Regulations, part 20, (10 CFR 20), section 20.2106 as incorporated by reference in section 30253. The user shall provide an annual report to each monitored individual pursuant to section 20.1502, incorporated by reference in section 30253, of the dose received in that monitoring year if:

1. The individual's occupational dose exceeds 100 mrem total effective dose equivalent or 100 mrem to any individual organ or tissue; or

2. The individual requests his or her annual dose report.

(B) At the request of a worker formerly engaged in work controlled by the user, the user shall furnish to the worker a report of the worker's exposure to radiation or radioactive material as shown in records maintained by the user pursuant to 10 CFR 20, section 20.2106 that has been incorporated by reference in section 30253, for each year the worker was required to be monitored pursuant to section 20.1502 and for each year the worker was required to be monitored under the monitoring requirements in effect prior to March 3, 1994. Such report shall be furnished within 30 days from the time the request is made, or within 30 days after the exposure of the individual has been determined by the user, whichever is later. This report shall cover the period of time that the worker's activities involved exposure to radiation from radioactive material licensed by, or radiation machines registered with, the Department and shall include the dates and locations of work under the license or registration in which the worker participated during this period.

(C) When a user is required pursuant to 10 CFR 20, sections 20.2202, 20.2203, or 20.2204, as incorporated by reference in section 30253, to report to the Department any exposure of an individual to radiation or radioactive material, the user shall also provide the individual a report on his exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Department.

(D) At the request of a worker who is terminating employment with the user that involved exposure to radiation or radioactive materials, during the current calendar quarter or the current year, each user shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the user during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

NOTE

Authority cited: Sections 114975, 115000, 131051, 131052, 131055 and 131200, Health and Safety Code. Reference: Sections 114940, 114965, 115000, 115060, 115110, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former section 30280 to section 30255 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

3. Amendment of subsections (a)(6)-(a)(6)(D) and amendment of Note filed 11-9-2010; operative 12-9-2010 (Register 2010, No. 46).

§30256. Vacating Installations: Records and Notice.

Note • History

(a) Each person granted a specific license pursuant to Group 2 of this Subchapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use by the Department. Before licensed activities are transferred or assigned in accordance with 30194(c), licensees shall transfer all records described in this section to the new licensee. In this case, the new licensee shall be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. The records shall include the following information important to decommissioning:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records shall include but not be limited to a description of any instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas, as for example, possible seepage into porous materials such as concrete. These records shall include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modification drawings of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or any radioactive materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:

(A) All areas designated and formerly designated restricted areas as defined in Title 10, Code of Federal Regulations, Section 20.1003 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253;

(B) All areas outside restricted areas that require documentation under (a)(1);

(C) All areas outside of restricted areas where current and previous wastes have been buried as documented under Title 10, Code of Federal Regulations, Section 20.2108 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253; and

(D) All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under Title 10, Code of Federal Regulations, Section 20.2002 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used pursuant to Section 30195.1.

(b) Each person granted a specific license pursuant to Group 2 of this Subchapter shall, no less than 30 days before vacating any installation which may have been contaminated with radioactive material as a result of the licensee's activities, notify the department in writing of intent to vacate. This notice shall be submitted on form CDPH 5314 (06/09), entitled “Certificate of Disposition of Materials,” which is incorporated by reference herein, and shall address all requirements specified in subsection (c).

(c) If a licensee does not submit an application for license renewal under section 30194, the licensee shall on or before the expiration date specified in the license:

(1) Terminate use of radioactive material;

(2) Remove radioactive contamination to the extent practicable except for those procedures covered by Subsection (d) of this section;

(3) Dispose of radioactive material in accordance with applicable regulations;

(4) Submit a completed form CDPH 5314 (06/09), which certifies information concerning the disposition of materials; and

(5) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates that the premises are suitable for release for unrestricted use in some other manner. The licensee shall, as appropriate:

(A) Report levels of radiation in units of microrads per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces, and report levels of radioactivity, including alpha, in units of disintegrations per minute (or microcuries) per 100 square centimeters removable and fixed for surfaces, microcuries per milliliter for water, and picocuries per gram for solids such as soils or concrete; and

(B) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(d) In addition to the information required under Subsections (c)(4) and (5), the licensee shall submit a plan for completion of decommissioning if the procedures necessary to carry out decommissioning have not been previously approved by the Department and could increase potential health and safety impacts to workers or to the public such as in any of the following cases:

(1) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; or

(2) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; or

(3) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(4) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(e) Procedures with potential health and safety impacts shall not be carried out prior to approval of the decommissioning plan.

(f) The proposed decommissioning plan, if required by Subsection (d) of this section or by license condition, shall include:

(1) Description of planned decommissioning activities;

(2) Description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning;

(3) A description of the planned final radiation survey;

(4) The information required in (a) (3) and any other information required by (a) that is considered necessary to support the adequacy of the decommissioning plan for approval; and

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning.

(g) The proposed decommissioning plan will be approved by the Department if the Department determines that the decommissioning will be completed as soon as is reasonable and that the health and safety of workers and the public will be adequately protected.

(h) Upon approval of the decommissioning plan by the Department, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall again submit the information required in subsection (c)(5) and shall certify the disposition of accumulated wastes from decommissioning by completing form CDPH 5314 (06/09).

(i) If the information submitted under subsection (c)(5) or (h) does not adequately demonstrate that the premises are suitable for release for unrestricted use, the Department shall inform the licensee of the appropriate further actions required for termination of license.

(j) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of residual radioactive material present as contamination until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the Department notifies the licensee in writing that the license is terminated.

(k) Specific licenses shall be terminated by written notice to the licensee when the Department determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release for unrestricted use; or other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release for unrestricted use.

NOTE

Authority cited: Sections 114975, 115000, 131051, 131052, 131055 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering of former section 30298 to section 30256 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

3. Amendment of section heading and section filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-16-95 order, including amendment of subsections (a), (c)(4) and (f)(3), new (f)(4) and subsection renumbering, and amendment of subsection (h) and Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

5. Amendment of subsection (a) filed 9-9-97; operative 10-9-97 (Register 97, No. 37).

6. Amendment of subsections (b), (c)(4) and (h) and amendment of Note filed 11-9-2010; operative 12-9-2010 (Register 2010, No. 46).

§30257. Bankruptcy Notification.

Note • History

(a) Each general licensee required to register pursuant to sections 30192.1(d)(1) or 30192.6(b)(1), and each specific licensee, shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against:

(1) The licensee;

(2) An entity (as that term is defined in 11 U.S.C. 101 (14)) controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate (as that term is defined in 11 U.S.C. 101 (2)) of the licensee.

(b) The notification to the Department shall indicate:

(1) The bankruptcy court in which the petition for bankruptcy was filed; and

(2) The date of the filing of the petition.

NOTE

Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115175, 115205, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. Renumbering of former section 30299 to section 30257 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).

§30258. General Definitions. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of article 2 and new article 2 (section 30258) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former article 2, see Register 62, No. 1.

2. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

3. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

4. Editorial correction deleting article heading (Register 94, No. 15).

Article 3. Surveys and Tests

§30265. Occupational Dose Limits. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of article 3 and new article 3 (sections 30265 and 30266) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history of article 3, see Register 62, No. 1.

2. Repealer of subsection (c) filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

3. Amendment of article heading and repealer of section filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30265.1. Determination of Prior Dose. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of subsection (b) (Register 87, No. 6).

3. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30266. Exposure of Individuals to Concentrations of Radioactive Material in Controlled Areas. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health ad Safety Code.

HISTORY

1. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 8).

2. Change without regulatory effect of NOTE (Register 88, No. 6).

3. Repealer and amendment of Note filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30268. Permissible Levels of Radiation in Uncontrolled Areas. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Change without regulatory effect adding Note (Register 87, No. 11).

2. Change without regulatory effect of subsection (a) (Register 88, No. 6).

3. Editorial correction of printing error restoring inadvertantly deleted History 2 (Register 92, No. 34).

4. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30269. Concentrations in Effluents to Uncontrolled Areas. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Change without regulatory effect adding Note (Register 87, No. 11).

2. Change without regulatory effect of subsection (a) (Register 88, No. 6).

3. Editorial correction of printing error restoring inadvertently deleted section (Register 92, No. 34).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30275. Surveys and Tests.

Note • History

(a) Each user shall make or cause to be made such surveys as are necessary for compliance with all provisions of this regulation.

(b) Upon instruction from the Department or other official agency specifically designated by the Department, each user shall perform or cause to have performed, and shall permit the Department or said agency to perform, such reasonable tests as the Department or said agency deems necessary for the protection of life, health, or property, including, but not limited to, tests of:

(1) Sources of radiation.

(2) Facilities wherein sources of radiation are used or stored.

(3) Radiation detection and monitoring instruments.

(4) Other equipment and devices used in connection with utilization or storage of sources of radiation.

(c) Each sealed source other than sources listed below, shall be tested for contamination prior to initial use and for leakage at least every six months:

(1) Hydrogen-3 or krypton-85 sources.

(2) Sealed sources containing licensed radioactive material in gaseous form.

(3) Source material.

(4) Sources containing radioactive material with a half life of 30 days or less.

(5) Sources of beta- and/or gamma-emitting radioactive material with an activity of 100 microcuries or less.

(6) Sources of alpha and/or neutron-emitting radioactive material with an activity of 10 microcuries or less.

In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If there is reason to suspect that a source might have been damaged, it shall be tested for leakage before further use. Contamination and leak tests shall be capable of determining the presence of 0.005 microcuries of removable contamination. When any contamination or leak test reveals the presence of 0.005 microcuries or more of removable contamination the user shall immediately withdraw the source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with applicable provisions of Group 2 of this subchapter. Two copies of a report shall be filed, within 5 days of the test, with the Department or other official agency specifically designated by the Department, describing the source involved, the test results, and the corrective action taken.

(d) The test sample shall be taken from the surface of the source, or source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. Where sealed sources are permanently mounted in devices or equipment, alternate tests for contamination and leakage may be approved by the Department.

(e) Tests for contamination and leakage, decontamination, and repair of sealed sources shall be performed only by persons specifically authorized by the Department to do so in accordance with provisions of Group 2 of this subchapter.

(f) Records of leak tests shall be maintained as specified in United States, title 10, Code of Federal Regulations, part 20, subpart L as incorporated by reference in section 30253..

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of article 4 and new article 4 (sections 30275 through 30281) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former article 4, see Register 62, No. 1.

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

3. Amendment filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

4. Editorial correction of printing error restoring inadvertantly deleted article heading (Register 92, No. 34).

5. Repealer of article heading and amendment of subsection (f) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30276. Personnel Monitoring. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Change without regulatory effect adding NOTE (Register 87, No. 11).

2. Amendment of subsection (a), new subsection (b) and subsection renumbering filed 10-10-91; operative 11-9-91 (Register 91, No. 52).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30277. Bio-Assays and Medical Review. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate Compliance filed 12-28-73 (Register 73, No. 52).

3. Change without regulatory effect adding NOTE (Register 87, No. 11).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30278. Caution Signs and Labels. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

2. Change without regulatory effect adding NOTE (Register 87, No. 10).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30278.1. Removal of Caution Labels from Empty Containers.

Note • History

Each user shall, prior to disposal of an empty uncontaminated container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 20. 203 (f)(4) (43 FR 22171).

HISTORY

1. New section filed 3-6-87; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 87, No. 10).

§30279. Special Requirements for High Radiation Areas and Radiation Machines Capable of Producing High Radiation Areas. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30279.1. Additional Special Requirements for Very High Radiation Areas. [Repealed]

Note • History

NOTE

(1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of NOTE (Register 88, No. 6).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30280. Notices, Instructions, and Reports to Personnel. [Renumbered]

Note • History

NOTE

Authority cited: Section 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25826, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 8-19-75 as an emergency; effective upon filing (Register 75, No. 34). Approved by CAL/OSHA Standards Board 12-16-75.

2. Certificate of Compliance filed 11-28-75 (Register 75, No. 48).

3. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

4. Change without regulatory effect of subsections (b)(4) and (b)(6)(B) (Register 88, No. 6).

5. Renumbering of former section 30280 to new section 30255 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30281. Storage and Control of Radioactive Material. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendments filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30282. Procedures for Opening Packages. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 6-19-73; effective thirtieth day thereafter (Register 73, No. 25).

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30285. General Requirement. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25812 and 25815, Health and Safety Code.

HISTORY

1. Repealer of article 5 and new article 5 (sections 30285, 30287, 30288) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former article 5, see Register 62, No. 1.

2. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

3. Repealer of article heading and section f iled 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30287. Disposal by Release into Sanitary Sewerage Systems. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Change without regulatory effect adding NOTE (Register 87, No. 11).

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30288. Disposal by Burial in Soil. [Repealed]

History

HISTORY

1. Repealer filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

§30289. Treatment or Disposal by Incineration. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

Article 3.1. Records and Notification

§30293. Records.

Note • History

(a) Each user shall keep records showing the receipt, transfer, and disposal of each source of radiation which is subject to licensure or registration pursuant to groups 1.5 and 2 of this subchapter as follows:

(1) The user shall retain each record of receipt of a source of radiation as long as the source of radiation is possessed and for three years following transfer or disposal of the source of radiation.

(2) The user who transferred the source of radiation shall retain each record of transfer for three years after each transfer unless a specific requirement in another part of the regulations in this subchapter dictates otherwise.

(3) The user who disposed of the radioactive material shall retain each record of disposal of the radioactive material until the Department terminates each license that authorizes disposal of the radioactive material.

(b) The user shall retain each record that is required by the regulations in this subchapter or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record shall be retained until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(c) Records which shall be maintained pursuant to this subchapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(d) If there is a conflict between the Department's regulations in this subchapter, license condition, or other written Department approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this subchapter for such records shall apply unless the Department, pursuant to 30104, has granted a specific exemption from the record retention requirements specified in the regulations in this subchapter.

(e) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall, if requested by the Department, forward the following records to the Department:

(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and

(2) Records required by Title 10, Code of Federal Regulations section 20.2103(b)(4), incorporated by reference in section 30253.

(f) If licensed activities are transferred or assigned in accordance with section 30194(c), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and

(2) Records required by Title 10, Code of Federal Regulations, section 20.2103(b)(4), incorporated by reference in section 30243.

(g) Prior to license termination, each licensee shall, if requested by the Department, forward the records required by section 30256(a) to the Department.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.

HISTORY

1. New article 3.1 (sections 30293 and 30295) and section filed 9-9-97; operative 10-9-97 (Register 97, No. 37). For prior history, see Register 94, No. 28.

§30294. Reports of Theft or Loss of Sources of Radiation. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment of subsections (a) and (c) filed 6-19-73; effective thirtieth day thereafter (Register 73, No. 25).

2. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

3. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30295. Notification of Incidents.

Note • History

(a) Each user shall notify the Department as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits.

(b) Each user shall notify the Department within 24 hours after the discovery of any of the following events involving radiation or radioactive materials:

(1) An unplanned contamination event involving licensed radioactive material that:

(A) Requires access to the contaminated area by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

(B) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 for the material; and

(C) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(A) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

(B) The equipment is required to be available and operable when it is disabled or fails to function; and

(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(A) The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 for the material; and

(B) The damage affects the integrity of the licensed material or its container.

Each user shall make reports required by subsections (a) and (b) by telephone to the Department. To the extent that the information is available at the time of notification, the information provided in these reports shall include:

(1) The caller's name and call back telephone number;

(2) A description of the event, including date and time;

(3) The exact location of the event;

(4) The isotopes, quantities, and chemical and physical form of the licensed material involved; and

(5) Any personnel radiation exposure data available.

(d) Each user who makes a report required by this section shall submit a written follow-up report within 30 days of the initial report. These written reports shall be sent to the Department and include:

(1) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

(2) The exact location of the event;

(3) The isotopes, quantities, and chemical and physical form of the licensed material involved;

(4) Date and time of the event;

(5) Corrective actions taken or planned and the results of any evaluation or assessment; and

(6) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.

HISTORY

1. New section filed 9-9-97; operative 10-9-97 (Register 97, No. 37). For prior history, see Register 94, No. 28.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30297. Reports of Overexposures and Excessive Levels and Concentrations. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New subsections (c) and (d) filed 5-13-69; effective thirtieth day thereafter (Register 69, No. 20).

2. Amendment of subsections (a) and (b) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

3. Amendment of subsection (a) filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

4. Amendment of subsection (a) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

5. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30298. Vacating Installations. [Renumbered]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Change without regulatory effect adding NOTE (Register 87, No. 11).

2. Renumbering of former section 30298 to new section 30256 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30299. Bankruptcy Notification. [Renumbered]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 4-19-91; operative 5-19-91 (Register 91, No. 20).

2. Renumbering of former section 30299 to new section 30257 filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

Article 4. Special Requirements for the Use of X-Ray in the Healing Arts

§30305. General Provisions.

Note • History

(a)(1) This article pertains to use of X-rays in medicine, dentistry, osteopathy, chiropractic, podiatry, and veterinary medicine. The provisions of this article are in addition to, and not in substitution for, other applicable provisions of this regulation and of Group 1 of this subchapter.

(2) Any existing machine or installation need not be replaced or substantially modified to conform to the requirements of this regulation provided that the user demonstrates to the Department's satisfaction achievement of equivalent protection through other means.

(3) No person shall make, sell, lease, transfer, lend, or install X-ray or fluoroscopic equipment or the supplies used in connection with such equipment unless such supplies and equipment, when properly placed in operation or properly used, will meet the requirements of this regulation. This includes responsibility for the delivery of cones or collimators, filters, adequate timers and fluoroscopic shutters (where applicable).

(4) For X-ray equipment manufactured after July 31, 1974, the user shall provide sufficient maintenance to keep the equipment in compliance with all applicable radiation protection sections of the Code of Federal Regulations, Title 21, Chapter 1, Subchapter J, Part 1020, Sections 1020.30, 1020.31, and 1020.32.

(5) Each installation shall be provided with such primary barriers and/or secondary barriers as are necessary to ensure compliance with title 10, Code of Federal Regulations, part 20, (10 CFR 20) subparts C and D incorporated by reference in section 30253. Special requirements are contained in title 24, California Code of Regulations, Part 2, Chapter 31C, sections 3101C through 3104C.

(b) Use.

(1) The user shall assure that all X-ray equipment under his jurisdiction is operated only by persons adequately instructed in safe operating procedures and competent in safe use of the equipment.

(2) The user shall provide safety rules to each individual operating X-ray equipment under his control, including any restrictions of the operating technique required for the safe operation of the particular X-ray apparatus, and require that the operator demonstrate familiarity with these rules.

(3) No user shall operate or permit the operation of X-ray equipment unless the equipment and installation meet the applicable requirements of these regulations and are appropriate for the procedures to be performed.

(4) Deliberate exposure of an individual to the useful beam for training or demonstration purposes shall not be permitted unless there is also a medical or dental indication for the exposure and the exposure is prescribed by a physician or dentist.

(c) Areas or rooms that contain permanently installed X-ray machines as the only source of radiation shall be posted with a sign or signs

CAUTION

X-RAY

in lieu of other signs required by the United States, title 10, Code of Federal Regulations, part 20, section 20.1902 as incorporated by reference in section 30253.

(d) High radiation areas caused by radiographic and fluoroscopic machines used solely in the healing arts and which are in compliance with the access control and signal requirements of title 24, California Code of Regulations, Part 2, Chapter 31C, sections 3101C through 3104C shall be exempt from the access control and signal requirements of 10 CFR 20, section 20.1601 as incorporated by reference in section 30253.

NOTE

Authority cited: Sections 100275, 114975, 115000, 131051, 131052, 131055 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000 and 115060, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

5. New subsection (a)(5) and repealer of subsection (c) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

6. Amendment of article heading and new subsections (c) and (d) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

8. Change without regulatory effect amending subsections (a)(5) and (d) and amending Note filed 11-12-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 46).

§30306. Definitions.

Note • History

(a) “Automatic exposure control” means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation.

(b) “Cineradiography” means the making of a motion picture record of the successive images appearing on a fluorescent screen.

(c) “Contact therapy” means irradiation of accessible lesions usually employing a very short source-skin distance and potentials of 40-50 KV.

(d) “Dead-man switch” means a switch so constructed that a circuit-closing contact can only be maintained by continuous pressure by the operator.

(e) “Diagnostic-type tube housing” means an X-ray tube housing so constructed that the leakage radiation measured at a distance of 1 meter from the source cannot exceed 100 milliroentgens in 1 hour when the tube is operated at its maximum continuous rate of current for the maximum rated tube potential.

(f) “Filter” means material placed in the useful beam to absorb preferentially the less penetrating radiations.

(g) “Interlock” means a device for precluding access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.

(h) “Leakage radiation” means all radiation coming from within the tube housing except the useful beam.

(i) “Protective barrier” means a barrier of attenuating materials used to reduce radiation exposure.

(j) “Primary protective barrier” means a barrier sufficient to attenuate the useful beam to the required degree.

(k) “Scattered radiation” means radiation that, during passage through matter, has been deviated in direction.

(l) “Secondary protective barrier” means a barrier sufficient to attenuate stray radiation to the required degree.

(m) “Shutter” means a device, generally of lead, fixed to an X-ray tube housing to intercept the useful beam.

(n) “Stray radiation” means radiation not serving any useful purpose. It includes leakage and scattered radiation.

(o) “Therapeutic-type tube housing” means,

(1) For X-ray therapy equipment not capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed 1 roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential.

(2) For X-ray therapy equipment capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed either 1 roentgen in an hour or 0.1 percent of the useful beam dose rate at 1 meter from the source, whichever is greater, when the machine is operated at its maximum rated continuous current for the maximum rated accelerating potential.

(3) In either case, small areas of reduced protection are acceptable provided the average reading over any 100 square centimeters area at 1 meter distance from the source does not exceed the values given above.

(p) “Useful beam” means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the tube housing. (T17-30306-T24).

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment of subsection (e) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30307. Fluoroscopic Installations

Note • History

(a) Equipment.

(1) The tube housing shall be of diagnostic type.

(2) The target-to-panel or target-to-table top distance should not be less than 18 inches and shall not be less than 12 inches.

(3) The total filtration permanently in the useful beam shall not be less than 2.5 millimeters aluminum equivalent. This requirement may be assumed to have been met if the half-value layer is not less than 2.5 millimeters aluminum at normal operating voltages.

(4) The equipment shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier. This barrier is usually the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism.

(A) The lead equivalent of the barrier of conventional fluoroscopes shall be at least 1.5 millimeters for equipment capable of operating up to 100 kVp, at least 1.8 millimeters for equipment whose maximum operating potential is greater than 100 kVp and less than 125 kVp, and at least 2.0 millimeters for equipment whose maximum operating potential is 125 kVp or greater. Special attention must be paid to the shielding of image intensifiers so that neither the useful beam nor scattered radiation from the intensifier can produce a radiation hazard to the operator or personnel. With the fluorescent screen 14 inches (35 cm) from the panel or table top, the exposure rate 2 inches 5 cm) beyond the viewing surface of the screen shall not exceed 30 mR/hr for each R per minute at the table top with the screen in the useful beam without a patient and with the fluoroscope operating at the highest potential employed.

(B) Collimators shall be provided to restrict the size of the useful beam to less than the area of the barrier. For conventional fluoroscopes this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left at all edges of the fluorescent screen with the screen centered in the beam at a distance of 35 cm (14 inches) from the panel or table top.

For image intensified fluoroscopy, shutters shall be provided which can be adjusted to restrict the X-ray field to the visible portion of the image receptor during fluoroscopy. For systems employing rectangular X-ray fields and circular image receptors, this requirement is met if the collimated beam forms a square which circumscribes, and is tangent to, the circular margin of the image receptor.

(C) The tube mounting and the carrier shall be so linked together that the carrier always intercepts the entire useful beam. The X-ray exposure shall automatically terminate when the carrier is removed from the useful beam.

(D) Collimators and adjustable diaphragms or shutters to restrict the size of the useful beam shall provide the same degree of protection as is required of the tube housing.

(5) The exposure switch shall be of the dead-man type.

(6) Each fluoroscopic unit shall be equipped with a manual-reset cumulative timing device, activated by the exposure switch, which will either indicate elapsed exposure time by a signal audible to the fluorocopist or turn off the apparatus when the total exposure exceeds a predetermined limit not exceeding five minutes in one or a series of exposures.

(7) Useful beam exposure rate.

(A) All fluoroscopic equipment. For routine fluoroscopy, the exposure rate measured at the point where the center of the useful beam enters a typical patient shall be as low as is practicable and shall not exceed 5 roentgens per minute under the conditions specified herein. This limit shall not apply during magnification procedures or the recording of fluoroscopic images where higher exposure rates are required. Compliance with this paragraph shall be determined using the measuring specifications of Section 30307(a)(7)(D), plus the following procedures when the automatic exposure rate control is used:

1. The useful beam exposure rate shall be measured with a phantom equivalent to 9 inches of water or 7 7/8 inches of lucite, intercepting the entire useful beam.

2. If the X-ray source is below the table, the X-ray exposure rate shall be measured with the nearest part of the imaging assembly located at 14 inches above the table top.

3. The field size at the point of exposure rate measurement shall be at least 6 1/4 square inches in area in the plane perpendicular to the central ray.

(B) Fluoroscopic equipment manufactured after August 1, 1974, and equipped with automatic exposure rate controls. Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopicimages, or when an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(C) Fluoroscopic equipment manufactured after August 1, 1974, without automatic exposure rate controls. Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopic images, or when an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(D) Measuring useful beam exposure rate compliance.

1. If the X-ray tube is below the table, the exposure rate shall be measured 1 centimeter above the tabletop or cradle.

2. If the X-ray tube is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

3. In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly.

(8) Mobile fluoroscopic equipment shall meet the requirements of this section where applicable, except that:

(A) Inherent provisions shall be made so that the machine is not operated at a source-skin distance of less than 30 cm (12 inches).

(B) Image intensification shall always be provided. Conventional fluoroscopic screens shall not be used.

(D) It shall be impossible to energize the useful beam of a mobile fluoroscope unless the entire useful beam is intercepted by the image receptor.

(9) Devices which indicate the X-ray tube potential and current shall be provided, and should be located in such a manner that the operator may monitor the tube potential and current during fluoroscopy.

(10) A shielding device of at least 0.25 millimeters lead equivalent shall be provided for covering the bucky-slot during fluoroscopy.

(11) Whenever practicable, protective drapes, or hinged or sliding panels, of at least 0.25 millimeters lead equivalent shall be provided between the patient and the fluoroscopist to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the machine. Such devices shall not substitute for wearing of a protective apron.

(b) Operating Procedures.

(1) Protective aprons of at least 0.25 mm lead equivalent shall be worn in the fluoroscopy room by each person, except the patient, whose body is likely to be exposed to 5 mR/hr or more.

(2) On fluoroscopes with automatic exposure controls the operator shall monitor the tube current and potential at least once each week to ascertain that they are in their usual ranges for a given set of operating parameters. This requirement may be met by adjusting the controls to usual settings for fluoroscoping an average patient, and using a phantom of any suitable material with attenuation roughly equivalent to six to ten inches of water. Whenever the monitored tube current or potential vary in a way which could increase the patient X-ray exposure rate by more than 25% over the latest exposure rate measurement required by Section 30307(b)(3), the cause(s) for the change shall be determined promptly and the patient exposure rate shall be remeasured. On fluoroscopes with manual exposure control only, the operator shall monitor the tube current and potential at least once each day during use to ascertain that they are within the normal ranges used by the facility. A written log shall be kept of all monitored readings and shall include at least the tube current and potential, the date, identification of the fluoroscope, and name of the person who did the monitoring. Records of all monitored readings shall be preserved at the facility for at least three years.

(3) Measurements of the table top or patient exposure rate shall be made at least once each year for units with automatic exposure control, and at least once each 3 years for units without automatic exposure control, and immediately following alteration or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.

(4) On cineradiography equipment, the exposure rates to which patients are normally subjected shall be determined at least once each year, and immediately following alterations or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30308. Radiographic Installations (Other Than Dental and Veterinary Medicine).

Note • History

(a) Equipment.

(1) The tube housing shall be of diagnostic type.

(2) Suitable devices (diaphragms, cones, adjustable collimators), capable of restricting the useful beam to the area of clinical interest shall be provided to define the beam and shall provide the same degree of attenuation as that required of the tube housing. Such devices shall be calibrated in terms of the size of the projected useful beam at specified source-film distances. For chest photofluorographic equipment, the collimator shall restrict the beam to dimensions no greater than those of the fluorographic screen. The field size indication on adjustable collimators shall be accurate to within 2 percent of the source-film distance. The light field shall be aligned with the X-ray field with the same degree of accuracy.

(3) For equipment manufactured prior to August 1, 1974, the aluminum equivalent of the total filtration in the useful beam shall be not less than that shown in Table 1:

Table 1

Minimum Total Filter

Operating kVp (Inherent plus added)

Below 50 kVp 0.5 mm aluminum

50-70 kVp 1.5 mm aluminum

Above 70 kVp 2.5 mm aluminum

For equipment manufactured on or after August 1, 1974, the half-value layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the appropriate value specified in Table 2.

Table 2

X-ray tube voltage (kilovolt peak)

Designed Measured Minimum HVL

Operating Range Minimum HVL (mm of Al)

Below 50 30 0.3

40 0.4

49 0.5

50 to 70 50 1.2

60 1.3

70 1.5

Above 70 70 2.1

80 2.3

90 2.5

100 2.7

110 3.0

120 3.2

130 3.5

140 3.8

150 4.1

(4) A device shall be provided to terminate the exposure after a pre-set time or exposure.

(5) A dead-man type of exposure switch shall be provided and so arranged that it cannot be conveniently operated outside a shielded area, except that exposure switches for “spot film” devices used in conjunction with fluoroscopic tables are excepted from this shielding requirement.

(6) The control panel shall include a device (usually a milliammeter) to give positive indication of the production of X-rays whenever the X-ray tube is energized.

(7) The control panel shall include devices (labeled control settings and/or meters) indicating the physical factors (such as kVp, mA, exposure time, or whether timing is automatic) used for the exposure.

(8) Machines equipped with beryllium window X-ray tubes shall contain keyed filter interlock switches in the tube housing and suitable indication on the control panel of the added filter in the useful beam if the total filtration permanently in the useful beam is less than 0.5 mm aluminum equivalent. The total filtration permanently in the useful beam shall be clearly indicated on the tube housing.

(9) The aluminum equivalent of the table top when a cassette tray is used under the table top, or the aluminum equivalent of the front panel of the vertical cassette holder, shall not be more than 1 mm at 100 kVp.

(b) Operating Procedures.

(1) No individual occupationally exposed to radiation shall be permitted to hold patients during exposures except during emergencies, nor shall any individual be regularly used for this service. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices such as protective gloves and apron and he shall be so positioned that no part of his body will be struck by the useful beam.

(2) Only individuals required for the radiographic procedure shall be in the radiographic room during exposure; and, except for the patient, all such persons shall be equipped with appropriate protective devices.

(3) The radiographic field shall be restricted to the area of clinical interest.

(4) Gonadal shielding of not less than 0.5 mm lead equivalent shall be used for patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the direct beam, except for cases in which this would interfere with the diagnostic procedure.

(5) The operator shall stand behind the barrier provided for his protection during radiographic exposures.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30309. Special Requirements for Mobile Radiographic Equipment.

Note • History

(a) Equipment.

(1) All requirements of Section 30308(a) apply except 30308 (a)(5) and 30308 (a)(9).

(2) The exposure control switch shall be of the dead-man type and shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.

(3) Inherent provisions shall be made so that the equipment is not operated at source-skin distances of less than 12 inches.

(b) Operating Procedures.

(1) All provisions of Section 30308(b) apply except 30308(b)(5).

(2) The target-to-skin distance shall be not less than 12 inches.

(3) Personnel monitoring shall be required for all individuals operating mobile X-ray equipment.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment of subsection (b)(1) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30310. Special Requirements for Chest Photofluorographic Installations.

Note • History

(a) Equipment.

(1) All provisions of Section 30308 (a) apply.

(2) A collimator shall restrict the useful beam to the area of the photofluorographic screen.

(3) The incident X-ray exposure where the central ray enters the patient shall not exceed 200 milliroentgens per radiograph for the average patient, and should not exceed 100 milliroentgens per radiograph.

(b) Operating Procedures.

(1) All provisions of Section 30308(b) apply.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30311. Dental Radiographic Installations.

Note • History

(a) Equipment.

(1) The tube housing shall be of diagnostic type.

(2) Diaphragms or cones shall be used for collimating the useful beam and shall provide the same degree of protection as the housing.

(A) For intra-oral radiography the useful beam shall be restricted to a diameter of not more than 7 cm (2.75 inches) at the surface of the skin.

(3) For intra-oral film exposures a cone or spacer frame shall provide a target-to-skin distance of not less than 18 cm (7 inches) with apparatus operating above 50 kVp or 10 cm (4 inches) with apparatus operating at 50 kVp or below.

(4) The total filtration permanently in the useful beam shall be equivalent to at least 0.5 millimeters of aluminum for equipment operating below 50 kVp, equivalent to at least 1.5 millimeters of aluminum for equipment operating from 50 kVp through 70 kVp, and equivalent to at least 2.5 millimeters of aluminum for equipment operating above 70 kVp.

(5) A device shall be provided to terminate the exposure after a pre-set time or exposure.

(6) The exposure control switch shall be of the dead-man type. If a recycling timer is employed it shall not be possible to make a repeat exposure without release of the exposure switch to reset the timer.

(7) Each installation shall be provided with a protective barrier for the operator or shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.

(8) Mechanical support of the tube head and cone shall maintain the exposure position without drift or vibration.

(9) Panoramic installations. This part applies to those installations which consist of a tube head with a collimator providing a narrow useful beam and an extra oral film carrier which are interlocked in their motion about the patient.

(A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), 30311 (a)(10).

(10) Cephalometric installations.

(A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), and 30311 (a)(9).

(B) The radiographic field shall be restricted to the area of the image receptor.

(11) The X-ray control panel shall include means for indicating X-ray tube voltage (kVp), tube current (mA), and exposure duration. The tube voltage and current shall be indicated by meters or by control settings. A milliammeter, a light or other device shall give clear and distinct visual or audible indication to the operator when X-rays are being produced.

(b) Operating Procedures.

(1) No individual occupationally exposed to radiation shall be permitted to hold patients or films during exposure, nor shall any individual be regularly used for this service.

(2) During each exposure, the operator shall stand at least 6 feet from the patient or behind a protective barrier.

(3) Only the patient shall be in the useful beam.

(4) Neither the tube housing nor the position indicating device (cone, cylinder) shall be hand-held during exposure.

(5) Fluoroscopy shall not be used in dental examinations.

(6) Each patient undergoing dental radiography shall be draped with a protective apron of not less than 0.25 millimeter lead-equivalent to cover the gonadal area.

(7) For intra-oral and cephalometric radiography the X-ray beam and the film shall be aligned very carefully with the area to be radiographed.

(8) Only persons required for the radiographic procedure shall be in the radiographic room during exposures.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Editorial correction (Register 74, No. 6).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

5. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§30312. Therapeutic X-Ray Installations.

Note • History

(a) Equipment.

(1) The tube housing shall be of therapeutic type.

(2) For equipment installed on or before August 1, 1979, permanent diaphragms or cones used for collimating the useful beam shall afford the same degree of protection as the housing. Adjustable or removable beam-defining diaphragms or cones shall transmit not more than 5 percent of the useful beam obtained at the maximum kilovoltage and with maximum treatment filter.

(3) For equipment installed after August 1, 1979, permanent beam-defining devices or diaphragms shall afford the same degree of protection as the housing. Adjustable or interchangeable beam-defining devices shall transmit no more than 2 percent of the useful beam for the portion of the useful beam which is to be attenuated by the beam limiting device. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the normal treatment distance.

(4) Filters shall be secured in place to prevent them from dropping out during treatment. A filter indication system shall be used on all therapy machines using interchangeable filters. It shall indicate, from the control panel, or from the control station, the presence or absence of any filter except compensating filters, and it shall be designed to permit easy identification of the filter in place. The filter slot shall be so constructed that the radiation escaping through it does not exceed 1 roentgen per hour at 1 meter, or, if the patient is likely to be exposed to radiation escaping from the slot, 30 roentgens per hour at 5 centimeters from the external opening. Each interchangeable filter shall be marked with its thickness and material.

(5) The X-ray tube shall be so mounted that it cannot turn or slide with respect to the aperture.

(6) Means shall be provided to immobilize the tube housing during stationary portal treatment.

(7) A suitable exposure control device such as an automatic timer, exposure meter, or dose meter shall be provided to terminate the exposure after a preset time interval or preset exposure or dose limit. A timer shall be provided to terminate the exposure after a preset time regardless of what other exposure limiting devices are present. Means shall be provided for the operator to terminate the exposure at any time.

(8) Equipment utilizing shutters to control the useful beam shall have a shutter position indicator on the control.

(9) An easily discernible indicator which shows whether or not X-rays are being produced shall be on the control panel.

(10) Mechanical and/or electrical stops shall be provided on X-ray machines capable of operating at 150 kVp or above to insure that the useful beam is oriented only toward primary barriers.

(11) When the relationship between the beam interceptor (when present) and the useful beam is not permanently fixed, mechanical or electrical stops shall be provided to insure that the beam is oriented only toward primary barriers.

(b) Operating Procedures.

(1) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.

(2) No patient other than the one being treated shall be in the treatment room during exposure.

(3) No person other than the patient shall be in the treatment room when the tube is operated at potentials exceeding 150 kVp. At operating potentials of 150 kVp or below, persons other than the patient and operator may be in the treatment room for good reason but only if they are adequately protected and their radiation exposure is appropriately monitored.

(4) A calibration of the output of each radiation therapy system shall be performed before the system is first used for irradiation of a patient, and thereafter at intervals not to exceed 24 months. Therapy equipment shall not be used for any therapy treatments except at those combinations of effective energy, field size, and treatment distance for which the equipment has been calibrated. The calibration shall be performed by or under the direct supervision of a person who has been determined by the Department to have adequate training, experience and knowledge in radiation therapy physics, and who shall be present at the facility during such calibration. After any change which might significantly alter the output, spatial distribution, or other characteristics of the therapy beam, the parameters which might be affected shall be measured.

(A) For therapy systems operating at potentials above 500 kVp, the determinations included in the calibration shall be provided in sufficient detail so that the absorbed dose in tissue in the useful beam may be calculated to within 5 percent. The calibration shall include, but shall not be limited to, the following determinations:

1. Verification that the equipment is operating in compliance with the design specifications concerning the light localizer, the side light and back-pointer alignment with the isocenter when these specifications are known and applicable, variation in the axis of rotation for the table, gantry and jaw system, and beam flatness and symmetry at specified depths.

2. The relative dose at various depths in a tissue equivalent phantom for each effective energy and the ranges of field sizes and treatment distances used for radiation therapy.

3. The congruence between the radiation field and the field indicated by the localizing device.

4. The uniformity of the radiation field and its dependency upon the direction of the useful beam.

5. The absolute dose per unit time and dose per monitor setting.

(B) For therapy systems operating at potentials between 150 kVp and 500 kVp inclusive, the calibration shall include, but shall not be limited to, the following determinations:

1. The exposure rates and/or dose rates for each combination of field size, technique factors, filter, and treatment distance used.

2. The degree of congruence between the radiation field and the field indicated by the localizing device if such device is present.

3. An evaluation of the uniformity of the radiation field symmetry for the field sizes used, and any dependence upon tube housing assembly orientation.

(5) All new installations and existing installations not previously surveyed shall have a radiation protection survey performed by or under the direction of a person determined by the Department to have adequate knowledge and training to advise regarding radiation protection needs, to measure ionizing radiation and to evaluate safety techniques. If the survey shows that supplementary shielding is required a resurvey shall be performed after its installation. In addition, a resurvey shall be made after every change which might decrease radiation protection significantly. The surveyor shall report his findings in writing to the user. The report shall indicate whether or not the installation is in compliance with all applicable radiation protection requirements of this section. The user shall report the findings of the survey in writing to the Department within 15 days of his receipt of the survey report.

(6) The exposure rate or dose rate of the useful beam and the size and shape of the useful beam shall be known with reasonable certainty at all times during operation of the radiation therapy apparatus for medical purposes.

(7) Spot checks shall be performed at least once each week for therapy systems operating at potentials above 500 kVp, and at least once each month for therapy systems operating at 500 kVp or below.

(A) The measurements taken during spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the system or the radiation delivered to a patient during a therapy procedure.

(B) For systems in which the calibrating person believes beam quality can vary significantly, spot checks shall include beam quality checks.

(C) The spot check procedures shall be in writing and shall have been developed or approved by the individual who made the most recent calibration of the system pursuant to Section 30312(b)(4). The written spot check procedures shall specify when measurements and determinations indicate an inconsistency or potential change in radiation output. When more than the minimum frequency of spot checking is necessary, the spot check procedures shall specify the frequency at which spot checks are to be performed.

(D) When spot check results are erratic or inconsistent with calibration data, the person who designed the spot check procedures, or a person of equivalent competence, shall be consulted immediately and the reason(s) for the inconsistency corrected before the system is used for patient irradiation.

(8) Calibration of the therapy beam shall be performed with a measurement instrument which has been calibrated within the preceding two years directly, or through no more than one exchange, at the National Institute of Standards and Technology, or facility determined acceptable by the Department. In addition, indirect spot checks or intercomparisons of measurement instruments with secondary standards shall be made at least each six months.

(9) Reports of each radiation safety survey spot check and calibration performed pursuant to this section shall be maintained at the facility for at least three years. A copy of the treatment data developed from the latest calibration shall be available for use by the operator at the treatment control station.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment of subsection (c)(5) filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

5. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

6. Change without regulatory effect amending subsection (b)(7)(C) and (b)(8) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

§30313. Special Requirements for X-Ray Therapy Equipment Operated at Potentials of 50 kV and Below.

Note • History

(a) Equipment.

(1) All provisions of Section 30312(a) apply.

(2) A therapeutic-type protective tube housing shall be used. Contact therapy machines shall meet the additional requirement that the leakage radiation at 2 inches from the surface of the housing not exceed 0.1 R/hr.

(3) Automatic timers shall be provided which will permit accurate presetting and determination of exposures as short as one second.

(b) Operating Procedures.

(1) All provisions of Section 30312(b) apply except 30312(b)(1) and 30312(b)(7).

(2) In the therapeutic application of apparatus constructed with beryllium or other low-filtration windows adequate shielding shall be required to protect against unnecessary exposure from the useful beam, and special safeguards are essential to avoid accidental exposures to the useful beam. There shall be on the control panel some easily discernible device which will give positive information as to whether or not the tube is energized.

(3) Machines having an output of more than 1,000 roentgens per minute at any accessible place shall not be left unattended without the power being shut off at the primary disconnecting source.

(4) If the X-ray tube of a contact therapy machine is hand-held during irradiation, the operator shall wear protective gloves and apron.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment of subsections (a)(1), (b)(1) and (b)(4) filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

5. Change without regulatory effect amending subsection (b)(3) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

6. Amendment of section heading filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30314. Veterinary Medicine Radiographic Installations.

Note • History

(a) Equipment.

(1) The tube housing shall be of diagnostic type.

(2) Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing.

(3) The total filtration permanently in the useful beam shall not be less than 1.5 millimeters aluminum-equivalent for equipment operating up to 70 kvp and 2.0 millimeters aluminum-equivalent for machines operated in excess of 70 kvp.

(4) A device shall be provided to terminate the exposure after a pre-set time or exposure.

(5) A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length so that the operator can stand out of the useful beam and at least 6 feet from the animal during all X-ray exposures.

(b) Operating Procedures.

(1) The operator shall stand well away from the tube housing and the animal during radiographic exposures. The operator shall not stand in the useful beam. If film must be held, it shall be held by individuals not occupationally exposed to radiation. Hand-held fluoroscopic screens shall not be used. The tube housing shall not be held by the operator. No individuals other than the operator shall be in the X-ray room while exposures are being made unless such person's assistance is required.

(2) In any application in which the operator is not located behind a protective barrier, clothing consisting of a protective apron having a lead-equivalent of not less than 0.25 millimeter shall be worn by the operator and any other individuals in the room during exposures.

(3) No individual shall be regularly employed to hold or support animals during radiation exposures. Operating personnel shall not perform this service except very infrequently and then only in cases in which no other method is available. Any individual holding or supporting an animal during radiation exposure shall wear protective gloves and apron having a lead-equivalent of not less than 0.25 millimeter.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

Article 4.5. Requirements for the Use of X-Ray in Mammography

§30315.10. Definitions.

Note • History

(a) The definitions in section 30100 shall apply to this article.

(b) As used in this article:

(1) “Action limit” means the minimum or maximum value of a quality assurance measurement representing acceptable performance.

(2) “Activities” means the operation of a mammography system to produce the mammogram, the initial interpretation of the mammogram, and the maintenance of the viewing conditions for that interpretation.

(3) “Adverse event” means an undesirable experience associated with mammography activities such as:

(A) Poor image quality;

(B) Failure to send mammography reports within 30 calendar days from the date of the mammographic examination to the referring physician or to the patient; and

(4) “Air kerma” means the kerma, measured in Gray (Gy), in a given mass of air.

(5) “Automatic exposure control” (AEC) means a device that automatically controls one or more technique factors in order to obtain at pre-selected locations a required quantity of radiation.

(6) “Average glandular dose” means the value in millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that estimates the average absorbed dose to the glandular tissue extrapolated from free air exposures and based on fixed filter thickness and target material.

(7) “Category I” means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, or a state medical society.

(8) “Clinical image review” means the process whereby the mammograms produced by a specific mammography system are evaluated for image quality.

(9) “Consumer” means an individual who chooses to comment on or complain in reference to a mammographic examination, including the patient or representative of the patient, such as a family member or referring physician.

(10) “Continuing education unit” means one hour of training received through either:

(A) Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or

(B) The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).

(11) “Direct supervision” means the oversight of operations that include the following:

(A) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's record.

(B) During performance of a mammographic examination, the supervising mammographic radiologic technologist is physically present to observe, and correct, as needed, the performance of the individual who is performing the mammographic examination.

(C) During performance of a survey, the supervising medical physicist is physically present to observe, and correct, as needed, the performance of the individual who is performing the survey.

(12) “Established operating level” means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.

(13) “Facility” means a hospital, outpatient department, clinic, radiology practice, an office of a physician, mobile setting, or other place or building in which a person conducts:

(A) Mammography activities; and/or

(B) Interventional mammography or research mammography.

(14) “Facility accreditation certificate” means a document issued by the Department authorizing a facility to perform mammography.

(15) “FDA” means the United States Food and Drug Administration.

(16) “Image receptor” means any device that transforms incident X-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

(17) “Interpreting physician” means a licensed physician who interprets mammograms and meets the requirements of section 30315.50.

(18) “Interim Facility Accreditation Certificate” means a document issued by the Department pursuant to section 30315.24.

(19) “Interventional mammography” means the creation of a mammogram during invasive interventions for localization, biopsy procedures, or therapeutic procedures.

(20) “Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.

(21) “Lead interpreting physician” means the interpreting physician designated either by the person who owns or leases the facility, or an authorized agent of that person to ensure that the facility's quality assurance program meets all of the requirements of this article.

(22) “Mammogram” means an X-ray image of the human breast.

(23) “Mammographic examination” means the performance of mammography on a human being.

(24) “Mammographic modality” means a technology for radiography of the breast such as screen-film mammography, digital mammography and xeromammography.

(25) “Mammography” means the procedure for creating a mammogram.

(26) “Mammography medical outcomes audit” means a systematic collection of mammography results and the comparison of those results with outcome data.

(27) “Mammography system” means a system that includes all of the following:

(A) A radiation machine used as a source of radiation to produce a mammogram;

(B) An imaging receptor used for the formation of a latent image of a mammogram or for converting X-ray photons to a digital signal;

(C) A processing device for changing a latent image of a mammogram or a digital signal to a visual image that can be used for diagnostic or therapeutic purposes; and

(D) A viewing device, such as a view box or computer monitor, used to visually evaluate a mammogram.

(28) “Mammography system evaluation” means an evaluation of the mammography system by a medical physicist to ensure the system is in compliance with sections 30316 and 30316.20(e).

(29) “Medical physicist” means an individual trained in performing mammography system evaluations, quality assurance testing evaluations and surveys.

(30) “Mobile service provider” means a person who performs mammography in a mobile setting.

(31) “Mobile setting” means a setting in which mammography is performed with a radiation machine that is fixed or used exclusively in a mobile vehicle or unit, or is transported to a different location for the purpose of providing mammography, but does not include a radiation machine moved from room to room within a facility.

(32) “Multi-reading” means two or more physicians interpreting the same mammogram, at least one of whom meets the requirements of section 30315.50.

(33) “Overall assessment of findings” means the results of an interpreting physician's evaluation of mammograms produced during a mammographic examination and categorized using the assessment categories specified in section 30317.40(a)(4).

(34) “Phantom” means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.

(35) “Phantom image” means a radiographic image of a phantom.

(36) “Physical science” means physics, chemistry, radiation science (including medical physics and health physics), and engineering.

(37) “Positive mammogram” means a mammogram that has an overall assessment of findings that are either “suspicious” or “highly suggestive of malignancy.”

(38) “Quality assurance technologist” means an individual who meets the requirements of section 30315.51 and has experience performing or assisting in the performance of quality assurance tests specified in section 30316.20(a) through (d) and (f)

(39) “Quality assurance testing evaluation” means an evaluation of a facility's quality assurance testing by a medical physicist to ensure quality assurance testing is performed in accordance with section 30316.20 excluding subsection (e) of section 30316.20.

(40) “Research mammography” means the creation of a mammogram with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of title 21, Code of Federal Regulations.

(41) “Serious adverse event” means an adverse event that may significantly compromise clinical outcomes, or an adverse event for which appropriate corrective action was not taken in a timely manner.

(42) “Serious complaint” means a report of a serious adverse event.

(43) “Source-to-image receptor distance” (SID) means the distance from the X-ray source to the center of the input surface of the image receptor.

(44) “Standard breast” means a 4.2 cm thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue.

(45) “Survey,” in lieu of the definition found in title 10, Code of Federal Regulations, section 20.1001 incorporated by reference in section 30253, means the on-site performance of a mammography system evaluation and a quality assurance testing evaluation by a medical physicist.

(46) “Traceable to a national standard” means that the instrument used to quantitatively measure radiation has been calibrated at:

(A) The National Institute of Standards and Technology (NIST); or

(B) A calibration laboratory that participates in a proficiency program with NIST at least once every two years during which the calibration laboratory achieves agreement within plus or minus 3.0 percent of the NIST standard at mammography energy levels.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

1. New article 4.5 (sections 30315.10-30320.90) and section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-10-2003 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (b)(17) and (b)(33), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.20. Facility Accreditation Certificate and Interim Facility Accreditation Certificate.

Note • History

(a) Except for persons only performing interventional mammography or research mammography, a person shall not perform mammography activities unless performed in a facility that:

(1) Possesses a current and valid Facility Accreditation Certificate or an Interim Facility Accreditation Certificate; and

(2) Meets the requirements of this subchapter.

(b) An Interim Facility Accreditation Certificate shall be valid for six months beginning on the date of issuance.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-10-2003 or emergency language will be repealed by operation of law on the following day.

2. Editorial correction adding inadvertently omitted History 1 (Register 2003, No. 8).

3. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.22. Eligibility for a Facility Accreditation Certificate.

Note • History

(a) To be eligible for a Facility Accreditation Certificate a facility shall:

(1) Submit the application described in section 30315.33;

(2) Comply with section 30108;

(3) Pass a Department inspection verifying that:

(A) Physicians interpreting mammograms meet the requirements of section 30315.50;

(B) Mammographic radiologic technologists meet the requirements of section 30315.51;

(D) Mammography systems meet the requirements of section 30316;

(E) The mammography quality assurance program is capable of meeting the requirements of section 30317.10;

(F) By following the procedure specified in section 30316.20(b), phantom images of a phantom that meets the requirements of section 30316.22 produced by all mammography systems, meet the criteria specified in section 30316.20(b)(1) through (3);

(G) By use of the facility's proposed technique factors for a standard breast, the average glandular dose for each radiation machine used for mammography does not exceed the value specified in section 30316.20(e)(10);

(H) The quality assurance manual meets the requirements of section 30317.20;

(I) The mammography procedures manual meets the requirements of section 30317.30;

(J) The facility is capable of ensuring mammograms and mammographic examination reports meet the requirements of sections 30316.50 and 30317.40;

(K) The facility is capable of conducting a mammography medical outcomes audit that meets the requirements of section 30317.60;

(L) The facility has a consumer complaint procedure that meets the requirements of section 30317.70; and

(M) The requirements of Group 3 of this regulation are met.

(4) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, for each machine that will be used to perform mammography, pass a clinical image review conducted by the Department pursuant to section 30315.35, or conducted by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and

(5) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.23. Renewal of a Facility Accreditation Certificate.

Note • History

(a) To renew a Facility Accreditation Certificate, a facility shall:

(1) Seven months prior to the expiration date of the facility accreditation certificate submit the facility application described in section 30315.33;

(2) For each radiation machine that will be used for mammography, either:

(A) Pass a clinical image review conducted by the Department pursuant to section 30315.35(c) prior to the expiration date of the current facility accreditation certificate; or

(B) Have the machine's accreditation renewed by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and

(3) Possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.24. Interim Facility Accreditation Certificate.

Note • History

An interim facility accreditation certificate shall not be issued until a facility has complied with section 30315.22(a)(1) through (3) and has obtained a provisional certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b)(2).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of section, transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.33. Complete Facility Application.

Note • History

(a) An application submitted for compliance with sections 30315.22 or 30315.23 shall be considered complete if the application contains the following:

(1) The legal name of the applicant, the mailing address, and the telephone number;

(2) The name under which the applicant's facility does business and, if doing business under a fictitious name, a copy of the applicant's fictitious name permit;

(3) The name of the contact person for the facility;

(4) The facility location address and mailing address if different from location address.

(5) The registration number issued by the Department pursuant to section 30108 and the expiration date of registration;

(6) The applicant's federal employer identification number and California taxpayer identification number;

(7) If the facility is accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), the name of that entity.

(8) If the applicant requests approval to perform mammography in a mobile setting:

(A) The physical address of each location where mammography will be performed;

(B) For each location where mammography will be performed, the name and telephone number of the responsible person who is allowing the service to be provided at the location;

(C) Whether the mammograms will be processed with an on-board processor or at specific locations. If the facility will process mammograms at specific locations, the physical address of each location where mammograms will be processed;

(D) Whether the radiation machine is fixed or used, exclusively, in a mobile vehicle or is transported to the use location and moved to where mammographic examinations will be performed. If the radiation machine is moved to where mammographic examinations will be performed, the designated room number within the physical building at each location of use; and

(E) A description of the quality assurance tests that will be performed each time the radiation machine is relocated.

(9) Responses to the following questions:

(A) “Have you ever performed mammography authorized pursuant to a certificate issued by FDA?” If the answer is yes, provide in your response the names under which mammography was performed;

(B) “If you have been certified by FDA to perform mammography, has that certificate ever been revoked or suspended, or has FDA ever denied to renew that certificate?” If the answer is yes, provide in your response the following:

1. The identity of any specific radiation machine(s) that failed to pass clinical image review;

2. The dates of failure;

3. The actions taken to correct any clinical image review deficiencies including physician or technologist training, radiation machine or processor repair and acquisition of replacement equipment or image receptors;

4. Whether the radiation machine passed the clinical image review subsequent to actions taken as identified in subsection (a)(9)(B)3 and when;

5. If, within the three years prior to the date of application, any radiation machine used for mammography identified in subsection (a)(15) failed clinical image review during a time when accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), copies of the failure reports; and

6. If accreditation issued by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), was suspended or revoked, a description of the circumstances that led to suspension or revocation.

(C) “Is any interpreting physician you seek to allow to interpret mammograms currently under a Department-directed plan of corrective action for interpretation done at some other facility?” If the answer is yes, provide in your response the following:

1. The name and medical license number of the interpreting physician; and

2. The facility's name and registration number where the interpreting physician was required to complete a directed plan of corrective action.

(10) The name of the individual designated as the lead interpreting physician.

(11) The name, medical license number, certificate number and expiration date as shown on the individuals certificate issued pursuant sections 30466(d) or 30467 of each physician who will interpret mammograms produced by the facility;

(12) The name, certificate number and expiration date of certification shown on the certificate issued pursuant to section 30455.1 for each mammographic radiologic technologist who will perform mammographic examinations for the facility;

(13) The name of each medical physicist who will perform the tests specified in section 30316.20(e) for the facility;

(14) The name of the quality assurance technologist;

(15) For each radiation machine that will be used to perform mammographic examinations:

(A) The machine's manufacturer, model number, and the facility's radiation machine identification number as specified in section 30317(g);

(B) Whether the machine will be used in a mobile setting. If the machine will not be used in a mobile setting, the designated room number within the facility where the machine is installed or fixed;

(C) Whether the machine is a screen-film, xeromammography or digital system. If the machine is a screen-film system, the name of the manufacturer of the screen and film, and the type of screen and film used; and

(D) If the machine requires a screen-film image receptor, a phantom image of a phantom that meets the requirements of section 30316.22.

(16) A copy of the report indicating the results of a mammography system evaluation performed less than 6 months prior to the date of the application by a medical physicist or in lieu thereof for renewal applications, a copy of the report indicating the results of a survey performed less than 12 months prior to the date of the renewal application by a medical physicist and if the mammography system evaluation report or the survey report identifies deficiencies or recommendations for improvements in facility operations:

(A) A list and description of corrective actions taken and the date corrections were achieved;

(B) Copies of work invoices;

(C) Documentation that those corrective actions were taken and those actions corrected the deficiencies or that those recommendations were followed.

(17) For each film processor that is used to process mammograms:

(A) The make and model number; and

(B) Whether the processor uses extended processing or standard processing.

(18) If this is a renewal application, the number of the following procedures performed in the previous year:

(A) Screening procedures;

(B) Diagnostic procedures;

(D) Biopsy procedures;

(E) Needle localization procedures; and

(F) Therapeutic procedures.

(19) If this is a renewal application, the identification number and expiration date shown on the FDA certificate issued to the applicant's facility;

(20) Whether the applicant participates or intends to participate in either the Breast Cancer Early Detection Program or the Breast and Cervical Cancer Control Program of the Department or any of their successors;

(21) If the applicant is a Medi-Cal provider, the nine-digit Medi-Cal number used to bill for mammographic examinations performed at the facility's location;

(22) If the applicant is a Medicare provider, the nine-digit Medicare number used to bill for mammographic examinations performed at the facility's location;

(23) Name, title, signature and date of signature of the applicant and lead interpreting physician.

NOTE

Authority cited: Sections 115060, 131051 and 131200, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of subsection (a)(15)(A) and Note filed 7-11-2007; operative 8-10-2007 (Register 2007, No. 28).

§30315.34. Application Processing Times.

Note • History

(a) Within 30 calendar days of receipt of an application for or renewal of a facility accreditation certificate, the Department shall:

(1) Notify the applicant that the application is complete; or

(2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete.

(b) Unless the applicant responds to the notification in subsection (a)(2) within 30 calendar days the application shall be deemed withdrawn and the applicant may reapply by submitting a new application.

(c) Within six months of receipt of a complete application, the Department shall issue or deny the facility accreditation certificate.

(d) The Department's time periods for processing an application for or renewal of a facility accreditation certificate from receipt of the initial application to the date the final decision is made, are as follows:

(1) The median time is five and one-half months;

(2) The minimum time is four months;

(3) The maximum time is 12 months.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 15376, Government Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (b), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.35. Clinical Image Review.

Note • History

(a) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, applicants for a facility accreditation certificate shall:

(1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and

(2) Within 75 calendar days of the date of issuance as shown on the interim facility accreditation certificate, submit those mammograms for clinical image review.

(b) If the mammograms fail the review, additional mammograms may be submitted if the resubmission is made no less than 75 calendar days prior to the expiration date of the interim facility accreditation certificate.

(1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and

(2) Submit those mammograms for clinical image review no less than 75 calendar days prior to the expiration date of the facility accreditation certificate.

(d) Mammograms submitted pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.36. Mammography Review.

Note • History

(a) Each facility possessing a facility accreditation certificate shall, upon request, make mammograms and reports specified in section 30317.40(a) available to the Department and allow those mammograms and reports to be removed from the facility for the purpose of evaluating mammogram image quality.

(b) For sample sizes of two mammographic examinations:

(1) If one mammographic examination fails the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan; or

(2) If both mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure. The facility shall be subject to additional review using a larger sample.

(1) If 20 percent of the mammographic examinations fail the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan;

(2) If 40 percent of the mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure; or

(3) If 80 percent or more of the mammographic examinations fail the review, the facility shall cease the performance of mammography and submit to additional review and:

(A) If 70 percent or more of the mammographic examinations pass this additional review, the facility may restart the performance of mammography after satisfactorily completing a plan of corrective action as directed by the Department and shall, within 75 calendar days of notification that the mammograms passed the review, submit mammograms in accordance with section 30315.35(a)(1); or

(B) If less than 70 percent of the mammographic examinations pass this additional review, the facility shall not restart the performance of mammography and shall notify every patient who had a mammogram at the facility during the two-year period preceding the date of failure. The notification shall be approved by the Department prior to mailing and include:

1. The name of the patient;

2. The date the patient's mammogram was performed;

3. The statement, “The Department of Health Services of the State of California has conducted a review of the mammograms produced by (the name of the facility) and has determined that the mammograms do not meet the standards set by the Department. Therefore, we strongly advise you to consult with your physician as soon as possible regarding a repeat mammographic examination.”

(d) Mammograms reviewed pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (c)(3)(B)3., transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.50. Interpreting Physician Requirements.

Note • History

(a) An interpreting physician for a facility shall:

(1) Possess a current and valid radiology supervisor and operator certificate issued pursuant to sections 30467 or 30466(d); and

(2) Meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(1).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.51. Personnel Requirements for Individuals Who Perform Mammography.

Note • History

(a) Mammographic examinations shall not be performed unless the individual who performs the mammographic examination:

(1) Possesses a current and valid mammographic radiologic technology certificate issued pursuant to section 30455.1; and

(2) Meets the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(2).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.52. Medical Physicist Requirements.

Note • History

(a) A medical physicist for a facility shall:

(1) Be authorized by the Department pursuant to section 30315.60;

(2) Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or 30 quarter hours of college undergraduate or graduate level physics;

(3) Complete 20 hours of documented specialized training in conducting surveys of mammography facilities; and

(4) Conduct a survey of at least one mammography facility and a total of at least ten mammography radiation machines under the direct supervision of a medical physicist who has already met the requirements of this section, but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total number of radiation machines surveyed. The period of time spent in meeting the survey requirement may be counted toward meeting the 20-hour training requirement in subsection (a)(3). After April 28, 1999, experience conducting surveys shall be acquired under the direct supervision of a medical physicist who meets the requirements of subsections (a)(1) through (4) and (b); or

(5) In lieu of subsections (a)(2) through (4), qualify as a medical physicist under Title 21, Code of Federal Regulations, section 900.12(a)(3), as published in the December 21, 1993 Federal Register (58 Fed.Reg. 67571) and have retained that qualification by maintenance of the active status of any licensure, approval, or certification required under those regulations and prior to April 28, 1999:

(A) Received a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics;

(B) After meeting the requirements of subsection (a)(5)(A), completed forty hours of documented specialized training in conducting surveys of mammography facilities; and

(C) After meeting the requirements of subsection (a)(5)(A), conducted surveys of at least one mammography facility and a total of at least 20 mammography radiation machines but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total radiation machine survey requirement. The period of time spent in meeting the survey requirement may be counted toward meeting the 40-hour training requirement in subsection (a)(5)(B).

(b) A medical physicist for a facility shall meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(3)(iii) and (iv).

NOTE

Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (a)(5), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30315.60. Authorization and Renewal of Authorization to Conduct Mammography Surveys, Revocation and Suspension of Authorization and Application Processing Times.

Note • History

(a) To be eligible for authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following:

(1) Name, social security number (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification), mailing address, daytime telephone number, and FAX number;

(2) Documentation that the applicant meets the requirements of:

(A) Sections 30315.52(a)(2) through (4); or

(B) Section 30315.52(a)(5).

(3) Documentation that the applicant meets the requirements of section 30315.52(b);

(4) Three sample survey reports, meeting the requirements of section 30316.60, indicating the name of the medical physicist providing direct supervision and that the applicant performed all tests. Each report shall include language and data that establishes that all tests were performed to determine if the facility meets the requirements of this article and that, if a test method is specified, the test method was followed; and

(5) The following information:

(A) Manufacturer, model and serial number of the phantom used to produce phantom images;

(B) Whether the type of system resolution tool used to evaluate system resolution is a bar pattern or, until October 28, 2002, a star pattern;

(D) Method used to evaluate compression;

(E) Type of instruments used to determine average glandular dose and a copy of the most recent calibration report for that instrument indicating that it complies with section 30316.61;

(F) Whether aluminum filters used to determine the radiation machine's half-value layer of the useful beam is type 1100 or type 1145;

(G) Manufacturer, model and serial number of the densitometer, sensitometer and photometer used during surveys; and

(H) A list of equipment used to evaluate the mammography system for artifacts and the radiation machine's AEC performance; or

(6) In lieu of subsections (a)(2) and (3), a copy of the letter issued to the applicant by FDA stating that the applicant met the requirements of title 21, Code of Federal Regulations, section 900.12(a)(3).

(b) Individuals approved by use of subsection (a)(2)(B) shall not provide direct supervision.

(c) Surveys of radiation machines used to perform interventional mammography or research mammography shall not be used to comply with this section.

(d) Authorization shall be valid for three years.

(e) To be eligible for renewal of authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following:

(2) The following information:

(A) If changes to the information submitted pursuant to subsection (a)(5) have occurred, the updated information;

(B) A copy of the most recent calibration report for the instrument used to determine average glandular dose.

(3) Documentation indicating that at least 8 hours of training in surveying radiation machines were received for each new mammographic modality; and

(4) Documentation that the applicant meets the requirements of section 30315.52(b).

(f) Authorization to conduct mammography surveys may be revoked, suspended, amended or restricted for any of the following:

(1) Failure to comply with section 30315.52(b);

(2) Knowingly conduct or perform mammography system evaluations, quality assurance testing evaluations or surveys that cause or would have caused, if not detected, a facility to be in violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department;

(3) Knowingly submits to the Department false, incorrect or fraudulent information;

(4) Failure to inform a facility that a violation of this article has occurred when the medical physicist knows of the violation; or

(5) Procuring authorization by fraud, or misrepresentation, or because of mistake.

(g) Within 10 calendar days of receipt of an application for or renewal of authorization, the Department shall:

(1) Notify the applicant that the application is complete; or

(2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete.

(h) Unless the applicant responds to the notification in subsection (g)(2) within 30 calendar days the application shall be deemed withdrawn.

(i) Within 30 calendar days of receipt of a complete application, the Department shall issue or deny the authorization.

(j) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (e) may reapply by submitting a new application.

(k) The Department's time periods for processing an application for authorization from receipt of the initial application to the date the final decision is made, are as follows:

(1) The median time is 30 calendar days;

(2) The minimum time is seven days;

(3) The maximum time is 90 calendar days.

NOTE

Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code; and Section 15376, Government Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (a)(4), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316. Mammography System Requirements.

Note • History

(a) A radiation machine designed for general purpose radiography, or special nonmammography procedures or that has been modified or equipped with special attachments for mammography shall not be used for mammography.

(b) Radiation machines used for mammography shall:

(1) Be specifically designed and manufactured for mammography and meet the requirements of section 30305(a)(4).

(2) Provide a tube-image receptor assembly that is capable of being fixed in any operating position where it is designed to operate and once fixed in any such position, does not undergo unintended motion and does not fail in the event of power interruption.

(3) If equipped with screen-film image receptors:

(A) Be able to be operated with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm;

(B) Have moving grids matched to all image receptor sizes provided; and

(4) If used to perform noninterventional problem solving procedures, have a radiographic magnification capability with at least one magnification value within the range of 1.4 to 2.0.

(5) When equipped with more than one focal spot, indicate, prior to exposure, which focal spot has been selected.

(6) When equipped with more than one target material, indicate, prior to exposure, the preselected target material.

(7) When equipped such that the target material and/or focal spot are selected by a system algorithm that is based on the exposure or on a test exposure, display, after the exposure, the target material and/or focal spot actually used during the exposure.

(8) Incorporate a compression device that:

(A) Effective October 28, 2002, provides:

1. An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and

2. Fine adjustment compression controls operable from both sides of the patient.

(B) Provides different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for “spot compression”) may be provided but shall be exempt from the requirements of subsection (b)(8)(C); and

(C) Except as provided in subsection (b)(8)(D), provides a compression paddle that is flat and parallel to the image receptor holder assembly and does not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. The chest wall edge shall not appear on the image;

(D) If the compression paddle is intended by the manufacturer's design to not be flat and parallel to the image receptor holder assembly during compression, the paddle shall meet the manufacturer's design specifications and maintenance requirements; and

(E) If the chest wall edge is bent upward for patient comfort, the edge shall not appear on the image.

(9) Provide manual selection of milliampere-seconds (mAs) or milliamperes (mA) and time, and;

(10) Indicate kVp, mA and time and/or mAs before the exposure begins, or when AEC is used, the technique factors that are set prior to the exposure;

(11) When the AEC mode is used, indicate the actual technique factors (kVp and mAs or mA and time) used, after completion of the exposure;

(12) If it is a screen-film system, provide an AEC mode that is operable in all combinations of equipment configuration provided on that unit, such as grid, nongrid, magnification, nonmagnification and various target-filter combinations, and:

(A) Provides a positioning or selection of the detector that is flexible in the placement of the detector under the target tissue;

(B) Clearly indicates the size and available positions of the detector at the X-ray input surface of the compression paddle;

(D) Provides a means to vary the selected optical density from the normal or baseline setting.

(13) If equipped with a light beam that passes through the X-ray beam-limiting device, the light provides an average illumination of 160 lux (15 foot candles) at the lesser of:

(A) 100 centimeters; or

(B) The maximum source-to-image-distance the machine can obtain.

(1) There are at least four image receptors of 18 x 24 centimeters (cm) and at least four image receptors of 24 x 30 cm available for use by the person performing mammographic examinations;

(2) The X-ray film and intensifying-screens are designated by the film manufacturer and the screen manufacturer as appropriate for mammography and the X-ray film matches the screen's spectral output as specified by the screen manufacturer;

(3) Chemical solutions used for processing mammograms are capable of developing the film so as to meet the minimum requirements specified by the film manufacturer;

(4) Special lights for film illumination, or hot lights, that are capable of producing light levels greater than that provided by the view box are available; and

(5) Film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all physicians interpreting mammograms for the facility.

(d) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (b)(9), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.10. Evaluations of New, Replaced or Repaired Equipment.

Note • History

(a) Whenever the following occur, the affected equipment shall meet the requirements specified in sections 30316 and 30316.20 before the affected equipment is used to produce or process mammograms:

(1) Installation of a new radiation machine or processor;

(2) Disassembly and reassembling of a radiation machine or processor at the same or a new location; or

(3) Repair or replacement of any major component of the mammography system.

(b) The evaluation to determine if equipment specified in subsections (a)(1) through (3) are in compliance with subsection (a) shall be performed by a medical physicist or an individual under the direct supervision of a medical physicist.

(1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24;

(2) Submit the results of tests with measurements and calculated data used to establish compliance with subsection (a), the information specified in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23) and the calibration record required in section 30316.61(a); and

(3) Pass a clinical image review conducted by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A) or by the Department in which mammograms shall:

(A) Be selected in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4);

(B) Be submitted within 75 calendar days of being notified by the Department that subsections (c)(1) and (2) have been met; and

(d) To use a radiation machine that was disassembled and reassembled for mammography, a facility shall:

(1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24;

(3) Submit a mammography system evaluation performed by a medical physicist or an individual under the direct supervision of a medical physicist.

(e) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (a), (c)(1)-(2) and (d)(1)-(2), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.20. Quality Assurance Testing.

Note • History

(a) Each facility using screen-film systems for mammography shall adjust and maintain each processor used to develop mammograms so that the manufacturer's technical development specifications for the mammography film in use are met. Each day mammograms are processed and before processing mammograms the facility shall determine that the processor used to develop mammograms, using the mammography film of the type used clinically, meets the following:

(1) Base plus fog-density is within plus 0.03 of the established operating level;

(2) Mid-density is within plus or minus 0.15 of the established operating level; and

(3) Density difference is within plus or minus 0.15 of the established operating level.

(b) Each facility using screen-film systems for mammography shall, each week in which mammography is performed, produce an image of a phantom that meets the requirements of section 30316.22. The test shall be performed prior to mammography on the day the test is performed. Before exposing the phantom an acrylic disc measuring one centimeter in diameter and four millimeters thick shall be placed on the phantom in the image area so it will not obscure details in the phantom and where it cannot cast a shadow on any portion of the AEC detector. The phantom shall then be exposed using the mammography film of the type used clinically and the techniques used for clinical images of a standard breast. The resulting phantom image shall meet the following:

(1) The center of the image has an optical density (OD) of at least 1.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.20 OD when compared to the established operating level;

(2) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.05 OD when compared to the established operating level; and

(3) Obtains a score of at least 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30.

(1) Test the residual fixer retained in the film to determine that it is no more than 5 micrograms per square centimeter; and

(2) Perform a repeat analysis on mammograms repeated or rejected. If the total repeat or reject rate changes from the previously determined rate by more than 2.0% of the total films included in the analysis, the reason(s) for the change shall be determined by the facility. Any corrective actions shall be documented and the results of those corrective actions shall be assessed. Test films, cleared films, or film processed as a result of exposure of a film bin shall not be included in the count for repeat analysis but shall be counted to determine reject rate changes and may be disposed of following completion of the analysis.

(d) Each facility conducting mammography shall, prior to initial use and at intervals not to exceed six months:

(1) Determine that the optical density attributable to darkroom fog does not exceed 0.05, by performing a test which uses mammography film of the type used clinically in the facility in which the film is exposed such that the film has a mid-density of no less than 1.4 OD, and is exposed to typical darkroom conditions for two minutes while such film, with one-half of the film covered, is placed on the counter top, emulsion side up. If the darkroom has a safelight used for mammography film, it shall be on during this test;

(2) Conduct testing on all cassettes used for mammography in the facility for screen-film contact using 40 mesh copper screen during which the entire area of the cassette that may be clinically exposed shall be tested; and

(3) Determine that the X-ray system is able to compress the breast with a force of at least 25 pounds and maintain this compression for at least 15 seconds, except that for systems with automatic compression, the maximum force applied without manual assistance shall be greater than 25 pounds and shall not exceed 45 pounds.

(e) Each facility conducting mammography shall, annually, ensure that a medical physicist verifies that:

(1) Until October 28, 2002, the automatic exposure control (AEC) can maintain film optical density within plus or minus 0.30 of the average of the optical densities measured using homogeneous acrylic thicknesses of 2, 4, and 6 centimeters and the kilovoltage peak (kVp) is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous acrylic shall have an optical density (OD) of at least 1.20. If the AEC cannot meet this requirement, a chart shall be posted that specifies appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions so that optical densities within plus or minus 0.30 of the average under phototimed conditions can be produced;

(2) After October 28, 2002, the AEC can maintain film optical density within plus or minus 0.15 of the average of the optical densities measured using homogeneous breast-tissue equivalent material thicknesses of 2, 4, and 6 centimeters (cm) and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous breast-tissue equivalent material shall have an OD of at least 1.20;

(3) When the AEC mode is used and the OD is increased or decreased from the normal or baseline setting, the net overall change in OD across the range of clinically used density control settings shall exceed the OD range established under subsection (e)(12) and if that net overall change in OD is equal to or greater than the maximum difference in OD allowed under subsection (e)(12), this change shall be distributed over a minimum of two density control settings removed from the normal or baseline setting;

(4) By using the protocol specified in subsection (b), the mammography system, if a screen-film system, can produce a phantom image that meets the following:

(A) The center of the image has an OD of at least 1.40;

(B) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40; and

(C) Obtains a score of 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30.

(D) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and the difference is not more than plus or minus 0.05 OD when compared to the facility's established operating level.

(5) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp is equal to or less than 0.02;

(6) The kVp is accurate to within plus or minus 5.0% of the indicated or selected kVp at the following:

(A) The lowest clinical kVp that can be measured by a kVp test device;

(B) The most commonly used clinical kVp; and

(7) The focal spot condition meets one of the following:

(A) Until October 28, 2002, the measured focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) shall be within the tolerance limits specified in Table 1. If a star pattern is used to evaluate focal spot condition, the star pattern shall, for evaluation of the large focal spot, be no larger than 1.5 degrees and, for evaluation of the small focal spot, be no larger than 1.0 degree.

Table 1

Focal Spot Tolerance Limit

Nominal Focal Spot Size (mm) Maximum Measured Dimensions

Width (mm) Length (mm)

0.10 0.15 0.15

0.15 0.23 0.23

0.20 0.30 0.30

0.30 0.45 0.65

0.40 0.60 0.85

0.60 0.90 1.30

(B) The focal spot condition shall be evaluated by determining the mammography system resolution in accordance with the following and meet the specified criteria:

(1) Each mammography system used for mammography, in combination with the mammography screen-film combination used in the facility, shall provide a minimum resolution of 11 cycles/millimeter (mm) (line-pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis;

(2) The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within 1 cm of the chest wall edge of the image receptor;

(3) When more than one target material is provided, the measurement in subsection (e)(7)(A) shall be made using the appropriate focal spot for each target material;

(4) When more than one source-image-distance (SID) is provided, the test shall be performed at the SID most commonly used clinically; and

(5) Test kVp shall be set at the value used clinically by the facility for a standard breast and shall be performed in the AEC mode, if available. If necessary, a suitable absorber may be placed in the beam to increase exposure times. The screen-film cassette combination used by the facility shall be used to test for this requirement and shall be placed in the normal location used for clinical procedures.

(8) The half-value layer (HVL) of the useful beam is not less than the value specified in Table 2 of section 30308(a)(3) for the minimum HVL. These values, extrapolated to the mammographic range, are shown as follows, except that values not shown in Table 2 may be determined by linear interpolation or extrapolation:

Table 2

X-ray Tube Voltage (kilovolt peak) and Minimum HVL

Designed Measured Operating Minimum HVL

Operating Range (kV) Voltage (kV) (mm of aluminum)

Below 50 20 0.20

25 0.25

30 0.30

(9) The coefficient of variation for both air kerma and milliampere-seconds (mAs) does not exceed 0.05;

(10) By performance of a test using the techniques the facility uses clinically for a standard breast, the average glandular dose delivered by screen-film systems during a single craniocaudal view of an FDA accepted phantom simulating a standard breast does not exceed 3.0 milligray (mGy) (0.3 rad) per exposure;

(11) All systems meet the following:

(A) Possess beam-limiting devices that allow the entire chest wall edge of the X-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the X-ray field does not extend beyond any edge of the image receptor by more than 2.0% of the SID;

(B) Provide that if a light field that passes through the X-ray beam limitation device is used, it is aligned with the X-ray field so that the total of any misalignment of the edges of the light field and the X-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2.0% of the SID; and

(C) The chest wall edge of the compression paddle does not extend beyond the chest wall edge of the image receptor by more than 1.0% of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image.

(12) The uniformity of screen speed of all cassettes in the facility are tested, and that the difference between the maximum and minimum optical densities do not exceed 0.30. The optical density of the test films shall be no less than 1.4;

(13) During the uniformity of screen speed test specified in subsection (e)(12), system artifacts are evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and performed on all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. The optical density of the test films shall be no less than 1.4;

(14) System artifacts are evaluated for all available focal spot sizes and target/filter combinations used clinically;

(15) Until October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 4.5 mGy air kerma per second (513 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector;

(16) After October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 7.0 mGy air kerma per second (800 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector;

(17) If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, it provides:

(A) An override capability to allow maintenance of compression;

(B) A continuous display of the override status; and

(18) The calibration of the densitometer and sensitometer used by the facility meets the manufacturer's specifications; and

(19) For systems with image receptor modalities other than screen-film, the quality assurance program meets the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems specified in subsection (e)(10).

(f) Each facility conducting mammography shall ensure that:

(1) The darkroom or the area used to load or unload mammography film is cleaned each day before any mammography is performed;

(2) Intensifying screens are cleaned each week using a screen cleaner recommended by the screen manufacturer; and

(3) All view boxes used to score phantom images and interpret mammograms are cleaned each week. If the view box used to interpret mammograms is at a different location than where the mammograms are taken, the facility shall ensure that documentation establishing the following is available to personnel and Department inspectors:

(A) Physical location(s) where the mammograms produced by the facility are interpreted;

(B) For each location, the individual responsible for ensuring the view boxes are cleaned at intervals not to exceed seven calendar days; and

(g) After completion of the tests specified in subsections (a), (b), (d) and (e)(4), (10) and (19), if any of the test results fail to meet the specified criteria, the source of the problem shall be identified and corrective actions shall be taken before any further mammographic examinations are performed or any films are processed using the component of the mammography system that failed the test.

(h) Each facility conducting mammography shall, if any of the results of the tests specified in subsections (c), (e)(1) through (3), (5) through (9) and (11) through (18) and (f) fall outside the action limits, identify the source of the problem and take corrective actions within 30 days of the test date.

(i) All quality assurance data collected during tests conducted pursuant to this section shall be analyzed and if any problems are detected by analysis of that data, the problems shall be corrected to ensure compliance with this section.

(j) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (b)-(b)(2), (c), (e)(2)-(3), (e)(6)(A), (e)(13) and (f)(2)-(3), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.22. Acceptable Phantoms.

Note • History

(a) A phantom shall not be used unless it is approved by the FDA and is:

(1) Mammographic Accreditation Phantom Model 156 produced by Radiation Measurement, Inc.;

(2) Mammographic Accreditation Phantom Model 18-220 produced by Nuclear Associates; or

(3) Equivalent in thickness to a standard breast and;

(A) Contains six nylon fibers with the following diameters:

1. 1.56 millimeters (mm);

2. 1.12 mm;

3. 0.89 mm;

4. 0.75 mm;

5. 0.54 mm;

6. 0.40 mm;

(B) Contains five aluminum oxide speck groups, each containing six specks and each speck in the group has the same diameter. The diameter of the specks shall be:

1. 0.54 mm;

2. 0.40 mm;

3. 0.32 mm;

4. 0.24 mm;

5. 0.16 mm; and

1. 2.00 mm;

2. 1.00 mm;

3. 0.75 mm;

4. 0.50 mm;

5. 0.25 mm.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (a), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.30. Phantom Image Scoring Protocol.

Note • History

(a) This section shall apply only to screen-film mammography systems.

(b) Phantom images shall be scored in accordance with the following protocol. Each of the following object groups shall be scored separately and shall meet the criteria specified in section 30316.20(b)(3) and (e)(4):

(1) Score the fibers as follows:

(A) Begin with the largest fiber and move down in size, adding one point for each full fiber until a score of zero or one half is given, then stop.

(B) If the entire length of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one.

(C) If at least half, but not all, of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one half.

(D) If less than one half of a fiber can be seen or if the location or orientation is incorrect, that fiber receives a score of zero.

(E) After determining the last fiber to be counted, look at the overall background for artifacts. If there are background objects that are fiber-like in appearance and are of equal or greater brightness than the last visible half or full fiber counted, subtract the last half or full fiber scored.

(2) Score the speck groups as follows:

(A) Begin with the largest speck group and move down in size adding one point for each full speck group until a score of one half or zero is given, then stop.

(B) If at least four of the specks in any group are visualized, the speck group is scored as one.

(D) If one speck or no specks from a group are visualized, the score is zero.

(E) After determining the last speck group to receive a full or one-half point, look at the overall background for artifacts. If there are speck-like artifacts within the insert region of the phantom that are of equal or greater brightness than individual specks counted in the last visible half or full speck group counted, subtract the artifact speck from the observed specks, one by one. Repeat the scoring of the last visible speck group after these deductions.

(3) Score the masses as follows:

(A) Begin with the largest mass and add one point for each full mass observed until a score of one half or zero is assigned, then stop.

(B) Score one for each mass that appears as a minus density object in the correct location that can be seen clearly enough to observe round, circumscribed borders.

(C) Score one-half if the mass is clearly present in the correct location, but the borders are not visualized as circular.

(D) After determining the last full or half mass to be counted, look at the overall background for artifacts. If there are background objects that are mass-like in appearance and are of equal or greater visibility than the last visible mass, subtract the last full or half point assigned from the original score.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.40. Processing of Mammograms and Phantom Images.

Note • History

Each facility possessing a facility accreditation certificate and conducting screen-film mammography shall process phantom images in the processor(s) designated by the facility to process mammograms.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.50. Mammographic Image Identification.

Note • History

(a) The following information shall be placed on each mammogram in a permanent, legible manner that does not obscure anatomic structures:

(1) Name of patient and an additional patient identifier;

(2) Date of examination;

(3) View and laterality, which shall be indicated on the image in a position near the axilla using the abbreviations specified in subsections (b) and (c);

(4) Facility name, city, state and zip code of the facility that performed the mammogram;

(5) Technologist identification;

(6) Identification of the cassette/screen used in producing the mammographic image; and

(7) Radiation machine identification if there is more than one radiation machine used for mammography at the facility.

(b) The following abbreviations shall be used to indicate laterality:

(1) Right: “R”;

(2) Left: “L”.

(1) Craniocaudal: “CC”;

(2) Mediolateral oblique: “MLO”;

(3) Mediolateral: “ML”;

(4) Lateromedial: “LM”;

(5) Lateromedial oblique: “LMO”.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30316.60. Medical Physicist Survey Reports.

Note • History

(a) Each facility conducting mammography shall undergo an annual survey by a medical physicist or an individual under the direct supervision of a medical physicist, and shall obtain a survey report, dated and signed by the medical physicist and, if an individual performed the survey under the direct supervision of a medical physicist, the individual being supervised, showing:

(1) The results with measurements and calculated data used for the mammography system evaluation and the calibration record required in section 30316.61(a);

(2) The results of the quality assurance testing evaluation, as well as written documentation of any corrective actions taken and their results; and

(3) Written recommendations for corrective actions according to all results required to be in the report, if applicable.

(b) The survey report, specified in subsection (a), shall be obtained within 30 calendar days of the date the medical physicist performed and completed the survey. A facility shall require the medical physicist to notify them within 72 hours of the date the tests were performed of any deficiencies that involve any of the items listed in subsection (g) of section 30316.20.

(c) The survey report shall identify each radiation machine by the facility's radiation machine identification number as specified in section 30317(g).

(d) The survey report, reviews, and calibration documentation required by this section shall be maintained in accordance with section 30319.20.

NOTE

Authority cited: Sections 115060, 131051 and 131200, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (a)(1), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of subsection (c) and Note filed 7-11-2007; operative 8-10-2007 (Register 2007, No. 28).

§30316.61. Instruments Used by Medical Physicists.

Note • History

(a) Instruments used by medical physicists to measure the air kerma or air kerma rate from a radiation machine shall be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration shall be traceable to a national standard and calibrated with an accuracy of plus or minus 6.0% (95% confidence level) in the mammography energy range. The calibration record shall be maintained in accordance with section 30319.20.

(b) Instrumentation used by the medical physicist to measure the illumination as specified in section 30316(b)(13) shall be calibrated in units of lux or foot candles and shall meet manufacturer specifications.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317. General Facility Requirements.

Note • History

(a) The facility shall designate a quality assurance technologist.

(b) Tests specified in section 30316.20(a) through (d) and (f) shall be performed by the quality assurance (QA) technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the QA technologist shall ensure that the specified tests are performed correctly. The QA technologist shall maintain documentation of training received by the other personnel.

(c) The facility's lead interpreting physician shall verify that the provisions of this section and sections 30316.20, 30316.40, 30316.50, 30316.60, 30317.10, 30317.20, 30317.30, 30317.40, 30317.60, and 30319.20 are met.

(d) A facility shall ensure an interpreting physician is available by telephone or in person for consultation when mammographic examinations are performed.

(e) A facility shall ensure that mammographic examinations are performed under the supervision, as defined in Health and Safety Code section 114850(g), of an individual who meets the requirements of section 30315.50.

(f) Each facility shall provide and require that all operators of radiation machines used for mammography use a chart or manual that specifies technique factors to be utilized relative to the patient's body habitus.

(g) Each facility shall maintain an inventory of each mammography X-ray machine. The inventory shall identify each machine by a unique radiation machine identification number. That number shall be permanently affixed to the machine.

NOTE

Authority cited: Sections 115060, 131051 and 131200, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

3. New subsection (g) and amendment of Note filed 7-11-2007; operative 8-10-2007 (Register 2007, No. 28).

§30317.10. Mammography Quality Assurance Program.

Note • History

(a) Each facility shall establish and maintain a mammography quality assurance (QA) program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility. A review of the QA program shall be conducted and documented by the lead interpreting physician at intervals not to exceed six months. The QA program shall, at a minimum, include the following:

(1) Establishment of operating levels meeting manufacturer specifications by which the criteria specified in section 30316.20(a) is compared.

(2) Documentation of accreditation by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) and certification by FDA;

(3) Documentation that each interpreting physician who interprets mammograms for the facility meets the requirements of section 30315.50.

(4) Documentation that each mammographic radiologic technologist who performs mammography meets the requirements of section 30315.51;

(5) Documentation that each medical physicist who performs the tests specified in section 30316.20(e) meets the requirements of section 30315.52;

(6) The QA manual required by section 30317.20;

(7) The mammography procedures manual required by section 30317.30; and

(8) If the facility is a mobile service provider, a list identifying the physical location where radiation machines are used.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.20. Quality Assurance Manual.

Note • History

(a) Each facility that performs mammography shall establish and maintain a written quality assurance (QA) manual. The lead interpreting physician shall document a review of the QA manual at intervals not to exceed six months. At a minimum, the QA manual shall contain:

(1) A list of names identifying the following:

(A) The lead interpreting physician designated by the facility;

(B) The quality assurance technologist;

(D) The company providing processor and equipment services.

(2) The procedures to be used to ensure that the tests specified in section 30316.20(a) through (d) and (f) are performed and the criteria have been met;

(3) The procedure for correcting each finding that fails to meet the requirements of section 30316.20(a) through (f);

(4) Examples of the forms to be used for each test specified in section 30316.20 (a) through (d) and (f);

(5) Documentation that equipment used during QA tests specified in section 30316.20 meet manufacturer specifications;

(6) The most recent survey report required to be obtained pursuant to section 30316.60 and evidence that instruments used by the medical physicist are calibrated pursuant to section 30316.61;

(7) Documentation of all QA tests required to be performed pursuant to section 30316.20(a) through (d) and (f);

(8) Documentation of compliance with section 30316.20(g) and (h);

(9) Documentation of compliance with section 30316.10 covering the previous two years;

(10) Documentation that each interpreting physician, mammographic radiologic technologist and medical physicist has reviewed the manual annually or, if any update has occurred, evidence that the manual has been reviewed by the said individuals; and

(11) Documentation of preventive and corrective maintenance, chemistry replacement and cleaning of each processor used to process mammograms. The documentation shall contain the signature of the individual who performed the maintenance.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.30. Mammography Procedures Manual.

Note • History

(a) Each facility shall establish a written mammography procedures manual. The lead interpreting physician shall document a review of the manual at intervals not to exceed six months. The mammography procedures manual shall, at a minimum, contain the following:

(1) The procedure for corrective action when the images interpreting physicians are asked to interpret are of poor quality and documentation that the procedure is followed;

(2) A policy that requires each interpreting physician to participate in the mammography medical outcomes audit as specified in section 30317.60;

(3) Examples of mammographic examination reports in lay language for each assessment of findings category and the procedures used to ensure the patient, if the patient does not indicate a health care provider, is referred to a health care provider if the patient's mammogram is interpreted by an interpreting physician as a positive mammogram;

(4) The procedure used to inquire whether or not the patient has prosthetic devices implanted in the breast prior to the mammographic examination and evidence that the procedure is followed. The procedure shall specify that except where contraindicated, or unless modified by a physician's directions, patients with such implants shall have mammographic views to maximize the visualization of breast tissue;

(5) The procedure to be used by each mammographic radiologic technologist to ensure that prior to each mammographic examination the mammography equipment is disinfected. The procedure shall comply with title 29, Code of Federal Regulations section 1910.1030 as of July 1, 2001, title 8, California Code of Regulations section 5193 and with the manufacturer's recommended procedures for cleaning and disinfection of the mammography equipment used in the facility;

(6) The procedures used to comply with section 30317.70 pertaining to consumer complaints;

(7) The procedure used to ensure mammographic examination reports are sent as required by section 30317.40; and

(8) Documentation that the mammography medical outcomes audit is performed as specified in section 30317.60.

(b) Procedures and policies developed to comply with this section shall be followed by the facility.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (a)(5), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.40. Mammographic Examination Reports.

Note • History

(a) Each facility shall ensure that a written report of the results of each mammographic examination conducted at that facility is prepared and includes at least the following:

(1) Name of the patient and an additional patient identifier;

(2) Date of the examination;

(3) Name of the interpreting physician who interpreted the mammogram;

(4) Overall assessment of findings, classified in one of the following categories:

(A) “Negative:” Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained);

(B) “Benign:” Also a negative assessment;

(D) “Suspicious:” Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

(E) “Highly suggestive of malignancy:” Finding(s) has a high probability of being malignant;

(5) In cases where a final assessment category cannot be assigned due to incomplete work-up, “Incomplete: Need additional imaging evaluation” shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and

(6) Recommendations made to the patient's health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring physician shall be addressed in the report to the extent possible, even if the assessment of findings is negative or benign.

(b) Each facility shall ensure that the report specified in subsection (a) is summarized in lay terms and sent no later than 30 calendar days from the date of the mammographic examination to the patient.

(c) Each facility shall ensure that the report specified in subsection (a) is sent no later than 30 calendar days from the date of the mammographic examination to the referring physician(s), or if the patient is self-referred, to the physician indicated by the patient or the physician to whom the facility refers the patient.

(d) Each facility shall verify that:

(1) Patients with an overall assessment of findings of “suspicious” or “highly suggestive of malignancy” and patients needing repeat examinations have received notification; and

(2) Physicians have received notification of patients with an overall assessment of findings of “suspicious” or “highly suggestive of malignancy” and needing repeat examinations.

(e) If an interpreting physician has given a mammogram an assessment of findings as “suspicious” or “highly suggestive of malignancy,” the facility shall attempt to communicate the results to the patient within five working days and the health care provider or if the health care provider is unavailable, to a responsible designee of the health care provider within three working days.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (a)(6) and (e), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.50. Mammogram and Report Retention.

Note • History

Unless otherwise required by law, each facility that performs mammography shall:

(a) Unless transferred in accordance with subsection (b), maintain mammograms and the reports specified in section 30317.40 for a minimum of seven years and if no additional mammograms of the patient are taken by the facility, mammograms and reports shall be maintained for a minimum of ten years.

(b) Upon request or on behalf of the patient, permanently or temporarily transfer the original mammograms and copies of the patient's mammographic examination reports to a medical institution, a physician or to the patient directly. Any fee charged for this service shall not exceed the documented cost of the service.

(c) If the facility will discontinue the performance of mammography, notify the Department prior to discontinuing mammography of how all records kept pursuant to subsection (a) will be maintained.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 123145, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.60. Mammography Medical Outcomes Audit.

Note • History

(a) Each facility possessing a facility accreditation certificate shall collect and review outcome data for all mammograms interpreted by the facility as a positive mammogram, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammographic examination report. Each facility shall analyze these outcome data for all interpreting physicians, both individually and collectively. The lead interpreting physician or an interpreting physician designated by the lead interpreting physician shall perform the analysis.

(b) For any cases of an individual diagnosed with breast cancer who was imaged at the facility and whose identity became known to the facility, the facility shall initiate follow-up on surgical and/or pathology results and conduct a review of any mammogram taken prior to the diagnosis of a malignancy. These cases shall be included in the analysis required pursuant to subsection (a).

(c) Each facility possessing a facility accreditation certificate shall ensure that the analysis required by subsection (a) is initiated no later than 12 months after the date of issuance of the facility accreditation certificate. The analysis shall be completed within 12 months of the date the analysis was initiated. Subsequent audit analyses shall be performed at least once every 12 months thereafter.

(d) The facility's lead interpreting physician or an interpreting physician designated by the lead interpreting physician, shall:

(1) Record the dates of the audit period(s);

(2) Document the results;

(3) Review the medical outcomes audit data;

(4) Analyze the results of the audit;

(5) Provide the results of the review of a specific interpreting physician to that interpreting physician and the overall results of the review for the facility review; and

(6) Provide a written description of any follow-up actions and the nature of the follow-up actions taken.

(e) Each facility shall maintain reports, outcome data, analyses and documentation of actions taken specified in this section in accordance with section 30319.20.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30317.70. Consumer Complaints.

Note • History

Each facility possessing a facility accreditation certificate shall:

(a) Establish a written procedure for collecting and resolving consumer complaints;

(b) Maintain a record of each serious complaint received by the facility in accordance with section 30319.20;

(c) Provide to the consumer, upon request, a copy of the facility's procedure required in subsection (a) and instructions for filing serious complaints to the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility;

(d) Report unresolved serious complaints to the Department within 30 calendar days of receiving the complaint.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (b), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30318.10. Additional Requirements for Mobile Service Providers.

Note • History

(a) Prior to the performance of mammography by a mobile service provider at a location other than a location identified on the application submitted pursuant to section 30315.22 or 30315.23, the provider shall notify the Department. The notification shall include:

(1) The name and address of the mobile service provider;

(2) The certificate number as shown on the facility accreditation certificate of the mobile service provider;

(3) The physical location of the new location where mammography will be performed;

(4) The name and telephone number of the individual who is allowing the service to be provided at the new location;

(5) If the radiation machine is moved to where the mammographic examinations will be performed, the designated room number within the physical building at the new location of use; and

(6) The physical location where mammograms produced at the new location will be processed.

(b) After each relocation of the radiation machine and before the performance of mammography on humans, the processor shall be tested to ensure that the criteria specified in section 30316.20(a) are met, and the radiation machine shall be tested to ensure that it meets the requirements of section 30316.20(b)(1) through (3). If a processor is not available at the location where mammography is performed, a phantom image shall be produced by using the procedure specified in section 30316.20(b). The selected kilovoltage-peak and milliampere-seconds (mAs) shall be recorded and compared to the mAs value previously established as meeting the phantom image criteria specified in section 30316.20(b). If the two mAs values are within plus or minus 10 percent of each other, mammography may be performed. If the values exceed the limits, mammography shall not be performed and corrective actions shall be taken to bring the two values within the limit.

(1) The mammograms shall be transported in a container that protects the film from exposure to light, heat, humidity, radiation, and conditions that may damage the mammograms and processed within 48 hours from the time the mammogram is taken;

(2) A log shall be maintained that includes the name of each patient and unique identification number, date, and time of the first exam of each batch, and date and time of batch processing in accordance with section 30319.20; and

(3) The container used to transport the mammograms shall be cleaned at intervals not to exceed seven days or if mammography is performed at greater intervals, before the mammograms are transported.

(d) Prior to processing mammograms, the provider shall ensure that the test specified in section 30316.20(a) has been met and that the phantom image produced during the test specified in subsection (c) of this section meets the phantom image criteria specified in section 30316.20(b) and if the phantom image fails due to processing problems, the problems shall be corrected prior to processing the mammograms. If the phantom image fails due to a non-processor problem, the provider may process the mammograms, but the lead interpreting physician shall evaluate each mammogram to determine whether any patient must be recalled to have their mammograms repeated. Prior to further clinical use, the mammography system shall be evaluated and problems corrected to ensure that the mammography system is in compliance with all requirements of this article.

(e) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (b) and (c)(1), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30318.11. Posting Requirements for Mobile Service Providers.

Note • History

(a) Each mobile service provider shall ensure the following are kept with each radiation machine used to perform mammography in a mobile setting:

(1) All items required to be posted pursuant to section 30255;

(2) The mammographic radiologic technologist's certificate issued pursuant to section 30455.1 to the individual performing the mammographic examination and posted so the patient can view it during the examination;

(3) For facilities performing mammography, the lead interpreting physician's radiology supervisor and operator certificate issued pursuant to section 30466(d) or 30467 and posted so the patient can view it during the examination;

(4) The document required to be posted on the radiation machine pursuant to Health and Safety Code section 115115(b) so the patient can view it during the examination;

(5) A copy of the certificate issued by FDA and posted so the patient can view it during the examination;

(6) The quality assurance records for on-board processors as specified in section 30316.20(a) for at least the last 30 calendar days.

(7) Documentation that, for each location of use visited in the last 30 calendar days, section 30318.10(b) has been met; and

(8) The quality assurance manual as specified in section 30317.10.

(b) Each provider shall maintain a log that identifies the date and physical location where each radiation machine is used.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30319. Notification Requirements.

Note • History

(a) Within 30 calendar days of the occurrence of any of the following events, each facility that performs mammography shall inform the Department of the event:

(1) Change in the information submitted in response to section 30315.22(a)(1);

(2) Change in the identity of the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility;

(3) Change in certification status with the FDA;

(4) Change in facility personnel and, if adding an interpreting physician, mammographic radiologic technologist, or medical physicist;

(5) Change in location of a radiation machine within the facility;

(6) Change in facility name or owner;

(7) Disassembly and reassembly of any radiation machine or processing equipment;

(8) Change in the accreditation status;

(9) Change in the facility's contact person.

(b) Notifications made pursuant to this section shall be made in writing and contain the name, signature and date of signature of the facility administrator, owner or designee.

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§30319.20. Record Keeping Requirements.

Note • History

(a) Each facility shall maintain and make available for inspection by the Department the records specified in Table 1 until Department inspection or the time interval specified which ever is greater:

Table 1. Record Keeping Requirements

(b) Each facility shall maintain records for inspection by the Department showing calibrations, maintenance, and modifications performed on each radiation machine for three years. These records shall include the date of the calibration, maintenance, or modification performed, the name of the individual making the record, and the manufacturer's model and the facility's radiation machine identification number as specified in section 30317(g).

(c) Each facility shall maintain records showing the receipt, transfer, and disposal of radiation machines pursuant to section 30293. These records shall include the date of receipt, transfers, or disposal, the name and signature of the individual making the record, and the manufacturer's model and the facility's radiation machine identification number as specified in section 30317(g). Records shall be maintained for inspection by the Department until the facility ceases use and disposes of the radiation machine.

NOTE

Authority cited: Sections 115060, 131051 and 131200, Health and Safety Code. Reference: Section 115060, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of subsections (b)-(c) and amendment of Note filed 7-11-2007; operative 8-10-2007 (Register 2007, No. 28).

§30320.90. Grounds for Suspension, Revocation, Amendment or Restriction of a Facility Accreditation Certificate.

Note • History

(a) A facility accreditation certificate may be revoked, suspended, amended or restricted for any of the following:

(1) Violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department;

(2) Failure to pay fees pursuant to sections 30145 or 30145.1;

(3) Refusal to submit to clinical image review or mammography review as directed by the Department;

(4) Failure of clinical images to pass clinical image review or mammography review;

(5) Failure to take corrective action when directed by the Department;

(6) Failure to report changes pursuant to section 30319;

(7) Procuring a facility accreditation certificate by fraud, or misrepresentation, or because of mistake;

(8) Failure to maintain mammograms and reports pursuant to section 30317.50;

(9) Failure to ensure the average glandular dose criteria specified in section 30316.20(e)(10) is not exceeded;

(10) Failure during a Department inspection to obtain the phantom image score specified in section 30316.20(b)(3);

(11) Failure to comply with policies or procedures required to be developed pursuant to section 30317.30; and

(12) Suspension or revocation of the facility's certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(a).

NOTE

Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100, 115115, 115145, 115165 and 115215, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

Article 5. Special Requirements for the Use of Radioactive Material in the Healing Arts [Repealed]

§30321. Accountability, Storage, and Transit. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of article 8 (30320, 30321) and new article 8 (30321) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former article 8 see Register 62, No. 1.

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

3. Amendment of article heading and subsection (b) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

5. Repealer of article 5 (sections 30321-30322) and section filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).

§30321.1. Confirming Removal of Implants. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 35.15(b) (vi) and (vii) (39 FR 26143 and 43 FR 553467).

HISTORY

1. New section filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

2. Repealer filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).

§30322. Records and Reports of Misadministration. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section field 9-5-89; operative 10-5-89 (Register 89, No. 36)

2. Repealer filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).

Article 6. Special Requirements for Radiographic Operations in Industrial Radiography

§30330. Definitions Specific to Industrial Radiography.

Note • History

(a) The definitions in section 30100 apply to this article.

(b) As used in this article:

(1) “Annual refresher safety training” means training conducted or provided by a licensee or registrant for its employees on radiation safety aspects of industrial radiography including the topics specified in sections 30333(d) or 30336.1(q);

(2) “Associated equipment” means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the sealed source (e.g., guide tube, control tube, control cable, removable source stop, “J” tube and collimator when it is used as an exposure head);

(3) “Cabinet X-ray system” means an X-ray system with the X-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed and intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. An X-ray tube used within a shielded part of a building, or X-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet X-ray system;

(4) “Collimator” means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure;

(5) “Control cable” means the cable that is connected to the source assembly and used to drive the source to and from the exposure location;

(6) “Control mechanism” means a device that enables the source assembly to be moved to and from the radiographic exposure device;

(7) “Control tube” means a protective sheath for guiding the control cable, which connects the control mechanism to the radiographic exposure device;

(8) “Exposure head” means a device that locates the sealed source in the selected working position;

(9) “Field radiography” means industrial radiography using a radiation machine but excludes cabinet X-ray systems and shielded-room radiography machines;

(10) “Field station” means a facility where licensed material may be stored or used and from which equipment is dispatched;

(11) “Guide tube” means a flexible or rigid tube (i.e., “J” tube) for guiding the source assembly and the attached control cable from the radiographic exposure device to the exposure head;

(12) “Identification card” (ID) means either an ID card issued by:

(A) A licensee, pursuant to section 30333(b)(2), designating the individual as a radioactive materials radiographer's assistant;

(B) A registrant, pursuant to section 30336.5, designating the individual as a radiation machine radiographer's assistant; or

(13) “Industrial radiography” means the examination of the physical structure, but not the microscopic structure, or elemental or chemical composition, of materials, other than human beings or animals, utilizing radiation;

(14) “Permanent radiographic installation” means a shielded installation or structure designed or intended for industrial radiography and in which industrial radiography is performed;

(15) “Practical examination” means a demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures;

(16) “Radiation Safety Officer” means an individual with the responsibility for the overall radiation safety program on behalf of the:

(A) Licensee and who meets the requirements of section 30333.07; or

(B) Registrant and who meets the requirements of section 30336.7;

(17) “Radiographer” means any individual who performs radiographic operations or who, while in attendance at the site where radiographic operations are being performed, personally supervises such operations and who is responsible to the user for assuring compliance with the requirements of this regulation, license or registration conditions and is certified pursuant to sections 30335.2 or 30335.4 or is in compliance with section 30335.3;

(18) “Radiographer certification” means written approval indicating that an individual has satisfactorily met the requirements to be a radiographer;

(19) “Radiographer trainer” means a radiographer who meets the requirements of sections 30333.05 or 30336.6;

(20) “Radiographer's assistant” means any individual who has met the requirements of sections 30333(b) or 30336.5(a)(1) and who must be under personal supervision as required by sections 30333(c) or 30336.1(o);

(21) “Radiographic exposure device” means any device containing a sealed source used to make a radiograph;

(22) “Radiographic operations” means all activities associated with the presence of radiation machines or radioactive sources for the performance of industrial radiography (except when being transported by a common or contract transport), and includes surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside a restricted area;

(23) “Radiographic personnel” means any radiographer, radiographer trainer, or radiographer's assistant;

(24) “Shielded position” means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement;

(25) “Shielded-room radiography” means industrial radiography using a radiation machine such that irradiation of the material occurs in an enclosed room designed to allow admittance of individuals and the room meets the requirements of subsections (d), (e) and (h) of section 30336;

(26) “Source assembly” means an assembly that consists of the sealed source and a connector that attaches the source to the control cable;

(27) “Source changer” means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources;

(28) “Storage area” means any location, facility, or vehicle which is used to store, to transport, or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source;

(29) “Storage container” means a container in which sealed sources are secured and stored;

(30) “S-tube” means a tube through which the radioactive source travels when inside a radiographic exposure device;

(31) “Temporary jobsite” means a location where radiographic operations are conducted and where licensed material may be stored other than those location(s) of use authorized on the license.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115230 and 115235, Health and Safety Code.

HISTORY

1. Repealer of article 9 and new article 9 (sections 30330 through 30336) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former article 9, see Register 62, No. 1.

2. Change without regulatory effect adding NOTE (Register 87, No. 11).

3. Amendment of article heading filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

5. Amendment of article heading and repealer and new section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30331. Eligibility for and Renewal of Approval as a Radiation Safety Training Provider and Provider Requirements.

Note • History

(a) To be eligible for or renewal of approval as a radiation safety training provider an applicant shall submit a complete application consisting of:

(1) The legal name, the mailing address and the telephone number of the applicant;

(2) The applicant's federal employer identification number and California taxpayer identification number, or if the applicant is an individual, the applicant's social security number (pursuant to the authority found in sections 131200 and 115000(b) of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification);

(3) Proof that the applicant's curriculum covers the subjects specified in section 30335.10 and includes, at a minimum:

(A) A description of course content covering those subjects;

(B) The number of hours spent on each subject; and

(4) The names of all instructors including each individual's training and experience in industrial radiography. There shall be at least one instructor who meets the requirements specified in sections 30333.05 and 30336.6 or at least two instructors such that one meets the requirements specified in section 30333.05 and the other meets the requirements of section 30336.6;

(5) A copy of a sample written examination and the correct answers to the test questions used for determining an individual's understanding of and competency in the subjects specified in section 30335.10. The examination shall be at least 50 questions in length. Successful completion shall be correctly answering at least 80 percent of the questions in a closed-book testing session; and

(6) The application fee specified in section 30336.8.

(b) Approval as a radiation safety training provider shall be valid for five years except that, for providers who possess a specific license issued pursuant to section 30195.3, the approval shall be valid for the period of time up to and including the expiration date as stated on the specific license unless that period of time is less than five years.

(1) Issue a certificate of training to each individual who satisfactorily completes radiation safety training. The certificate shall contain, at a minimum, the:

(A) Legal Name of the individual;

(B) Name and provider number as shown on the provider's approval;

(D) Statement “I (printed name of trainer or radiation safety officer) certify that the individual named on this certificate has satisfactorily completed the radiation safety training curriculum specified in Title 17, California Code of Regulations, section 30335.10;” and

(E) Original signature and date of signature of the provider's trainer or radiation safety officer;

(2) Maintain records of attendance for five years from the individual's completion of the radiation safety training;

(3) Notify the Department 30 calendar days prior to any change in the information submitted pursuant to subsections (a)(1) through (a)(4);

(4) Meet and continually maintain all standards set forth in the application and this section; and

(5) Be subject to Department audit.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965 and 114970, Health and Safety Code.

HISTORY

1. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Renumbering of former subsections (a)(5) and (a)(6) to subsections (a)(6) and (a)(7), and the new subsection (a)(5) filed 7-12-89; operative 8-11-89 (Register 89, No. 28).

3. Repealer and new section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332. Performance Requirements for Radiographic Exposure Devices, Storage Containers, and Source Changers.

Note • History

(a) All radiographic exposure devices and associated equipment used after January 10, 1996 shall comply with the following:

(1) Except as provided in subsection (b), each radiographic exposure device, source assembly or sealed source and all associated equipment shall meet the requirements specified in American National Standard N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” published as NBS Handbook 136, issued January 1981 (ANSI N432)*;

(2) Each radiographic exposure device shall have attached to it a durable, legible, clearly visible label bearing the:

(A) Chemical symbol and mass number of the radionuclide in the device;

(B) Activity and date on which this activity was last measured;

(D) Manufacturer of the sealed source; and

(E) Licensee's name, address and telephone number;

(3) Radiographic exposure devices intended for use as Type B transport containers shall meet the applicable requirements of section 30373;

(4) Modification of radiographic exposure devices, source changers, source assemblies and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the safety design features of the system;

(5) For radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation:

(A) The coupling between the source assembly and the control cable shall be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling shall be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions;

(B) The device shall automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device;

(C) The outlet fittings, lock box, and control cable fittings on each radiographic exposure device shall be equipped with safety plugs or covers which shall be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter;

(D) Each sealed source or source assembly shall have attached to it or engraved in it, a durable, legible, visible label with the words “Danger--Radioactive.” The label shall not interfere with the safe operation of the exposure device or associated equipment;

(E) The guide tube shall have passed the crushing tests for the control tube as specified in ANSI N432 and a kinking resistance test that closely approximates the kinking forces likely to be encountered during use;

(F) Guide tubes shall be used when moving the source out of the device.

(G) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations;

(H) The guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N432; and

(I) Source changers shall provide a system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the control cable to or from a source assembly.

(b) Equipment used in radiographic operations need not comply with section 8.9.2(c) of the Endurance Test in ANSI N432, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the industrial radiography equipment can realistically exert on the lever or crankshaft of the control mechanism.

(c) Storage containers and source changers shall not exceed a radiation exposure rate of 200 millirems per hour (mrem/hr) at any exterior surface and 10 mrem/hr at one meter from any exterior surface with the sealed source in the shielded position.

________

*Copies of American National Standard N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography” (published as NBS Handbook 136, issued January 1981) may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 and from the American National Standards Institute, Inc., Global Engineering Documents, 1819 L Street, NW, Suite 600, Washington DC 20036 or at “http://global.ihs.com” using the title as the search parameter.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former section 30332(a) to section 30332(a) and (b), renumbering and amendment of former section 30332(b) to section 30332.1, renumbering and amendment of former section 30332(c) to section 30332.3, renumbering and amendment of former section 30332(d) to section 30332.4, renumbering and amendment of former section 30332(e) to section 30332.5, renumbering and amendment of former section 30332(f) to section 30332.6, and renumbering and amendment of former section 30332(g) to section 30332.7 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section heading and Note and new subsections (c)-(c)(5)(I) filed 9-16-92; operative 10-16-92 (Register 92, No. 38).

3. Amendment of section, Note and footnote filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.1. Security of Radiographic Exposure Devices, Storage Containers and Source Changers.

Note • History

(a) Each radiographic exposure device shall be provided with a lock or outer locked container designed to prevent unauthorized or accidental exposure and shall be kept locked, and if a keyed-lock, with the key removed, at all times except during authorized use or when under the direct surveillance of a radiographer or radiographer's assistant. In addition, during radiographic operations a sealed source assembly shall be secured in the shielded position each time the source is returned to that position.

(b) Each storage container and source changer shall be provided with a lock and kept locked, and if a keyed-lock, with the key removed, when containing a sealed source except when the container is under the direct surveillance of a radiographer or radiographer's assistant.

(c) Locked radiographic exposure devices, storage containers and source changers shall be physically secured to prevent tampering or unauthorized removal.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(b) to Section 30332.1 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.2. Security of Permanent Radiographic Installations.

Note • History

(a) Each entrance that is used for personnel access to the high radiation area, defined in title 10, Code of Federal Regulations, Part 20 (10 CFR 20), section 20.1003 incorporated by reference in section 30253, in a permanent radiographic installation shall have either:

(1) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep-dose equivalent, defined in 10 CFR 20, section 20.1003 incorporated by reference in section 30253, of 0.1 rem in one hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates; or

(2) Both conspicuously visible and audible warning signals to warn of the presence of radiation. The visible signal shall be continuously actuated by radiation whenever a source is exposed. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed.

(b) If access is controlled pursuant to subsection (a)(1), the entrance control device shall be tested monthly. If access is controlled pursuant to subsection (a)(2), the system shall be tested with a radiation source each day before the installation is used for radiographic operations and shall include a check of both the visible and audible warning signals. In either case, if an entrance control device or warning signal is operating improperly, it shall be immediately labeled as defective and repaired within 30 calendar days. The installation may continue to be used during this 30-day period provided the licensee complies with section 30334 and each individual wears an alarming ratemeter in addition to other dosimeters required by section 30333.2(a).

(c) Documentation demonstrating compliance with this section shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Repealer and new section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.3. Radiation Survey Instruments.

Note • History

(a) Each user shall maintain a sufficient number of calibrated and operable radiation survey instruments to make radiation surveys as required by this regulation. Each instrument shall be capable of measuring a range of two millirems per hour through one rem per hour.

(b) Each radiation survey instrument shall be calibrated:

(1) At intervals not to exceed six months and after each instrument servicing;

(2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments at three points between two and 1000 millirems per hour; and

(3) So that an accuracy within plus or minus 20 percent of the calibration source can be demonstrated at each point checked.

(c) Records of the results of instrument calibrations shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(c) to Section 30332.3 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.4. Leak Testing, Repair, Tagging, Opening, Modification, and Replacement of Sealed Sources and Depleted Uranium Shielding.

Note • History

(a) Replacement of any sealed source in a radiographic exposure device, and leak testing, repair, tagging, opening or any other modification of any sealed source shall be performed only by persons specifically authorized by the Department to do so pursuant to Group 2 of this subchapter.

(b) Leak testing of sealed sources and radiographic exposure devices using depleted uranium (DU) shielding and an S-tube configuration shall be performed in accordance with section 30275 except that testing of radiographic exposure devices shall be tested for DU contamination at intervals not to exceed 12 months. If the test reveals the presence of 0.005 microcuries or more of removable DU contamination, the radiographic exposure device shall be removed from service and an evaluation of the S-tube shall be made. If the evaluation reveals that the S-tube is worn through, the radiographic exposure device shall not be used. Radiographic exposure devices with DU shielding need not be tested while in storage and not in use except that before using or transferring such a device, the device shall be tested for DU contamination if the interval of storage or non-use exceeded 12 months.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(d) to Section 30332.4 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.5. Quarterly Inventory of Sealed Sources.

Note • History

(a) Each user shall conduct a quarterly physical inventory to account for all sealed sources under his control.

(b) Records of the inventories shall be maintained for three years, kept available for inspection and include the:

(1) Quantities and kinds of radioactive material;

(2) Location of sealed sources;

(3) Date of the inventory; and

(4) Name of the individual conducting the inventory.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(e) to Section 30332.5 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.6. Utilization Logs.

Note • History

(a) Each user shall maintain current logs, which shall be maintained for three years and kept available for inspection at the address specified in his license, containing the following information for each sealed source:

(1) A description (or make, model, and serial number) of the radiographic exposure device or transport or storage container in which the sealed source is located;

(2) The identity and signature of the radiographer to whom assigned; and

(3) Locations where used and dates of use including the dates removed and returned to storage.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(f) to Section 30332.6 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.7. Inspection and Maintenance of Radiographic Exposure Devices, Storage Containers, Source Changers and Survey Instruments.

Note • History

(a) Each user shall perform visual and operability checks on survey instruments, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability shall be performed using a radiation source. If equipment problems are found, the equipment shall be removed from service until repaired.

(b) Each user shall establish and implement written procedures for:

(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure components important to safety are functioning. Replacement components shall meet design specifications. If equipment problems are found, the equipment shall be removed from service until repaired; and

(2) Inspection and maintenance necessary to assure that Type B packages are shipped and maintained in accordance with section 30373.

(c) Records of equipment problems and of any maintenance performed pursuant to this section shall be maintained for three years after the record is made. The record shall include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.

(d) Documentation demonstrating compliance with this section shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30332(g) to Section 30332.7 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section heading and repealer and new section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30332.8. Reporting Requirements.

Note • History

(a) In addition to the reporting requirements specified in section 30295 and under other sections of this subchapter, each licensee shall provide a written report to the Department within 30 days of the occurrence of any of the following incidents involving radiographic exposure devices and associated equipment:

(1) Unintentional disconnection of the source assembly from the control cable;

(2) Inability to retract the source assembly to its fully shielded position and secure it in this position; or

(3) Failure of any component (critical to safe operation of the device) to properly perform its intended function.

(b) The licensee shall include the following information in each report submitted under subsection (a):

(1) A description of the equipment problem;

(2) Cause of each incident, if known;

(3) Manufacturer and model number of equipment involved in the incident;

(4) Place, time and date of the incident;

(5) Actions taken to establish normal operations;

(6) Corrective actions taken or planned to prevent recurrence; and

(7) Qualifications of personnel involved in the incident.

(c) Any licensee conducting radiographic operations or storing radioactive material at any location not listed on the license for a period in excess of 180 days in a calendar year shall notify the Department prior to exceeding the 180 days.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.

HISTORY

1. New section filed 9-9-97; operative 10-9-97 (Register 97, No. 37). For prior history, see Register 94, No. 28.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333. Training and Supervision for Radiographers and Radiographer's Assistants Using Sealed Sources.

Note • History

(a) Prior to allowing an individual to perform as a radiographer, a user shall ensure the individual is a certified radioactive materials radiographer and has:

(1) Received copies of, instruction in, and demonstrated understanding of, applicable provisions of Group 3 of this subchapter, the conditions of the user's radioactive material license and operating and emergency procedures by successful completion of a written or oral examination covering this material. Instruction in this material shall be at least eight hours long. The examination shall be at least 50 questions in length. Successful completion shall be correctly answering at least 80 percent of the questions in a closed-book testing session;

(2) Demonstrated competence to use the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments employed by the user by successful completion of a practical examination covering this material. Instruction in this material shall be at least four hours long; and

(3) Received the instruction and training specified in subsections (a)(1) and (a)(2) from a radioactive materials radiographer trainer or radiation safety officer.

(b) Prior to allowing an individual to perform as a radioactive materials radiographer's assistant, a user shall:

(1) Ensure the individual has:

(A) Received copies of, instruction in, and demonstrated understanding of, applicable provisions of Group 3 of this subchapter, the conditions of the user's radioactive material license and operating and emergency procedures by successful completion of a written examination covering this material. Instruction in this material shall be at least eight hours long. The examination shall be at least 50 questions in length. Successful completion shall be correctly answering at least 80 percent of the questions in a closed-book testing session;

(B) Demonstrated competence to use the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments employed by the user by successful completion of a practical examination covering this material. Instruction in this material shall be at least four hours long; and

(C) Received the instruction and training specified in subsections (b)(1)(A) and (b)(1)(B) from a radioactive materials radiographer trainer or the user's radiation safety officer.

(2) Once the individual has met the requirements of subsection (b)(1), issue to the individual a durable identification card, resistant to water, containing:

(A) The statement “I certify that (the printed name of the individual) has met the requirements to be a radiographer's assistant.”;

(B) The name and license number, as shown on the specific license, of the user issuing the card; and

(c) Whenever a radiographer's assistant uses radiographic exposure devices, sealed sources or related source handling tools, or conducts radiation surveys required by section 30334 to determine that the sealed source has returned to the shielded position after an exposure, the radiographer's assistant shall be under the personal supervision of a radiographer trainer. The personal supervision shall include:

(1) The radiographer trainer's physical presence at the site where the sealed sources are being used;

(2) The ability of the radiographer trainer to give immediate assistance if required; and

(3) The radiographer trainer's watching the assistant's performance of the operations referred to in this section.

(d) Each user shall provide annual refresher safety training to all radiographic personnel at intervals not to exceed 12 months. The radiation safety officer (RSO) or an individual designated by the RSO shall conduct this training and, at a minimum, address or provide:

(1) Results of internal and Department inspections;

(2) New procedures or equipment;

(3) New or revised regulations about industrial radiography using sealed sources;

(4) Accidents or errors that have been observed and steps to prevent their recurrence; and

(5) Opportunities for individuals to ask safety questions.

(e) Except in those operations where a single individual serves as one of the radiographers required by section 30334(b) and the radiation safety officer (RSO) and performs all radiographic operations, the RSO or the RSO's designee shall conduct an internal inspection program to assure that radiographers and radiographer's assistants comply with this regulation and license conditions and the licensee's operating and emergency procedures. The inspection program shall include or provide:

(1) Observation of the performance of each radiographer and radiographer's assistants during an actual radiographic operation at intervals not to exceed six months; and

(2) That, if a radiographer or a radiographer's assistant has not participated in a radiographic operation for more than six months since the last inspection, that individual's performance shall be observed and recorded the next time the individual participates in a radiographic operation.

(f) Documentation demonstrating compliance with this section shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30333(a) to Section 30333(a)-(c), renumbering and amendment of former Section 30333(b) to Section 30333.1, and renumbering and amendment of former Section 30333(c) to Section 30333.2 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Register 72, No. 42.

2. Amendment of section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333.05. Radioactive Materials Radiographer Trainer Requirements.

Note • History

(a) A user shall not allow any individual to act as a radioactive materials radiographer trainer unless the:

(1) Individual is a radioactive materials radiographer who:

(A) Is certified pursuant to section 30335.2 or is in compliance with section 30335.3;

(B) Has complied with the requirements of section 30333(a)(1) and (2); and

(C) Has at least 2,000 hours of experience as a radiographer using sealed sources, performing radiographic operations, radiation surveys and radiation safety related activities. The experience may not include film development and interpretation, darkroom activities, travel, safety meetings, classroom training, and any work activity not related to the performance of industrial radiography; and

(2) User has received, pursuant to subsection (b), an amended license identifying the individual as a radiographer trainer.

(b) A user may apply for amendment of the specific license to identify a radiographer trainer by submitting:

(1) The name and license number as shown on the applicant's specific license; and

(2) For each individual who will perform as a radiographer trainer:

(A) The name and number as shown on the individual's radiographer certificate issued by the Department or a copy of both sides of the certification identification card issued by one of the entities listed in section 30335.3(b); and

(B) Documentation that the individual has complied with subsections (a)(1)(B) and (a)(1)(C). The documentation shall include the beginning and ending dates of the experience, the name of licensee under whom the experience was obtained and, for each radiographic exposure device used, the model and manufacturer's name.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333.07. Radioactive Material Radiation Safety Officer Requirements.

Note • History

(a) For an individual to be a radiation safety officer (RSO) for a specific licensee, the individual shall:

(1) Meet the requirements of section 30333.05(a)(1). Possession of a provisional radiographer certificate issued pursuant to section 30335.4 is not acceptable for complying with this section. No more than 900 hours of experience as a radiographer using radiation machines may be counted toward meeting the 2,000 hours specified in section 30333.05(a)(1)(C); and

(2) Have completed 4,000 hours of experience using radioactive materials and experience in radiation protection activities such as developing or implementing procedures relating to the protection of workers and the public from radiation including the development or implementation of procedures for radiation surveys, leak testing of radioactive sources, assessment of dosimetry for radiation work, determination of necessary radiation shielding, review of survey, leak testing, and personnel dose measurements, training of personnel, use and maintenance of sealed sources and devices, monitoring of radiation emergency events, sealed source and device security, disposal of radioactive material, audits of radiographic operations, survey meter maintenance and calibration, and transportation of radioactive material.

(b) The RSO shall ensure that radiation safety activities are being performed in accordance with approved procedures, conditions of the licensee's license, and the requirements of this regulation in the daily operation of the licensee's radiation safety program. Designation of an RSO does not relieve the specific licensee of any of its responsibility for complying with the Act and this regulation.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333.1. Operating and Emergency Procedures.

Note • History

(a) Each user shall establish, implement, maintain and keep current written operating and emergency procedures which shall include detailed instructions in at least the following matters:

(1) The handling and use of radiographic exposure devices and the manner of employment to control and limit radiation exposures to individuals;

(2) Methods and occasions for conducting radiation surveys;

(3) Methods and occasions for controlling access to radiography areas;

(4) Methods and occasions for locking and securing radiographic exposure devices, transport and storage containers and sealed sources;

(5) Personnel monitoring and the use of personnel monitoring devices;

(6) Steps that must be taken immediately by radiographic personnel in the event a pocket dosimeter is found to be off scale or an alarm ratemeter alarms unexpectedly;

(7) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicle, placarding of vehicles when needed and control of the sealed sources during transportation;

(8) Procedures in the event of an accident, including sealed source handling, minimizing radiation exposure to individuals, and notifying proper persons;

(9) Maintenance of records;

(10) The inspection, maintenance, and operability checks of radiographic exposure devices, survey instruments, transport and storage containers and source changers; and

(11) Source recovery procedures if licensee will perform source recovery.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Renumbering and amendment of former Section 30333(b) to Section 30333.2 filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior history, see Register 72, No. 42.

2. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333.2. Personnel Monitoring Control.

Note • History

(a) Radiographic operations using sealed sources shall not be performed unless, at all times during radiographic operations, all radiographic personnel wear, on the trunk of the body, a direct reading pocket dosimeter, an operating alarm ratemeter, and a personnel dosimeter that requires processing to determine the radiation dose except that at permanent radiographic installations, the wearing of an alarming ratemeter is not required. Each personnel dosimeter shall be assigned to and worn by only one individual.

(b) Film badges shall be replaced at periods not to exceed one month and other personnel dosimeters that require processing to determine the radiation dose shall be replaced at periods not to exceed three months. After replacement, personnel dosimeters shall be sent for processing by the users' dosimetry processor meeting the requirements of section 20.1501(c) of title 10, Code of Federal Regulations incorporated by reference in section 30253 as soon as possible but no later than recommended by the dosimetry processor.

(c) Pocket dosimeters shall have a range from zero to 200 millirems and be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

(d) Pocket or electronic personal dosimeters shall be read and exposures recorded at the beginning and end of each shift. A record of these exposures shall be retained for three years after the record is made and indicate, for each dosimeter used, the manufacturers name, model and serial number and name of individual to whom assigned.

(e) Pocket and electronic personal dosimeters shall be checked at periods not to exceed one year for correct response to radiation and shall read within plus or minus 20 percent of the true radiation exposure.

(f) If an individual's pocket dosimeter is found to be discharged beyond its range or if the individual's electronic personal dosimeter reads greater than 200 millirems and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter shall be sent for processing within 24 hours. The individual may not resume work associated with any source of radiation until the individual's radiation exposure has been determined. The user's radiation safety officer or his designee shall make this determination and the results shall be kept available for inspection and maintained until the Department terminates the license.

(g) Reports received from the dosimetry processor shall be retained for inspection until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(h) Each alarming ratemeter shall:

(1) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift;

(2) Be set to give an alarm signal at a preset dose rate of 500 millirems per hour;

(3) Require special means to change the preset alarm function;

(4) Be calibrated at periods not to exceed one year for correct response to radiation; and

(5) Alarm within plus or minus 20 percent of the true radiation dose rate.

(i) Alarming ratemeter calibration records shall be maintained for three years.

(j) If a personnel dosimeter that requires processing to determine the radiation dose is lost or damaged during radiographic operations, the worker shall cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The radiation safety officer shall perform the calculation. The results with measurements, calculated data, and assumptions made to obtain the calculated exposure and the time period for which the personnel dosimeter was lost or damaged shall be retained for inspection until the Department terminates the license.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115235, Health and Safety Code.

HISTORY

1. Repealer and new section filed 7-18-94 as an emergency; operative 7-18-94 (Register 94, No. 29). A Certificate of Compliance must be transmitted to OAL by 11-15-94 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 86, No. 28.

2. Editorial correction of subsection (a) (Register 94, No. 51).

3. Certificate of Compliance as to 7-18-94 order including amendment of Note transmitted to OAL 11-7-94 and filed 12-21-94 (Register 94, No. 51).

4. Amendment of section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30333.3. Location of Documents and Records.

Note • History

(a) In addition to the requirements of section 30293, each licensee shall maintain copies of records required by this regulation at the location identified in the specific license.

(b) Each licensee shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite:

(1) The license authorizing the use of licensed material;

(2) A copy this regulation, as defined in section 30100;

(3) Utilization records for each radiographic exposure device dispatched from that location as required by section 30332.6.

(4) Records of equipment problems identified in daily checks of equipment as required by section 30332.7;

(5) Records of alarm system and entrance control checks required by section 30332.2, if applicable;

(6) Records of direct reading dosimeters such as pocket dosimeter and/or electronic personal dosimeters readings as required by section 30333.2;

(7) Operating and emergency procedures required by section 30333.1;

(8) Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by section 30332.3;

(9) Evidence of the latest calibrations of alarm ratemeters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by section 30333.2;

(10) Latest survey records required by section 30334(h);

(11) Shipping papers for the transportation of radioactive materials required by section 30373; and

(12) When operating under reciprocity pursuant to section 30225, a copy of the Department's Notice of Reciprocal Recognition.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30334. Precautionary Procedures in Radiographic Operations Using Sealed Sources.

Note • History

(a) Radiographic operations shall not be performed unless performed by radiographic personnel.

(b) Industrial radiography, at a location other than at a permanent radiographic installation, shall not be performed, unless there are at least two radiographic personnel one of whom is a radiographer. If one of the personnel is a radiographer's assistant, the other shall be a radiographer trainer indicated as such on the specific license.

(1) Each radiographer has in their possession a current and valid certification identification (ID) card issued to them by the Department or the radiographer is in compliance with section 30335.3(a); and

(2) Each radiographer's assistant has in their possession the ID card issued to them by the licensee pursuant to section 30333(b)(2).

(d) During each radiographic operation, radiographic personnel shall maintain visual surveillance of the operation to protect against unauthorized entry into a high radiation area, except at permanent radiographic installations where all entryways are locked and the requirements of section 30332.2 are met.

(e) Areas in which industrial radiography is being performed shall be conspicuously posted as required by section 20.1902 of title 10, Code of Federal Regulations, part 20 (10 CFR 20) incorporated by reference in section 30253. Section 20.1903 of 10 CFR 20 shall not apply to industrial radiography.

(f) Radiographic operations shall not be performed unless calibrated and operable radiation survey instruments meeting the requirements of section 30332.3 are available and used.

(g) A radiation survey shall be made after each radiographic exposure and before exchanging films, repositioning the exposure head, or dismantling equipment to determine that the sealed source has been returned to its shielded position. The entire circumferences of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall include the guide tube.

(h) A radiation survey shall be made to determine that each sealed source is in its shielded condition prior to locking a radiographic exposure device, storage container or source changer as required by section 30332.1. Records of all such surveys shall indicate the manufacturer's name, model and serial number of the alarming ratemeter worn by and survey instrument used by the surveyor and the exposure value obtained. These records shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. Amendment of subsection (b) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

2. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

3. Change without regulatory effect of subsection (c) (Register 87, No. 4).

4. Amendment of subsections (c)-(e), relettering of former subsection (f) to subsection (g) and new subsection (f) filed 7-12-89; operative 8-11-89 (Register 89, No. 28).

5. Change without regulatory effect amending subsection (f) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

6. Amendment of subsections (a)(1) and (b) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

8. Amendment of section heading, section and Note filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335. Minimum Subjects to Be Covered in Training Radiographers. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815 and 25876, Health and Safety Code.

HISTORY

1. Amendment of subsection (c) filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

2. New subsections (b)(3)(D), (d) and (e) filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28)

3. Repealer filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.1. Radiographer Certification Categories.

Note • History

(a) The categories for radiographer certificates are:

(1) Radioactive materials;

(2) Radiation machines; and

(3) Combination (Radioactive materials and radiation machines).

(b) A radiographer certificate in the:

(1) Category of radioactive materials authorizes the individual to perform radiographic operations using sealed sources under a specific licensee;

(2) Category of radiation machines authorizes the individual to perform radiographic operations using radiation machines under a registrant; and

(3) Combination category authorizes the individual to perform radiographic operations using sealed sources and radiation machines under a licensee and registrant as applicable.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.2. Eligibility for and Renewal of a Radiographer Certificate.

Note • History

(a) Except as provided in sections 30335.3 or 30335.4, to be eligible for or renewal of a radiographer certificate an individual shall:

(1) Submit the application described in section 30335.5; and

(2) Pass a Department examination. If any applicant fails the test three times, the individual shall no longer be eligible unless they obtain additional radiation safety training and experience as directed by the Department. If any applicant fails the test on the fourth try, the individual shall not be eligible to take the exam for one year after which they may reapply pursuant to this section if the radiation safety training and experience requirements have been met in the year immediately preceding the date of re-application.

(b) The radiographer certificate shall be valid for five years.

(c) To renew an expired radiographer certificate, an applicant shall comply with subsection (a) and shall be considered as an initial applicant.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.3. Reciprocal Recognition.

Note • History

(a) Individuals certified by one of the entities listed in subsection (b) for the specified category need not possess a Department issued radiographer certificate provided:

(1) The individual's certification is current and valid;

(2) No escalated enforcement action is pending with the U.S. Nuclear Regulatory Commission, the certifying entity or any other state; and

(3) The certification identification card issued by the certifying entity is in the possession of the individual during radiographic operations within the jurisdiction of the Department in which the individual participates.

(b) The following certifying entities are recognized for compliance with subsection (a) in the:

(1) Category of radioactive materials by the:

(A) State of Alabama, Georgia, Illinois, Iowa, Louisiana, Maine, North Dakota, Oklahoma, South Carolina, or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Radiography Radiation Safety Personnel Certification;

(2) Category of radiation machines by the:

(A) State of Alabama, Illinois, Iowa, Louisiana, Maine, North Dakota, or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Radiography Radiation Safety Personnel Certification; or

(3) Combination category (radioactive materials and radiation machines) by the:

(A) State of Alabama, Illinois, Iowa, Louisiana, Maine, North Dakota, or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Radiography Radiation Safety Personnel Certification.

(c) Reciprocal recognition granted pursuant to this section may be revoked, suspended, amended or restricted for any of the following:

(1) Failure to maintain the certification upon which the reciprocal recognition was granted;

(2) Violation of any provision of the Act, any regulation promulgated pursuant to the Act, or any order of the Department;

(3) Incompetence or gross negligence in performing radiographic operations; or

(4) Exposing any individual to radiation with the intent to harm that individual.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.4. Provisional Radiographer Certificates.

Note • History

(a) Until December 31, 2009, an application for a provisional radiographer certificate shall be considered complete if the applicant submits the information for the certificate category as specified below. After December 31, 2009, applications for provisional radiographer certificates will not be accepted. To obtain a provisional radiographer certificate in the:

(1) Radioactive materials category, submit the information specified in section 30335.5(b)(1) and (2), the application fee specified in section 30336.8 and:

(A) If specified on a specific license as a radiographer, the name and license number as shown on the specific license; or

(B) Except as provided in subsection (b), if designated as a radiographer by a licensee, the name and license number of the licensee as shown on the specific license, and a letter from the licensee signed by the licensee's radiation safety officer verifying that the applicant has met the requirements of section 30335.10, has participated in (number of hours) hours of radiographic operations using radioactive materials and has demonstrated the capability of working independently as a radiographer. The number of hours of participation shall be at least 200 but shall not include the number of hours spent in safety meetings, classroom training, travel, darkroom activities, film development and interpretation, and any work activity not related to the performance of industrial radiography. If the training specified in section 30335.10 and the required hours were obtained under multiple licensees, the applicant shall submit enough documents to support completion of all required training;

(2) Radiation machine category, submit the information specified in section 30335.5(b)(1) and (2), the application fee specified in section 30336.8 and, except as provided in subsection (b):

(A) Documentation that the requirements of section 30335.10 have been met. Documentation shall indicate where the training occurred, total number of hours spent on the subjects listed in section 30335.10, and include a copy of the training certificate if one was issued. If a training certificate was not issued, the applicant shall so state; and

(B) Documentation of at least 120 hours of participation in radiographic operations using radiation machines. The hours of participation shall not include safety meetings, classroom training, travel, darkroom activities, film development and interpretation, and any work activity not related to the performance of industrial radiography. Documentation shall indicate the name and registration number of the registrant under whom the operations were performed, the dates and total number of hours of participation. If participation occurred under multiple registrants, the applicant shall submit enough documents to support completion of the 120 hours; or

(3) Combination category, submit the information specified in section 30335.5(b)(1) and (2), the information specified in subsections (a)(1) and (a)(2)(B) of this section and the application fee specified in section 30336.8. Individuals applying for the combination category must complete both the 200 hours of participation using radioactive material and 120 hours using radiation machines for a total of 320 hours.

(b) In lieu of the requirement in subsections (a)(1)(B) or (a)(2), training obtained through providers approved by one of the entities listed in section 30335.3(b) for the specified certificate category shall be accepted if the applicant completed that training. Documentation of completion shall be submitted.

(c) Certificates issued pursuant to this section shall be valid for two years and shall not be renewable. Applications for a renewable radiographer certificate shall be submitted pursuant to section 30335.2 and be considered as initial applications.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.5. Complete Radiographer Certificate Application.

Note • History

(a) For applicants possessing a current provisional radiographer certificate in a specified category issued pursuant to section 30335.4, an application submitted for compliance with section 30335.2 shall be considered complete if the application contains the applicant's legal name, mailing address, telephone number, the certificate number as shown on their provisional certificate and the examination fee as specified in section 30336.8.

(b) For applicants who do not possess a current provisional radiographer certificate, an application submitted for compliance with section 30335.2 shall be considered complete if the application contains:

(1) The legal name, mailing address, and telephone number of the applicant;

(2) The applicant's social security number (pursuant to the authority found in sections 131200 and 115000(b) of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification);

(3) Except as provided in subsection (c), for a radiographer certificate in the radioactive materials category:

(A) A copy of the applicant's certificate of training issued by a radiation safety training provider approved pursuant to section 30331 or if renewing the radiographer certificate, the certificate number as shown on the certificate; and

(B) Except for renewal applicants, documentation of at least 200 hours of participation in radiographic operations using radioactive material. The hours of participation shall not include the time spent on completing the requirements specified in section 30333(b)(1), safety meetings, classroom training, travel, darkroom activities, film development and interpretation, and any work activity not related to the performance of industrial radiography. Documentation shall be a letter from the licensee under whom the operations were performed verifying that the applicant has demonstrated the capability of independently working as a radiographer. The letter shall indicate the licensee's name and license number as shown on the specific license, the dates and total number of hours of participation and be signed by the licensee's radiation safety officer. If participation occurred under multiple licensees, the applicant shall submit enough documents to support completion of the 200 hours;

(4) Except as provided in subsection (c), for a radiographer certificate in the radiation machine category:

(B) Except for renewal applicants, documentation of at least 120 hours of participation in radiographic operations using radiation machines. The hours of participation shall not include the time spent on completing the requirements specified in section 30336.5(a)(1), safety meetings, classroom training, travel, darkroom activities, film development and interpretation, and any work activity not related to the performance of industrial radiography. Documentation shall indicate the name and registration number of the registrant under whom the operations were performed, the dates and total number of hours of participation. If participation occurred under multiple registrants, the applicant shall submit enough documents to support completion of the 120 hours;

(5) Except as provided in subsection (c), for a radiographer certificate in the combination category, all items specified in subsections (b)(3) and (b)(4)(B). Individuals applying for the combination category must complete both the 200 hours of participation using radioactive material and 120 hours using radiation machines for a total of 320 hours; and

(6) An application fee and an examination fee as specified in section 30336.8.

(c) In lieu of the requirement in subsections (b)(3), (b)(4) or (b)(5) to obtain training from providers approved pursuant to section 30331 and experience under a licensee or registrant, training obtained through providers approved by one of the entities listed in section 30335.3(b) for the specified certificate category shall be accepted if the applicant has completed that training. Documentation of completion shall be submitted.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.6. Notification of Change of Name or Address.

Note • History

Each individual certified pursuant to this Article shall report to the Department in writing any change of name or mailing address within 30 calendar days of the change.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30335.10. Radiation Safety Training Curriculum.

Note • History

An applicant for approval as a radiation safety training provider shall ensure each student completes at least 40 hours of training in:

(a) Fundamentals of Radiation Safety that addresses:

(1) Characteristics of radiation;

(2) Units of radiation dose and quantity of radioactivity;

(3) Significance of radiation dose to include hazards of excessive exposure to radiation, biological effects of radiation dose, radiation protection standards and case histories of industrial radiography accidents;

(4) Levels of radiation from radiation machines and radiographic exposure devices; and

(5) Methods of controlling radiation dose: working time, working distance, shielding.

(b) Radiation instrumentation that addresses:

(1) Use of radiation survey instruments: operation, calibration, and limitations;

(2) Radiation survey techniques; and

(3) Characteristics and use of personnel monitoring equipment: film badges, pocket dosimeters and chambers, thermoluminescent dosimeters, alarming ratemeters, and optically stimulated luminescent dosimeters.

(1) Operation and control of radiographic exposure devices, remote handling equipment, storage and transport containers, source changers, storage, control and disposal of radioactive material;

(2) Operation and control of radiation machines; and

(3) Inspection and maintenance of equipment.

(d) Federal and State radiation control regulations pertaining to industrial radiography.

(e) Generic written operating and emergency procedures addressing the procedures specified in section 30333.1.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336. Requirements for Shielded-Room Radiography.

Note • History

(a) A user conducting shielded-room radiography shall designate an individual as the radiation safety officer. This individual shall meet the criteria specified in section 30336.7.

(b) A user shall not allow any individual to perform shielded-room radiography unless the individual:

(1) Has completed the training specified in section 30335.10 from a provider approved pursuant to section 30331;

(2) Has received copies of, instruction in, and demonstrated understanding of, the user's operating and emergency procedures by obtaining a passing grade of at least 80 percent on a written examination covering this material. The written examination shall be at least 50 questions in length. Instruction in this material shall be at least eight hours long; and

(3) Has demonstrated competence to use the radiation machines and survey instruments employed by the user and in the kinds of radiographic operations that will be performed by obtaining a passing grade of at least 80 percent on a practical examination covering this material. The practical examination shall be at least 25 questions in length. Instruction in this material shall be at least four hours long.

(c) A user shall supply personnel dosimeters that require processing to determine the radiation dose to and require the use by every individual who operates, who makes “setups,” or who performs maintenance on a shielded-room radiography unit. Each personnel dosimeter shall be assigned to and worn by only one individual and processed in accordance with section 30333.2(b). Reports received from the dosimetry processor shall be available for inspection and maintained until the Department terminates the user's registration. If a personnel dosimeter is lost or damaged during radiographic operations, the worker shall immediately cease work using radiation sources until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The radiation safety officer shall perform the calculation. The results with measurements, calculated data, and assumptions made to obtain the calculated exposure and the time period for which the personnel dosimeter was lost or damaged shall be retained for inspection until the Department terminates the user's registration.

(d) All openings through which an individual could gain access to the room shall be interlocked so that the radiation machine will not operate unless all openings are securely closed. The required controls shall be designed such that an individual is not prevented from leaving the room.

(e) The room shall not be occupied during radiation exposures.

(f) A device shall be installed within the room that will, upon actuation, terminate production of radiation. It shall not be possible to reset, override, or bypass the device from outside the room.

(g) Radiation machines used in shielded-room radiography shall meet the requirements specified in American National Standard N537-1976 “Radiological Safety Standard for the Design of Radiographic and Fluoroscopic Industrial X-ray Equipment” published as NBS Handbook 123, issued August 1977*, which is incorporated by reference.

(h) The interior of the room shall be shielded so that every location on the exterior does not exceed the dose limits for an unrestricted area as specified in 10 CFR 20, subpart D incorporated by reference in section 30253.

(i) Documentation demonstrating compliance with this section shall be maintained for three years and kept available for inspection.

____________

*Copies of American National Standard N537-1976 “Radiological Safety Standard for the Design of Radiographic and Fluoroscopic Industrial X-ray Equipment” (published as NBS Handbook 123, issued August 1977) may be purchased from the American National Standards Institute, Inc., Global Engineering Documents, 1819 L Street, NW, Suite 600, Washington DC 20036 or at “http://global.ihs.com” document number “NBS HDBK 123.”

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970 and 115060, Health and Safety Code.

HISTORY

1. Amendment of subsection (c)(4) filed 5-13-69; effective thirtieth day thereafter (Register 69, No. 20).

2. Amendment of subsection (c)(5) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).

3. Change without regulatory effect adding NOTE (Register 87, No. 11).

4. Amendment of subsections (a), (b) and (c)(5) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

6. Repealer and new section heading, section and Note and filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336.1. Requirements for Field Radiography.

Note • History

(a) A user conducting field radiography shall designate an individual as the radiation safety officer. This individual shall meet the criteria specified in section 30336.7.

(b) Except as provided in subsection (e), field radiography shall not be performed unless:

(1) Performed by radiographic personnel; and

(2) There are at least two radiographic personnel one of whom is a radiation machine radiographer. If one of the personnel is a radiation machine radiographer's assistant, the other shall be a radiation machine radiographer trainer; and

(3) During each radiographic operation, radiographic personnel maintain visual surveillance of the operation to protect against unauthorized entry into a high radiation area.

(c) Except as provided in subsection (e), a user shall not allow any individual to act as a radiation machine radiographer unless the individual:

(1) Is a certified radiation machine radiographer or is in compliance with section 30335.3; and

(2) Has met the requirements of section 30336.5(a)(1).

(d) Except as provided in subsection (e), a user shall not allow any individual to act as a radiation machine radiographer's assistant unless the individual meets the requirements of section 30336.5(a)(1) and is under personal supervision of a radiation machine radiographer trainer or the radiation safety officer as required pursuant to subsection (o).

(e) The requirements of subsections (b), (c), (d), (n) and (o) do not apply if:

(1) Field radiography is performed with a radiation machine that is not capable of exceeding an operating potential of 150 kVp;

(2) The operator of the radiation machine has received at least eight hours of instruction in, and demonstrated, by successful completion of a written examination, an understanding of the following subjects. The examination shall be at least 50 questions in length. Successful completion shall be correctly answering at least 80 percent of the questions in a closed-book testing session:

(A) Characteristics of X-radiation;

(B) Units of radiation dose;

(D) Radiation levels from radiation machines;

(E) Methods of controlling radiation exposure: time, distance, and shielding;

(F) Use of radiation survey instruments: operation, calibration, and limitations;

(G) Radiation survey techniques;

(H) Characteristics and use of personnel monitoring equipment; and

(I) Use of radiation machines in radiography; and

(3) The operator has demonstrated competence to safely use the radiation machine in the kinds of radiographic operations that will be performed. Demonstration shall be by successful completion of a practical examination covering this material. Instruction in this material shall be at least four hours long.

(f) Each user shall implement, keep current, and maintain written operating procedures for the kinds of radiation machines and the kinds of radiographic procedures employed. These procedures shall include detailed instructions in at least the following:

(1) Means to be employed to control and limit exposure to individuals;

(2) Methods and occasions for conducting radiation surveys and for controlling access to radiography areas; and

(3) The use of radiation survey instruments and personnel monitoring devices.

(g) Radiographic operations shall not be performed unless, for each radiation machine energized, at least one radiation survey instrument, which meets the requirements of section 30332.3, capable of measuring radiation of the energies and at the dose rates to be encountered is available and used. Each registrant shall perform visual and operability checks on all survey instruments before use on each day the radiographic equipment is to be used to ensure that the radiographic equipment is in good working condition. Survey instrument operability shall be performed using a radiation source. If equipment problems are found, the equipment shall be removed from service until repaired.

(h) Areas in which field radiography is being performed shall be conspicuously posted as required by title 10 Code of Federal Regulation (CFR) Part 20, subpart J incorporated by reference in section 30253. The limits of a high radiation area need not be separately defined and posted if the surrounding radiation area is posted and controlled as a high radiation area.

(i) The boundaries of the controlled area for each “setup” shall be determined by a radiation survey during the first radiographic exposure to confirm that subsection (e) has been met and that unrestricted areas do not have radiation levels in excess of the limits specified in 10 CFR 20, subpart D incorporated by reference in section 30253. A radiation survey shall be made after each radiographic exposure to determine that the radiation machine is “off.” Survey results and records of boundary locations shall be maintained for three years and kept available for inspection.

(j) Protection against unauthorized entry into a high radiation area shall be controlled in accordance with section 20.1601(a) through (d) of 10 CFR 20 incorporated by reference in section 30253.

(k) Each user shall maintain current utilization logs, which shall be maintained for three years and kept available for inspection, containing the following information for each radiation machine:

(1) The identity of the machine;

(2) The location, date, and the identity of the individual operator for each use; and

(3) The voltage, current, and exposure time for each use.

(l) All requirements of section 30333.2 apply.

(m) Radiation machines used in field radiography shall meet the requirements specified in American National Standard N537-1976 “Radiological Safety Standard for the Design of Radiographic and Fluoroscopic Industrial X-ray Equipment” published as NBS Handbook 123, issued August 1977*, which is incorporated by reference.

(n) Unless exempted pursuant to subsection (e), field radiography shall not be performed unless, during radiographic operations:

(1) Each radiographer has in their possession the identification (ID) card issued to them by the Department and the ID card is current and valid or the radiographer is in compliance with section 30335.3(a); and

(2) Each radiographer's assistant has in their possession the ID card issued to them by the registrant pursuant to section 30336.5(a)(2).

(o) Unless exempted pursuant to subsection (e), whenever a radiation machine radiographer's assistant (RA) uses radiation machines or conducts radiation surveys to determine that the radiation machine is “off,” the RA shall be under the personal supervision of a radiation machine radiographer trainer or the radiation safety officer. The personal supervision shall include:

(1) The radiographer trainer's physical presence at the site where the radiation machine is being used;

(2) The ability of the radiographer trainer to give immediate assistance if required; and

(3) The radiographer trainer's watching the RA's performance of the operations referred to in this section.

(p) If a user possesses a radiation machine such that an individual could, in a single exposure to the primary beam with the machine set at maximum exposure factors, receive an exposure exceeding 10 percent of the occupational dose limits specified in title 10, Code of Federal Regulations, Part 20, subpart C incorporated by reference in section 30253, the user shall establish and maintain an internal inspection program to ensure radiographers and radiographer's assistants comply with this regulation and registration conditions and the registrant's operating and emergency procedures. The inspection program shall include or provide:

(1) Observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed six months;

(3) Retention of inspection records on the performance of radiographers or radiographer's assistants for three years.

(q) Each user shall provide annual refresher safety training to each radiographer and radiographer's assistant at intervals not to exceed 12 months. This training shall, at a minimum, address or provide:

(1) If an inspection program is required pursuant to subsection (p), results of internal inspections;

(2) Results of Department inspections;

(3) New procedures or equipment;

(4) New or revised regulations about industrial radiography using radiation machines;

(5) Accidents or errors that have been observed and steps to prevent recurrence; and

(6) Opportunities for individuals to ask safety questions.

(r) Unless otherwise stated in this section, documentation demonstrating compliance with this section shall be maintained for three years and available for inspection.

___________

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970 and 115060, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336.5. Requirements for Radiation Machine Radiographer's Assistants.

Note • History

(a) Prior to allowing an individual to perform as a radiation machine radiographer's assistant, a user shall:

(1) Ensure the individual has:

(A) Received copies of, instruction in, and demonstrated understanding of, the user's operating and emergency procedures by obtaining a passing grade of at least 80 percent on a written examination covering this material. The written examination shall be at least 50 questions in length. Instruction in this material shall be at least eight hours long; and

(B) Demonstrated competence to use the radiation machines and survey instruments employed by the user and in the kinds of radiographic operations that will be performed by obtaining a passing grade of at least 80 percent on a practical examination covering this material. The practical examination shall be at least 25 questions in length. Instruction in this material shall be at lest four hours long; and

(C) Received the instruction and training specified in subsections (a)(1)(A) and (a)(1)(B) from a radiation machine radiographer trainer or the registrant's radiation safety officer.

(2) Once the individual has met the requirements of subsection (a)(1), issue to the individual a durable identification (ID) card, resistant to water, containing the:

(A) Statement “I certify that (the name of the individual) has met the requirements to be a radiation machine radiographer's assistant.”;

(B) Name and registration number of the registrant issuing the ID card; and

(C) Printed name, signature and date of signature of the registrant's radiation safety officer or radiation machine radiographer trainer.

(b) A user may apply to be an approved provider of radiation safety training in accordance with section 30331.

NOTE

Authority cited: Sections 114975, 115000, 115060, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970 and 115060, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336.6. Radiation Machine Radiographer Trainer Requirements.

Note • History

(a) A user shall not allow any individual to act as a radiation machine radiographer trainer unless the individual:

(1) Is a certified radiation machine radiographer or is in compliance with section 30335.3;

(2) Has complied with the requirements of section 30336.5(a)(1); and

(3) Has at least 2,000 hours of experience using radiation machines, performing radiographic operations, radiation surveys and radiation safety related activities. The experience shall not include film development and interpretation, darkroom activities, travel, safety meetings, classroom training, performance of cabinet radiography, and/or any work activity not related to the performance of industrial radiography. Documentation shall specify:

(A) The user's name, registration number and name of the user's radiation safety officer;

(B) The beginning and ending dates of the experience; and

(b) Documentation demonstrating compliance with this section shall be maintained and available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 115060, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970 and 115060, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336.7. Radiation Machine Radiation Safety Officer Requirements.

Note • History

(a) Except as specified in subsection (c), for an individual to be a radiation safety officer (RSO) for a registrant, the individual shall:

(1) Meet the requirements of section 30336.6(a). Possession of a provisional radiographer certificate issued pursuant to section 30335.4 is not acceptable for complying with this section. No more than 900 hours of experience as a radiographer using radioactive material may be counted toward meeting the 2,000 hours specified in section 30336.6(a)(3); and

(2) Have completed 4,000 hours of experience using radiation machines and experience in radiation protection activities such as developing or implementing procedures relating to the protection of workers and the public from radiation including the development or implementation of procedures for radiation surveys, assessment of dosimetry for radiation work, determination of necessary radiation shielding, review of survey and personnel dose measurements, training of personnel, use and maintenance of radiation machines, monitoring of radiation emergency events, radiation machine security, audits of radiographic operations, and survey meter maintenance and calibration.

(b) The RSO shall ensure that radiation safety activities are being performed in accordance with the requirements of this regulation in the daily operation of the registrant's radiation safety program. Designation of an RSO does not relieve the registrant of any of its responsibility for complying with the Act and this regulation.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000 and 115060, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30336.8. Industrial Radiography Certification and Provider Fees.

Note • History

(a) The application fee for any category of radiographer certificate shall be $75.00.

(b) The examination fee for any category of radiographer certificate shall be $75.00. Each individual repeating a failed examination shall pay a fee of $75.00.

(d) The fee for replacement of a Department identification card shall be $10.00.

(e) Fees required by this section shall be nonrefundable.

NOTE

Authority cited: Sections 114975, 115000, 115065, 115080, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115065 and 115080, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30337. Requirements for Use of Cabinet X-ray Systems.

Note • History

(a) As used in this section:

(1) “Access panel” means any barrier or panel which is designed to be removed or opened for maintenance or service purposes, requires tools to open, and permits access to the interior of the cabinet;

(2) “Aperture” means any opening in the outside surface of the cabinet, other than a port, which remains open during generation of X-rays;

(3) “Door” means any barrier which is designed to be movable or opened for routine operation purposes, does not generally require tools to open, and permits access to the interior of the cabinet;

(4) “External surface” means the outside surface of the radiation machine, including the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across any aperture or port;

(5) “Ground fault” means an accidental electrical grounding of an electrical conductor;

(6) “Port” means any opening in the outside surface of the radiation machine which is designed to remain open, during generation of X-rays, for the purpose of conveying material to be irradiated into and out of the cabinet, or for partial insertion for irradiation of an object whose dimensions do not permit complete insertion into the cabinet;

(7) “Primary beam” means the radiation emitted directly from the target and passing through the window of the X-ray tube;

(8) “Safety interlock” means a device, which is intended to prevent the generation of radiation when access by any part of the human body to the interior of the detection system through a door or access panel is possible;

(9) X-ray system means an assemblage of components for the controlled generation of X-rays;

(10) “X-ray tube” means any electron tube, which is designed for the conversion of electrical energy into X-ray energy.

(b) Cabinet X-ray systems shall meet and be continually maintained to ensure the following are met:

(1) Radiation emitted from the system shall not, under any condition of use, exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters (cm) outside the external surface, or any door or port. The exposure shall be determined by measurements averaged over a cross-sectional area of ten square cm with no linear dimension greater than five cm with doors and access panels fully closed as well as fixed at any position, which will allow the generation of X-rays;

(2) The insertion of any part of the human body through any port into the primary beam shall not be possible. The insertion of any part of the human body through any aperture shall not be possible;

(3) The system shall have a lock-and-key control, which will ensure that X-ray generation is not possible with the key removed. When the system is not in use, the key shall be removed and controlled to prohibit unauthorized use of the system;

(4) The system shall have a control or controls to initiate and terminate the generation of X-rays other than by functioning of a safety interlock or the main power control;

(5) The system shall have two independent means (indicators), which indicate when and only when X-rays are being generated. At least one of the indicators shall be illuminated when X-rays are being generated. One, but not both, of the required indicators may be a milliammeter labeled to indicate X-ray tube current. All other indicators shall be legibly labeled “X-RAY ON.” If the X-ray generation period is less than one-half second, the indicators shall be activated for one-half second and shall be discernible from any point at which initiation of X-ray generation is possible. Failure of a single component of the system shall not cause failure of both indicators to perform their intended function. The system shall have additional means other than milliammeters as needed to insure that at least one indicator is visible from each door, access panel, and port. If the X-ray generation period is less than one-half second, the indicators shall be activated for one-half second and be legibly labeled “X-RAY ON”;

(6) In systems used to inspect objects such as, but not limited to, baggage, boxes, backpacks, purses, and mail, the system shall be designed such that:

(A) During an exposure or preset succession of exposures of one-half second or greater duration, the operator can terminate the exposure or preset succession of exposures at any time and is in a position that permits surveillance of the ports and doors during X-ray generation; and

(B) During an exposure or preset succession of exposures of less than one-half second duration, completion of the exposure in progress may continue but shall enable the operator to prevent additional exposures;

(7) There shall be permanently affixed or inscribed:

(A) At the location of any controls which can be used to initiate X-ray generation, a clearly legible and visible label bearing the statement: “Caution: X-Rays Produced When Energized;” and

(B) Adjacent to each port a clearly legible and visible label bearing the statement: “Caution: Do Not Insert Any Part of the Body When System is Energized--X-ray Hazard;”

(8) Each door shall have a minimum of two safety interlocks. One, but not both of the required interlocks shall be such that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and such disconnection shall not be dependent upon any moving part other than the door;

(9) Each access panel shall have at least one safety interlock;

(10) Following interruption of X-ray generation by the functioning of any safety interlock, use of a control provided in accordance with subsection (b)(4) shall be necessary for resumption of X-ray generation;

(11) Failure of any single component of the system shall not cause failure of more than one required safety interlock; and

(12) A ground fault shall not result in the generation of X-rays.

(1) Received copies of, instruction in, and demonstrated understanding of, the user's operating and emergency procedures by obtaining a passing grade of at least 80 percent on a written examination covering this material. The written examination shall be at least 50 questions in length; and

(2) Demonstrated competence to use the radiation machines by obtaining a passing grade of at least 80 percent on a practical examination covering this material. The practical examination shall be at least 25 questions in length. An individual operating such a system need not obtain radiographer certification.

(d) Interlocks shall be annually tested to ensure they function as designed.

(e) The user shall conduct an annual evaluation of the cabinet X-ray system to ensure compliance with title 10, Code of Federal Regulations, Part 20, subpart D incorporated by reference in section 30253.

(f) Individuals shall not be exposed to the primary beam.

(g) Documentation demonstrating compliance with this section shall be maintained for three years and kept available for inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970 and 115060, Health and Safety Code.

HISTORY

1. New section filed 10-29-73 as an emergency; effective upon filing (Register 73, No. 44).

2. Certificate of Compliance filed 2-22-74 (Register 74, No. 8).

3. Change without regulatory effect adding NOTE (Register 87, No. 11).

4. Amendment of section heading, section and Note and filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§30338. Grounds for Suspension, Revocation, Amendment, or Restriction of Radiographer Certificates and Radiation Safety Training Provider Approvals.

Note • History

Radiographer certificates and any approval as a radiation safety training provider issued under this article may be revoked, suspended, amended or restricted for any of the following:

(a) Violation of any provision of the Act, any regulation promulgated pursuant to the Act, or any order of the Department.

(b) Failure to pay fees pursuant to section 30336.8.

(d) Failure to take corrective action when directed by the Department.

(e) Failure to maintain the standard under which the training provider was approved pursuant to section 30331.

(f) Incompetence or gross negligence in performing radiographic operations.

(g) Procuring any certificate or approval by fraud, or misrepresentation, or because of mistake.

(h) Exposing any individual to radiation deliberately.

(i) Failure to comply with policies or procedures required to be developed pursuant to sections 30333.1 or 30336.1(e).

(j) Failure to provide complete and accurate information to the Department when required.

(k) Failure to pass a Department audit or inspection.

NOTE

Authority cited: Sections 114975, 115000, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

Article 7. Radiation Safety Requirements for Well Logging Operations

§30345.1. Scope.

Note • History

The regulations in this Article shall apply to all licensees or registrants who use sources of radiation for well logging operations including oil, gas, mineral-logging, radioactive markers, or subsurface tracer studies.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5). For prior history of former article 10, see Register 85, No. 48.

2. Amendment of article heading filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30345.2. Definitions.

Note • History

(a) The definitions in section 30100 apply to this article.

(b) As used in this article:

(1) “Energy compensation source” means a small sealed source (not exceeding an activity of 100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use;

(2) “Field station” means a facility where licensed radioactive material or radiation machines may be stored or used and from which equipment is dispatched to temporary jobsites;

(3) “Fresh Water Aquifer” means a geologic formation that is capable of yielding fresh water to a well or spring;

(4) “Injection tool” means a device used for controlled subsurface injection of radioactive tracer material;

(5) “Irretrievable well logging source” means any sealed source containing radioactive material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended;

(6) “Logging assistant” means any individual who, under the personal supervision of a logging supervisor, handles radiation sources that are not in logging tools or shipping containers or who performs surveys required by section 30348.4;

(7) “Logging supervisor” means any individual who uses radiation sources or provides personal supervision in the use of radiation sources at a temporary jobsite and who is responsible to the user for assuring compliance with the requirements of this regulation and the conditions of the license;

(8) “Logging tool” means a device used subsurface to perform well logging;

(9) “Personal supervision” means guidance and instruction by a logging supervisor who is physically present at a temporary jobsite, who is in personal contact with logging assistants, and who can give immediate assistance;

(10) “Radioactive marker” means radioactive material used for depth determination or direction orientation. The term includes radioactive collar markers and radioactive iron nails;

(11) “Safety review” means a periodic review provided by the user for its employees on radiation safety as it relates to well logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and safety questions by employees;

(12) “Source holder” means a housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging;

(13) “Subsurface tracer study” means the release of unsealed radioactive material or a substance labeled with radioactive material in a single well for the purpose of tracing the movement or position of the material or substance in the well or adjacent formation;

(14) “Surface casing for protecting fresh water aquifers” means a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well;

(15) “Temporary jobsite” means a place where licensed radioactive materials or radiation machines are present for the purpose of performing well logging or subsurface tracer studies;

(16) “Tritium neutron generator target source” means a tritium source used within a neutron generator tube to produce neutrons for use in well logging applications;

(17) “Uranium sinker bar” means a weight containing depleted uranium used to pull a logging tool towards the bottom of a well;

(18) “Well” means a drilled hole in which well logging may be performed and includes drilled holes for the purpose of oil, gas, mineral, groundwater, or geological exploration;

(19) “Well logging” means all operations involving the lowering and raising of measuring devices or tools which contain radiation sources or are used to detect radiation sources in wells for the purpose of obtaining information about the well or adjacent formations which may be used in oil, gas, mineral, groundwater, or geological exploration;

(20) “Wireline” means a cable containing one or more electrical conductors, which is used to lower and raise logging tools in the well-bore.

NOTE

Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 114985, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of section and Note filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§30345.3. Specific License for Well Logging.

Note • History

(a) The applicant for licensure or registration as described in Section 30194 shall meet the requirements specified in that section and any special requirements contained in this section.

(b) The applicant shall develop a program for training logging supervisors and logging assistants and submit to the Department a description of this program which specifies:

(1) Initial training;

(2) On the job training;

(3) Annual safety reviews provided by the licensee;

(4) Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the regulations and licensing requirements and the applicant's operating and emergency procedures; and

(5) Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the regulations and licensing requirements and the applicant's operating and emergency procedures.

(c) The applicant shall submit to the Department written operating and emergency procedures as described in Section 30348.2 or an outline or summary of the procedures that include the important radiation safety aspects of the procedures.

(d) The applicant shall establish and submit to the Department its program for annual inspections of the job performance of each logging supervisor to ensure that the Department regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records must be retained for three years after each annual internal inspection.

(e) The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.

(f) If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the Department. The description shall include:

(1) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the person who will analyze the wipe samples.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346. Agreement with Well Owner or Operator.

Note • History

(a) No licensee shall perform well logging services operations with a sealed source unless, prior to commencement of the operation, the licensee has a written agreement with the well operator, well-owner, drilling contractor, or land owner describing who shall be responsible for meeting the following requirements:

(1) In the event a sealed source is lodged downhole, a reasonable effort shall be made to recover it.

(2) A person shall not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture.

(3) Radiation monitoring required in Section 30348.5(a) shall be performed.

(4) If the environment, any equipment, or personnel are contaminated with licensed radioactive material, they shall be decontaminated before release from the site or release for unrestricted use.

(5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements shall be implemented within 30 days:

(A) Each irretrievable well logging source shall be immobilized and sealed in place with a cement plug.

(B) A mechanical device to prevent inadvertent intrusion on the source shall be set at some point in the well above the cement plug, unless the cement plug and source are not accessible to any subsequent drilling operations.

(C) A permanent identification plaque, constructed of long lasting material such as stainless steel, brass, bronze, or monel, shall be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque shall be at least 7 inches square and 1/8 inch thick. The plaque shall contain the word “Caution”, the radiation symbol (color requirements as described in Section 30278(a) do not have to be met), the date the source was abandoned, the name of the well owner or well operator as appropriate, the well name and well identification number(s) or other designations, an identification of the sealed source(s) by radionuclide and quantity, the depth of the source and the depth to the top of the plug and an appropriate warning such as “Do not reenter this well”.

(b) The licensee shall retain a copy of the written agreement for three years after the completion of the well logging operation.

(c) A licensee may apply, pursuant to Section 30104, for approval on a case-by-case basis of proposed procedures to abandon an irretrievable well logging source in a manner not otherwise authorized in paragraph (a)(5) above.

(d) A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still otherwise meet the requirements in Sections (a)(1) through (a)(5).

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5). For prior history, see Register 87, No. 28.

§30346.1. Labels, Security and Transportation.

Note • History

(a) The license shall not use a radiation source or source holder or logging tool that contains radioactive material unless the smallest component that is transported as a separate piece of equipment with the radioactive material inside bears a durable, legible, and clearly visible marking or label. The marking or label shall contain the radiation symbol specified in the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253 and the wording “Danger (or Caution) Radioactive Material”.

(b) The licensee shall not use a container to store radioactive material unless the container has securely attached to it a durable, legible, and clearly visible label. The label must contain the radiation symbol specified in the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253 and the wording “CAUTION (or DANGER) RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)”.

(d) The licensee shall store each source containing radioactive material in a storage container or transportation package. The container or package must be locked and physically secured to prevent tampering or removal of radiation sources from storage by unauthorized personnel. The licensee shall store radiation sources in a manner which will minimize danger from explosion or fire.

(e) The licensee shall lock and physically secure the transport package containing radiation sources in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the radioactive material from the vehicle.

NOTE

Authority cited: Sections 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsections (a) and (b) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

4. Amendment of subsection (c) and Note filed 4-24-2009; operative 5-24-2009 (Register 2009, No. 17).

§30346.2. Radiation Detection Instruments.

Note • History

(a) The licensee or registrant shall keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this section and by Section 30275. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.1 mR per hour through at least 50 mR per hour. Survey instruments acquired before the effective date of these regulations shall be capable of measuring 0.1 mR per hour through at least 20 mR per hour.

(b) The licensee or registrant shall have available additional calibrated and operable radiation survey instruments with the sensitivity to detect the low radiation and contamination levels that could be encountered if a sealed source ruptured. The licensee may own the instrument or may have a procedure to obtain them quickly from a second party.

(c) The licensee or registrant shall have each radiation survey instrument required under subsection (a) above calibrated:

(1) At intervals not to exceed six months and after instrument servicing;

(2) At two points located approximately 1/3 and 2/3 of full scale on each scale for linear scale instruments, at mid range of each decade and at two points on each decade for logarithmic scale instruments, and at appropriate points for digital instruments; and

(3) So that an accuracy within plus or minus 20 percent of the calibration standards can be demonstrated on each scale.

(d) The licensee or registrant shall retain calibration records for at least three years after the date of calibration for inspection by the Department.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.3. Leak Testing of Sealed Sources.

Note • History

Each licensee who uses a sealed source shall have the source tested for leakage as described in section 30275, except that energy compensation sources (ECS) that are not exempt from testing pursuant to section 30275(c) shall be tested at intervals not to exceed three years. In the absence of a certificate from a transferor that a test has been made within the three years before the transfer, the ECS may not be used until tested.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of section and Note filed 3-1-2007; operative 3-31-2007 (Register 2007, No. 9).

§30346.4. Physical Inventory.

Note • History

Each licensee shall conduct a semi-annual physical inventory to account for all licensed radioactive material received and possessed under the license. The licensee shall retain records of the inventory for three years from the date of the inventory for inspection by the Department. The inventory shall indicate the quantity and kind of radioactive material, the location of the radioactive material, the date of the inventory, and the name of the individual conducting the inventory. Physical inventory records may be combined with leak test records.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.5. Records of Material Use.

Note • History

(a) Each licensee or registrant user shall maintain records for each use of radiation sources showing:

(1) The make, model number, and a serial number or a description of each radiation source used;

(2) In the case of unsealed radioactive material used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well and the disposition of any unused tracer materials;

(3) The identity of the logging supervisor who is responsible for the radiation sources and the identity of logging assistants present; and

(4) The location and date of use of the radiation source.

(b) The licensee or registrant shall make the records required by subsection (a) of this section available for inspection by the Department. The records shall be kept for three years from the date of the recorded event.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.6. Design and Performance Criteria for Sealed Sources.

Note • History

(a) A licensee shall not use a sealed source in well logging unless the sealed source:

(1) Is doubly encapsulated;

(2) Contains licensed radioactive material whose chemical and physical forms are as insoluble and nondispersible as practical; and

(3) Meets one of the following:

(A) For a sealed source manufactured on or before July 14, 1989, meets the requirements of USASI N5.10-1968, “Classification of Sealed Radioactive Sources”* which is incorporated by reference; or

(B) For a sealed source manufactured after July 14, 1989, meets the oil-well logging requirements of ANSI/HPS N43.6-1997, “Sealed Radioactive Sources Classification”* which is incorporated by reference; or

(C) For a sealed source manufactured after July 14, 1989, if the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests:

1. The test source shall be held at - 40 deg. C. for 20 minutes, 600 deg. C. for one hour, and then be subject to a thermal shock test with a temperature drop from 600 deg. C. to 20 deg. C. within 15 seconds;

2. A 5 kg. steel hammer, 2.5 cm. in diameter, shall be dropped from a height of 1 meter onto the test source;

3. The test source shall be subject to a vibration from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes;

4. A one gram hammer and pin, 0.3 cm pin diameter, shall be dropped from a height of 1 m onto the test source; and

5. The test source shall be subjected to an external pressure of 24,600 pounds per square inch absolute (1.695 X 107 pascals).

(b) The requirements in subsection (a) do not apply to sealed sources that contain radioactive material in gaseous form or to energy compensation sources (ECS). ECSs shall be registered pursuant to section 30192.1(b).

_______

*Copies of USASI N5.10-1968, “Classification of Sealed Radioactive Sources” may be obtained from the Department. Copies of American National Standard N43.6-1997,” Sealed Radioactive Sources--Classification” may be purchased from the American National Standards Institute, Inc., Global Engineering Documents, 1819 L Street, NW, Suite 600, Washington DC 20036 or at “http://global.ihs.com” using “ANSI N43.6” as the document number; or the Health Physics Society at http://hps.org/documents/hpsstandardsorder.pdf.

NOTE

Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of section and Note filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§30346.7. Inspection, Maintenance and Opening of a Source Holder.

Note • History

(a) Each licensee shall visually check source holders, logging tools, and source handling tools, for defects before each use to ensure that the equipment is in good working condition and that required labeling is present. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing the date of check, name of inspector, equipment involved, defects found, and repairs made. These record shall be retained for three years after the defect is found.

(b) Each licensee shall have a program of semi-annual visual inspection and routine maintenance of source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars to ensure that the required labeling is legible and that no physical damage is visible. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing date, equipment involved, inspection and maintenance operations performed, any defects found, and any actions taken to correct the defects. These records must be retained for three years after the defect is found.

(c) Removal of a sealed source from a source holder or logging tool, and maintenance on sealed sources or holders in which sealed sources are contained shall not be performed by the licensee unless a written procedure developed pursuant to Section 30348.2 has been approved by the Department.

(d) If a sealed source is stuck in the source holder, the licensee shall not perform any operation, such as drilling, cutting, or chiseling on the source holder unless the licensee is specifically approved by the Department.

(e) The opening, repair, or modification of any sealed source is prohibited unless performed by persons specifically approved to do so by the Department.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.8. Subsurface Tracer Studies.

Note • History

(a) The licensee shall require all personnel handling radioactive tracer material to use protective gloves and, if required by the license, other protective clothing and equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites.

(b) The licensee shall not knowingly inject radioactive material into fresh water aquifers unless specifically authorized to do so by the Department.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25608, 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.9. Radioactive Markers.

Note • History

The licensee shall use radioactive markers in wells only if the individual markers contain quantities of radioactive material not exceeding the quantities specified in Section 30235 Schedule A. The use of markers is subject to the requirements of Section 30346.4 only.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.10. Uranium Sinker Bars.

Note • History

The licensee shall use a uranium sinker bar in well logging, only if it is legibly impressed with the words “Caution--Radioactive-Depleted Uranium” and “Notify Civil Authorities (or Company Name) If Found.”

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30346.11. Use of Energy Compensation Sources.

Note • History

A licensee may use an energy compensation source (ECS), which is contained in a logging tool, or other tool components, provided the ECS contains quantities of licensed materials not exceeding 100 microcuries. For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of sections 30346.3, 30346.4 and 30346.5. For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of sections 30346, 30346.3, 30346.4, 30346.5 and 30350.3 and the procedure required to be developed and implemented pursuant to section 30348.2(a)(1).

NOTE

Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§30346.12. Use of Tritium Neutron Generator Target Sources.

Note • History

(a) Use of a tritium neutron generator target source shall be subject to the requirements of this article except:

(1) Sections 30346, 30346.6, and 30350.3 shall not apply when the:

(A) Activity of the source is no more than 30 curies; and

(B) Source is used in a well with a surface casing for protecting fresh water acquifers; or

(2) Section 30346.6 shall not apply when the:

(A) Activity of the source is greater than 30 curies; or

(B) Source is used in a well without a surface casing to protect fresh water acquifers.

NOTE

Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§30348.1. Training Requirements.

Note • History

(a) The licensee or registrant shall not permit an individual to act as a logging supervisor until that person:

(1) Has completed training in the subjects outlined in subsection (e) of this section;

(2) Has received copies of, and instruction in:

(A) Regulations contained in Subchapter 4, Title 17, California Code of Regulations;

(B) The Department license or registration under which the logging supervisor will perform well logging; and

(3) Has completed on-the-job training and demonstrated competence in the use of radiation sources, remote handling tools, and radiation survey instruments by a field evaluation; and

(4) Has demonstrated understanding of the requirements in paragraphs (a)(1) and (2) of this section by successfully completing a written test.

(b) The licensee or registrant shall not permit an individual to act as a logging assistant until that person:

(1) Has received instruction in applicable requirements of the United States, title 10, Code of Federal Regulations, part 20, subparts C, D, F, G, I, J, K, L, and M as incorporated by reference in section 30253;

(2) Has received copies of, and instruction in, the licensee's or registrant's operating and emergency procedures required by Section 30365.2;

(3) Has demonstrated understanding of the materials listed in paragraphs (b)(1) and (2) of this section by successfully completing a written or oral test; and

(4) Has received instruction in the use of radiation sources, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.

(c) The licensee or registrant shall provide safety reviews for logging supervisors and logging assistants at least once during each calendar year.

(d) The licensee or registrant shall maintain a record on each logging supervisor's and logging assistant's training and annual safety review. The training records must include copies of written tests and dates of oral tests. The training records must be retained for three years following the date of termination of employment. Records of annual safety reviews must list the topics discussed and be retained for three years.

(e) The licensee or registrant shall include the following subjects in the training required in paragraph (a)(1) of this section:

(1) Fundamentals of radiation safety including:

(A) Characteristics of radiation;

(B) Units of radiation dose and quantity of radioactivity;

(D) Levels of radiation from licensed material;

(E) Methods of controlling radiation dose (time, distance, and shielding); and

(F) Radiation safety practices, including prevention of contamination, and methods of decontamination.

(2) Radiation detection instruments including:

(A) Use, operation, calibration, and limitations of radiation survey instruments;

(B) Survey techniques; and

(3) Equipment to be used including:

(A) Operation of equipment, including source handling equipment and remote handling tools;

(B) Storage, control, and disposal of licensed material; and

(4) The requirement of pertinent regulations, and

(5) Case histories of accidents in well logging.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsection (b)(1) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30348.2. Operating and Emergency Procedures.

Note • History

(a) Each licensee shall develop and follow written operating and emergency procedures that cover:

(1) The handling and use of radiation sources, including protection of fresh water aquifers, if appropriate;

(2) The use of remote handling tools for handling sealed sources and radioactive tracer material except low-activity calibration sources;

(3) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination, as required by Section 30348.4 (c)-(e);

(4) Minimizing personnel exposure including exposures from inhalation and ingestion of radioactive tracer materials;

(5) Methods and occasions for locking and securing stored radioactive materials;

(6) Personnel monitoring and the use of personnel monitoring equipment;

(7) Transportation of radioactive materials to field stations or temporary jobsites, packaging of licensed materials for transport in vehicles, placarding of vehicles when needed, and physically securing radioactive materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal;

(8) Picking up, receiving, and opening packages containing radioactive materials, in accordance with the United States, title 10, Code of Federal Regulations, part 20, section 20.1906 as incorporated by reference in section 30253;

(9) For the use of tracers, decontamination of the environment, equipment, and personnel;

(10) Maintenance of records generated by logging personnel at temporary fieldsites;

(11) Inspection and maintenance of sealed sources, source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars as required by Section 30346.10;

(12) Actions to be taken if a sealed source is lodged in a well;

(13) Notifying proper persons in the event of an accident; and

(14) Actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive materials and actions to obtain suitable radiation survey instruments as required by Section 30346.2(b).

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsection (a)(8) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30348.3. Personnel Monitoring.

Note • History

(a) The user shall not permit an individual to act as a logging supervisor or logging assistant unless that person wears, at all times during the handling of radiation sources, a personnel dosimeter that requires processing to determine the radiation dose. Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be replaced at least monthly and other personnel dosimeters replaced at least quarterly. After replacement, personnel dosimeters shall be sent for processing by the users' dosimetry processor meeting the requirements of section 20.1501(c) of title 10, Code of Federal Regulations incorporated by reference in section 30253 as soon as possible but no later than recommended by the dosimetry processor.

(b) The licensee shall provide bioassay services to individuals using radioactive materials in subsurface tracer studies if required by the license.

(c) Reports received from the dosimetry processor shall be retained for inspection until the Department terminates each license or registration that authorizes the activity that is subject to the recordkeeping requirement.

NOTE

Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115110, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Repealer of subsection (c) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

4. Amendment of subsection (a), new subsection (c) and amendment of Note filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§30348.4. Radiation Surveys.

Note • History

(a) The licensee shall make radiation surveys including, but not limited to, the surveys required under subsections (b) through (e) of this section, of each area where radioactive materials are used and stored.

(b) Before transporting radioactive materials, the licensee shall make a radiation survey of the position occupied by each individual in the vehicle and of the exterior of each vehicle used to transport radioactive materials.

(c) If the sealed source assembly is removed from the logging tool before departure from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter.

(d) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation.

(e) The licensee shall make a radiation survey at the temporary jobsite before and after each subsurface tracer study to confirm the absence of contamination.

(f) The results of surveys required under subsections (a) through (e) of this section must be recorded and must include the date of the survey, the name of the individual making the survey, the identification of the survey instrument used, and the location of the survey. The licensee shall retain records of surveys for inspection by the Department for three years after they are made.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30348.5. Radioactive Contamination Control.

Note • History

(a) If the licensee detects evidence that a sealed source has ruptured or radioactive materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by Section 30348.2.

(b) If contamination results from the use of radioactive material in well logging, the licensee shall decontaminate all work areas, equipment, and unrestricted areas.

(c) During efforts to recover a sealed source lodged in a well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30350. Security.

Note • History

(a) A logging supervisor shall be physically present at a temporary jobsite whenever radioactive materials or particle accelerators are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the jobsite in order to obtain assistance if a source becomes lodged in a well.

(b) During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a “controlled area”, as defined in title 10, Code of Federal Regulations, section 20.1003, as incorporated by reference by section 30253.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5). For prior history, see Register 87, No. 28.

2. Repealer of article 11 heading filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28)

4. Amendment of subsection (b) and Note filed 10-15-2001; operative 11-14-2001 (Register 2001, No. 42).

§30350.1. Documents and Records Required at Field Stations.

Note • History

(a) Each licensee or registrant shall maintain the following documents and records at the field station:

(1) A copy of the California Code of Regulations, Title 17; Subchapter 4;

(2) The license or registration authorizing the use of radioactive material or particle accelerators;

(3) Operating and emergency procedures required by Section 30348.2.

(4) The record of radiation survey instrument calibrations required by Section 30346.2.

(5) The record of leak test results required by Section 30346.3.

(6) Physical inventory records required by Section 30346.4.

(7) Utilization records required by Section 30346.5.

(8) Records of inspection and maintenance required by Section 30346.7.

(9) Training records required by Section 30348.1; and

(10) Survey records required by Section 30348.4.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30350.2. Documents and Records Required at Temporary Jobsites.

Note • History

(a) Each licensee or registrant conducting operations at a temporary jobsite shall maintain the following documents and records at the temporary jobsite until the well logging operation is completed:

(1) Operating and emergency procedures required by Section 30348.2.

(2) Evidence of latest calibration of the radiation survey instruments in use at the site required by Section 30346.2.

(3) Latest survey records required by Section 30348.4(a)(2), (3), and (5).

(4) The shipping papers for the transportation of radioactive materials required by Group 4, Article 1 of this chapter; and

(5) When operating under reciprocity pursuant to Section 30225 of this chapter, a copy of the U.S. Nuclear Regulatory Commission or Agreement State license authorizing use of radioactive materials.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§30350.3. Notification of Incidents and Lost Sources; Abandonment Procedures for Irretrievable Sources.

Note • History

(a) The licensee shall immediately notify the Department by telephone and subsequently, within 30 days, by confirmation letter if the licensee knows or has reason to believe that a sealed source has been ruptured. The letter must designate the well or other location, describe the magnitude and extent of the escape of radioactive materials, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.

(b) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts to recover the sealed source will not be successful, the licensee shall:

(1) Notify the Department by telephone of the circumstances that resulted in the inability to retrieve the source and:

(A) Obtain approval to implement abandonment procedures; or

(B) Report that abandonment was implemented before receiving Department approval because the licensee believed there was an immediate threat to public health and safety;

(2) Advise the well owner or operator, as appropriate, of the abandonment procedures under section 30346(a)(5); and

(3) Either ensure that abandonment procedures are implemented within 30 days after the sealed source has been classified as irretrievable or request an extension of time if unable to complete the abandonment procedures.

(c) The licensee shall, within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the Department. The licensee shall send a copy of the report to each appropriate State or Federal agency that issued permits or otherwise approved of the drilling operation. The report shall contain the following information:

(1) Date of occurrence;

(2) A description of the irretrievable well logging source involved including the radionuclide and its quantity, chemical, and physical form;

(3) Surface location and identification of the well;

(4) Results of efforts to immobilize and seal the source in place;

(5) A brief description of the attempted recovery effort;

(6) Depth of the source;

(7) Depth of the top of the cement plug;

(8) Depth of the well;

(9) If the licensee implemented abandonment procedures prior to Department approval pursuant to subsection (b)(1)(B), the reasons why the licensee believed there was an immediate threat to public health and safety including any documents on which those reasons are based;

(10) Any other information, such as a warning statement, contained on the permanent identification plaque; and

(11) State and Federal agencies receiving a copy of this report.

NOTE

Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Repealer of subsection (b) and subsection redesignation filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

4. Amendment of subsection (b)(1), new subsections (b)(1)(A)-(B), amendment of subsection (b)(2), new subsection (b)(9), subsection renumbering and amendment of Note filed 3-1-2007; operative 3-31-2007 (Register 2007, No. 9).

§30353. Particle Accelerators For Well Logging.

Note • History

(a) Registrants who use particle accelerators for well logging purposes shall comply with Group 1.5, and Articles 1, 3, 4, and 13 of Group 3.

(b) No registrant shall permit above ground testing of particle accelerators designed for use in well logging which results in the production of radiation except in areas or facilities controlled or shielded so that the requirements of the United States, title 10, Code of Federal Regulations, part 20, subpart C and D as incorporated by reference in section 30253 are met.

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, and 25815, Health and Safety Code.

HISTORY

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsection (b) filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30355. Appendix A. Concentrations in Air and Water Above Natural Background. [Repealed]

Note • History

NOTE

Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former section see Register 62, No. 1, and 63, No. 26.

2. Repealer and new section filed 11-16-67; effective thirtieth day thereafter (Register 67, No. 46).

3. Amendment filed 7-22-71; effective thirtieth day thereafter (Register 71, No. 30).

4. Amendment filed 6-19-73; effective thirtieth day thereafter (Register 73, No. 25).

5. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

6. Repealer of article 12 heading and section filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30356. Appendix B. [Repealed]

History

HISTORY

1. Amendment filed 6-19-73; effective thirtieth day thereafter (Register 73, No. 25). For prior history, see Register 71, No. 46.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and filed 7-14-94 (Register 94, No. 28).

§30357. Form RH 2364--Notice to Employees. [Repealed]

History

HISTORY

1. Repealer filed 8-23-76; effective thirtieth day thereafter (Register 76, No. 35). For prior history, see Register 73, No. 25.

§30358. Form RH 2365--Current Occupational External Radiation Exposure. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 5-13-69; effective thirtieth day thereafter (Register 69, No. 20).

2. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

Group 4. Transportation of Radioactive Material

Article 1. Requirements for Transportation of Radioactive Material

§30373. Transportation Regulations.

Note • History

(a) Except as authorized in a general license or a specific license, or as exempted in this subchapter, a licensee may not deliver radioactive material to a carrier for transport or transport radioactive material. Licensees authorized to receive, possess, use or transfer radioactive material shall, if they deliver radioactive material to a carrier for transport, transport it outside the site of usage as specified in the specific license, or on public highways, comply with, appropriate to the mode of transport, title 10, Code of Federal Regulations, part 71 (10 CFR 71) and Appendix A (as of January 1, 2007), which is hereby incorporated by reference with the following exceptions:

(1) 10 CFR 71, sections 71.0 through 71.3, 71.6 through 71.13, 71.14(b), 71.16, 71.18, 71.19, 71.24, 71.25, 71.31 through 71.45, 71.51 through 71.81, 71.91, 71.93, 71.95, 71.99, 71.100, 71.101(c)(2), (d), (e), and (f), 71.103(a), (c) through (f), and 71.107 through 71.131 are not incorporated by reference;

(2) Any references to the United States Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the “Department” as defined in section 30100, except for the reference found in the definition of “certificate of compliance” in 10 CFR 71.4;

(3) The terms “Close reflection by water,” “Containment system,” “Maximum normal operating pressure,” “Optimum interspersed hydrogenous moderation,” “Spent nuclear fuel or spent fuel,” and “State” found in 10 CFR 71.4 are not incorporated by reference;

(4) When the term “licensed material” is used within the material incorporated by this section, it shall mean any radioactive material including source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the NRC, or by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control Program Directors, Inc.; and

(5) Federal Department of Transportation regulations as of January 1, 2007 referenced in 10 CFR 71.5 are hereby incorporated by reference.

(b) Persons are exempt from this regulation to the extent that they transport any radioactive material or offer any radioactive material to a carrier for transportation where such transportation is subject to the exclusive jurisdiction of the United States Federal Government.

(c) Physicians are exempt from the requirements of this section to the extent that they transport radioactive material for use in the practice of medicine. However, any physician operating under this exemption shall possess a specific license issued pursuant to section 30195 authorizing human use of radioactive material.

NOTE

(1) Authority cited: Sections 114765, 114820, 115000 and 131200, Health and Safety Code. Reference: Sections 114740, 114765, 131050, 131051 and 131052, Health and Safety Code.

Note: (2) Copies of Title 10, Code of Federal Regulations --Energy, and Title 49, Code of Federal Regulations--Transportation, are for sale by the Superintendent of Documents, U.S.Government Printing Office, Washington, D.C. 20402. Copies can also be obtained at: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1.

HISTORY

1. Repealer of group 4 and new group 4 (sections 30365-30380) filed 11-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior history, see Register 62, No. 1.

2. Repealer of article 1 (sections 30365, 30366 and 30368); repealer of article 2 (section 30370); renumbering and amendment of former article 3 (section 30373) to article 1 (section 30373); repealer of article 4 (section 30378) and repealer of article 5 (section 30380) filed 6-6-85; effective thirtieth day thereafter (Register 85, No. 23). For prior history, see Registers 76, No. 4; 73, No. 25; 69, No. 20; and 67, No. 46.

3. Change without regulatory effect of NOTE (Register 88, No. 6).

4. Amendment of subsection (a) filed 9-16-92; operative 10-16-92 (Register 92, No. 38).

5. Amendment of section and Note filed 4-24-2009; operative 5-24-2009 (Register 2009, No. 17).

Group 5. Participation by Local Health Departments

§30385. Authority. [Repealed]

History

HISTORY

1. Repealer of Article 1 (Sections 30385 and 30386) filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

§30390. General Definitions. [Repealed]

History

HISTORY

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

2. Repealer of Article 2 (Section 30390) filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

Article 1. Local Health Departments

§30393. Participation in Control Program.

Note • History

Participation in the State radiation control program shall be pursuant to an approved contract between the Department and the local health department. A local health department desiring to participate in the State radiation control program within its area of jurisdiction shall apply to the Department.

NOTE

Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code.

HISTORY

1. Renumbering of former Article 3 to Article 1 and amendment of Section 30393 filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

§30394. Application for Participation.

Note • History

Application shall be made in writing, and shall set forth:

(a) The names and qualifications of personnel to be assigned to the radiation control program;

(b) The numbers and types of radiation survey instruments available;

(c) The administrative relationship between the radiation control program and other programs of the local health department; and

(d) A showing that the radiation control program proposed by the local health department is compatible with standards imposed upon the State by the U.S. Nuclear Regulatory Commission pursuant to the agreement contained in the Health and Safety Code, Section 25876, and the general policy statement “Guidelines for NRC Review of Agreement State Radiation Control Programs” (46 FR 59341).

NOTE

Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code.

HISTORY

1. Amendment filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

2. Change without regulatory effect of subsection (d) (Register 88, No. 6).

§30395. Contract Authorizing Participation.

Note • History

(a) An application will be approved if the Department determines with the concurrence of the Department of Industrial Relations that the showings required by Section 30394 are complete.

(b) Any authorization pursuant to this article shall be in the form of a contract setting forth, as a minimum:

(1) Duties and responsibilities of the local health department;

(2) Conditions of financial reimbursement to the local health department; and

(3) Terms and conditions for termination of the contract.

NOTE

Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code.

HISTORY

1. Repealer of former Section 30395, and renumbering and amendment of former Section 30396 to Section 30395 filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

§30397. Terms of Participation.

History

HISTORY

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No. 4).

2. Repealer filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

Subchapter 4.5. Radiologic Technology

Group 1. Administration

Article 1. Definitions

§30400. Fluoroscopy.

Note • History

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code.

HISTORY

1. New Subchapter 4.5 (Sections 30400-30438) filed 12-3-70; effective thirtieth day thereafter (Register 70, No. 49).

2. Repealer of Group 1 (Articles 1-6, Sections 30400-30407 and Articles 8-10, Sections 30409-30411); repealer of Group 2 (Articles 1-4, Sections 30412-30419); repealer of Group 3 (Articles 1-9, Sections 30420-30437.1); repealer of Group 5 (Articles 1-6, Sections 30439-30451, not consecutive); repealer of Group 6 (Articles 1-6, Sections 30460-30468, not consecutive) and new Group 1 (Articles 1-5, Sections 30400-30405); new Group 2 (Articles 1-7, Sections 30420-30436, not consecutive); new Group 3 (Articles 1 and 2, Sections 30440-30447); new Group 4 (Article 1, Sections 30450-30452); and new Group 5 (Article 1, Sections 30460-30468) filed 8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior history, see Registers 78, No. 10; 76, No. 49; 76, No. 4; 72, No. 32; 72, No. 26; 71, No. 41; 71, No. 25; 71, No. 17 and 71, No. 16.

3. Renumbering of former section 30400 to new section 30400.40 filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30400.5. Approved Continuing Education Credit.

Note • History

“Approved continuing education credit” means one hour of instruction received in subjects related to the application of X-ray to the human body and accepted for purposes of credentialing, assigning professional status or certification by the:

(a) American Registry of Radiologic Technologists;

(b) Medical Board of California;

(d) California Board of Chiropractic Examiners;

(e) Board of Podiatric Medicine; or

(f) Board of Dental Examiners.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106995, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. New section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30400.40. Fluoroscopy.

Note • History

“Fluoroscopy” means a radiological examination utilizing fluorescence for the observation of the transient image.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 107110, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. Renumbering of former section 30400 to new section 30400.40, including amendment of Note, filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30400.60. Mammographic Examination.

Note • History

“Mammographic examination” means the performance of mammography on a human being.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106995, 114845, 114870(b) and (c), Health and Safety Code.

HISTORY

1. New section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30400.85. Radiography.

Note • History

“Radiography” means the recording of static images on any suitable medium by passing X-rays through portions of the human body, and includes one or more of the following:

(a) Positioning the patient.

(b) Selecting exposure factors.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 106975, 107045, 107110, 114850, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. Renumbering of former section 30401 to new section 30400.85, including amendment of Note, filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30400.95. X-ray Bone Densitometry.

Note • History

“X-ray bone densitometry” means a radiologic examination of all or part of the skeleton utilizing X-rays from an X-ray source which is mechanically ganged to a detector for scanning all or part of the skeleton under computer control.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 107045 and 114870(c), Health and Safety Code.

HISTORY

1. Renumbering of former section 30401.6 to new section 30400.95, including amendment of Note, filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30401. Radiography.

Note • History

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code.

HISTORY

1. Renumbering of former section 30401 to new section 30400.85 filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30401.6. X-ray Bone Densitometry.

Note • History

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code.

HISTORY

1. New section filed 9-15-97 as an emergency; operative 9-15-97 (Register 97, No. 38). A Certificate of Compliance must be transmitted to OAL by 1-13-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 9-15-97 order, including amendment of section heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

3. Renumbering of former section 30401.6 to new section 30400.95 filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Article 2. Special Permits

§30402. Special Permits.

Note

(a) To obtain a special permit an applicant shall have on file with the Department a complete application.

(b) The Department considers an application for a special permit complete if all of the following conditions have been met:

(1) Application is made on forms furnished by the Department.

(2) Fee is paid pursuant to Section 30408.

(3) The application is accompanied by:

(A) A statement from a licentiate of the healing arts who holds a certificate or permit issued pursuant to Sections 30466 or 30467 attesting that efforts to employ a Certified Radiologic Technologist were unsuccessful.

(B) A copy of a notice of employment opportunity for a radiologic technologist in a local newspaper or periodical for the position for which the special permit is being sought.

(4) The Department ascertains, by reviewing X-ray machine registration records, that no other medical X-ray facility capable of providing the same radiologic health care that would be delivered at the applicant's facility is available in the locality where the special permit is being sought.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25670, Health and Safety Code.

Article 3. Requirements for Continuing Education Performance, and Renewal of Certificates and Permits

§30403. Requirements for Continuing Education and Performance of Mammographic Examinations.

Note • History

(a) Each individual certified or permitted pursuant to sections 30440, 30444, and/or 30451 shall, in the two years immediately preceding the expiration date of the certificate or permit, earn 24 approved continuing education credits, except that each individual who is certified pursuant to sections 30440(a) and 30455.1 shall meet the requirements of subsection (c).

(b) Each individual certified or permitted pursuant to sections 30466 and 30467 shall, in the two years immediately preceding the expiration date of the certificate or permit, earn 10 approved continuing education credits.

(c) Each individual certified pursuant to sections 30440(a) and 30455.1 shall, in the two years immediately preceding the expiration date of the certificate or permit:

(1) Earn 24 approved continuing education credits, 10 of which shall be in mammography; and

(2) Perform at least 200 mammographic examinations.

(d) The two-year period referred to in subsections (a), (b) and (c) and in section 30403.5 shall begin on the expiration date of the certificate or permit:

(1) In the year 2001 for individuals with a certificate or permit that ends in an odd number; and

(2) In the year 2002 for individuals with a certificate or permit that ends in an even number.

NOTE

Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. Amendment of article 3 heading and repealer and new section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30403.5. Renewal Procedures.

Note • History

Each individual seeking renewal of a certificate or permit issued pursuant to this subchapter shall:

(a) At least 30 calendar days prior to the expiration date on the certificate or permit, submit to the Department a complete application for renewal consisting of the applicant's name, mailing address, telephone number, and certificate or permit type and number.

(b) Every two years, submit to the Department the following information for each approved continuing education credit as required by section 30403 subsections (a), (b) and (c)(1):

(1) The identity of the group listed in section 30400.5 that has accepted the instruction;

(2) The provider of the instruction;

(3) The title, if any, of the instruction;

(4) The date(s) of the instruction; and

(5) The location of the instruction;

(c) Submit to the Department an attestation every two years of having completed mammographic examinations as required pursuant to section 30403 subsection (c)(2); and

(d) Pay the fee as required by section 30408.

NOTE

Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. New section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30403.8. Recordkeeping Requirement.

Note • History

Each individual certified or permitted pursuant to this subchapter shall maintain the document(s) that evidence the individual having earned approved continuing education credits and/or completing mammographic examinations for five years following the dates the credits were earned and/or the mammographic examinations were completed. Such document(s) shall be made available to the Department upon request.

NOTE

Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107035, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. New section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Article 4. Display of Certificates and Permits

§30404. Display.

Note

(a) Any radiologic technologist who holds a certificate pursuant to Section 30440 or a fluoroscopy permit pursuant to Section 30451 shall prominently display such certificate or permit, or a copy thereof, at each place where the technologist performs activities which require a radiologic technologist certificate or permit.

(b) Any limited permittee who holds a permit pursuant to Section 30444 shall prominently display such permit, or a copy thereof, at each place where the limited permittee performs functions which require a limited permit.

(c) Any licentiate who holds a certificate or permit pursuant to Sections 30466 or 30467 shall prominently display such certificate or permit, or a copy thereof, at each place of practice where the licentiate performs activities which require a licentiate certificate or permit.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25671 and 25699, Health and Safety Code.

Article 5. Deadlines

§30405. Deadlines.

Note

(a) For purposes of this subchapter:

(1) Submission of an application or information, documents, or fees supporting an application shall be deemed to occur on the date the application, information, documents, or fees are received by the Department.

(2) An application is considered complete when all documents, information, or fees required to be submitted on or with the application have been received by the Department, and the applicant has passed required examinations.

(3) Written notification by the Department to applicants shall be deemed to occur on the date the notifications are postmarked.

(b) The Department shall notify the applicant, within 30 calendar days of submission of an application for any certificate or permit issued under this subchapter, of one of the following:

(1) That the application is complete and the Department's decision regarding the application.

(2) That the application is not accepted for filing and what specific information, documentation or fee the applicant shall submit within 30 calendar days in order for the Department to consider the application acceptable.

(3) That the application is acceptable and what examinations the applicant shall pass within 180 calendar days in order to complete the application.

(1) Within 30 calendar days of notification pursuant to subsection (b), respond to the Department's request to submit specific information, documentation or fee, or

(2) Within 180 calendar days of notification pursuant to subsection (b), pass Department-approved examinations.

(d) Any applicant deemed by the Department to have withdrawn an application pursuant to paragraph (c) may reapply by submitting a new application.

(e) The Department's time periods for processing an application, from the date the initial application is received by the Department to the date the application is complete and the final decision is made regarding any certificate or permit issued under this subchapter are as follows:

(1) The median time for processing an application is 90 calendar days.

(2) The minimum time for processing an application is one day.

(3) The maximum time for processing an application is 240 calendar days.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 15376, Government Code.

Article 6. Change of Name and Address

§30406. Change of Name and Address.

Note • History

Each individual certified or permitted pursuant to this subchapter shall report to the Department any change of name or mailing address within 30 calendar days of the change.

NOTE

Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 107015, 107110, 114870(b), (c) and (e), Health and Safety Code.

HISTORY

1. New article 6 (section 30406) and section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Article 7. Fees

§30408. Fees.

Note • History

(a) For any certificate or permit issued pursuant to this subchapter in accordance with the Radiologic Technology Act (Health and Safety Code section 27(f)), the application fee shall be $85.00 for licentiates and $75.00 for technologists and limited permittees. If required to pass an examination to obtain the certificate or permit, the examination fee shall be $75.00 for each examination administered by the Department or as specified by the entities or organizations designated by the Department to administer Department-approved examinations.

(b) The fee for repeating an examination failed within the previous 12 months shall be $75.00 per examination.

(c) Each individual applying to renew a certificate or permit shall pay an annual renewal fee of $35.00. The renewal fee shall be collected biennially and such fee shall be twice the annual renewal fee.

(d) The fee for a duplicate certificate or permit shall be $1.09.

(e) The penalty fee for renewal of any expired certificate or permit shall be $5.44 and shall be in addition to the fee for renewal.

(f) Failure to pay the annual fee for renewal on or before the expiration date of the certificate or permit shall automatically suspend the certificate or permit. If the annual renewal fee is not paid within six months following such date, the certificate or permit shall be revoked. A certificate or permit revoked for nonpayment of the renewal fee may be reinstated within five years from the time of revocation upon payment of the penalty fee specified in subsection (e) plus twice the annual renewal fee specified in subsection (c). If the application for reinstatement is not made within five years from the date of suspension of the certificate or permit, the certificate or permit shall be canceled and shall not be subject to reinstatement.

(g) Each person applying to be an approved school of radiologic technology shall pay an application fee of $1,175.00 with the application for approval.

(h) Each approved school of radiologic technology shall, on or before the anniversary of the effective date of approval, pay a fee of $190.00 and, for each physical location where clinical education is given, a fee of $110.00

(i) Each person approved as a limited permit X-ray technician school pursuant to sections 30424, 30425, 30427, or 30427.2 that requests approval to provide training in a new limited permit category as specified in sections 30442 and 30443 shall pay an application fee of $430.00 with the application for approval.

(j) Any school failing to pay the annual fees by the anniversary of the effective date of the approval shall immediately cease operations requiring Department approval until such time as the annual fees and a late fee of 25 percent of the annual fees has been paid.

(k) Fees required by this section shall be nonrefundable.

NOTE

Authority cited: Sections 100275, 114870 and 115000, Health and Safety Code. Reference: Sections 107080, 107085, 107090, 107095 and 107100, Health and Safety Code.

HISTORY

1. Amendment filed 3-7-78; effective thirtieth day thereafter (Register 78, No. 10).

2. Amendment of subsections (a)-(f), and adoption of subsections (g), (h), and Note filed 11-1-93 as an emergency; operative 11-1-93 (Register 93, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-1-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 11-1-93 order transmitted to OAL 2-24-94; disapproved by OAL 4-7-94 (Register 94, No. 27).

4. Amendment of subsections (a)-(f) and new subsections (g)-(h) and Note refiled 7-6-94 as an emergency; operative 7-6-94 (Register 94, No. 27). A Certificate of Compliance must be transmitted to OAL by 11-3-94 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and filed 7-20-94 (Register 94, No. 29).

6. Amendment of section and NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

Article 8. Authorization to X-Ray Technicians to Perform Digital Radiography

§30410. Authorization to X-Ray Technicians to Perform Digital Radiography.

Note • History

(a) Any individual holding a current and valid limited permit in the following categories, as defined in section 30443, may perform digital radiography within their respective scopes of practice if the individual has completed 20 hours or more of the instruction specified in section 30410.2:

(1) Chest radiography.

(2) Extremities radiography.

(3) Gastrointestinal radiography.

(4) Genitourinary radiography.

(5) Leg-podiatric radiography.

(6) Skull radiography.

(7) Torso-skeletal radiography.

(b) To be eligible for authorization pursuant to subsection (a), the individual shall submit the following to the department:

(1) Name and permit number as specified on the individual's limited permit issued by the Department; and

(2) Documentation that the individual has completed the instruction in digital radiologic technology specified in section 30410.2 from a:

(A) Diagnostic radiologic technology school approved by the Department as meeting the requirements of section 30421;

(B) Limited permit X-ray technician school approved by the Department as meeting the requirements of section 30424; or

(C) Provider whose continuing education activity pertaining to the subject areas specified in section 30410.2 is designated as “Category A” credit by an organization approved by the American Registry of Radiologic Technologists as a Recognized Continuing Education Evaluation Mechanism.

(c) Completion of the instruction specified in section 30410.2 shall be considered 20 approved continuing education credits for purposes of complying with section 30403 only if the credit is identified in accordance with section 30403.5(b).

NOTE

Authority cited: Sections 114870, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 106995, 114840, 114845 and 114870, Health and Safety Code.

HISTORY

1. New article 8 (sections 30410-30140.2) and section filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

§30410.2. Instruction in Digital Radiologic Technology.

Note • History

(a) Instruction in digital radiologic technology shall be no less than 20 hours in length and shall include all of the following:

(1) Basic principles of digital radiography addressing digital image characteristics, types of digital receptors in cassette-less systems and cassette-based systems, comparison of detector properties and evaluative criteria, and dynamic range versus latitude;

(2) Image acquisition addressing raw data acquisition, and image extraction and exposure indicators in cassette-less and cassette-based systems;

(3) Image acquisition errors addressing exposure field recognition, histogram analysis error, low intensity radiation response, scatter control such as coning and use of optimal exposures, and grid use including Moiré effect;

(4) Software (default) image processing addressing automatic rescaling, final image processing, effects of excessive processing, and recognition of image processing errors that affect image clarity;

(5) Fundamental principles of exposure addressing optimal receptor exposure, receptor response and detective quantum efficiency, selection of exposure factors, exposure myths associated with digital imaging systems, controlling patient exposure, monitoring patient exposure;

(6) Image evaluation addressing evidence of appropriate exposure level and exposure recognition failure or histogram analysis error, contrast, recorded detail, and artifacts;

(7) Quality assurance and maintenance issues addressing initial acceptance testing, cassette-based system reader preventive maintenance, plate maintenance, uniformity of default processing codes, and reject analysis; and

(8) Image display issues to include types of viewing monitors as compared to film/screen, picture archiving and communication systems, teleradiology, and operator responsibilities such as image annotation and manipulation, and patient confidentiality.

NOTE

Authority cited: Sections 114870, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 106995, 114840, 114845 and 114870, Health and Safety Code.

HISTORY

1. New section filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

Group 2. Training of Students of Radiologic Technology

Article 1. General

§30420. Application Procedure.

Note • History

Applicants seeking approval of a school or a course of study in radiologic technology shall submit to the Department all of the following:

(a) An application on forms furnished by the Department.

(b) Documents which explain the nature and extent of education and training to be offered.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code.

HISTORY

1. New Group 2 (Articles 1-7, Sections 30420-30436, not consecutive) filed 8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior history, see Registers 78, No. 10; 72, No. 32; 72, No. 26; 71, No. 25; 71, No. 17 and 71, No. 16.

Article 2. Radiologic Technology Schools

§30421. Diagnostic Radiologic Technology Schools.

Note • History

(a) In order to be approved by the Department as a diagnostic radiologic technology school, a training facility shall include in its curriculum all requirements of subsections (b) through (g), inclusive, of this section.

(b) The course of study shall meet at least the following:

(1) 520 hours of formal classroom instruction.

(2) 50 hours of general radiographic laboratory.

(3) 75 hours of positioning laboratory.

(4) 25 hours of radiation protection laboratory.

(5) 1850 hours of supervised clinical education.

Subject Hours of Instruction

(1) Radiation protection pertaining to radiography 50

(2) Introduction to radiologic technology 5

(3) Professional ethics 5

(4) Anatomy and physiology 50

(5) Medical terminology 15

(6) Physics and electricity 40

(7) Principles of radiographic exposure 30

(8) Film/image receptor processing (theory and equipment) 10

(9) Survey of diseases 10

(10) Nursing procedures 15

(11) Pediatric radiography 10

(12) Procedures involving contrast media 80

(13) Departmental administrative and office procedures 5

(14) Equipment and accessory care 5

(15) Radiographic positioning 70

(16) Film critique 80

(17) Senior student seminar 20

(18) Digital radiologic technology as specified in

section 30410.2 20

(d) In the general radiographic laboratory each student shall perform experiments, using phantoms, to illustrate at least the following:

(1) X-ray output (effects of kilovoltage, milliamperage, filtration, distance, and heel effect).

(2) Radiographic contrast--subject and film (kilovoltage, filtration, scatter radiation, film type and speed, exposure, processing).

(3) Control of scatter radiation (collimation, field size accuracy, X-ray/light-field congruence, grids, air gap technique)

(4) Intensifying screens (type and speed, screen-film contact, cassette types).

(5) Image sharpness (penumbra, inverse square law, source and subject-film distance, size of the focal spot, motion, magnification and distortion).

(6) Quality control experiments.

(e) In the positioning laboratory each student shall:

(1) Position simulated patients for routine X-ray procedures to illustrate different patient care situations.

(2) Perform on phantoms X-ray procedures to illustrate the selection of exposure factors, proper positioning, film and other image receptor processing/developing techniques.

(f) In the radiation protection laboratory each student shall perform experiments to illustrate at least all of the following:

(1) Methods of reducing dose per exposure to patient (limiting exposure field, use of filters, optimum kilovoltage techniques, film-intensifying screen combinations, gonadal shielding, source-film distance).

(2) Reduction of dose to personnel (shielding, such as X-ray tube housing and primary protective barriers, protection against secondary or scatter radiation).

(3) Safe practice for protection of personnel (monitoring, use of protective shielding and distance in portable work, use of protective clothing).

(g) In the supervised clinical education each student shall perform or assist in the performance of not less than the following number of radiographic procedures:

Procedures Number

(1) Chest 200

(2) Bony skeleton 400

(3) Gastrointestinal and genitourinary 200

(4) Vascular and contrast studies 50

(5) Special studies and X-ray imaging modalities 50

(6) Bedside and surgical 50

(h) Each training facility approved as a diagnostic radiologic technology school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved diagnostic radiologic technology school to maintain any of these standards shall be grounds for suspension or revocation of approval.

NOTE

Authority cited: Sections 114870, 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 107045 and 114870(d), Health and Safety Code.

HISTORY

1. Amendment of subsection (b)(1), new subsection (c)(18) and amendment of Note filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

§30422. Therapeutic Radiologic Technology Schools.

Note

(a) In order to be approved by the Department as a therapeutic radiologic technology school, a training facility shall include in its curriculum all requirements of subsections (b) through (g), inclusive, of this section.

(b) The course of study shall meet at least all of the following:

(1) 455 hours of formal classroom instruction.

(2) 15 hours of general radiographic laboratory.

(3) 60 hours of physics and radiation protection laboratory.

(4) 75 hours of radiotherapy laboratory.

(5) 1500 hours of supervised clinical education.

Subject Hours of Instruction

(1) Radiation protection pertaining to

radiation therapy 50

(2) Introduction and orientation 5

(3) Professional ethics 5

(4) Anatomy and physiology 50

(5) Medical terminology 10

(6) Physics of radiation therapy 85

(7) Mathematics 15

(8) Pathology 25

(9) Nursing procedures 25

(10) Radiobiology and chemotherapy 25

(11) Principles of radiation therapy 25

(12) Technical radiation therapy and treatment planning 55

(13) Intercavitary and interstitial therapy 25

(14) Principles of radiography 35

(15) Senior student seminar 20

(d) In the general radiographic laboratory each student shall perform experiments, using phantoms, to illustrate at least the following:

(1) X-ray output (effects of kilovoltage, milliamperage, filtration, distance).

(2) Radiographic contrast (kilovoltage, filtration, scatter, film type, exposure, processing).

(3) Control of scatter (collimation, grids).

(4) Intensifying screens (type, screen-film contact, cassette).

(5) Sharpness (penumbra, inverse square law, source and phantom-film distance, size of the focal spot, motion, magnification and distortion).

(e) In the physics and radiation protection laboratory each student shall perform experiments that will illustrate at least all of the following:

(1) Method of reducing dose to the patient (shutters, cones, collimators, filters, optimum exposure techniques, optimum film and screen use, gonadal shielding, source-film distance).

(2) Reduction of dose to personnel (shielding of the X-ray tube and treatment room, protection against secondary radiation, monitoring, protective clothing).

(3) Quality control procedures:

(A) Identification of parts of basic therapy equipment.

(B) Functions of various types of therapy equipment.

(D) Use of computer in treatment planning.

(E) Calibration of therapy equipment and use of ionization chambers.

(F) Care and safe operation of equipment (testing for safety, interlocks, shutters, communication and viewing systems, erratic operation of machinery, daily inspection and routine maintenance, emergency procedures).

(G) Handling of radioactive materials (use of radiation measuring devices, area surveys, wipe and leak tests, storage and disposal, emergency decontamination).

(f) In the radiotherapy procedures laboratory each student shall:

(1) Manipulate treatment and simulator units.

(2) Operate darkroom equipment and accessories, including automatic processor.

(3) On simulated patients and phantoms, position and select exposure factors for routine localization procedures such as chest, abdomen, head and neck, and pelvis.

(4) Position simulated patients and phantoms for treatment of chest, pelvis and abdomen.

(g) During the supervised clinical education each student shall perform or assist in performing radiation therapy procedures involving the following:

(1) Head and neck.

(2) Central nervous system.

(3) Respiratory system.

(4) Digestive system.

(5) Reproductive system.

(6) Urinary system.

(7) Endocrine system.

(8) Circulatory system.

(9) Reticulo-endothelial system.

(10) Skin.

(11) Soft tissue.

(12) Pediatric.

(13) Metastases.

(h) Each training facility approved as a therapeutic radiologic technology school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved therapeutic radiologic technology school to maintain any of these standards shall be grounds for suspension or revocation of approval.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code.

Article 3. Radiologic Technologist Fluoroscopy Permit Schools

§30423. Radiologic Technologist Fluoroscopy Permit Schools.

Note

(a) In order to be approved by the Department as a radiologic technologist fluoroscopy permit school, a school shall offer a course of study that includes in its curriculum all requirements of subsections (b) and (c) of this section.

(b) The classroom instruction shall include at least the following:

Subject Hours of Instruction

(1) Fluoroscopy regulations and radiation safety 10

(2) Fluoroscopy equipment 5

(3) X-ray image intensifiers 4

(4) Television, including closed circuit equipment 4

(5) Image recording and image recording equipment 6

(6) Special fluoroscopy equipment 5

(7) Mobile image intensified units 2

(8) Anatomy and physiology of the eye 2

(9) Three-dimensional and radiological anatomy 2

(c) At least 15 hours of laboratory in which each student shall conduct experiments on phantoms to illustrate at least the following:

(1) Methods of reducing dose to patients during fluoroscopy procedures.

(2) Methods of reducing exposure to self and personnel.

(3) Image recording during the exposure of phantom.

(4) Quality control of fluoroscopy equipment.

(d) Each training facility approved as a radiologic technology fluoroscopy permit school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved radiologic technology fluoroscopy permit school to maintain any of these standards shall be grounds for suspension or revocation of approval.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code.

Article 4. Limited Permit X-Ray Technician Schools

§30424. Limited Permit X-Ray Technician Schools Teaching the Chest, Extremities, Gastrointestinal, Genitourinary, Leg-Podiatric, Skull, or Torso-Skeletal Categories.

Note • History

(a) An applicant for approval as a Limited Permit X-ray Technician School teaching chest, extremities, gastrointestinal, genitourinary, leg-podiatric, skull, or torso-skeletal categories shall require that each student who graduates from the school complete, for each limited permit category, the following course of study, within 24 months of beginning the course of study, and the supervised clinical education within one consecutive period of 12 months during that 24 month period:

(1) One hundred forty (140) hours of formal classroom education for each limited permit category, which shall include the following:

Subject Hours of Instruction

(A) Radiation protection and safety 50

(B) Radiological physics 15

(D) Equipment operation and care 10

(E) Darkroom and film processing 10

(F) Medical terminology 5

(G) Medical ethics 1

(H) Nursing procedures 4

(I) Film critique 5

(J) Anatomy and physiology 5

(K) Digital radiologic technology as specified in

section 30410.2 20

(2) For each category, the following hours of specialized classroom instruction in anatomy and physiology, and positioning:

Category Hours of Instruction

(A) Chest 10

(B) Extremities 20

(D) Genitourinary 10

(E) Leg-podiatric 10

(F) Skull 30

(G) Torso-skeletal 30

(3) Fifteen (15) hours of radiation protection laboratory during which each student shall conduct experiments that demonstrate:

(A) Methods of reducing dose per exposure to patient.

(B) Methods of reducing dose to personnel.

(4) Ten (10) hours of general radiographic laboratory during which each student shall conduct experiments that demonstrate:

(A) Effects of kilovoltage, milliamperage, filtration, distance, and heel effect on radiographic contrast and detail.

(B) Control of scatter.

(5) Supervised clinical education for each category during which each student shall perform or assist in the performance of the following number of radiographic procedures:

Category Number of Procedures

(A) Chest 100

(B) Extremities 100

(D) Genitourinary 100

(E) Leg-podiatric 50

(F) Skull 100

(G) Torso-skeletal 200

NOTE

Authority cited: Sections 114870(a), 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code.

HISTORY

1. Editorial correction of subsection (b)(2)(E) (Register 2000. No. 1).

2. Amendment of section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

3. Amendment of subsections (a)(1) and (a)(1)(A), new subsection (a)(1)(K) and amendment of Note filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

§30425. Limited Permit X-Ray Technician Schools Teaching the Dental Laboratory Category.

Note • History

(a) An applicant for approval as a limited permit X-ray technician school teaching the Dental Laboratory category shall require that each student who graduates from the school complete the following course of study within 24 months of beginning the course of study, and the supervised clinical education within one consecutive period of 12 months during that 24 month period:

(1) One hundred and twenty (120) hours of formal classroom education, extending over a period of no less than six months, which shall include the following:

Subject Hours of Instruction

(A) Radiation protection and safety 30

(B) Radiological physics 15

(D) Equipment operation and care 10

(E) Darkroom, dental and medical film processing 10

(F) Professional ethics and hygienic procedures 4

(G) Cephalometrics 16

(H) Terminology 5

(I) Film critique 5

(J) Computers and image formation 10

(2) Forty-five (45) hours of specialized instruction in:

Subject Hours of Instruction

(A) Intra-oral anatomy and physiology, and positioning 20

(B) Extra-oral anatomy and physiology, and positioning 20

dental bone age determination 5

(3) Twenty-five (25) hours of laboratory during which each student shall perform experiments using phantoms that demonstrate:

(A) Methods of reducing dose per exposure to the patient and operator.

(B) Effects of kilovoltage, milliamperage, filtration and distance on radiographic contrast and detail.

(4) Supervised clinical education during which each student shall perform or assist in the performance of the following number of radiographic procedures:

Procedures Minimum Number

(A) Peri-apical survey (consisting of at least 14 films) 100

(B) Bitewing survey (consisting of at least four films) 50

(D) Cephalometrics 100

(E) Mandible, lateral view 50

(F) Panographic 50

(G) Temporo-mandibular joints 20

(H) Dental bone age studies 20

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code.

HISTORY

1. Amendment of section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30426. Photofluorographic Chest X-Ray Technician Courses of Study.

Note • History

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Sections 114870(c), 114870(d) and 107045, Health and Safety Code.

HISTORY

1. Repealer of section and amendment of Note filed 11-24-98; operative 12-24-98 (Register 98, No. 48).

§30427. Limited Permit X-Ray Technician Schools Teaching the Dermatology X-Ray Therapy Category.

Note • History

An applicant for approval as a limited permit X-ray technician school teaching the dermatology X-ray therapy category shall require that each student who graduates from the school complete the following course of study within 12 months of beginning the course of study:

(a) Thirty hours (30) of formal classroom education, which shall include the following:

Subject Hours of Instruction

(1) Radiation protection and safety 5

(2) Biological effects of radiation 5

(3) Radiological physics and equipment 10

(4) Structure and function of the skin 2

(5) Application of X-rays to dermatology 8

(b) Supervised clinical education during which each student shall assist or perform procedures on at least the following malignancies: Basal cell carcinoma, squamous carcinoma, and mycosis fungoides.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code.

HISTORY

1. Amendment of section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

§30427.2. Limited Permit X-Ray Technician Schools Teaching the X-Ray Bone Densitometry Category.

Note • History

An applicant for approval as a limited permit X-ray technician school teaching the X-ray bone densitometry category shall require that each student who graduates from the school complete the following course of study within 12 months of beginning the course of study:

(a) Eighteen (18) hours of formal classroom education consisting of the following:

Subject Hours of Instruction

(1) Radiation physics, biology, and protection 3

(2) Bone biology, bone disease and therapy, and

densitometry parameters 3

(3) X-ray bone densitometry equipment 4

(4) Computers and image formation 3

(5) Anatomy and positioning 4

(6) Ethics and patient handling 1

(b) Four (4) hours of laboratory training during which each student shall perform experiments using phantoms and evaluate images.

(c) Supervised clinical education during which each student shall perform the following number of radiographic procedures:

Procedure Number

(1) Posterior/Anterior spine 5

(2) Hip 5

(3) Extremity 10

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 9-15-97 order, including amendment of section heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

3. Amendment of section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Article 5. On-the-Job Training for X-Ray Technicians

§30428. Approval of On-the-Job Training.

Note • History

(a) In order to be approved by the Department as an on-the-job training program, the supervisor and operator and the prospective student of radiologic technology shall submit to the Department an application for each limited permit category on forms furnished by the Department.

(b) The application for approval shall include a training schedule for each limited permit category applied for.

(c) The standards for approval of on-the-job training programs shall be those standards required of approved schools for limited permits as outlined in Sections 30424 and 30425 or for limited permit courses of study as outlined in Section 30427.

(d) Limited permit categories for on-the-job training programs shall be restricted to the categories listed in Section 30442.

(e) Each approved on-the-job training program shall meet and maintain all applicable standards set forth in this section and in Sections 30424, 30425 and 30427. Failure of an applicant to meet the applicable standards shall be grounds for denial of approval. Failure of an approved on-the-job training program to maintain any of the applicable standards shall be grounds for suspension or revocation of approval.

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114875, Health and Safety Code.

HISTORY

1. Amendment of subsections (c) and (e) and Note filed 11-24-98; operative 12-24-98 (Register 98, No. 48).

Article 6. Notification

§30435. Notification Requirements.

Note

Within 30 days after any of the following, an official of an approved school, course of study, or on-the-job training program shall, on forms furnished by the Department, inform the Department of:

(a) Change in facility location or telephone number.

(b) Change in course offerings.

(d) Change of affiliation agreements.

(e) Names and addresses of students who have been dismissed, suspended or who have voluntarily withdrawn from the clinical education.

(f) Names and addresses of students who have graduated.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code.

Article 7. Disciplinary Action

§30436. Standards for Suspension or Revocation of Approval.

Note • History

(a) Approval of any school or on-the-job training program, which has been granted pursuant to section 30420 or 30428, may be revoked, suspended, limited or conditioned for any of the following reasons:

(1) Violation of any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, or any regulation promulgated pursuant thereto; or

(2) If, at any time, fewer than 75% of the Department-approved examinations referenced in sections 30440, 30444, 30451 and 30455.1 and administered in the previous five years to graduates of the school have received a passing score.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 107045, 114840, 114870(b)-(d), 114875 and 114880, Health and Safety Code.

HISTORY

1. Repealer and new section heading, section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Article 8. Additional School Requirements and Recordkeeping

§30437. Additional School Requirements and Recordkeeping.

Note • History

(a) A school approved pursuant to section 30420 shall:

(1) Issue to each student who graduates or who successfully completes a required course of study, a certificate or diploma, which includes:

(A) The student's name;

(B) The name or the category listed in section 30442 or course of study completed by the student;

(D) The number of the certificate issued by the Department to the school; and

(E) The signature of the school's chief executive officer, dean or department administrator.

(2) Within 30 days of discontinuance of the school:

(A) Notify the Department of how all records kept pursuant to subsection (b) will be preserved and surrender the school approval certificate to the Department; or

(B) Notify the Department, transmit all records required to be kept pursuant to subsection (b) to the Department and surrender the school approval certificate to the Department.

(3) Within 30 days of discontinuance of instruction in any limited permit category notify the Department.

(b) Each school approved pursuant to section 30420 and each on-the-job training program approved pursuant to 30428 shall retain for at least five years:

(1) Records of attendance;

(2) Proof of participation in clinical education;

(3) Proof of performance of laboratory procedures;

(4) Certificates or diplomas issued; and

(5) Program transcripts.

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 107000, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code.

HISTORY

1. New article 8 (section 30437) and section filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

Group 3. Certificates for Radiologic Technologists and Permits for Limited Permit X-Ray Technicians

Article 1. Certification of Technologists

§30440. Issuance of Certificates.

Note • History

To obtain a radiologic technology certificate an applicant shall have on file with the Department an application as described in Section 30441, and in addition:

(a) For the diagnostic radiologic technology certificate, shall pass Department-approved examinations in:

(1) Diagnostic radiation protection and safety, and

(2) Diagnostic radiologic technology.

(b) For the therapeutic radiologic technology certificate, shall pass Department-approved examinations in:

(1) Therapeutic radiation protection and safety, and

(2) Therapeutic radiologic technology.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(b) and 25677, Health and Safety Code.

HISTORY

1. New Group 3 (Articles 1 and 2, Sections 30440-30447) filed 8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior history, see Registers 78, No. 10; 72, No. 32; 72, No. 26; and 71, No. 16.

§30441. Acceptable Applications.

Note • History

The Department considers an application for a radiologic technologist certificate acceptable if all of the following conditions have been met:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25675, Health and Safety Code.

HISTORY

1. Change without regulatory effect amending subsection (a) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).

Article 2. Permits for Limited Permit X-Ray Technicians

§30442. Categories.

Note • History

The categories for limited permits are:

(a) Chest radiography.

(b) Dental laboratory radiography.

(d) Extremities radiography.

(e) Gastrointestinal radiography.

(f) Genitourinary radiography.

(g) Leg-podiatric radiography.

(h) Skull radiography.

(i) Torso-skeletal radiography.

(j) X-ray bone densitometry.

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code.

HISTORY

1. New subsection (k) and amendment of Note filed 9-15-97 as an emergency; operative 9-15-97 (Register 97, No. 38). A Certificate of Compliance must be transmitted to OAL by 1-13-98 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 9-15-97 order, including amendment of subsection (k), transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

3. Repealer of subsection (h) and subsection relettering filed 11-24-98; operative 12-24-98 (Register 98, No. 48).

§30443. Scopes.

Note • History

The scope of each limited permit is as follows:

(a) Chest radiography permit: radiography of the heart and lungs.

(b) Dental laboratory radiography permit: radiography of the intra-oral cavity, skull, and hand and wrist, for dental purposes.

(c) Dermatology X-ray therapy permit: application of X-ray to human beings for the treatment of diseases and tumors of the skin.

(d) Extremities radiography permit: radiography of the upper extremities, including shoulder girdle, and lower extremities, excluding pelvis.

(e) Gastrointestinal radiography permit: radiography of the esophagus, stomach, small and large intestine, and biliary tract.

(f) Genitourinary radiography permit: radiography of the kidneys, ureters, urinary bladder, urethra, and internal and external genitalia.

(g) Leg-podiatric radiography permit: radiography of the knee, tibia and fibula, and ankle and foot.

(h) Skull radiography permit: radiography of the bone and soft tissues of the skull and upper neck.

(i) Torso-skeletal radiography permit: radiography of the shoulder girdle, rib cage and sternum, vertebral column, pelvis and hip joints.

(j) X-ray bone densitometry permit: radiography of the total skeleton or part thereof, using X-ray bone densitometry.

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 9-15-97 order, including amendment of subsection (k), transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

3. Repealer of subsection (h) and subsection relettering filed 11-24-98; operative 12-24-98 (Register 98, No. 48).

§30444. Issuance of Limited Permits.

Note

To obtain any of the limited permits described in Section 30442 an applicant shall fulfill all of the following conditions:

(a) Have on file with the Department an application, as described in Section 30445, for each permit applied for, and

(b) Pass Department approved examinations in:

(1) Radiation protection and safety, for each permit category applied for, and

(2) Radiologic technology, for each permit category applied for.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code.

§30445. Acceptable Applications.

Note • History

The Department considers an application for a limited permit acceptable if all of the following conditions have been met:

(a) The following is submitted to the Department:

(1) The legal name, mailing address, and telephone number of the applicant;

(2) The applicant's social security number (pursuant to the authority found in sections 131050, 131051, 131200 and 114870 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification); and

(3) Identification of the permit category for which the individual is applying.

(b) Fee is paid pursuant to Section 30408.

(1) A limited permit X-ray technician school graduation diploma or certificate in the limited permit category applied for.

(2) A statement, signed by the supervisor and operator who provided the training, attesting that the applicant has completed Department-approved on-the-job training in the limited permit category applied for.

(3) A resume showing that education, training, and clinical experience is equivalent to the limited permit X-ray technician school curriculum in the limited permit category applied for.

(d) For authorization to perform procedures involving digital radiography upon issuance of the limited permit pursuant to section 30444, documentation is submitted showing completion of instruction in digital radiologic technology specified in section 30410.2 from any entity specified in section 30410(b)(2).

NOTE

Authority cited: Sections 114870, 131050, 131051 and 131200, Health and Safety Code. Reference: Section 106995, Health and Safety Code.

HISTORY

1. Repealer and new subsection (a), new subsections (a)(1)-(3), amendment of subsection (c)(1), new subsection (d) and amendment of Note filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

§30445.1. Acceptable Applications: X-ray Bone Densitometry.

Note • History

All persons authorized by the Department to perform X-ray bone densitometry as of September 1, 1997, who make application for limited permit in the category of X-ray bone densitometry on or before September 1, 1998, shall be deemed to have met the requirements of sections 30444(b) and 30445(c) for the purpose of making application for a limited permit in the category of X-ray bone densitometry.

NOTE

Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 9-15-97 order, including amendment of section heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

§30446. Title.

Note • History

No person other than an individual to whom the Department has issued a limited permit described in section 30442 shall use the title “X-ray Technician” or “XT.”

NOTE

Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Section 106990, Health and Safety Code.

HISTORY

1. Repealer and new section and amendment of Note filed 6-26-97; operative 7-26-97 (Register 97, No. 26).

§30447. Restrictions.

Note • History

(a) Limited permits issued pursuant to section 30444 exclude authorization to:

(1) Operate fluoroscopy equipment during exposure of a patient to X-rays.

(2) Operate portable or mobile X-ray equipment.

(3) Perform procedures involving computerized tomography.

(4) Perform mammography procedures.

(5) Perform vascular procedures.

(6) Perform procedures involving scanned projection radiography (digital radiography or digital tomography), or digital fluorography.

(b) Exclusions listed in subsections (a)(2) and (a)(6) shall not apply to individuals who possess a current and valid limited permit in X-ray Bone Densitometry, issued pursuant to section 30444.

(c) The exclusions listed in subsection (a)(6) shall not apply to individuals who possess a current and valid limited permit in Dental Laboratory Radiography, issued pursuant to section 30444.

(d) The exclusion listed in subsection (a)(6) shall not apply to individuals who have been issued:

(1) Authorization to perform digital radiography pursuant to section 30410.

(2) A limited permit pursuant to section 30444 indicating the individual has met the requirements of section 30410.

NOTE

Authority cited: Sections 114870(a), 131050, 131051 and 131200, Health and Safety Code. Reference: Sections 106965, 106975, 114845, 114850, 114870(c), 114875 and 114880, Health and Safety Code.

HISTORY

1. Amendment of section and Note filed 10-29-2001; operative 11-28-2001 (Register 2001, No. 44).

2. New subsections (d)-(d)(2) and amendment of Note filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

Group 4. Use of Fluoroscopy Equipment by Radiologic Technologists

Article 1. Radiologic Technologist Fluoroscopy Permits

§30450. Permit Requirement.

Note • History

A radiologic technologist fluoroscopy permit issued by the Department shall be required of any technologist who exposes a patient to X-rays in a fluoroscopy mode, or who does one or more of the following during fluoroscopy of a patient:

(a) Positions the patient.

(b) Positions the fluoroscopy equipment.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code.

HISTORY

1. New Group 4 (Article 1, Sections 30450-30452) filed 8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior history, see Register 78, No. 10.

§30451. Issuance of Technologist Fluoroscopy Permits.

Note

To obtain a radiologic technologist fluoroscopy permit an applicant shall fulfill all of the following:

(a) File with the Department an application as described in Section 30452, and

(b) Pass Department-approved examinations in:

(1) Fluoroscopy radiation protection and safety, and

(2) Use of fluoroscopy and ancillary equipment.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code.

§30452. Acceptable Applications.

Note

The Department considers an application for a radiologic technologist fluoroscopy permit acceptable if all of the following conditions have been met:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408.

(1) A copy of technologist fluoroscopy school graduation diploma or certificate.

(2) A resume showing that education, training and experience is equivalent to that of the radiologic technologist fluoroscopy school curriculum as specified in Section 30423.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25675, Health and Safety Code.

Group 4.5 Use of Mammography Equipment by Radiologic Technologists

Article 1. Mammographic Technology Certificates

§30455.1. Issuance of a Mammographic Radiologic Technology Certificate.

Note • History

(a) To obtain a Mammographic Radiologic Technology Certificate an applicant shall hold a valid and current Diagnostic Radiologic Technology Certificate issued pursuant to Section 30440(a) and shall comply with all of the following:

(1) File with the Department a complete application on the Department form entitled “Application for a Certificate in Radiologic Technology”, Form DHS 8200 (6/96);

(2) Submit a fee pursuant to Section 30408;

(3) Submit evidence of having been awarded a mammographic radiologic technology school graduation diploma or certificate; and

(4) Pass a Department examination in mammography technology, including radiation protection and mammography quality assurance.

(b) The following may be substituted for the requirement in subsection (a)(3) with respect to applications filed prior to July 1, 2000:

(1) Advanced certification in mammography issued to the applicant by the American Registry of Radiologic Technologists; or

(2) Evidence of having completed 40 hours of continuing education in mammography courses.

NOTE

Authority cited: Sections 100275 and 114870, Health and Safety Code. Reference: Sections 114840, 114845 and 114870, Health and Safety Code.

HISTORY

1. New group 4.5, article 1, and section filed 11-1-93 as an emergency; operative 11-1-93 (Register 93, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-1-94 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 11-1-93 order transmitted to OAL 2-24-94; disapproved by OAL 4-7-94 (Register 94, No. 27).

3. New group 4.5, article 1 and section refiled with amendments 7-6-94 as an emergency; operative 7-6-94 (Register 94, No. 27). A Certificate of Compliance must be transmitted to OAL by 11-3-94 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and filed 7-20-94 (Register 94, No. 29).

5. Amendment of subsections (a)(1), (a)(2), (b) and (b)(2), repealer of subsection (b)(3) and amendment of subsection (c) and Note filed 7-26-96 as an emergency; operative 7-26-96 (Register 96, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-25-96 or emergency language will be repealed by operation of law on the following day.

6. Editorial correction of subsection (b) (Register 96, No. 49).

7. Certificate of Compliance as to 7-26-96 order transmitted to OAL 11-1-96 and filed 12-2-96 (Register 96, No. 49).

8. Amendment of subsection (b) and repealer of subsection (c) filed 7-29-98; operative 8-28-98 (Register 98, No. 31).

Group 5. Certification of Licentiates

Article 1. Licentiate Certificates and Permits

§30460. Licentiate Certificate.

Note • History

The certificate category for licentiates of the healing arts is: Radiology supervisor and operator.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

HISTORY

1. New Group 5 (Article 1, Sections 30460-30468) filed 8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior history, see Registers 78, No. 10; 72, No. 26 and 71, No. 41.

§30461. Licentiate Permits.

Note

The permit categories for licentiates of the healing arts are:

(a) Fluoroscopy supervisor and operator.

(b) Radiography supervisor and operator.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30462. Radiology Certificate.

Note

A radiology supervisor and operator certificate issued by the Department shall be required of any licentiate of the healing arts who practices as a radiologist.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30463. Fluoroscopy Permits.

Note

A fluoroscopy supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who does one or more of the following:

(a) Actuates or energizes fluoroscopy equipment.

(b) Directly controls radiation exposure to the patient during fluoroscopy procedures.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30464. Radiography Permits.

Note

A radiography supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who does one or more of the following:

(a) Actuates or energizes radiography X-ray equipment.

(b) Supervises one or more persons who hold radiologic technologist certificates pursuant to Section 30440(a).

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30465. Dermatology Permits.

Note

A dermatology supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who practices dermatology and who uses X-ray therapy equipment for the treatment of diseases and tumors of the skin.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30466. Issuance of Licentiate Certificates or Permits.

Note

To obtain a licentiate certificate or any licentiate permit an applicant shall have on file with the Department an application as described in Section 30468, and in addition:

(a) For obtaining a fluoroscopy supervisor and operator permit, shall pass a Department approved examination in fluoroscopy radiation protection and safety, and use and supervision of use of fluoroscopy and ancillary equipment.

(b) For obtaining a radiography supervisor and operator permit, shall pass a Department approved examination in radiography radiation protection and safety, and use and supervision of use of radiography and ancillary equipment.

(c) For obtaining a dermatology supervisor and operator permit, shall pass a Department approved examination in dermatology radiation protection and safety, and application and supervision of application of X-rays for treating diseases and tumors of the skin.

(d) For obtaining a radiology supervisor and operator certificate, shall pass examinations specified in subsections (a) and (b) of this section, unless qualified for a certificate pursuant to Section 30467.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

§30467. Certification of Qualified Licentiates.

Note

An applicant who is certified by the American Board of Radiology or the American Osteopathic Board of Radiology, upon submission of an application, fee and documentary evidence of board certification, shall be issued a radiology supervisor and operator certificate.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25699.1, Health and Safety Code.

§30468. Acceptable Applications.

Note

The Department considers an application for a licentiate certificate or permit acceptable if:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408, and

(1) Physician and surgeon.

(2) Osteopathic physician and surgeon.

(3) Podiatrist.

(4) Chiropractor.

NOTE

Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code.

Group 7. Requirements for Land Disposal of Radioactive Waste

Article 1. Applicable Federal Regulations

§30470. Low-Level Radioactive Waste Disposal.

Note • History

The regulations governing low-level radioactive waste in the U.S. Government Code of Federal Regulations (CFR), Title 10, Code of Federal Regulations Part 61, as published in the Federal Register on June 22, 1993 (58 Fed. Reg. 33886) are hereby adopted by reference with the following exceptions:

(a) The Department of Health Services shall be substituted in all cases where Commission, Office of Nuclear Material Safety and Safeguards or U.S. Nuclear Regulatory Commission are cited and the Department of Industrial Relations shall be substituted in all cases where the U.S. Department of Labor is cited.

(b) The following sections are deleted: 61.4, 61.5, 61.8, 61.23(i), 61.23(j).

NOTE

Authority cited: Sections 100275, 115010, 115230 and 115235, Health and Safety Code. Reference: Section 115010, Health and Safety Code.

HISTORY

1. New Group 7 (Articles 1-8, Sections 30470-30499, not consecutive) filed 4-5-84 as an emergency; effective upon filing (Register 84, No. 14). No Certificate of Compliance required to be filed with OAL pursuant to Health and Safety Code Section 25812.

2. Editorial correction of HISTORY NOTE No. 1 and reprinting of Group 7 (Articles 1-8, Sections 30470-30499, not consecutive) which was inadvertently deleted in Register 85, No. 34. The text of Group 7 as filed with the Secretary of State on 4-5-84 remains in effect uninterrupted (Register 85, No. 45).

3. Amendment of first paragraph and Note filed 3-16-99; operative 4-15-99 (Register 99, No. 12).

§30471. Transfer for Disposal, Manifests and Record Keeping.

Note • History

The regulations governing the transfer of radioactive materials and manifests in Title 10, Code of Federal Regulations, Parts 20.2006, 61.12(n), 61.80(f) and (l), as published in the March 27, 1995 Federal Register (60 Fed. Reg. 15649) are hereby incorporated by reference.

NOTE

Authority cited: Sections 100275, 115010, 115230 and 115235, Health and Safety Code. Reference: Section 115010, Health and Safety Code.

HISTORY

1. Amendment of section heading, section and Note filed 6-17-99; operative 7-17-99 (Register 99, No. 25).

Article 2. General

§30473. Definitions.

Note

(a) “Debt” means the obligations of the licensee or the named owner thereof which are fixed as to amount and which give the obligee rights as to assets of the licensee or any portion thereof which are superior to the rights of the licensee.

(b) “Equity” means the total book value of tangible and intangible assets which exceeds the amount of debt.

(c) “Letter of Acceptance” means a confirmation by the applicant that it agrees to be the license designee and commits itself to perform in accordance with statements, representations and procedures contained in its application.

(d) “Reasonable cost” means a cost which is reasonable if, in its nature or amount, does not exceed that which would be incurred by a prudent person under the circumstances prevailing at the time the decision was made to incur the cost.

NOTE

Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code.

Article 3. Proprietary Documents

§30475. Proprietary Documents.

Note

All documents submitted pursuant to the instructions in this group which are proprietary, private or confidential shall be so identified by the applying license designee or licensee as appropriate.

NOTE

Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code.

Article 4. Selection of License Designee

§30477. Application for Selection as License Designee.

Note

(a) Application for designation shall be made to the Department and shall be accompanied by a filing fee of ten thousand dollars.

(b) The application for designation shall contain all of the following:

(1) The information described in Title 10, Code of Federal Regulations, Part 61.11 and 61.12, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248), except 61.11(c)(1), (2) and (3) and 61.12(a), (h) and (i).

(2) A description of any limitation in the site design which would restrict the receipt for disposal of low-level waste due to radiation levels, waste form, waste class or waste packaging.

(3) A description of the natural and demographic characteristics which will be emphasized in selection of the disposal site, including geologic, hydrologic, meteorologic, climatologic and biotic features of the disposal site and vicinity.

(4) A plan for community involvement in the site selection and development process, including brief descriptions of the applicant's experience with waste disposal or other developments requiring community involvement.

(5) The financial information called for in Title 10, Code of Federal Regulations, Parts 61.15, 61.61, 61.62, 61.63, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248); a description of the sources of financing, the terms of financing; the filing of a financial pro forma; and revenue documentation.

(6) An estimate in 1984 dollars of the charges to be levied on waste received for disposal. The estimate shall assume the following:

(A) A preoperational period of five years, commencing in August 1984.

(B) An operating period of 20 years.

(D) Administrative controls extending for 100 years following the operating period.

(E) A site capacity of 250,000 cubic meters.

(F) A waste mix as described for Region 4 in Table D.9 “Untreated” Waste Volumes Projected to be Generated to the Year 2000 per Region (m3), U.S. Nuclear Regulatory Commission, Draft Environmental Impact Statement on 10 CFR Part 61 NUREG-0782, Volume 3, September 1981.

NOTE

Authority cited: Sections 208, 25812.5(c) and 25812.5(e), Health and Safety Code. Reference: Sections 25812.5(c) and (e), Health and Safety Code.

§30479. Standards for Selecting the License Designee.

Note

(a) The applicants shall be ranked in accordance with the degree to which their application demonstrates their ability to:

(1) Meet the financial standards and qualifications by reason of training, experience and character to carry out the disposal operations;

(2) Provide the best concept for site development and operation as required by Title 10, Code of Federal Regulations, Part 61.23, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248) except that information which would pertain only to a specific site;

(3) Present an effective program to deal with concerns of the public regarding establishment of a low-level radioactive waste disposal site; and

(4) Establish, based on estimates, a reasonable schedule of charges for disposal of low-level radioactive waste.

NOTE

Authority cited: Sections 208 and 25812.5(c), Health and Safety Code. Reference: Section 25812.5(c), Health and Safety Code.

§30481. Acceptance by License Designee.

Note

(a) The applicant ranked highest pursuant to Section 30479 shall, within five days of notification of its ranking, either:

(1) File a letter of acceptance, post a performance bond of one million dollars in favor of the Department and pay the annual license fee; or

(2) File a letter withdrawing their application.

(b) In the event that the highest ranked applicant withdraws its application, the next highest ranked applicant shall follow the processes set forth in Section 30481(a).

NOTE

Authority cited: Sections 208 and 25812.5(c), Health and Safety Code. Reference: Section 25812.5(c), Health and Safety Code.

Article 5. Forfeiture of Performance Bond

§30483. Standards for Forfeiture of the Performance Bond.

Note

(a) The performance bond posted pursuant to Section 30481 shall be forfeited upon:

(1) Declaration of insolvency or voluntary reorganization under the bankruptcy laws, or

(2) Failure to maintain the promised schedule and such failure is not the result of an act of God or Departmentally caused delay and the license designee cannot provide assurance that this delay will be remedied without jeopardizing the overall project schedule.

(3) Failure to comply with requirements of this group, or

(4) Failure to pay the performance bond premium 30 days prior to its expiration.

(b) Upon the issuance of the operating license the licensee shall be relieved of its obligation to maintain the performance bond.

NOTE

Authority cited: Sections 208 and 25812.5(f), Health and Safety Code. Reference: Section 25812.5(f), Health and Safety Code.

Article 6. Fees

§30485. License Fee.

Note

The license designee or the licensee shall pay an annual license fee of two-hundred fifty thousand dollars.

NOTE

Authority cited: Sections 208 and 25812(d), Health and Safety Code. Reference: Section 25812(d), Health and Safety Code.

Article 7. Financial Assurances

§30487. Additional Licensee Requirements and Financial Assurances.

Note

(a) The licensee shall retain a certified public accounting firm approved by the Department for the purpose of making reports and audits of the operation of the low-level radioactive waste disposal site.

(b) An unqualified audit statement shall be prepared annually with respect to all matters which bear upon the license designee's or the licensee's ability to operate pursuant to the Letter of Acceptance or license. The unqualified annual audited statement shall be submitted to the Department no later than three months after the end of the license designee's or licensee's fiscal year in each year following the filing of the Letter of Acceptance, or issuance of the license.

(c) No security interest in the site shall be executed by the licensee without the consent of the Department which would give a creditor any right to stop the operation of the site.

NOTE

Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code.

§30489. Funding for Disposal Site Closure and Stabilization.

Note

(a) Funding for the approved plan for closure and stabilization shall be obtained from a closure surcharge of ten percent of the disposal charges levied by the licensee on disposers of low-level radioactive waste.

(b) The surcharge shall be deposited, within thirty days following collection, with a trustee approved by the Department, in a fund which shall be known as the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. All balances in the fund shall be invested by the trustee in accordance with the investment standards set forth in Government Code, Section 16408.2.

(c) The amount of the financial assurance mechanism, Title 10, Code of Federal Regulations, Part 61.62, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248), shall change as necessary to take into account both the increased costs of closure and the available balance in the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. Changes in costs caused by inflation shall be calculated using an inflation factor derived from the annual Implicit Price Deflator for Gross National Product as published by the U.S. Department of Commerce in its Survey of Current Business. The inflation factor is calculated by dividing the latest published annual Deflator by the Deflator for the previous year.

(d) Payment for site closure and stabilization shall be made from the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. Upon filing a petition to close, a licensee or any other person authorized to perform closure shall request payment for closure expenditures by submitting itemized bills to the trustee. The trustee is authorized to pay those bills which the trustee finds to be in accord with the approved plan and shall make reports of the expenditures to the Department quarterly in the first 12 months of closure and annually thereafter.

NOTE

Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code.

§30491. Liability Insurance.

Note

The licensee shall carry nuclear liability insurance of no less than ten million dollars for both sudden and accidental or slow and gradual contamination to people or property off site.

NOTE

Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code.

Article 8. Rate Review and Approval Process

§30493. Establishment and Approval of Rates.

Note

(a) The licensee shall establish a schedule of rates for waste disposal subject to approval by the Department.

(b) The rates for disposing of waste shall remain in effect for no less than two years from the effective date of the rates and shall be subject to review by the Department biennially.

(c) Any proposal to establish or change disposal rates shall be made to the Department by the licensee or a waste generator.

NOTE

Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code.

§30495. Calculation of the Rate Schedule.

Note

(a) The rate schedule shall be determined by dividing the total rate base, as calculated pursuant to Section 30495(c), by the sum of the estimated or actual amounts of all classes of waste received.

(b) Twenty-two months following establishment of the rate schedule, the licensee shall furnish the Department with the actual monthly disposal volumes by class compared with those assumed for that year.

(1) Amortization on a straight-line basis, over a 20 year operating period, of costs incurred prior to the start of site operations. Costs shall include:

(A) Site acquisition costs, including but not limited to acquiring the land for the low-level radioactive disposal site and deeding the land to the State;

(B) Licensing costs, including but not limited to the costs associated with initial site selection, and the development of any plans, reports, designs, manuals and schedules necessitated by this group;

(C) Site development costs, including but not limited to grading, development of roads, installation of fencing and lighting, or installation of a system of wells and air monitors;

(D) Administrative costs, incurred during the time between approval of the Letter of Acceptance and licensure that have not been included in prior items.

(2) Depreciation on a twenty year straight-line basis of all buildings and equipment used in the operation of the disposal site and not including those costs specified in Section 30495(c)(1).

(3) Site operating costs consisting of those necessary and reasonable costs incurred during the daily operations of the disposal site.

(A) Costs applicable to services, facilities, equipment or supplies furnished to the licensee by organizations related to the licensee by common ownership or control are includable as site operating costs for the purpose of rate determination at the actual cost to the related organization.

(B) Fines or penalties are not includable as site operating costs in the rate base.

(4) The actual interest costs for any necessary short-term or long-term debt provided that the borrowed funds were devoted to the disposal site.

(5) A return factor specified by the licensee.

NOTE

Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code.

§30497. Rate Review Documentation.

Note

(a) For the purpose of verifying the rate base upon which rates have been proposed or established, including any rate base changes affecting the calculating of proposed rates, the licensee shall supply the following reports:

(1) Semiannual reports of all costs specified in Section 30495(c) incurred prior to the issuance of the license.

(2) An annual financial report which includes data used or proposed to be used by the licensee in the calculation of the rate base and/or rates for disposal of waste. This report shall be due within three (3) months of the licensee's fiscal year.

(3) The books and records supporting the reports referred to in this section shall be maintained in a form capable of and subject to review and audit by the Department.

(4) All contracts made by the licensee which require payments by the licensee of five percent or more of the latest annual reported gross revenue shall require that an independent audit report be made available to the Department.

NOTE

Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code.

§30499. Adjustment of Rate Schedule.

Note

If the actual volumes differ by five percent or more from the estimated total for the twenty-two month period, the rates shall be adjusted on the biennial review date to reflect the over- or under-estimation.

NOTE

Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code.

Subchapter 4.6. Nuclear Medicine Technology

Article 1. Definitions

§30500. Certified Technologist, Nuclear Medicine.

Note • History

“Certified technologist, nuclear medicine” means a person who holds a current certificate issued pursuant to Section 30532.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Government Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For history of former Section 30500, See Register 84, No. 43.

§30501. Direct Supervision.

Note • History

“Direct supervision” means that the supervisor is physically present in the same room with the certified technologist, nuclear medicine, special permit holder or student of nuclear medicine technology at the time the nuclear medicine technology procedure is being performed.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. Renumbering of former Section 30501 to Section 30690 and new Section 30501 filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30502. General Supervision.

Note • History

(a) “General Supervision” means that the supervisor is responsible for, and has control of, all of the following:

(1) Quality, technical and medical aspects of all nuclear medicine technology procedures.

(2) Radiation health and safety of patients, ancillary personnel and other persons.

(3) Ascertaining that certified technologists, nuclear medicine, maintain their competency by participation in management-sponsored or formal continuing education or training offered by professional organizations or societies, or by institutions of higher learning.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior history, see Register 84, No. 43.

2. Amendment of subsection (a)(3) filed 8-3-94; operative 9-2-94 (Register 94, No. 31).

§30503. In Vitro Test.

Note • History

“In vitro test” means a nuclear medicine technology procedure in which the radioactive material is not administered to a human being.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30504. In Vivo Test.

Note • History

“In vivo test” means a nuclear medicine technology procedure in which the radioactive material is administered to a human being.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30505. Licensed Clinical Bioanalyst.

Note • History

“Licensed clinical bioanalyst” means a person who holds a current license issued pursuant to Section 1260 of the California Business and Professions Code to practice clinical laboratory bioanalysis.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code; and Section 1260, Business and Professions Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30506. Nuclear Medicine Physician.

Note • History

“Nuclear medicine physician” means a physician and surgeon who is authorized by a specific radioactive material license issued pursuant to Section 30195 of this title to use radioactive material for diagnosis and treatment of disease in human beings.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30507. Nuclear Medicine Technology Procedures.

Note • History

(a) “Nuclear medicine technology procedure” means procedures utilizing radioactive material for the diagnosis and treatment of disease in human beings, and include, but are not limited to, one or more of the following:

(1) Administration of radioactive material to human beings for diagnostic purposes.

(2) Withdrawal of blood samples for an in vitro test.

(3) Oral administration of radioactive material to human beings for therapeutic purposes.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30508. Special Permit.

Note • History

“Special permit” means a permit issued pursuant to Section 30541.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30509. Student of Nuclear Medicine Technology.

Note • History

“Student of nuclear medicine technology” means a person who has started and is in good standing in a course of instruction which, if successfully completed, would permit the person to receive a certificate in nuclear medicine technology issued pursuant to Section 30532.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30510. Supervisor.

Note • History

“Supervisor” means a nuclear medicine physician, or, when performing in vitro tests, a physician and surgeon or a licensed clinical bioanalyst.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior history, see Register 68, No. 20.

Article 2. Certification of Nuclear Medicine Technologists

§30520. Competency Criteria.

Note • History

(a) To meet the competency criteria for basic education in nuclear medicine technology, an applicant shall have successfully completed college level instruction in at least the following:

(1) Human anatomy and physiology.

(2) Physics.

(3) Mathematics

(4) Medical terminology.

(5) Oral and written communications.

(6) General chemistry.

(7) Medical ethics.

(8) Methods of patient care.

(9) Radiation safety and protection.

(10) Nuclear medicine physics.

(11) Radiation physics.

(12) Nuclear instrumentation.

(13) Statistics.

(14) Radionuclide chemistry.

(15) Radiopharmacology.

(16) Department organization and function.

(17) Radiation biology.

(18) Nuclear medicine in vivo and in vitro tests.

(19) Radionuclide therapy.

(20) Computer applications.

(b) To meet the competency criteria for laboratory instruction in nuclear medicine technology, an applicant shall have successfully completed college level instruction and training in at least the following:

(1) Collimators--sensitivity versus resolution.

(2) Survey instruments--composition, function, calibration and use.

(3) Gamma ray spectrometry--composition, function and use.

(4) Nuclear generators and dose calibration.

(5) Preparation of radioactive material for nuclear medicine technology procedures.

(6) Radioactive material waste handling techniques.

(c) To meet the competency criteria for clinical experience in nuclear medicine technology, an applicant shall have successfully performed at least all of the following:

(1) Fifty in vitro tests.

(2) Participation in ten oral administrations of radioactive material to human beings for therapeutic purposes.

(3) Ten of each of the following nuclear medicine technology procedures.

(A) Brain imaging and cisternography.

(B) Bone imaging.

(D) Cardiac imaging.

(E) Pulmonary imaging.

(F) Gastrointestinal imaging.

(G) Genitourinary imaging.

(H) Great vessel imaging.

(I) Tumor and abscess imaging.

(4) Ten of each of the following in vivo tests:

(A) Thyroid uptake.

(B) Blood volume.

(5) Ten administrations of radioactive material to human beings for the purpose of performing nuclear medicine technology procedures after having received instruction in all of the following:

(A) Pertinent anatomy and physiology of all possible venipuncture sites.

(B) Choice of instruments, intravenous solutions, and equipment.

(D) Techniques of intravenous line establishment.

(E) Hazards and complications of venipuncture.

(F) Post-puncture care.

(G) Composition and purpose of antianaphylaxis tray.

(H) First aid and instruction in basic cardiopulmonary resuscitation.

(I) Care of specimen.

(6) Ten withdrawals of blood samples for in vitro tests.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior history, see Register 68, No. 20.

§30521. Supervision Requirements.

Note • History

(a) Certified technologists, nuclear medicine, special permit holders, and students of nuclear medicine technology shall be under:

(1) General supervision when performing nuclear medicine technology procedures.

(2) Direct supervision when performing oral administration of radioactive material to human beings for therapeutic purposes.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Article 3. Administration

§30530. Acceptable Applications.

Note • History

(a) The Department considers an application for a certificate in nuclear medicine technology acceptable if all of the following conditions have been met:

(1) Application is made on a Nuclear Medicine Technology Certificate Application form DHS 8435 (7/87) furnished by the Department.

(2) Fee is paid pursuant to Section 30535.

(3) Documentation provided with the application establishes that the applicant's basic education, laboratory instruction and clinical experience meet at least the competency criteria set forth in Section 30520.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior history, see Register 68, No. 23.

§30531. Application Process and Deadlines.

Note • History

(a) Submission of an application, documents, information, or fees supporting the application for any certificate or special permit issued under this subchapter shall be deemed to occur on the date the application, documents, information, or fees are received by the Department.

(1) An application is considered complete when all documents, information, or fees required to be submitted on or with the application have been received by the Department, and the applicant has passed any required examination.

(2) Written notification by the Department to applicants shall be deemed to occur on the date the notification is postmarked.

(b) The Department shall notify the applicant, within 30 calendar days of submission of the application for any certificate or special permit issued under this subchapter, of one of the following:

(1) That the application is complete and the Department's decision regarding the application.

(2) That the application is not accepted for filing and what specific documents, information, or fees the applicant shall submit within 30 calendar days in order for the Department to consider the application acceptable.

(3) That the application is acceptable and what examination the applicant shall pass in order to complete the application.

(c) The Department shall notify the applicant, within 60 calendar days of the date of any examination required by subsection (b)(3) of the results of the examination.

(d) The Department shall deem an application for a certificate or special permit issued under this subchapter to have been withdrawn by the applicant who fails to:

(1) Within 30 calendar days of notification, pursuant to subsection (b), respond to the Department's request to submit specific documentation, information, or fees; or

(2) Within 180 calendar days of notification pursuant to subsection (b), pass any required examination.

(e) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (d) may reapply by submitting a new application.

(f) The Department's time periods for processing an application, from the date the initial application is received by the Department to the date the application is complete and the final decision is made regarding a certificate or special permit issued under this subchapter are as follows:

(1) The median time for processing an application is 90 calendar days.

(2) The minimum time for processing an application is one day.

(3) The maximum time for processing an application is 240 calendar days.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30532. Issuance of Certificates.

Note • History

(a) To obtain a certificate in nuclear medicine technology an applicant shall have on file with the Department an acceptable application as described in Section 30530, and

(1) Pass an examination in nuclear medicine technology administered by the Department, or

(2) Submit documentary evidence of having passed an examination equivalent to that administered by the Department and offered by one of the following:

(A) Nuclear Medicine Technology Certification Board.

(B) American Registry of Radiologic Technologists.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30533. Scopes of Certificates.

Note • History

(a) Certificates shall be issued for one or more of the following:

(1) Diagnostic in vivo and in vitro tests involving measurement of uptake, dilution, or excretion, including venipuncture, but not involving imaging.

(2) Diagnostic nuclear medicine technology procedures involving imaging, including venipuncture.

(3) Use of generators and reagent kits for preparation of radioactive material.

(4) Internal radioactive material therapy.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

2. Amendment of subsections (a)(1)-(2) and repealer of subsection (a)(5) filed 8-3-94; operative 9-2-94 (Register 94, No. 31).

§30534. Title.

Note • History

No person other than individuals to whom the Department has issued a certificate in nuclear medicine technology shall use the title “Certified Technologist, Nuclear Medicine” or “CTNM.”

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626, 25629 and 25631, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30535. Fees.

Note • History

(a) Each individual applying for a certificate in nuclear medicine technology shall pay an application fee of $153.00.

(b) Each individual applying for a special permit in nuclear medicine technology shall pay an application fee of $183.00.

(d) The fee for replacement of a certificate in nuclear medicine technology shall be $12.00.

(e) Each individual applying for renewal of a certificate in nuclear medicine technology shall pay a renewal application fee of $175.00.

(f) Any individual who fails to pay the renewal application fee by the expiration date of the certificate shall immediately cease performance of duties requiring a certificate in nuclear medicine technology until such time as the fee and a late fee of 25 percent of the annual renewal application fee has been paid.

(g) Fees required by this section shall be nonrefundable.

NOTE

Authority cited: Sections 100275 and 107160, Health and Safety Code. Reference: Section 107160, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

2. Amendment of section and NOTE filed 6-22-2005 as an emergency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-20-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 6-22-2005 order transmitted to OAL 9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30536. Renewal Procedures.

Note • History

(a) Certificates issued pursuant to Section 30532 shall expire five years from the date of issuance.

(b) Applications for renewal of each certificate shall be:

(1) Made on a Nuclear Medicine Technology Certificate Renewal form DHS 8437 (4/88) furnished by the Department.

(2) Accompanied by fee paid pursuant to Section 30535.

(3) Filed with the Department at least 60 days prior to the expiration date of each certificate.

(c) The Department considers an application for renewal of a certificate in nuclear medicine technology complete if the following conditions have been met.

(1) Documentation submitted with the application establishes that the applicant has participated in management-sponsored or formal continuing education or training offered by one or more of the following:

(A) Professional organizations or societies.

(B) Institutions of higher learning.

(2) The applicant's education and training includes at least five clock hours since the last certificate renewal or initial application in each of the scopes specified in Section 30533 for which the certificate was issued.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30537. Notification Requirements.

Note • History

(a) Every person who holds a current certificate issued pursuant to Section 30532 shall report to the Department any change of name or mailing address within 30 days of the change.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Article 4. Exemptions and Enforcement

§30540. Students of Nuclear Medicine Technology.

Note • History

The provisions of Section 30532 shall not apply to students of nuclear medicine technology when such students are performing nuclear medicine technology procedures under supervision as outlined in Section 30521 and are under direct guidance of an instructor who holds a current certificate issued pursuant to Section 30532.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626 and 25631, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior history, see Register 84, No. 43.

§30541. Special Permits.

Note • History

(a) To obtain a special permit in nuclear medicine technology, an applicant shall have on file with the Department a complete special permit application.

(b) The Department considers an application for a special permit complete if all the following conditions have been met:

(1) Application is made on a Nuclear Medicine Technology Special Permit Application form DHS 8436 (7/87) furnished by the Department.

(2) Fee is paid pursuant to Section 30535.

(3) The application is accompanied by a statement from the employer, verified by the Department, that the people in the locality in which the special permit is sought would be denied nuclear medicine technology services because of unavailability of certified technologists, nuclear medicine.

(d) Special permits shall not be transferable to another facility.

(e) Minimum qualifications for an applicant for a special permit shall be any of the following:

(1) Bachelor's degree in physical or biological sciences or equivalent, issued by an institution of higher learning.

(2) Sixty semester units in physical or biological sciences or equivalent, obtained in an institution of higher learning.

(3) Proof of state or national registration or certification in radiologic technology, medical technology, nursing, or respiratory technology.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30542. Display.

Note • History

Any nuclear medicine technologist who holds a current certificate issued pursuant to Section 30532 shall prominently display such certificate or photocopy thereof at each facility where the technologist is performing nuclear medicine technology procedures.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626 and 25631, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30543. Inspection.

Note • History

The owner, occupant, or person in charge of any private or public facility specified as a condition of a license, certificate, or special permit issued pursuant to this Subchapter shall permit any officer, employee, or designated agent of the Department to enter such property at all reasonable times for the purpose of inspecting those areas of the property where authorized nuclear medicine technology procedures are performed and determining whether or not there is compliance with or a violation of provisions specified in Sections 25625 to 25631, inclusive, of the Health and Safety Code, or of this subchapter.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 25631, Health and Safety Code.

HISTORY

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30550. Fuel Tank Emissions.

History

HISTORY

1. New section filed 11-9-64; effective thirtieth day thereafter (Register 64, No. 22).

2. Repealer filed 5-24-68; effective thirtieth day thereafter (Register 68, No. 20).

§30560. Carburetor Hot Soak Emissions.

History

HISTORY

1. New section filed 11-9-64; effective thirtieth day thereafter (Register 64, No. 22).

2. Repealer filed 5-24-68; effective thirtieth day thereafter (Register 68, No. 20).

§30570. Exhaust Odor and Irritation.

Note • History

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Section 11349.7, Government Code.

HISTORY

1. New section filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 20).

2. Repealer filed 10-24-84; effective thirtieth day thereafter (Register 84, No. 43).

Subchapter 5. Air Sanitation*

* For regulations of Air Resource Board see Title 13, Chapter 3.

Article 1. Standards for Ambient Air Quality

§30690. Table of Standards and Explanatory Footnotes.

History

(a) Table of Standards

(b) Footnotes.

(1) Hydrocarbons are a group of substances most of which, normally, are toxic only at concentrations in the order of several hundred parts per million. However, a number of hydrocarbons can react photochemically at very low concentrations to produce irritating and toxic substances. Because of the large number of hydrocarbons involved, the complexity of the photochemical reactions and the reactivity of other compounds such as nitrogen dioxide and ozone, it is not yet possible to establish “serious” and “emergency” levels for hydrocarbons. From the public health standpoint, the concentration of those hydrocarbons which react photochemically should be maintained at or below the level associated with the oxidant index defined in the “adverse” standard.

(2) Ozone, at 1 ppm for eight hours daily for about a year, has produced bronchiolitis and fibrositis in rodents. Extropolation of these data to man is difficult. Functional impairment data have been reported; at 1.25 ppm some effect is observed on residual volume and diffusing capacity. The variability of the tests was not reported. Additional data would be needed before a standard is set.

(3) A value of 2.0 ppm of ozone for one hour may produce serious interference with function in health persons and the assumption is made that this might cause acute illness in sensitive persons.

(4) Nitrogen dioxide, at concentrations above 2.5 ppm. causes acute damage to sensitive plants. One ppm for eight hours will produce significant growth reduction, expressed as fresh and dry weight, with no visible lesions of damage. High levels (150-220 ppm) in short exposures produce fibrotic changes in the lungs of man that may end fatally.

(5) Given certain assumptions concerning ventilatory rates, acute sickness might result from a carbon monoxide level of 240 ppm for one hour in sensitive groups because of inactivation of ten percent of the body's hemoglobin. In any event it is clear that when a population exposure limit has been set for carbon monoxide, because of exposure from other sources, community air pollution standards should be based on some fraction of this limit.

(6) Hydrogen sulfide is not known to produce chronic disease in humans but there may be durable sequelae from acute exposures. The disagreeable odor may interfere with appetite in sensitive groups of persons at about 5 ppm. At high concentrations loss of the sense of smell occurs. This has been reported at 100 ppm for exposure lasting two to fifteen minutes. Conjunctivitis and mild respiratory tract irritation have been reported at levels of 50-100 ppm for one hour.

(7) Acute sickness and death with neurotoxicity may occur at concentrations of several hundred ppm. It is very unlikely these levels will occur in community air pollution.

(8) A sulfuric acid mist level of 1 mg/M3 with an average particle size of 1 micron will produce a respiratory response in man. It is not possible to generalize from this fro all air pollution conditions, because under natural conditions, particle size will vary. Only with large droplets would sensory irritation be produced without other physiological effects.

(9) A level of 5 mg/M3 of sulfuric acid mist for a few minutes produces coughing and irritation in normal individuals. Presumably, it could cause acute illness in sensitive groups of persons in a period of one hour.

(10) Carcinogens include a few organic compounds such as some polycyclic hydrocarbons and some metals such as arsenic and chromium. Studies on effects of such substances are currently under way, but there are not sufficient data, at present, to set standards. In the meantime, it is recommended that concentrations of carcinogens in air should be kept as low as possible.

(11) Hydrogen fluoride and other airborne fluorides settle upon and some are absorbed into vegetation. When forage crops containing 30-50 ppm of fluoride measured on a dry weight basis are regularly consumed over a long period the teeth and bones of cattle may show changes, depending on age, nutritional factors and the form of fluoride ingested. Such changes may or may not have any economic effect. Fluorides at these levels do not necessarily cause injury to the forage plants themselves. However, injury may be produced in certain species of vegetation upon long term exposure to low levels of atmospheric fluorides.

(12) The irritating properties of hydrogen fluoride in experimental human exposure have been manifested by desquamation of the skin, at concentrations of 2-5 ppm. mucous membrane irritation also occurs from hydrogen fluorides but quantitative data are not adequate to support a standard.

(13) It is clear that lead levels should be set on the basis of average values for long periods. While data are abundant concerning human response to eight-hours-a-day, five- days-a-week exposures, data are insufficient for the effects of the continuous exposure inherent in community air pollution. While laboratory studies will be pursued with vigor, it becomes very important that local agencies collect data on existing lead levels. Since lead exposures are from multiple sources, community air pollution standards should be based on a portion of the total limit for population exposure.

HISTORY

1. Amendment filed 3-26-62; effective thirtieth day thereafter (Register 62, No. 6).

2. Amendment filed 11-23-65; effective thirtieth day thereafter (Register 65, No. 23).

3. Renumbering of former Section 30501 to Section 30690 and new Section 30501 filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Subchapter 6. Organized Camps

Article 1. General

§30700. Definitions.

Note • History

(a) “Aquatics Supervisor” means a person who provides supervision to the aquatic facility, staff and program of the camp meeting the requirements of Section 30741(d)(1).

(b) “Camp” means an organized camp as defined in Health and Safety Code, section 18897 and does not include facilities, programs and arrangements listed in Health and Safety Code, section 1596.792.

(c) “Counselor” means a person who is directly involved with camp program activities and camper supervision meeting the requirements of Section 30751(b) and (c).

(d) “Director” means a person who is responsible for day-to-day decision making and supervision of the camp program and staff meeting the requirements of Section 30751(a).

(e) “Health Screening” means an examination to identify observable evidence of illness, injury, or communicable disease; to review and update each person's health history; and to identify current medical treatment (including medication), allergies or dietetic restrictions.

(f) “Health Supervisor” means a person who is either a physician, registered nurse, licensed vocational nurse who is licensed pursuant to Division 2 of the Business and Professions Code or a person who is trained in accordance with section 1596.866 of the Health and Safety Code.

(g) “Site Operator” means an individual, partnership, joint venture, or organization that owns, leases, or rents an organized camp site.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer of Subchapter 6 and new Subchapter 6 (Sections 30700-30703, 30710-30715, 30720-30723, 30730-30736, 30740, 30741, 30750 and 30751) filed 4-2-68; effective thirtieth day thereafter. Approved by State Building Standards Commission (Register 68, No. 14). See Register 62, No. 2, for former sections.

2. New subsection (e) filed 11-28-80; effective thirtieth day thereafter (Register 80, No. 48).

3. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

4. Repealer and new section and amendment of Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30701. Limitation of Scope.

Note • History

The minimum standards pertaining to physical facilities set forth in this subchapter shall not apply to camping activities carried out:

(a) In locations away from the main living and housing areas of the camp and where primitive living conditions, that is, conditions lacking service facilities such as water, sewage, bathing, food, or housing, are an inherent part of the planned activity; or

(b) Where government regulated campgrounds, beaches, or parks are utilized that have the equivalent physical facilities as those required by this subchapter.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Editorial renumbering of former Section T17-30701 to Section 30701 and new NOTE filed 11-5-84 (Register 84, No. 45).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30702. General Camp Safety Requirements.

Note • History

The camp and established trails, shall be in an area properly drained and free or protected from natural or man-made hazards, such as mine pits, quarries, and high-speed roads, or large numbers of insects and venomous snakes. Poison oak shall be controlled. Excessive dust that may be injurious to health and safety in the main living and housing areas of the camp shall be prevented by suitable means.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section heading, section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30703. Notice of Intention to Operate.

Note • History

(a) At least 30 days prior to the operation of any camp in any calendar year, written notice shall be sent by the site operator to the local health officer of the city, county, or city and county in which the camp is located, setting forth the name, location and mailing address of the person or agency that owns the camp, the name and address of the person or agency proposing to operate the camp and the proposed dates of occupancy during that calendar year. Camps which operate year-round shall provide only an initial notice of operation.

(b) Written notice shall be sent to the local health officer at least 30 days prior to:

(1) Construction of any new camp,

(2) Any major expansion of physical facilities or

(3) Any changes to items of information required in (a) above.

(c) The local health officer shall acknowledge receipt in writing, within seven days, of said notices and shall, at the same time, send a copy to the State Fire Marshal.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30704. Requirements for Camps.

Note • History

On an annual basis and at change of ownership the site operator shall submit to the local health officer:

(a) A written verification that the camp is accredited by the American Camp Association, (formerly the American Camping Association)

or:

(b)(1) A written description of operating procedures that describes the program of organized and supervised activities of the camp in the following areas:

(A) Supervisor qualifications and training

(B) Staff skill verification criteria and process

(D) Staff-to-participant supervision ratios

(E) Equipment needed

(F) Safety procedures

(G) Emergency procedures specific to location

(H) Environmental hazards

(I) Access and equipment control

(J) Equipment and maintenance repair

(2) An accepted reference for these operating procedures are the following chapters of the Accreditation Standards for Camp Programs and Services (2007 Edition) published by the American Camp Association, Martinsville, Indiana, identified as:

(A) PD -- Program -- Design and Activities

(B) PA -- Program -- Aquatics

(D) PH -- Program -- Horseback Riding

(E) PT -- Program -- Trip and Travel

(c) A written statement by the Director that the Director has reviewed the criminal history record check and voluntary disclosure statement as described in section 30751 for all individuals for which it is required by section 30751(a), and documentation of the criminal history record check of the Director.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 2. Utilities

§30710. Water Supply.

Note • History

(a) A dependable supply of potable water adequate to furnish 50 gallons of water per person per day shall be available. Where pit or chemical toilets are used, this figure may be reduced to 30 gallons per person per day.

(b) The water supply system shall conform to the following:

(1) Water wells shall be constructed in accordance with the requirements of California Bulletin 74-81, Well Water Standards, Chapter II and Appendices A, B, C (December 1981) and California Bulletin 74-90 (June 1991), Well Water Standards published by the Department of Water Resources, State of California Resources Agency.

(2) Springs shall meet the following requirements:

(A) Use of a spring as a potable water source shall not be permitted if it is located on the side of or at the foot of a hill where cesspools, privies, sewers, or other sources of contamination would be located above the spring and in the path of the groundwater flow toward the spring. In no case shall a spring be used if it is located closer than 200 feet to an upstream potential source of contamination.

(B) Springs used as a potable water source shall be developed with a tight box or enclosure including a watertight cover with no openings that will permit entrance of surface waters, windblown dusts or small animals.

(3) No stream sources for potable water shall be used without treatment.

(4) Water supply, quality, monitoring, storage, and distribution shall comply with the requirements of the California Safe Drinking Water Act, Health and Safety Code, Section 116270, et seq.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30711. Drinking Water.

Note • History

Drinking water shall be provided and be centrally located in the camp.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section heading, section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30712. Handwashing Facilities.

Note • History

Handwashing facilities shall be provided adjacent to all flush toilets. Single service soap dispensers shall be provided at handwashing facilities, except for those handwashing facilities located in camper housing facilities.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11). For prior history, see Register 86, No. 18.

§30713. Showers.

Note • History

When campers are present for three or more consecutive days and nights, showers shall be provided.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11). For prior history, see Register 86, No. 18.

§30714. Toilets.

Note • History

Toilets shall be provided at the ratio required in Table 4-4, Part 5, Title 24, California Code of Regulations. Pit or chemical toilets may only be used in remote areas where a plumbing system for water distribution is unavailable. Pit or chemical toilets shall be located so as not to endanger water supplies and shall be so constructed as to exclude flies and vermin.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30715. Plumbing. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

4. Repealer filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 3. Housing

§30720. Building Structures.

Note • History

(a) Plans and specifications for every building or structure shall be approved by the local health officer prior to start of any construction.

(b) Nothing in this section shall prohibit the State Department of Public Health or local health officer from contracting with the Office of the State Architect of the Department of General Services or any private or other governmental agency for the review of design and performance of inspection of construction of camp buildings and structures, in accordance with the provisions of this section.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 11-28-80; effective thirtieth day thereafter (Register 80, No. 48).

3. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

4. Amendment of subsection (b) and deletion of reference citation filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

5. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30721. Sleeping Accommodations.

Note • History

Head-to-head sleeping accommodations shall be prohibited. A minimum space of 18 inches, or a physical barrier, shall be provided between bed units including sleeping bags.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New subsection (c) filed 11-28-80; effective thirtieth day thereafter (Register 80, No. 48).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30722. Repair, Safety, Maintenance and Sanitation.

Note • History

(a) Every building, structure, tent, tent structure, cabin, and premises shall be kept in good repair, and shall be maintained in a safe and sanitary condition, clean and free from accumulations of paper, rubbish, or standing water, satisfactory to the local health officer.

(b) All appliances, equipment, devices, facilities, electrical, mechanical, plumbing, refrigerating and ventilating systems shall be kept in good repair, and shall be maintained in a safe and sanitary condition satisfactory to the local health officer.

(c) When provided, mattresses, mattress covers, blankets, sheets, pillows, and/or sleeping bags shall be maintained sanitary and in good condition. Blankets, sheets, pillows, and/or sleeping bags shall be laundered and/or sanitized prior to issuance to a camper. Mattresses shall be covered with waterproof material or washable covers so as to be easily cleaned and sanitized.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of subsections (a) and (b) and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30723. Overhead Electrical Line Construction.

Note • History

All overhead electrical lines installed in camp shall be in accordance with the Public Utilities Commission, General Order No. 95 (January 2006), Rules for Overhead Electrical Line Construction.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

3. Amendment of section heading, section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30724. Mechanical Installation. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

3. Repealer filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 4. Food Service Facilities and Operations

§30730. Food Service Facilities.

Note • History

Food service facilities shall comply with the requirements of the California Retail Food Code, Health and Safety Code, Section 113700, et seq.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Repealer of former Section T17-30730 and new Section 30730 filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18). For prior history, see Register 71, No. 14.

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30731. Light, Ventilation and Sanitary Facilities.

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

§30732. Cleaning and Sanitizing of Multiuse Utensils.

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

§30733. Storage of Food, Utensils and Equipment.

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

§30734. Health Requisites for Food Service Personnel.

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

Article 4.1. Food Service Facilities and Operations at Intermittent Short-Term Organized Camps [Repealed] new='mq'

§30734.1. Food Service Facilities and Operations at Intermittent Short-Term Organized Camps. [Repealed]

Note • History

NOTE

Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code.

HISTORY

1. New Article 4.1 (Section 30734.1) filed 11-28-80; effective thirtieth day thereafter (Register 80, No. 48).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Repealer of article 4.1 (section 30734.1) and section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 5. Solid Waste

§30735. Garbage and Refuse.

Note • History

All garbage and refuse shall be deposited and stored in flytight containers, removed and disposed of at a frequency and in a manner satisfactory to the local health officer.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 6. Vector Control

§30736. Vectors and Pests.

Note • History

Every camp shall have a plan and equipment for coping with excessive numbers of flies, mosquitoes and other insects and with rodents. At times or places where special risk of transmission of disease to humans from insects, rodents or other animals exists, the camp shall institute special measures to protect the campers, under the guidance of the local health officer.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New NOTE filed 7-12-84 (Register 84, No. 28).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 7. Swimming and Bathing

§30740. Swimming Facilities.

Note • History

All swimming pools, pools, wading pools and special purpose pools which are located in or provided for any camp shall be designed, constructed, maintained, and operated in accordance with the provisions of Article 5, Chapter 5, Part 10, Division 104, of the Health and Safety Code, Sections 116035-116068, and with the applicable provisions of Chapter 20, Division 4, Title 22, and Chapter 31, Part 2, Title 24, Sections 3101B-3137B.2, and Figures 31B-1-31B-5 of the California Code of Regulations.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30741. Lake, Stream, River or Ocean Swimming.

Note • History

(a) A plan for the use of any lake, stream, river or the ocean by any camp for swimming or boating shall be:

(1) Developed and maintained by the Director,

(2) Submitted to the local health officer prior to use, and

(3) Implemented in accordance with any special conditions that may be specified in writing by the local health officer to protect health and safety.

(b) Any camp which uses places such as lakes, streams, rivers or the ocean for swimming shall be equipped with at least one lifeboat or equivalent water safety device that is suited to the size, location and use of the water facility, population of the camp, and dangers inherent to the water facility as determined by the Director of the camp and that shall:

(1) Be used for no other purpose than for saving lives or for other emergencies,

(2) Be kept in good repair and readily accessible to the areas of potential use, and

(3) Comply with Harbors and Navigation Code Section 652.

(c) No camp shall maintain or use a lake, stream or river unless careful soundings of depth of water and location of eddies and pools and determinations of the presence and nature of dangerous currents, sunken logs, rocks and obstructions in the lake, stream or river have been made and:

(1) Legible signs indicating in plain letters, the depth of water, the location of pools or eddies, and the presence and direction of currents of water shall be posted at any lake, stream or river used by a camp for camper swimming, and

(2) The signs shall be visible from the swimming or bathing area during the season when bathing and swimming are permitted.

(d) Lifeguard services equivalent to those defined in Section 116028, Health and Safety Code, shall be provided at any location used for swimming by campers.

(1) There shall be a designated aquatics supervisor who is at least 18 years of age and who shall possess an American Red Cross Lifeguard Certificate, YMCA Swim Lifesaving Certificate or its equivalent certificate.

(2) Lifeguard service shall be provided at a ratio of 1 lifeguard for each 25 campers in the water.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section heading, section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 8. Supervision

§30750. Health Supervision.

Note • History

(a) Every camper and each staff member entering camp shall furnish a health history of his or her health status that is completed and signed by the individual camper or staff member, or by the parent or guardian if the camper or staff member is under the age of 18. This history shall be kept on-site as long as the camper or staff member is at camp and shall include the following:

(1) A description of any health condition requiring medication, treatment, special restriction or consideration while at camp,

(2) A record of immunizations including date of the last tetanus shot,

(3) A record of any allergies.

(b) A signed statement by a parent or guardian to seek emergency medical treatment shall be provided for each staff member or camper, except those minors accompanied in camp by a parent or guardian. The local health officer, when necessary for the protection of the health of campers and staff members, may require special inoculations and testing for each camper and staff member entering camp.

(c) There shall be a full-time adult Health Supervisor charged with health supervision at the camp when campers are present

(d) Health screening shall be conducted under the supervision of the Health Supervisor by qualified staff that meet the requirements of section 30700(f) for:

(1) All staff prior to the arrival of campers; and

(2) All campers under the age of 18 who are unaccompanied by a parent or guardian within 24 hours of arrival at camp.

(e) If a physician is not on site when campers are present, arrangements shall be made for a physician to be available on an on-call basis. An infirmary (tentage or other shelter), with provision for isolating patients, shall be provided. Advance arrangements shall be made for the immediate removal of seriously sick or injured campers or staff members to a point of adequate medical care, on recommendation of a physician. This subsection shall not apply to intermittent short-term organized camps operating less then 72 hours except when required by the local health officer for the protection of the health of campers and adult supervisors.

(f) A medical logbook shall be maintained by the Health Supervisor which includes at least the following information for each accident, injury or illness:

(1) Name of the person treated;

(2) Dosage and intervals of any medication dispensed;

(3) First aid or medical treatment rendered;

(4) Name of the person administering the first aid or medical treatment;

(5) Date and time of treatment; and

(6) Date parent/guardian notified of accident, illness or injury.

(g) The Health Supervisors or the site operator shall report all occurrences of foodborne illness, suspected foodborne illness, or any other reportable disease as required by California Code of Regulations Title 17, section 2500(b) promptly to the local health officer for the camp location.

(h) All medication brought to a camp by campers that needs to be dispensed by the Health Supervisor or qualified staff that meet the requirements of section 30700(f) shall be:

(1) In the original container and labeled in accordance with California Health and Safety Code, Division 104, Part 5, Chapter 6, Article 3, commencing with section 11330, or

(2) In containers accompanied by specific written dispensing instructions from a parent, legal guardian, or physician licensed pursuant to Division 2 of the Business and Professions Code, and

(3) Stored in a locked container when unattended by the Health Supervisor.

(i) A written health care plan developed and maintained by the Health Supervisor shall be used at the camp. The health plan shall include:

(1) The responsibilities and authority of the Health Supervisor and other qualified health staff meeting the requirements of section 30700(f) that provide health care including first aid,

(2) The procedures for camp health care and sanitation,

(3) A record keeping process,

(4) A plan for provisions and maintenance of supplies and equipment, and

(5) The relationships and agreements with local medical personnel, hospitals, and providers of emergency care and other emergency care providers.

(6) A plan to prevent and control the spread of pandemic flu or other communicable diseases among campers.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment filed 11-29-80; effective thirtieth day thereafter (Register 80, No. 48).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30751. General and Safety Supervision.

Note • History

(a) When campers are present, every camp shall have a Director at the camp in charge who is at least 25 years of age and has at least two seasons of administrative or supervisory experience in camp activities. The Director shall provide staff for the care, protection, and supervision of the campers. The Director and all camp counselors shall not have direct unsupervised contact with campers without first obtaining a satisfactory criminal history record check from the California Department of Justice, Bureau of Criminal Identification, or U.S. Department of Justice National Sex Offender Public Registry, and a voluntary disclosure statement that contains the same information as standard HR-4 Staff Screening of the Accreditation Standards for Camp Programs and Services, American Camp Association (2007 Edition).

(b) When campers are present, there shall be at least one counselor who is a high school graduate or who is at least 18 years of age, for each 10 campers under 16 years of age.

(c) The Health Supervisor shall verify that all counselors have been trained in the principles of first aid and cardiopulmonary resuscitation.

(d) Subsections (b) and (c) shall not apply to intermittent organized short-term camps.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. Amendment and new subsection (d) filed 11-28-80; effective thirtieth day thereafter (Register 80, No. 48).

2. Relettering of former subsection (d) to (e) and new subsection (d) filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30752. Firearms.

Note • History

All firearms and ammunition, when not in use for authorized camp activities, shall be stored in a cabinet designated for this use and locked. The key shall be in the possession of the Director or qualified designee meeting the requirements of section 30751(a).

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section heading, repealer and new section and amendment of Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§30753. Emergency Plan.

Note • History

(a) Each camp shall retain on site a written site specific plan, approved by the Director, outlining procedures which deal with the following emergency situations:

(1) Natural disasters.

(2) Lost campers.

(3) Fires.

(4) Transportation emergencies.

(5) Severe illnesses and injuries.

(6) Strangers in camp.

(7) Aquatic emergencies as appropriate for the site.

(8) Other emergency situations as appropriate for the site.

(b) The site specific plan shall include procedures for:

(1) Evacuation of the camp site,

(2) Control of vehicular traffic through the camp, and

(3) Communication from persons at the site of an emergency to the emergency medical facilities, the nearest fire station, and both administrative and health staff of the camp.

NOTE

Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

2. Amendment of section heading, section and Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Subchapter 7. Wiping Rags

Article 1. Definitions

NOTE

Authority cited: Sections 208, 3900, 3901, 15020 and 25800-25870, Health and Safety Code; Section 1224, Business and Professions Code. Reference: Sections 3900, 3901, 15000-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482 and 1242.5, Business and Professions Code.

HISTORY

1. New Subchapter 7, Articles 1 and 2 (Sections 30800 and 30801) filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50).

2. Amendment filed 7-2-80; effective thirtieth day thereafter (Register 80, No. 27).

3. Repealer of Article 1 (Section 30800) filed 10-24-84; effective thirtieth day thereafter (Register 84, No. 43).

Article 2. Minimum Standards for Sanitizing

§30801. Standards.

Note • History

The wiping rags or materials to be processed and used as wiping rags shall be washed using an effective soap or detergent and thoroughly rinsed to remove soap or detergent and soil. Wiping rags shall be exposed to water at a minimum temperature of 71oC (160oF) for at least 24 minutes during the washing process.

NOTE

Authority cited: Sections 208 and 3901, Health and Safety Code. Reference: Section 3901, Health and Safety Code.

HISTORY

1. Amendment filed 10-24-84; effective thirtieth day thereafter (Register 84, No. 43).

Subchapter 8. Drinking Utensils and Ice Buckets

Article 1. Definitions

§30850. Single Service.

Note • History

“Single service” means a utensil, container, implement, wrapper, or other article designed for use only once and then discarded in the preparation, storage, display, service, consumption, or sale of food or beverage.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

HISTORY

1. New Subchapter 8 (Sections 30850-30858) filed 12-21-78; effective thirtieth day thereafter (Register 78, No. 51).

§30851. Multiuse.

Note

“Multiuse” means a utensil, container, implement, wrapper, or other article designed for use more than once in the preparation, storage, display, service, consumption, or sale of food or beverage.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

Article 2. Washing, Sanitizing, and Handling of Drinking Utensils and Ice Buckets in Hotels, Motels, and Other Public Places

§30852. Utensils and Containers, Conditions of Use and Storage.

Note • History

(a) Multiuse and single service drinking utensils and ice buckets shall be protected from dirt, vermin, droplet infection, overhead leakage, and other potential contamination during handling, storage, and distribution.

(b) Multiuse drinking utensils or ice buckets may be used in guest rooms under the following conditions:

(1) They are thoroughly washed and sanitized after each use.

(2) The drinking utensils, prior to distribution, are placed in protective bags with the open end of the utensil placed in the closed end of the bag to prevent handling of the lip contact surface.

(3) No utensil shall be labeled or otherwise indicate to have been cleaned and sanitized unless it has been cleaned and sanitized in accordance with Section 30853 and/or 30855.

(c) Single service drinking utensils or ice buckets may be used in guest rooms under the conditions that the drinking utensils are dispensed by one of the following methods:

(1) From a dispenser which keeps the lip contact surface enclosed.

(2) Individually wrapped.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

HISTORY

1. Amendment filed 2-28-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 9).

§30853. Hand Dishwashing and Sanitizing.

Note

(a) Multiuse drinking utensils or ice buckets shall be washed and sanitized in a three-compartment metal sink equipped with hot and cold running water and integral metal drain boards.

(b) The drinking utensils and ice buckets shall be processed in the following sequence:

(1) Washed with hot water 40.5-49o Celsius (105-120oF) and detergent in the first sink compartment until thoroughly cleaned.

(2) Rinsed in hot water 40.5-49o Celsius (105-120oF) in the second compartment.

(3) Immersed in the third compartment containing a bactericidal solution in such concentration and for such time as specified in Section 30854.

(c) A facility with a two-compartment metal sink with metal drainboards on the effective date of these regulations may continue to use such sink utilizing procedures listed in (1) and (3) of Subsection 30853(b) until replacement is necessary because of deterioration or modernization of premises.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

§30854. Sanitizing Solutions for Hand Dishwashing.

Note

(a) Multiuse utensils and ice buckets shall be sanitized by immersion in one of the following bactericidal solutions for a minimum of 30 seconds in the last sink compartment.

(1) 100 parts per million (ppm) of available chlorine from either hypochlorite or organic chlorine approved by the Department.

(2) 200 ppm of a quaternary ammonium compound approved by the Department.

(3) 25 ppm of available iodine.

(4) 25 ppm of iodophor.

(5) 25 ppm of bromine-chlorine compounds.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

§30855. Machine Washing and Sanitizing.

Note

(a) All dishwashing machines shall be designed, installed, and operated to thoroughly clean and provide an effective bactericidal rinse.

(b) Commercial type of dishwashing machines when used in food establishments regulated by the California Restaurant Act, shall meet all the requirements of that chapter (Chapter 11, Division 22, of the Health and Safety Code, commencing with Section 28520). These include, but are not limited to, the following:

(1) Hot water sanitizing dishwashing machines.

(2) Chemical sanitizing dishwashing machines approved by the Department.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

§30856. Sanitizing Requirements for Dishwashing Machines.

Note

(a) The hot water sanitizing commercial dishwashing machine shall be connected to a hot water system that is installed and maintained to continuously provide water at least 82.2o Celsius (180oF) at the final rinse manifold of the machine during the required bactericidal rinse cycle.

(b) The domestic type hot water sanitizing dishwashing machine shall produce a minimum water temperature of 74o Celsius (165oF) during the wash and rinse cycles.

(1) A sanitizing solution of at least 50 ppm hypochlorite.

(2) A sanitizing solution of at least 12.5 ppm iodophor.

(3) Any other bactericidal solution approved by the Department.

(d) Any other method approved by the Department.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

§30857. Maintenance and Construction Requirements.

Note

(a) All drinking utensils, ice buckets, shelves, sinks, dishwashing machines, and other related equipment shall be:

(1) Constructed of non-toxic materials,

(2) Constructed, installed, and maintained as to be readily cleanable, and

(3) Kept clean and in good repair.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

§30858. Inspection Authority.

Note

(a) The Director, agents, or Registered Sanitarians appointed by the Director, and local health officers, Registered Sanitarians, and duly authorized agents thereof may at reasonable times enter and inspect any hotels, motels, or other public places governed by these regulations.

NOTE

Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code.

Chapter 6. Lead Poisoning Prevention Programs

Article 1. Definitions

§33001. Applicant.

Note • History

“Applicant” means a business entity either applying for an exemption pursuant to section 105310(d) of the Health and Safety Code and Section 33040 of this chapter, or applying for a reassessment of the fees pursuant to section 33050 of this chapter. “Applicant” includes any other business entity who was historically associated with the business entity making the application.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

1. New chapter 6, article 3 (sections 33001-33030, not consecutive) filed 2-1-93 as an emergency; operative 2-1-93 (Register 93, No. 6). A Certificate of Compliance must be transmitted to OAL 6-1-93 or emergency language will be repealed by law on the following day. For prior history, see Register 78, No. 24.

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and filed 7-12-93 (Register 93, No. 29).

3. Amendment of subsection (c)(2) and new subsection (c)(4) filed 5-15-95; operative 6-14-95. Exempt from OAL review pursuant to Health and Safety Code section 372.7(h) (Register 95, No. 20).

4. Repealer of article 3 heading and section and new article 1 (sections 33001-33015) and section filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

5. Repealer of article 3 heading and section and new article 1 (sections 33001-33015) and section refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

6. Repealer of article 3 heading and section and new article 1 (sections 33001-33015) and section refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

7. Certificate of Compliance as to 3-12-2002 order, including amendment of section, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33002. Architectural Coating.

Note • History

“Architectural coating” means any product which is used as, or usable as, a coating applied to the interior or exterior surfaces of stationary structures and their appurtenances, to portable buildings, to pavements, or to curbs, such as house and trim paints, varnishes, stains, lacquers, industrial maintenance coatings, primers, undercoaters, and traffic coatings.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

1. New section filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

3. New section refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33003. Architectural Coating Distribution.

Note • History

“Architectural coating distribution” means any of the following:

(a) The manufacturing, producing, blending, or compounding of architectural coating in this state, and the sale, donation, barter, or use of the architectural coating in this state.

(b) The importing of architectural coating into this state with respect to which there has been no prior distribution subject to the fee, and the sale, donation, barter, or use of architectural coating in this state.

(c) The receiving in this state by a distributor of architectural coating with respect to which there has been no prior distribution subject to the fee, or the receipt in this state by any business entity of architectural coating with respect to which there has not been a prior distribution on which a fee has been paid pursuant to this section, and the sale, donation, barter, or use of the architectural coating in this state.

(d) The sale of architectural coatings by any business entity required to be registered pursuant to Revenue and Taxation Code Section 6001 et seq., when it is shipped into this state by the seller or delivered by the seller to a carrier, customs broker, or forwarding agent, whether hired by the order of the purchaser or not, for shipment into this state for subsequent sale, donation, barter, or use in this state.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of subsections (c)-(d) and amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33004. Architectural Coating Distributor.

Note • History

“Architectural coating distributor” means each business entity that distributes or has distributed architectural coatings, excluding each business entity that the Department has:

(a) Currently granted an exemption pursuant to section 33040;

(b) Determined to be insolvent; or

(c) Determined did not distribute architectural coatings in or about 1978, and is not historically associated with an architectural coating distributor which distributed architectural coatings in or about 1978.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of section, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33005. Appurtenance.

Note • History

“Appurtenance” means accessories to an architectural structure, such as hand railings, cabinets, bathroom and kitchen fixtures, fences, decking, furniture, rain-gutters and down spouts, window screens, lamp-posts, heating and air conditioning equipment, other mechanical equipment, large fixed stationary tools and concrete forms.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33006. Business Entity.

Note • History

“Business entity” means any natural person, or form of business organization, including, but not limited to, a corporation, trust, firm, joint stock company, business concern, partnership, limited liability company, or association.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33007. Department.

Note • History

“Department” means the California Department of Public Health.

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code. Reference: Sections 105280(c), 105310, 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

5. Amendment of section and Note filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

§33008. Environmental Lead Contamination.

Note • History

“Environmental lead contamination” means the persistent presence of lead in the environment, in quantifiable amounts, that results in ongoing and chronic exposure to children.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105280(g), 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33009. Fee.

Note • History

“Fee” means a fee imposed under Health and Safety Code section 105310 and implementing regulations.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33010. Historically Associated.

Note • History

“Historically Associated” means that the business entity has a significant relationship to another business entity, such as a business entity which:

(a) Is the alter ego, successor, successor-in-interest, or predecessor, in full or part, of another business entity;

(b) Purchased controlling or significant interest in another business entity;

(d) Exists by way of a merger, consolidation, or reorganization of another business entity;

(e) Acquired the products of another business entity, unless the business entity from which the products were acquired is assessed a fee for the same products;

(f) Acquired a trademark or the goodwill of another business entity, unless the business entity from which the trademark or goodwill was acquired is assessed a fee for the same products.

(g) Acquired significant operating assets from another business entity, including, but not limited to, acquisition of substantially all of a means of production, such as a factory or refinery.

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code; and Ch. 799, Stats. 1991, Sec. 11. Reference: Sections 105310, 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 2-1-93 as an emergency; operative 2-1-93 (Register 93, No. 6). A Certificate of Compliance must be transmitted to OAL 6-1-93 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and filed 7-12-93 (Register 93, No. 29).

3. Repealer and new section filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

4. Repealer and new section refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

5. Repealer and new section refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

6. Certificate of Compliance as to 3-12-2002 order, including amendment of first paragraph and amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

7. Amendment of subsection (h), new subsection (g) and amendment of Note filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

§33011. Industry.

Note • History

“Industry” means motor vehicle fuel distributors, architectural coating distributors, or facilities releasing lead into ambient air in California.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33012. Motor Vehicle Fuel.

Note • History

“Motor vehicle fuel” means gasoline, natural gasoline, blends of gasoline and alcohol containing more than 15 percent gasoline, and any inflammable liquid, by whatever name the liquid may be known or sold, which is used or is usable for propelling motor vehicles operated or suitable for operation on the highway. “Motor vehicle fuel” does not include kerosene, liquefied petroleum gas, natural gas in liquid or gaseous form, ethanol, methanol, or inflammable liquids specifically manufactured for racing motor vehicles which do not contain gasoline or natural gasoline and which are distributed and used for racing motor vehicles at a racetrack.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33013. Motor Vehicle Fuel Distribution.

Note • History

“Motor vehicle fuel distribution” means any of the following:

(a) The refining, manufacturing, producing, blending, or compounding of motor vehicle fuel in this state, and the sale, donation, barter, or use of motor vehicle fuel in this state.

(b) The importing of motor vehicle fuel into this state with respect to which there has been no prior distribution subject to the fee, and the sale, donation, barter, or use of motor vehicle fuel in this state.

(c) The receiving in this state by a motor vehicle fuel distributor of motor vehicle fuel with respect to which there has been no prior distribution subject to the fee, or the receipt in this state by any business entity of motor vehicle fuel with respect to which there has not been a prior distribution on which a fee has been paid pursuant to this section, and the sale, donation, barter, or use of the motor vehicle fuel in this state.

(d) The sale of motor vehicle fuel by any business entity required to be registered pursuant to Revenue and Taxation Code Section 6001 et seq., when it is shipped into this state by the seller or delivered by the seller to a carrier, customs broker, or forwarding agent, whether hired by the order of the purchaser or not, for shipment into this state for subsequent sale, donation, barter, or use in this state.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of subsections (c)-(d) and amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33014. Motor Vehicle Fuel Distributor.

Note • History

“Motor vehicle fuel distributor” means each business entity that distributes or has distributed motor vehicle fuel excluding each business entity that the Department has:

(a) Currently granted an exemption pursuant to section 33040;

(b) Determined to be insolvent; or

(c) Determined did not distribute motor vehicle fuel in or about 1991, and is not historically associated with a motor vehicle fuel distributor which distributed motor vehicle fuel in or about 1991.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of section and Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§33015. Ongoing and Chronic Exposure.

Note • History

“Ongoing and chronic exposure” means exposure to lead that has been dispersed into the environment by industry which has not been abated in accordance with Title 17, California Code of Regulations, Division 1, Chapter 8, section 35001 et seq.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment of section, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

Article 2. Fees

§33020. Fees Attributable to Leaded Architectural Coatings.

Note • History

(a) Each architectural coating distributor shall pay a fee assessed and collected by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows:

____ x D

WHERE:

A = Total gallons of architectural coatings distributed in or about 1978 by each architectural coatings distributor, as estimated by the Department based upon the best available data compiled and held by the Department.

The estimate of each architectural coating distributor's 1978 distributions shall include the Department's estimate of the total gallons of architectural coating products distributed in 1978 from any and all business operations for which the architectural coating distributor is currently responsible, including by historical association as determined by the Department pursuant to section 33060.

B = Total gallons of architectural coating distributed in or about 1978 by all architectural coating distributors, as estimated by the Department based upon the best available data compiled and held by the Department.

D = $2,260,000.00 + the annual adjustment pursuant to Health and Safety Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code; and Ch. 799, Stats. 1991, Sec. 11. Reference: Sections 105310, 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and filed 7-12-93 (Register 93, No. 29).

3. New article 2 (sections 33020-33030) and amendment of section and Note filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

4. New article 2 (sections 33020-33030) and amendment of section and Note refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

5. New article 2 (sections 33020-33030) and amendment of section and Note refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

6. Certificate of Compliance as to 3-12-2002 order, including amendment of subsection (a), transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

7. Amendment of subsection (a) and amendment of Note filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

§33025. Fees Attributable to Leaded Gasoline.

Note • History

(a) Each motor vehicle fuel distributor shall pay a fee, assessed and collected annually by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows:

____ x D

WHERE:

A = Total gallons of motor vehicle fuel distributed in or about 1991 by each motor vehicle fuel distributor, as estimated by the Department based upon the best available data compiled and held by the Department.

The estimate of each motor vehicle fuel distributor's 1991 distributions shall include the Department's estimate of the total gallons of motor vehicle fuel distributed in 1991 from any and all business operations for which the motor vehicle fuel distributor is currently responsible, including by historical association as determined by the Department pursuant to section 33060.

B = Total gallons of motor vehicle fuel distributed in or about 1991 by all motor vehicle fuel distributors, as estimated by the Department based upon the best available data compiled and held by the Department.

D = $13,640,000.00 + the annual adjustment pursuant to Health and Safety Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code; and Ch. 799, Stats. 1991, Sec. 11. Reference: Sections 105310, 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

4. Certificate of Compliance as to 3-12-2002 order, including amendment subsection (a) and amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

5. Amendment of subsection (a) and amendment of Note filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

§33030. Fees Attributable to Facilities Releasing Lead into Ambient Air in California.

Note • History

(a) Facilities that have reported releases of lead or lead compounds into ambient air in California pursuant to the Superfund Amendments and Reauthorization Act, Title III, Section 313, shall pay a fee, assessed by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows:

____ x C

WHERE:

A = The total pounds of lead and lead compounds reported to be released by each facility into the California ambient air in the most recent calendar year for which data are available, as reported pursuant to the Superfund Amendments and Reauthorization Act, Title III, Section 313.

B = The total pounds of lead and lead compounds reported to be released by all facilities into California ambient air in the most recent calendar year for which data are available, as reported pursuant to the Superfunds Amendments and Reauthorization Act, Title III, Section 313.

C = $100,000 + the annual adjustment pursuant to Health and Safety Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code; and Ch. 799, Stats. 1991, Sec. 11. Reference: Sections 105310, 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and filed 7-12-93 (Register 93, No. 29).

3. Amendment of section heading, section and Note filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

4. Amendment of section heading, section and Note refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

5. Amendment of section heading, section and Note refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

6. Certificate of Compliance as to 3-12-2002 order transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

Article 3. Exemption from Fees

§33040. Exemption From Fees.

Note • History

(a) An exemption from the fee imposed under Health and Safety Code section 105310 shall be granted to an applicant who can demonstrate, as determined by the Department, that all of the following are true:

(1) The industry with which the applicant is associated is not currently engaged in the stream of commerce of lead or products containing lead;

(2) The industry with which the applicant is associated was not historically engaged in the stream of commerce of lead or products containing lead;

(3) The industry with which the applicant is associated is not otherwise responsible for identifiable sources of lead which currently contribute to environmental lead contamination;

(4) The industry with which the applicant is associated is not otherwise responsible for identifiable sources of lead which have historically contributed to environmental lead contamination.

(b) An applicant who does not seek or who fails to demonstrate entitlement to an exemption under subsection (a) shall qualify for an exemption if the applicant can demonstrate, as determined by the Department, that either:

(1) The applicant's industry did not contribute in any manner to environmental lead contamination, or

(2) The applicant's lead, or products containing lead, with which the applicant is currently, or was historically, associated does not currently, or did not historically, result in environmental lead contamination.

(c) It shall be presumed that the applicant is subject to the fee until the applicant establishes the contrary to the satisfaction of the Department. The presumption may be rebutted by providing a complete application and any other documentation that the Department requires to establish the applicant's entitlement to the exemption. Contents of an application shall include, but are not limited to:

(1) A thorough statement, made under penalty of perjury, which demonstrates the applicant's entitlement to the exemption. The sworn statement shall also contain the declarant's basis of knowledge for making the statements contained therein. If the person making the statement is not reasonably available to the applicant, a certified copy of a transcript of sworn testimony may be submitted. If such prior sworn testimony is used, the applicant must also provide a declaration as to why the declarant is not available. More than one statement may be submitted when necessary to prove the elements of the exemption.

(2) Records providing the information specified below shall be submitted in duplicate with a sworn statement under penalty of perjury establishing the reliability and completeness of the records, including a description of their mode of preparation and maintenance:

(A) The formulation for all products manufactured and all products sold by the applicant, including the International Union of Pure and Applied Chemical (IUPAC) name and Chemical Abstract Service (CAS) number for all ingredients used;

(B) The total amount of lead manufactured, distributed, and sold each year in the applicant's products;

(C) Any actions taken by the applicant to abate the lead dispersed into the environment by the applicant's products in accordance with Title 17, California Code of Regulations, Division 1, Chapter 8, section 35001 et seq;

(D) Any records, or portion thereof, which the applicant wants to protect as a trade secret shall be submitted in a separate sealed envelope clearly marked on the outside as “Trade Secret Material.” For purposes of this section, “trade secret” shall have the same meaning as in the Uniform Trade Secrets Act, Civil Code section 3426 et seq. The application shall contain a declaration under penalty of perjury describing why the applicant believes the material is a trade secret. After review, the Department will either grant the trade secret request and keep the material confidential, or deny the request, return all copies of the trade secret material to the applicant, and not consider the trade secret material in its determination. The Department's refusal to grant a requested claim of trade secret does not excuse the applicant from establishing all elements of the claim for exemption. Any material which the Department agrees to consider as a trade secret shall be exempt from disclosure under the Public Records Act, Government Code section 6250 et seq. Records for which the Department has denied protection as a trade secret shall also be exempt from disclosure under the Public Records Act during the time the records are in the possession of the Department.

(3) A cover letter containing the name and address of the applicant, the applicant's Board of Equalization account number, the name, address and telephone number of the person to contact about the application, a summary of the basis for the exemption, and a listing of all items included with the application.

(d) The application shall be delivered to the Department at the following address:

FEE EXEMPTION REQUEST
CHILDHOOD LEAD POISONING PREVENTION BRANCH
DEPARTMENT OF PUBLIC HEALTH
850 MARINA BAY PARKWAY, BUILDING P, THIRD FLOOR
RICHMOND, CA 94804-6403

(e) An exemption granted under this section is valid for a period specified by the Department of at least one calendar year. The Department may reexamine an exemption if the facts underlying the applicant's basis for exemption have changed or issues arise regarding the appropriateness of the exemption.

(f) The Department may, in its sole discretion, decide the application for exemption based upon the information submitted, or may request the submission of additional information prior to making a written decision. If the applicant does not provide the additional material requested by the Department, then the Department may decide the matter based upon the material already presented.

(g) The Department shall either grant or deny the exemption.

(1) If the application for exemption is denied, the applicant may, within 30 days after receipt of the Department's written decision, request reconsideration of the decision from the Department. The request for reconsideration shall be in writing, and shall detail the reasons why the applicant believes the original decision was in error.

(2) The Department may decide the matter based upon the record submitted in the application, or may request the submission of additional information. The Department's decision on the reconsideration shall be in writing, and shall either grant the exemption, or specify the reasons for its denial.

(h) An applicant who has paid the fee, and thereafter been granted an exemption by the Department, may apply for a refund to the Board of Equalization. The request for a refund must be in writing and mailed to:

STATE BOARD OF EQUALIZATION
FUEL TAXES DIVISION, MIC:30
P.O. BOX 942879
SACRAMENTO, CA 94279-0001

NOTE

Authority cited: Sections 105310 and 131200, Health and Safety Code; and Ch. 799, Stats. 1991, Sec. 11. Reference: Sections 105250, 105310, 124160(b), 124165, 131050, 131051 and 131052, Health and Safety Code.

HISTORY

1. New section filed 5-15-95; operative 6-14-95. Exempt from OAL review pursuant to Health and Safety Code section 372.7(h) (Register 95, No. 20).

2. New article 3 (section 33040) and amendment of section and Note filed 7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Compliance must be transmitted to OAL by 11-16-2001 or emergency language will be repealed by operation of law on the following day. Exempt from OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 29).

3. New article 3 (section 33040) and amendment of section and Note refiled 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

4. New article 3 (section 33040) and amendment of section and Note refiled 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency language will be repealed by operation of law on the following day. Exempt for OAL review pursuant to Health and Safety Code section 105310(h) (Register 2002, No. 11).

5. Certificate of Compliance as to 3-12-2002 order, including amendment of subsection (c)(2)(C) and amendment of Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

6. Repealer of subsection (c)(1)(D), subsection relettering, amendment of subsections (d)-(e), repealer of subsections (f)-(f)(2), subsection relettering, amendment of newly designated subsections (g)-(g)(2) and amendment of Note filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

Article 4. Application to Reassess Fee

§33050. Application to Reassess Fee.

Note • History

(a) An applicant requesting a reassessment of the fee imposed under Health and Safety Code section 105310 shall submit an application to the Department which contains:

(1) A statement or statements, made under penalty of perjury, which demonstrates the applicant's entitlement to a reassessed fee, and which includes a statement that the applicant has paid in full any and all fees assessed by the Board of Equalization pursuant to this Chapter. The sworn statement(s) shall also contain the basis of knowledge for making the statements contained therein.

(2) Records identifying the total gallons of motor vehicle fuel distributed by the applicant in or about 1991 or the total gallons of architectural coatings distributed by the applicant in or about 1978. Records, such as sales data, annual reports, or other information, shall be submitted in duplicate with a sworn statement under penalty of perjury establishing the reliability and completeness of the records, including a description of their mode of preparation and maintenance. Any records, or portion thereof, which the applicant wants to protect as a trade secret shall be submitted in a separate sealed envelope clearly marked on the outside as “Trade Secret Material.” For purposes of this section, “trade secret” shall have the same meaning as in the Uniform Trade Secrets Act, Civil Code section 3426 et seq. The application shall contain a declaration under penalty of perjury describing why the applicant believes the material is a trade secret.

(b) If the application is denied, the applicant may, within 30 days after receipt of the Department's written decision, request reconsideration of the decision from the Department. The request for reconsideration shall be in writing, and shall detail the reasons why the applicant believes the original decision was in error.

(c) Any claim for refund shall be submitted to the Board of Equalization by the applicant within the statutory time frames established by Revenue and Taxation Code Section 43451 et seq.

NOTE

Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code.

HISTORY

1. New article 4 (section 33050) and section filed 8-22-2002; operative 8-22-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 34).

§33060. Transfer of Operating Assets.

Note • History

(a) Where an assessed business entity sells or transfers some or all of its operating assets to another business entity the Department will determine whether an historical association has been established between the two business entities. The Department will make a determination based upon the best available information compiled and held by the Department, without regard to whether an application has been filed by any party pursuant to section 33060(b). If an historical association has been established, then the acquiring business entity shall be responsible for the fee for the historical activity of the acquired business operations, beginning with the fee for the calendar year in which the operating assets were acquired.

(b) A party may file an application with the Department seeking a determination under section 33060(a), including an application seeking reconsideration of a determination already made by the Department under section 33060(a). An application filed under this section shall include:

(1) A brief statement, made under penalty of perjury, describing the business operations and business entities in question and stating the basis of the application;

(2) A copy of relevant portions of the purchase and sale agreement that would identify what assets were sold, when the assets were sold, and to whom the assets were sold;

(3) Any other documentation that would demonstrate a transfer of ownership of the operating assets, or otherwise support the stated basis of the application.

(c) If the application is denied, the applicant may, within 30 days after receipt of the Department's written decision, request reconsideration of the decision from the Department. The request for reconsideration shall be in writing, and shall detail the reasons why the applicant believes the original decision was in error.

NOTE

HISTORY

1. New section filed 1-29-2009; operative 1-29-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 10531(h) (Register 2009, No. 5).

Chapter 7. Health Facilities Planning [Repealed]

HISTORY

1. Repealer of Chapter 7 (Sections 40500-40532, not consecutive) filed 11-12-76 as an emergency; effective upon filling (Register 76, No. 46). For prior history see Registers 70, No. 43; 71, No. 4; and 76, No. 34.

2. Certificate of Compliance filed 3-8-77 (Register 77, No. 11).

Chapter 7.5 Eminent Domain Procedures for Nonprofit Hospitals [Repealed]

HISTORY

1. New Chapter 7.5 (Sections 43000-43050, not consecutive) filed 11-24-75; effective thirtieth day thereafter (Register 75, No. 48).

2. Repealer of Chapter 7.5 (Sections 43000-43050) filed 7-25-77; effective thirtieth day thereafter (Register 77, No. 31).

Chapter 7.7 Fire Protection Loans [Repealed]

NOTE

Authority cited: Sections 208 and 13111.3, Health and Safety Code.

HISTORY

1. New Chapter 7.7 (Sections 44000-44100, not consecutive) filed 7-25-75 as an emergency; effective upon filing (Register 75, No. 6).

2. Certificate of Compliance filed 5-2-75 (Register 75, No. 18).

3. Repealer of Chapter 7.7 (Sections 44000-44100, not consecutive) filed 7-25-78; effective thirtieth day thereafter (Register 78, No. 30). For prior history, see Registers 75, No. 6; 75, No. 18; 75, No. 19; 75, No. 52; 76, No. 12 and 76, No. 18.

Chapter 8. Accreditation, Certification and Work Practices for Lead-Based Paint and Lead Hazards

Article 1. Definitions

§35001. Abatement.

Note • History

“Abatement” means any set of measures designed to reduce or eliminate lead hazards or lead-based paint for public and residential buildings, but does not include containment or cleaning.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New chapter 8, article 1 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New chapter 8, article 1 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of chapter heading, section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of chapter heading, section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of chapter heading and section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35002. Accreditation.

Note • History

“Accreditation” means the Department has reviewed and finds acceptable a training provider's written application for accreditation, and has conducted and finds acceptable, an on-site audit as specified in subsection 35078(e).

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35003. Accredited Training Provider.

Note • History

“Accredited training provider” means any individual, corporation, partnership or other unincorporated association or public entity to which the Department has granted accreditation or provisional accreditation to offer lead-related construction courses and continuing education instruction.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35004. CDPH-Approved Course.

Note • History

“CDPH-approved course” means any lead-related construction course that satisfies the requirements specified in sections 35056, 35057, 35061, 35065, 35066, or 35067 as determined by CDPH pursuant to sections 35076 and 35078.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Amendment of section heading, new section and amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18). For prior history, see Register 99, No. 2.

§35005. Certified Lead Inspector/Assessor.

Note • History

“Certified lead inspector/assessor” means an individual who has received a certificate or an interim certificate from the Department as a “certified lead inspector/assessor”.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35005 to new section 35015, and renumbering of former section 35018 to new section 35005, including amendment of section heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35005 to new section 35015, and renumbering of former section 35018 to new section 35005, including amendment of section heading, section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35005.1. Certified Lead Project Designer.

Note • History

“Certified lead project designer” means an individual who has received a certificate from the Department as a “certified lead project designer.”

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18). For prior history, see Register 99, No. 2.

§35006. Certified Lead Project Monitor.

Note • History

“Certified lead project monitor” means an individual who has received a certificate or an interim certificate from the Department as a “certified lead project monitor.”

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35006 to new section 35018, and renumbering of former section 35019 to new section 35006, including amendment of section heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35006 to new section 35018, and renumbering of former section 35019 to new section 35006, including amendment of section heading, section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35007. Certified Lead Sampling Technician.

Note • History

“Certified lead sampling technician” means an individual who has received a certificate or an interim certificate from the Department as a “certified lead sampling technician”.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35007 to new section 35019, and renumbering of former section 35020 to new section 35007, including amendment of section heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35007 to new section 35019, and renumbering of former section 35020 to new section 35007, including amendment of section heading, section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35008. Certified Lead Supervisor.

Note • History

“Certified lead supervisor” means an individual who has received a certificate or an interim certificate from the Department as a “certified lead supervisor”.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35008 to new section 35020, and renumbering of former section 35021 to new section 35008, including amendment of section heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35008 to new section 35020, and renumbering of former section 35021 to new section 35008, including amendment of section heading, section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35009. Certified Lead Worker.

Note • History

“Certified lead worker” means an individual who has received a certificate from the Department as a “certified lead worker”.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35009 to new section 35021, and renumbering of former section 35023 to new section 35009, including amendment of section heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35009 to new section 35021, and renumbering of former section 35023 to new section 35009, including amendment of section heading, section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35010. Certificate.

Note • History

“Certificate” means the document issued by the Department to an individual who meets the requirements for certification as described in sections 35083, 35085, 35087, 35089, or 35091.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35010 to new section 35023 and new section 35010 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35010 to new section 35023 and new section 35010 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35011. Guest Instructor.

Note • History

NOTE

Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35011 to new section 35025 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35011 to new section 35025 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

§35012. Certified Industrial Hygienist.

Note • History

“Certified industrial hygienist” (CIH) means a person who has met the education, experience, and examination requirements of an industrial hygiene certification organization governed by the American Board of Industrial Hygiene.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35012 to new section 35026, and renumbering of former section 35004 to new section 35012, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35012 to new section 35026, and renumbering of former section 35004 to new section 35012, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35013. Clearance Inspection.

Note • History

“Clearance inspection” means an on-site limited investigation, as described in Chapter 15: Clearance, sections II-VI, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35013 to section 35014 and new section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35013 to new section 35027 and new section 35013 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35013 to new section 35027 and new section 35013 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35014. Component.

Note • History

“Component” means a structural element or fixture, such as a wall, floor, ceiling, door, window, molding, trim, trestle, tank, stair, railing, cabinet, gutter, or downspout.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35013 to section 35014 and former section 35014 to section 35015 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35014 to new section 35028 and new section 35014 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35014 to new section 35028 and new section 35014 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35015. Contact Hour.

Note • History

“Contact hour” means 60 minutes of lead-related construction training which may include a break of not more than ten minutes.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35014 to section 35015 and former section 35015 to section 35016 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35015 to new section 35029, and renumbering of former section 35005 to new section 35015, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35015 to new section 35029, and renumbering of former section 35005 to new section 35015, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35016. Containment.

Note • History

“Containment” means a system, process, or barrier used to contain lead hazards inside a work area such as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995, Chapter 8, “Containment and Barrier Systems,” Table 8.1, Table 8.2, and Table 8.3, or “Guide for Containing Surface Preparation Debris Generated During Paint Removal Operations,” Society for Protective Coatings, Technology Guide 6, October 1, 2004.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b), 124165 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35015 to section 35016 and former section 35016 to section 35017 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35016 to new section 35030 and new section 35016 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35016 to new section 35030 and new section 35016 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35017. Job Tasks.

Note • History

NOTE

Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35016 to section 35017 and former section 35017 to section 35018 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35017 to new section 35032 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35017 to new section 35032 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

§35018. Continuing Education.

Note • History

“Continuing education” means lead-related construction instruction, other than a course as described in section 35004, that satisfies the requirements specified in section 35070 or 35072.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35017 to section 35018 and former section 35018 to section 35019 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35018 to new section 35005, and renumbering of former section 35006 to new section 35018, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35018 to new section 35005, and renumbering of former section 35006 to new section 35018, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35019. Course Completion Form.

Note • History

“Course Completion Form” means documentation, on CDPH Form 8493 (6/07), issued by an accredited training provider to an individual and the Department as proof of successful completion of a CDPH-approved lead-related construction course or continuing education instruction.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35018 to section 35019 and former section 35019 to section 35020 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35019 to new section 35006, and renumbering of former section 35007 to new section 35019, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35019 to new section 35006, and renumbering of former section 35007 to new section 35019, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35020. Demonstration Testing.

Note • History

“Demonstration testing” means the observation and scoring by an instructor or a guest instructor of an individual student's job task and equipment use skills taught during a course or continuing education instruction.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35019 to section 35020 and former section 35020 to section 35021 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35020 to new section 35007, and renumbering of former section 35008 to new section 35020, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35020 to new section 35007, and renumbering of former section 35008 to new section 35020, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35021. Department.

Note • History

“Department” means the California Department of Public Health (CDPH).

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35020 to section 35021 and former section 35021 to section 35022 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35021 to new section 35008, and renumbering of former section 35009 to new section 35021, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35021 to new section 35008, and renumbering of former section 35009 to new section 35021, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35022. Deteriorated Lead-Based Paint.

Note • History

“Deteriorated lead-based paint” means lead-based paint or presumed lead-based paint that is cracking, chalking, flaking, chipping, peeling, non-intact, failed, or otherwise separating from a component.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35021 to section 35022 and former section 35022 to section 35023 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35022 to new section 35040 and new section 35022 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35022 to new section 35040 and new section 35022 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35023. DHS-Approved Course. [Repealed]

Note • History

NOTE

Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35022 to section 35023 and former section 35023 to section 35024 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35023 to new section 35009, and renumbering of former section 35010 to new section 35023, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35023 to new section 35009, and renumbering of former section 35010 to new section 35023, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Repealer filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35024. Photo Identification Number.

Note • History

NOTE

Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35023 to section 35024 and former section 35024 to section 35025 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35024 to new section 35041 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35024 to new section 35041 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

§35025. Guest Instructor.

Note • History

“Guest instructor” means an individual who is responsible for providing less than 30% of training in any course.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35024 to section 35025 and former section 35025 to section 35026 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35025 to new section 35042, and renumbering of former section 35011 to new section 35025, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35025 to new section 35042, and renumbering of former section 35011 to new section 35025, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35026. Hands-on Training.

Note • History

“Hands-on training” means training during which students practice skills that they will be expected to perform at the worksite.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35026 to section 35027 and former section 35027 to section 35028 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35026 to new section 35044, and renumbering of former section 35012 to new section 35026, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35026 to new section 35044, and renumbering of former section 35012 to new section 35026, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35027. Industrial Building.

Note • History

“Industrial building” means a structure that is used primarily for industrial activity, which is generally not open to the public, including but not limited to, warehouses, factories, and storage facilities. “Industrial building” does not include any structure which fits the definition of a public building or a residential building.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering and amendment of former section 35026 to section 35027 and former section 35027 to section 35028 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35027 to new section 35045, and renumbering of former section 35013 to new section 35027, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35027 to new section 35045, and renumbering of former section 35013 to new section 35027, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35028. Instructor.

Note • History

“Instructor” means an individual who is responsible for providing 30% or more of training in any course or continuing education instruction.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35027 to section 35028 and former section 35028 to section 35029 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35028 to new section 35046, and renumbering of former section 35014 to new section 35028, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35028 to new section 35046, and renumbering of former section 35014 to new section 35028, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35029. Interactive/Participatory Teaching Methods.

Note • History

“Interactive/participatory teaching methods” mean instruction which consists of active participation of the students, such as brainstorming, hands-on training, demonstration and practice, small group problem-solving, learning games, discussions, risk mapping, field visits, walk-throughs, problem-posing, group work assignments, homework review sessions, question-and-answer periods, skits, or role-playing sessions. Lecture is not considered an interactive/participatory teaching method.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35028 to section 35029 and former section 35029 to section 35030 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35029 to new section 35048, and renumbering of former section 35015 to new section 35029, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35029 to new section 35048, and renumbering of former section 35015 to new section 35029, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35030. Interim Certificate.

Note • History

“Interim certificate” means the document issued by the Department to an individual who meets the requirements for interim certification as described in section 35093.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including renumbering of former section 35029 to section 35030 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35030 to new section 35049, and renumbering of former section 35016 to new section 35030, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35030 to new section 35049, and renumbering of former section 35016 to new section 35030, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35031. Job Tasks.

Note • History

“Job tasks” mean the specific activities performed in the context of work.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Amendment of section heading, new section and amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18). For prior history, see Register 99, No. 2.

§35032. Lead Activities.

Note • History

“Lead activities” means abatement, lead hazard evaluation, lead-related construction work, or any activity which disturbs lead-based paint, presumed lead-based paint, or creates a lead hazard.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 2 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 2 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 2 to precede new section 35051, renumbering former section 35032 to new section 35052, and renumbering former section 35017 to new section 35032, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment moving article 2 to precede new section 35051, renumbering former section 35032 to new section 35052 and renumbering former section 35017 to new section 35032, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, repealer and new section and amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35033. Lead-Based Paint.

Note • History

“Lead-based paint” means paint or other surface coatings that contain an amount of lead equal to, or in excess of:

(a) one milligram per square centimeter (1.0 mg/cm2); or

(b) half of one percent (0.5%) by weight.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

2. New section refiled with amendment of subsection (b)(1) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (b)(3) and (d) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35033 to new section 35053 and new section 35033 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35033 to new section 35053 and new section 35033 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35034. Lead Certification Examination.

Note • History

“Lead certification examination” means the statewide examination offered by the Department to applicants for certification.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35034 to new section 35054 and new section 35034 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35034 to new section 35054 and new section 35034 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35035. Lead-Contaminated Dust.

Note • History

“Lead-contaminated dust” means dust that contains an amount of lead equal to, or in excess of:

(a) forty micrograms per square foot (40 mg/ft2) for interior floor surfaces; or

(b) two hundred and fifty micrograms per square foot (250 mg/ft2) for interior horizontal surfaces; or

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b), 124165 and 131051, Health and Safety Code.

HISTORY

1. New article 3 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 3 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (a)(3)-(a)(3)(A) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 3 heading formerly preceding section 35035 to precede section 35055, renumbering of former section 35035 to new section 35055 and new section 35035 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment moving article 3 heading formerly preceding section 35035 to precede section 35055, renumbering of former section 35035 to new section 35055 and new section 35035 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35036. Lead-Contaminated Soil.

Note • History

“Lead-contaminated soil” means bare soil that contains an amount of lead equal to, or in excess of, four hundred parts per million (400 ppm) in children's play areas and one thousand parts per million (1000 ppm) in all other areas.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b), 124165, and 131051, Health and Safety Code.

HISTORY

1. New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35037. Lead Hazard.

Note • History

“Lead hazard” means deteriorated lead-based paint, lead contaminated dust, lead contaminated soil, disturbing lead-based paint or presumed lead-based paint without containment, or any other nuisance which may result in persistent and quantifiable lead exposure.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and 131200, Health and Safety Code. Reference: Sections 17920(l), 17920.3(c) and (k), 105250(a), 105250(b), 105280(g), 124160(b), 124165 and 131051, Health and Safety Code; Sections 1941, 3479, 3480 and 3481, Civil Code; Section 17274(b), Revenue and Taxation Code; and Section 11349(c) and 11349(e), Government Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35038. Lead Hazard Evaluation.

Note • History

“Lead hazard evaluation” means the on-site investigation, for compensation, of lead-based paint or lead hazards for public and residential buildings, but does not include:

(a) activities intended to determine adequacy of containment; or

(b) air monitoring for lead, as specified in Title 8, California Code of Regulations, section 1532.1, and Title 17, California Code of Regulations, sections 70100 and 70200; or

(c) testing components removed from a residential or public building for lead to determine the applicability of hazardous waste requirements specified in Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, and California Health and Safety Code, section 25163, subdivision (c).

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35039. Lead Inspection.

Note • History

“Lead inspection” means a surface by surface investigation to determine the presence of lead-based paint as described in Chapter 7: Lead-Based Paint Inspection, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, 1997 Revision.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35040. Lead-Related Construction Work.

Note • History

“Lead-related construction work” means any construction, alteration, painting, demolition, salvage, renovation, repair, or maintenance of any residential or public building, including preparation and cleanup, that, by using or disturbing lead-containing material or soil, may result in significant exposure of adults or children to lead.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35022 to new section 35040, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35022 to new section 35040, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35041. Photo Identification Number.

Note • History

“Photo identification number” means the number listed on a form of photo identification, such as a passport or California Department of Motor Vehicles driver's license or identification card, which matches a trained individual with a Course Completion Form.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35024 to new section 35041, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35024 to new section 35041, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35042. Postsecondary Education.

Note • History

“Postsecondary education” means education completed at a junior college, college, or university accredited by a national or regional accrediting agency which is recognized by the U.S. Department of Education or a state agency authorized to approve such institutions.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35025 to new section 35042, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35025 to new section 35042, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35043. Presumed Lead-Based Paint.

Note • History

“Presumed lead-based paint” means paint or surface coating affixed to a component in or on a structure constructed prior to January 1, 1978. “Presumed lead-based paint” does not include paint or surface coating that has been tested and found to contain an amount of lead less than one milligram per square centimeter (1.0 mg/cm2) or less than half of one percent (0.5%) by weight.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b), 124165 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35044. Provisional Accreditation.

Note • History

“Provisional accreditation” means the Department has reviewed and finds acceptable a training provider's written application for accreditation, but has not conducted an on-site audit as specified in subsection 35078(e).

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35026 to new section 35044, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35026 to new section 35044, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35045. Public Building.

Note • History

“Public building” means a structure, or part of a structure, and its land, which is generally accessible to the public, including but not limited to, schools, daycare centers, museums, airports, hospitals, stores, convention centers, government facilities, office buildings and any other building which is not an industrial building or a residential building.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35027 to new section 35045, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35027 to new section 35045, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35046. Residential Building.

Note • History

“Residential building” means a structure, or part of a structure, and its land, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of one or more persons.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35028 to new section 35046, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35028 to new section 35046, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35047. Risk Assessment.

Note • History

“Risk Assessment” means an on-site investigation to determine the existence, nature, severity, and location of lead hazards, as described in Chapter 5: Risk Assessment, section II (A), (B), (C) and (D), “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35048. Train-the-Trainer Course.

Note • History

“Train-the-trainer course” means a course that includes, but is not limited to, instruction in the planning and teaching of adult education, adult learning principles, designing training objectives, selecting and designing training activities, creating an effective learning environment, facilitating group involvement and discussions, and strategies for dealing with difficult training situations and difficult learners.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35029 to new section 35048, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35029 to new section 35048, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35049. Training Director.

Note • History

“Training Director” means the individual, designated by an accredited training provider, who monitors the performance and qualifications of instructors and guest instructors, the quantity and quality of training provided, and who is responsible for ensuring that an accredited training provider complies with the requirements for accreditation.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35030 to new section 35049, including amendment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35030 to new section 35049, including amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35050. Work Area.

Note • History

“Work area” means an area where lead activities are conducted.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b) and 131051, Health and Safety Code.

HISTORY

1. New article 4 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 4 and section refiled with amendment of subsection (d)(9)(B) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of subsection (d)(9) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 4 heading to precede section 35056, renumbering of former section 35050 to new section 35056 and new section 35050 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment moving article 4 heading to precede section 35056, renumbering of former section 35050 to new section 35056 and new section 35050 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 2. Eligibility Requirements for Accreditation and Course Approval

§35051. Representation of Accreditation Status.

Note • History

Unless accredited pursuant to the requirements of this chapter, no person shall represent himself or herself as, or do business as, an accredited training provider.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200, Health and Safety Code. Reference: Sections 16240 and 17200, Business and Professions Code; and Section 131051, Health and Safety Code.

HISTORY

1. Amendment moving article 2 heading formerly preceding section 35032 to precede section 35051 and new section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Amendment moving article 2 heading formerly preceding section 35032 to precede section 35051 and new section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35052. Eligibility Requirements.

Note • History

To qualify for and maintain accreditation, a training provider shall conduct at least one CDPH-approved course in California at least once during each calendar year, satisfy the applicable requirements specified in sections 35053 and 35054 and comply with all applicable requirements specified in sections 35076 and 35078.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35032 to new section 35052, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35032 to new section 35052, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35053. Personnel Requirements.

Note • History

(a) Each course shall be administered by a Training Director with the following minimum qualifications:

(1) Two years of experience administering training programs or two years of experience teaching or training adults;

(2) Successful completion of a 40 hour train-the-trainer course, or two years experience teaching or training adults, or an associate degree or higher in education from a postsecondary educational institution;

(3) A bachelor or graduate-level degree in building construction technology, engineering, industrial hygiene, safety, or health, or two years of experience managing an environmental or occupational health and safety program; and

(4) Successful completion of 24 contact hours of lead-related construction training from any of the required topics listed in sections 35056, 35057, 35061, or 35065.

(b) Each course shall be taught by an instructor with the following minimum qualifications:

(1) Successful completion of a 40 hour train-the-trainer course, or one year of experience teaching or training adults, or an associate degree or higher in education from a postsecondary educational institution;

(2) Successful completion of 24 contact hours of lead-related construction training from any of the required topics listed in sections 35056, 35057, 35061, or 35065;

(3) One year of experience related to health, safety, or regulatory aspects of lead-related construction in the topic area of the lead-related construction course they will be teaching or one year of lead-related construction experience in the topic area of the lead-related construction course they will be teaching, or CDPH certification in the discipline of the course in which they will be teaching. Except that, instructors of hands-on training must have two years of lead-related construction or related experience in the topic area of the lead-related construction course they will be teaching; and

(4) Successful completion of seven contact hours of continuing education instruction annually.

(c) Only an instructor receiving a satisfactory annual performance review by the Training Director shall provide course or continuing education instruction, unless the instructor is also the Training Director.

(d) Each qualified guest instructor shall have a minimum of one year of experience related to the subject matter that they teach. Except that, guest instructors of hands-on training shall have a minimum of two years of lead-related construction or related experience.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35033 to new section 35053, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35033 to new section 35053, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (b)(3), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of subsection (b)(3) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35054. Operational Requirements.

Note • History

(a) An accredited training provider shall provide facilities for classroom instruction, hands-on training, and simulated field visits. The training provider shall also provide equipment, instructional material, and instructor personnel to provide training needed to achieve the objectives for which the course or continuing education instruction is offered. Equipment shall be maintained in proper working condition and licensed and stored in compliance with applicable requirements and regulations.

(b) A student-to-instructor ratio of not greater than ten to one shall be maintained during hands-on training and instructors shall provide attention to and observation of each student's activities.

(d) An accredited training provider shall administer a final examination to eligible students seeking a Course Completion Form in each course or continuing education instruction.

(e) A minimum score of 70% shall be considered a passing score on a final examination.

(f) An accredited training provider shall allow a student who fails to attain a passing score on a final examination to retake the examination up to two more times within 30 calendar days from the date the original examination was given. These examinations shall be different from, but equivalent to, the original final examination.

(g) Within 30 calendar days of a student passing a final examination, an accredited training provider shall issue a completed Course Completion Form to the student and the Department.

(h) A final examination shall be designed to test a student's knowledge of information and ability to perform job tasks taught in a course or continuing education instruction. This examination may be administered verbally or in written form, shall be given to student's individually, shall include demonstration testing if hands-on training is done, and shall consist of the following:

(1) Demonstration testing shall comprise a minimum of 15% and shall not exceed 35% of the final examination, except for the lead-related construction work course which shall not exceed 50%; and

(2) A minimum of 100 questions for the lead-related construction inspection and assessment course and the lead-related construction supervision and project monitoring course; or

(3) A minimum of 75 questions for the lead-related construction Certified Industrial Hygienist course; or

(4) A minimum of 50 questions for the lead-related construction work course and the lead-related construction supplemental supervision and project monitoring course; or

(5) A minimum of 30 questions for the lead-related construction sampling technician course; or

(6) A minimum of five questions for each contact hour of continuing education instruction.

(i) CDPH Form 8493 (6/07), Course Completion Form, shall contain the following information:

(1) Student's name, residence address (and mailing address, if different), telephone number, and date of birth;

(2) Student's photo identification number and description of type of identification document;

(3) Student's authorization to release, to the Department, information contained on CDPH Form 8493 (6/07), Course Completion Form;

(4) Student's verification of understanding that possession of the Course Completion Form does not constitute certification by CDPH;

(5) Student's verification of understanding that, to be eligible for interim certification or certification renewal, an application for interim certification or certification shall be made to CDPH within one year of successful completion of the final examination;

(6) Student's signature and date;

(7) Accredited training provider's name;

(8) Title and number of the course or continuing education instruction;

(9) Number of contact hours completed;

(10) Dates and location(s) of the course or continuing education instruction and CDPH Form 8493 (6/07), Course Completion Form Number and date of student's completion of core instruction if different;

(11) Date the student passed the course or continuing education final examination; and

(12) Training Director's name, printed or typed, signature, and date verifying, under penalty of perjury, that all information contained on CDPH Form 8493 (6/07), Course Completion Form, is true and correct.

(j) An accredited training provider shall maintain, at its principal place of business in California, for at least five years, accurate records of the following:

(1) Daily student attendance;

(2) Examination results for each student, including results of demonstration testing;

(3) Completed Course Completion Forms;

(4) Training Director and instructor qualifications;

(5) Documentation of approval or authority to operate granted by the Bureau for Private Postsecondary and Vocational Education;

(6) Current course curriculum materials and documents reflecting any changes made to these materials;

(7) Examinations for each course, including demonstration testing protocol; and

(8) Completed student evaluation forms for each course.

(k) An accredited training provider shall notify CDPH at least 48 hours prior to offering or canceling a course or continuing education training. The notification shall include type of course or training, instructor(s), date(s), time(s), and location(s), including street address.

(l) An accredited training provider shall submit documentation of instructor qualifications as specified in §35053(b) to CDPH at least 48 hours prior to an instructor teaching a course or continuing education.

(m) An accredited training provider shall maintain approval or authority to operate granted by the Bureau for Private Postsecondary and Vocational Education.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former section 35034 to new section 35054, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former section 35034 to new section 35054, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsections (j)(5) and (m), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 3. Core Instruction

§35055. Core Instructional Requirements.

Note • History

(a) Each course, except the lead-related construction work course and the lead-related construction sampling technician course, shall include a minimum of five contact hours of the following core instructional requirements:

(1) At least one contact hour of background information on lead and health effects related to lead exposure, including:

(A) Identification of sources of environmental lead such as surface dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Summary of lead abatement control options, including interim controls;

(E) The nature of lead-related diseases;

(F) Pathways of exposure in children and adults;

(G) Dose-response relationships, and blood lead levels in children and adults;

(H) Effects on the nervous, reproductive (male and female), musculo-skeletal, cardiovascular, and blood-forming systems and kidneys;

(I) Different effects on children and adults, including women during pregnancy;

(J) Symptoms and diagnosis of poisoning in children and adults and CDPH-reportable blood lead levels;

(K) Medical treatment for lead poisoning, including, chelation therapy; and

(L) How lead in the body is absorbed, distributed, and eliminated.

(2) At least one contact hour on relevant federal, state and local regulatory requirements including:

(A) Requirements for the identification, management, transport, record keeping, and disposal of hazardous waste set forth in Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, Health and Safety Code section 25163, subdivision (c), and Chapter 6.5, Article 10.8, of the Health and Safety Code;

(B) Ambient Air Quality Standards for lead set forth in Title 17, California Code of Regulations, sections 70100 and 70200;

(C) Injury and Illness Prevention Program requirements set forth in Title 8, California Code of Regulations, sections 1509 and 3203;

(D) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1; and

(E) Standards for hazard communication in the work place set forth in the “Clear and Reasonable Warnings,” Title 22, California Code of Regulations, subsections 12601(c) & (d) and in “Hazard Communication,” Title 8, California Code of Regulations, section 5194.

(3) At least one contact hour on respiratory protection and personal protective equipment including:

(A) Standards and criteria for establishing a respiratory protection program set forth in Title 8, California Code of Regulations, sections 5141 and 5144 and Occupational Safety and Health Administration (OSHA) respirator requirements set forth in 29 Code of Federal Regulations, section 1910.134 (1998);

(B) Classes and characteristics of respirators;

(D) Proper selection, inspection, donning, doffing, use, maintenance, and storage procedures for respirators;

(E) Methods for field testing the face piece seal (user seal check procedures);

(F) Qualitative and quantitative fit testing procedures;

(G) Factors that alter respirator fit, e.g. facial hair;

(H) Selection and use of personal protective clothing;

(I) Storage and handling of non-disposable clothing; and

(J) Proper use of protective clothing and equipment set forth in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1.

(4) Discussion of the roles and responsibilities of the interim certified individual, the need for further on-the-job training and the need to work with other personnel during lead-related construction activities, including public health and housing agency officials.

(b) Individuals in possession of a CDPH Form 8493 (6/07), Course Completion Form in any course, except a lead-related construction Work course, shall not be required to retake the core instructional requirements when seeking a Course Completion Form in another course, provided the course begins no more than three years after the date of the final examination on the initial Course Completion Form.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Amendment moving article 3 heading formerly preceding section 35035 to precede section 35055, and renumbering former section 35035 to new section 35055, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Amendment moving article 3 heading formerly preceding section 35035 to precede section 35055, and renumbering former section 35035 to new section 35055, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsections (a)(1), (a)(1)(C), (a)(1)(F), (a)(1)(G), (a)(1)(J), (a)(1)(K), (a)(2), (a)(3), (a)(3)(A) and (a)(3)(E), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of subsections (a), (a)(1)(J) and (b) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 4. Lead-Related Construction Inspection and Assessment Course

§35056. Course Requirements.

Note • History

(a) A lead-related construction Inspection and Assessment course shall consist of a minimum of 40 contact hours which includes core instructional requirements specified in section 35055, methodology requirements specified in subsection 35056(b), hands-on training, as specified in subsection 35056(c), and classroom instruction, as specified in subsection 35056(d).

(b) At least 16 of the 40 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least ten contact hours of hands-on training.

(1) Inspection and hazard assessment techniques as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(2) Participation in a simulated field visit which includes:

(A) Walk-through building inspection;

(B) Discussion of data collection, including sample location determination; and

(d) Classroom instruction shall include:

(1) Federal guidelines as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision.

(2) State regulations specified in Title 17, California Code of Regulations, Division 1, Chapter 8, Sections 36000 and 36100.

(3) Roles and responsibilities of local health officials versus private sector Inspector/Assessors when conducting lead hazard assessments.

(4) Potential hazard exposure circumstances, including, but not limited to, electrical, heat stress, fire, explosion, and chemical air contaminants, slips, trips, falls and disturbances of friable asbestos.

(5) At least one contact hour on radiation information and safety training requirements as follows:

(A) CDPH radiation safety training requirements as specified in Title 17, California Code of Regulations, sections 30100-30355;

(B) Ionizing radiation including atomic structure, units of radiation, radioactivity, radioactive decay, ionization, radiation absorption in matter, and radiation detection; and

(C) Safe use of X-ray florescent (XRF) analyzers, including direct and indirect analyzers and limitations (substrate interference), transportation, storage, record keeping and license requirements.

(6) At least five contact hours on job tasks associated with lead hazard inspection procedures as follows:

(A) Review and interpretation of previous inspection records, including sample collection and analysis, abatement activities, and source information;

(B) Inspection plan development, including notification of property owners and occupants, building access, use of warning signs, and disruption minimization.

(C) Hazard communication with property owners, occupants, and neighbors relative to the reduction or elimination of sources of lead at the job site such as paint, dust, soil, water, imported ceramic pottery, home remedies, or occupational take-home sources;

(D) Visual inspections and clearance inspections;

(E) Sample collection including equipment, procedures, quality assurance and contamination factors before, during and after abatement, as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(F) Sample analysis, including selection of an EPA recognized laboratory under the National Lead Laboratory Accreditation Program to test paint, dust, soil samples and other media and quality assurance procedures; and

(G) Post-inspection procedures and written reports.

(7) At least five contact hours on job tasks associated with lead hazard risk assessment as follows:

(A) HUD protocol for risk assessment and interim controls as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(B) Assessment of leaded paint surface damage, including disturbance potential of lead-related construction work;

(D) Public and lead-related construction work personnel health considerations, including medical confidentiality.

(8) Record keeping as specified in CDPH radiation materials control regulations in the California Code of Regulations, title 17, sections 30100-30355; and “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision.

(9) Lead-related construction techniques in residential and public buildings as follows:

(A) Abatement options, including interim controls;

(B) Clean-up and disposal procedures, contamination prevention and dust minimization, including high efficiency particulate air (HEPA) vacuums as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and

(10) Inspector/Assessor qualifications, responsibilities, legal obligations and conflicts of interest.

(11) Insurance issues relating to lead-related construction, work and abatement including liability insurance, claims-made and occurrence policies, and environmental and pollution liability policy clauses, and bonding.

(12) Classroom discussion of a simulated field visit.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 5 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 5 and section refiled with amendment of subsection (c)(2) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (d)(1)(A)-(B), (d)(5)(A), and (d)(5)(J) and new subsection (d)(1)(C) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 4 heading formerly preceding section 35050 to precede section 35056 and moving article 5 heading formerly preceding section 35056 to precede section 35057, renumbering former section 35056 to new section 35057, and renumbering former section 35050 to new section 35056, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment moving article 4 heading formerly preceding section 35050 to precede section 35056 and moving article 5 heading formerly preceding section 35056 to precede section 35057, renumbering former section 35056 to new section 35057, and renumbering former section 35050 to new section 35056, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (c)(5)(A) and (c)(8) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 5. Lead-Related Construction Supervision and Project Monitoring Course

§35057. Course Requirements.

Note • History

(a) A lead-related construction supervision and project monitoring course shall consist of a minimum of 40 contact hours which includes core instructional requirements specified in section 35055, methodology requirements specified in subsection 35057(b), hands-on training, as specified in subsection 35057(c), classroom instruction, as specified in subsection 35057(d), and a demonstration of respirator fit testing as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1.

(b) At least 16 of the 40 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least eight contact hours of hands-on training.

(1) Exposure assessment including paint chip collection and air monitoring and worker protection practices including personal protective equipment as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1;

(2) Clearance inspections such as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and

(3) Lead-related construction supervision and project monitoring, including, use of engineering controls, construction and use of containment and barrier systems for at least two worksite preparation levels, removal methods, interim control methods, clean-up including high efficiency particulate air (HEPA) vacuums, use of negative air machines, and waste disposal as specified in, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision.

(d) Classroom instruction shall include:

(1) Regulatory requirements as specified in:

(A) National Emission Standards for Hazardous Air Pollutants set forth in Title 40, Code of Federal Regulations, section 50.12 (1992);

(B) Relevant State Contractor Licensing Board requirements for conducting work as a contractor set forth in section 7026 and following of the Business and Professions Code;

(C) Permitting requirements for lower risk treatment activities set forth in Health and Safety Code, Chapter 6.5, Article 9, sections 25200.3, 25201.5, and Title 22, California Code of Regulations, Division 4.5, Chapter 45; and

(D) Work practice requirements set forth in Title 17, California Code of Regulations, sections 36000 and 36100.

(2) Identification and prevention of hazards encountered during lead-related construction as follows:

(A) Emergency procedures for sudden releases; and

(B) Electrical, heat stress, fire, explosion and other hazards, chemical air contaminants, slips, trips, falls and disturbances of friable asbestos.

(3) Job tasks associated with sample collection and analysis procedures as follows:

(A) Sample collection equipment, and procedures, quality assurance methods and contamination factors before, during and after abatement, as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(B) Sample analysis, including interpretation and quality assurance procedures; and

(4) At least five contact hours on job tasks associated with lead-related construction including the following:

(A) Interior and exterior leaded paint, soil and dust abatement methods (including chemical, enclosure, hand, mechanical, blasting, encapsulation), interim control methods, use of engineering controls, clean-up techniques (including high efficiency particulate air (HEPA) vacuums), and worksite preparation (including use of negative air machines), as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(B) Lead-related construction work and abatement as a portion of a renovation project;

(D) Work practices as follows:

1. Construction, use, and maintenance of containment and barrier systems;

2. Warning signs and their placement; and

3. Electrical and ventilation systems lockout.

(E) Meeting housing codes and standards;

(F) Special lead-related construction procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and lead exposure minimization;

(G) Development of detailed schedules to comply with project design requirements and execution of tasks, including but not limited to, resident notification, building access, warning signs, and occupant disruption minimization;

(H) Identification and implementation of personal hygiene practices including, but not limited to, entry and exit procedures for the work area, provision and use of showers; and avoidance of eating, drinking, smoking, chewing, and applying cosmetics in the work or changing area;

(I) Hazard communication with property owners, occupants and neighbors relative to the reduction or elimination of sources of lead at the job site such as paint, lead dust, soil, water, imported ceramic pottery, home remedies, and occupational take-home exposures; and

(J) Administrative tasks associated with supervision and project monitoring:

1. Contract specifications, preparation and administration;

2. Cost estimation, including strategies for cost reduction;

3. Development and administration of an illness and injury prevention program; and

4. Record keeping as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1.

(5) Supervision and project monitoring job tasks associated with lead-related construction project design as follows:

(A) Review of inspection reports;

(B) Performance of clearance testing methods as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and

(6) Conflicts of interest related to the performance of supervision, inspection, and project monitoring tasks.

(7) Medical surveillance and removal protection as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1, including but not limited to, issues involved in selecting and using medical services;

(8) Insurance issues relating to lead-related construction including:

(A) Workers' compensation coverage and exclusions; and

(B) Liability insurance, claims-made and occurrence policies, environmental and pollution liability policy clauses, and bonding.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Amendment moving article 5 heading formerly preceding section 35056 to precede section 35057, and renumbering former section 35056 to new section 35057, including amendment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Amendment moving article 5 heading formerly preceding section 35056 to precede section 35057, and renumbering former section 35056 to new section 35057, including amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 6. Lead-Related Construction Sampling Technician Course

§35061. Course Requirements.

Note • History

(a) A lead-related construction sampling technician course shall consist of a minimum of 8 contact hours, with at least 5 contact hours taught using interactive/participatory teaching methods. The course shall include:

(1) At least thirty minutes of classroom instruction on lead and health effects related to lead exposure, including:

(A) Identification of sources of lead hazards;

(B) Numerical standards for lead-contaminated dust, lead-contaminated soil, and lead-based paint; and

(2) At least one contact hour of classroom instruction on lead hazard evaluation activities and requirements specified in Title 17, California Code of Regulations, section 36000. Classroom instruction shall delineate the responsibilities of an inspector/assessor and sampling technician as specified in section 36000(d).

(3) At least one contact hour on job tasks associated with lead hazard evaluation as follows:

(A) Professional responsibilities and limitations as specified in Health and Safety Code sections 105253 through 105256, inclusive.

(B) Sampling or testing soil, dust, and paint only when an inspector/assessor identifies the specific locations where soil, dust, and paint are to be sampled or tested, interprets the results, and complies with the record keeping and reporting requirements;

(D) Sample collection and testing procedures for paint, dust, and soil; and

(E) Post-sampling and post-testing procedures.

(4) At least three and one half contact hours of hands-on training including:

(A) Sample collection, including equipment, procedures, and quality assurance, as described in:

1. Chapter 5: Risk Assessment, section II (D), and Appendix 13.3 “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995; and

2. Chapter 7: Lead-Based Paint Inspection, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, 1997.

(B) Participation in simulated field visit, including visual inspections, collection of dust, paint and soil samples, and practice with an X-ray Fluorescence (XRF) analyzer.

(5) At least thirty minutes of classroom instruction on radiation information and safety training requirements specified in Title 17, California Code of Regulations, division 1, chapter 5, subchapter 4, groups 1, 1.5, and 2. This instruction shall emphasize that sampling technicians are required to complete an additional eight hours of training prior to operating an X-ray Fluorescence (XRF) analyzer for lead hazard evaluation.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 6 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 6 and section refiled with amendment of subsection (d)(2) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (e)(1)(A)-(B), (e)(5)(B) and (e)(5)(J) and new subsection (e)(1)(C) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (c)(1), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of article heading, repealer and new section and amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 7. Lead-Related Construction Work Course

§35065. Course Requirements.

Note • History

(a) A lead-related construction work course shall consist of a minimum of 24 contact hours which includes methodology requirements specified in subsection 35065(b), hands-on training, as specified in subsection 35065(c), classroom instruction, as specified in subsection 35065(d), and a demonstration of respirator fit testing as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1.

(b) At least 12 of the 24 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least ten contact hours of hands-on training.

(1) Exposure assessment including air monitoring and worker protection practices including personal protective equipment as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1; and

(2) Lead-related construction work, including, construction and use of containment and barrier systems for at least two worksite preparation levels, removal methods, interim control methods, waste disposal, use of high efficiency particulate air (HEPA) vacuums, electrical and ventilation system lockout, clean-up, and personal hygiene.

(d) Classroom instruction shall include:

(1) At least one contact hour of regulatory requirements as specified in:

(A) Injury and Illness Prevention Program requirements set forth in Title 8, California Code of Regulations, sections 1509 and 3203;

(B) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1;

(C) Standards for hazard communication in the work place set forth in the “Clear and Reasonable Warnings,” Title 22, California Code of Regulations, subsections 12601(c) and (d) and in “Hazard Communication,” Title 8, California Code of Regulations, section 5194; and

(D) Work practice standards set forth in Title 17, California Code of Regulations, sections 36000 and 36100.

(2) At least one contact hour of background information on lead, including:

(A) Identification of sources of environmental lead contamination such as surface dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Health effects related to lead exposure, including but not limited to:

1. Pathways of exposure in children and adults;

2. Dose-response relationships and blood lead levels in children and adults;

3. Effects on the nervous, reproductive (male and female), musculo-skeletal, cardiovascular, and blood-forming systems and kidneys;

4. Different effects on children and adults, including women during pregnancy;

5. Symptoms and diagnosis of poisoning in children and adults and CDPH-reportable blood lead levels; and

6. Medical treatment for lead poisoning, including chelation therapy.

(3) At least two contact hours on respiratory protection and personal protective equipment, including:

(A) Elements of a respiratory protection program set forth in Title 8, California Code of Regulations, sections 5141 and 5144 and Occupational Safety and Health Administration (OSHA) respirator requirements set forth in 29 Code of Federal Regulations, section 1910.134 (1998);

(B) Classes and characteristics of respirators;

(D) Proper selection, inspection, donning, doffing, use, maintenance, and storage procedures for respirators;

(E) Methods for field testing the face piece seal (user seal check procedures);

(F) Qualitative and quantitative fit testing procedures;

(G) Factors that alter respirator fit, e.g. facial hair;

(H) Selection and use of personal protective clothing;

(I) Storage and handling of non-disposable clothing; and

(4) At least eight contact hours on job tasks associated with lead-related construction including:

(A) Tasks as described in, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision as follows:

1. Sampling methods for paint, dust, and soil;

2. Construction and use of containment and barrier systems for all interior and exterior worksite preparation levels;

3. Interior and exterior leaded paint, soil and dust abatement methods (including chemical, enclosure, hand, mechanical, blasting, encapsulation), and interim control methods;

4. Use of administrative and engineering controls; and

5. Clean-up techniques (including high efficiency particulate air (HEPA) vacuums);

(B) Construction, use and maintenance of containment and barrier systems;

(D) Electrical and ventilation systems lockout;

(E) Hazardous and non-hazardous waste characterization and disposal;

(F) Personal hygiene, including entry and exit procedures for the work area, use of showers, avoidance of eating, drinking, smoking, chewing, and applying cosmetics in the work or changing area, avoidance of take-home exposures; and

(G) Identification and prevention of hazards as follows:

1. Emergency procedures for sudden releases; and

2. Electrical, heat, stress, fire, explosion and other hazards, chemical air contaminants, slips, trips, falls and disturbances of friable asbestos.

(5) Medical monitoring requirements as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1, including:

(A) Discussion of the need for medical monitoring of lead toxicity and disclosure of medical history for lead-related construction work; and

(B) Treatment of lead poisoning cases, including medical removal procedures and the issue involved in selecting medical services.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 7 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 7 and section refiled with amendment of subsection (c)(2) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (d)(2)(D)5. and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 8. Lead-Related Construction Supplemental Supervision and Project Monitoring Course

§35066. Course Requirements.

Note • History

(a) A lead-related construction supplemental supervision course shall consist of a minimum of 16 contact hours which includes methodology requirements specified in subsection 35066(b), hands-on training, as specified in section 35066(c), and classroom instruction, as specified in subsection 35066(d).

(b) At least four of the 16 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least one contact hour of hands-on training.

(1) Exposure assessment including paint chip collection and air monitoring as specified in the Construction Safety Orders, Title 8, California Code of Regulations, section 1532.1; and

(d) Classroom instruction shall include:

(1) Regulatory requirements as specified in:

(A) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1;

(B) Section 35055(a)(2)(A) and (B); and

(2) Job tasks associated with sample collection and analysis procedures as specified in section 35057(d)(3).

(3) At least five contact hours on job tasks associated with lead-related construction as specified in section 35057(d)(4).

(4) Supervision and project monitoring job tasks associated with lead-related construction project design as specified in 35057(d)(5).

(5) Supervision and project monitoring issues as specified in 35057(d)(6)(7) and (8).

(6) Discussion of the roles and responsibilities of the interim certified individual as specified in 35055(a)(4).

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Renumbering of former article 8 to new article 9, new article 8 (section 35066) and new section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering of former article 8 to new article 9, new article 8 (section 35066) and new section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 9. Lead-Related Construction Certified Industrial Hygienist Course

§35067. Course Requirements.

Note • History

(a) A lead-related construction certified industrial hygienist course shall consist of a minimum of 24 contact hours which includes methodology requirements specified in subsection 35067(b), hands-on training, as specified in subsection 35067(c), and classroom instruction, as specified in subsection 35067(d).

(b) At least eight of the 24 required contact hours shall be hands-on training.

(2) Simulated field visit associated with lead-related construction inspection and assessment which includes:

(A) Walk-through building inspection;

(B) Discussion of data collection, including sample location determination; and

(3) Simulated field visit associated with developing lead-related construction project designs which includes:

(A) Building walk-through for development of project design; and

(B) On-site discussion of project design.

(d) Classroom instruction shall include:

(1) Background information on lead, including:

(A) Identification of sources of environmental lead such as surface dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Summary of lead abatement control options, including interim controls.

(2) Relevant federal, state and local regulatory requirements:

(A) Requirements for the identification, management, transport, record keeping, and disposal of hazardous waste set forth in Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, and Health and Safety Code section 25163, subdivision (c), and Chapter 6.5, Article 10.8;

(B) Ambient Air Quality Standards for lead set forth in Title 17, California Code of Regulations, sections 70100 and 70200;

(D) National Emission Standards for Hazardous Air Pollutants set forth in 40 Code of Federal Regulations, section 50.12 (1992);

(E) Relevant State Contractor Licensing Board requirements for conducting work as a contractor set forth in section 7026 and following of the Business and Professions Code;

(F) Permitting requirements for lower risk treatment activities set forth in Health and Safety Code, Chapter 6.5, Article 9, sections 25200.3, 25201.5, and Title 22, California Code of Regulations, Division 4.5, Chapter 45; and

(G) Work practice requirements set forth in Title 17, California Code of Regulations, sections 36000 and 36100.

(3) Federal guidelines as specified in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision.

(4) Roles and responsibilities of local health officials versus private sector Inspector/Assessors when conducting lead hazard assessments.

(5) Job tasks associated with lead hazard inspection procedures as follows:

(A) Review and interpretation of previous inspection records;

(B) Inspection plan development, including notification of property owners and occupants, building access, use of warning signs, and disruption minimization;

(D) Visual inspections and clearance inspections;

(E) Investigation protocol for assessing multiple sources of lead exposure;

(F) Sample collection including equipment, procedures, quality assurance and contamination factors before, during and after abatement, as described in “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”, U.S. Department of Housing and Urban Development, June 1995, or most recent revision;

(G) Sample analysis, including selection of an EPA recognized laboratory to test paint, dust, soil samples and other media and quality assurance procedures; and

(H) Post-inspection procedures and written reports.

(6) Job tasks associated with lead hazard risk assessment as follows:

(B) Assessment of leaded paint surface damage, including disturbance potential of lead-related construction activities;

(D) Public and lead-related construction personnel health considerations, including medical confidentiality.

(7) Lead-based paint abatement techniques in residential and public, buildings as follows:

(A) Abatement options, including interim controls;

(8) Inspector/Assessor qualifications, responsibilities, legal obligations and conflicts of interest.

(9) Insurance issues relating to lead-related construction including:

(A) Workers' compensation coverage and exclusions; and

(B) Liability insurance, claims-made and occurrence policies, and environmental and pollution liability policy clauses, and bonding.

(10) Job tasks associated with lead-related construction including, but not not limited to, the following:

(A) Abatement as a portion of a renovation project;

(B) Notification of other contractors working at the construction site;

1. Construction and maintenance of containment barriers;

2. Warning signs and their placement; and

3. Electrical and ventilation systems lockout;

(D) Meeting housing codes and standards;

(E) Procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and exposure minimization;

(F) Development of detailed schedules to comply with project design requirements and execution of tasks, including but not limited to, resident notification, building access, warning signs, and occupant disruption minimization; and

(G) Administrative tasks associated with supervision and project monitoring:

1. Contract specifications, preparation and administration;

2. Cost estimation, including strategies for cost reduction.

(11) Supervision and project monitoring job tasks associated with project design as follows:

(A) Review of inspection reports;

(12) Conflicts of interest related to the performance of supervision, inspection, and project monitoring tasks.

(13) Job tasks associated with lead-related construction project design as follows:

(A) Development and modification of project design specifications:

1. Working with other consultants such as industrial hygienists, construction journeymen, engineers, and housing specialists;

2. Prescriptive and performance specifications;

3. Drawing preparation, including interpretation of as-built drawings;

4. Structure modification;

5. Special design procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and exposure minimization;

6. Selection of abatement and interim control methods;

7. Cost estimation for budgeting purposes, including strategies for cost reduction; and

8. Scheduling parameters, including resident notification, building access, warning signs, and occupant disruption minimization.

(14) Classroom discussion of simulated field visits.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. Certificate of Compliance as to 10-21-94 order including renumbering of former article 8 to article 9, new article 8 (section 35067) and new section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

2. Renumbering of former article 8 to new article 9 and amendment of section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

3. Renumbering of former article 8 to new article 9 and amendment of section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 7-20-98 order, including amendment of section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

5. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 10. Continuing Education

§35070. Continuing Education for Workers Requirements.

Note • History

(a) Continuing education for workers shall only be provided by an accredited training provider approved by the Department to offer the lead-related construction work course.

(b) Continuing education instruction shall be designed to increase or enhance skills and knowledge necessary to perform the job tasks and job functions associated with certification and shall be offered in minimum increments of one contact hour.

(c) At least 40% of continuing education instruction for workers shall be taught using interactive/participatory teaching methods.

(d) Continuing education topics shall include:

(1) An overview of safety practices relevant to tasks conducted by certified lead workers;

(2) An update on federal, state, or local statutes or regulations relevant to tasks conducted by certified lead workers; and

(3) An update on new lead-related construction techniques or technologies relevant to tasks conducted by certified lead workers.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 8 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 8 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 8 to article 9 and former article 9 to article 10 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former article 9 to new article 10 and amendment of section heading, section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former article 9 to new article 10 and amendment of section heading, section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsections (a) and (d)(1), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35072. General Continuing Education Requirements.

Note • History

(a) General continuing education shall only be provided by an accredited training provider approved to offer one of the following lead-related construction courses: inspection and assessment, supervision and project monitoring, supplemental supervision and project monitoring, project design, sampling technician, or Certified Industrial Hygienist.

(b) General continuing education instruction shall be designed to increase or enhance skills and knowledge necessary to perform the job tasks and job functions associated with certification or interim certification and shall be offered in minimum increments of one contact hour.

(c) At least 25% of general continuing education instruction shall be taught using interactive/participatory teaching methods.

(d) General continuing education topics shall include:

(1) An overview of safety practices in lead-related construction;

(2) An update on federal, state, or local statutes or regulations relevant to tasks conducted by certified lead inspector/assessors, project designers, sampling technicians, project monitors, and supervisors; and

(3) An update on lead-related construction techniques or technologies relevant to tasks conducted by certified lead inspector/assessors, project designers, sampling technicians, project monitors, and supervisors.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (d)(2), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of subsections (a) and (d)(2)-(3) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 11. Application Requirements and Procedures for Training Provider Accreditation, Renewal, or Course Approval

§35076. Application Requirements.

Note • History

(a) A complete application for provisional accreditation or provisional course approval shall consist of a completed CDPH Form 8487 (6/07), Application for Training Provider Accreditation and Course Approval, and required documentation as follows:

(1) Type of application:

(A) Accreditation; or

(B) Course Approval.

(2) Type of course or training applicant seeks to provide:

(A) Lead-related construction inspection and assessment course;

(B) Lead-related construction supervision and project monitoring course;

(D) Lead-related construction work course;

(E) Lead-related construction supplemental supervision course;

(F) Lead-related construction Certified Industrial Hygienist course;

(G) Lead-related construction general continuing education and number of contact hours; or

(H) Lead-related construction continuing education for workers and number of contact hours.

(3) Applicant information:

(A) Training provider's name, street address (principal place of business), mailing address (if different from street address), telephone number, and fax number, if applicable; and

(B) Training Director's name, street address and mailing address (if different from street address).

(4) Operational information:

(A) Description of training facility (including classroom and field site), equipment, and equipment storage;

(B) Description of record keeping procedures;

(C) One copy of the entire course or continuing education instruction curriculum, including, but not limited to, learning objectives, documentation of the length and sequence of topics to be covered during the course(s) or continuing education instruction, student and instructor manuals, handouts, quizzes, and homework;

(D) Student-to-instructor ratio during hands-on training;

(E) Description of the amount and type of hands-on training;

(F) Description of the teaching methods to be used for each major topic and for hands-on training;

(G) Description of the audio/visual aids to be used for each major topic; and

(H) List of languages, other than English, in which training will be offered.

(5) Personnel information:

(A) Documentation of Training Director's qualifications pursuant to paragraphs 35053(a)(1)-(4);

(B) Name(s) of instructor(s);

(D) Documentation of instructors' qualifications pursuant to paragraphs 35053(b)(1)-(4);

(E) Name(s) of guest instructor(s);

(F) Course(s) or topic(s) guest instructor(s) will teach; and

(G) Documentation of guest instructors' qualifications pursuant to subsection 35053(d).

(6) Final examination information:

(A) List of skills and knowledge to be tested;

(B) One copy of the entire final examination and correct answers, including demonstration testing criteria and protocol;

(D) One copy of each retake examination and correct answers.

(7) Compliance with other relevant regulations:

(A) Documentation of approval under Section 94915, or exemption under Section 94739, or disclosure under Section 94931, of the California Education Code, as applicable; and

(B) Documentation of compliance with any radiological licensing, storage, and use requirements of the California Department of Public Health Radiologic Health Branch set forth in Title 17, California Code of Regulations, Division 1, Chapter 5, Subchapter 4, 4.5, and 4.6; and

(8) Applicant's name, printed or typed, signature, title, and date, verifying under penalty of perjury, that all information contained on and submitted with CDPH Form 8487 (6/07), Application for Training Provider Accreditation, is true and correct.

(b) A training provider seeking to renew accreditation shall submit a completed CDPH Form 8557 (6/07) Renewal of Training Provider Accreditation and Course Approval, and required documentation as follows:

(1) Type of course(s) or training applicant is currently approved to offer:

(A) Lead-related construction inspection and assessment course;

(B) Lead-related construction supervision and project monitoring course;

(D) Lead-related construction work course;

(E) Lead-related construction supplemental supervision course;

(F) Lead-related construction Certified Industrial Hygienist course;

(G) Lead-related construction general continuing education and number of contact hours; or

(H) Lead-related construction continuing education for workers and number of contact hours.

(2) Applicant information:

(A) Training provider's name, street address (principal place of business), mailing address (if different from street address), telephone number, and fax number, if applicable;

(B) Training Director's name, street address and mailing address (if different from street address);

(D) Current course or continuing education instruction number(s); and

(3) A description of the training facility (including classroom and field site), equipment, and equipment storage, if changed since the original application for accreditation;

(4) Personnel information:

(A) Documentation of instructor's qualifications pursuant to paragraphs 35053(b)(1)-(4);

(B) Name(s) of instructor(s);

(D) Name(s) of guest instructor(s);

(E) Course(s) or topic(s) guest instructor(s) will teach; and

(F) Documentation of guest instructors' qualifications pursuant to subsection 35053(d).

(5) Final examination information:

(A) One copy of the entire final examination and correct answers, including demonstration testing;

(B) One copy of the student examination scoresheet or other record; and

(6) Compliance with other relevant regulations:

(A) Documentation of approval under Section 94915, or exemption under Section 64739, or disclosure under Section 94931, of the California Education Code, as applicable; and

(7) Applicant's name, printed or typed, signature, title, and date, verifying under penalty of perjury, that all information contained on and submitted with CDPH Form 8557 (6/07), Application for Renewal of Training Provider Accreditation, is true and correct.

(c) An accredited training provider seeking CDPH approval to offer an additional course shall submit a completed CDPH Form 8487 (6/07), Application for Training Provider Accreditation, and required documentation, except an applicant need not re-submit unchanged information and documentation that was submitted with the original application for accreditation.

(d) An accredited training provider shall notify the Department within 30 calendar days of a change of address.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 9 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 9 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 9 to article 10 and former article 10 to article 11 and amendment of section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 10 to new article 11 and amendment of section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering and amendment of former article 10 to new article 11 and amendment of section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a), (a)(2)(C), (a)(7)(B), (a)(8), (b), (b)(1)(C), (b)(6)(B), (b)(7) and (c) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35078. Accreditation Procedures.

Note • History

(a) Within 30 calendar days of receipt of an application for accreditation, renewal, or course approval, the Department shall inform the applicant in writing that the application is either complete or incomplete and what additional information documentation is required to complete the application.

(1) If an applicant submits required information or documentation within 30 days from the issuance date of the notice of incompleteness, the Department shall issue a written notice of completeness.

(2) If an applicant fails to submit required information or documentation within 30 days from the issuance date of the notice of incompleteness, the application shall be deemed to be abandoned and reapplication shall be required.

(3) An application may be withdrawn by written request to the Department.

(b) Within 60 calendar days from the issuance date of the notice of completeness, the Department shall grant or deny provisional accreditation, renewal, or provisional course approval.

(1) If denied, the Department shall state, in writing, the reasons for denial.

(2) If granted, a written notice containing an accreditation number and course number(s), shall be sent to the applicant.

(A) The issuance date of the written notice shall be the effective date of provisional accreditation, renewal, or provisional course approval.

(B) Upon issuance of the written notice granting provisional accreditation or course approval, an accredited training provider may commence offering a CDPH-approved course(s).

(1) Pursuant to the Permit Reform Act, Government Code section 15376, the minimum, median, and maximum elapsed time to process an application for accreditation, renewal, or course approval, and issue a written notification of approval shall be as follows:

(A) Minimum: 15 calendar days.

(B) Median: 30 calendar days.

(2) The Department may exceed the maximum time as provided above if the applicant requests in writing a delay of consideration of the application or issuance of a written notification of provisional accreditation, renewal, or provisional course approval.

(d) In making a determination of whether to grant or deny provisional accreditation, renewal, or provisional course approval, the Department may take into consideration various factors, including, but not limited to the following:

(1) Failure to satisfy eligibility requirements for accreditation;

(2) Failure to satisfy eligibility requirements for course approval;

(3) Past history of revocation of accreditation;

(4) False statements in the application; or

(5) Failure to provide further required documentation or information requested by the Department.

(e) Provisional status shall be removed if an accreditation audit indicates that requirements for accreditation are satisfied.

(1) A provisionally accredited training provider shall permit the Department to conduct an accreditation audit without charge to the Department. Advance notice shall not be required prior to conducting an accreditation audit.

(2) An accreditation audit shall be conducted within 365 calendar days following the issuance of provisional accreditation.

(3) An accreditation audit shall be performed on site and shall include, but not be limited to, a review of: records, including Course Completion Forms and attendance records; facilities; instructional curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials; course content; and coverage.

(f) Provisional status shall be removed if a course audit indicates that requirements for CDPH course approval are satisfied.

(1) A provisionally accredited or accredited training provider shall permit the Department to conduct a course audit without charge to the Department. Advance notice shall not be required prior to conducting a course audit.

(2) A course audit shall be conducted within 365 calendar days following the issuance of provisional course approval.

(3) A course audit shall be performed on site and shall include, but not be limited to, a review of: instructional curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials, course content; and coverage.

(g) If an accreditation or course audit indicates that requirements for accreditation or course approval are not satisfied, the Department shall issue, within seven working days of completion of the accreditation or course audit, written notice of required modifications.

(1) Written notice shall include an explanation of the Department's audit process, a statement of inadequacies found upon audit, possible actions that may be imposed, a description of procedures available if the training provider desires an opportunity to explain or justify the findings of the audit, steps that must be taken to correct any inadequacies, and any applicable deadlines.

(h) If an accreditation or course audit indicates that requirements for accreditation or course approval are satisfied, a written notice removing provisional accreditation or provisional course approval shall be issued within seven working days after completion of an accreditation or course audit.

(1) Accreditation shall be valid for a period of three years and shall not be transferable.

(2) Renewal applications shall be required at least 120 calendar days prior to the expiration date of accreditation.

(i) An accredited training provider shall permit the Department to conduct on-site investigations at any time. Advance notice shall not be required. On-site investigations may include, but are not limited to, a review of: records, including Course Completion Forms and attendance records; facilities; training curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials; course content; and coverage.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (c)(1), (e)(2) and (f)(2) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

5. Amendment of section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (b)(2)(B) and (f) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 12. Suspension or Revocation of Accreditation, Provisional Accreditation, or DHS Course Approval

§35080. Action to Suspend or Revoke Accreditation, Provisional Accreditation, or Course Approval.

Note • History

(a) Accreditation, provisional accreditation, or course approval may be suspended or revoked by the Department for:

(1) Failure to adhere to the standards and requirements for accreditation, provisional accreditation, or course approval;

(2) Failure to properly administer, score, or maintain security of a required examination, examination answers, or results;

(3) Failure to maintain approval or authority to operate granted by the Council For Private Postsecondary and Vocational Education;

(4) Falsification of accreditation records, instructor qualifications, or other accreditation information;

(5) Failure to provide the required course contact hours, course content, or coverage;

(6) Misrepresentation of the contents of a course;

(7) Failure to submit required information or notifications in a timely manner;

(8) Failure to maintain required records;

(9) Failure to comply with relevant federal, state, or local leaded paint statutes or regulations;

(10) Failure to make modifications required by the Department within 30 days from the issuance date of the written notice of required modifications; or

(11) Other conditions revealed by any means which would warrant suspension or revocation.

(b) Suspension or revocation and an appeal of any suspension or revocation shall be conducted in compliance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.

(c) Prior to suspension or revocation, an accredited or provisionally accredited training provider will be given an opportunity, except in the case of willful violation or threat to public health and safety, to remedy deficiencies that may result in suspension or revocation.

(1) The accredited or provisionally accredited training provider shall be given a statement which includes the Department's findings, an explanation of what the accredited or provisionally accredited training provider must do to comply with the regulations, and the time period in which the accredited or provisionally accredited training provider must act.

(2) The accredited or provisionally accredited training provider must remedy the deficiencies within a reasonable time specified by the Department which shall be no more than 30 calendar days after the issuance date of the statement of deficiencies.

(d) A training provider shall not offer course training when accreditation, provisional accreditation, or CDPH course approval is suspended or revoked, except, the Department, at its discretion, may permit the training provider to continue to offer training to students already enrolled. If training is not permitted to continue, a refund of all tuition and other charges shall be provided to students already enrolled, if applicable.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 10 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 10 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 10 to article 11 and former article 11 to article 12 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 11 to new article 12 and amendment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering of former article 11 to new article 12 and amendment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (d) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 13. Eligibility Requirements and Application Procedures for Certification or Interim Certification

§35081. Representation of Certification Status.

Note • History

Unless certified pursuant to the requirements of this chapter, no person shall represent themselves as, or do business as, a certified lead-inspector/assessor, certified lead project designer, certified lead sampling technician, certified lead project monitor, certified lead supervisor, or certified lead worker.

NOTE

HISTORY

1. Renumbering and amendment former article 12 to new article 13 and new section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Renumbering and amendment of former article 12 to new article 13 and new section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35082. Application Timeliness.

Note • History

(a) Applicants for certification or interim certification shall apply to the Department within one year from the issuance date of CDPH Form 8493 (6/07), Course Completion Form.

(b) Applicants failing to apply within one year from the issuance date of CDPH Form 8493 (6/07), Course Completion Form, shall complete a minimum of seven contact hours of:

(1) General continuing education in order to be eligible to apply for inspector/assessor, project designer, sampling technician and/or project monitor certification or interim certification;

(2) General continuing education or continuing education for workers in order to be eligible to apply for supervisor certification or interim certification; or

(3) Continuing education for workers in order to be eligible to apply for worker certification.

(c) Applicants failing to apply within three years from the issuance date of CDPH Form 8493 (6/07), Course Completion Form, shall retake the appropriate CDPH-Approved course to be eligible to apply for certification.

(d) Applications for certification or interim certification renewal shall be submitted at least 120 calendar days prior to the expiration date indicated on the certificate or interim certificate.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 11 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 11 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 11 to article 12 and former article 12 to article 13 and amendment of section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of subsections (a) and (b), new subsections (c) and (d), and amendment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsections (a) and (b), new subsections (c) and (d), and amendment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (b) and new subsections (b)(1)-(3), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35083. Inspector/Assessor.

Note • History

To qualify for certification as a certified lead inspector/assessor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements:

(a) Possess CDPH Form 8493 (6/07), Course Completion Form, from a lead-related construction inspection and assessment course; and

(b) Pass the lead certification examination for inspector/assessors offered by the Department; and either:

(1) Have a bachelor's degree in biological, chemical, or physical science, or a related field and one year of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(2) Have an associate degree in biological, chemical, or physical science, or a related field, or 20 semester or 30 quarter units in biological, chemical, or physical science, or a related field, and two years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(3) Have a high school diploma or equivalent and at least three years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(4) Be a certified industrial hygienist and possess CDPH Form 8493 (6/07), Course Completion Form, from a lead-related construction Certified Industrial Hygienist course.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (b) and (c) and new subsection (d) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a) and (b)(4) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35085. Supervisor.

Note • History

To qualify for certification as a certified lead supervisor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements:

(a) Possess CDPH Form 8493 (6/07), Course Completion Form, from a lead-related construction supervision and project monitoring course or possess CDPH Forms 8493 (6/07), Course Completion Forms, from a lead-related construction work course and a lead-related construction supplemental supervision and project monitoring course; and

(b) Pass the lead certification examination for supervisors offered by the Department; and either:

(1) Have one year of experience as a certified lead worker; or

(2) Have two years of experience in lead-related construction or a related field (e.g., asbestos, the building trades, or environmental remediation work) conducting environmental health, occupational safety, or environmental hazard control.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (a) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35087. Project Monitor.

Note • History

To qualify for certification as a certified lead project monitor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements:

(b) Pass the lead certification examination for project monitors offered by the Department; and either:

(1) Have a bachelor's degree in biological, chemical, or physical science, or a related field and one year of experience in lead-related construction or a related field (e.g., asbestos, environmental remediation work, or other construction) conducting or monitoring environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(2) Have an associate degree in biological, chemical, or physical science, or a related field, or 20 semester or 30 quarter units in biological, chemical, or physical science, or a related field and one year of experience as a certified lead supervisor or two years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting or monitoring environmental health, occupational safety, or environmental hazard reduction projects or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(3) Have a high school diploma or equivalent plus two years experience as a certified lead supervisor, or three years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting or monitoring environmental health, occupational safety or environmental hazard reduction projects, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or

(4) Be a certified industrial hygienist and possess CDPH Form 8493 (6/07), Course Completion Form, from a lead-related construction Certified Industrial Hygienist course.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (b) and (c) and new subsection (d) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a) and (b)(4) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35088. Project Designer.

Note • History

(a) To qualify for certification renewal as a certified lead project designer, a certified lead project designer shall comply with all applicable requirements specified in sections 35095(b), 35095(c), and 35096.

(b) Certification applications for project designer are no longer accepted by the Department. Only a certification renewal application from a certified lead project designer will be accepted by the Department.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35089. Sampling Technician.

Note • History

To qualify for certification as a certified lead sampling technician, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and possess CDPH Form 8493 (6/07), Course Completion Form, from the lead-related construction sampling technician course or the lead-related construction inspection and assessment course.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order including amendment of subsections (a)-(c) and new subsection (d) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (a), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35091. Worker.

Note • History

To qualify for certification as a certified lead worker, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and possess CDPH Form 8493 (6/07), Course Completion Form, from a lead-related construction work course.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35093. Interim Certification and Renewal.

Note • History

(a) Applications for interim certification shall be accepted through August 30, 1998. Applications for renewal of interim certification shall be accepted through December 31, 1998. Individuals who possess interim certificates with expiration dates after April 30, 1999 shall not be eligible to renew their interim certificate(s) and must take and pass the Department's certification examination to be eligible to apply for certification.

(b) To qualify for interim certification as a lead inspector/assessor, an individual shall comply with all applicable requirements specified in sections 35083, 35095 and 35096, except for the certification examination requirements specified in subsection 35083(b).

(c) To qualify for interim certification as a lead supervisor an individual shall comply with all applicable requirements specified in sections 35085, 35095 and 35096, except for the certification examination requirements specified in subsection 35085(b).

(d) To qualify for interim certification as a lead project monitor an individual shall comply with all applicable requirements specified in sections 35087, 35095 and 35096, except for the certification examination requirements specified in subsection 35087(b).

(e) To qualify for interim certification as a lead project designer an individual shall comply with all applicable requirements specified in sections 35089, 35095 and 35096, except for the certification examination requirements specified in subsection 35089(b).

(f) Individuals failing to apply for renewal within one year after the expiration date of an interim certificate, shall comply with applicable subsections (b) of sections 35083, 35085, 35087, and 35089, and subsections 35095(b), and 35096(f)(1) to be eligible to apply for certification.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35095. Application Requirements.

Note • History

(a) A complete application for certification or interim certification shall consist of a non-refundable $75.00 application fee per certificate or interim certificate requested and a completed CDPH Form 8488 (6/07), Application for Lead Certification, with required documentation:

(1) Type of certification or interim certification requested and amount of fee(s) paid:

(A) Certified lead inspector/assessor;

(B) Certified lead supervisor;

(D) Certified lead project monitor; or

(E) Certified lead worker.

(2) Applicant's name, residence address, (and mailing address, if different), telephone number, date of birth, gender, race/ethnicity and photo identification number with a description of the photo identification document.

(3) Documentation of applicant's education, training, and experience, including:

(A) Original Course Completion Form, CDPH Form 8493 (6/07), for a course issued by an accredited training provider.

(B) A Proof of Experience CDPH Form 8539 (6/07) for each employer providing documentation of completion of lead-related construction or other applicable experience. Each Proof of Experience form shall contain:

1. The applicant's name;

2. The name and address of the applicant's employer;

3. The name and telephone number of the applicant's supervisor, or the names and phone numbers of three client references, if self-employed;

4. The applicant's employment dates;

5. Descriptions of specific lead-related construction or other applicable activities performed;

6. Estimated percentage of time associated with lead-related construction or other applicable activities; and

7. The name, title, and signature of the applicant's supervisor or employer, or the applicant's signature, if self-employed, verifying, under penalty of perjury, that the information contained on the Proof of Experience CDPH Form 8539 (6/07) is true and correct.

(D) Certified Industrial Hygienists, who possess a Course Completion Form from a lead-related construction Certified Industrial Hygienist course, may substitute a copy of their American Board of Industrial Hygiene Certificate, or its equivalent, for evidence of both experience and postsecondary education documentation.

(4) Two passport style, 1 inch by 1 inch, photographs.

(5) Applicant's signature and date signed, verifying, under penalty of perjury, that all information contained on and submitted with CDPH Form 8488 (6/07), Application for Lead Certification, is true and correct.

(b) A complete application for certification or interim certification renewal shall consist of a completed CDPH Form 8553 (6/07), Renewal of Lead Certification, and a non-refundable seventy-five dollar application fee for each certificate or interim certificate renewal requested with the following required documentation:

(1) If not submitted to the Department in the previous year, an original Course Completion Form CDPH Form 8493 (6/07) issued by an accredited training provider for:

(A) General continuing education, if the application is for renewal of inspector/assessor, project designer, sampling technician, or project monitor certification or interim certification; or

(B) General continuing education or continuing education for workers, if the application is for renewal of supervisor certification or interim certification; or

(2) Documentation specified in sections 35095(a)(2), and 35095(a)(5); and

(3) Certificate or interim certificate number(s), expiration date(s) and amounts of fee(s) paid.

(c) Certified or interim certified individuals shall notify the Department within 30 calendar days of a change of address.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

2. New section refiled with amendment of subsection (a)(4) 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (b)(1) and new subsections (b)(1)(A)-(C), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a), (a)(1)(C), (a)(3)(A)-(B), (a)(3)(B)7. and (a)(5)-(b)(1)(A) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§35096. Certification, Interim Certification, and Renewal Procedures.

Note • History

(a) Within 30 calendar days of receipt of an application for certification, interim certification or renewal, the Department shall inform the applicant in writing that the application is either complete or incomplete and what additional information or documentation is required to complete the application.

(1) If an applicant submits required information or documentation within 30 days from the issuance date of the notice of incompleteness, the Department shall issue a written notice of completeness.

(2) If an applicant fails to submit required information or documentation within 180 days from the issuance date of the notice of incompleteness, the application shall be deemed to be abandoned and reapplication shall be required.

(3) An application may be withdrawn or amended only by written request to the Department.

(b) Within 60 calendar days from the issuance date of the notice of completeness, the Department shall grant or deny interim certification, renewal, or permission to sit for the Department's lead certification examination in the certification discipline applied for.

(1) If denied, the Department shall state, in writing, the reasons for denial.

(2) If granted, an interim certificate, renewal, or permission notice shall be sent to the applicant and the issuance date of the interim certificate, renewal, or permission notice shall be the effective date of interim certification, renewal, or permission notice.

(c) Within 30 calendar days from the date an individual passes the lead certification examination in the certification discipline applied for, the Department shall grant or deny certification.

(1) Individuals who fail to pass the lead certification examination in the certification discipline applied for within 180 days from the issuance date of the permission notice, shall retake the CDPH-approved lead-related construction course in that discipline, and comply with Section 35095, excepting subsections 35095(a)(3)(B), 35095(a)(3)(C), 35095(a)(3)(D), and 35095(a)(4), to be eligible to re-apply for permission to sit for the lead certification examination.

(2) An individual shall take the lead certification examination no more than three times within 180 days from the issuance date of the permission notice.

(d) Processing Time:

(1) Pursuant to the Permit Reform Act, Government Code section 15376, the minimum, median, and maximum elapsed time to process a completed application for a certificate or interim certificate and issue a written notification of approval shall be as follows:

(A) Minimum: 15 calendar days.

(B) Median: 120 calendar days.

(2) The Department may exceed the maximum time as provided above if the applicant requests in writing a delay of consideration of the application or issuance of a certificate or interim certificate.

(e) In making a determination of whether to grant, deny, or renew certification or interim certification, or permission to sit for a lead certification examination, the Department may take into consideration various factors, including, but not limited to, the following:

(1) Failure to satisfy eligibility requirements for certification or interim certification;

(2) Type and amount of lead-related construction training;

(3) Failure to provide further required documentation or information requested by the Department;

(4) Past history of citations or violations of existing regulations or standards;

(5) Past history of revocation of a Certificate or Interim Certificate; or

(6) False or misleading statements in the application.

(f) Certification or interim certification shall be non-transferable and shall be effective for a period of one year.

(1) Certified or interim certified individuals shall complete a minimum of seven contact hours of continuing education instruction every two years to be eligible to apply for certification or interim certification renewal.

(2) Certified individuals applying for renewal more than three years after the expiration date of the certificate or interim certificate shall retake the required CDPH-approved lead-related construction course and comply with section 35095(a)(3)(A), 35095(b) to be eligible to apply for certification renewal.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (c)(2), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (c)(1) and (f)(2) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 14. Suspension or Revocation of Certification or Interim Certification

§35097. Action to Suspend or Revoke Certification or Interim Certification.

Note • History

(a) Certification or interim certification may be suspended or revoked by the Department for:

(1) Any false statement in the application;

(2) Violations of relevant local, state, or federal statutes or regulations;

(3) Misrepresentation, failure to disclose relevant facts, fraud, or issuance by mistake;

(4) Failure to comply with California Code of Regulations, Title 17, sections 36000 or 36100; or

(5) Failure to comply with any relevant regulation or order of the Department.

(c) Prior to suspension or revocation, a certified or interim certified individual shall be given an opportunity, except in the case of willful violation or threat to public health and safety, to remedy deficiencies that may result in suspension or revocation.

(1) The certified or interim certified individual shall be given a statement which includes the Department's findings, an explanation of what the certified or interim certified individual must do to comply with the regulations, and the time period in which the certified or interim certified individual shall act.

(2) The certified or interim certified individual must remedy the deficiencies within a reasonable time specified by the Department which shall be no more than 30 calendar days after the issuance date of the statement of deficiencies.

(d) Any individual whose certification or interim certification has been suspended or revoked shall not be eligible to perform activities which require CDPH lead certification.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 12 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 12 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 12 to article 13 and former article 13 to article 14 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 13 to new article 14 and amendment of section heading, section and Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering and amendment of former article 13 to new article 14 and amendment of section heading, section and Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsection (d), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (d) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 15. Enforcement

§35099. Funding for Enforcement.

Note • History

The amount of $100,000.00 shall be allocated to the Division of Occupational Safety and Health annually to be expended for the division's costs of enforcing compliance with training and certification requirements.

NOTE

Authority cited: Sections 105250, 124160 and 131200, Health and Safety Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

HISTORY

1. New article 13 and section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94 or emergency language will be repealed by operation of law on the following day.

2. New article 13 and section refiled 10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-24-94 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of former article 13 to new article 14 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 14 to new article 15 and amendment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

5. Renumbering and amendment of former article 14 to new article 15 and amendment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Article 16. Work Practice Standards

§36000. Requirements for Lead Hazard Evaluation for Public and Residential Buildings.

Note • History

(a) Lead hazard evaluation for public and residential buildings shall:

(1) Be conducted only by a certified lead inspector/assessor or as specified in Subsections (c)(3)(A) or (d). The certified lead inspector/assessor, certified lead project monitor, and certified lead sampling technician conducting lead hazard evaluation shall not conduct abatement on the same structure.

(2) Be conducted in a manner in which paint, dust, and soil is tested in accordance with the procedures described in Chapter 5: Risk Assessment, section II (A)(B)(C)(D), “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995 and Chapter 7: Lead-Based Paint Inspection, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, 1997 Revision, and which provides quantitative results.

(3) Be conducted in a manner in which paint, dust, and soil samples taken for laboratory analysis are analyzed by a laboratory that is recognized by the U.S. Environmental Protection Agency pursuant to United States Code, Title 15, Section 2685(b).

(4) Be documented in a lead hazard evaluation report which shall include a completed California Department of Public Health (CDPH) Form 8552 (6/07) and the following attachments:

(A) A foundation diagram, site map, or sketch of the structure, indicating the specific locations of each lead hazard or presence of lead-based paint, and results of the visual inspection, if applicable;

(B) A summary of each testing method, device, and sampling procedure used;

(D) The results of laboratory analysis on collected samples, if applicable, including the name, address, and telephone number of each laboratory.

(b) The certified lead inspector/assessor conducting the lead hazard evaluation for a public or residential building shall retain the original completed copy of CDPH Form 8552 (6/07) and attachments for a minimum of three years and distribute copies as follows;

(1) A copy of the completed CDPH Form 8552 (6/07) and attachments to the person who ordered the lead hazard evaluation;

(2) A copy of the completed CDPH Form 8552 (6/07) to the Department within thirty days of completion; and

(3) A copy of the attachments to the Department upon request.

(1) A lead inspection shall be conducted in accordance with procedures described in Chapter 7: Lead-Based Paint Inspection, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, 1997 Revision.

(2) A risk assessment shall be conducted in accordance with procedures described in Chapter 5: Risk Assessment, section II(A), (B), (C), and (D), “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995 and shall include a written description of abatement options for each identified lead hazard, a suggested prioritization for addressing each lead hazard, and recommendations for a maintenance and monitoring schedule.

(3) A clearance inspection shall be conducted:

(A) By a certified lead inspector/assessor or a certified lead project monitor.

(B) In accordance with procedures such as described in Chapter 15: Clearance, sections II-VI, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995.

(d) A sampling technician shall only conduct visual inspections and sample or test soil, dust, and paint provided an inspector/assessor identifies the specific locations where soil, dust, and paint is sampled or tested, interprets the results, and complies with the record keeping and reporting requirements in section 36000(b). A sampling technician is prohibited from conducting visual inspections, or sampling or testing paint, dust, and soil, if those activities are:

(1) conducted as an “appropriate case management” activity, as defined in Health and Safety Code section 105280(a); or

(2) conducted in a structure that is inhabited by an individual with a blood lead level equal to or greater than 10 micrograms per deciliter.

(e) Individuals operating an X-ray Fluorescence (XRF) analyzer to conduct lead hazard evaluation shall comply with regulatory requirements specified in Title 17, California Code of Regulations, division 1, chapter 5, subchapter 4, such as obtaining a license and completing an additional eight hours of training.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and 131200, Health and Safety Code. Reference: Sections 100170, 105250(a), 105250(b), 124160(b), 124165 and 131051, Health and Safety Code; Sections 17200, 17203 and 17205, Business and Professions Code; and Sections 11180 and 11181, Government Code.

HISTORY

1. New article 16 (sections 36000-36100) and section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of History 1 (Register 98, No. 30).

3. New article 16 (sections 36000-36100) and section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 7-20-98 order, including amendment of section heading and section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

5. Amendment of subsections (a)(1), (a)(4) and (b)-(b)(2), new subsections (d)-(e) and amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§36050. Lead-Safe Work Practices.

Note • History

(a) Any individual conducting lead activities, excluding lead hazard evaluation, shall:

(1) Use containment;

(2) Ensure that the work area has no visible dust or debris following the completion of a project;

(3) Demonstrate compliance with (a)(1) and (a)(2) to the Department or local enforcement agency, as defined in section 105251 of the Health and Safety Code, upon request.

NOTE

Authority cited: Sections 105250, 105255, 105256, 124160, 124165 and 131200, Health and Safety Code. Reference: Sections 105250, 105251, 105255, 105256, 124160, 124165 and 131051, Health and Safety Code.

HISTORY

1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§36100. Requirements for Abatement for Public and Residential Buildings.

Note • History

(a) Abatement for public and residential buildings which is designed to reduce lead paint or lead hazards for a minimum of twenty years shall be conducted:

(1) Only by a certified lead supervisor or a certified lead worker. A certified lead supervisor shall be onsite during all work site preparation and during the post-abatement cleanup of work areas. At all other times when abatement is conducted, the certified lead supervisor shall be onsite or available by telephone, pager or answering service, and able to be present at the work area in no more than two hours.

(2) According to the procedures specified in Chapter 12: Abatement, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995.

(3) Using containment and in a manner which does not result in contaimination of non-work areas with lead-contaminated dust, lead-contaminated soil, or lead-based paint debris.

(4) In accordance with an abatement plan prepared by a certified lead supervisor, certified lead project monitor, or certified lead project designer which shall:

(A) Include the following information:

1. A detailed written description of the measures and management procedures, including containment, that will be utilized during abatement to prevent exposure to lead hazards;

2. A detailed written description of abatement, including methods of abatement and locations of rooms and components where abatement is planned;

3. A recommended schedule for re-inspection, based upon the type of abatement; and

4. Instructions on how to maintain potential lead hazards in safe condition.

(B) Be retained and made available to the Department upon request for a period of at least three years by the preparer.

(5) After notification is posted and delivered pursuant to subsection (c), the certified lead supervisor conducting abatement shall retain records of notification for at least three years.

(6) In a manner in which after abatement is completed, a clearance inspection is conducted in accordance with Section 36000(a) and Section 36000(c)(3) of this Chapter.

(b) Abatement for public and residential buildings which is designed to reduce lead paint or lead hazards for less than twenty years shall be conducted:

(A) According to procedures specified in Chapter 11: Interim Controls, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing,” U.S. Department of Housing and Urban Development, June 1995.

(2) Using containment and in a manner which does not result in contamination of non-work areas with lead-contaminated dust, lead-contaminated soil, or lead-based paint debris.

(3) In a manner to ensure that the work area has no lead contaminated dust following the completion of abatement.

(4) In a manner to ensure that a clearance inspection is conducted following the completion of abatement, if abatement was conducted in response to an identified case of lead poisoning as defined in Section 105280(b) of the California Health and Safety Code.

(5) After notification is posted and delivered pursuant to subsection (c).

(c) Prior to conducting abatement, the individual conducting abatement shall provide notification by completing an Abatement of Lead Hazards Notification, CDPH 8551 (6/07), form and:

(1) Posting at all entrances to the work area a copy of the completed form which shall not be removed until abatement has been completed and, for abatement conducted pursuant to subsection (a), a clearance inspection has been completed; and

(2) Delivering a copy of the completed form to the Department. Except for abatement conducted in response to an identified case of lead poisoning as defined in Section 105280(b) of the Health and Safety Code, the completed form shall be delivered to the Department at least five days prior to conducting abatement.

(d) Any individual conducting abatement or disturbing lead-based paint without containment shall permit the Department, or enforcement agencies, as specified in the California Health and Safety Code Sections 17960, 17961, and 17965, to access work areas to determine compliance with the requirements of this section.

NOTE

Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and 131200, Health and Safety Code. Reference: Sections 17960, 17961, 17964, 17970, 17972, 17980, 100170, 100175, 105250(a), 105250(b), 105280(a), 124160(b), 124165 and 131050, Health and Safety Code; Section 3494, Civil Code; Section 17200, Business and Professions Code; Section 17274(b), Revenue and Taxation Code; and Sections 11180 and 11181, Government Code.

HISTORY

3. Certificate of Compliance as to 7-20-98 order, including amendment of section heading and section, transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of subsection (c) and Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

Chapter 9. Screening for Childhood Lead Poisoning

Petitioners in the lawsuit Healthy Children Organizing Project, et al. v. Department of Health Services, et al., Superior Court of California in and for the City and County of San Francisco, Case No. 313012, challenged the validity of the emergency regulations, “Screening for Childhood Lead Poisoning”. The court found that the regulations did not comply with the statutory requirements. In response to the court order and comments received during the open comment period, the Department revised the regulations. The revised regulations were submitted to the court and made available for public comment. The following regulations reflect changes made in response to public comments already received and further changes that will be made available for an additional public comment period. The Department sought adoption of these emergency regulations for the purpose of avoiding the lapse of the medical standard of care and avoiding confusion among impacted health care providers during the period between the normal expiration of the prior emergency regulations and the completion of the regulatory process.

Article 1. Definitions

§37000. Health Care Provider.

Note • History

“Health care provider” means a person licensed to practice medicine pursuant to Article 3 (commencing with Section 2050) of Chapter 5 of Division 2 of the Business and Professions Code; a person licensed to practice as a nurse practitioner pursuant to Article 8 (commencing with Section 2834) of Chapter 6 of Division 2 of the Business and Professions Code; or a person licensed to practice as a physician's assistant pursuant to Article 3 (commencing with Section 3513) of Chapter 7.7 of Division 2 of the Business and Professions Code.

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

1. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections 37000-37025) and section filed 10-10-2000 as an emergency; operative 10-10-2000 (Register 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-7-2001 or emergency language will be repealed by operation of law on the following day. For prior history of chapter 9, see Register 77, No. 26.

2. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections 37000-37025) and section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register 2000, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-8-2001 or emergency language will be repealed by operation of law on the following day.

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

4. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections 37000-37025) and section filed 6-4-2001 as an emergency; operative 6-9-2001 (Register 2001, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-9-2001 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-4-2001 order transmitted to OAL 10-4-2001 and filed 11-19-2001 (Register 2001, No. 47).

§37005. Physician.

Note • History

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

1. New section filed 10-10-2000 as an emergency; operative 10-10-2000 (Register 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-7-2001 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register 2000, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-8-2001 or emergency language will be repealed by operation of law on the following day.

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

§37010. Physician's Assistant.

Note • History

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

§37015. Primary Medical Care.

Note • History

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

§37020. Publicly Funded Program for Low Income Children.

Note • History

“Publicly funded program for low income children” means:

(a) Medi-Cal, as defined in Chapter 7 (commencing with Section 14000) and Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code;

(b) Child Health and Disability Prevention program, as defined in Article 6 (commencing with Section 124025) of Chapter 3 of Part 2 of Division 106 of the Health and Safety Code;

(d) Special Supplemental Nutrition Program for Women, Infants and Children, as defined in Article 2 (commencing with Section 123275) of Chapter 1 of Part 2 of Division 106 of the Health and Safety Code; or

(e) Any federally funded or State of California funded program that provides medical services or preventive healthcare to children in families whose income is equal to or less than the maximum qualifying income level for participation in any of the programs specified in subsections (a) through (d).

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

4. New section filed 6-4-2001 as an emergency; operative 6-9-2001 (Register 2001, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-9-2001 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-4-2001 order, including amendment of subsection (d), transmitted to OAL 10-4-2001 and filed 11-19-2001 (Register 2001, No. 47).

§37025. Screening.

Note • History

“Screening” means testing an asymptomatic child for lead poisoning by analyzing the child's blood for concentration of lead.

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

5. Certificate of Compliance as to 6-4-2001 order transmitted to OAL 10-4-2001 and filed 11-19-2001 (Register 2001, No. 47).

Article 2. Standard of Care on Screening for Childhood Lead Poisoning

§37100. Requirements.

Note • History

(a) Except as provided in subsections (c) and (d), every health care provider who performs a periodic health assessment of a child, at the ages specified in subsection (b), shall comply with the following standard of care:

(1) Provide oral or written anticipatory guidance to a parent or guardian of the child, including, at a minimum, the information that children can be harmed by exposure to lead, especially deteriorating or disturbed lead-based paint and the dust from it, and are particularly at risk of lead poisoning from the time the child begins to crawl until 72 months of age.

(2) If the child receives services from a publicly funded program for low-income children, order the child screened for lead poisoning as the child is presumed to be at risk of lead poisoning.

(3) If the child does not receive services from a publicly funded program for low-income children, evaluate the child's risk of lead poisoning by asking a parent or guardian of the child the following question: “Does your child live in, or spend a lot of time in, a place built before 1978 that has peeling or chipped paint or that has been recently renovated?” If the parent or guardian answers “yes” or “don't know” to the question, order the child screened for lead poisoning.

(b) Except as provided in subsections (c) and (d), the health care provider shall perform the actions specified in subsection (a) at each of the following times:

(1) The anticipatory guidance required by subsection (a)(1) shall be performed at each periodic health assessment, starting at 6 months of age and continuing until 72 months of age.

(2) The screening and evaluation required by subsections (a)(2) or (3) shall be performed:

(A) When the child is 12 months of age.

(B) When the child is 24 months of age.

(C) Whenever the health care provider performing a periodic health assessment becomes aware that the child is 12 months to 24 months of age and the actions specified in subsections (a)(2) or (3) were not taken at 12 months of age or thereafter.

(D) Whenever the health care provider performing a periodic health assessment becomes aware that the child is 24 months to 72 months of age and the actions specified in subsections (a)(2) or (3) were not taken when the child was 24 months of age or thereafter.

(E) Whenever the health care provider performing a periodic health assessment of a child 12 to 72 months of age becomes aware that, in the professional judgment of the health care provider, a change in circumstances has put the child at risk of lead poisoning.

(c) The health care provider shall have no duty to order a child screened for lead poisoning if a parent or guardian of the child, or other person with legal authority to withhold consent, refuses to consent to the screening.

(d) The health care provider shall have no duty to order a child screened for lead poisoning, if and so long as the risk of screening is a greater risk to the child's health than the risk of lead poisoning, in the professional judgment of the health care provider. The health care provider shall document the reasons for not screening in the child's medical record.

(e) Upon receiving the results of a blood lead analysis in which the blood lead level is equal to or greater than 10 micrograms of lead per deciliter of blood, the health care provider shall take those actions that are reasonable and medically necessary to reduce, to the extent possible, the child's blood lead level below 10 micrograms of lead per deciliter of blood, such as the following:

(1) Education of a parent or guardian on lead hazards and lead poisoning;

(2) Clinical evaluation for complications of lead poisoning;

(3) Follow-up blood lead analyses:

(A) At one- to two-month intervals until the blood lead level has remained less than 15 micrograms of lead per deciliter of blood for at least six calendar months and the source of the lead poisoning has been removed or remediated; and

(B) Thereafter, unless the child has received additional lead-hazard exposure, at three-month intervals until the child is 36 months of age;

(4) Referring the family to the local childhood lead poisoning prevention program or, if none, the local health jurisdiction; and

(5) Chelation therapy, if appropriate in the professional judgment of the health care provider.

(f) A health care provider who fails to comply with this standard of care may be subject to the disciplinary provisions of Article 12 (commencing with Section 2220) of Chapter 5 of Division 2 the Business and Professions Code.

NOTE

Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code.

HISTORY

1. New article 2 (section 37100) and section filed 10-10-2000 as an emergency; operative 10-10-2000 (Register 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-7-2001 or emergency language will be repealed by operation of law on the following day.

2. New article 2 (section 37100) and section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register 2000, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-8-2001 or emergency language will be repealed by operation of law on the following day.

3. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 23).

4. New article 2 (section 37100) and section filed 6-4-2001 as an emergency; operative 6-9-2001 (Register 2001, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-9-2001 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-4-2001 order, including amendment of subsection (f) and new Note, transmitted to OAL 10-4-2001 and filed 11-19-2001 (Register 2001, No. 47).

Chapter 11. Occupational Lead Poisoning Prevention Program

Article 1. Definitions

§38001. Occupational Lead Poisoning Prevention Program: Definitions.

Note • History

(a) “Altered or disturbed” means subjected to a process that may result in the release of dust, mist, fume, or other particles; such processes may include, but are not limited to, cutting, welding, grinding, polishing, machining, scraping, melting, sanding, spraying or pressure blasting.

(b) “De minimus amount” means any of the following:

(1) Lead present in materials which are altered or disturbed and have a lead concentration less than 0.5% (5000 ppm) by weight;

(2) Lead present in materials where the total weight of such materials altered or disturbed during the calendar year is known to be 16 ounces (one pound) or less by weight;

(3) Lead present in materials where no such material is altered or disturbed at any individual employee's place of employment on more than one day during the calendar year, i.e., if no employee works on more than one day during the calendar year in any location where lead-containing materials are being altered or disturbed, then the amount is de minimus.

(c) “Employee” means any individual employed for at least 160 hours in the prior calendar year, regardless of whether the individual's specific job involved potential exposure to lead or lead-containing materials.

(d) “Lead evaluation” means a review of the place of employment and the materials and processes involved in the operation of an employer's business, including but not limited to review of Material Safety Data Sheets or other manufacturer-supplied data, product labeling, or analytical testing results for presence of lead in materials of unknown composition.

(e) “Lead was not present at the place of employment” means that no amount of lead or lead-containing material was present at the place of employment or in the materials and processes used in the operation of the employer's business, with the following exceptions:

(1) Lead that was not altered or disturbed during the operation of the employer's business and was present in a form, or contained in such a manner, that it could not be inhaled or ingested (examples are undisturbed building materials, unused materials and supplies, intact lead storage batteries); or

(2) Lead present as a result of general environmental contamination which was not the result of the operation of the employer's business.

(f) “Metal work” means the machining or casting of metals or metal alloys.

(g) “Occupational Lead Poisoning Fee” means a fee pursuant to section 105190 of the Health and Safety Code which is assessed annually by the State Board of Equalization on employers with 10 or more employees in industries identified by the Department of Health Services as having documented evidence of potential occupational lead poisoning. These industries are listed by four-digit Standard Industrial Classification (SIC) Code in Section 38005.

(h) “Place of employment” means any location, not limited to a fixed site, where employees carry out work duties which are a part of a business operation.

(i) “Prior calendar year” means the time period from January 1 to December 31 of the year preceding that year in which the Occupational Lead Poisoning Fee is due.

(j) “Standard Industrial Classification (SIC) Code” means a system of four-digit numerical codes to designate the activities of a business operation, set forth by the U.S. Office of Management and Budget in the Standard Industrial Classification Manual, 1987.

NOTE

Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105185, 105190, 105191 and 105195, Health and Safety Code.

HISTORY

1. New chapter 11 and section filed 1-15-93 as an emergency; operative 1-15-93 (Register 93, No. 3). A Certificate of Compliance must be transmitted to OAL 5-17-93 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 1-15-93 order including amendment of subsections (a), (b) and (h) transmitted to OAL 4-28-93 and filed 6-10-93 (Register 93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operative 5-1-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-97 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and filed 9-17-97 (Register 97, No. 38).

Article 2. Waivers of the Occupational Lead Poisoning Fee

§38002. Fee Waiver Eligibility.

Note • History

(a) An employer in an industry listed in section 38005 is eligible for a waiver of the Occupational Lead Poisoning Fee if the employer can demonstrate, by completing the procedures specified in section 38003, that:

(1) Lead was not present at the place of employment during the prior calendar year; or

(2) Lead was present at the place of employment during the prior calendar year only in a de minimus amount.

(b) An employer in an industry listed in section 38005 is not required to pay the Occupational Lead Poisoning Fee if the employer had fewer than 10 employees during the previous year.

(c) An employer in an industry listed in section 38005 that involves painting, including but not limited to Standard Industrial Classification Code 1721, “Painting and Paper Hanging,” is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed paint in or on a building constructed prior to 1978 or on a painted metal structure, unless the employer demonstrates that lead was not present in any of the altered or disturbed paint, or was present only in a de minimus amount.

(d) An employer in an industry listed in section 38005 that involves demolition, including but not limited to Standard Industrial Classification Code 1795, “Wrecking and Demolition Work,” is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed a painted metal structure, or a building with painted surfaces that was constructed prior to 1978, unless the employer demonstrates that lead was not present in any of the disturbed paint, or was present only in a de minimus amount.

(e) An employer in an industry listed in section 38005 that involves handling or processing of scrap metal, including but not limited to Standard Industrial Classification Code 5093, “Scrap and Waste Materials,” is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed materials that may contain lead or have a lead-containing coating, unless the employer demonstrates that lead was not present in any of the altered or disturbed materials, or was present only in a de minimus amount.

(f) An employer's request for a fee waiver may be denied for any of the following reasons:

(1) Identification of the presence of lead in a greater than de minimus amount at the place of employment or in the materials or processes used in the operation of the employer's business; or

(2) Failure of an employer to request a fee waiver and supply the documentation required in section 38003(d) within 180 days following the due date of the Occupational Lead Poisoning Fee; or

(3) Failure of an employer to provide sufficient and accurate information by which to evaluate the request for a fee waiver.

(g) The Department shall give written notice to the employer of the denial of an employer's request for a fee waiver and the reason or reasons for the denial.

(h) An employer whose request for a fee waiver is denied shall have 15 working days from receipt of notice of the denial to request a reconsideration of the denial and to supply any additional facts which the employer believes support the granting of the fee waiver request.

NOTE

Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

HISTORY

1. New section filed 1-15-93 as an emergency; operative 1-15-93 (Register 93, No. 3). A Certificate of Compliance must be transmitted to OAL 5-17-93 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 1-15-93 order including of amendment of subsections (a), (g)(1)-(2), (h) and (i) transmitted to OAL 4-28-93 and filed 6-10-93 (Register 93, No. 24).

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and filed 9-17-97 (Register 97, No. 38).

§38003. Procedures for Application of a Waiver.

Note • History

(a) An employer requesting a fee waiver shall conduct a lead evaluation of the premises, materials and processes used in the operation of the employer's business during the prior calendar year to determine whether lead was present. This evaluation shall include, but not be limited to, review of Material Safety Data Sheets or other manufacturer-supplied data, product labeling, or analytical testing results for presence of lead in materials of unknown composition.

(b) An employer requesting a fee waiver shall establish that lead was not present, or was present only in a de minimus amount, at the place of employment during the prior calendar year.

(c) An employer requesting a fee waiver shall have 180 days following the due date of the Occupational Lead Poisoning Fee to submit documentation that lead was not present, or was present only in a de minimus amount, at the place of employment during the prior calendar year.

(d) An employer requesting a fee waiver shall demonstrate that lead was not present, or was present in a de minimus amount, at the place of employment by providing documentation that includes:

(1) A Request for a Waiver of the Occupational Lead Poisoning Fee [DHS Form 8484 (4/97)], which is hereby incorporated by reference, containing the following information:

(A) Name, title, and affiliation of the person who conducted the lead evaluation of the employer's business operation as outlined in section 38003(a) and, if a consultant, also telephone number and address.

(B) Statement signed by the person conducting the lead evaluation that attests that, to the best of the person's knowledge, no lead or lead-containing materials were present in any amount, or were present only in a de minimus amount (as defined in section 38001) during the prior calendar year, in the premises, materials and processes used in the operation of the business.

(C) Description of the nature of the employer's business, including a description of the products manufactured and/or services provided.

(D) The employer's Board of Equalization-designated, 8-digit account number provided to the employer at the time the Occupational Lead Poisoning Fee is assessed.

(E) Name, title, company, address, telephone number, and signature of an authorized representative of the employer who is requesting the fee waiver.

(F) An employer in an industry listed in section 38005 that involves construction work, who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing painted surfaces by completing Part B of Form DHS 8484 (4/97).

(G) An employer in an industry listed in section 38005 that involves detective, guard, armored car or other security services, who wishes to apply for a waiver, shall identify the extent to which the company's operations involved altering or disturbing lead materials by discharging weapons on company time by completing Part C of Form DHS 8484 (4/97).

(H) An employer in an industry listed in section 38005 that involves metal work who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing lead-containing metals or alloys (including lead-containing brass or bronze) by completing Part D of Form DHS 8484 (4/97).

(I) An employer in an industry listed in section 38005 that involves the handling or processing of scrap metal who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing lead-containing or lead-painted scrap metal by completing Part E of Form DHS 8484 (4/97).

(2) Correspondence from an employer, workers' compensation representative, or consultant that includes all of the information outlined in section 38003(d)(1).

(e) An employer requesting a fee waiver may be required to provide additional information describing the nature of the employer's business, including the premises, materials or processes used in the operation of the employer's business.

(f) Results of industrial hygiene monitoring tests that show non-detectable concentrations of lead in workplace air shall not be considered sufficient documentation that lead was not present at the place of employment.

NOTE

Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 1-15-93 order transmitted to OAL 4-28-93 and filed 6-10-93 (Register 93, No. 24).

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and filed 9-17-97 (Register 97, No. 38).

§38004. Periods for Which Fee Waivers Are Granted.

Note • History

(a) The Department shall have the discretion to grant a permanent or annual waiver of the Occupational Lead Poisoning Fee to an employer who has provided acceptable documentation that lead was not present at the place of employment, or was present only in a de minimus amount. The decision to grant a permanent waiver or annual waiver shall be based on:

(1) A description of the employer's business operation;

(2) The potential for lead use within the industries classified under the employer's Standard Industrial Classification Code;

(3) The likelihood that the employer's business operation may change over time, causing lead to become present at the place of employment in a greater than de minimus amount.

(b) The Department shall, at the timer a fee waiver is granted, inform the employer of whether the waiver is granted on a permanent or annual basis.

(c) The Department shall rescind a company's permanent waiver of the Occupational Lead Poisoning Fee if the Department obtains evidence, including but not limited to a substantiated case report of occupational lead poisoning in an employee, that indicates that lead is present in a greater than de minimus amount at the place of employment.

(d) The Department shall rescind a company's annual waiver of the Occupational Lead Poisoning Fee if the Department obtains evidence, including but not limited to a substantiated case report of occupational lead poisoning in an employee, that indicates that lead was present in a greater than de minimus amount at the place of employment during the calendar year for which the annual waiver was granted.

(e) An employer who is granted a permanent fee waiver shall notify the Department within 30 days of any changes in the premises, materials or processes used in the operation of the business that result in lead being present in a greater than de minimus amount at the place of employment.

(f) An employer who is granted an annual waiver shall notify the Department within 30 days if the employer becomes aware that lead was present in a greater than de minimus amount at the place of employment during the calendar year for which the annual waiver was granted.

NOTE

Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 1-15-93 order transmitted to OAL 4-28-93 and filed 6-10-93 (Register 93, No. 24).

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and filed 9-17-97 (Register 97, No. 38).

Article 3. Applicable Industries

§38005. Occupational Lead Poisoning Fee: Applicable Industries.

Note • History

(a) The list of industries in section 105195 of the California Health and Safety Code for which the Occupational Lead Poisoning Fee is applicable is hereby modified as follows:

SIC Code Industry

(1) 1041 Gold ores

(2) 1521 General contractors -- Single-family houses

(3) 1541 General contractors -- Industrial buildings and

warehouses

(4) 1542 General contractors -- Nonresidential buildings,

other than industrial buildings and warehouses

(5) 1611 Highway and street construction, except elevated

highways

(6) 1622 Bridge, tunnel, and elevated highway construction

(7) 1623 Water, sewer, pipeline and communications and

power line construction

(8) 1629 Heavy construction, not elsewhere classified

(9) 1711 Plumbing, heating, and air-conditioning

(10) 1721 Painting and paper hanging

(11) 1761 Roofing, siding and sheet metal work

(12) 1791 Structural steel erection

(13) 1795 Wrecking and demolition work

(14) 1796 Installation or erection of building equipment, not

elsewhere classified

(15) 1799 Special trade contractors, not elsewhere classified

(16) 2759 Commercial printing, not elsewhere classified

(17) 2782 Blankbooks, looseleaf binders and devices

(18) 2816 Inorganic pigments

(19) 2819 Industrial inorganic chemicals, not elsewhere

classified

(20) 2821 Plastics material, synthetic resins, and

nonvulcanizable elastomers

(21) 2851 Paints, varnishes, lacquers, enamels, and allied

products

(22) 2869 Industrial organic chemicals, not elsewhere

classified

(23) 2891 Adhesives and sealants

(24) 2892 Explosives

(25) 2899 Chemicals and chemical preparations, not

elsewhere classified

(26) 3053 Gaskets, packing, and sealing devices

(27) 3069 Fabricated rubber products, not elsewhere classified

(28) 3087 Custom compounding of purchased plastics resins

(29) 3089 Plastics products, not elsewhere classified

(30) 3229 Pressed and blown glass and glassware, not

elsewhere classified

(31) 3231 Glass products, made of purchased glass

(32) 3253 Ceramic floor and wall tile

(33) 3261 Vitreous china plumbing fixtures and china and

earthenware fittings and bathroom accessories

(34) 3262 Vitreous china table and kitchen articles

(35) 3269 Pottery products, not elsewhere classified

(36) 3312 Steel works, blast furnaces (including coke ovens),

and rolling mills

(37) 3313 Electrometallurgical products, except steel

(38) 3315 Steel wiredrawing and steel nails and spikes

(39) 3316 Cold-rolled steel sheet, strip and bars

(40) 3317 Steel pipe and tubes

(41) 3321 Gray and ductile iron foundries

(42) 3325 Steel foundries, not elsewhere classified

(43) 3331 Primary smelting and refining of copper

(44) 3339 Primary smelting and refining of nonferrous metals,

except copper and aluminum

(45) 3341 Secondary smelting and refining of nonferrous

metals

(46) 3351 Rolling, drawing, and extruding of copper

(47) 3356 Rolling, drawing, and extruding of nonferrous

metals, except copper and aluminum

(48) 3357 Drawing and insulating of nonferrous wire

(49) 3363 Aluminum die-castings

(50) 3364 Nonferrous die-castings, except aluminum

(51) 3365 Aluminum foundries

(52) 3366 Copper foundries

(53) 3369 Nonferrous foundries, except aluminum and copper

(54) 3398 Metal heat treating

(55) 3399 Primary metal products, not elsewhere classified

(56) 3411 Metal cans

(57) 3429 Hardware, not elsewhere classified

(58) 3431 Enameled iron and metal sanitary ware

(59) 3432 Plumbing fixture fittings and trim

(60) 3433 Heating equipment, except electric and warm air

furnaces

(61) 3441 Fabricated structural metal

(62) 3444 Sheet metal work

(63) 3463 Nonferrous forgings

(64) 3479 Coating, engraving, and allied services, not

elsewhere classified

(65) 3484 Small arms

(66) 3491 Industrial valves

(67) 3492 Fluid power valves and hose fittings

(68) 3494 Valves and pipe fittings, not elsewhere classified

(69) 3496 Miscellaneous fabricated wire products

(70) 3497 Metal foil and leaf

(71) 3532 Mining machinery and equipment, except oil and

gas field machinery and equipment

(72) 3544 Special dies and tools, die sets, jigs and fixtures, and

industrial molds

(73) 3561 Pumps and pumping equipment

(74) 3567 Industrial process furnaces and ovens

(75) 3585 Air-conditioning and warm air heating equipment

and commercial and industrial refrigeration

equipment

(76) 3599 Industrial and commercial machinery and

equipment, not elsewhere classified

(77) 3624 Carbon and graphite products

(78) 3661 Telephone and telegraph apparatus

(79) 3663 Radio and television broadcasting and

communications equipment

(80) 3669 Communications equipment, not elsewhere

classified

(81) 3671 Electron tubes

(82) 3674 Semiconductors and related devices

(83) 3678 Electronic connectors

(84) 3679 Electronic components, not elsewhere classified

(85) 3691 Storage batteries

(86) 3692 Primary batteries, dry and wet

(87) 3699 Electrical machinery, equipment and supplies, not

elsewhere classified

(88) 3711 Motor vehicles and passenger car bodies

(89) 3714 Motor vehicle parts and accessories

(90) 3721 Aircraft

(91) 3728 Aircraft parts and auxiliary equipment, not

elsewhere classified

(92) 3812 Search, detection, navigation, guidance,

aeronautical, and nautical systems and instruments

(93) 3825 Instruments for measuring and testing of electricity

and electrical signals

(94) 3829 Measuring and controlling devices, not elsewhere

classified

(95) 3844 X-ray apparatus and tubes and related irradiation

apparatus

(96) 3914 Silverware, plated ware, and stainless steel ware

(97) 3949 Sporting and athletic goods, not elsewhere classified

(98) 3953 Marking devices

(99) 3965 Fasteners, buttons, needles, and pins

(100) 4813 Telephone communications, except radiotelephone

(101) 4911 Electric services

(102) 5064 Electrical appliances, television and radio sets

(103) 5093 Scrap and waste materials

(104) 5941 Sporting goods stores and bicycle shops

(105) 7381 Detective, guard, and armored car services

(106) 7538 General automotive repair shops

(107) 7539 Automotive repair shops, not elsewhere classified

(108) 7997 Membership sports and recreation clubs

(109) 7999 Amusement and recreation services, not elsewhere

classified

(110) 8734 Testing laboratories

NOTE

Authority cited: Sections 105185 and 105195, Health and Safety Code. Reference: Section 105195, Health and Safety Code.

HISTORY

2. Certificate of Compliance as to 1-15-93 order transmitted to OAL 4-28-93 and filed 6-10-93 (Register 93, No. 24).

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and filed 9-17-97 (Register 97, No. 38).

Division 2. Health and Welfare Agency--Department of Developmental Services Regulations

Chapter 1. General Provisions

(For prior history of former Chapter 1 (sections 50000-50150), see Register 82, No. 23.)

Subchapter 2. Monthly Parental Fee

Article 1. General

§50201. Authority.

Note • History

These regulations prescribe financial responsibility procedures for determining ability to pay and the level of payment due from parents of minor children receiving services provided by the state or purchased with state funds through regional centers. These regulations implement and make specific the provisions of Sections 4782 and 4784 of the Welfare and Institutions Code. Reference is also made to Sections 4648(b) and 4677 of the Code.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4648(b), 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Repealer of Chapter 2 (Sections 50200-50207) and new Chapter 2 (Sections 50201-50227, not consecutive) filed 10-6-78; effective thirtieth day thereafter (Register 78, No. 40). For prior history, see Register 72, Nos. 11 and 27.

2. Editorial reorganization of Part II (Chapters 2, 3, 4, 5 and 8, Sections 50201-59100, not consecutive) to Part II (Chapters 1 and 3, Sections 50201-54529, not consecutive) filed 9-28-83 (Register 83, No. 40). For prior history, see Registers 82, No. 35; 81, Nos. 52 and 9; 80, No. 26; 79, No. 13; 78, No. 40; and 76, No. 51.

3. Editorial redesignation of former Chapter 2 (Articles 1-3, Sections 50201-50227, not consecutive) to Chapter 1, Subchapter 2 (Articles 1-3, Sections 50201-50227, not consecutive) filed 9-28-83 (Register 83, No. 40). For prior history, see Registers 80, No. 26 and 78, No. 40.

4. Repealer of Subchapter 2 (Articles 1-3, Sections 50201-50227, not consecutive) and new Subchapter 2 (Articles 1-5, Sections 50201-50241, not consecutive) filed 1-18-84; effective thirtieth day thereafter (Register 84, No. 3).

5. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

6. Amendment filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

7. Change without regulatory effect deleting text reference to Welfare and Institutions Code Section 4785, which was repealed by Stats. 1984, c. 1789, Section 4 (Register 86, No. 33).

§50203. Forms.

Note • History

(a) Regional centers shall use parental financial responsibility forms prescribed by the State Department of Developmental Services.

(b) Other forms shall not be substituted by regional centers unless specifically approved by the Department.

NOTE

Authority cited: Sections 4409, 4631, 4640 and 4748, Welfare and Institutions Code. Reference: Sections 4631, 4640, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

Article 2. Definitions

§50205. Ability to Pay.

Note • History

“Ability to Pay” means financial capability to pay the cost of raising a normal child at home, as determined by the Director of Developmental Services.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4631(a), 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50207. Gross Family Income.

Note • History

Gross family income includes any money or benefit acquired, earned, or received as payment for labor or services, support, gift or inheritance, or return on investments by parents or eligible dependents.

Provided however, that the following shall not be considered as gross family income:

1. Earned income and the return on investment of a minor child living at home or in 24 hour out of home placement;

2. Child support payment for a minor child eligible for developmental services to the extent that it is sent or paid to a regional center or state hospital trust office as offset to the cost of services.

Provided further that the parental fee assessment against the noncustodial parent shall be reduced by the amount of child support awarded by the court on behalf of the client.

Provided further, that the includible income from the operation of a business or from self-employment is the net income after deducting business expenses. However, depreciation, amortization, and depletion shall not be allowed as business expense deductions.

Provided finally, that the community property interest of a parent in the gross income of a stepparent, shall be used in determining family income.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4631(a), 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect deleting text reference to amounts excluded from the community property interest of a parent in the gross income of a stepparent pursuant to Civil Code Section 5127.5, which was repealed by Stats. 1984, c. 1671, Section 14 (Register 86, No. 33).

4. Amendment filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§50209. Eligible Dependent.

Note • History

Any person who depends on the gross family income for more than one-half of his or her support shall be considered an eligible dependent provided such person's income, other than the earned income of a minor child living at home, is reported and included in the gross family income. Provided however, that a child with developmental disabilities who is living in a community placement or residing in a state hospital shall be considered an eligible dependent regardless of the extent of his dependency on gross family income. Provided further, that a parent who has remarried and the stepparent shall be considered as one eligible dependent, and not two, for the purpose of computing the parental fee.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4631(a), 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50211. Parental Fee.

Note • History

“Parental Fee” means the determined and/or scheduled sum which parents are required to pay to the Developmental Disabilities Program Development Fund.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect deleting reference to Welfare and Institutions Code Section 4785, which was repealed by Stats. 1984, c. 1789, Section 4 (Register 86, No. 33).

§50213. Parental Fee Schedule.

Note • History

“Parental Fee Schedule” means the official table of tabulated and scaled fees as authorized and established by the Director of Developmental Services with the approval of the State Council on Developmental Disabilities.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50215. Parents.

Note • History

“Parents” means the natural or adoptive parents, or either of them, of a child with developmental disabilities under 18 years of age.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

Article 3. Administrative Provisions

§50221. Centralized Parental Fee Program.

Note • History

(a) The Department of Developmental Services shall determine, assess, bill, revise, adjust and collect determined parental fees. Determination and assessment shall be in accordance with the Parental Fee Schedule as defined in Section 50213 and parental financial information. Collection of accounts shall be in accordance with applicable laws and standard collection procedures.

(b) All parental fees paid to or received by a regional center shall be recorded and accounted for in accordance with standard accounting principles. Such fees shall be reported and remitted monthly by regional center to the Department of Developmental Services.

(c) The Department of Developmental Services shall remit all parental fee payments received from parents or from regional centers to the State Treasury, within 60 calendar days of receipt, to be deposited in the Developmental Disabilities Program Development Fund (DDPDF).

(d) Regional Centers shall provide the Department of Developmental Services with such information and documents as may be required to determine, assess, bill, revise, adjust, and collect parental fees.

NOTE

Authority cited: Sections 4409, 4631, 4640 and 4748, Welfare and Institutions Code. Reference: Sections 4631, 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84 No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

Article 4. Determination of Ability to Pay

§50223. Services Requiring Ability to Pay Determinations.

Note • History

Conditions requiring an ability to pay determination shall be:

(a) All 24-hour out-of-home community care received through a regional center for children under the age of 18;

(b) 24-hour care for such minor children in state hospitals.

Provided, however, that no ability to pay determination shall be made for services required by state or federal law, or both, to be provided to children without charge to their parents.

Provided further, in no case shall the parental fee exceed the net cost of services purchased by the state or the regional center.

NOTE

Authority cited: Sections 4409, 4631 and 4748, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50225. Regional Center Responsibilities.

Note • History

Regional centers shall have the following duties and responsibilities:

(a) Identify all children with developmental disabilities who are receiving services as specified in Section 50223.

(b) Provide the Department of Developmental Services with a listing of new placements, terminated cases, and client deaths for those clients identified in paragraph (a) of this section. Such listing shall be provided not later than the 20th day of the month following the month of such occurrence and shall be provided in the format as determined by the Department of Developmental Services.

(c) Inform parents of children who will be receiving services as identified in Section 50223 that the Department of Developmental Services is required to determine parents' ability to pay, and to assess, bill, and collect parental fees pursuant to Chapter 9 of Division 4.5 of the Welfare and Institutions Code.

(d) Within 10 working days after placement of a minor child, provide the parent(s) a package containing an informational letter, a Family Financial Statement (FFS), and a return envelope. The informational letter, FFS, and envelope shall be provided to the centers by the Department of Developmental Services.

(e) A copy of each informational letter given or sent to parent(s), indicating the addressee and the date given or mailed, shall be attached to and submitted with the report identified in paragraph (b) of this section.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4620, 4631, 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new section filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect of subsection (d) (Register 86, No. 33).

§50227. Notification to Parents.

Note • History

(a) The Department of Developmental Services shall notify parents in writing of parental fee determination results and advise them of their right to appeal the determination under Section 50241. A copy of the Confirmation Letter will be sent to the regional center.

(b) Parental fee liability shall be effective on the first day of the month following the month that the client is placed in a 24-hour out-of-home facility.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4620, 4631, 4677, 4748, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new section filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50229. Parent(s) Disclosure of Financial Information.

Note • History

The parent(s) of a child who is currently receiving services as specified in Section 50223, or who has been referred for placement pursuant to the same section, shall complete and submit to the Department of Developmental Services and annually thereafter, a Client Benefit Questionnaire and Family Financial Statement. If the parent(s) refuses or fails to complete and submit this form, within 30 days from the date on the informational letter, the Department of Developmental Services shall assess a fee for the full cost of services or the maximum allowable fee, whichever is less. Upon receipt of the properly completed FFS, the Department of Developmental Services will determine the appropriate rate and adjust the account as necessary.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. New section filed 2-9-84; designated effective 2-17-84 pursuant to Government Code Section 11346.2(d) (Register 84, No. 6).

2. Repealer and new section filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect (Register 86, No. 33).

§50230. Determination of Amount of Monthly Parental Fee.

Note • History

(a) The maximum parental fee shall be in accordance with the Parental Fee Schedule as defined in Section 50213.

(b) Parental fees for those families with more than one child having developmental disabilities and receiving services as specified in Section 50223 shall be made using the fee schedule and the following adjustments.

(A) First Child 100% of the Fee Schedule Amount

(B) Second Child 50% of the Fee Schedule Amount

(D) Fourth Child 25% of the Fee Schedule Amount

NOTE

Authority cited: Sections 4409, 4631 and 4677, Welfare and Institutions Code. Reference: Sections 4677, 4732 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 10-31-84; designated effective 1-1-85 unless a statute enacted before that date supercedes Welfare and Institutions Code Section 4784(b), Statutes of 1984, Chapter 1729, Section 3, which exempts parental fee schedules from Title 2, Division 3, Part I, Chapter 3.5, Section 11340 et seq., Government Code, the Administrative Procedure Act (Register 84, No. 44).

Article 5. Determining Required Levels of Payment

§50231. Gross Family Income Adjustments.

Note • History

(a) Client related expenditures shall be reported as an annual amount for the 12 months immediately preceding a determination of ability to pay. Qualified client related expenditures which the Department of Developmental Services may accept to reduce gross family income, subject to verification, are:

(1) Annual amounts paid from gross family income to reduce or liquidate medical debts incurred by parents on behalf of and before a child with developmental disability began receiving services provided by the state or secured through a regional center.

(2) Annual amounts paid from gross family income for the current medical expenses of a child with a developmental disability provided that such expenses have not been paid or are not currently reimbursable with state funds, health insurance, health care benefits, or other third party resources.

(3) Annual amounts paid from gross family income for the developmentally disabled child's share of any premium payments paid for an individual, family, or group health care plan.

(4) Annual amounts paid from gross family income to other government agencies as payment for services provided for a child with a developmental disability.

(5) Annual amounts paid from gross family income for the clothing needs of a child with a developmental disability.

(6) Annual amounts paid from gross family income for personal needs and incidentals for the child with a developmental disability.

(7) Annual amounts paid from gross family income for recreation and entertainment for the child with a developmental disability.

(b) “Qualified client related expenditures” as enumerated in 50231 subsection (a) may be applied as an adjustment to reduce gross family income prior to application of the parental fee schedule for the purpose of determining ability to pay and assessing the required fee.

(c) Client related expenditures as enumerated in 50231(a) do not include those that are paid for or are reimbursable by the client's SSI/SSP, SSA, or other benefits paid to or on behalf of the client.

(d) The maximum monthly parental fee shall be in accordance with the Parental Fee Schedule as defined in Section 50213.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50233. Major Unusual Expense Allowance.

Note • History

The Department of Developmental Services may allow claims for major unusual expenses which limit ability to pay and which will create hardship if a required payment should be imposed. Any qualified allowance shall be applied as an adjustment to reduce the gross family income used to determine parents' ability and level of payment. In determining what constitutes a major unusual expense, the Department of Developmental Services shall include for consideration, but not be limited to, the following factors:

1. Expenditures which consume a substantial portion of Gross Family Income;

2. An expenditure over which parents have no control, e.g., natural disaster, catastrophic uninsured casualty loss, death of an immediate family member, extreme medical expense.

Hardship, in this sense, implies that the result of imposing the monthly parental fee, would be privation or lack of what is needed for basic family necessities, food, shelter, clothing, medical care, etc., not merely a reduction of the family's standard of living.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4748, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. New section filed 2-9-84; designated effective 2-17-84 pursuant to Government Code Section 11346.2(d) (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50235. Transportation Expense Allowance.

Note • History

Reasonable transportation expenses incurred by parents to visit a child with developmental disability in any placement facility may be claimed as client related expenditures and applied as an adjustment to reduce gross family income.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50237. Substantiation of Determination Data.

Note • History

The Department of Developmental Services may require substantiation of information set forth in the Family Financial Statement. Substantiation may be in the form of State and Federal Income Tax Returns, W-2 Forms, payroll stubs, and copies of bills, receipts, or cancelled checks. Parents may be required to sign release of information forms for employment and/or income verification.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new section filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect (Register 86, No. 33).

§50239. Termination of Required Payments.

Note • History

Assessment of required payments shall be terminated at the end of the month in which a child with developmental disabilities receiving services becomes 18 years of age. When services terminate because of the client's death or discharge, the monthly parental fee will be terminated as of the last day of the month proceeding the month of death or discharge.

Provided however, that parental fees previously assessed and still unpaid at time of termination of the monthly parental fee shall continue to be billed until paid in full or adjusted.

NOTE

Authority cited: Sections 4409 and 4631, Welfare and Institutions Code. Reference Sections 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

§50241. Appeal.

Note • History

Parents who are dissatisfied with the decision as to the determination of ability to pay and/or the amount of parental fee may, within 30 days of receipt of the parental fee confirmation letter, request an appeal of the determination or the amount of the fee. The appeal must be in writing and addressed to the Director of Developmental Services, and must state the reason(s) for the appeal. The Department of Developmental Services will send a copy of the appeal to the appropriate regional center director within five days of its receipt.

Parents may discontinue making payments of the assessed fee pending notification of the appeal results. Provided however, that if parents fail or refuse to provide the Department pertinent financial information within 60 days of the request for an appeal, the appeal shall be deemed withdrawn and collection activities shall be resumed.

The Director or designee shall, within 30 days after receipt of all pertinent financial information requested by the Department, review the appeal and provide written notice of the decision to the appellant and the appropriate regional center.

All decisions regarding parental fee appeals may be made retroactive to the date the appealed fee was established.

NOTE

Authority cited: Sections 4409, 4501 and 4631, Welfare and Institutions Code. Reference: Sections 4512, 4620, 4648(b), 4677, 4782 and 4784, Welfare and Institutions Code.

HISTORY

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code Section 11346.2(d) (Register 85, No. 33).

Subchapter 2.5. Family Cost Participation

Article 1. General

§50243. Purpose.

Note • History

These regulations implement and make specific the provisions of Section 4783 of the Welfare and Institutions Code related to the Family Cost Participation Program.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

1. New subchapter 2.5 (articles 1-4), article 1 (section 50243) and section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emergency language will be repealed by operation of law on the following day.

2. New chapter 2.5 (articles 1-4), article 1 (section 50243) and section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

Article 2. Definitions

§50245. Developmental Disability.

Note • History

For the purposes of these regulations, the term “developmental disability” shall have the same meaning as provided in Section 4512 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4512 and 4783, Welfare and Institutions Code.

HISTORY

1. New article 2 (sections 50245-50253) and section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emergency language will be repealed by operation of law on the following day.

2. New article 2 (sections 50245-50253) and section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50247. Medi-Cal Eligible Consumers.

Note • History

Medi-Cal eligible includes consumers who are institutionally deemed. The term “institutionally deemed” means that the income and resources of a parent are not deemed to the consumer, therefore making the consumer eligible for Medi-Cal if all other Medi-Cal eligibility criteria are met.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 1915(c)(3), Social Security Act; and Section 4783, Welfare and Institutions Code.

HISTORY

1. New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50249. Family Cost Participation Schedule.

Note • History

The Family Cost Participation Schedule means the official table developed by the Department of Developmental Services and used by the regional centers to determine the amount of family cost participation. This table is reflective of the Federal Poverty Guidelines as adjusted for family size and scaled by income levels and establishes the lowest family cost participation at five percent (5%). The Department of Developmental Services shall adjust this schedule consistent with changes in the Federal Poverty Guidelines but not more often than once each calendar year.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50251. Gross Annual Income.

Note • History

Gross annual income is the income of the parents as reported on their latest California State or Federal Income Tax return and includes any money or benefit acquired, earned, or received as payment for labor or services, support, or return on investments. Income from the operation of a business or from self-employment is the net income after deducting business expenses. Depreciation, amortization, and depletion shall not be allowed as business expense deductions. The regional center executive director may determine appropriate documentation necessary for family cost participation consistent with Section 4783(g)(2).

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50253. Persons Living in the Family Home.

Note • History

(a) A person living in the family home is any person who depends on the gross annual income of the parents for more than one-half of his/her support.

(b) In the case of divorce, legal separation, or established paternity where income from both parents is used, all persons who depend on the gross annual income of the parents for more than one-half of his/her support shall be considered persons living in the family home.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order, including amendment of section, transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

Article 3. Administrative Provisions

§50255. Parent Responsible for Cost Participation.

Note • History

(a) The parents of a child who meet the definition under Section 4783(a)(1) of the Welfare and Institutions Code shall be jointly and severally responsible for the assessed amount of family cost participation. However, in the case of a divorce, legal separation, or established paternity, the family cost participation assessment shall be computed on the gross annual income of both parents unless inconsistent with a court order stating otherwise.

(b) In the event that a custodial parent certifies in writing that income information from the non-custodial parent cannot be obtained by the custodial parent, then only the income of the custodial parent may be used to determine the cost participation.

(c) This program shall not exempt parents from responsibilities for day care pursuant to Section 4685(c)(6) of the Welfare and Institutions Code.

NOTE

Authority Cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4685(c)(6) and 4783, Welfare and Institutions Code.

HISTORY

1. New article 3 (sections 50255-50257) and section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emergency language will be repealed by operation of law on the following day.

2. New article 3 (sections 50255-50257) and section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order, including new subsection (b) and subsection relettering, transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50257. Program Administration.

Note • History

(a) The Department of Developmental Services shall develop a pamphlet describing the Family Cost Participation Program. Regional centers shall provide the pamphlet to the parents of children, ages 3 through 17 years, during initial intake and assessment and at all subsequent IPP review meetings where changes occur to day care, camping, or respite services.

(b) Regional centers shall use all forms and documents developed by the Department of Developmental Services to administer the Family Cost Participation Program.

(c) Regional centers are responsible for funding their authorized share of services without regard to the family's cost participation assessment.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4685(c)(6) and 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

Article 4. Assessment of the Family Cost Participation

§50259. Assessment of the Family Cost Participation.

Note • History

(a) The amount of the family cost participation shall not impact any services other than those identified in Section 4783(c) of the Welfare and Institutions Code.

(b) Reductions in the assessed amount pursuant to Section 4783(d)(1)(2)(3) and (4) of the Welfare and Institutions Code, because of multiple minor children receiving services, shall only be applied to the Family Cost Participation Program assessment, and shall not reduce the fees for consumers in 24-hour out-of-home placements as determined pursuant to Sections 4677, 4782, and 4784 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4677, 4782, 4783 and 4784, Welfare and Institutions Code.

HISTORY

1. New article 4 (sections 50259-50267) and section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emergency language will be repealed by operation of law on the following day.

2. New article 4 (sections 50259-50267) and section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50261. Maximum Family Cost Participation Assessment.

Note • History

(a) Each parent shall provide the regional center with his or her proof of gross annual income pursuant to Section 4783(g)(2) and (i) of the Welfare and Institutions Code, within ten (10) working days from the date of the parents' signatures on the Individual Program Plan. The regional center may grant a ten (10) working day extension to provide documentation, if parents have acted in good faith. In no event shall more than one ten (10) working day extension be granted. Failure to provide the information will result in the regional center setting the cost participation at the maximum amount, pursuant to Section 4783(g)(4) of the Welfare and Institutions Code.

(b) The Individual Program Plan signature page shall include a statement indicating that the regional center shall fund respite, day care, and camping services consistent with the Family Cost Participation Program, if applicable.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order, including amendment of subsection (a), transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50262. Confidentiality and Retention of Income Documentation.

Note • History

(a) Any documentation submitted pursuant to Sections 50261, 50265, or 50267 shall be considered records obtained in the course of providing intake, assessment, and services and shall be confidential pursuant to Section 4514 of the Welfare and Institutions Code.

(b) Any documentation submitted pursuant to Sections 50261, 50265, or 50267, any documents relied on by the executive director pursuant to 50265, and correspondence from the regional center, shall be retained by the regional center for 3 years.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4514 and 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50263. Waiver Exemption.

Note • History

Parents whose child is Institutionally Deemed Medi-Cal eligible shall be exempt from the Family Cost Participation Program for that child.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 1915(c)(3), Social Security Act; and Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50265. Adjustment by Regional Center Executive Director.

Note • History

(a) Adjustment to the assessed amount of the family cost participation may be made by the regional center executive director for a substantiated unavoidable and uninsured catastrophic loss that would temporarily limit the ability of the parents to pay and create a direct economic impact if the amount of the family cost participation were not reduced. Unavoidable and uninsured catastrophic losses may include, but are not limited to, natural disasters, an accident or major injuries to an immediate family member, or extraordinary medical expenses. The executive director may also make an adjustment for significant unreimbursed medical costs associated with the care for a child who is a regional center consumer.

(b) Direct economic impact means that the result of not granting the adjustment would deprive the family of what is needed for basic family necessities, including but not limited to, food, shelter, clothing, or medical care. A direct economic impact is a substantial change that impacts more than just the family's standard of living.

(c) Adjustments made pursuant to this Section shall be calculated by deducting the documented non-reimbursed dollar cost of the direct economic impact request from the gross annual income, and then re-assessing the amount of family cost participation by applying the Family Cost Participation Schedule against the reduced income amount.

(d) Family cost participation assessments that have been adjusted as a result of the regional center executive director granting an adjustment shall be re-determined at least annually.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Section 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order, including amendment of subsection (a), transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

§50267. Assessment and Reassessment of Cost Participation.

Note • History

(a) The original amount of the family cost participation shall be assessed upon completion of the initial Individual Program Plan and reassessed every third year thereafter to coincide with the review of the consumer's Individual Program Plan, pursuant to Section 4646(b) of the Welfare and Institutions Code.

(b) Family cost participation assessments may be reduced or increased if there is an ongoing reduction or increase in the gross annual income upon which the amount of the family cost participation was determined, or a reduction or increase in the amount of services provided to the consumer pursuant to a change in the Individual Program Plan, or a change in family size.

NOTE

Authority cited: Section 4783, Welfare and Institutions Code. Reference: Sections 4646(b) and 4783, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005, No. 29).

Subchapter 3. Department of Developmental Services--Conflict of Interest Code

NOTE:Pursuant to a regulation of the Fair Political Practices Commission (Title 2, CCR, section 18750(k)(2)), an agency adopting a conflict of interest code has the options of requesting that the code either be (1) printed in the CCR in its entirety or (2) incorporated by reference into the CCR. Here, the adopting agency has requested incorporation by reference. However, the full text of the regulations is available to the public for review or purchase at cost at the following locations:

DEPARTMENT OF DEVELOPMENTAL SERVICES
1600 9TH STREET, ROOM 240
SACRAMENTO, CA 95814

SECRETARY OF STATE (ARCHIVES)
1020 O STREET
SACRAMENTO, CA 95814

FAIR POLITICAL PRACTICES COMMISSION
428 J STREET, SUITE 800
SACRAMENTO, CA 95814

The Conflict of Interest Code is designated as Subchapter 3, Chapter 1 of Division 2 of Title 17 of the California Code of Regulations, and consists of sections numbered and titled as follows:

Subchapter 3. Department of Developmental Services--

Conflict of Interest Code

Section

50300. General Provisions

Appendix

NOTE

Authority cited: Sections 87300 and 87304, Government Code. Reference: Sections 87300, et seq., Government Code.

HISTORY

1. Editorial renumbering of former chapter 8 (section 59100) to chapter 1, subchapter 3 (section 50300) filed 9-28-83 (Register 83, No. 40). For prior history, see Registers 81, No. 9; and 79, No. 13.

2. Editorial correction of printing error (Register 84, No. 5).

3. Amendment of section and Appendix filed 2-10-93; operative 2-10-93. Approved by Fair Political Practices Commission 1-15-93 (Register 93, No. 7).

4. Change without regulatory effect amending addresses for the agency and the Fair Political Practices Commission filed 7-15-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 29).

5. Amendment of General Provisions and Appendix filed 12-2-2003; operative 1-1-2004. Approved by Fair Political Practices Commission 9-18-2003 (Register 2003, No. 49).

6. Amendment filed 11-10-2010; operative 12-10-2010. Approved by Fair Political Practices Commission 9-1-2010 (Register 2010, No. 46).

Subchapter 4. Rules for Conducting Research

Article 1. Definitions

§50401. Definitions.

Note • History

As used in this subchapter, the following words have the specified meanings.

(a) “Clients Rights Advocate” means the individual or individuals assigned by a regional center or state hospital to be responsible for ensuring that the civil, legal and service rights of persons with developmental disabilities are available and guaranteed to such persons.

(b) “Consultant” means a person who gives expert or professional advice and who has competence in special areas or who can provide expertise beyond or in addition to that available to the IRB.

(d) “Health and Welfare Agency” means the Health and Welfare Agency as defined in Section 12800 of the Government Code.

(e) “Human Subject” means a living individual about whom a researcher conducting research obtains (1) date through intervention or interaction with the individual, or (2) confidential information.

(f) “Informed Consent” means the knowing consent of an individual or his or her legally authorized representative that is given without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion to participate in an activity. For consent to be “informed,” the individual or his or her legally authorized representative must possess accurate and complete information about the procedures which are to be performed, understand the information provided, and give consent voluntarily.

(g) “Institutional Review Board (IRB)” means a review board constituted and convened in accordance with the regulations in this subchapter by a state hospital or regional center servicing persons with developmental disabilities for the purpose of reviewing and approving or disapproving research involving human subjects.

(h) “Minimal Risk” means that the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that ordinarily encountered in the daily life of the human subject or during the performance of routine physical or psychological examinations or tests.

(i) “Regional Center” means a diagnostic, counseling, and service coordination center for persons with developmental disabilities and their families which is established and operated pursuant to Chapter 5 of Division 4.5 of the Welfare and Institutions Code by a private nonprofit community agency/corporation acting as a contracting agency.

(j) “Research” means the systematic investigation and acquisition of information for the purpose of developing or contributing to general knowledge, social programs, or scientific advancement and includes the collection of data for possible publication. Studies of the effect of routine treatment services, or the gathering of feedback information about routine treatment services, shall be considered research only if the data are collected with the aim of possible publication.

(k) “Researcher” means the principal investigator or project director who has responsibility for conducting the research.

(l) “Research Protocol” means a written description of the proposed research activity which is submitted for the appropriate IRB review and consideration and which is written in accordance with these regulations.

(m) “Risk” means any potential for harm anticipated in the proposed research which is greater than what might ordinarily be encountered in the daily life of the human subject or during the performance of routine physical or psychological examinations or tests.

(n) “State Hospital” means a state hospital serving people with developmental disabilities.

(o) “State Institutional Review Board” (State IRB) means a group of individuals constituted and convened in accordance with federal regulations (e.g., Title 45, Code of Federal Regulations, Section 46.101, et seq.) and approved as the State IRB by the U.S. Department of Health and Human Services to review and approve or disapprove research involving human subjects. For purposes of these regulations, the State IRB shall mean the federally approved IRB for the Health and Welfare Agency of the State of California.

(p) “Statistical Data” means aggregate information pertaining to individuals which is in such a form that it is not traceable back to the individuals.

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e), 4517, 5328(e) and 5329, Welfare and Institutions Code.

HISTORY

1. New subchapter 4 (Articles 1-2, Sections 50401-50429, not consecutive) filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

Article 2. Rules for the Conduct of Research

§50403. Scope of Subchapter.

Note • History

(a) These regulations apply to all research conducted by or at state hospitals, regional centers, or by other persons or at places subject to Section 4514 of the Welfare and Institutions Code, whenever the researcher requests access to information or records which are confidential under Section 4514(e) of the Welfare and Institutions Code.

(b) Research involving the collection or study or existing data, statistical information, documents, records, or pathological or diagnostic specimens is exempted from these regulations if:

(1) such information is publicly available, or if

(2) the information provided to the investigator is in such a form that human subjects cannot be identified either directly or through identifiers linked to the human subjects.

(c) These regulations do not apply to audits, reviews or studies conducted by federal, state, or local government agencies in the exercise of their management or administrative responsibilities.

(d) The IRB may exempt research activities from the requirements of these regulations if the only involvement of human subjects will be in one or more of the following categories:

(1) research conducted in established or commonly accepted educational settings, involving normal educational practices, when the data are recorded in such a manner that the subject cannot be identified such as

(A) research on regular and special education instructional strategies, or

(B) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods;

(2) research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources or through identifiers linked to the subjects; or

(3) research involving survey or interview procedures or the observation of behavior open to public view.

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

§50405. Institutional Review Boards (IRBs).

Note • History

(a) An IRB shall review all research protocols pertaining to research involving human subjects who are served by state hospitals or regional centers.

(b) Each state hospital shall establish an IRB to review and approve or disapprove research protocols and to assure that the protocols meet the requirements of this subchapter.

(c) Each regional center may establish an IRB and procedures to review and approve or disapprove research protocols and to assure that such protocols meet the requirements of Section 4514 of the Welfare and Institutions Code. The regional center's IRB shall review and approve or disapprove the research protocols that involve their clients except those residing in a state hospital in accordance with the procedures established by the regional center pursuant to this section.

(d) If a regional center does not choose to establish an IRB, the regional center shall submit the research protocol directly to the Department. The Department shall create or designate the IRB that shall review and approve or disapprove the research protocol, pursuant to Sections 50407 through 50429.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e), 4791 and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50407. Review Structure for Research Protocol.

Note • History

(a) Before any research involving human subjects may be conducted at state hospitals, the research protocol shall be reviewed and approved by the following entities:

(1) the IRB responsible for reviewing research for the particular persons who will be the subjects of the research;

(2) the Executive Director of the state hospital with which the IRB is affiliated; and

(3) the State IRB if required by federal laws or regulations.

(b) If the research protocol requires obtaining confidential information about clients of more than one state hospital, the requirement for IRB review shall be met by having the research protocol reviewed and approved by either:

(1) each IRB individually, or

(2) a joint IRB composed of one or more representatives from each IRB involved.

(c) If the research protocol involves a statewide sampling of subjects, or subjects from a regional center with no IRB, the requirement for IRB review shall be met by submitting the research protocol to the Department which shall create or designate the IRB to review the protocol.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50409. Continuing Review of Research Activities at State Hospitals.

Note • History

(a) The IRB shall conduct continuing review of approved research at intervals appropriate to the degree of risk involved in the research but not less than annually.

(b) At any time the Executive Director of the state hospital or the IRB shall have authority to revoke approval of the research if it is determined that any of the following occur:

(1) The research as conducted involves greater risks to the human subjects than had been anticipated when the protocol was approved;

(2) There is a subsequently discovered violation of clients' rights;

(3) There is a violation of the oath of confidentiality by the researcher or his or her agents; or

(4) The protocol is not being applied as approved.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section heading and Note filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50411. Composition of the IRB at State Hospitals.

Note • History

(a) Each state hospital IRB shall have at least five members, including:

(1) Persons with varying educational and professional backgrounds sufficient to ensure a complete and adequate review of research activities commonly conducted by or at the facility;

(2) Persons with sufficient expertise and experience to promote respect for their advice and counsel in safeguarding the rights and welfare of human subjects;

(3) Persons possessing both the professional competence to review specific research activities and the ability to ascertain the acceptability of proposed research in terms of facility commitments and regulations, applicable law, and standards of professional conduct and practice;

(4) Both men and women with diversity of backgrounds, racial, and cultural characteristics, and with sensitivity to community attitudes;

(5) at least one member whose primary concerns are in nonscientific areas and who are concerned with the rights or persons with developmental disabilities; for example, a lawyer, a member of the clergy, a clients' rights advocate; and

(6) at least one member who is not affiliated with the facility and who is not part of the immediate family of a person who is affiliated with the facility.

(b) Excluded from membership are the Executive Director of the state hospital and the clinical director of the state hospital by which the IRB was constituted.

(c) Excluded from voting on specific projects are members who have been or are participants in , or associated with, the research proposal.

(d) If the state hospital does not have a separate committee to review the technical research design aspects of a research protocol, at least three members of the IRB shall have sufficient experience and expertise in conducting and critiquing research methodology to ensure the adequacy of review of research design and method.

(e) The IRB may call upon consultants as deemed necessary to render technical advice.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 174; Sections 4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e), 4791 and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50413. Responsibilities of the Researcher.

Note • History

Before any research involving human subjects is initiated at a state hospital, the research shall:

(a) Identify each state hospital in which the human subjects are residents or with which the human subjects are affiliated.

(b) Prepare a written research protocol containing:

(1) A statement indicating whether the researcher considers the research to be exempt from these regulations as outlined in Section 50403(d) and the reasons for this determination. Even if the researcher considers the research to be exempt pursuant to Section 50403(d), the requirements of Section 50413 shall be met by the researcher.

(2) A summary of the nature, purpose and design of the research including:

(A) the specific questions to be addressed;

(B) the research methods such as sampling, data collection, and data analysis to be employed to answer these questions; and

(3) A full description of the type of human subjects proposed to be involved in the research, including their characteristics, the total number anticipated, how they will be selected and the rationale for the use of this population.

(4) A full description of how the subjects will be used in the activity. If human remains or material that used to be part of a human body are to be used, details as to their origin, nature and disposition should be given.

(5) A full description and assessment of potential benefits, if any, to the individual human subjects, the group or class of which the subjects are members, society in general , and to science as a result of the activity.

(6) A description and assessment of potential risks, if any, to the individual human subjects, the group or class of which the subjects are members, and to society in general as a result of the activity, whether such risks by physical, psychological, social or legal. The protocol shall assess the likelihood, severity and duration of such risks. If the research methods create potential risks, the protocol shall describe other less risky methods, if any, which were considered and explain why they will not be used.

(A) Human subjects shall be considered at risk in research if they are involved without having given their informed consent.

(B) Human subjects shall not be considered at risk if they are involved in a research activity which makes use of:

1. observations of behavior open to public view,

2. materials available to the public, or

3. statistical data.

(7) A description of the means to be taken to minimize such risks, including the means by which the subject's personal privacy is to be protected and the confidentiality of the information obtained from or about the subject is to be maintained. The protocol shall assess the likely effectiveness of such precautionary measures.

(8) A description of the procedures to be used in obtaining and documenting the prior informed consent of the subject. Copies of the material to be used in obtaining informed consent shall be attached to the protocol.

(9) A waiver of the requirement for written informed consent, if sought. The justification for the waiver shall be specified.

(10) The questionnaires or interview schedules, if any are to be used in the project. If they are not available at the time of submission, an informative description of their content and of the manner of administration shall be included in the protocol, along with an assurance that, when completed, they will be filed with the IRB.

(11) A description of any special or unusual circumstances regarding the research activity which the researcher believes could be relevant or material to the IRB's decision.

(12) A statement which indicates acceptance of responsibility for ensuring that the research activity will be conducted by the researcher, and his or her associated research and staff assistants, in accordance with the procedures outlines in the research protocol and these regulations.

(d) Submit a copy of his or her vita, including address and telephone number, and any prior experience in research involving confidential information.

(e) Include a copy of the application if the researcher is applying for federal, state or other funds for the research.

(f) Submit the written protocol to IRBs appropriate for the particular group of human subjects involved.

(g) Send an informational copy of the research protocol after it is approved by the IRB(s) and Executive Director(s) to the Director of the Department at his office in Sacramento.

(h) Submit to the IRB a supplement to the original protocol approved by the IRB if the supplement proposes to change the involvement of human subjects in the research in a way that is materially different from that which was initially approved by the IRB.

(i) The researcher shall be responsible for securing the approval of the Food and Drug Administration (FDA) and for notifying the IRB of that approval whenever an investigational new drug or device exemption is required pursuant to law.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsections (b)(6), (b)(10) and (e) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§50415. Responsibilities of the IRB at State Hospitals.

Note • History

(a) The IRB shall make available a copy of the regulations in this subchapter to any person inquiring about doing research covered by this subchapter.

(b) The IRB shall meet and review all written research protocols within 31 days of receipt.

(c) The IRB shall review the written research protocol and make a determination as to whether or not the research is exempt from these regulations as specified in 50403(d).

(d) The IRB may request from the researcher any additional information necessary to complete its review, and may require modifications in the research activity or protocol before approval may be granted.

(e) The IRB shall approve, disapprove or defer the research protocol in writing, giving reasons for the disapproval or deferment and any requested modifications, within 31 days of its review meeting.

(f) The IRB shall give the researcher the opportunity to respond to these comments in writing or in person and shall re-review protocols which have been modified at the IRB's request. The IRB shall review resubmitted research protocols within 31 days of resubmission.

(g) The IRB shall prepare and maintain adequate documentation of IRB activities, including

(1) copies of all submitted protocols, consent documents and other attachments;

(2) minutes of meetings including persons present and a summary of decisions and actions taken;

(3) records of continuing review activities;

(4) names, occupations, earned degrees, licenses, certifications and other pertinent information about members' qualifications; and

(5) changes in committee membership.

The IRB shall submit copies of meeting minutes, reports of continuing review activities, members' qualifications and changes in membership to the State IRB on an ongoing basis.

(h) The IRB shall review proposed research at convened meetings at which a majority of the members are present. In order for the research to be approved, it shall receive the approval of either three members present or a majority of those members present at the meeting, whichever is a larger number.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50417. Criteria for State Hospital IRB Approval of Research Protocols.

Note • History

In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:

(a) Risks to human subjects are minimized by using procedures, when possible, which are:

(1) Consistent with sound research design and which do not unnecessarily expose subjects to risk; and

(2) Already being performed on the subjects for diagnostic or treatment purposes.

(b) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB shall consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The IRB shall not consider possible long-range effects of applying knowledge gained in the research, such as the possible effects of the research on public policy as among those research risks that fall within the purview of its responsibility.

(c) Selection of subjects is appropriate and equitable. In making this assessment, the IRB shall take into account the purposes of the research and the setting in which the research will be conducted.

(d) The procedures described in the protocol for obtaining and documenting prior informed consent from each prospective subject or the subject's legally authorized representative are in accordance with these regulations.

(e) The material is to be used in obtaining informed consent are in accordance with these regulations.

(f) There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(g) The researcher possesses professional qualifications, competence and integrity.

(h) If the state hospital does not have a separate entity to review the technical aspects of research protocols, the IRB also shall review the research for:

(1) scientific merit and relevance, including relevance to the missions of the state hospital, or facility; and

(2) adequacy of research design and appropriateness of research methodology.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50419. Appealing an IRB Decision.

Note • History

Any researcher may appeal an unfavorable decision of an IRB to the State IRB in writing within 31 days of the date of the written notice of disapproval.

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

§50421. Confidentiality of Client Information and Records Used in Research.

Note • History

(a) All client data and information obtained in the course of the research shall be confidential and shall be disclosed only to qualified professional persons providing services to the client or to other research personnel operating pursuant to the approved protocol.

(b) Prior to obtaining access to any confidential records or information for the purpose of doing research, each researcher, including but not limited to employees of the facility maintaining the records or information, shall sign an oath of confidentiality as follows:

__________________

Date

As a condition of doing research concerning persons with developmental disabilities who have received services from ___________________________ (fill in the facility, agency or person), I, ____________________, agree to obtain the prior informed consent of such persons who have received services to the maximum degree possible as determined by the appropriate institutional review board or boards for protection of human subjects reviewing my research, or such person's parents, guardian, or conservator, and I further agree not to divulge any information obtained in the course of such research to unauthorized persons and not to publish or otherwise make public any information regarding persons who have received services such that the person who received services is identifiable.

I recognize that the unauthorized release of confidential information may make me subject to a civil action under provisions of the Welfare and Institutions Code.

_________________________

Signed

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

§50423. Informed Consent.

Note • History

(a) Before confidential records or information may be released or disclosed to a researcher, the researcher must obtain prior informed consent from the person about whom the records or information pertain, or the person's legally authorized representative, to the maximum degree possible as determined by the appropriate IRB.

(b) The researcher shall seek such consent only after the appropriate IRB has approved the research protocol, and only in the manner prescribed by the IRB, which shall be under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether to participate, and that minimize the possibility of coercion or undue influence.

(c) The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.

(d) No informed consent, whether oral or written, may include any language through which the research subject or the representative waives or appears to waive any of the research subject's legal rights, or any language which releases or appears to release the researcher, the facility, or its agents or any other person or entity from liability for negligence.

NOTE

Authority cited; Section 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

§50425. Basic Elements of Informed Consent.

Note • History

(a) Except as provided in Sections 50427, 50429(c), in seeking informed consent, the researcher shall ensure that the following information is provided to each subject or representative:

(1) An explanation of the research, including its purposes, the duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing how the confidentiality of records which identify the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any compensation will be provided, and a description of any medical treatments that will be provided if a research-related injury occurs;

(7) A listing of the name, address and phone number of the persons to contact for answers to questions about the research, research subjects' rights, and possible research-related injury to the subject;

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;

(9) A statement that the confidentiality of the subjects shall be maintained in any report of the findings of the research project, unless expressly consented to by the client or his or her legally authorized representative.

(b) When appropriate, one or more of the following elements of information shall be provided to each subject:

(1) A statement of anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's consent;

(2) An explanation of any costs to the subject that may result from participation in the research;

(3) A description of the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; and

(4) A statement indicating that the subject will be advised of any significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation.

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Change without regulatory effect amending subsection (b)(2) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§50427. Waiver of Requirement of Informed Consent at State Hospitals.

Note • History

A state hospital IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

(a) The research involves no more than minimal risk to the subjects and involves no procedures for which written consent is normally required;

(b) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(d) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality;

(e) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

NOTE

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50429. Documentation of Informed Consent.

Note • History

(a) Except as provided in Section 50427, informed consent shall be documented by the use of a written consent form that:

(1) embodies the elements of informed consent required by Section 50425;

(2) is approved by the appropriate IRB or IRBs; and

(3) is signed by the subject or the subject's legally authorized representative.

(b) Research investigators shall ensure that each person signing the written consent form is given a copy of that form.

(1) a written consent document that embodies the elements of informed consent required by Section 50425. This form may be read by or read to the subject or the subject's legally authorized representative, but, in any event, the researcher shall give either the subject or the representative adequate opportunity to read and understand the form before signing it; or,

(2) a “short form” written consent document stating that the elements of informed consent required by Section 50425 have been presented orally to the subject or the subject's legally authorized representative. When the “short form” is used, the researcher shall insure that:

(A) a witness is present at the oral presentation,

(B) the short form is signed by the subject or the representative,

(D) the person obtaining consent signs a copy of the summary,

(E) a copy of both the short form and summary is given to the subject or the representative, and

(F) the written summary of what is to be said to the subject or the representative receives the prior approval of the IRB.

(d) In cases where the documentation requirement is waived, the IRB may require the researcher to provide subjects with a written statement regarding the research.

NOTE

Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

HISTORY

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

Subchapter 5. Clients' Rights

Article 1. Purpose and Definitions

§50500. Intent and Purpose.

Note • History

The intent and purpose of this subchapter is to implement, interpret, and make specific the statutory provisions of the Lanterman Developmental Disabilities Services Act (Division 4.5 of the Welfare and Institutions Code, commencing with Section 4500) relative to the rights of persons receiving services pursuant to said Act.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4416, 4441, 4502, 4503, 4504 and 4648, Welfare and Institutions Code.

HISTORY

1. New Subchapter 5 (Articles 1-6, Sections 50500-50550, not consecutive) filed 12-23-81; effective thirtieth day thereafter (Register 81, No. 52).

2. Editorial redesignation of former Chapter 4 (Subchapters 5 and 6, Sections 50500-50667, not consecutive) to Chapter 1, Subchapters 5 and 6 (Sections 50500-50667, not consecutive) filed 9-28-83 (Register 83, No. 40).

§50501. Definitions.

Note

(a) As used in this subchapter the following words and phrases have the specified meaning:

(1) Client. “Client” means any person with a developmental disability who is receiving services, is an applicant for services, or has been referred for services pursuant to the Lanterman Developmental Disabilities Services Act.

(2) Clients' rights advocate. “Clients' rights advocate” means the individual or individuals assigned by a regional center or state hospital to be responsible for clients' rights assurance for persons with developmental disabilities.

(3) Clients' Rights Assurance. “Clients' Rights Assurance” refers to the comprehensive program of ensuring that the civil, legal and service rights of persons with developmental disabilities are available and guaranteed to such persons.

(4) Clients' Rights Officer. “Clients' Rights Officer” is the person assigned by the director to implement the department's clients' rights assurance endeavors on a statewide basis and to provide technical assistance and functional supervision to the network of clients' rights advocates throughout California.

(5) Community care facility. “Community care facility” means any licensed facility defined in Health and Safety Code Section 1502.

(6) Department. “Department” means the State Department of Developmental Services.

(7) Developmental disability. “Developmental disability” means any condition included within the definition of this term by Welfare and Institutions Code Section 4512(a) and applicable regulations promulgated by the Director.

(8) Director. “Director” means the Director of the State Department of Developmental Services.

(9) Health facility. “Health facility” means any licensed facility defined in Health and Safety Code Section 1250.

(10) Postural support. “Postural support” refers to any device other than orthopedic braces used to assist clients in achieving proper body position and balance. These devices are distinguished from restraints.

(11) Physician. “Physician” means a person licensed as a physician and surgeon by the California Board of Medical Quality Assurance or California Board of Osteopathic Examiners.

(12) Professional person in charge of the facility. “Professional person in charge of the facility” means:

(A) In a health facility, a physician, psychiatrist, psychologist, social worker, or registered nurse who is designated by the licensee as the professional person clinically in charge of the facility.

(B) In a community care facility, the administrator of the facility as designated by the licensee.

(13) Psychiatrist. “Psychiatrist” means a person who is licensed as a physician and surgeon by the California Board of Medical Quality Assurance or the California Board of Osteopathic Examiners and who is certified or eligible for certification by the American Board of Psychiatry and Neurology, or the American Osteopathic Board of Neurology and Psychiatry, or is a physician who is licensed by the California Board of Medical Quality Assurance or the California Board of Osteopathic Examiners and has specialized training and/or experience in psychiatry.

(14) Psychologist. “Psychologist” means a person licensed by the California Board of Medical Quality Assurance and (1) who possesses an earned doctorate degree in psychology from an educational institution meeting the criteria of subdivision (c) of Section 2914 of the Business and Professions Code and (2) has not less than two years of clinical experience in a multidisciplinary facility licensed or operated by this or another state, or by the U.S. to provide health care, or is listed in the National Register of Health Service Providers in Psychology, as adopted by the Council for the National Register of Health Service Providers in Psychology.

(15) Registered nurse. “Registered nurse” means a person licensed as such by the California Board of Registered Nursing.

(16) Restraint. “Restraint” means control of the client's behavior or activities through the use of physical or pharmaceutical means other than postural supports. For the purpose of these regulations, restraint is distinguished from the temporary constraint of a client by direct physical contact only, where there is clear evidence for believing the existence of an imminent danger to either the client or others if such constraint is not accomplished.

(17) Seclusion. “Seclusion” is the involuntary isolation of a client in a locked room. As used in this subchapter, seclusion does not include isolation of a client for the purpose of containing any contagious disease when written order of a physician directs such isolation for this limited purpose. Such medical isolation shall not be in a locked room unless the physician's order expressly directs it on the basis of a finding that, if not locked, the particular client's isolation cannot be maintained.

(18) Service catchment area. “Service catchment area” refers to that geographical area within which a regional center provides services specified in its contract with the Department as required by Welfare and Institutions Code Section 4640.

(19) Social worker. “Social worker” means a person who is a graduate of a school of social work accredited or approved by the Council on Social Work Education and has one year of social work experience in a health care setting or who is licensed as such by the California Board of Behavioral Science Examiners.

(20) Services. “Services” means anything included within the definition of services set forth in Welfare and Institutions Code Section 4512(b) and in regulations promulgated by the Director.

(21) State hospital. “State hospital” means any of the licensed state operated health facilities designated in Welfare and Institutions Code Section 4440.

(b) Any word, term, or phrase not specifically defined but used in this subchapter shall have the meaning ascribed by common, contemporary accepted usage unless to do so would result in absurd interpretation or otherwise be inconsistent with its context. In cases of conflict in construction, words, phrases, or terms of art shall have the meaning apparent by their context and most reconcilable with the intent of this subchapter.

(c) Use of the masculine gender in this subchapter shall be understood as including the feminine and use of the singular as including the plural.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4415 and 4416, Welfare and Institutions Code.

Article 2. Rights of Persons with Developmental Disabilities

§50510. Application of This Subchapter.

Note

Each person with a developmental disability, as defined by this subchapter, is entitled to the same rights, protections, and responsibilities as all other persons under the laws and Constitution of the State of California, and under the laws and the Constitution of the United States. Unless otherwise restricted by law, these rights may be exercised at will by any person with a developmental disability. These rights include, but are not limited to, the following:

(a) Access Rights.

(1) A right to treatment and habilitation services. Treatment and habilitation services shall foster the developmental potential of the person. Such services shall protect the personal liberty of the individual and shall be provided under conditions which are the least restrictive necessary to achieve the purposes of treatment.

(2) A right to dignity, privacy, and humane care.

(3) A right to participate in an appropriate program of publicly-supported education, regardless of the degree of handicap.

(4) A right to religious freedom and practice, including the right to attend services or to refuse attendance, to participate in worship or not to participate in worship.

(5) A right to prompt and appropriate medical care and treatment.

(6) A right to social interaction and participation in community activities.

(7) A right to physical exercise and recreational opportunities.

(8) A right to be free from harm, including unnecessary physical restraint, or isolation, excessive medication, abuse or neglect. Medication shall not be used as punishment, for convenience of staff, as a substitute for program, or in quantities that interfere with the treatment program.

(9) A right to be free from hazardous procedures.

(10) A right to advocacy services, as provided by law, to protect and assert the civil, legal, and service rights to which any person with a developmental disability is entitled.

(11) A right to be free from discrimination by exclusion from participation in, or denial of the benefits of, any program or activity which receives public funds solely by reason of being a person with a developmental disability.

(12) A right of access to the courts for purposes including, but not limited to the following:

(A) To protect or assert any right to which any person with a developmental disability is entitled;

(B) To question a treatment decision affecting such rights, once the administrative remedies provided by law, if any, have been exhausted;

(C) To inquire into the terms and conditions of placement in any community care or health facility, or state hospital, by way of a writ of habeas corpus, and

(D) To contest a guardianship or conservatorship, its terms, and/or the individual or entity appointed as guardian or conservator.

(b) Personal Rights. Each person with a developmental disability who has been admitted or committed to a state hospital, community care facility, or health facility shall have rights which include, but are not limited to, the following:

(1) To keep and be allowed to spend one's own money for personal and incidental needs.

(2) To keep and wear one's own clothing.

(3) To keep and use one's own personal possessions, including toilet articles.

(4) To have access to individual storage space for one's private use.

(5) To see visitors each day.

(6) To have reasonable access to telephones, both to make and receive confidential calls, and to have calls made for one upon request.

(7) To mail and receive unopened correspondence and to have ready access to letter-writing materials, including sufficient postage in the form of United States postal stamps.

(8) To refuse electroconvulsive therapy (“ECT”).

(9) To refuse behavior modification techniques which cause pain or trauma.

(10) To refuse psychosurgery. Psychosurgery means those operations currently referred to as lobotomy, psychiatric surgery, and behavioral surgery and all other forms of brain surgery if the surgery is performed for any of the following purposes:

(A) Modification or control of thoughts, feelings, actions, or behavior rather than treatment of a known and diagnosed physical disease of the brain.

(B) Modification of normal brain function or normal brain tissue in order to control thoughts, feelings, actions, or behavior.

(C) Treatment of abnormal brain function or abnormal brain tissue in order to modify thoughts, feelings, actions, or behavior when the abnormality is not an established cause for those thought, feelings, actions, or behavior.

(11) Other rights as specified by administrative regulations of any federal, state, or local agency.

(c) Rights of State Hospital Residents. In addition to all of the other rights provided for in this subchapter, each person with a developmental disability who resides in a state hospital shall be accorded the following rights:

(1) If involuntarily detained, to have access to a current and up-to-date copy of the California Welfare and Institutions Code. This right includes the right to have assistance from the Clients' Rights Advocate in the reading and understanding of the Code.

(2) To give or withhold consent for treatments and procedures, in the absence of a judicial order or other provision of law which provides for the exercise of this right to devolve to another party.

(3) To be provided with the amount of funds specified in Welfare and Institutions Code Section 4473 for personal and incidental use if, following the initial thirty (30) days of state hospital residency, the person is not receiving an amount of income for such use which is equal to or greater than the amount authorized by Section 4473.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4423, 4473, 4503 and 4504, Welfare and Institutions Code.

§50515. Use of Seclusion or Restraint, “Time Out.”

Note

(a) Seclusion. No person with a developmental disability shall be placed in seclusion. The use of “time out” procedures may be employed only under the following circumstances:

(1) State Hospital. The procedure used complies with regulations promulgated by the director pursuant to Welfare and Institutions Code Section 4505.

(2) Community Care or Health Facility. A written agreement exists between the placing regional center and the facility which complies with regulations promulgated by the director pursuant to Welfare and Institutions Code Section 4505.

(b) Restraint(s). Restraint(s) shall not be used on any person with a developmental disability unless:

(1) In a state hospital or other health facility, there is full compliance with applicable licensing regulations governing the use of restraints, and where such use does not continue for any period longer than that necessary to control the behavior for which such restraint is employed.

(2) In a community care facility, there is full compliance with the requirements of Title 22, California Administrative Code, Section 80403(f) and any other applicable licensing regulations, and where such use does not continue for any period longer than that necessary to control the behavior for which such restraint is employed.

Postural supports may only be used upon written order of a physician and may only include soft ties, seat belts, spring release trays or cloth sheeting and shall only be used to improve a client's mobility and independent functioning rather than to restrict movement.

NOTE

Authority cited: Section 11152, Government Code; Sections 4416 and 4441, Welfare and Institutions Code. Reference: Section 4502(h), Welfare and Institutions Code.

Article 3. Notification of Rights

§50520. Notification of Rights.

Note

(a) State Hospital.

(1) Posting of Rights. The rights contained in Section 50510 of this subchapter shall be prominently posted in both English and Spanish, on forms provided by the Department, in each living area serving persons with a developmental disability. The posted form shall contain the name, office location within the hospital, and phone number of the clients' rights advocate. It shall be the responsibility of the chief executive officer to assure compliance with the posting requirements of this section.

(2) Personal Notification of Rights. Within twenty-four (24) hours after entry into the hospital as a resident, annually thereafter, and at any other point in time when the client's legal status changes, each person with a developmental disability shall be personally informed and served with a printed copy of all rights in Section 50510 and shall have these rights explained in a language or modality he understands. If the resident cannot be effectively informed of such rights because of his physical or mental condition at the time such notification is otherwise due, a good faith effort having been made to inform him, notation of this fact shall be entered into the resident's treatment record at the hospital, accompanied by a description of the manner in which such notification was attempted, and signed by a third party witnessing the attempt at notification. Additionally, a copy of the rights listing provided the resident shall be signed by the resident, or his authorized representative, and placed in the resident's file at the facility.

(3) Written Notice to Representative. A written notice shall be sent to or otherwise served upon the resident's parent, guardian, conservator, or legally authorized personal representative, as applicable (e.g., if a minor, the parent or guardian; if a conservatee, the conservator; if neither, or if the resident expresses a preference for, the person designated by the resident as his personal representative, if any), at any time notification pursuant to subsection (a), (2), above, is made. This notice shall include: a copy of the rights in Section 50510 and information noting the date of the resident's most recent notification of same, as well as the name, address and phone number of the clients' rights advocate of both the hospital and the regional center which was involved in the resident's placement at the hospital, if any.

(b) Community Care or Health Facility.

(1) Posting. The rights contained in Section 50510 (a) and (b) of this subchapter shall be prominently posted in both English and Spanish on forms provided through the regional center by the department, in each community care or health facility serving any person with a developmental disability. The posted form shall contain the name, address and phone number of the clients' rights advocate of the regional center within whose service catchment area the facility is located. It shall be the responsibility of the professional person in charge of the facility to assure compliance with the posting requirement of this subsection.

(2) Personal Notification of Rights. Within twenty-four (24) hours of entry into the facility as a resident or program participant, annually thereafter, and at any other point in time that the client's legal status changes, each person with a developmental disability shall be personally informed of the rights in Section 50510 (a) and (b) and shall have these rights explained to him in a language or modality he understands. If the person cannot be effectively informed of such rights because of his physical or mental condition at the time such notification is otherwise due, a good faith effort having been made to inform him, notation of this fact shall be entered into the person's treatment record at the facility, accompanied by a description of the manner in which such notification was attempted, signed by a third party who has witnessed the attempt at notification. Additionally, a copy of the rights listing provided the resident shall be signed by the resident, or his authorized representative, and placed in the resident's file at the facility.

(3) Written Notice to Representative. A written notice shall be sent to or otherwise served upon the person's parent, guardian, conservator or legally authorized personal representative, as applicable (e.g., if a minor, the parent or guardian; if a conservatee, the conservator; if neither, or if the resident expresses a preference for, the person nominated by the client as his personal representative, if any), at the time notification pursuant to subsection (b), (2), above, is made or attempted. This notice shall include: a copy of the rights in Section 50510 (a) and (b) and information noting the date of the person's most recent notification of same, as well as the name, address and phone number of the clients' rights advocate in the regional center in whose service catchment area the facility is located.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4415, 4416 and 4503, Welfare and Institutions Code. Reference: Sections 4415, 4416, 4648(b) and (c), Welfare and Institutions Code.

Article 4. Denial of Rights

§50530. Denial of Rights.

Note

(a) Except as provided in this article, no right specified in Section 50510 shall be denied any client. In the absence of a court order, the terms of which expressly provide for limitation of a particular right to which a given client is otherwise entitled, no right contained in Section 50510 shall be denied unless there is full compliance with this article. Only those rights listed in Section 50510(b), (1) through (7), may be denied pursuant to this article.

(b) Only the professional person in charge of the facility or his designee may deny a right for good cause. The name of the professional person in charge of the facility, for the purposes of this article, shall be on file at the facility. If a designee of the professional person in charge of the facility is authorized to deny rights for good cause, a written formal designation naming the designee shall be signed by the professional person in charge of the facility and shall be on file at the facility.

(c) Good cause for the denial of any right in Section 50510 (b), (1) through (7), inclusive, exists only when the professional person in charge of the facility, or his duly authorized designee, makes an express finding that:

(1) The exercise of the specific right sought to be denied would be injurious to the individual otherwise entitled to exercise it; or

(2) There is evidence that the specific right sought to be denied if exercised by that individual, would seriously infringe on the rights of others; or

(3) The institution or facility would suffer serious damage to the physical plant if the specific right is not denied; and

(4) There is no less restrictive means of protecting the specific interest listed in (1), (2), or (3) of this subsection.

(d) The reason used to justify the denial for good cause of any right must be related to the specific right denied. A right shall not be withheld or denied as a punitive measure, nor shall any right be considered a privilege to be earned.

(e) A treatment modality, approach or plan shall not constitute good cause for the denial of any right specified in this subchapter.

(f) A right shall not continue to be denied when the good cause for its denial no longer exists. Each denial for good cause shall be reviewed at a minimum of each thirty (30) days, beginning from the first date when the denial takes place, for assessment of the continued validity of the good cause upon which the denial is predicated. Upon expiration of the good cause, any denied right shall be promptly reinstated. At each review a specific finding shall be made that the good cause for continuing the denial exists, including that it is still the least restrictive means, or the denial shall terminate.

(g) At the time any good cause denial commences, the person who is being denied any right shall be informed of the right to appeal the denial decision either by way of the complaint process established by Section 50540 of this subchapter or by way of a fair hearing as provided in Welfare and Institutions Code Sections 4700-4725. If the person is unable to comprehend such information, the notification of the right to appeal shall be made to such person's parent or guardian, if a minor, conservator, personal or legal representative.

(h) When, for good cause as defined in this section, the professional person in charge of the facility proposes to deny any right to any person who is lawfully entitled to leave the facility at will, the professional person in charge of the facility shall first advise such person or, if the person is unable to comprehend, the person's parent or guardian, if a minor, conservator, personal or legal representative, of the right to elect to leave the facility without submitting to the proposed denial or to submit to the denial but appeal its basis. In no case shall any person who is lawfully entitled to leave the facility at will have any right denied him without first being advised of this right of choice.

(i) Waiver of any right guaranteed by this subchapter must be knowing, intelligent, voluntary and made by the person to whom the right legally devolves. No waiver is valid unless it satisfies these elements, is in writing, and is approved by signature of the clients' rights advocate having responsibility for the facility. The clients' rights advocate of the regional center in whose service catchment area the facility is located is the responsible party for all community care and health facilities other than state hospitals.

NOTE

Authority cited: Section 11152, Government Code; and Section 4416, Welfare and Institutions Code. Reference: Sections 4503, 4504 and 4648(b), Welfare and Institutions Code.

§50532. Documentation of Rights Denials.

Note

(a) Each denial of a right for good cause, as provided in Section 50530 of this article, shall be noted in the facility's treatment record of the person whose right has been denied. This documentation shall take place immediately upon the denial of any right or, in the event of an emergency, in no case later than twenty-four (24) hours from the time of the denial. If an emergency does not permit immediate documentation, a Special Incident Report shall be submitted to the department setting forth the particulars of such emergency. In state hospitals, this Report shall be submitted through the clients' rights advocate. In any licensed health or community care facility, this Report shall be submitted through the clients' rights advocate for the regional center in whose service catchment area the facility is located.

(b) The treatment record notation shall be on forms provided by the department and shall include:

(1) Date and time the right was denied.

(2) Specific right denied.

(3) Specific good cause rationale of Section 50530(c) which permits denial.

(4) Name(s) of any staff member(s) involved in the denial decision.

(5) Signature of the professional person in charge of the facility, or his designee, authorizing the denial.

(6) A special incident report, to the director of the department in the event of an emergency not permitting documentation immediately upon the denial of any right.

(7) If the person appealed the denial of the right, the date of the request and the outcome, if any, of the appeal.

(c) Each denial notation shall include the dates of the thirty (30) day reviews and documentation of the continuing good cause basis for the denial of right, required by Section 50530 (c).

(d) If the person lawfully entitled to leave the facility at the time of the denial elects to remain in the facility, it shall be recorded in the treatment record that the person was informed of his rights pursuant to Section 50530 (g) and (h). The notation shall be signed by the staff member who informed the person.

(e) The restoration date of any previously denied right shall be entered in the treatment record.

NOTE

Authority cited: Section 11152, Government Code; and Section 4504, Welfare and Institutions Code. Reference: Sections 4504 and 6005, Welfare and Institutions Code; Aden v. Younger (1976) 57 C.A. 3d 662, at pps. 681-682.

§50534. Access to Denial of Rights Information.

Note

Information pertaining to any denial of rights for good cause contained in an individual's treatment record shall be made available upon request, to such individual, his attorney, his parent or guardian if the individual whose right is denied is a minor, his conservator, the clients' rights advocate, and the State Department of Developmental Services.

NOTE

Authority cited: Section 11152, Government Code; and Section 4504, Welfare and Institutions Code. Reference: Sections 4422 and 4504, Welfare and Institutions Code.

§50536. Reporting Good Cause Denials of Rights.

Note

(a) Except for state hospitals having a full-time clients' rights advocate, each facility serving regional center clients shall forward a copy of all documentation of any denial of rights for good cause required by Section 50532 (a) through (f) to the regional center in whose service catchment area the facility is located as promptly as possible, but not to exceed ten (10) days from the effective day of such denial.

(b) Upon receipt of the documentation of good cause right denial, the clients' rights advocate shall review for compliance with Section 50530 and use it as reference in the compilation of the quarterly reports required by Section 50538.

NOTE

Authority cited: Section 11152, Government Code, and Sections 4416, 4504, Welfare and Institutions Code. Reference: Section 4504, Welfare and Institutions Code.

§50538. Quarterly Reports on the Denial of Rights for Good Cause.

Note

As described in Welfare and Institutions Code Section 4504, each state hospital and each regional center shall, by the last day of each January, April, July, and October, report on forms provided by the department all of the following information concerning any good cause denial of rights which has transpired during the preceding quarter:

(a) An appropriate identification number or other code which will enable the state hospital or regional center to identify the person(s) whose rights have been denied for good cause. A different number or code shall be used for each person and such person's number or code shall remain constant on all future reporting about that person.

(b) The date that the right was denied.

(c) The specific right denied and the specific rationale of Section 50530 (c), (1) through (4), inclusive, for the denial.

(d) The date that the right was restored or, if not restored the date(s) of each thirty (30) day review conducted as required by Section 50530 (f).

State hospital reports shall provide the information by living unit. Regional centers shall submit the information by facility. The forms shall be mailed to the Director of Developmental Services.

NOTE

Authority cited: Section 11152, Government Code, and Sections 4416, 4504, Welfare and Institutions Code. Reference: Section 4504, Welfare and Institutions Code; Aden v. Younger (1976) 57 Cal. App. 3d 662, pps. 681-682.

Article 5. Complaint Procedure

§50540. Complaint Procedure.

Note • History

(a) Each client or any representative acting on behalf of any client, who believes that any right to which the client is entitled has been abused, punitively withheld, or improperly or unreasonably denied, may pursue a complaint as provided in this section.

(b) Initial referral of any complaint taken pursuant to this section shall be to the clients' rights advocate responsible for the facility in which such person is a resident or of which such person is a client.

Except for state hospitals, the responsible clients' rights advocate shall be the person assigned such duties by the regional center within whose service catchment area the facility is geographically located.

The clients' rights advocate shall, within ten working days of receiving a complaint, investigate the complaint and send a written proposed resolution to the complainant.

(c) If the complainant expresses dissatisfaction with the action taken or proposed by the clients' rights advocate, the complaint shall be referred, by the clients' rights advocate, within five (5) working days, to the director of the state hospital or of the regional center in whose service catchment area the facility is located.

(d) If the complaint is not resolved to the satisfaction of the complainant within ten (10) working days by the director of the state hospital or regional center, it shall be referred by that director to the Department of Developmental Services' clients' rights officer, whose responsibility it shall be to make a recommendation to the director of the State Department of Developmental Services for final administrative decision.

NOTE

Authority cited: Section 4503, Welfare and Institutions Code; and section 11152, Government Code. Reference: Sections 4502, 4503, Welfare and Institutions Code.

HISTORY

1. Amendment of subsections (b) and (d) and NOTE filed 2-25-92; operative 3-6-92 (Register 92, No. 12).

Article 6. Clients' Rights Advocate

§50550. Assignment of Clients' Rights Advocate.

Note

Each state hospital and regional center shall have at least one (1) staff member, or the functional equivalent thereof, who is assigned on a full-time basis to fulfill the duties of the clients' rights advocate. Such duties shall include, but not be limited to, the following:

(a) State Hospital Clients' Rights Advocate.

(1) To assure that the rights of each person with a developmental disability who resides in the hospital are guaranteed, protected and asserted as requested by or on behalf of any resident.

(2) To monitor compliance with the posting requirements and the notification of rights provisions of Section 50520.

(3) To investigate and facilitate resolution of complaints concerning any violation, withholding, or punitive denial of any right, which is brought by or on behalf of any resident.

(4) To initiate inquiry into any right's violation, withholding, or punitive denial of any right to which any hospital resident with a developmental disability is entitled where such resident is unable to do so because of physical or mental condition.

(5) To assist residents in the pursuit of administrative and legal remedies. If the complaint is against an employee, a policy, or the operations of the state hospital, the clients' rights advocate may refer the resident to an agency which can provide independent representation.

(6) To monitor and review all reports of denial of rights for good cause of any resident of the hospital, as required by Section 50536.

(7) To advise the state hospital executive officer on the development, implementation and maintenance of a clients' rights assurance program in the state hospital.

(8) To serve as a consultant and resource person on issues relative to the rights of persons with developmental disabilities for all persons within the hospital.

(9) To act as liaison between the state hospital and the Clients' Rights Office.

(b) Regional Center Clients' Rights Advocate.

(1) To assure that the rights of each developmentally disabled client served by the regional center, including applicants and individuals referred for services, are guaranteed, protected, and asserted as requested by or on behalf of the client.

(2) To monitor compliance with the posting requirements of Section 50520 (b), and the notification of rights provisions of Section 50520 in any licensed facility which serves clients of the regional center.

(3) To investigate and to facilitate resolution of all complaints involving violation, withholding or punitive denial of rights which are brought by or on behalf of any client served by the regional center.

(4) To initiate inquiry into any violation, withholding or punitive denial of any right to which a regional center client is entitled where the client is unable to do so.

(5) To assist clients in the pursuit of administrative and legal remedies. If the complaint is against an employee, a policy, or the operations of the regional center, the clients' rights advocate may refer the client to any agency which can provide representation.

(6) To advise the regional center director on the development and implementation of the regional center clients' rights assurance program.

(7) To serve as local consultant and resource person on the issue of rights for individuals with developmental disabilities to clients, families, regional center staff and other interested persons within the area served by the regional center.

(8) To act as the liaison between the regional center and the Clients' Rights Office.

(9) To review and monitor all reports concerning the denial of rights for good cause which are submitted as required by Section 50536.

NOTE

Authority cited: Section 11152, Government Code, and Sections 4415, 4416, 4503, 4504, Welfare and Institutions Code. Reference: Sections 4503, 4504, 4648(b) and (c), Welfare and Institutions Code.

Subchapter 6. Service Provider Accountability

Article 1. General Provisions

§50601. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense and words in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct.

NOTE

Authority cited: Section 4648.2, Welfare and Institutions Code. Reference: Section 4648.1, Welfare and Institutions Code.

HISTORY

1. New subchapter 6 (article 1, sections 50601-50612) filed 9-22-89; operative 10-22-89 (Register 89, No. 40). For prior history, see Register 88, No. 29.

2. Editorial correction of article heading (Register 92, No. 21).

§50602. Definitions.

Note • History

The following definitions govern the construction of sections within this subchapter unless the context requires otherwise:

(a) “Administrative Overhead Allocations” means the division of administrative overhead among the various affiliate or commonly-owned programs and/or services. Administrative overhead includes such expenses as salaries for management staff and accountants, legal fees, office space and equipment, and utility costs.

(b) “Affiliate or Commonly-Owned Organizations” means two or more programs and/or services that are owned by the same person, corporation or entity.

(c) “Auditing” means any examination of records and source documentation, pertaining to the service program and/or the provision of services to persons with developmental disabilities of any individual, group, or entity by the Department, regional center, or any authorized agency representative. This examination is conducted for purposes of determining compliance with fiscal or fiscally related program or service provisions of applicable statute, regulations, contracts, or agreements governing the service program and/or the provision of services to persons with developmental disabilities. Such examination shall include any procedures as considered necessary by the auditor under the circumstances to perform the examination.

(d) “Authorized Agency Representative” means a person authorized to act on behalf of the Department or regional center by law, by court order, or by a written statement signed by the Director of the Department or the executive director of a regional center.

(e) “Department” means the State Department of Developmental Services.

(f) “Draft Audit Report” means the written document summarizing the audit findings and recommendations that is prepared by the regional center and is forwarded to the service provider for response pursuant to Section 50606(d)(1).

(g) “Emergency Services” means those services which must be provided or purchased by a regional center in order to protect a consumer from immediate danger to his/her physical or mental health or safety.

(h) “Electronic record” means a record created, generated, sent, communicated, received, or stored by electronic means.

(i) “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with an electronic record and executed or adopted by a person with the intent to sign the electronic record.

(j) “Final Audit Report” means the written document prepared by the regional center pursuant to Section 50606(f). “Final audit report” is synonymous with “audit report” as defined in Section 50701(g).

(k) “Parent Organization” means a separate and distinct corporation or entity which operates two or more programs and/or services.

(l) “Preliminary Audit Report” means the written document prepared by the regional center and forwarded to the Department pursuant to Section 50606(e)(1) when the audit involves the review of documentation relied upon as the basis for establishing a rate of payment for a service provider. Preliminary audit reports include the following items:

(1) The regional center's draft audit report;

(2) The service provider's response to the draft audit report; and

(3) The regional center's reply to the service provider's response.

(m) “Record” means any book or document evidencing operational, financial, and service activities of a service provider or regional center pertaining to the service program and/or the provision of services to persons with developmental disabilities. Examples include books of account, general ledgers, subsidiary ledgers, check registers, canceled checks, contracts, correspondence, financial statements, internal reports, bank statements, standard cost statements, consumer files, purchase of service authorizations, and documents evidencing consumer services. All consumer records shall be treated as confidential.

(n) “Service” means the process by which the regional center, or service provider, delivers a service directed towards the alleviation of a developmental disability or toward the social, personal, physical, or economic habilitation or rehabilitation of an individual with such a disability, and consistent with the requirements set forth in Title 17, California Code of Regulations Section 56551(d) and Welfare and Institutions Code, Sections 4646.5(a)(4) and 4648(a). Such services include, but are not limited to those specified in Section 4512 of the Welfare and Institutions Code.

(o) “Service Provider” means a person, program, or any other entity, or any other person connected therewith, vendored to provide services to regional center consumers. Service providers do not include those applicants specified in Title 17, California Code of Regulations, Section 54310(d) and (e).

(p) “Service Record” means a book or document evidencing the service activities provided by a service provider or regional center.

(q) “Source Documentation” means the medium upon which evidence of a transaction is initially recorded. Examples of source documents include, but are not limited to, purchase requisitions, purchase orders, purchase of service authorizations, staffing schedules, employee hourly time reports, invoices and attendance documents for regional center consumers and all other persons provided services. Source documents are used to prepare records and reports.

(r) “Unique Consumer Identifier” means a unique number assigned to identify each regional center consumer which is used instead of the consumer name to maintain confidentiality.

(s) “Units of Service” means increments of service provided to regional center consumers which are used to charge and invoice the regional center for services provided. The increment of service is specified as hours, days or transportation mileage or any other increment of service agreed to by the Department, regional center and service provider. It is used by the Department to determine a rate of reimbursement.

(t) “Vendored” means the successful completion of the process used to determine whether an applicant meets all legal and regulatory requirements to provide service to regional center consumers. This process must be completed in order for a person, program or facility to receive payment from a regional center for services rendered a regional center consumer.

(u) “Vendoring Regional Center” means the regional center in the service catchment area in which the service provider is located, and to which a potential service provider must submit an application for vendorization. Service catchment area is defined in Section 50501(a)(18).

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4648(a), 4648.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4512(b), 4641.5, 4646.5, 4648, 4648.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (m) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL by 3-4-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (m) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of Note and History 3 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

6. Amendment of subsection (m) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

7. Amendment of subsection (m) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (m), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

10. Change without regulatory effect amending subsections (g), (k), (m), and (o)-(r) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

11. New subsections (h) and (i), subsection relettering and amendment of Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

§50603. Access to Service Provider Records.

Note • History

(a) The service provider shall permit right of access to:

(1) Any books, documents, papers, computerized data, source documents, consumer records, or other records of the service provider pertaining to the service program and/or provision of services to persons with developmental disabilities. All consumer records shall be treated as confidential.

(2) Any facilities belonging to or used by the service provider pertaining to the service program and/or the provision of services to persons with developmental disabilities.

(b) The right of access referred to in Section 50603(a) shall be applicable to the Department, regional center, or any other authorized agency representative and to the California Department of Health Services and the United States Department of Health and Human Services when federal government funds are involved in the payment for services.

(d) The right of access in this section shall be used to audit, review, examine, excerpt, reproduce, and/or make transcripts.

(e) The rights of access in this section shall not be limited to the required record retention period as specified in Section 50605(a).

(f) All service provider records, including corporate records, shall be made immediately available to persons specified in Section 50603(b) for purposes specified in Section 50603(d) above.

(g) The rights of access in this section shall not be limited by a requirement of prior notice. Access without prior notice shall be limited to situations where the Department or regional center determines that the purpose of the access would be thwarted if advance notice were given such as in the case of suspected fraud, imminent destruction of records or similar circumstances.

(h) Access to any records pertaining to any regional center consumer in the facility or to the operation of the facility, to the extent such operation pertains to the service program and/or the provision of services to persons with developmental disabilities, shall be provided upon request and in accord with confidentiality statutes.

(i) If requested by regional center staff, the service provider shall make provision for a regional center consumer to be interviewed in private. The written consent of the consumer or, where appropriate, the parent, guardian or conservator shall be obtained before the interview is conducted. A third party of the consumer's choice may be present during the interview if the consumer so desires.

NOTE

Authority cited: Sections 4405 and 4648.2, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Section 4648.1, Welfare and Institutions Code; Section 11152, Government Code; and Section 1902(a)(4) and (a)(27), Social Security Act, Title 42 CFR, Code of Federal Regulations, CFR 431.107(b).

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (b) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (b) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of Note and History 3 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

6. Editorial correction of printing error deleting duplicate section (Register 94, No. 17).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(1), (h) and (i) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§50604. Service Provider Record Maintenance Requirements.

Note • History

(a) Service providers shall maintain financial records which consistently use a single method of accounting. These financial records shall clearly reflect the nature and amounts of all costs and all income. All transactions for each month shall be entered into the financial records within 30 days after the end of that month.

(b) Subsection (a) shall apply to residential facilities for the purposes described in subsection (c), day programs, transportation companies, and other non-medical service providers which provide ongoing services to regional center consumers on a regular basis each month, except that the following service providers shall be exempt:

(1) Residential facilities in which regional center consumers represent less than ten percent of the total consumers served by the facility during the last 12 month period.

(2) Residential facilities in which regional center consumers represent more than ten percent of the total consumers served by the facility; however, no Departmental funds are received for the care and services provided to those consumers.

(c) Subsection (a) shall apply to residential facilities not exempted pursuant to subsections (b)(1) and (2) only for the following purposes:

(1) To facilitate residential cost studies performed by the Department or authorized agency representative;

(2) To ensure that staffing schedules in conformance with staffing level requirements, if any, are supported by payroll records and source documents;

(3) To ensure that revenue and cost information are available to support administrative overhead allocations of parent organizations, if applicable; and

(4) To ensure that revenue and cost information are available to support intercompany transactions with affiliate or commonly-owned organizations, if applicable.

(d) All service providers shall maintain complete service records to support all billing/invoicing for each regional center consumer in the program. This requirement may be satisfied by retaining an electronic record of the information in the record, if the record reflects accurately the information set forth in the record at the time it was first generated in its final form as an electronic record or otherwise, and the electronic record remains accessible for later reference. Service records used to support service providers' billing/invoicing shall include, but not be limited to:

(1) Information identifying each regional center consumer including the Unique Consumer Identifier and consumer name;

(2) Documentation for each consumer reflecting the dates for program entrance and exit, if applicable, as authorized by a regional center.

(3) A record of services provided to each consumer. The record shall include:

(A) For the purchase of medical equipment and/or supplies, and/or other merchandise, the date of the purchase, name of the entity/individual from whom the equipment, supplies, and/or merchandise is purchased, the item(s) purchased, and the cost of each item; or

(B) For transportation services, the dates of service, city or county where service was provided, and the number of miles driven or trips provided; or

(C) For community-based day programs, the dates of service, place where service was provided, the start and end times of service provided to the consumer, and the daily or hourly units of service provided. For community-based day program services provided solely in natural environments, the city and county where service was provided shall be reported as the place where service was provided. For community-based day programs whose services are provided at the facility only or at both the facility and in the community, the street address of the facility shall be reported as the place where service was provided; or

(D) For all other services, the date, the start and end times of service provided to the consumer, street address where service was provided, and daily or hourly units of service provided.

(E) For goods and/or services purchased utilizing a voucher or Participant-Directed Services, as described in California Code of Regulations, Title 17, Section 58884(a)(1), in addition to the information specified above, the name of the actual provider of the goods and/or services. For services provided by an individual selected by the consumer or family member, the date of birth, social security number (or a copy of any document accepted by the federal government which establishes identity and employment eligibility which has been compared to the original by the vendored family member and declared under penalty of perjury to be a true and correct copy), address, and telephone number of the individual who actually provided the service must also be maintained.

(F) For contracts reimbursed based on units of service other than as specified above, units of service shall also be maintained pursuant to (A), (B), (C), or (D) above, as applicable.

(e) All service providers' records shall be supported by source documentation.

(f) Nothing specified in this section shall be construed as superseding other record maintenance requirements set forth in statute or regulation.

NOTE

Authority cited: Sections 4631(a)(2) and 4648.12(c)(1)(B), Welfare and Institutions Code. Reference: Sections 4631, 4641.5, 4648.1 and 4648.12(c), Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (b)-(b)(2) and (d)-(d)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment of subsections (d)(2)-(3), new subsections (d)(3)(A)-(E) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (d)(2)-(3), new subsections (d)(3)(A)-(E) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsections (d)(2)-(3), new subsections (d)(3)(A)-(E) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

6. Amendment of subsection (d)(3)(D) filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (d)(3)(B), new subsection (d)(3)(C), subsection relettering and amendment of newly designated subsections (d)(3)(D) and (F), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

8. Refiling of 8-27-2004 order, including incorporation of relettering of subsection (d)(3)(D) to (d)(3)(E) in intervening action, 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 12-22-2004 order, including futher amendment of subsection (d)(3)(E), transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

10. Amendment of subsection (d)(3)(E) and Note filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

11. Amendment of subsection (d) and Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

§50605. Service Provider Record Retention Requirements.

Note • History

(a) All service providers' financial and service records, including source documentation, shall be retained for a minimum of five years from the date of final payment for the State fiscal year in which services were rendered. This requirement may be satisfied by retaining an electronic record of the information in the record, if the record reflects accurately the information set forth in the record at the time it was first generated in its final form as an electronic record or otherwise, and the electronic record remains accessible for later reference.

(b) If an audit is in progress or an appeal pursuant to Subchapter 7 (commencing with Section 50700) is pending at the end of the time specified in Section 50605(a), the service providers' records shall be retained until all audit exceptions have been resolved.

NOTE

Authority cited: Section 4648.2, Welfare and Institutions Code. Reference: Sections 4641.5 and 4648.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (a) filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (a) refiled 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 12-22-2004 order transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

5. Amendment of subsections (a) and (c) and Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

§50606. Regional Center Auditing Requirements.

Note • History

(a) To the extent that regional centers determine that it is necessary, regional centers shall audit records of service providers. Such audits shall be:

(1) Performed utilizing existing personnel resources; and

(2) Commenced within three years following the final payment for the fiscal year under audit.

(b) Audits shall be performed to accomplish any or all of the following objectives as applicable to the specific service provider:

(1) Verification that the service provider's documentation submitted to the regional center as a basis for establishing a rate of payment by the Department is:

(A) Complete, including other sources of revenue related to the service program or provision of services to persons with developmental disabilities;

(B) Accurate; and

(2) Verification that the service billings/invoices submitted by the service provider to the regional center for payment are supported by the service providers' consumer attendance and service records.

(3) Verification that the service providers' handling and accounting of the consumers' personal and incidental funds is in accordance with applicable regulations including, but not limited to, Title 17, California Code of Regulations, Sections 56557(b)(3)(G) and 56602(d), and Title 22, California Code of Regulations, Section 80026.

(4) Verification through analysis of payroll and consumer service records that staff-to-consumer ratios required by regulation, contract, or agreement are met.

(A) Verification that the required staff-to-consumer ratios are being met shall be determined as follows:

1. For activity centers, adult development centers, and behavior management programs:

a. For each month of the audit period multiply the number of actual consumer days of attendance by the number of direct service hours operated per day;

b. Divide the total computed in a. by the approved staffing ratio to compute the number of direct care staff hours required during the approved program hours each month to maintain the approved staffing ratio; and

c. Compare the number of direct care staff hours actually provided during the approved program hours for each month with the number of direct care staff hours required for each month computed pursuant to b.

2. For social recreation programs, independent living programs, and infant development programs:

a. For each month of the audit period determine the actual hours of consumer attendance for each month;

b. Divide the actual hours of attendance pursuant to a. by the approved staffing ratio to compute the number of direct care staff hours required during the approved program hours each month to maintain the approved staffing ratio; and

(B) If a determination is made that the approved staff-to-consumer ratio has not been met, the amount of any overpayments shall be determined as follows:

1. Subtract the number of direct care staff hours actually provided during the audit period from the number of direct care staff hours required pursuant to (A)1. or (A)2.;

2. Multiply the amount computed in 1. by the average hourly salary and wage and fringe benefit costs reported pursuant to Sections 57434(a)(1)(A) and (a)(2) and which were utilized to calculate the vendor's rate of reimbursement received during the audit period.

(5) Verification of compliance with other provisions of applicable statute, regulations, contracts, or agreements governing the service program and/or the provision of services to persons with developmental disabilities.

(c) If an audit of a service provider not vendored by the auditing regional center is proposed, such audit shall be coordinated with the vendoring regional center. If the service provider has already been audited for the same time period, the auditing regional center shall rely, to the extent possible, on the work performed by the vendoring regional center.

(d) Upon completion of an audit, the regional center shall process the audit findings and/or recommendations defined in Title 17, California Code of Regulations, Section 50701, as follows:

(1) A draft of the audit report shall be forwarded to the service provider for comment within sixty (60) days of completion of work performed at the service provider's location.

(2) The service provider shall be given thirty (30) days in which to respond to the audit report draft from time of its receipt.

(e) If an audit of a service provider involves review of documentation submitted to either the regional center or the Department and relied upon as the basis for establishing a rate of payment for that service provider, the regional center shall forward its preliminary audit report to the Department.

(1) The preliminary audit report shall include the service providers' response to the audit findings and/or recommendations as an attachment.

(2) The preliminary audit report shall include the regional center's reply to the providers' response as an attachment.

(3) The Department shall consider the preliminary audit report in establishing a rate. If an adjustment to the rate is proposed:

(A) The effective date of the adjusted rate of payment shall be determined by the Department based on information contained in the preliminary audit report and supporting audit working papers.

(B) The adjusted rate of payment shall be calculated and submitted by the Department to the regional center for use in determining any amounts which may be due from or due to the service provider.

(4) The Department shall notify the regional center if it is determined that an adjustment to the rate of payment is not necessary after considering the preliminary audit report.

(f) The final audit report shall be issued by the regional center, within 90 days of the deadline for the service provider's response.

(1) The final report shall notify the service provider of its right to appeal the audit findings pursuant to Title 17, California Code of Regulations, Section 50730.

(2) The final report shall incorporate the response of the service provider and the regional center's reply to the response.

(3) A copy of the rate letter issued by the Department adjusting the rate of payment shall be enclosed with the final report, if applicable.

(4) The final report shall include a breakdown of any amounts due the regional center and Department by fiscal year and require remittance in accordance with Section 50705. If an amount is due the service provider, the final report shall include a breakdown of any amounts due by State fiscal year. Procedures for requesting payment of the amount due from the regional center shall also be included.

(5) When a remittance pursuant to subsection (4) is made, a copy of the check and any transmittal document shall be sent to the Department.

(6) Upon issuance, a copy of the final report shall be sent to the Department.

(g) The auditing work performed by the regional center shall, to the maximum extent that the auditor determines practicable, follow the standards for financial and compliance audits, as listed in the “Standards for Audit of Governmental Organizations, Programs, Activities and Functions,” 1981 Revision, sued by the Comptroller General of the United States, United States General Accounting Office, which is incorporated by reference herein.

(1) The auditing work performed by the regional center shall, at a minimum, meet the following standards:

(A) In all matters relating to the audit work, the regional center staff involved shall be free from conflicts of interest as defined in Title 17, California Code of Regulations, Section 54521, and in Section 4627 of the Welfare and Institutions Code.

(B) Due professional care shall be used in conducting the audit and in preparing related reports.

(C) When factors external to the audit organization and the auditor restrict the audit or interfere with the auditor's ability to form objective opinions and conclusions, the auditor shall attempt to remove the limitation or, failing that, disclose the limitation in the audit report.

(D) A review shall be made of compliance with applicable statutes and regulations governing the service program and/or the provision of services to persons with developmental disabilities.

(E) A written record of the auditor's work shall be retained in the form of working papers.

(F) Final audit reports shall be submitted to the appropriate officials of the organization audited and to the appropriate officials of the regional center and the Department. Copies of the reports shall also be:

1. Sent to the other officials who may be responsible for taking action and to others authorized to receive such reports.

2. Made available for public inspection, unless restricted by law or regulations; and

3. Accompanied by a transmittal document which specifies that the report is subject to appeal and includes the status of any such appeal.

(G) For purposes of subsection (F) “other officials” and “others” authorized to receive such reports include, but shall not be limited to, those designated by law or regulation to receive such reports, legislators, and those of other levels of government that have provided funds to the audited entity.

(h) The reports specified in this section shall be written reports.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631, 4648.2, 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4629(f), 4631, 4648.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. New subsections (b)(4)(A)-(B)2 filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§50607. Regional Center Contracting Requirements.

Note • History

When a regional center enters into a contract with a service provider, the contract shall include, but not be limited to, the following general provisions.

(a) Contract provisions stating the parties, the general purpose, the services to be provided, the date of execution, and the applicable statutes and regulations applying to the contract.

(b) A contract provision requiring a signature by authorized representatives of all contracting parties. An electronic signature shall satisfy this requirement.

(d) Contract provisions to include the definitions of terms unique to the contract or contracted service.

(e) A contract provision stating that the execution of any amendment or modification to the regional center/service provider contract shall comply with the requirements of applicable statutes and regulations.

(f) A provision stating that the service provider and the agents and employees of the service provider, in the performance of the contract, shall act in an independent capacity, and not as officers or employees or agents of the State of California or the regional center.

(g) A provision stating that assignment of the contract for consumer services shall not be allowed.

(h) A contract provision indicating that all services shall be rendered in accordance with specifically identified provisions of statute, and Federal and State regulations.

(i) A contract provision stating that the terms of the contract shall not be construed to excuse compliance with existing statutes or regulations.

(j) A contract provision stating that subcontracting of services for which the service provider is vendored shall not be permitted except for contracts for transportation services or community-based day program services pursuant to Title 17, California Code of Regulations, Section 56710(b).

NOTE

Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4629(f), 4631, 4641.5, 4648.1, 4690.1 and 4691, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (k) filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

3. Repealer of subsection (h) and relettering, amendment of subsection (j) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Repealer of subsection (h) and relettering, amendment of subsection (j) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of Note and History 4 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (g) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsection (b) and Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

§50608. Contract Duties and Responsibilities.

Note • History

When a regional center enters into a contract with a service provider, the contract shall include, but not be limited to, the following provisions specifying the duties and responsibilities of the service provider.

(a) A contract provision requiring that the level of service provided shall, at a minimum, be consistent with the service provider's program design, if applicable, and any other program related documentation relied upon by the Department as a basis for establishing rates of payment.

(1) The service provider's program design shall be made a part of the contract.

(2) The service provider's program design shall include, but not be limited to:

(A) A written statement of the facility's purpose and goals;

(B) A description of the services provided;

(D) Consumer entrance and exit criteria;

(E) Job descriptions of all positions;

(F) Staff qualifications for each job description;

(G) A staffing plan which indicates the staff-to-consumer ratio for delivery of direct care services for all hours the consumers are under the supervision of the facility;

(H) A staff training plan, if any; and

(I) Hours and location of service.

(b) A contract provision requiring the service provider to maintain books, records, documents and other evidence pertaining to all income, expenses, and services relating to and/or affecting the performance of the contract.

(c) A contract provision requiring the service provider to maintain service records to support all billings/invoicing as specified in Section 50604(d)(1) through (3)(F), as applicable.

(d) A contract provision requiring the service provider to submit to the regional center with their billings/invoices the information specified in (c) above for the billing period.

(e) A contract provision requiring the service provider to adopt and periodically review, a written internal procedure to resolve consumer grievances pursuant to Welfare and Institutions Code Section 4705.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4631 and 4648.2, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4525, 4629(f), 4631 and 4648.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40.)

2. Amendment of Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

3. Change without regulatory effect amending subsections (a)(2)(D), (a)(2)(G) and (c) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. New subsections (c)-(d), subsection relettering and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

5. New subsections (c)-(d), subsection relettering and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

6. New subsections (c)-(d), subsection relettering and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (c), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§50609. Contract Fiscal Provisions.

Note • History

The regional center/service provider contract shall include, but not be limited to, the following fiscal or fiscally related provisions:

(a) Provisions specifying details for the payment of services rendered including, but not limited to:

(1) The method of payment;

(2) The time of payment;

(3) a requirement that the rate of payment, in accordance with referenced contract exhibits, contains one of the following:

(A) An exhibit displaying Departmental or regional center documentation reflecting the proposed rate of payment per unit of service; the definition of a unit of service; and the necessary data and mathematical computation used to establish the proposed rate of payment per unit of service.

(B) An exhibit displaying Departmental documentation reflecting the various ranges of proposed rates of payment for residential care services and other applicable services subject to such maximum limitations.

(4) A detailed description of the method to be used in determining the units of service allowed for billing/invoicing in accordance with the referenced contract exhibits required under Section 50609(a)(3).

(b) A provision specifying the basis used by the Department to establish the rate of payment for services.

(1) A provision identifying a contract exhibit which shall contain the service provider's fiscal and program related documentation relied upon as the basis for establishing the rate of payment.

(A) A provision indicating that both parties to the contract have come to a full understanding and agreement of a specified method used to accumulate data contained in the service provider's documentation.

1. A provision indicating that the service provider attests that the method referred to in Section 50609(b)(1)(A) was used to accumulate data contained in the service provider's documentation.

(B) A provision indicating that the service provider attests that such fiscal and program related documentation is:

1. complete;

2. accurate to the best of the service provider's knowledge;

3. supported by records and source documentation;

4. prepared in accordance with the instructions provided by the Department and;

5. subject to audit.

(d) A provision specifying that the consideration to be paid the service provider, as provided herein, shall be the total compensation for performance of the contract and its requirements, unless otherwise expressly provided.

(e) When Federal Government funds are involved, a provision requiring service provider compliance with all Federal rules including, but not limited to the applicable sections of the Code of Federal Regulations.

(f) A provision specifying the maximum amount which can be paid under this contract.

NOTE

Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Section 4629(f), 4631 and 4648.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

§50610. Contract Fiscal Audit.

Note • History

(a) The regional center/service provider contract shall include, but not be limited to, audit provisions as follows:

(1) A provision that the service provider's records pertaining to the service program and/or the provision of services to persons with developmental disabilities shall be open for audit by the Department, regional center, and any authorized agency representative for a minimum period of three years from the date of the final payment for the State fiscal year.

(2) A provision indicating that the service provider shall agree to utilize and be bound by Title 17, California Code of Regulations, Sections 50700, et seq. should the service provider elect to appeal any audit findings and/or recommendations.

(3) A provision indicating that the service provider shall accept financial liability for any audit findings and/or recommendations disclosed by audit and promptly repay amounts owed unless appealed and liquidation is stayed pursuant to Title 17, California Code of Regulations, Section 50705.

NOTE

Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions Code and Section 11152, Government Code. Reference: Sections 4629(f), 4631 and 4648.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

§50611. Contract Termination.

Note • History

(a) The regional center/service provider contract shall contain the requirements for the termination of the contract.

(b) The provision for contract termination by the regional center shall include:

(1) The methods by which termination will be effected;

(2) The basis for settlement; and

(3) A description of the conditions which shall constitute possible grounds for termination of the contract and/or payment. Such conditions shall include, but not be limited to, those in which it is determined that:

(A) The service provider has not complied with provisions of its contract, the terms of the purchase of service authorization, applicable Federal and State regulations, or statutes governing the service program and/or the provision of services to persons with developmental disabilities.

(4) The Department, regional center, or any authorized representative shall determine whether the conditions, specified in Section 50611(b)(3) above, exist to constitute possible grounds for contract termination. Such determination shall be:

(A) Conveyed to the service provider 30 days in advance of payment and/or contract termination, pursuant to Welfare and Institutions Code, Section 4710.

(B) In the form of a notice containing the provisions for contract termination specified in subsections (b)(1) through (3).

(1) A requirement that notice be given to the regional center in writing; and

(2) A requirement that notice be given at least 30 days prior to contract termination.

(d) In no event, shall a regional center or service provider terminate a contract without complying with the requirements set forth in statute and regulation including, but not limited to, Welfare and Institutions Code, Sections 4502, 4646, 4646.3, 4648, 4710, and 4741.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631, 4648.2 and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4502, 4629(f), 4631, 4646.5, 4648.1 and 4741, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§50612. Regional Center Purchase of Service Requirements.

Note • History

(a) A purchase of service authorization shall be obtained from the regional center for all services purchased out of center funds. This requirement may be satisfied if the information is provided, sent, or delivered, as the case may be, in an electronic record capable of retention by the recipient at the time of receipt.

(b) The authorization shall be in advance of the provision of service, except as follows:

(1) A retroactive authorization shall be allowed for emergency services if services are rendered by a vendored service provider:

(A) At a time when authorized personnel of the regional center cannot be reached by the service provider either by telephone or in person (e.g., during the night or on weekends or holidays);

(B) Where the service provider, consumer, or the consumer's parent, guardian or conservator, notifies the regional center within five working days following the provision of service; and

(1) The authorization shall be in writing, except as follows:

(A) A verbal authorization by the regional center director or his authorized agency representative shall be allowed to provide emergency services utilizing the following procedures:

1. An immediate notation is made in the case record showing the date and nature of such authorization; and

2. The verbal authorization is confirmed with a written authorization from the regional center as soon as possible, but no later than the regional center's next cyclical production of purchase of service authorization documents.

(d) All authorizations which are not self-limiting in nature shall be cancelled in writing at the time a consumer case is closed by the regional center.

(e) The regional center purchase of service authorization shall contain the requirements for terminating payments to service providers. The provision for termination shall be consistent with the requirements set forth in Sections 4710, 4715, and 4741, Welfare and Institutions Code.

(1) The circumstances for terminating payments by the regional center shall include:

(A) The relocation of the consumer as a result of consumer or, where appropriate, the parent, guardian or conservator dissatisfaction;

(B) The relocation of a facility resident as a result of the determination of immediate danger or reasonable cause as defined in Title 17, California Code of Regulations, Section 56551(j) and (p); or

(2) In no event, shall a regional center terminate payments to service providers without complying with the requirements set forth in statute and regulation including, but not limited to, Welfare and Institutions Code, Sections 4648, 4710 and 4715.

(f) A copy of the purchase of service authorization shall be retained by the regional center. This requirement may be satisfied by retaining an electronic record of the information in the record, if the record reflects accurately the information set forth in the record at the time it was first generated in its final form as an electronic record or otherwise, and the electronic record remains accessible for later reference.

NOTE

Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4629(f), 4631, 4641.5 and 4648.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (b)(1)(B), (d), (e)(1)(A) and (e)(1)(C) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment of subsections (a) and (f) and Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

Subchapter 7. Fiscal Audit Appeals

Article 1. General

§50700. Purpose and Scope.

Note • History

The procedures described in this subchapter shall be applicable to and govern all appeals from audit reports, Letters of Findings and formal decisions issued by the Department of Development Services or regional centers which result from fiscal audits of regional centers and/or their contractors conducted pursuant to Welfare and Institutions Code, Sections 4648.2 and 4780.5. Additionally, the procedures described herein may be used to appeal other fiscal audits conducted by the Department if provided for by way of regulation or agreement.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4631, 4635, 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. New Chapter 4, Subchapter 6 (Articles 1-3, Sections 50600-50667, not consecutive) filed 6-26-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Editorial redesignation of former Chapter 4 (Subchapters 5 and 6, Sections 50500-50667, not consecutive) to Chapter 1 (Subchapters 5 and 6, Sections 50500-50667, not consecutive) filed 9-28-83 (Register 83, No. 40)

3. Renumbering of former Subchapter 6 to Subchapter 7, and renumbering and amendment of former Section 50600 to Section 50700 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50701. Definitions.

Note • History

The following definitions govern the construction of sections within this subchapter unless the context otherwise requires:

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. “May” means permissive. “Shall” means mandatory. “Should” means suggested or recommended.

(a) “Administrative review” means the preliminary investigation of the “Statement of Disputed Issues” submitted by an appellant as a part of its initial appeal. The investigation shall be conducted by an appeals review officer of the Department and may include, but not be limited to, the following:

(1) A review of all documents submitted by the parties;

(2) An interview of the parties and any prospective witnesses;

(3) An on-site inspection of records;

(4) An informal conference.

(b) “Appellant” means any individual, entity or organization which is in the process or has properly filed an appeal in accordance with the provisions of this subchapter. An appellant may act through any duly authorized agent or legal counsel designated pursuant to subsection (c) of Section 50730.

(c) “Appeal” means a written notification to the Department by any individual, entity or organization audited by the Department or regional center which disputes or protests a written report, finding or decision issued by the Department or regional center relating to such audit.

(d) “Appeals review officer” means an individual designated by the Department to conduct the administrative review.

(e) An “audit adjustment” means a finding contained in an audit report that either the fiscal requirements governing the individual, entity or organization audited have not been complied with to a specified extent or that a previously reported or claimed amount does not agree with an audited amount.

(f) An “audit exception” means a type of audit adjustment or management comment which is against the interests of the individual, entity or organization audited.

(g) An “audit report” means a document issued by the Department or regional center which results from a fiscal examination of the accounts, records and transactions of any individual, entity or organization subject to audit by the Department or regional center. The audit report may contain findings, such as audit exceptions, audit adjustments or management comments, as well as management recommendations, schedules and any other items of explanation necessary to provide an analysis of the fiscal activities for the period covered by the audit.

(h) “Date of mailing” means the date postmarked on the envelope if postage was prepaid and the envelope was properly addressed.

(i) “Days” means calendar days.

(j) “Department” means the State Department of Development Services unless otherwise specified. The Department shall act through its authorized representatives.

(k) “Director” means the Director of the State Department of Development Services.

(l) “Duplicate” means a facsimile of the original produced by the same impression or from the same matrix as the original or by some other technique of accurate reproduction.

(m) A “finding” means a relevant, written conclusion arrived at as a result of an audit, an administrative review or hearing and is contained in the audit workpapers, audit report, Letter of Findings, or decision related to the audit in question.

(n) “Formal hearing” means an administrative hearing conducted by a hearing officer pursuant to Welfare and Institutions Code Section 4648.2, 4780.5 and the provisions of this subchapter.

(o) “Hearing officer” means a person appointed by the Director pursuant to Welfare and Institutions Code Sections 4648.2 and 4780.5 to conduct formal hearings under this subchapter.

(p) “Informal conference” means a meeting conducted by an appeals review officer as a part of the administrative review to clarify or resolve facts and issues in dispute.

(q) A “management comment” means a finding contained in an audit report describing management practices of the individual, entity or organization audited as such practices relate to its fiscal activities.

(r) A “management recommendation” means a corrective action proposed by the Department or regional center to enable the individual, entity or organization audited to better comply with appropriate fiscal requirements.

(s) “Party” means an appellant, regional center or the Department. “Party also means an individual, entity, or organization joined to an appeal as an additional party pursuant to subsection (b) of Section 50708.” The term “party” does not include the appeals review officer, the hearing officer, the Director, or any witnesses.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50601 to Section 50701 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of Note (Register 2002, No. 46).

§50702. Revised Audit Report.

Note • History

(a) A revised audit report may be issued by or on behalf of the Department or regional center for the fiscal period or periods for which proceedings are pending under this subchapter.

(b) The appeals review officer or hearing officer may suspend their respective proceedings until identification of any additional disputes that may result from a revised audit report.

(c) Additional issues in dispute which are raised by the revised audit report may be included in the proceedings at the request of the appellant in accordance with Section 50730.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4631, 4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50602 to Section 50702 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of of subsection (c) (Register 2002, No. 46).

§50703. Department Mailings.

Note • History

A mailing by the Department shall be deemed to have been properly executed if addressed and mailed to the last address on record with the Department.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50603 to Section 50703 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50704. Disqualification of Appeals Review Officer or Hearing Officer.

Note • History

(a) An appeals review officer or hearing officer shall upon his/her own motion withdraw from any proceedings in which he/she:

(1) Cannot give a fair or impartial hearing;

(2) Has a personal or pecuniary interest.

(b) A party may request the disqualification of an appeals review officer or hearing officer by filing an affidavit prior to the taking of evidence at a hearing, stating with particularity the grounds upon which it is claimed that a fair and impartial hearing cannot be accorded. The issue shall be determined by the appeals review officer or the hearing officer.

NOTE

Authority cited: Sections 11152, and 11512, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11181 and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50604 to Section 50704 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50705. Recovery of Overpayments.

Note • History

(a) Where the Department, as a result of an audit, establishes that an overpayment has been made to an individual, entity or organization, the Department shall begin liquidation of the overpayment 30 days after the issuance of the audit report, except that:

(1) Where the appellant has requested an administrative review pursuant to Section 50730 of this subchapter, liquidation of the disputed overpayments shall be deferred until the Letter of Findings has become final;

(2) If any overpayments remain in dispute after the administrative review, the appellant may file with the hearing officer, a request for stay of liquidation pending the outcome of the formal hearing. To be considered, such request shall be in writing, and shall be submitted with the request for formal hearing pursuant to Section 50750. Such request for stay must set forth reasons why liquidation should be stayed for the duration of the formal hearing process. The hearing officer may in his/her discretion, make such orders as he/she deems necessary pursuant to such request, including, but not limited to, a temporary stay of liquidation.

(b) When the overpayment is due and owing, it shall be recovered by any of the following methods:

(1) Lump sum payment;

(2) Offset against current payments due;

(3) A repayment agreement of not more than five years duration from the date the agreement is made;

(4) Any other method of recovery available to and deemed appropriate by the Director.

(1) The overpayment is recovered;

(2) The Department and/or the regional center enters into a repayment agreement which satisfies such overpayment;

(3) The Department determines that, as a result of proceedings under this subchapter, there is no overpayment.

(d) The regional center shall promptly remit all recoveries to the Department along with the information necessary to identify the causal audit report, the applicable fiscal year and the applicable audit adjustment.

(e) Nothing in this section shall prohibit an individual, entity or organization audited by the Department or regional center from repaying all or a part of the disputed overpayment without prejudice to its right to a hearing under this subchapter.

(f) Any recovered overpayment that is subsequently determined to have been erroneously collected shall be promptly refunded to the appellant.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.1, 4648.2, and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4635, 4648.1, and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50605 to Section 50705 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50706. Costs and Attorneys Fees.

Note • History

(a) Except as otherwise expressly provided in this subchapter, the Department:

(1) Shall assume all expenses related to the operation and maintenance of the appeal process;

(2) Shall not reimburse under the provisions of this subchapter an appellant's expenses or costs incident to prosecuting an appeal.

(b) No party shall be liable to any other party for attorneys fees which result from proceedings under this subchapter.

(c) The Department shall not be liable to, nor reimburse, either through any contract, entered into after the effective date of this section, or by any other means, for the following expenses which may result from proceedings under this subchapter, except as ordered by the Director in the decision:

(1) Attorney fees;

(2) Costs incurred or assessed pursuant to the following sections:

(A) 50753 (g);

(B) 50754 (e);

(D) 50755 (c);

(E) 50758 (m);

(3) Any other special costs duly assessed against a party by the appeals review officer or hearing officer in accordance with such other powers as may be granted herein.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1, and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50606 to Section 50706 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50707. Consolidation of Appeals.

Note • History

(a) Parties may seek consolidation of two or more requests for administrative review or formal hearing which are pending on appeal, for the reduction of effort and expense of separate appeals, where the issues stated and evidence cover much the same ground and can advantageously be combined in one appeal. Such request shall be in writing and may be made if:

(1) An appellant has consecutive or multiple appeals, or two or more appellants have concurrent appeals;

(2) The appeals involved common questions of law or fact; and

(3) No substantial right of any party will be prejudiced.

(b) Upon such request, the appeals review officer or hearing officer may order a joint review or hearing of any or all matters in issue in the appeals, may order all the appeals consolidated, or may make such orders concerning the proceedings as may tend to avoid unnecessary delay. In exercising his/her discretion, the appeals review officer or hearing officer may refer to appropriate principles of California law governing consolidations of actions and/or class actions. The appeals review officer or hearing officer shall provide adequate notice to the parties of any requests for consolidation or orders resulting therefrom which may affect them.

(d) The appeals review officer or hearing officer may issue a single Letter of Findings or decision for the matters decided as a result of a consolidated administrative review or hearing.

(e) The appeals review officer or hearing officer may, for good cause, sever appeals previously consolidated.

(f) The appeals review officer's order granting or denying a request for consolidation is appealable immediately. The grounds for appeal shall be limited to abuse of discretion.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1, and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50607 to Section 50707 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50708. Additional Parties.

Note • History

(a) Appellants may submit a joint appeal where the issues involve the same transaction or series of transactions and there is a common question of law or fact; or where the appellants are each asserting claims to a particular amount in controversy, which are adverse to the Department or regional center. It is not necessary that each appellant be interested as to every issue presented in the joint appeal.

(b) The appeals review officer or hearing officer may, on his/her own motion, or upon the written request of a party, order the joinder of an individual, organization, or entity not a party to the appeal whenever it appears necessary to avoid injury to absent persons, to bring a real party in interest into the proceedings, or to otherwise obtain a complete settlement of a controversy in one appeal.

(c) The appeals review officer or hearing officer shall furnish adequate notice to all parties of joint appeals or orders for joinder, and shall provide for proper service of process on persons to be joined in the proceedings.

(d) The appeals review officer or hearing officer may make such orders concerning additional parties as he/she deems necessary in his/her discretion, including, but not limited to the following:

(1) Granting continuances and holding additional conferences or hearing to accommodate an additional party;

(2) Finding for one or more of the appellants according to their respective rights to relief, or resolving conflicting claims between appellants;

(3) Ordering severance of appeals or parties previously joined; or

(4) Issuing a single Letter of Findings or decision for matters decided as a result of a merged administrative review or hearing.

(e) In exercising his/her discretion, the appeals review officer or hearing officer may utilize appropriate principles of California law governing third party practice.

(f) The appeals review officer's order granting or denying a request for joinder is appealable immediately. The grounds for appeal shall be limited to abuse of discretion.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50608 to Section 50708 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of Note (Register 2002, No. 46).

Article 2. Administrative Review

§50730. Request for Administrative Review.

Note • History

(a) An individual, entity, or organization which disagrees with any portion or aspect of an audit report issued by the Department or regional center may request an administrative review. The appellant's written request shall be submitted to the Department within 30 days after the receipt of the audit report. The request may be amended at any time during the 30-day period.

(b) If the appellant does not submit the written request within the 30-day period, the appeals review officer shall deny such request, and all audit exceptions or findings in the report shall be deemed final unless the appellant establishes good cause for late filing.

(c) The request shall be known as a “Statement of Disputed Issues.” It shall be in writing, signed by the appellant or his/her authorized agent, and shall state the address of the appellant and of the agent, if any agent has been designated. An appellant shall specify the name and address of the individual authorized on behalf of the appellant to receive any and all documents, including the final decision of the Director, relating to proceedings conducted pursuant to this subchapter. The Statement of Disputed Issues need not be formal, but it shall be both complete and specific as to each audit exception or finding being protested. In addition, it shall set forth all of the appellant's contentions as to those exceptions or findings, and the estimated dollar amount of each exception or finding being appealed.

(d) If the appeals review officer determines that a Statement of Disputed Issues fails to state the grounds upon which objections to the audit report are based, with sufficient completeness and specificity for full resolution of the issues presented, he/she shall notify the appellant, in writing, that it does not comply with the requirements of this subchapter.

(e) The appellant has 15 days after the date of mailing of such notice within which to file an amended Statement of Disputed Issues. If the appellant does not amend his/her appeal to correct the stated deficiencies within the time permitted, all audit exceptions or findings affected shall be dismissed from the appeal, unless good cause is shown for the noncompliance.

(f) The appellant shall attach to the Statement of Disputed Issues all documents which he/she intends to introduce into evidence in support of stated contentions. An appellant that is unable to locate, prepare, or compile such documents within the appeal period specified in Subsection (a) above, shall include a statement to this effect in the Statement of Disputed Issues. The appellant shall have an additional 30 days after the expiration of the initial 30-day period in which to submit the documents. Documents that are not submitted within this period shall not be accepted into evidence at any stage of the appeal process unless good cause is shown for the failure to present the documents within the prescribed period.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4631, 4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50630 to Section 50730 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50731. Informal Conference.

Note • History

(a) The appeals review officer may schedule and preside at an informal conference if he/she determines that it is appropriate as part of the administrative review process. The appeals review officer shall determine the time and place of an informal conference giving due consideration to the reasonable request of a party.

(b) Written notice of the time and place of the informal conference shall be mailed to each party at least 30 days before the date of the informal conference. This period may be shortened with the consent of all parties. Any party may waive notice.

(c) Efforts shall be made to resolve the facts and issues in dispute in a fair and reasonable manner, subject to the requirements of state and federal law. Matters in dispute, raised in the appellant's Statement of Disputed Issues pursuant to Section 50730, which are not discussed or raised at the informal conference shall not be deemed waived.

(d) The Department shall make an electronic record of the proceedings.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. References: Sections 4629, 4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50631 to Section 50731 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50732. Letter of Findings.

Note • History

The results of the administrative review shall be submitted to the parties, within 60 days after the close of the administrative review record, in the form of a written document entitled “Letter of Findings.” The Letter of Findings shall be final unless a timely request for a formal hearing is made. Upon becoming final, the Letter of Findings has the legal effect of amending the audit report and supersedes it to the extent there are any inconsistencies.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. References: Sections 4635, 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50632 to Section 50732 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

Article 3. Formal Hearing

§50750. Request for Formal Hearing.

Note • History

(a) Upon receipt of the Letter of Findings following the administrative review, a party may appeal for a formal hearing conducted by a hearing officer.

(b) The requirements made applicable to requests for administrative review by Section 50730 shall apply to requests for formal hearing submitted pursuant to this section.

(c) A party shall have 30 days following the receipt of the Letter of Findings within which to file a request for formal hearing with the Department representative identified in the Letter of Findings. The party shall simultaneously submit a copy of such request to each other party. The request shall be deemed filed on the date mailed to the Department.

(d) Within 30 days after receipt of the copy of the request for formal hearing, each such other party shall submit a position statement. The position statement shall set forth the validity of each audit exception or finding in dispute.

(e) A request for formal hearing filed after the time permitted in subsection (c) above, shall be denied by the hearing officer unless the party shows good cause for late filing.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. References: Sections 4629, 4631, 4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50650 to Section 50750 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50751. Time and Place of Formal Hearing.

Note • History

(a) The hearing officer shall determine the time and place of a formal hearing. It shall be held in one of the following counties:

(1) San Francisco if the appellant resides within the First Judicial Appellate District, as defined in California Rules of Court. Appendix--Division III, Section 3;

(2) Los Angeles if the appellant resides within the Second or Fourth Judicial Appellate District, as defined in California Rules of Court. Appendix--Division III, Section 3; or

(3) Sacramento if the appellant resides within the Third or Fifth Judicial Appellate District, as defined in California Rules of Court. Appendix--Division III, Section 3.

(b) The hearing officer may schedule the formal hearing to be held in a location other than the one described in subsection (a) above, if he/she determines that it is necessary for the convenience of the parties and in the interests of justice.

(c) Except as provided in Section 50760, the hearing officer shall give written notice to the parties of the time and place of the formal hearing not less than 30 days prior to such date. This period may be shortened with the consent of all parties. Any party may waive notice.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2, and 4780.5, Welfare and Institutions Code. References: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50651 to Section 50751 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50752. Severance of Issues.

Note • History

(a) The hearing officer, upon his/her own motion, or upon the motion of any party, may hear any particular issue or issues before hearing any other issue in the proceeding, if the hearing officers finds that the resolution of the particular issue or issues could abate further proceedings.

(b) A proposed interlocutory decision on a separately heard issue may be prepared by the hearing officer and adopted by the Director as the final decision on the specified issued,

(c) Hearing on any remaining issues presented by the appellant's request for formal hearing may be postponed until the interlocutory decision has been issued.

NOTE

Authority cited: Sections 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. References: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50652 to Section 50752 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of Note (Register 2002, No. 46).

§50753. Discovery.

Note • History

(a) A party, after filing a request for a formal hearing, may make a written demand for information to an opposing party. The party receiving such demand must comply within 30 days after its mailing, provided that the 30th day precedes the hearing date and the demand is entitled to:

(1) Obtain the names and addresses of witnesses to the extent known to the other party, including, but not limited to, those intended to be called to testify at the formal hearing;

(2) Inspect and make a copy of any of the following in the possession or custody or under the control of the other party:

(A) Statements pertaining to the subject matter of the proceeding made by any party to another party or person;

(B) Statements of witnesses then proposed to be called by the party and of other persons having personal knowledge of the acts, omissions or events which are the basis for disputed audit findings, not included in Subsection (2) (A) above;

(C) All writings, including, but not limited to, audit work papers, client records, medical records, and invoices or things which the party then proposes to offer into evidence;

(D) Other real or documentary evidence which is relevant and ordinarily admissible in administrative proceedings.

(b) Any records received pursuant to a demand for information under this section which contains client identifying information shall be maintained as confidential information.

(c) For the purpose of this section, “statements” includes written statements by persons, signed or otherwise authenticated by such persons, stenographic, mechanical, electrical or other recordings, or transcripts thereof, or oral statements by persons, and written reports of summaries of such oral statements.

(d) Nothing in this section shall authorize the inspection or copying of any writing or thing which is privileged from disclosure by law or otherwise made confidential or protected as the attorney's work product.

(e) Any denial of discovery shall be in writing and shall be accompanied by a written statement describing the specific reasons for denial as to each item of discovery denied. Such a denial shall be mailed within 30 days after the date of filing the request for discovery.

(f) Any party claiming his/her demand for discovery, pursuant to this section, has not been complied with, may serve upon the nonresponsive party and file with the hearing officer a verified petition to compel discovery. The petition shall set forth the facts showing that the nonresponsive party failed or refused to comply, a description of matter sought to be discovered, the reason or reasons why such matter is discoverable under this section, and ground or grounds of the nonresponsive party's refusal so far as known to the petitioner.

(g) The petition shall be served and filed within 15 days after the nonresponsive party first evidenced his/her failure or refusal to comply with this section, or within 30 days after the demand was made and the party has failed to reply to the demand whichever period is longer. If, from a reading of the petition, the hearing officer is satisfied that the petition sets forth good cause for relief, the hearing officer shall issue a subpoena duces tecum directed at the nonresponsive party requiring him/her to comply within 15 days after the issuance of the subpoena; otherwise, the hearing officer shall issue a written denial. The subpoena duces tecum shall be served upon the nonresponsive party by personal delivery or certified mail. Further proceedings shall be in accordance with Subsection 50754.

(h) Parties requesting discovery pursuant to this section shall be liable for all actual and reasonable costs arising therefrom, except that where a demand is contested, the losing party shall be responsible for all actual and reasonable costs arising from such contest.

(i) The provisions of this section provide the exclusive right to and the method of discovery as to any proceeding governed by this article.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, 11182, 11184, and 11189, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50653 to Section 50753 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Change without regulatory effect amending subsection (g) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§50754. Subpoenas and Witnesses.

Note • History

(a) The hearing officer is authorized to issue subpoenas and subpoenas duces tecum before the formal hearing, for attendance of witnesses or production of documents at the formal hearing, as necessary or at the request of any party. The hearing officer may also issue subpoenas and subpoenas duces tecum after the formal hearing has commenced. Compliance with the provisions of Section 1985, California Code of Civil Procedure shall be a condition precedent to the issuance of a subpoena duces tecum.

(b) The process issued pursuant to subsection (a) above, shall be extended to all parts of the State and shall be served in accordance with the provisions of Sections 1987 and 1988, California Code of Civil Procedure. No witness shall be obligated to attend at a place out of the county in which he/she resides unless the distance be less than 50 miles from his/her place of residence.

(c) Any person receiving a subpoena duces tecum issued by the hearing officer pursuant to this article shall comply within the time stated, by:

(1) Producing the evidence required; or

(2) Filing an affidavit setting forth reasons why such evidence should not be produced.

(d) Where the person receiving the subpoena duces tecum files an affidavit pursuant to Subsection (2) above, the hearing officer shall, based upon a reading of both the affidavit and the petition, either deny the petition and withdraw the subpoena duces tecum, or order the affiant to produce the evidence as required by the subpoena. If a person fails to comply, the hearing officer may refer the matter to the Chief Counsel of the Department for institution of court proceedings pursuant to Government Code Section 11187, to compel production of the evidence; or, in the case of a party, the hearing officer may decide the appeal against the nonresponsive party.

(e) All witnesses appearing pursuant to subpoena, other than the parties or officers or employees of the state or any political subdivision thereof, shall receive fees and all witnesses appearing pursuant to subpoena, except the parties, shall receive mileage reimbursement from the party which requested the subpoena, in the same amount and under the same circumstances as prescribed by law for witnesses in civil actions in a superior court.

(f) Witnesses appearing pursuant to subpoena, except the parties, who attend formal hearings at points so far removed from their residences as to prohibit return thereto from day to day shall be entitled, in addition to fees and mileage, to a per diem compensation of $3.00 for expenses of subsistence for each day of actual attendance and for each day necessarily occupied in traveling to and from the hearing. Fees, mileage and expenses of subsistence shall be paid by the party at whose request the witness is subpoenaed.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4631, 4648.1 and 4780.5, Welfare and Institutions Code; Sections 1985, 1987, and 1988, Code of Civil Procedure; and Sections 11180, 11181, 11182, 11184, 11185, 11186, 11187, 11188, 11189, 11190, and 11191, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50654 to Section 50754 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50755. Depositions.

Note • History

(a) On verified petition of any party, the hearing officer may order that the testimony of any material witness residing within or without the state be taken by deposition in the manner prescribed by law for depositions in civil actions. The petition shall set forth:

(1) The nature of the pending proceeding;

(2) The name and address of the witness whose testimony is desired;

(3) A showing of the materiality of his/her testimony;

(4) A showing that the witness will be unable or cannot be compelled to attend; and

(5) A request for an order requiring the witness to appear and testify before an officer named in the petition for that purpose.

(b) The hearing officer's order for taking of testimony by deposition from a witness residing out-of-state shall be supported by a court order. The court order shall be obtained by filing a petition in the Superior Court of Sacramento County, in accordance with Section 11189 of the Government Code.

(c) Parties requesting depositions pursuant to this section, shall be liable for actual and reasonable costs arising therefrom.

NOTE

HISTORY

1. Renumbering and amendment of former Section 50655 to Section 50755 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50756. Affidavits.

Note • History

(a) Any party shall mail or deliver to all other parties, at least 20 days prior to a formal hearing or a continued hearing, a copy of any affidavit to be introduced in evidence, together with a notice as provided in Subsection (b) below. Unless an opposing party, within ten days after such mailing or delivery, mails or delivers to the proponent a request to cross-examine an affiant, the right to cross-examine such affiant is waived and the affidavit, if introduced in evidence, shall be given the same effect as if the affiant had testified orally. If an opportunity to cross-examine an affiant is not offered after request therefor is made as herein provided, the affidavit may be introduced in evidence, but shall be given only the same effect as other hearsay evidence.

(b) The notice referred to in Subsection (a) above, shall be in a form prescribed by the Department.

(c) “Affidavit” as used in this subchapter means either an affidavit under oath or an unsworn, written declaration under penalty of perjury.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11181 and 11182, Government Code.

HISTORY

1. Renumbering of former Section 50656 to Section 50756 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50757. Preparation for Formal Hearing.

Note • History

A party appearing at a formal hearing shall have necessary evidence and witnesses present and be ready to proceed. Two copies of any documents to be introduced in evidence shall be made available. The hearing officer, if necessary and following reasonable notice, may require the parties to submit, prior to a formal hearing, a written statement of contentions and reasons, together with any requested documents. A copy of such written statement and documents shall be provided to the parties.

NOTE

HISTORY

1. Renumbering of former Section 50657 to Section 50757 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50758. Conduct of Formal Hearing.

Note • History

(a) Testimony shall be taken only on oath, affirmation or penalty of perjury.

(b) The proceedings at the formal hearing shall be electronically recorded or reported by phonographic reporter.

(1) Call and examine parties and witnesses;

(2) Introduce exhibits;

(3) Question opposing witnesses and parties on any matter relevant to the issue even though the matter was not covered in the direct examination;

(4) Impeach any witness regardless of which party first called the witness to testify;

(5) Rebut the evidence against him/her.

(d) The appellant shall not be called to testify during presentation of the Department's prima facie case pursuant to subsection (k) of this section. An appellant who declines to testify or present his/her case may be called and examined by the Department as if under cross-examination.

(e) The formal hearing need not be conducted according to technical rules relating to evidence and witnesses.

(f) Irrelevant repetitious evidence shall be excluded.

(g) Relevant evidence, including hearsay, shall be admitted if it is the sort of evidence on which responsible persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule which might make improper the admission of such evidence over objection in civil actions, provided:

(1) Hearsay evidence shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions;

(2) The rules of privilege shall be effective to the same extent that they are now or hereafter may be recognized in civil actions;

(3) The evidence shall be excluded if its probative value is outweighed by excessive consumption of time, undue repetition, or its prejudicial effect.

(h) The “best evidence” rule (Evidence Code Section 1500) does not apply unless:

(1) A genuine question is raised as to the authenticity of the original or the duplicate; or

(2) It would be unfair to admit the duplicate in lieu of the original.

(i) A hearing officer may question any party or witness.

(j) The hearing officer shall control the taking of evidence in a manner best suited to ascertain the facts and safeguard the rights of the parties. Prior to taking evidence, the hearing officer shall set forth the order in which evidence will be received.

(k) The Department or regional center shall present its findings and evidence first at the hearing. The Department or regional center has the burden of proof of demonstrating, by a preponderance of the evidence, that the findings were correctly made. Once the Department or regional center has presented such a prima facie case, the burden of proof shifts to the appellant to demonstrate, by a preponderance of the evidence, that the appellant's position regarding disputed issues is correct.

(l) The burden of producing evidence is the obligation of introducing sufficient testamentary or demonstrative evidence to establish the existence of an alleged fact. A party who, in support of his/her position, alleges a fact which is specifically or generally disputed by the opposing party, as the burden of producing evidence as to that fact. If the party having the burden of producing evidence fails to introduce sufficient evidence, the hearing officer shall find against such party as to the existence of the particular fact alleged.

(m) The hearing shall be conducted in the English language. The proponent of any testimony to be offered by a witness who does not speak the English language proficiently shall provide an interpreter, approved by the hearing officer as proficient in the English language and the language in which the witness will testify, to serve as interpreter during the hearing. The cost of the interpreter shall be paid by the party providing the interpreter.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182, Government Code.

HISTORY

1. Renumbering and amendment of former Section 50658 to Section 50758 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of subsection (k) (Register 2002, No. 46).

§50759. Official Notice.

Note • History

(a) The hearing officer shall take official notice of those matters which must be judicially noticed by a court under Section 451 of the Evidence Code. The hearing officer may take official notice of those matters set forth in Section 452 of the Evidence Code.

(b) Parties present at the formal hearing shall be informed of the matters to be noticed, and those matters shall be noted in the record, referred to therein, or appended thereto.

(c) If the hearing officer has been requested to take, or has taken, or proposes to take official notice of such matters, the hearing officer shall afford each party reasonable opportunity before closing the record, to present to the hearing officer information relevant to:

(1) The propriety of taking official notice of the matter; or

(2) The probative value to be accorded to the matter to be noticed.

(d) If the hearing officer resorts to any source of information not received at the formal hearing, including the advice of persons learned in the subject matter, such information and its source, shall be made a part of the record in the appeal and the hearing officer shall afford each party reasonable opportunity to rebut such information before official notice of the matter may be taken.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50659 to Section 50759 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50760. Continued or Further Hearings.

Note • History

(a) Upon the hearing officer's own motion or upon the request of a party, the hearing officer may, for good cause, continue a formal hearing to another time or place. Oral notice of the time and place of the continued formal hearing may be given to each party present at the formal hearing. Such oral notice shall be confirmed in writing by the hearing officer within five days unless waived by the parties.

(b) Upon the hearing officer's own motion or upon a written request by a party, the hearing officer may, for good cause, order a further formal hearing prior to his/her issuance of notice of dismissal or adoption of his/her proposed decision by the Director. Notice of the further formal hearing shall be mailed to the parties not less than 30 days prior to such hearing. This period may be shortened with the consent of all parties. Any party may waive notice.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50660 to Section 50760 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50761. Introduction of New Evidence.

Note • History

The hearing officer upon a showing of good cause consistent with Subsection 50730(f), in order to obtain new evidence necessary for the proper determination of the case, may:

(a) Continue the formal hearing and hold the record open in order to permit any party to produce additional evidence;

(b) Close the hearing and hold the record open in order to permit the introduction of additional documentary evidence. Any material submitted after the close of the formal hearing shall be served upon all parties and each party shall have reasonable opportunity for rebuttal;

(c) Order a further formal hearing if the nature of the additional evidence or the refutation thereof make a further hearing desirable.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50661 to Section 50761 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50762. Representation at a Formal Hearing.

Note • History

A hearing officer may refuse to allow any person to represent a party in any hearing when the person:

(a) Engages in unethical, disruptive or contemptuous conduct which impairs the appeals process; or

(b) Either intentionally and repeatedly or willfully fails to comply with the proper instructions or orders of the hearing officer or the provisions of this subchapter.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50662 to Section 50762 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50763. Oral Arguments and Briefs.

Note • History

(a) The formal hearing shall be an evidentiary hearing. However, the hearing officer may, in his/her discretion, permit the submission of oral or written arguments, if requested to do so by a party prior to the close of the formal hearing. The parties shall be advised as to the time and manner in which arguments are to be submitted.

(b) The hearing officer may require any party to submit memoranda or affidavits pertaining to any or all issues raised in the formal hearing.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5 Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50663 to Section 50763 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50764. Decision.

Note • History

(a) The hearing officer shall take the matter under submission at the conclusion of the hearing. A proposed decision, in a form that may be adopted as the decision of the Director, shall be submitted within 60 days after the close of the formal hearing record. The proposed decision shall be in writing and shall contain findings of fact, a determination of the issues presented, and an order.

(b) The Director may adopt the proposed decision in its entirety or may revise the amount due and adopt the balance of the proposed decision.

(c) If the proposed decision is not adopted under Subsection (b) above, the Director may decide the case upon his/her review of the record, including the transcript, without taking additional evidence, or may remand the matter to the same hearing officer to take additional evidence. Upon remand, the hearing officer shall prepare a proposed decision, as provided in Subsection (a) above, upon the additional evidence and the transcript and other papers, which are part of the record of the prior hearing.

(d) The decision shall be final upon adoption by the Director. Copies of the decision of the Director shall be provided to the parties; the appellant's copy shall be delivered by certified mail.

(e) If a party to a formal hearing other than the appellant fails to appear at a hearing and the hearing officer issues a decision on the merits adverse to that party's interests, the decision shall be accompanied by a statement of the party's right to make application to vacate the decision. The application shall be in writing and shall be mailed within 10 days after personal service or mailing of the decision. Upon a showing of good cause for failure to appear at the hearing, the Director may issue an order to vacate his/her decision and the matter may be set for further hearing. Lack of good cause will be inferred when a continuance of the hearing was not promptly requested by the applicant upon discovery of the reasons for failure to appear at the hearing as scheduled.

(f) The parties shall be given written notice of an order granting or denying any application to vacate a decision.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4635, 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering and amendment of former Section 50664 to Section 50764 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of subsection (b) (Register 2002, No. 46).

§50765. Dismissal.

Note • History

(a) A dismissal may be issued by the hearing officer if an appellant fails to appear at a formal hearing. A copy of such dismissal shall be mailed to each party together with a statement of the appellant's right to reopen the hearing.

(b) The Director may vacate any dismissal if the appellant makes application in writing, within 10 days after personal service or receipt of such dismissal, showing good cause for failure to appear at the hearing. Lack of good cause will be presumed when a continuance of the formal hearing was not promptly requested by the appellant upon discovery of the reasons for his/her inability to appear at the hearing as scheduled. If a dismissal has been vacated by the Director, the hearing officer shall reschedule the hearing. Notice of the time and place of the hearing shall be sent to the parties not less than 30 days prior to the scheduled hearing date. This period may be shortened with the consent of all parties. Any party may waive notice.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50665 to Section 50765 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

§50766. Reconsideration.

Note • History

(a) The Director may order a reconsideration of all or part of the decision on his/her own motion or on petition of any party. The power to order a reconsideration shall expire 30 days after delivery or mailing of a decision to the appellant. The petition of a party shall be deemed denied if the Director takes no action within the time allowed for ordering reconsideration.

(b) If a reconsideration is ordered, the Director may:

(1) Issue a revised decision based upon a review of all the pertinent parts of the records and such additional evidence and arguments as he/she may permit; or

(2) Assign the case to a hearing officer for preparation of a revised decision based upon the records and such additional oral or written evidence as may be necessary. Preparation and adoption of the revised decision shall be in accordance with the procedures provided for in Section 50764.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50666 to Section 50766 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Change without regulatory effect amending subsection (b)(2) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§50767. Judicial Review.

Note • History

The final decision of the Director shall be subject to judicial review in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within six months after the date of mailing of the Director's final decision.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648.2 and 4780.5, Welfare and Institutions Code. Reference: Sections 4635, 4648.1 and 4780.5, Welfare and Institutions Code.

HISTORY

1. Renumbering of former Section 50667 to Section 50767 filed 7-5-88; operative 8-4-88 (Register 88, No. 29).

Subchapter 8. Peer Review of Behavior Modification Interventions That Cause Pain or Trauma, and Electroconvulsive Therapy

Article 1. General Provisions

§50800. Meaning of Words.

Note • History

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New Subchapter 8 (Articles 1-4, Sections 50800-50835, not consecutive) filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50801. Definitions.

Note • History

The following definitions govern the construction of sections within this subchapter unless the context requires otherwise:

(a) “Behavior modification” means an occurrence under which any person subjects a client at any time or place to stimuli, events, acts, activities, or responses that are intended to cause that client to change, adapt, or alter the occurrence or performance of his or her behavior, provided that it shall not be construed to prohibit conduct which is otherwise privileged pursuant to the provisions of Section 692 through 694 of the California Penal Code.

(b) “Behavior Modification Review Committee” means the group of persons within the developmental center or regional center appointed to review and consider for approval or denial behavior modification interventions that cause pain or trauma, in accordance with Article 3. For the purposes of these regulations, the Behavior Modification Review Committee is intended to serve as the Peer Review Committee required in Welfare and Institutions Code, Section 4505.

(c) “Behavior Modification Interventions that Cause Pain or Trauma” means every form of behavior modification, as defined in these regulations, that a Behavior Modification Review Committee determines will result in or cause the recipient to experience either pain or trauma as those terms are defined in these regulations.

(d) “Care provider” means any person, corporation, partnership, agency or other entity which directly or indirectly owns, administers, or operates a developmental center, a community care facility as defined in Sections 1502 and 1504 of the Health and Safety Code, or a health facility as defined in Section 1250 of the Health and Safety Code. Unless otherwise stated, this term also includes all agents, employees, and contractors of the care provider involved with or responsible for the provision of care to clients.

(e) “Client” means any person who is eligible for regional center services pursuant to Chapter 3, Subchapter 1 (beginning with Section 54000), and who resides in a developmental center, a licensed community care facility, or a licensed health facility, or receives services in a program described in Health and Safety Code, Section 1502.

(f) “Consent” means that the client or the client's parent/guardian/conservator has had the proposed procedure explained in terms understandable to the consentor, including prior unsuccessful interventions, the expected side effects and/or risks of the proposed procedure, and the client or the client's parent/guardian/conservator agrees in writing to the procedure. Consent may be withdrawn at any time.

(g) “Department” means the Department of Developmental Services.

(h) “Developmental Center” means a center which is operated by the State and serves persons with developmental disabilities.

(i) “Director” means the Director of the Department of Developmental Services.

(j) “Electroconvulsive Therapy” (ECT) means a treatment procedure for mental disorders in which a convulsive reaction is inducted by passing an electric current through the cerebral cortex by means of electrodes placed bilaterally or unilaterally on the patient's head. ECT is a treatment of last resort.

(k) “Electroconvulsive Therapy (ECT) Review Committee” means the group of persons appointed to review and consider for approval or denial requests to conduct ECT. For the purpose of these regulations the ECT Review Committee is intended to serve as the Peer Review Committee required in Welfare and Institutions Code, Section 4505.

(l) “Pain” means a subjectively experienced, substantially unpleasant bodily sensation; it ordinarily results from, or is induced by physiological stimuli which may include, but not be limited to injury, bodily contact, situational stress, heat, cold, noise, physical exertion, or immobilization. Typical observable responses may include, but not be limited to, evasive action, verbal exclamation or protest, escape, resistance, stiffening, grimacing, and reflexive avoidance or fainting. Some individuals may not exhibit any perceivable response.

(m) “Program” means a planned, organized approach to habilitative treatment of clients that is developed and implementated in accordance with the provisions of Article 2 (commencing with Section 4640) of Chapter 5 of Part 2 of Division 4.1 of the Welfare and Institutions Code, or with developmental center procedures subject to approval by the Department.

(n) “Qualified Professional” means a person designated to review proposed treatment plans in accordance with Article 2 of these regulations.

(o) “Regional Center” means a private nonprofit community agency that provides services for persons with developmental disabilities and their families under contract to the Department pursuant to Welfare and Institutions Code, Section 4620 et seq.

(p) “Trauma” means an occurrence under which the client experiences either:

(1) Tissue damage: or

(2) Severe and long-lasting emotional distress.

(q) “Treatment Plan” means the written description of a program containing ECT or behavior modification interventions that may cause pain or trauma, that is prepared for review and approval in accordance with this subchapter.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4503, 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50802. Limitations on Use of Behavior Modification Interventions That May Cause Pain or Trauma.

Note • History

All care providers shall be prohibited from using any form of behavior modification intervention that may cause pain or trauma upon the client unless this behavior modification has been developed into a program that is fully described in a treatment plan proposed by the Interdisciplinary Team and either endorsed for implementation by a qualified professional pursuant to Article 2, or approved by a Behavior Modification Review Committee pursuant to Article 3.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Article 2. Review by Qualified Professional

§50810. Designation of Qualified Professionals.

Note • History

(a) Each regional center and developmental center shall designate in writing one or more persons to serve as qualified professionals to be responsible for reviewing proposed treatment plans that may cause pain or trauma in accordance with this article. Only physicians or psychologists licensed by the State Department of Consumer Affairs to practice in the State of California or other professionals whose California licensure permits the practice of behavior modification programs may be so designated. The regional center or developmental center, as appropriate, shall designate a sufficient number of qualified professionals to review all proposed treatment plans that may cause pain or trauma within a reasonable period of time following the date of the plans' submission for review.

(b) Each qualified professional designated in (a) shall possess the following minimum qualifications:

(1) One year of experience designing behavior modification programs for persons with developmental disabilities; or

(2) Two years of experience teaching behavior modification at the college level or above.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (a) and (b)(1) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§50811. Procedures for Review of Proposed Treatment Plans.

Note • History

(a) Interdisciplinary Teams intending to apply or institute any form of behavior modification interventions that may cause pain or trauma shall, prior to its implementation:

(1) Incorporate or develop the behavior modification into a complete program that is described in a proposed treatment plan as described in Section 50822;

(2) Obtain consent for the implementation of the proposed treatment plan; and

(3) Except as specified in (f), forward the proposed treatment plan and documentation of consent for review by the qualified professional designated for the client pursuant to Section 50810.

(b) The qualified professional shall:

(1) Review all treatment plans forwarded for review pursuant to this article within a reasonable time; and

(2) Enter into the client's treatment record a notation of the scope of the review that was conducted, along with the determination made concerning whether the treatment plan involves pain or trauma.

(c) Under no instance shall a qualified professional approve a treatment plan that has the potential to cause pain or trauma.

(d) Upon his/her determination that the proposed treatment plan can be approved for implementation, the qualified professional shall:

(1) Place his/her original signature and California professional license number on the treatment plan to indicate approval;

(2) Make the proper entries in the client's treatment record in accordance with subsection (b) (2); and

(3) Forward the approved plan to the client's case manager for implementation through the Individual Program Plan process. The approval shall be effective for a period not to exceed one year.

(e) Upon his/her determination that the proposed treatment plan may cause pain or trauma, the qualified professional shall:

(1) Forward the plan and a copy of the written results of his/her review to the Behavior Modification Review Committee designated by the client's regional center or developmental center, providing consent to the proposed treatment plan has been documented; or

(2) Disapprove the plan and return it to the Interdisciplinary Team which proposed the plan when consent has not been documented.

(f) When a qualified professional is a member of an Interdisciplinary Team that develops a proposed treatment plan pursuant to (a) (1), the provisions of (a) (3) and (b) shall not apply. Such qualified professional shall comply with the provisions of paragraph (C) through (e) of this section.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Article 3. Review of Behavior Modification Treatment Plans

§50820. Establishment of Behavior Modification Review Committees.

Note • History

() Each regional center and developmental center shall establish one or more committees to be known as Behavior Modification Review Committees, which shall be responsible for the review and consideration for approval or denial of behavior modification interventions that may cause pain or trauma in the manner specified in this article.

(b) Each Behavior Modification Review Committee shall consist of not less than three persons. The committee shall include at least one California licensed psychologist or other professional whose California licensure permits the practice of behavior modification programs, one California licensed physician, and one Clients' Rights Advocate. The person responsible for the development or implementation, or for review under Section 50811, of the treatment plan that is before the committee for approval shall not sit on the committee for any portion of the review and approval of the treatment plan.

(c) either the physician or psychologist or other professional specified in (b) shall have at least three years experience in:

(1) The supervision of the implementation of behavior modification programs;

(2) Teaching behavior modification at the college level or above; or

(3) A combination of (1) and (2).

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50821. Procedures for Review by Behavior Modification Review Committee.

Note • History

(a) The Behavior Modification Review Committee shall:

(1) Complete a review, within a reasonable time, of each proposed treatment plan which has been referred to the committee pursuant to Section 50811.

(2) Upon completion of its review, send written notification to the Interdisciplinary Team which prepared the proposed treatment plan of its decision to approve or disapprove the plan.

(b) Approval of a treatment plan shall be by consensus, and documented pursuant to Section 50822.

(c) Disapproval of a treatment plan shall include the reasons for the action along with any suggested changes to the plan which could lead to subsequent approval.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50822. Criteria for Approval of Behavior Modification Programs Involving Pain or Trauma.

Note • History

(a) All proposed treatment plans for behavior modification which may cause pain or trauma shall:

(1) Describe the program which is proposed for implementation.

(2) Prescribe procedures for the monitoring and implementation of the behavior modification program by the Interdisciplinary Team.

(3) Identify those staff members authorized to use the approved interventions.

(4) Be accompanied by all of the following:

(A) Documentation that consent has been given for the program described in the treatment plan.

(B) A functional analysis of the target behavior(s).

(D) Evidence of a prior review for the proposed treatment plan by the client's physician, including a statement that:

1. Medical intervention to remediate the target behaviors is not an appropriate course of action; and

2. There are no medical contraindications to the proposed treatment plans.

(b) A Behavior Modification Review Committee shall approve a proposed treatment plan only after making a finding that all of the following conditions exists:

(1) All of the information specified in subsection (a) is present.

(2) The treatment Plan:

(A) Conforms to the requirements of the license of the facility in which it is to be performed.

(B) Is designed solely for the purpose of achieving the goal of enabling the client to lead a more independent, productive, and normal life as expressed in the Lanterman Developmental Disabilities Services Act (Welfare and Institutions Code, Sections 4500 et seq.)

(3) The history of prior interventions demonstrates that all less restrictive alternative methods have been tried without success.

(4) The procedures prescribed in the plan for the monitoring and implementation of the program are adequate.

(5) Each element of the behavior modification program described in the plan is technically adequate and appropriate in light of prevailing behavior modification standards within the psychological treatment profession.

(6) The potential harm from not providing each element of the program outweighs the potential harm created by implementing each element.

(7) The program will not cause irreparable harm to the client.

(c) No treatment plan shall be deemed approved by the Behavior Modification Review Committee until the committee has completed and transmitted a written notice of approval to the initiating Interdisciplinary Team that includes an express finding concerning each of the elements listed above, along with a statement of the supporting facts and reasons for each finding.

(d) Approval by the Behavior Modification Review Committee shall be effective for a period not to exceed one year.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50823. Behavior Modification Reporting Requirements.

Note • History

(a) Each regional center director and developmental center executive director shall prepare and submit to the Director by February 15 of each year the following annual reports from their respective Behavior Modification Review Committees:

(1) The number and type of behavior modification treatment plans approved by the Behavior Modification Review Committee during the reporting period; and

(2) The source and type of license held by each facility in which approved treatment plans were implemented during the reporting period.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Article 4. Electroconvulsive Therapy (ECT)

§50830. Limitations on the Use of ECT.

Note • History

Physicians shall be prohibited from using ECT on a regional center client unless the use of ECT has been developed into a program that is fully described in a proposed treatment plan that has been approved by the ECT Review Committee pursuant to section 50833.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50831. Procedure for Seeking Approval to Use ECT.

Note • History

(a) All proposals to use ECT shall be developed into a program that is fully described in a treatment plan. The proposed treatment plan shall include at a minimum:

(1) A description of:

(A) The reasons for proposing the use of ECT which shall include:

(1) A list of the client behaviors, symptoms, and diagnoses leading to the decision to propose the use of ECT.

(2) The results of other, less restrictive alternative treatments used to modify these behaviors or alleviate the described symptoms.

(B) The anticipated benefits to the client of using ECT, with a statement of the probable consequences of denying the use of ECT.

(C) The number and frequency of proposed treatments, their methods of administration, and the medical support to be used during the course of treatments.

(2) The methods to be used to determine and document the results of the treatments.

(3) Consent that shall be:

(A) Limited to a specified maximum number of treatments over a maximum period of time not to exceed 30 days. Additional treatments in number or time, not to exceed 30 days, shall require a renewed written consent.

(B) Revocable at any time before or between treatments. Withdrawals of consent may be either oral or written and shall be given effect immediately.

(b) The proposed treatment plan shall be submitted in writing to the ECT Review Committee.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50832. Electroconvulsive Therapy (ECT) Review Committee.

Note • History

(a) The ECT Review Committee shall be established and shall consist of at least four persons, including:

(1) Two board certified psychiatrists and/or neurologists, licensed in California with experience in electroconvulsive treatment; one of whom shall be appointed by the facility and one of whom shall be appointed by the local mental health director. Neither of these physicians shall be the client's treating physicians.

(2) A representative from the Department of Developmental Services appointed by the Director who will function as a Clients Rights Advocate; and

(3) A representative from the Area Board serving the area in which the client resides, appointed by the Chairperson of the Area Board.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

2. Editorial correction amending subsection (a)(2) and restoring inadvertently omitted subsection (a)(3) (Register 2006, No. 20).

§50833. Criteria for Approval of ECT.

Note • History

(a) The following criteria are required, at a minimum, for approval of ECT:

(1) The ECT Review Committee shall consider for approval or denial only those proposed treatment plans which have met the requirements specified in Section 50831.

Approval is predicated upon the unanimous agreement of the ECT Review Committee with the treating physician's determinations.

(3) If the ECT Review Committee approves the proposed treatment plan, their approval shall be limited to 30 days, effective upon written notification of the committee's approval shall be limited to 30 days, effective upon written notification of the committee's approval. Further, the approval of the ECT Review Committee shall be nullified if the treatment plan is not followed exactly as written when approved.

(4) Approval of the proposed plan by the ECT Peer Review Committee shall not supersede or replace the review requirements necessary under Section 5325 et seq. of the Welfare and Institutions Code. The review of a proposal to use ECT with a person with both developmental disabilities and a mental illness that might justify the use of ECT shall be completed separately and independently by both the ECT Peer Review Committee pursuant to these regulations and the reviewing entity required by Sections 5325 et seq. of the Welfare and Institutions Code.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50834. Procedures for Review of Proposed ECT.

Note • History

(a) The ECT Review Committee shall complete its review of all treatment plans submitted pursuant to Section 50831 within 30 calendar days of receipt of the plans. The chairperson of the ECT Review Committee shall telephone the requesting physician and relay the committee's approval or denial of the proposed treatment plan on the day the review is completed.

(b) Written notice of the approval or denial shall:

(1) Be mailed within five working days of the telephone notice pursuant to paragraph (a).

(2) Include express findings of conformity or nonconformity to the criteria in Section 50833 with statements of reasons for each finding.

(3) Be documented in the client's treatment record.

(4) Be signed by all members of the ECT Review Committee.

(5) Be permanently attached to the treatment plan as proposed.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§50835. Reporting Requirements.

Note • History

The physician conducting the ECT shall submit a narrative progress report within 30 days of completion of the treatment to the ECT Review Committee. The report shall include, but not be limited to, the number of treatments given and the benefits derived. This regulation shall also apply to physicians who are small businesses.

NOTE

Authority cited: Section 4505, Welfare and Institutions Code. Reference: Section 4505, Welfare and Institutions Code.

HISTORY

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Subchapter 9. Fair Hearings

Article 1. General Provisions and Definitions

§50900. Intent and Purpose.

Note • History

The intent and purpose of this subchapter is to implement, interpret, and make specific, and this subchapter shall be read in conjunction with, the statutory provisions of the Lanterman Developmental Disabilities Services Act (Division 4.5 of the Welfare and Institutions Code, commencing with Section 4700) relative to the fair hearing procedures and fair hearing rights of persons applying for or receiving services pursuant to said Act. It is the intent of this subchapter:

(a) To implement the fair hearing procedures such that resolutions of disagreements may be accomplished at the earliest opportunity.

(b) To interpret the fair hearing procedures in a manner which protects the claimant's fair hearing rights and promotes the rights of claimants to dignity, privacy, and humane care as established by the Lanterman Developmental Disabilities Services Act.

(c) To make specific the responsibilities of the claimant, service agency, and state department to conduct full and impartial fair hearings to resolve differences between service agencies and persons applying for or receiving services pursuant to the Lanterman Developmental Disabilities Services Act.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4501, 4502 and 4705, Welfare and Institutions Code.

HISTORY

1. New subchapter 9 (Articles 1-4, Sections 50900-50964, not consecutive) filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§50902. Definitions.

Note • History

Whenever the following terms are used in Chapter 7 of Division 4.5 of the Welfare and Institutions Code (commencing with Section 4700) and in this subchapter, the following definition shall apply:

(a) “Authorized Representative” means those persons described in Section 4701.6 of the Welfare and Institutions Code, and a representative appointed by the Area Board pursuant to subsection (e) of Section 4705 of the Welfare and Institutions Code.

(b) “Business Day” or “Working Day” means any day that is not a Saturday, Sunday, or holiday as specified in Sections 6700 and 6701 of the Government Code.

(c) “Clients' Rights Advocate” means the person assigned by a service agency to be responsible for rights assurance for applicants, recipients, and persons with developmental disabilities.

(d) “Immediately” or “Immediate” means within two (2) business days.

(e) “Recipient” means those persons described in Section 4703.5 of the Welfare and Institutions Code and persons receiving services for prevention of a developmental disability.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4701, 4702, 4702.6, 4703, 4703.5, 4703.7, 4705, 4710, 4710.5, 4710.6, 4710.7, 4710.9, 4711, 4712, 4712.2, 4715, 4726, 4727 and 4728, Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect amending subsection (a) filed 4-21-99 pursuant to section 100, title 1, California Code of Regulations (Register 99, No. 17).

§50904. Computation of Time for Performance of Act.

Note

If the last date of the performance of any act required within a specified period of time by these regulations or the provisions of Chapter 7 of Division 4.5 of the Welfare and Institutions Code (commencing with Section 4700) is not a business day, then such period shall be extended to the next business day.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4701, 4710, 4710.5, 4710.6, 4710.7, 4710.8, 4710.9, 4712, 4712.2, 4712.5, 4713 and 4715, Welfare and Institutions Code.

Article 2. Adequate Notice

§50920. Appeal to Be Filed with Service Agency.

Note

The portion of the adequate notice describing the fair hearing appeal procedure shall emphasize the requirement of filing a request for fair hearing with the service agency, and shall explain to the applicant, recipient, and authorized representative, if any, that the service agency will forward the request to the responsible state agency. The requirement of subsection (e) of Section 4701 of the Welfare and Institutions Code to give notice of the name and address of the responsible state agency with whom an appeal may be filed is intended solely to require the provision of information to the applicant, recipient, or authorized representative, and does not supplant the procedure described in subsections (a) and (b) of Section 4710.9 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4701(e) and (g) and 4710.9, Welfare and Institutions Code.

§50922. Notice to Clients' Rights Advocate Regarding Adult Without Conservator.

Note

If a client entitled to adequate notice is an adult, without a court-appointed conservator, the service agency shall also provide the adequate notice to the service agency's clients' rights advocate.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4710(a) and 4710.8(b), Welfare and Institutions Code.

§50924. Notice to Regional Center Director for Conservatee of Director of Developmental Services.

Note

When the Director of Developmental Services is the conservator of the person, or person and estate, of an applicant or recipient entitled to adequate notice, the conservator's notice shall be given to the director of the regional center which is delegated the responsibility and authority for serving as that applicant or recipient's conservator of the person pursuant to Section 416.19 of the Health and Safety Code and to the service agency's Client's Rights Advocate.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Section 4710(a), Welfare and Institutions Code.

Article 3. Procedures for Fair Hearings

§50930. Notice of Right to Request Consolidation.

Note

The written decision of the service agency director resulting from the informal meeting shall include in its explanation of procedures for appeal, notice of the right to request consolidation of appeals involving a common question of law or fact.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4710.7(b) and 4712.2, Welfare and Institutions Code.

§50932. Notice of and Consent to Consolidation.

Note

(a) The hearing officer shall notify a party and the authorized representative, if any, in writing that a request for consolidation of his or her appeal with another appeal has been received, and such notification shall include an explanation that consolidation may necessitate disclosure of confidential information about each claimant to other claimants and their authorized representatives.

(b) Whether or not written consent or objections to consolidation are received by the hearing officer at the time of the fair hearing, the hearing officer in all cases shall explain the claimants' rights to confidentiality pursuant to subsection (a) and obtain consent to consolidation from each claimant or authorized representative on the record prior to the taking of testimony. If a claimant, authorized representative, or service agency objects to consolidation on the record, the hearing officer shall decide whether to consolidate that case as if written objections had been submitted prior to the hearing.

(c) Any request for consolidation may constitute good cause for the hearing officer to continue a hearing beyond 30 days but no longer than 45 days from the receipt of the request for fair hearing.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4712 and 4712.2, Welfare and Institutions Code.

§50934. Claimant Objection to Authorized Representative.

Note

When the claimant objects to a person appointed by the Area Board to serve as an authorized representative, that person shall not serve as the authorized representative. The Area Board shall consult with the claimant and may appoint another person to serve as authorized representative if the claimant consents and does not personally appoint an authorized representative.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4701.6 and 4710.8(b), Welfare and Institutions Code.

§50936. Notice of Documents Provided to Hearing Officer.

Note • History

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4710.9 and 4712(d), Welfare and Institutions Code.

HISTORY

1. Change without regulatory effect repealing section filed 4-21-99 pursuant to section 100, title 1, California Code of Regulations (Register 99, No. 17).

§50938. Submission of Written Argument.

Note

(a) When the hearing officer determines that there are complex issues of law or fact or novel interpretations of difficult questions of law, the hearing officer may cause the record of the fair hearing to be held open for submission of written argument by either or both parties. New or additional evidence, not already entered into evidence on the record, may not be included with the written argument unless the hearing officer grants permission on the record to the belated admission of the evidence.

(b) Whenever written argument or new or additional evidence is submitted to the hearing officer pursuant to subsection (a), the submitting party shall mail or deliver a copy to the other party.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Sections 4710.6, 4712 and 4712.5, Welfare and Institutions Code.

Article 4. Miscellaneous Provisions

§50960. Internal Grievance Procedure.

Note

The written internal grievance procedure mandated by subsection (a) of Section 4705 of the Welfare and Institutions Code shall include, but not be limited to, the rights specified in subsection (a) of Section 47106 of the Welfare and Institutions Code.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Section 4705(a), Welfare and Institutions Code.

§50962. Hearing Procedure in Nontechnical Language.

Note

Service agencies shall write their fair hearing procedures mandated by subsection (a) of Section 4705 of the Welfare and Institutions Code in clear and nontechnical language.

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Section 4705(a) and (c), Welfare and Institutions Code.

§50964. Regulations to Be Posted.

Note

The service agency shall prominently display a copy of these regulations on the premises of the service agency with the service agency's fair hearing procedure and the provisions of Chapter 7 of Division 4.5 of the Welfare and Institutions Code (commencing with Section 4700).

NOTE

Authority cited: Section 4705, Welfare and Institutions Code. Reference: Section 4705(c), Welfare and Institutions Code.

§50966. Receipt of Fair Hearing Request by Office of Administrative Hearings.

Note • History

(a) Upon receipt of a fair hearing request from a claimant, service agencies shall not have the discretion to determine the appropriateness or timeliness of the fair hearing request. All fair hearing requests received by a service agency shall be immediately forwarded to the agency designated for conducting fair hearings and, if applicable, the agency designated for conducting mediations.

(b) If a service agency believes that a fair hearing request raises issues that are not appropriately addressed through a fair hearing pursuant to Section 4700 et seq. of the Welfare and Institutions Code, or for other reasons does not comply with statutory requirements, the service agency may file a request to have the matter dismissed with the agency responsible for conducting hearings. Such dismissal requests shall state the reasons for the request.

NOTE

Authority cited: Section 4707, Welfare and Institutions Code. Reference: Sections 4710.5 and 4711.5, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

Article 5. Mediation

§50980. Confidentiality of Mediation.

Note • History

Confidentiality of mediation shall be governed by Chapter 2, Division 9 of the Evidence Code, commencing with §1115.

NOTE

Authority cited: Section 4707, Welfare and Institutions Code. Reference: Section 4711.5, Welfare and Institutions Code.

HISTORY

1. New article 5 (sections 50980-50992) and section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

§50984. Continuances in Mediation.

Note • History

(a) The standard for granting a continuance request in mediation shall be good cause, as defined in Section 4712, Welfare and Institutions Code.

(b) A continuance granted to a claimant in mediation shall extend the timeline for rendering a final decision, should the matter proceed to hearing.

(c) The extension of time for the final decision resulting from the continuance shall only be as long as the time period of the continuance.

NOTE

Authority cited: Section 4707, Welfare and Institutions Code. Reference: Sections 4710.6(c), 4711.5 and 4712, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

§50988. Mediation Request Made Subsequent to Fair Hearing Request.

Note • History

(a) A claimant may request mediation at any time prior to five days before the first day of the fair hearing.

(b) A claimant requesting mediation after the fair hearing request has been submitted must do so in writing. Such request may be made by submitting an amended fair hearing request form.

(c) The written request for mediation shall be submitted to the service agency. The service agency shall immediately forward a copy of the written request for mediation to the agency responsible for conducting mediations, the Department, and the agency responsible for conducting fair hearings. The service agency shall have five days from the date of the written request for mediation to accept or reject mediation. Such decision shall be communicated immediately to the claimant and the agency responsible for conducting mediations.

(d) Upon receipt of the written request for mediation, the agency responsible for conducting mediations shall schedule the mediation to take place within 20 days of the date of the written request. The agency shall provide notice to the claimant and service agency regarding the time, date and location of the mediation and notice to the claimant in compliance with Section 4711 of the Welfare and Institutions Code.

(e) A mediation request made subsequent to a fair hearing request and agreed to by the service agency shall constitute good cause for continuing the fair hearing. In such instances, the timeline for scheduling the fair hearing and rendering a final decision shall be extended 20 days.

NOTE

Authority cited: Section 4707, Welfare and Institutions Code. Reference: Sections 4702.6, 4710.5, 4710.6, 4711 and 4711.5, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

§50992. Time and Place of Mediation; Nonadversarial.

Note • History

(a) The mediation shall be held at a time and place reasonably convenient to the claimant.

(b) Mediation shall be conducted in a nonadversarial manner. Witnesses and other forms of evidence, other than to explain one party's position to the other, shall not be presented in mediation.

NOTE

Authority cited: Section 4707, Welfare and Institutions Code. Reference: Section 4711.5, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

Chapter 2. Early Intervention Services

Subchapter 1. General Provisions

Article 1. Definitions

§52000. Meaning of Words.

Note • History

(a) Words shall have their usual meaning unless the context of a definition clearly indicates a different meaning. Words used in their present tense include the future tense; words in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct; “may” denotes permissive conduct.

(b) The following definitions shall apply to the words used in this subchapter:

(1) Acidemia means an excessive acidity of the blood wherein the acid-base balance of the body is disturbed.

(2) Adaptive development means the acquisition of skills that are required to meet environmental demands. Adaptive development includes, but is not limited to, activities of self-care, such as dressing, eating, toileting, self-direction, environmental problem-solving and attention/arousal.

(3) Asphyxia neonatorum means a condition caused by insufficient oxygen at or near the time of birth.

(4) Assessment means the ongoing procedures used by qualified personnel throughout the period of an infant's or toddler's eligibility for early intervention services to identify the infant's or toddler's unique strengths and needs and the services appropriate to meet those needs. Assessment also includes the identification of the family's resources, priorities, and concerns regarding the development of the infant or toddler and the supports and services necessary to enhance the family's capacity to meet the developmental needs of the eligible infant or toddler.

(5) Authorized representative means the parent or guardian of a minor, or person who is legally entitled to act on behalf of the infant, toddler or family.

(6) Biomedical insult is a general term referring to those biological or medical conditions such as infection or brain injury which may result in developmental delay or disability.

(7) Cognitive development means the acquisition of learning through ongoing interactions with the environment. Cognitive development involves perceiving, thinking, problem solving and remembering information.

(8) Communication development means the acquisition of expressive and/or receptive language skills which include understanding and/or using any of the following: gestures, facial expressions, speech reading, sign language, body postures and vocal and visual contacts with another person.

(9) Complainant means any individual or organization filing a written complaint pursuant to the provisions of Subchapter 5, Article 3.

(10) Concerns means areas that family members identify as needs, issues or problems they want to address as part of the individualized family service plan (IFSP) or the evaluation and assessment process which are related to meeting the developmental needs of the infant or toddler.

(11) Day means calendar day unless otherwise stated.

(12) Early intervention services means those services designed to meet the developmental needs of each eligible infant or toddler and the needs of the family related to the infant's or toddler's development. The services include but are not limited to assistive technology; audiology; family training; counseling and home visits; health services; medical services only for diagnostic or evaluation purposes; nursing services; nutrition services, occupational therapy; physical therapy; psychological services; service coordination; social work services; special instruction; speech and language services; transportation and related costs; and vision services. Early intervention services may include such services as respite and other family support services.

(13) Evaluation means procedures used by qualified personnel to determine an infant's or toddler's present level of development.

(14) Exception circumstances means events beyond the control of the regional center or local education agency (LEA). These include but are not limited to the infant's or toddler's or parent's illness, the infant's or toddler's and parent's absence from the geographical area, inability to locate the parent, or a natural disaster. Delays caused by the failure to obtain copies of existing records or other administrative events do not constitute exceptional circumstances.

(15) Family means the primary caregivers and others who assume major long-term roles in an infant's or toddler's daily life.

(16) Fine motor means the use of muscles that control small and detailed movements of the body, as an example, in the hand related to manual dexterity and coordination.

(17) Funded Capacity means the number of eligible infants, between 12 and 16 students per instructional unit, that the California Department of Education requires LEAs to serve to maintain funding for their classes/programs/services in a given year pursuant to Education Code section 56728.8 as it read on November 1, 1993.

(18) Gross motor means the use of large muscle groups of the body, arms, or legs, as in sitting up, walking, or balancing.

(19) Health status means a description of the physical and mental condition of an infant or toddler. Health status may include current diagnoses, medications, required regular medical procedures, current medical supplies and technological devices, primary and specially care providers, and immunization status, nutrition and oral health.

(20) Hearing impairment means a condition, whether permanent or fluctuating, which impairs the processing of linguistic information through hearing, even with amplification, and which adversely affects an infant's or toddler's development. Processing linguistic information includes speech and language reception and speech and language discrimination.

(21) Hyperbilirubinemia means a condition in which an excessive amount of bilirubin, a bile pigment released from the breakdown of red blood cells, is in the blood.

(22) Hypertonia means a condition of excessive tone or tension in the skeletal muscles.

(23) Hypotonia means a condition of diminished tone of the skeletal muscles.

(24) Hypoglycemia means a condition in which the blood sugar is abnormally low.

(25) Immediate need means a situation in which an infant or toddler requires early intervention services without delay pursuant to a physician's order or written determination by the multidisciplinary team specifying consequences of a delay in the provision of services.

(26) Individual program plan (IPP) means a plan developed for persons with developmental disabilities to describe the provisions of services and supports to meet the written goals and objectives pursuant to Welfare and Institutions Code sections 4646-4648.

(27) Individualized education program (IEP) means a written statement that is developed and implemented pursuant to Title 20 United States Code Section 1401(b)(20).

(28) Individualized family service plan (IFSP) means a written plan for providing early intervention services to infants or toddlers and their families who have been determined eligible for early intervention services. The plan must: (A) Be developed in accordance with Sections 52100 through 52110; and, (B) Be based on the evaluation and assessment processes described in Sections 52082 though 52086 of these regulations.

(29) Informed clinical opinion means the judgment of a qualified professional who is a member of the multidisciplinary team. Informed clinical opinion is based on but is not limited to opinions derived from: a review of records, parental and professional observation of the infant or toddler, and professional knowledge.

(30) Language of the parent's choice means a primary written or oral language or mode of communication that the family chooses as a means of communication. Language of the parent's choice may be the native language. If the parent is deaf or blind or has no written language, the mode of communication shall be that normally used by the parent such as sign language, braille, or oral communication.

(31) Local education agency (LEA) means the school district in which the infant or toddler resides or the county office of education or the special education local plan area (SELPA) that is responsible for providing early intervention services to infants and toddlers with disabilities.

(32) Low incidence disability means a severe disabling condition with an expected incidence rate of less than one percent of the total statewide enrollment in kindergarten through grade 12. For purposes of this definition, severe disabling conditions are hearing impairments, vision impairments, and severe orthopedic impairments, or any combination thereof.

(33) Mediation means a voluntary resolution process in which an impartial third party may assist the disagreeing parties to resolve issues prior to a due process hearing.

(34) Multidisciplinary team means two or more individuals of various disciplines or professions, and the parent, who participate in the provision of integrated and coordinated services, including evaluation, assessment, and IFSP development.

(35) Natural environments means settings that are natural or typical for the infant or toddler's age peers who have no disability including the home and community settings in which children without disabilities participate.

(36) Parent means:

(A) A natural or adoptive parent of a child;

(B) A guardian;

(C) A person acting in place of a parent (such as a grandparent or stepparent with whom the child lives, or a person who is legally responsible for the child's welfare);

(D) A surrogate parent who has been assigned in accordance with 34 CFR 303.406 and 17 CCR 52175 of these regulations; or

(E) A foster parent, when:

1. The foster parent has no interest that would conflict with the interests of the child,

2. The natural parents' authority to make the decisions required of parents has been limited or relinquished under State law, and

3. The foster parent is willing to make the decisions required of parents.

(37) Payor of last resort means the regional center or LEA that is required to pay for early intervention services listed on the IFSP when third party payers or other agencies do not have an obligation to pay as required by 34 CFR 303.527.

(38) Personally identifiable means information that includes:

(A) The full name of the infant or toddler, infant's or toddler's parent, or other family member;

(B) The address of the infant or toddler;

(D) A list of personal characteristics or other information that would make it possible to identify the infant or toddler with reasonable certainty.

(39) Physical development means the acquisition of fine and gross motor skills involved in functional movement. Physical development includes vision, hearing and health status.

(40) Priorities means a family's choice for the focus of early intervention services as well as for the ways in which early intervention services will be incorporated into the family's day-to-day organization, routine and planning.

(41) Qualified means that a person meets state certification, licensing, credentialing, registration, or other comparable requirements for the area in which he or she is providing early intervention services, or, in the absence of such approved or recognized requirements, meets the Department of Developmental Services or California Department of Education requirements.

(42) Record means the documentation in the infant's or toddler's regional center client file and/or the LEA's cumulative file.

(43) Regional center means a diagnostic, counseling and service coordination center for persons with developmental disabilities and their families which is established and operated pursuant to Chapter 5 of Division 4.5 of the Welfare and Institutions Code, Sections 4620 through 4669, by a private nonprofit community agency/corporation acting as a contractor for the Department of Developmental Services.

(44) Referral means the receipt of oral or written information that causes a record to be opened for an infant or toddler who may be eligible for early intervention services.

(45) Resources means the strengths, abilities, formal and informal supports of the family available to meet the developmental needs of the infant or toddler.

(46) Severe orthopedic impairment means a condition which adversely affects an infant's or toddler's development. Such orthopedic impairments include impairments caused by congenital anomaly, impairments caused by disease and impairments from other causes which may affect functional movement and/or growth.

(47) Social or emotional development means the acquisition of capacities for human relationships, emotional expression, communication and learning. Social or emotional development is based on the motivation to engage in positive interaction and to sustain personal relationships and precedes the development of effective coping skills, self esteem and the ability to take advantage of opportunities for learning. Differences in temperament, self regulation, range and intensity of affect and modulating one's response to the environment are additional factors influencing social or emotional development.

(48) Solely low incidence disability means one or a combination of low incidence disabilities which are vision impairment, severe orthopedic impairment, and hearing impairment which is the primary disability and has a significant impact on learning and development of the infant or toddler as determined by the IFSP team of the LEA. The infant or toddler who has a solely low incidence disability shall not be eligible for services from a regional center.

(49) Teratogen means an agent or factor that causes the production of physical defects in the developing embryo.

(50) Vision impairment means a visual condition which, even with correction, adversely affects the infant's or toddler's development.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 95014 and 95028, Government Code; Sections 3001(y) and 3030, Title 5 California Code of Regulations; Sections 1432, 1436 and 1440, Title 20 United States Code; Sections 303.12, 303.16, 303.17, 303.18, 303.19, 303.21, 303.321, 303.322, 303.340, 303.342, 303.343, 303.344, 303.345, 303.401, 303.402, 303.403, 303.406, 303.420, 303.511 and 303.527 Title 34 Code of Federal Regulations.

HISTORY

1. New subchapter 1, article 1 (section 52000) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Change without regulatory effect adding chapter 2 heading filed 8-7-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 32).

3. Editorial correction of subsections (b)(24), (b)(27) and (b)(47) (Register 98, No. 5).

4. New chapter 2, subsection 1, article 1 (section 52000) and section, including amendment of subsection (b)(27) and Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

5. New chapter 2, subchapter 1, article 1 (section 52000) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

7. Amendment of subsection (b)(36), new subsections (b)(36)(A)-(b)(36)(E)3., and amendment of Note filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

Article 2. Eligibility for California's Early Start Program

§52020. General.

Note • History

An infant or toddler shall be eligible for early intervention services if he or she is between birth up to thirty-six months of age and meets one of the criteria specified in Section 52022 as determined by means of evaluation pursuant to Section 52082 of these regulations and needs early intervention services.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1432(5), Title 20 United States Code; Sections 95014(a) and 95016, Government Code; and Section 303.16, Title 34 Code of Federal Regulations.

HISTORY

1. New article 2 (sections 52020-52022) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New article 2 (sections 52020-52022) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52020-52022) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52022. Eligibility Criteria.

Note • History

(a) Developmental Delay

A developmental delay exists if there is a significant difference pursuant to 52082 between the infant's or toddler's current level of functioning and the expected level of development for his or her age in one or more of the following developmental areas:

(1) Cognitive;

(2) Physical: including fine and gross motor, vision, and hearing;

(3) Communication;

(4) Social or emotional;

(5) Adaptive.

(b) Established Risk

(1) An established risk condition exists when an infant or toddler has a condition of known etiology which has a high probability of resulting in developmental delay; or

(2) An established risk condition exists when an infant or toddler has a solely low incidence disability.

(1) High risk for a developmental disability exists when a multidisciplinary team determines that an infant or toddler has a combination of two or more of the following factors that requires early intervention services based on evaluation and assessment pursuant to section 52082 and section 52084:

(A) Prematurity of less than 32 weeks gestation and/or low birth weight of less than 1500 grams.

(B) Assisted ventilation for 48 hours or longer during the first 28 days of life.

(D) Asphyxia neonatorum associated with a five minute Apgar score of 0 to 5.

(E) Severe and persistent metabolic abnormality, including but not limited to hypoglycemia, acidemia, and hyperbilirubinemia in excess of the usual exchange transfusion level.

(F) Neonatal seizures or nonfebrile seizures during the first three years of life.

(G) Central nervous system lesion or abnormality.

(H) Central nervous system infection.

(I) Biomedical insult including, but not limited to, injury, accident or illness which may seriously or permanently affect developmental outcome.

(J) Multiple congenital anomalies or genetic disorders which may affect developmental outcome.

(K) Prenatal exposure to known teratogens.

(L) Prenatal substance exposure, positive infant neonatal toxicology screen or symptomatic neonatal toxicity or withdrawal.

(M) Clinically significant failure to thrive, including, but not limited to, weight persistently below the third percentile for age on standard growth charts or less than 85% of the ideal weight for age and/or acute weight loss or failure to gain weight with the loss of two or more major percentiles on the growth curve.

(N) Persistent hypotonia or hypertonia, beyond that otherwise associated with a known diagnostic condition.

(2) High risk for a developmental disability also exists when a multidisciplinary team determines that the parent of the infant or toddler is a person with a developmental disability and the infant or toddler requires early intervention services based on evaluation and assessment as specified in section 52082 and section 52084.

(d) A developmental delay shall not be determined based on:

(1) Temporary physical disability;

(2) Cultural or economic factors;

(3) The normal process of second language acquisition; or

(4) Manifestation of dialect and sociolinguistic variance.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1432(5), 1432(3) and 1435(a)(1), Title 20 United States Code; Sections 303.10, 303.16 and 303.300, Title 34 Code of Federal Regulations; Sections 95014 and 95028(b)(2), Government Code; and Section 4642, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Subchapter 2. Program and Service Components

Article 1. Child Find & Referral

§52040. Child Find.

Note • History

(a) Regional centers and LEAs shall conduct child find activities to locate all infants and toddlers who may be eligible for early intervention services.

(b) Child find activities may include:

(1) Assigning liaisons to local hospitals and hospitals with neonatal intensive care units;

(2) Contacting local parent organizations and support groups;

(3) Distributing early intervention materials to agencies and individuals providing medical, social and educational services in the community;

(4) Community-wide health and developmental screening;

(5) Producing and distributing public service announcements;

(6) Producing pamphlets, brochures and other written communication; and,

(7) Making presentations to local professional groups, philanthropic organizations and other organizations established to inform and/or to serve culturally diverse populations.

(d) Primary referral sources include but are not limited to hospitals, including prenatal and postnatal care facilities, physicians, parents, child care programs, LEAs, public health facilities, other social services agencies and other health care providers.

(e) Regional centers and LEAs shall inform primary referral sources of the:

(1) Eligibility criteria for early intervention services;

(2) Types of early intervention services available through the Early Start Program;

(3) Contact persons and telephone numbers for regional centers and LEAs; and,

(4) Federal requirement that a referral shall be made to the regional center or LEA within two (2) working days of identification of an infant or toddler who is in need of early intervention services.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1435(a)(5), Title 20, United States Code; Section 303.321, Title 34 Code of Federal Regulations; and Section 95022(b) and (e), Government Code.

HISTORY

1. New subchapter 2, article 1 (sections 52040-52060) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of subsection (b) (Register 98, No. 5).

3. New subchapter 2, article 1 (sections 52040-52060) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New subchapter 2, article 1 (sections 52040-52060) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (d) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52060. Referral.

Note • History

The regional center or LEA that receives an oral or written referral for early intervention services shall ensure that:

(a) The date of the referral is documented in the infant's or toddler's record;

(b) A service coordinator is assigned pursuant to Section 52120 of these regulations; and,

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 303.321(d), Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Evaluation and Assessment

§52082. Procedures for Evaluation to Determine Eligibility.

Note • History

(a) The determination of eligibility for an infant or toddler shall be made by qualified personnel of the regional center or LEA. The determination shall be made with the participation of the multidisciplinary team including the parent.

(b) Evaluation to determine eligibility shall be based on informed clinical opinion and include:

(1) A review of pertinent records related to the infant or toddler's health status and medical history provided by qualified health professionals who have evaluated or assessed the infant or toddler;

(2) Information obtained from parental observation and report; and,

(3) Evaluation by qualified personnel of the infant's or toddler's level of functioning in each of the following areas:

(A) Cognitive development;

(B) Physical and motor development, including vision and hearing;

(D) Social or emotional development; and,

(E) Adaptive development.

(d) Standardized tests or instruments may be used as part of the evaluation specified in 52082(b) above, and, if used, they shall:

(1) Be selected to ensure that, when administered to an infant or toddler with impaired sensory, motor or speaking skills, the tests produce results that accurately reflect the infant's or toddler's aptitude, developmental level, or any other factors the test purports to measure and not the infant's or toddler's impaired sensory, motor or speaking skills unless those skills are the factors the test purports to measure;

(2) Be validated for the specific purpose for which they are used.

(e) If standardized, normed or criterion referenced instruments are used as part of the evaluation specified in 52082(b) above, a significant difference between an infant's or toddler's current level of functioning and the expected level of development for his or her age shall be established when an infant's or toddler's age equivalent score falls one third below age expectation.

(f) Procedures and materials for evaluation and assessment of infants and toddlers shall be selected and administered so as not to be racially or culturally discriminatory.

(g) Infants or toddlers with solely low incidence disabilities shall be evaluated and assessed by qualified personnel of the LEA whose professional preparation, license or credential authorization are specific to the suspected disability.

(h) Regional centers, LEAs and multidisciplinary teams shall not presume or determine eligibility, including eligibility for medical services provided through the Department of Health Care Services, for any other state or local government program or service when conducting evaluations or assessments of an infant or toddler or their family.

(i) Evaluations for eligibility shall be conducted in natural environments whenever possible.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 303.300(b) and (c), 303.322, 303.344 and 303.323(b) and (c), Title 34 Code of Federal Regulations; and Sections 95014(a)(1) and 95016, Government Code.

HISTORY

1. New article 2 (sections 52082-52086) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of subsections (b) and (d)(2)(B) (Register 98, No. 5).

3. New article 2 (sections 52082-52086) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New article 2 (sections 52082-52086) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

6. Amendment of section heading and subsection (b) and new subsection (i) filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

7. Change without regulatory effect amending subsection (h) filed 9-24-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 39).

§52084. Assessment for Service Planning.

Note • History

(a) Assessment for service planning for eligible infants or toddlers shall identify all of the following:

(1) The infant or toddler's unique strengths and needs in each of the five areas specified in Section 52082(b)(3);

(2) Early intervention and other services appropriate to meet the needs identified in (a)(1) of this subsection; and

(3) If the family consents to a family assessment, the resources, priorities and concerns of the family and the supports and services necessary to enhance the family's capacity to meet the developmental needs of an infant or toddler with a disability.

(b) For purposes of service planning, regional centers and LEAs may use existing evaluation materials if the multidisciplinary team agrees that the existing materials adequately describe the levels of development and service needs for the infant or toddler.

(c) Assessment for service planning shall be based on age appropriate methods and procedures which may include any of the following:

(1) A review of information related to the infant's or toddler's health status and medical history provided by qualified health professionals who have evaluated or assessed the infant or toddler;

(2) Developmental observations by qualified personnel and the parent;

(3) Other procedures used by qualified personnel to determine the presence of a developmental delay, established risk condition, or high risk for a developmental disability; and

(4) Standardized tests or instruments.

(d) Assessments of family resources, priorities and concerns related to enhancing the development of the infant or toddler shall be voluntary on the part of the family. The family assessment shall:

(1) Be conducted by qualified personnel trained to utilize appropriate methods and procedures;

(2) Be based on information provided by the family through a personal interview;

(3) Incorporate the family's description of its resources, priorities and concerns related to enhancing the development of the infant or toddler; and,

(4) Be conducted in the language of the family's choice or other mode of communication unless it is not feasible to do so.

(e) Assessments for service planning shall be conducted in natural environments whenever possible.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections Sections 1435(a)(3) and 1436(a)(1), Title 20 United States Code; Section 303.322, Title 34 Code of Federal Regulations; and Sections 95014 and 95016, Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (a)(3), repealer and new subsection (b), and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. Amendment of subsection (e) filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

§52086. Time Lines for Completion of Evaluation and Assessment.

Note • History

(a) Except as provided in subsection (b), the initial evaluation and assessment for eligibility for each infant or toddler shall be completed within 45 days of the date that the regional center or LEA received the referral.

(b) In the event of exceptional circumstances which make it impossible to complete the initial evaluation and assessment for eligibility within 45 days of receiving a referral, the service coordinator shall:

(1) Document the exceptional circumstances in the infant's or toddler's record;

(2) Inform the parent of the reasons for the delay;

(3) Inform the parent of an alternative time line which includes a specific date for completing the evaluation as soon as possible; and,

(4) Document that the parent has been informed and is in agreement with the reasons documented for the extension beyond 45 days.

(c) If an infant or toddler has been determined eligible but the assessment required in Section 52082 has not been completed within 45 days of receiving a referral because of exceptional circumstances, the service coordinator shall:

(1) Document the exceptional circumstances in the infant's or toddler's record;

(2) Inform the parent of the reasons for the delay;

(3) Develop an interim IFSP pursuant to Section 52107 of these regulations; and,

(4) Provide the services agreed upon in the interim IFSP.

(d) At the parent's signed request, regional centers or LEAs may extend the 45 day time line for completion of evaluation and assessment. The request for an extension shall be documented in the infant's or toddler's record.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1435(a)(3), Title 20 United States Code; Sections 303.322(d), 303.322(e) and 303.345(b), Title 34 Code of Federal Regulations; and Sections 95016(b) and 95020(b), Government Code.

HISTORY

2. Editorial correction of subsection (b)(3) (Register 98, No. 5).

3. New section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (a) and (b)(4) and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Subchapter 3. Individualized Family Service Plan

Article 1. General

§52100. Individualized Family Service Plan (IFSP).

Note • History

Regional centers and/or LEAs shall ensure that a written IFSP is developed for providing early intervention services. The IFSP shall address the infant's or toddler's developmental needs and the needs of the family related to meeting the developmental needs of the infant or toddler. An IFSP shall be developed and implemented for each infant or toddler who has been evaluated, assessed and determined to be eligible for early intervention services.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(4) and 1436(a)(2), Title 20 United States Code; Sections 303.14, 303.340 and 303.342, Title 34 Code of Federal Regulations; and Section 95020, Government Code.

HISTORY

1. New subchapter 3, article 1 (section 52100) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New subchapter 3, article 1 (section 52100) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New subchapter 3, article 1 (section 52100) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Content and Procedures for the IFSP

§52102. Procedures for IFSP Development, Review and Evaluation.

Note • History

(a) An initial IFSP shall be developed by the regional center and/or LEA for each eligible infant or toddler, who has been evaluated and assessed, within 45 days of the receipt , by either the regional center or LEA, of the oral or written referral except as provided for in Section 52107 of these regulations.

(b) A periodic review of the IFSP for an infant or toddler and the infant's or toddler's family shall be conducted every six months, or more frequently if service needs change, or if the parent requests such a review.

(1) The degree to which progress toward achieving the outcomes is being made; and

(2) All modifications or revisions of the outcomes or services as necessary.

(d) The periodic review of the IFSP may be carried out by a meeting or by another means that is acceptable to the parent and other participants.

(e) An annual meeting to review the IFSP shall be conducted to document the infant's or toddler's progress and revise its provisions and shall include team members as specified in Section 52104 of these regulations.

(f) Information obtained from ongoing assessment shall be used in reviewing and revising outcomes and determining the appropriate services that will be provided or continued.

(g) All IFSP meetings shall be conducted:

(1) In settings and at times or by means that are reasonably convenient to the parent; and

(2) In the language of parent's choice unless it is clearly not feasible to do so.

(h) Meeting arrangements shall be made with, and written notice provided to, the parent and other members of the multidisciplinary team in a timely manner to ensure attendance at the IFSP meeting pursuant to the general notice requirements contained in Section 52161 of these regulations.

(i) The contents of the initial and annual IFSP and changes to the IFSP resulting from the periodic review shall be fully explained and a legible copy of the document given to the parent. Written consent from the parent shall be obtained prior to the provision of early intervention services described in the IFSP as required in Section 52162(a) of these regulations.

(j) If the parent does not provide consent with respect to a particular early intervention service listed in the IFSP or withdraws consent after first providing it, that service shall not be provided. The early intervention services to which parental consent is obtained shall be provided.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(4) and 1436, Title 20 United States Code; Sections 303.340, 303.342, 303.343, 303.344 and 303.403, Title 34 Code of Federal Regulations; and Section 95020(b), Government Code.

HISTORY

1. New article 2 (sections 52102-52110) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New article 2 (sections 52102-52110) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52102-52110) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (a), (h) and (i) and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52104. Participants in Initial and Annual IFSP Meetings and Periodic Reviews.

Note • History

(a) Each initial IFSP meeting and each annual IFSP meeting shall include the following participants:

(1) The parent of the infant or toddler;

(2) The service coordinator who has been working with the family since the initial referral of the infant or toddler for evaluation and assessment or who has been designated by the regional center or LEA to be responsible for implementation of the IFSP; and,

(3) The person(s) who conducted the evaluations or assessments.

(b) If requested by the parent, each initial IFSP meeting and each annual IFSP meeting shall include the following participants:

(1) Other family members; and

(2) An advocate or person outside of the family.

(c) Each IFSP meeting shall include persons who will be providing services to the infant or toddler and family, as appropriate.

(d) Each periodic review of the IFSP shall include:

(1) The parent;

(2) The service coordinator;

(3) Service providers as appropriate; and,

(4) Other family members, an advocate or person outside of the family upon parent request.

(e) If either the evaluators or assessors are unable to attend an initial, or annual IFSP meeting, arrangements shall be made for the person's involvement through other means, including:

(1) Participating in a telephone conference call;

(2) Having a knowledgeable representative attend an IFSP meeting; and

(3) Making pertinent records available at the IFSP meeting.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(b)(4) and 1436(b), Title 20 United States Code; Section 95020(e), Government Code; and Section 303.343, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (e) and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52106. Content of IFSP.

Note • History

(a) For purposes of this Section:

(1) Duration means the period between the initiation date of services and the ending date of services in the IFSP.

(2) Frequency means the number of days or sessions that a service will be provided during a specified period of time, such as, two times each week or four times each month.

(3) Initiation means the beginning date of the service.

(4) Intensity means the length of time the service is provided during each session, and whether the service is provided in a group or individual setting.

(5) Location means the environment where early intervention services are provided.

(6) Method means how a service is provided by qualified persons to accomplish a specified outcome.

(b) The IFSP shall include the following:

(1) With the agreement of the parent, a statement of the family's resources, priorities, and concerns related to enhancing the development of the infant or toddler;

(2) A statement, based on evaluation and assessment information, of the infant's or toddler's present levels of:

(A) Physical development including fine and gross motor development, vision, hearing, and health status;

(B) Cognitive development;

(D) Social or emotional development; and,

(E) Adaptive development;

(3) The statement of present levels of development required in subsection (b)(2) of this section shall be based on evidence that can be measured or observed by a qualified professional;

(4) A statement of the developmental outcomes expected for the infant or toddler and the criteria, procedures, and time lines used to determine the degree to which progress toward achieving outcomes is being made. Such outcomes shall be based on the identified needs of the infant or toddler and family pursuant to assessment;

(5) A statement about the outcomes for the family when services for the family are related to meeting the special developmental needs of the infant or toddler;

(6) Statements of the specific early intervention services necessary to meet the unique needs of the infant or toddler and the family to achieve the outcomes including:

(A) The frequency, intensity, and method of delivering the services;

(B) The location where the services will be delivered;

1. The statements of location shall specify the natural environments such as home, child care, school program, or private program where early intervention services shall be provided; and

2. The statement shall include a justification of the extent, if any, to which the services will not be provided in a natural environment.

(D) The anticipated duration of the services;

(E) The scheduled days when services/programs will not be available when the service provider operates a program which has a fixed schedule which includes breaks in service for periods such as holidays or vacations; and

(F) The name of the regional center, LEA or service provider providing each early intervention service;

(7) The funding source for other or non-required services provided by any entity other than regional centers or LEAs including the procedures that will be followed to obtain such funding;

(8) The name of the service coordinator; and,

(9) A statement of the transition steps, which are initiated when the toddler is two years nine months, or at the discretion of all parties, up to six months before the toddler turns three years old, that are necessary to ensure the transition of the toddler to:

(A) Preschool services under Part B of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1400-1420, if the toddler with a disability is eligible; or

(B) Other public and private services that may be needed by the toddler pursuant to Section 52112 of these regulations.

(c) Regional centers and LEAs shall not place an infant or toddler on a waiting list for early intervention services required by the IFSP.

(d) Regional centers and LEAs shall arrange, provide or purchase early intervention services required by the IFSP as soon as possible.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1400-1420 and 1436(d), Title 20 United States Code; Sections 303.12 and 303.344, Title 34 Code of Federal Regulations; and Section 95020, Government Code.

HISTORY

2. Change without regulatory effect amending subsections (a)(4) and (b)(9) filed 8-7-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 32).

3. Editorial correction of subsections (b)(6)(C) and (b)(6)(E) (Register 98, No. 5).

4. New section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

5. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (a)(2), (a)(5), (a)(6), (b)(6)(E) and (b)(9), new subsections (b)(6)(B)1. and 2., and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52107. Interim IFSP.

Note • History

(a) An interim IFSP may be developed for an infant or toddler, who has been determined eligible for early intervention services. The early intervention services may begin before the completion of the assessment if there is an immediate need to provide services and the infant's or toddler's parent has given written consent.

(b) The interim IFSP shall include:

(1) Time lines for completing assessments;

(2) The name of the service coordinator responsible for completion of evaluation and assessment within the 45 day timeline and implementation of the interim IFSP;

(3) The services agreed upon at the interim IFSP meeting as necessary for the infant or toddler.

(c) An interim IFSP meeting shall provide for the participation of the parent and the service coordinator and the persons responsible for the assessment at a minimum pursuant to Section 52104(a) of these regulations. Provisions shall be made for the participation of other family members, an advocate or person outside of the family at the parent's request.

(d) The immediate need, the early intervention services needed and the name of the service coordinator must be documented in the infant's or toddler's interim IFSP.

(e) The existence of an interim IFSP does not absolve the regional center or LEA from complying with the 45 day time period to complete the initial assessment in all five areas of development.

(f) An interim IFSP developed to meet an immediate need shall be followed by an IFSP meeting within the 45-day period that commenced with the referral except as provided for in Section 52086(d) of these regulations.

(g) An interim IFSP may be developed for an infant or toddler who has been determined eligible when exceptional circumstances prevent the completion of assessment within 45 days.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 303.322(e)(2)(ii) and 303.345, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (b)(2) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52108. Designation of Services on the IFSP.

Note • History

(a) Each service on the IFSP shall be designated as one of the following:

(1) A required early intervention service. These services shall be provided, purchased or arranged by a regional center or LEA; or

(2) Other public programs providing services that may benefit the infant, toddler and/or family which the eligible infant or toddler or his or her family may be eligible to receive, subject to the statutory, regulatory and other program criteria of those programs or agencies. These services may include but not be limited to: residential care; family reunification services, Head Start, Supplemental Security Income; Supplemental Security Programs; Temporary Assistance to Needy Families and food stamps; Medi-Cal; or

(3) A referral to a community service that may be provided to an eligible infant or toddler or his or her family but is not required under the California Early Intervention Services Act, Government Code Sections 95000-95030.

(A) A non required service includes but is not limited to: employment; child care; housing; medical services such as surgery, or medication, hospitalization, medical devices necessary to control or treat a medical condition, or immunizations, well-baby care, income support, family or marital counseling unrelated to the infant or toddler's development, and substance abuse counseling.

(B) The IFSP shall, to the extent appropriate, include the steps and time lines for the service coordinator to assist the parent to secure those services through public or private sources.

(b) The receipt of required early intervention services listed on the IFSP, pursuant to Section 52108(a)(1) of these regulations, from other state or federal agencies such as California Children Services, is dependent on the infant or toddler and the infant's or toddler's parent meeting the statutory, regulatory, and other program criteria of the agency and/or program that provides those services. These criteria may include financial eligibility and medical condition eligibility as diagnosed by program certified personnel, and on the availability of funding for the program.

(1) In the event that the infant or toddler or infant's or toddler's parent is not eligible to receive those agency services, or funding for the program is unavailable, the required early intervention services shall be provided by the regional center or the LEA.

(2) The parent shall be informed in writing of this provision during the initial 45 day evaluation and assessment period and/or during the IFSP meeting.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1435(a)(4), Title 20 United States Code; Sections 303.12, 303.522 and 303.527(c), Title 34 Code of Federal Regulations; and Section 95020(d), Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (a)(2) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52109. Basis for the Provision of and Payment for Services Through Regional Centers.

Note • History

(a) Regional centers shall provide, arrange, or purchase early intervention services, as required by the infant's or toddler's IFSP, and be payor of last resort for infants and toddlers determined eligible for early intervention services as:

(1) Developmentally delayed pursuant to 52022(a);

(2) Established risk pursuant to 52022(b)(1); or

(3) High risk for developmental disability pursuant to 52022(c).

(b) Regional centers shall be the payor of last resort after all other public sources for payment have been reviewed to determine if a referral shall be made by the service coordinator and/or the parent. Referrals may include but not be limited to California Children Services, Medi-Cal, or other public agencies that may have responsibility for payment. This review shall not delay the provision of early intervention services specified on the IFSP. Early Intervention services specified on the IFSP shall begin as soon as possible.

(c) The use of the family's private insurance to pay for evaluation, assessment, and required early intervention services specified on the infant or toddler's IFSP, shall be voluntary.

For purposes of this subsection, voluntary means there is documentation in the child's record that parents have been informed of their right to receive evaluation, assessment and required early intervention services at no cost to the family and that the use of private insurance is voluntary.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(10) and (c) and 1440, Title 20 United States Code; Sections 303.12, 303.520 and 303.527, Title 34 Code of Federal Regulations; and Sections 95004 and 95014(b), Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (b) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. Amendment of section heading and subsection (b), new subsection (c) and amendment of Note filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

§52110. Basis for the Provision of Services Through LEAs.

Note • History

(a) LEAs shall provide, arrange, or purchase early intervention services, as required by the infant's or toddler's IFSP, and be payor of last resort for infants and toddlers with solely low incidence disabilities determined eligible for early intervention services under the category of established risk as specified in Section 52022(b)(2) of these regulations and who are not eligible for regional center services.

(b) LEAs, pursuant to Education Code Section 56425, shall provide services for infants and toddlers who are also eligible for regional center services when the infant or toddler is identified as an individual with exceptional needs pursuant to Education Code Section 56026 and Title 5 California Code of Regulations Section 3030 and who requires intensive special education services and:

(1) The infant or toddler is functioning at or below 50% of his or her chronological age level in any one of the following skill areas:

(A) Gross or fine motor development;

(B) Receptive or expressive language development;

(D) Cognitive development;

(E) Visual development; or,

(2) The infant or toddler is functioning between 51% and 75% of his or her age level in any two of the skill areas identified in (b)(1)(A) through (b)(1)(E) of this section; or,

(3) Has a condition of known etiology which has a high probability of resulting in developmental delay as specified in section 52022(b)(1); and,

(4) The LEA is operating below the funded capacity as required by Government Code section 95014(c).

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1440, Title 20 United States Code; Sections 303.520 and 303.527, Title 34 Code of Federal Regulations; and Sections 95014(b) and (c), Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 3. Transfer and Transition Procedures

§52111. Transfer.

Note • History

(a) Regional centers and LEAs shall use existing information whenever possible to determine continued eligibility and to minimize delay in the provision of appropriate early intervention services when an eligible infant's or toddler's residence changes to another regional center or LEA.

(b) The procedures contained in Welfare and Institutions Code section 4643.5, pertaining to transfers between regional centers, shall apply for an infant or toddler with an existing IFSP who moves from an area where he or she received early intervention services from a regional center into another regional center area.

(c) The procedures contained in Education Code section 56325, pertaining to an IEP, shall apply instead for an infant or toddler with an existing IFSP who moves from an area where he or she received early intervention services from an LEA into another LEA that provides early intervention services and the LEA is operating below the funded capacity, or for an infant or toddler with a solely low incidence disability.

(d) For an infant or toddler, with an existing IFSP, who is receiving early intervention services from an LEA:

(1) Who has not been determined eligible for regional center services; and,

(2) Who moves from an area where an LEA provides early intervention services to an area where there are no services available for the infant or toddler through the LEA.

(A) With parent consent, the sending LEA, if informed about the move by the family, shall notify the receiving regional center as soon as possible of a move to the new area and transmit the infant or toddler's record to expedite service delivery in the new area; or

(B) With parent consent, the LEA shall transmit the infant or toddler's record upon request of the receiving regional center if the LEA was not previously informed of the move by the family.

1. Assign a service coordinator as specified in section 52060; and,

2. Arrange, purchase or provide early intervention services to the extent possible within existing resources as specified on the infant's or toddler's current IFSP as soon as possible; and,

3. Within 30 days of receipt of evaluation and assessment materials from the LEA determine eligibility and conduct a periodic review of the IFSP.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 4643.5, Welfare and Institutions Code; and Section 56325, Education Code.

HISTORY

1. Amendment of article 3 heading and new section filed 7-28-98; operative 8-27-98 (Register 98, No. 31).

§52112. Transition from Early Intervention Services.

Note • History

(a) LEAs shall provide special education and related services to eligible children at age three. Pursuant to the requirements contained in Title 34 Code of Federal Regulations, Section 303.344, each LEA shall participate in the transition planning for toddlers served under the Early Intervention Services Act, Government Code Sections 95000-95030, who may be eligible for preschool programs under Part B of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1400-1420, before the toddler is two years nine months, or at the discretion of all parties up to six months before the child turns three to ensure that an IEP has been developed and is implemented by the toddler's third birthday.

(b) The service coordinator, six months before the third birthday of the toddler receiving early intervention services, shall:

(1) Notify the parent of a toddler who may be eligible for special education and related services under Part B of the Individuals with Disabilities Education Act that transition planning will occur within the next three to six months;

(2) Notify the LEA where the toddler resides that there will be an IFSP meeting requiring the attendance of an LEA representative pursuant to 34 CFR 300.132, before the toddler is two years nine months, or at the discretion of all parties, up to six months before the toddler turns three years old to specify the transition steps necessary for movement into services under Part B of the Individuals with Disabilities Education Act; and,

(3) Within thirty days following notification of the parent and the LEA, the family, service coordinator, and LEA shall agree on the date for the IFSP to specify the transition steps necessary for movement into services under Part B.

(c) For all toddlers with an IFSP, the transition steps contained in the IFSP at two years nine months or earlier shall include all of the following:

(1) Discussions with and providing information to parents regarding:

(A) The toddler's transition to special education for a toddler with a disability who may be eligible for special education and related services under Part B of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1400-1420; and,

(B) Steps to prepare the toddler for changes in service delivery, including steps to help the toddler adjust to, and function in, a new setting;

(2) Provide information about community resources such as Head Start, Child Development Preschools, private or public preschool, for a toddler who will not be eligible for special education services after thirty six months of age; and,

(3) A projected date for conducting a final review of the IFSP to review the early intervention services and the transition outcomes by age three.

(d) For toddlers who may be eligible for preschool services from the LEA under Part B of The Individuals with Disabilities Education Act, Title 20 United States Code Section 1400-1420, the transition steps necessary for movement into services under Part B or other appropriate program, written at the IFSP meeting before the toddler is two years nine months, or, at the discretion of all parties, up to six months before the toddler's third birthday, shall include all of the following:

(1) With parental consent, the transmission of information about the toddler to the LEA including evaluation and assessment information and copies of IFSPs that have been developed and implemented;

(2) Identifying needed assessments to determine regional center and special education eligibility and determining the regional center or LEA responsible and time lines for completing the needed assessments;

(3) Statements of the steps necessary to ensure that the referral to an LEA is received by the LEA in a timely manner to ensure that assessments required under the provisions of Part B of the Individuals with Disabilities Education Act are completed and an IEP is implemented by the toddler's third birthday;

(4) A referral for evaluation and assessment for services under Part B of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1400-1420, no later than the time that the toddler is two years nine months of age or before the LEA's break in school services if the toddler will become three years of age during a break in school services. The transition IFSP shall contain steps necessary to satisfy the referral and IEP development requirements contained in Education Code Sections 56321 and 56344;

(5) Identification of the people responsible for convening an IEP and final IFSP meeting, and the person responsible for convening an IPP meeting, if necessary, for a toddler by age three to:

(A) Review the progress toward meeting the early intervention services outcomes identified in the IFSP;

(B) Determine the eligibility for special education and develop the IEP; and,

(C) Develop an IPP if the toddler is also eligible for services under the Lanterman Developmental Disabilities Services Act as required in Welfare and Institutions Code Section 4646.

(e) If a toddler is older than two years and six months on the date of the initial IFSP, the IFSP shall include steps to ensure transition to Special Education Services under Part B of the Individuals with Disabilities Education Act or other services that may be appropriate.

(f) Regional centers may continue providing or purchasing services for a preschooler who has been determined eligible for regional center services:

(1) Until the beginning of the next school term after the toddler's third birthday during a period when the LEA special education preschool program is not in session; and,

(2) When the multidisciplinary team determines that services are necessary until the LEA special education program resumes.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1436(d)(8), Title 20 United States Code; Sections 303.148, 303.322, 303.340, 303.342, 303.343, 303.344(h) and 303.346, Title 34 Code of Federal Regulations; and Sections 56321, 56343 and 56344, Education Code.

HISTORY

1. New article 3 (section 52112) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of subsection (b)(1) (Register 98, No. 5).

3. New article 3 (section 52112) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New article 3 (section 52112) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Subchapter 4. Service Coordination and Interagency Agreements

Article 1. Service Coordination

§52120. General.

Note • History

(a) Regional centers or LEAs shall assign a service coordinator under the following circumstances:

(1) At the time that infants or toddlers are referred for evaluation and assessment; and,

(2) When infants or toddlers are determined eligible for early intervention services from regional centers and/or LEAs.

(b) A parent may perform service coordination activities for his or her own infant or toddler in collaboration with the service coordinator assigned by the regional center or LEA.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 303.22 and 303.344(g), Title 34 Code of Federal Regulations; and Section 95018, Government Code.

HISTORY

1. New subchapter 4, article 1 (sections 52120-52122) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of subsection (a)(1) and History 1 (Register 98, No. 5).

3. New subchapter 4, article 1 (sections 52120-52122) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New subchapter 4, article 1 (sections 52120-52122) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52121. Service Coordination Responsibilities.

Note • History

(a) The service coordinator shall:

(1) Provide the initial notice to the parent pursuant to Section 52160 of these regulations;

(2) Obtain consent pursuant to Section 52162 of these regulations and provide written notice pursuant to Section 52161;

(3) Serve as the primary point of contact for coordinating services and assistance for the infant's or toddler's parent, service providers and regional center and/or public agencies;

(4) Inform the parent of the availability of additional non-required services as specified in Section 52108(a)(3)(A) of these regulations which may provide assistance to the family;

(5) Facilitate the delivery of services on the initiation date identified in the IFSP;

(6) Continuously seek the appropriate services and service providers necessary to enhance the development of each infant or toddler being served for the duration of the infant's or toddler's eligibility;

(7) Coordinate the performance of initial and subsequent evaluations and assessments;

(8) Participate in the development and review of the IFSP;

(9) Monitor the delivery of services and the degree to which progress toward achieving outcomes is being made through the periodic review of the IFSP;

(10) Inform the parent of advocacy services and procedural safeguards contained in these regulations;

(11) Facilitate the exchange of information between service providers including health providers, medical case managers, regional centers and LEAs; and

(12) Facilitate the development of transition steps in the IFSP.

(b) Service Coordination may include medical case management services provided by another agency such as High Risk Infant Follow-up Program, California Children Services or Medi-Cal Managed Care.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1436(d)(8), Title 20 United States Code; Sections 303.22 and 303.344(g), Title 34 Code of Federal Regulations; and Section 95018, Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (b) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52122. Service Coordinator Qualifications.

Note • History

Service coordinators shall have demonstrated knowledge about:

(a) Infants and toddlers who are referred for evaluation and assessment or who are eligible for early intervention services;

(b) Working with families and community resources; and

(1) Parent rights and responsibilities;

(2) Due process;

(3) Confidentiality;

(4) Required components of the IFSP;

(5) Time lines specified within these regulations beginning with section 52000 et seq.; in Sections 52086(a), 52112(b), 52164(b), 52168(c), 52171(a) and 52174(c) of these regulations;

(6) Transition processes from the early intervention service system specified in section 52112 of these regulations; and,

(7) The system of payments for services identified in the IFSP.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1436(d)(8), Title 20 United States Code; Sections 303.22(d) and 303.344(g), Title 34 Code of Federal Regulations; and Section 95018, Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (c)(5) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Interagency Agreements

§52140. Local Interagency Agreements.

Note • History

(a) Regional centers and LEAs shall develop and maintain local interagency agreements.

(b) Local interagency agreements shall include, but not be limited to, the following:

(1) The responsibilities of each LEA and regional center for meeting the terms of the agreement;

(2) Procedures for coordination of child find activities with local public agencies and regional centers to identify infants and toddlers who may be eligible for early intervention services;

(3) Specific procedures for coordination of referrals for evaluation and assessment;

(4) Procedures for the assignment of a service coordinator;

(5) Interagency procedures for identifying the responsibilities of the regional center and LEA for completing the evaluation and assessment and determining eligibility within the time requirements contained in Section 52086 of these regulations, when an infant or toddler may receive services from both the regional center and LEA;

(6) Procedures for the timely exchange of information between regional centers and LEAs;

(7) Mechanisms for ensuring the availability of contacts at regional centers and LEAs at all times during the year;

(8) Procedures for interagency IFSP development when infants and toddlers may be eligible for early intervention services from the regional center and the LEA or other state or local programs or services;

(9) Procedures to ensure the provision of services during periods of school vacations when services are required on the IFSP;

(10) Transition planning procedures which begin at least six months prior to a toddler's third birthday pursuant to Section 52112 of these regulations;

(11) Procedures for resolving disputes between regional centers and LEAs;

(12) Procedures for the training and assignment of surrogate parents; and

(13) Procedures for accepting transfers of infants or toddlers with existing IFSPs.

(d) Interagency agreements shall be reviewed by both parties annually, revised as necessary, dated, and signed by both parties.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1435(a)(10, Title 20 United States Code; Sections 303.1, 303.174, 303.523 and 303.524, Title 34 Code of Federal Regulations.

HISTORY

1. New article 2 (section 52140) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New article 2 (section 52140) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New article 2 (section 52140) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (c), new subsection (d), and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Subchapter 5. Procedural Safeguards

Article 1. Notice and Consent

§52160. Initial and Annual Notice.

Note • History

Prior to the initial evaluation and assessment to determine eligibility required in Section 52082 of these regulations and annually thereafter, service coordinators shall give written notice to the parent, which shall include:

(a) The personally identifiable information maintained by the regional center or LEA;

(b) The types of information used in the evaluation, assessment and IFSP development; and,

(c) The methods that regional centers and LEAs use to protect the confidentiality of personally identifiable information including:

(1) The sources from whom personally identifiable information is gathered;

(2) The uses to be made of the personally identifiable information;

(3) The policies and procedures which regional centers and LEAs follow regarding storage, disclosure to third parties, retention, and destruction of personally identifiable information as required in Title 34 Code of Federal Regulations, Sections 300.572 through 300.573; and,

(4) The rights of parents and infants and toddlers regarding access to information, including the rights accorded to families in these regulations and the rights under the Family Education Rights and Privacy Act of 1974, Title 20, United States Code, Section 1232(g) and implementing regulations in Title 34 Code of Federal Regulations, Section 99.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 99.7, 300.561(a)(4) and 303.460, Title 34 Code of Federal Regulations; and Sections 1232(g), 1476(b)(12) and 1480(2) and (3), Title 20 United States Code; and Section 95007(g), Government Code.

HISTORY

1. New subchapter 5, article 1 (sections 52160-52162) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of Note (Register 98, No. 5).

3. New subchapter 5, article 1 (sections 52160-52162) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New subchapter 5, article 1 (sections 52160-52162) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52161. General Notice Requirements.

Note • History

(a) Written notice shall be given to the parent of an infant or toddler, eligible or suspected to be eligible to receive early intervention services, a reasonable time before a regional center or LEA proposes, or refuses, to initiate or change:

(1) The identification, evaluation, assessment or placement of the infant or toddler; or

(2) Early intervention services to the infant or toddler and the infant's or toddler's family.

(b) The notice shall be in sufficient detail to inform the parent about:

(1) The action that is being proposed or refused;

(2) The reasons for taking the action; and

(3) All procedural safeguards that are available under Title 34 Code of Federal Regulations, Sections 303.400 through 303.460.

(1) Written using words that are understandable to the general public; and

(2) Provided in the language of the parent's choice, unless it is clearly not feasible to do so. The regional center or LEA shall take steps to ensure that:

(A) The notice is translated;

(B) The parent understands the notice; and

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 95007(g), Government Code; Sections 1435(a)(13) and 1439(6)-(7), Title 20 United States Code; and Sections 303.403(a), 303.403(b) and 303.403(c)(1)-(2), Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52162. Consent.

Note • History

(a) The service coordinator shall obtain written parental consent before:

(1) The initial evaluation and assessment of an infant or toddler is conducted; and

(2) Early intervention services are initiated.

(b) The infant's or toddler's record shall contain written evidence that the parent has been informed:

(1) Of information relevant to the evaluation, assessment, early intervention service, or exchange of records for which consent is sought, in the language of the parent's choice, and agrees to the completion of the evaluation or assessment and the provision of early intervention services;

(2) That consent is voluntary and may be revoked at any time;

(3) That he/she may accept or decline any early intervention service and may decline such service after first accepting it, and continue to receive other early intervention services; and,

(4) About who will receive the records and a listing of the records to be exchanged.

(1) That the parent has been informed of the nature of the evaluation and assessment or the early intervention services that would have been provided;

(2) That the parent has been informed that the infant or toddler will not receive the evaluation and assessment or early intervention services unless consent is given; and,

(3) That the infant's or toddler's record contains documentation of the attempts to obtain consent.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1480, Title 20 United States Code; Sections 303.401(a)(1)-(3), 303.403(c)(2)(iii), 303.404(a), 303.404(b) and 303.405, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Access Rights

§52164. Access Rights.

Note • History

(a) A regional center and/or LEA shall permit the parent or authorized representative to inspect and review any record relating to their infant or toddler.

(b) The regional center and/or LEA shall comply with a request for access to records before any meeting regarding an IFSP or any hearing relating to the identification, evaluation, assessment, placement, or the provision of early intervention services to the infant or toddler and in no case more than 5 working days after the request has been made.

(c) A regional center and/or LEA shall respond to requests for explanations and interpretations of the content of a record from parents with the requested explanation or interpretation.

(d) A regional center and/or LEA may presume that the parent has authority to inspect and review records relating to their infant or toddler unless there is a court order, state statute, or legally binding document relating to such matters as divorce, separation or custody that specifically revokes those rights.

(e) Each service coordinator shall provide parents, on request, a list of the types and locations of records collected or used by the regional center or LEA.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(13) and 1439(4), Title 20 United States Code; Sections 300.562, 300.565, 300.576, 303.402 and 303.460, Title 34 Code of Federal Regulations; and Section 95007(g), Government Code.

HISTORY

1. New article 2 (sections 52164-52169) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New article 2 (sections 52164-52169) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52164-52169) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (c) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52165. Documentation of Access.

Note • History

(a) The regional center and/or LEA providing early intervention services to the infant or toddler shall maintain documentation specifying to whom the record was disclosed other than parents and authorized employees specified by the regional center or LEA. The parent may inspect the documentation.

(b) Documentation of access shall include:

(1) The name of the person to whom the record was disclosed;

(2) The date the record was disclosed; and

(3) The purpose for which the record was disclosed.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(13) and 1439(4), Title 20 United States Code; Sections 300.402 and 303.460, Title 34 Code of Federal Regulations; and Section 95007(g), Government Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52166. Records on More Than One Infant or Toddler.

Note • History

If a record includes information on more than one infant or toddler, the regional center or LEA shall provide, for the parent's inspection or review, only the information relating to their infant or toddler or inform the parent of that specific information.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1439(2) and (3), Title 20 United States Code; and Sections 300.564 and 303.460, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52167. Fees for Copies of Records.

Note • History

(a) A regional center or LEA may charge a reasonable fee for copies of records in an amount not to exceed the actual cost of reproducing records.

(b) The amount of the fee shall not prevent the parents from exercising their right to inspect and review those records.

(c) A regional center or LEA may not charge a fee to search for or retrieve records requested by parents or an authorized representative.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1439(3), Title 20 United States Code; Sections 300.566 and 303.460, Title 34 Code of Federal Regulations; and Section 49065, Education Code.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52168. Amendment of Records at Parental Request.

Note • History

(a) A parent, who believes that information in a regional center's or LEA's records is inaccurate or misleading or violates the privacy or other rights of an infant or toddler or family, may request that the director of the regional center or the Superintendent of the LEA amend or remove the information over which the regional center or LEA has authority.

(b) The service coordinator, upon request, shall assist a parent in communicating with those persons who created information contained in the record, when the regional center or LEA did not originate the information which the parent believes is inaccurate, misleading, or violates the privacy or other rights of an infant or toddler or family.

(c) No later than 14 days after receipt of the request for amendment or removal of information from a record, the regional center or LEA shall notify the parent if the request has been denied and advise the parent of the right to a meeting with the Director of the regional center or the Superintendent of the LEA pursuant to Title 34 Code of Federal Regulations, Section 99.20(c).

(d) If the result of the meeting is that the record will not be amended, the regional center or LEA shall inform the parent of the right to place, in the record maintained on the infant or toddler, a statement commenting on the information contained in the record or setting forth any reasons for disagreeing with the contents of any document in the child's records, regardless of whether the document was created by the regional center or LEA or by any other agency or individual.

(e) Any statement placed in the record of the infant or toddler pursuant to subsection (d) above shall:

(1) Be kept by the regional center or LEA as part of the record of the infant or toddler as long as the contested portion of the record is maintained by the regional center or LEA; and,

(2) Accompany the record of the infant or toddler if the contested portion is disclosed by the regional center or LEA.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 300.566, 300.567, 300.569 and 303.460, Title 34 Code of Federal Regulations.

HISTORY

2. Editorial correction of subsection (b) (Register 98, No. 5).

3. New section, including amendment of subsection (e) and Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (c)-(e) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52169. Consent for Release of Information.

Note • History

Written parental consent shall be obtained before personally identifiable information is disclosed in writing or orally to anyone other than authorized employees specified by the regional center or LEA.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 1435(a)(13) and 1439(2), Title 20 United States Code; and Sections 300.571 and 303.460, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 3. Complaint Process

§52170. Complaint Procedures.

Note • History

(a) A complaint shall be a written and signed statement alleging that a regional center, LEA or any private service provider receiving funds under Part C of the Individuals with Disabilities Education Act, Title 20 United States Code, Sections 1431-1445, has violated any federal or state law or regulation governing the provision of early intervention services including the process of determining eligibility provided through Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445, for infants or toddlers and their families.

(b) Any individual or organization may file a complaint.

(1) Not more than one year before the date that the complaint is received by the Department of Developmental Services unless a longer period is reasonable because the alleged violation continues for that child or other children; or

(2) Not more than three years before the date on which the complaint is received by the Department of Developmental Services, if the complainant is requesting reimbursement or corrective action as remediation of the complaint.

(d) The procedures under Chapter 1, commencing with Section 4500 of Division 4.5 of the Welfare and Institutions Code or Part 30, commencing with Section 56500 of the Education Code, or Title 5 California Code of Regulations Section 4600 et seq., shall not be used for resolving complaints regarding California's Early Start Program.

(e) Each regional center and LEA shall inform the parent and other interested individuals or organizations of the right to file a complaint directly with the Department of Developmental Services at the following address:

DEPARTMENT OF DEVELOPMENTAL SERVICES
OFFICE OF HUMAN RIGHTS
ATTENTION: EARLY START COMPLAINT UNIT
1600 NINTH STREET, ROOM 240, M.S. 2-15
SACRAMENTO, CA 95814

(f) If the complainant is unable to provide the complaint in writing, the service coordinator shall directly assist the complainant or provide assistance to identify resources which can aid the complainant in completing the written complaint.

(g) The complaint shall include the following:

(1) The name, address and phone number of the complainant;

(2) A statement that a regional center, LEA or any private service provider receiving funds under Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445, has violated any federal or state law or regulation of a Part C requirement governing the provision of early intervention services for infants or toddlers and their families in California;

(3) A statement of facts upon which the alleged violation is based;

(4) The party allegedly responsible; and

(5) A description of the voluntary steps taken at the local level to resolve the complaint, if any.

(h) Mediation is available at any time to resolve disagreements involving any matter related to IDEA Part C.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Sections 303.22 and 303.510-303.512, Title 34 Code of Federal Regulations; and Section 95007(f), Government Code.

HISTORY

1. New article 3 (sections 52170-52171) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of Note (Register 98, No. 5).

3. New article 3 (sections 52170-52171) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New article 3 (sections 52170-52171) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

6. New subsections (c)-(c)(2), subsection relettering, amendment of newly designated subsection (e) and amendment of Note filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

7. Amendment of subsections (a) and (g)(2) and new subsection (h) filed 2-17-2011; operative 3-19-2011 (Register 2011, No. 7).

§52171. Complaint Investigation.

Note • History

(a) Within 60 days of receipt of the complaint the Department of Developmental Services shall:

(1) Assign the investigation of the complaint to a state interagency team or to the appropriate state agency that is responsible for the administration of the regional center, LEA or any private service provider receiving funds under Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445, named in the complaint, which shall:

(A) Conduct an investigation, on-site if necessary; and

(B) Give the complainant the opportunity to submit additional information, either orally or in writing, about the allegations in the complaint;

(2) Review all relevant information and make a determination as to whether there has been a violation of a statutory or regulatory requirement contained in:

(A) Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445;

(B) The Federal regulations pertaining to Part C of the Individuals with Disabilities Education Act;

(D) Regulations contained in this chapter;

(E) Welfare and Institutions Code, Division 4.5, Chapter 5, beginning with Section 4500; or,

(F) Education Code beginning with Sections 56425 through 56431.

(3) Provide a written decision to all parties which addresses each allegation and includes:

(A) Findings and conclusions;

(B) The reasons for the final decision;

(D) Time lines for completion of the corrective actions; and,

(E) Provisions for technical assistance.

(4) If the decision of the Department of Developmental Services includes remedies for denial of appropriate services, the remedies may include:

(A) Actions to remediate denial of those services, including as appropriate, the awarding of monetary reimbursement or other corrective action appropriate to the needs of the child and the child's family, and

(B) Actions to assure that services are provided appropriately in the future for infants and toddlers with disabilities and their families

(b) An extension of the time limit under paragraph (a) of this Section shall be made by the Department of Developmental Services when events beyond the control of the Department of Developmental Services occur including but not limited to the complainant's illness, the complainant's absence from the geographical area, inability to locate the complainant, or a natural disaster.

(c) If a written complaint is received that is also the subject of a due process hearing pursuant to 34 CFR 303.420 and 17 CCR 52172 and 52174, or contains multiple issues, of which one or more are part of that hearing, the Department of Developmental Services shall set aside any part of the complaint that is being addressed in the due process hearing, until the conclusion of the hearing. Any issue in the complaint that is not part of the due process action will be resolved by the Department of Developmental Services within the 60 calendar-day time line using the complaint procedures described in this section.

(d) If an issue is raised in a complaint filed under this section that has previously been decided in a due process hearing involving the same parties, the hearing decision is binding, and the Department of Developmental Services shall inform the complainant to that effect.

(e) The Department of Developmental Services shall resolve any complaint alleging the failure of a public agency or private service provider to implement a due process decision.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 303.510-303.512, Title 34 Code of Federal Regulations; and Section 52007(g), Government Code.

HISTORY

2. Editorial correction of section heading (Register 98, No. 5).

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (a)(1), (a)(2)(A) and (B) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

6. Repealer and new subsection (a)(4), new subsections (a)(4)(A), (a)(4)(B) and (c)-(e) and amendment of Note filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

Article 4. Mediation and Due Process Procedures

§52172. Procedures That Apply to Both Mediation and Due Process.

Note • History

(a) A parent may request a mediation conference and/or a due process hearing under any of the following circumstances:

(1) A regional center or LEA proposes to initiate or change the identification, evaluation, assessment, placement or provision of appropriate early intervention services;

(2) A regional center or LEA refuses to initiate or change the identification, evaluation, assessment, placement or provision of appropriate early intervention services; or,

(b) A parent may also request a mediation conference at any time to resolve disagreements involving any matter related to IDEA, Part C.

(c) A regional center or LEA may request a mediation conference or a due process hearing when the parent refuses to consent to all or any part of an evaluation and assessment of the infant or toddler.

(d) All requests for a mediation conference and/or due process hearing shall be in writing and filed with the contractor that the Department of Developmental Services uses for mediation and due process hearings. If a parent is unable to make a request for mediation or a due process hearing in writing, the service coordinator shall assist the parent in filing the request.

(e) The duration for either a mediation conference or a due process hearing shall not exceed a total thirty days for each process from the receipt of the mediation or due process request to the mailing of the mediation agreement or hearing decision. If a mediation conference is requested at or during the time of a due process hearing the mediation conference resolution shall occur prior to the due process hearing.

(f) The location of the mediation and/or due process hearing shall be at a time and place reasonably convenient to the parent.

(g) During the pendency of mediation and/or due process hearing procedures, the infant or toddler shall continue to receive the early intervention services listed on the IFSP they are currently receiving. If mediation and/or due process hearing involves the initiation of a service(s) the infant or toddler shall receive those services that are not in dispute.

(h) Mediation and due process hearings shall be conducted in English and interpreted in the language of the family's choice or other mode of communication.

NOTE

Authority cited: Sections 95009 and 95028, Government Code; and Section 4712(k), Welfare and Institutions Code. Reference: Sections 1435(a)(13) and 1439(l), Title 20 United States Code; Sections 303.420 and accompanying notes, 303.421, 303.423 and 303.425, Title 34 Code of Federal Regulations; and Section 95007(g), Government Code.

HISTORY

1. New article 4 (sections 52172-52174) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of Note (Register 98, No. 5).

3. New article 4 (sections 52172-52174) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. New article 4 (sections 52172-52174) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

6. New subsection (b), subsection relettering and amendment of newly designated subsection (e) filed 2-17-2011; operative 3-19-2011 (Register 2011, No. 7).

§52173. Mediation Procedures.

Note • History

(a) Mediation shall be voluntary.

(b) Mediation is available at any time to resolve disagreements involving any matter related to IDEA Part C.

(c) The mediation conference shall be conducted by a mediator who is an impartial, third party with no personal or professional interest that would conflict with his or her objectivity in mediating a disagreement.

(d) The due process hearing officer shall be a different person than the mediator when mediation does not resolve the disagreement.

(e) The mediator shall be trained in communication, mediation and problem solving and shall be knowledgeable about early intervention programs and the federal and state laws and regulations applicable to Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445, and the California Early Intervention Services Act, Government Code Sections 95000-95030.

(f) The mediator shall be under contract with the Department of Developmental Services.

(g) A person who otherwise qualifies under Subsection (c) and (d) of this Section as a mediator is not an employee of the Department of Developmental Services solely because the person is paid by the Department of Developmental Services to conduct the mediation process.

(h) A parent may be accompanied by any representative at the mediation.

(i) The mediator shall ensure that written agreements from the mediation conference are signed and provided to all participants at the conclusion of the mediation conference.

(j) Discussions during mediation must be confidential and may not be used as evidence in any subsequent due process or civil proceedings.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1439(1), Title 20 United States Code; Sections 303.420(a)-(b) and accompanying notes, 303.421(a)-(b) and 303.422, Title 34 Code of Federal Regulations.

HISTORY

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (e) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. New subsection (j) filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

6. Repealer and new subsection (b) filed 2-17-2011; operative 3-19-2011 (Register 2011, No. 7).

§52174. Due Process Hearing Procedures.

Note • History

(a) The hearing shall be conducted by a due process hearing officer who is an impartial, third party with no personal or professional interest that would conflict with his or her objectivity in conducting the hearing.

(b) The due process hearing officer shall be knowledgeable about the federal and state laws and regulations applicable to Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445, and the California Early Intervention Services Act, Government Code Sections 95000-95030, the Lanterman Developmental Disabilities Services Act, Welfare and Institutions Code sections 4500 et seq.; and Part 30 of the California Education Code, commencing with Section 56500 et seq.

(1) Listen to the presentation of relevant viewpoints about the issue of disagreement;

(2) Examine the evidence presented during the hearing;

(3) Issue a decision that is in compliance with federal and state law;

(4) Provide documentation of the proceedings, including findings of fact and a written decision; and

(5) Ensure that the decision is mailed to each party after completion of the hearing and within 30 days of receipt of the due process hearing request.

(d) A parent involved in a due process hearing shall have the right to:

(1) Be accompanied and advised by counsel and/or by an individual with special knowledge and training with respect to early intervention services;

(2) Present evidence and confront, cross-examine, and compel the attendance of witnesses;

(3) Prohibit the introduction of any evidence at the proceeding that has not been disclosed to the parent or the other party at least five days before the proceeding;

(4) Obtain a written or electronic, verbatim transcription of the proceeding;

(5) Obtain written findings of fact and decision.

(e) The hearing officer shall be under contract with the Department of Developmental Services. A person who otherwise qualifies under Subsection (a) or (b) of this Section is not an employee of a regional center or LEA solely because the person is paid by the agency to conduct the due process hearing.

(f) Disputes which occur related to an IEP meeting which may occur prior to the child's third birthday and which pertain to proposed Part B preschool placements or services shall be filed with and processed by the agent or division of the Department of Education which is responsible for administering due process mediations and hearings pursuant to Part B of the Individuals with Disabilities Education Act and Part 30 of the California Education Code, commencing with section 56500 et seq.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1439(l), Title 20 United States Code; Sections 303.421(a)-(b), 303.422(b) and 303.423(b), Title 34 Code of Federal Regulations; and Section 95007(g), Government Code.

HISTORY

2. New section, including amendment of subsection (d)(1) and Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsection (b), new subsection (f) and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 5. Surrogate Parents

§52175. Surrogate Parents.

Note • History

(a) Regional centers or LEAs shall assign an individual to act as a surrogate parent if:

(1) No parent can be identified;

(2) The infant or toddler is a dependent of the juvenile court and the parental rights of the parent have been limited by the court or relinquished; or

(3) The parent cannot be located, after reasonable efforts by the regional center or LEA.

(b) Interagency agreements as required in Section 52140(b)(12) shall include procedures for:

(1) Determining whether an infant or toddler needs a surrogate parent;

(2) Assigning a surrogate parent to the infant or toddler consistent with the provisions of this Article and Government Code section 7579.5;

(3) Ensuring that surrogates have no interest that conflicts with the interests of the infant or toddler he or she represents;

(4) Ensuring that surrogates have knowledge and skills that ensure adequate representation of the infant or toddler;

(5) Ensuring that the surrogate parent is not an employee of any state agency, regional center, LEA or service provider involved in the provision of early intervention services to the infant or toddler. A person who otherwise qualifies as a surrogate parent is not an employee solely because he or she is paid by a state agency, regional center or LEA to serve as a surrogate parent.

(1) The evaluation and assessment of the infant or toddler;

(2) Development and implementation of the infant's or toddler's IFSP including annual evaluations, assessments and periodic reviews;

(3) The ongoing provision of early intervention services to the infant or toddler;

(4) Requesting mediation or due process hearings; and,

(5) Any other early intervention service established under Part C of the Individuals with Disabilities Education Act, Title 20 United States Code Sections 1431-1445.

(d) A surrogate parent may not provide consent for medical services for which consent by a parent or legal guardian is required.

NOTE

Authority cited: Sections 95009 and 95028, Government Code. Reference: Section 1439(5), Title 20 United States Code; Sections 303.18 and 303.406(a-e), Title 34 Code of Federal Regulations; and Section 95022(f), Government Code.

HISTORY

1. New article 5 (section 52175) and section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code section 95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98, or emergency language will be repealed by operation of law on the following day.

2. New article 5 (section 52175) and section, including amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emergency language will be repealed by operation of law on the following day.

3. New article 5 (section 52175) and section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsections (b), (b)(2), (b)(5) and (c)(5) and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. Amendment of subsection (b)(5) filed 1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

Chapter 3. Community Services

Subchapter 1. General

Article 1. Definitions

§54000. Developmental Disability.

Note • History

(a) “Developmental Disability” means a disability that is attributable to mental retardation, cerebral palsy, epilepsy, autism, or disabling conditions found to be closely related to mental retardation or to require treatment similar to that required for individuals with mental retardation.

(b) The Developmental Disability shall:

(1) Originate before age eighteen;

(2) Be likely to continue indefinitely;

(3) Constitute a substantial disability for the individual as defined in the article.

(1) Solely psychiatric disorders where there is impaired intellectual or social functioning which originated as a result of the psychiatric disorder or treatment given for such a disorder. Such psychiatric disorders include psycho-social deprivation and/or psychosis, severe neurosis or personality disorders even where social and intellectual functioning have become seriously impaired as an integral manifestation of the disorder.

(2) Solely learning disabilities. A learning disability is a condition which manifests as a significant discrepancy between estimated cognitive potential and actual level of educational performance and which is not a result of generalized mental retardation, educational or psycho-social deprivation, psychiatric disorder, or sensory loss.

(3) Solely physical in nature. These conditions include congenital anomalies or conditions acquired through disease, accident, or faulty development which are not associated with a neurological impairment that results in a need for treatment similar to that required for mental retardation.

NOTE

Authority cited: Section 4512, Welfare and Institutions Code. Reference: Sections 4500 et seq., Welfare and Institutions Code.

HISTORY

1. New section filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Editorial redesignation of former Chapter 5 (Subchapter 1, Sections 54000-54010) to Chapter 3, (Subchapter 1, Sections 54000-54010) filed 9-28-83 (Register 83, No. 40).

3. Change without regulatory effect amending subsections (a) and (b)(3) filed 10-29-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 44).

§54001. Substantial Disability.

Note • History

(a) “Substantial disability” means:

(1) A condition which results in major impairment of cognitive and/or social functioning, representing sufficient impairment to require interdisciplinary planning and coordination of special or generic services to assist the individual in achieving maximum potential; and

(2) The existence of significant functional limitations, as determined by the regional center, in three or more of the following areas of major life activity, as appropriate to the person's age:

(A) Receptive and expressive language;

(B) Learning;

(D) Mobility;

(E) Self-direction;

(F) Capacity for independent living;

(G) Economic self-sufficiency.

(b) The assessment of substantial disability shall be made by a group of Regional Center professionals of differing disciplines and shall include consideration of similar qualification appraisals performed by other interdisciplinary bodies of the Department serving the potential client. The group shall include as a minimum a program coordinator, a physician, and a psychologist.

(c) The Regional Center professional group shall consult the potential client, parents, guardians/conservators, educators, advocates, and other client representatives to the extent that they are willing and available to participate in its deliberations and to the extent that the appropriate consent is obtained.

(d) Any reassessment of substantial disability for purposes of continuing eligibility shall utilize the same criteria under which the individual was originally made eligible.

NOTE

Authority cited: Section 4512, Welfare and Institutions Code. Reference: Section 4512, Welfare and Institutions Code.

HISTORY

1. New section filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Amendment of section heading, section and Note filed 9-25-2003 as an emergency; operative 9-25-2003 (Register 2003, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-23-2004 or emergency language will be repealed by operation of law on the following day.

3. Amendment of section heading, section and Note refiled 1-23-2004 as an emergency; operative 1-24-2004 (Register 2004, No. 4). A Certificate of Compliance must be transmitted to OAL by 5-24-2004 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 1-23-2004 order, including amendment of subsection (a)(2)(A), transmitted to OAL 3-3-2004 and filed 4-12-2004 (Register 2004, No. 16).

§54002. Cognitive.

Note • History

“Cognitive” as used in this chapter means the ability of an individual to solve problems with insight, to adapt to new situations, to think abstractly and to profit from experience.

NOTE

Authority cited: Section 4512, Welfare and Institutions Code. Reference: Sections 4500 et seq., Welfare and Institutions Code.

HISTORY

1. New section filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

Article 2. Eligibility

§54010. Eligibility for Regional Center Services.

Note • History

(a) Any resident of the State of California believed to have a developmental disability, and any resident of the State of California believed to be at high risk of parenting an infant with a developmental disability shall be eligible, upon application to the regional center, for initial intake, diagnostic and counseling services, and a determination regarding the need for assessment.

(b) Eligibility for ongoing regional center services shall be contingent upon the determination, after intake and assessment, that the person has a developmental disability that constitutes a substantial disability as defined in Article 1 of this subchapter.

(c) Any individual deemed ineligible may appeal the decision in accordance with Welfare and Institutions Code, Sections 4700-4716. The Director's decision resulting from a fair hearing appeals process shall be final and binding on all parties.

NOTE

Authority cited: Sections 4512 and 4640, Welfare and Institutions Code. Reference: Sections 4512, 4640, 4642, 4643 and 4644, Welfare and Institutions Code.

HISTORY

1. New section filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).

2. Order of Repeal of subsection (c) and relettering of subsection (d) to subsection (c) filed 8-26-82 by OAL pursuant to Government Code Section 11349.7(j) (Register 82, No. 35).

3. Amendment of subsections (b)-(c) and amendment of Note filed 9-25-2003 as an emergency; operative 9-25-2003 (Register 2003, No. 39). A Certificate of Compliance must be transmitted to OAL by 1-23-2004 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (b)-(c) and amendment of Note refiled 1-23-2004 as an emergency; operative 1-24-2004 (Register 2004, No. 4). A Certificate of Compliance must be transmitted to OAL by 5-24-2004 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 1-23-2004 order transmitted to OAL 3-3-2004 and filed 4-12-2004 (Register 2004, No. 16).

Subchapter 2. Vendorization

Article 1. Definitions

§54300. Meaning of Words.

Note • History

NOTE

Authority cited: Sections 4405, and 4648(a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Article II, Chapter 5, Division 4.5, Welfare and Institutions Code.

HISTORY

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90, No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

Article 2. Vendorization Process

§54302. Definitions.

Note • History

(a) Except as provided in subsection (b) below, the following definitions shall apply to the language contained in Sections 54310 through 54390 of these regulations:

(1) “Accreditation” means a formal determination and recognition by CARF that a Work Activity or Supported Employment Program is in compliance with the service delivery standards CARF has established for the program.

(2) “Activity Center” means a community-based day program that serves adults who generally have acquired most basic self-care skills, have some ability to interact with others, are able to make their needs known, and respond to instructions. Activity center programs focus on the development and maintenance of the functional skills required for self-advocacy, community integration and employment;

(3) “Adult” means a person 18 years of age or older;

(4) “Adult Day Health Care Program” means an Adult Day Health Care Program as defined in Health and Safety Code Section 1570.7(a);

(5) “Adult Day Programs” means those community-based day programs defined in (a)(1), above and (a)(6), (11), (13), (31), and (60) below;

(6) “Adult Day Services” means the broad category of nonresidential services under which adult day programs are categorized;

(7) “Adult Development Center” means a community-based day program that serves adults who are in the process of acquiring self-help skills. Individuals who attend adult development centers generally need sustained support and direction in developing the ability to interact with others, to make their needs known, and to respond to instructions. Adult development center programs focus on the development and maintenance of the functional skills required for self-advocacy, community integration, employment, and self-care;

(8) “Age Appropriate” means the consideration of the chronological age of the person in the use of activities, instructional locations, and techniques;

(9) “Applicant” means an individual, partnership, group, association, corporation, nonprofit organization, institution, or entity, and the officers, directors, boards of directors, owners, managing employees or agents thereof, that apply to the regional center to become a vendor;

(10) “Authorized Agency Representative” means a person authorized to act on behalf of either the Department or the regional center, by law, by court order, or by a written statement signed by the Director of the Department or the regional center director, respectively;

(11) “Authorized Consumer Representative” means the parent or guardian of a minor, conservator of an adult, or person who is legally entitled to act on behalf of the consumer;

(12) “Behavior Management Program” means a community-based day program that serves adults with severe behavior disorders and/or dual diagnosis who, because of their behavior problems, are not eligible for or acceptable in any other community-based day program;

(13) “CARF” means The Rehabilitation Accreditation Commission, as referenced in Welfare and Institutions Code, Section 4851.

(14) “Certification” means a certification determination completed by the Department of Rehabilitation.

(15) “Child” means a person under the age of 18 years;

(16) “Community-based Day Programs” means those programs which provide services to individuals on an hourly or daily basis, but less than a 24-hour basis in the community rather than at a developmental center. Only the following types of services are community-based day programs: activity centers, adult development centers, behavior management programs, independent living programs, infant developmental programs and social recreation programs;

(17) “Community Integration” means presence, participation and interaction in natural environments;

(18) “Congregate Living Health Facility” means a Congregate Living Health Facility as defined in Health and Safety Code Section 1250(i)(1);

(19) “Consumer” means an individual who has been determined by a regional center to meet the eligibility criteria of the Welfare and Institutions Code, Section 4512, and of Title 17, Sections 54000, 54001 and 54010, and for whom the regional center has accepted responsibility;

(20) “Controlling Agency” means any agency, department, or commission that by statute requires standards to be met for the issuance of a license, credential, registration, certificate or permit required for the operation or provision of service;

(21) “Days” means calendar days unless otherwise stated;

(22) “Department” means the Department of Developmental Services;

(23) “Developmental Center” means any institution referred to in the Welfare and Institutions Code, Section 4440. Developmental Center is synonymous with state hospital;

(24) “DHS” means the Department of Health Services;

(25) “DSS” means the Department of Social Services;

(26) “Direct Care Staff” means staff who personally provide direct services to consumers. Personnel who are responsible for other staff functions may be considered direct care staff only during that time when they are providing direct services to consumers or are involved in program preparation functions;

(27) “Direct Services” means hands-on training provided by the vendor in accordance with the requirements of the consumer's Individual Program Plan and the provisions of Section 56720 of these regulations;

(28) “Director” means the Director of the Department of Developmental Services;

(29) “Family Member” means an individual who: A) Has a developmentally disabled person residing with him or her; B) Is responsible for the 24-hour care and supervision of the developmentally disabled person; and C) Is not a licensed or certified resident care facility or foster family home receiving funds from any public agency or regional center for the care and supervision provided;

(30) “Functional Skills” means those skills which enable an individual to communicate, interact with others and to perform tasks which have practical utility and meaning at home, in the community or on the job;

(31) “Generic Agency” means any agency which has a legal responsibility to serve all members of the general public and which is receiving public funds for providing such services;

(32) “Generic Support(s)” means voluntary service organizations, commercial businesses, non-profit organizations, generic agencies, and similar entities in the community whose services and products are regularly available to those members of the general public needing them.

(33) “Group Practice” means more than one individual which functions as a business entity while providing services to individuals;

(34) “Habilitation Services” means community-based services purchased or provided for adults with developmental disabilities, including services provided under the Work Activity Program and the Supported Employment Program, to prepare and maintain these adults at their highest level of vocational functioning, or to prepare them for referral to Vocational Rehabilitation services;

(35) “Independent Living Program” means a community-based day program that provides to adult consumers the functional skills training necessary to secure a self-sustaining, independent living situation in the community and/or may provide the support necessary to maintain those skills. Independent living programs focus on functional skills training for adult consumers who generally have acquired basic self-help skills and who, because of their physical disabilities, do not possess basic self-help skills, but who employ and supervise aides to assist them in meeting their personal needs;

(36) “Individual Program Plan (IPP)” means a written plan that is developed by a regional center interdisciplinary (ID) team, in accordance with the provisions of the Welfare and Institutions Code, Sections 4646 and 4646.5;

(37) “Infant Development Program” means a community-based day program defined in the Welfare and Institutions Code, Section 4693;

(38) “In-home Respite Services” means intermittent or regularly scheduled temporary non-medical care and supervision provided in the consumer's own home and designed to do all of the following:

(A) Assist family members in maintaining the consumer at home;

(B) Provide appropriate care and supervision to protect the consumer's safety in the absence of family members;

(D) Attend to the consumer's basic self-help needs and other activities of daily living, including interaction, socialization, and continuation of usual daily routines which would ordinarily be performed by the family member;

(39) “Interdisciplinary (ID) Team” means the group of persons convened in accordance with the Welfare and Institutions Code, Section 4646, for the purpose of preparing a consumer's IPP;

(40) “Intermediate Care Facility” means an Intermediate Care Facility as defined in Health and Safety Code Section 1250(d);

(41) “Intermediate Care Facility/Developmentally Disabled (ICF/DD)” means a licensed residential health facility which provides care and support services to developmentally disabled consumers whose primary need is for developmental services and who have a recurring, but intermittent, need for skilled nursing services;

(42) “Intermediate Care Facility/Developmentally Disabled-Habilitative (ICF/DD-H)” means a licensed residential health facility which has as its primary purpose the furnishing of 24-hour personal care, developmental training, habilitative, and supportive health services in a facility with 15 beds or less to residents with developmental disabilities;

(43) “Intermediate Care Facility/Developmentally Disabled-Nursing (ICF/DD-N)” means a licensed residential health facility which has as its primary purpose the furnishing of 24-hour nursing supervision, personal care, and training in habilitative services in a facility with 4-15 beds to medically fragile developmentally disabled consumers, or to consumers who demonstrate a significant developmental delay that may lead to a developmental disability if not treated. Such consumers must have been certified by a physician as not requiring skilled nursing care;

(44) “Long-Term Health Care Facility” means an Adult Day Health Care Program, a Congregate Living Health Facility, a Skilled Nursing Facility (SNF), an Intermediate Care Facility (ICF), an Intermediate Care Facility/Developmentally Disabled (ICF/DD), an Intermediate Care Facility/Developmentally Disabled-Habilitative (ICF/DD-H), or an Intermediate Care Facility/Developmentally Disabled-Nursing (ICF/DD-N);

(45) “Management Organization” means a separate and distinct corporation or entity which operates two or more services;

(46) “Mobility Training” means individually planned activities and instruction which enable adults with developmental disabilities to utilize the most normalizing independent transportation modes possible;

(47) “Natural Environment” means places and social contexts commonly used by individuals without developmental disabilities;

(48) “Natural Supports” means, pursuant to Welfare and Institutions Code, Section 4512(e), personal associations and relationships typically developed in the family and community that enhance or maintain the quality and security of life for people;

(49) “Nonresidential Services” means all services provided by any vendor other than a residential facility;

(50) “Nursing Facility” means a licensed health facility or a distinct part of a hospital which provides continuous skilled nursing and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis. It provides 24-hour inpatient care and, as a minimum, includes physician, skilled nursing, dietary and pharmaceutical services, and an activity program;

(51) “Program Preparation Functions” means secondary activities performed by non-residential direct care staff, such as preparation of lesson plans, completion of the necessary documentation required by these regulations, preparation and clean-up of the area where the direct service is provided to consumers, or involvement in other duties such as staff meetings and parent conferences;

(52) “Purchase of Service Funds” means those funds identified in the Budget Act for the purpose of purchasing services, provided by vendors, for consumers;

(53) “Reasonably suspected” means an objectively reasonable suspicion that a person would entertain, based upon facts that could cause a reasonable person in a like position, drawing, when appropriate, on his or her training and experience, to suspect abuse.

(54) “Regional Center” means a diagnostic, counseling, and service coordination center for developmentally disabled persons and their families which is established and operated pursuant to the Welfare and Institutions Code, Sections 4620 through 4669, by a private nonprofit community agency or corporation acting as a contracting agency. As used in these regulations, any reference to the regional center shall, by reference, be applicable to those agencies or persons with which the regional center contracts to provide service coordination to consumers under the provisions of the Welfare and institutions Code, Section 4648;

(55) “Residential Facility” means any licensed community care facility as defined in Health and Safety Code Section 1502(a)(1), (4), (5) or (6), or a licensed residential care facility for the elderly as defined in Health and Safety Code Section 1569.2;

(56) “Self-Advocacy” means the awareness, motivation and ability of an individual to represent and communicate his or her own interests, to exercise personal choice, to exert control over his or her environment, and to avoid exploitation and abuse;

(57) “Self-Care” means meeting one's physical and personal needs, such as dressing, grooming and hygiene without dependence on others or having the ability to direct others to meet those needs;

(58) “Service Catchment Area” means the geographical area within which a regional center provides services specified in its contract with the Department as required by the Welfare and Institutions Code, Section 4640;

(59) “Service Code” means a number which is assigned by the vendoring regional center to a vendor which indicates the type of authorized service to be provided;

(60) “Service Contract” means an agreement entered into between a regional center and a non-residential vendor which specifies the level of payment and units of service to be used by the vendor to charge and invoice the regional center for services provided to consumers;

(61) “Service Design” means a written description of the service delivery capabilities and orientation developed, maintained, and implemented by a SLS vendor;

(62) “Services” means assistance provided, and duties performed, by a vendor for a consumer;

(63) “Skilled Nursing Facility (SNF)” means a Skilled Nursing Facility as defined in Health and Safety Code Section 1250(c);

(64) “Social Recreation Program” means a community-based day program which provides community integration and self-advocacy training as they relate to recreation and leisure pursuits;

(65) “Special Incident Report” is the documentation prepared by vendor staff or long-term health care facility staff detailing a special incident and provided to the regional center;

(66) “Staffing Ratio” or “Staff-to-Consumer Ratio” means the numerical relation of the number of direct care staff to the number of consumers;

(67) “Statewide Vendor Panel” means the statewide listing of all vendors which contains information specified in Section 54334 of these regulations;

(68) “Subcode” means a series of a maximum of five numbers and/or letters which is assigned by the vendoring regional center to a vendor for billing purposes;

(69) “Supported Employment” means services that are provided by a job coach in order to support and maintain an individual with developmental disabilities in employment;

(70) “Supported Employment Program” means a program that meets the requirements of the term supported employment , as defined in this section, and of the terms, integrated work, supported employment placement, allowable supported employment services, group services, and individualized services as defined in Section 58801.

(71) “Supported Living Service(s) (SLS)” means those services and supports referenced in Section 54349(a) through (e), and specified as SLS service and support components in Title 17, Section 58614, which are provided by a SLS vendor, paid for by the regional center, and support consumers' efforts to:

(A) Live in their own homes, as defined in Title 17, Section 58601(a)(3);

(B) Participate in community activities to the extent appropriate to each consumer's interests and capacity; and

(72) “Unit of Service” means the increment of service provided to consumers which is used to charge and invoice the regional center for services provided. The increment of service is specified as hours, days, transportation mileage or any other increment of service agreed to by the Department, regional center and the vendor;

(73) “User Regional Center” or “Utilizing Regional Center” means any regional center which utilizes a service within the vendoring regional center's catchment area;

(74) “Vendor” means an applicant which has been given a vendor identification number and has completed the vendorization process, and includes those specified in Section 54310(d) and (e);

(75) “Vendor Application” or “Application Packet” means the form, DS 1890 (7/2011), and the information specified in Section 54310(a)(1) through (10) of these regulations;

(76) “Vendor Identification Number” means the unique number which is assigned to each vendor in order to establish a recordkeeping and tracking system for regional centers' billing purposes;

(77) “Vendoring Regional Center” means the regional center in whose service catchment area the vendor is located;

(78) “Vendorization” means the process used to:

(A) Verify that an applicant meets all of the requirements and standards pursuant to Section 54310 of these regulations prior to the provision of services to consumers; and

(B) Assign vendor identification numbers, service codes and subcodes, for the purpose of identifying vendor expenditures;

(79) “Voucher” means a written authorization issued by a regional center to a family member or consumer to procure the service for which the voucher was issued and which specifies the maximum reimbursement authorized by the regional center.

(80) “Work Activity Program” includes, but is not limited to, Work Activity centers or settings that provide support to consumers engaged in paid work and have demonstrated that the program is in compliance with Department of Rehabilitation certification standards or are accredited by CARF;

(b) The following definitions shall apply to Section 54311:

(1) “Excluded Individuals or Entities” means either those individuals and entities that have been placed on the U.S. Department of Health and Human Services Office of Inspector General (OIG) List of Excluded Individuals/Entities and the Department of Health Care Services (DHCS) Medi-Cal Suspended and Ineligible Provider list or those individuals and entities that meet the criteria included in Section 54311(a)(6);

(2) “Indirect Ownership Interest” means an ownership interest in an entity that has an ownership interest in the applicant or vendor entity. This term includes an ownership interest in any entity that has an indirect ownership interest in the applicant or vendor entity;

(3) “Managing Employee” means a general manager, business manager, administrator, director, or other individual who exercises operational or managerial control over, or who directly or indirectly conducts the day-to-day operation of an institution, organization, agency or business entity;

(4) “Ownership Interest” means the possession of equity in the capital, the stock or the profits of an applicant or vendor entity;

(5) “Person with an Ownership or Control Interest” means a person or corporation that:

(A) Has an ownership interest totaling 5 percent or more in an applicant or vendor entity;

(B) Has an indirect ownership interest equal to 5 percent or more of an applicant or vendor entity;

(C) Has a combination of direct or indirect ownership interests equal to 5 percent or more in an applicant or vendor entity;

(D) Owns an interest of 5 percent or more in any mortgage, deed of trust, note, or other obligation secured by the applicant or vendor entity if that interest equals at least 5 percent of the value of the property or assets of the applicant or vendor entity;

(E) Is an officer or director of an applicant or vendor entity that is organized as a corporation; or

(F) Is a partner in an applicant or vendor entity that is organized as a partnership;

(6) “Significant Business Transaction” means any business transaction or series of transactions that, during any one fiscal year, exceed the lesser of $25,000 or 5 percent of an applicant or vendor's total operating expenses;

(7) “Subcontractor” means an individual, agency, or organization to which an applicant or vendor entity has contracted or delegated some of its management functions or responsibilities of providing services;

(8) “Wholly Owned Supplier” means a supplier whose total ownership interest is held by an applicant or vendor entity or by a person, persons, or other entity with an ownership or control interest in an applicant or vendor entity.

NOTE

Authority cited: Sections 4405, 4648(a), 4648.12(c)(1)(A), 4689.7(c) and 4866, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 1250 and 1502, Health and Safety Code; Sections 240, 242, 243.4, 245, 261, 264.1, 273d, 285, 286, 288, 288a, 289, 311.2, 311.3, 311.4, 647a, 11165.1, 11165.2, 11165.3 and 11165.6, Penal Code; Sections 4504, 4512(i), 4646.5, 4648(a), 4648.12, 4689.7(c), 4691, 4693, 4791, 4851, 12305.81(a)(2), 15610.57 and 15610.63; and Article II, Chapter 5, Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (a)(14) and (a)(46) and subsection renumbering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Editorial correction of printing error restoring article heading (Register 92, No. 34).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of subsection (a)(57) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

9. Amendment of subsections (a)(2) and (a)(57) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

10. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

11. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13), (a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsection renumbering and amendment of Note filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

12. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13), (a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsection renumbering and amendment of Note refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (a)(62), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

14. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13), (a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsection renumbering and amendment of Note refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

15. Certificate of Compliance as to 8-14-95 order, including further amendment of subsections (a)(13), (a)(39), (a)(51) and (a)(59)(A), transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

16. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

17. Amendment of section and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

18. Amendment of section and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

19. Certificate of Compliance as to 10-20-98 order, including further amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

20. Amendment of subsection (a)(16), (a)(34)(D), (a)(53)(A)4., (a)(53)(B)3., (a)(62)(B)-(C), (a)(66)-(a)(66)(A), (a)(66)(C), subsection renumbering of duplicate subsection (a)(71) et seq., amendment of newly designated subsections (a)(72)-(73) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

21. Repealer of subsections (a)(53)-(a)(53)(B)3. and (a)(62)-(a)(62)(C), subsection renumbering and amendment of subsection (a)(61) filed 6-27-2001 as an emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-29-2001 or emergency language will be repealed by operation of law on the following day.

22. Reinstatement of section as it existed prior to 6-27-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 43).

23. Repealer of subsections (a)(53)-(a)(53)(B)3. and (a)(62)-(C), subsection renumbering and amendment of subsection (a)(61) filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

24. Certificate of Compliance as to 10-25-2001 order, including new subsection (a)(49) and subsection renumbering, transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

25. New definitions of “Accreditation,” “CARF,” “Certification,” “Habilitation Services,” “Supported Employment,” “Supported Employment Program” and “Work Activity Program” and subsection renumbering filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

26. Reinstatement of section as it existed prior to 7-22-2004 emergency amendment by operation of Government Code section 11346.1(f) (Register 2004, No. 49).

27. New definitions of “Accreditation,” “CARF,” “Certification,” “Habilitation Services,” “Supported Employment,” “Supported Employment Program” and “Work Activity Program” and subsection renumbering refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

28. New definitions of “Accreditation,” “CARF,” “Certification,” “Habilitation Services,” “Supported Employment,” “Supported Employment Program” and “Work Activity Program” and subsection renumbering refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

29. Certificate of Compliance as to 3-30-2005 order, including further amendment of definitions of “Supported Employment” and “Work Activity Program,” transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

30. Amendment of subsections (a), (a)(9), (a)(75) and (a)(78)(A), new subsections (b)-(b)(8) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54306. Service Bank Application. [Repealed]

Note • History

NOTE

Authority cited: Chapter 93, Statutes of 1991, Section 2(g); Sections 4405 and 4648(b), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Chapter 93, Statutes of 1991, Section 2(g); and Sections 4502, 4631, 4648(b) and 4691, Welfare and Institutions Code.

HISTORY

1. New section filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

3. Repealer filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Editorial correction of printing error moving article heading to section 54302 (Register 92, No. 34).

§54308. Determination of Need and Notice Requirements. [Repealed]

Note • History

NOTE

HISTORY

3. Repealer filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

§54310. Vendor Application Requirements.

Note • History

(a) An applicant who desires to be vendored shall submit Form DS 1890 (7/2011), entitled Vendor Application, and the information specified in (1) through (10) below, to the vendoring regional center.

(1) Applicant's name, including the name of any governing body or management organization;

(2) Applicant's Social Security Number, Federal Tax ID number, or a copy of any document accepted by the federal government which establishes identity of applicant;

(3) Applicant's mailing address;

(4) Address of service, if applicable;

(5) Name of family member, owner or executive director, as applicable;

(6) Types of service to be provided;

(7) Telephone number;

(8) Facility capacity, if applicable;

(9) Identification of the type of consultants, subcontractors and community resources to be used by the vendor as part of its service.

(10) Copies of:

(A) Any license, credential, registration, certificate or permit required for the performance or operation of the service, or proof of application for such document;

(B) Any academic degree required for performance or operation of the service;

(C) Any waiver from licensure, registration, certification, credential, or permit from the responsible controlling agency;

(D) The proposed or existing program design as required in Sections 56712 and 56762 of these regulations, if applicable, for applicants seeking vendorization as community-based day programs;

(E) The proposed or existing staff qualifications and duty statements as required in Sections 56722 and 56724 of these regulations for applicants seeking vendorization as community-based day programs;

(F) The proposed or existing service design as required in Section 56780 of these regulations for applicants seeking vendorization as in-home respite service agencies;

(G) The proposed or existing program design as required in Section 58811 of these regulations for applicants seeking vendorization as habilitation service providers;

(H) The proposed or existing staff qualifications and duty statements as required in Sections 56790 and 56792 of these regulations for applicants seeking vendorization as in-home respite services agencies;

(I) The proposed service design as required in Sections 58630 and 58631 of these regulations for applicants seeking vendorization to provide supported living service;

(J) The signed Home and Community-Based Services Provider Agreement (6/99) with the Department of Health Services, obtainable from the regional centers as part of the vendorization packet, for those applicants whose proposed service is eligible for Medi-Cal reimbursement; and

(K) The proposed program design as required by Subchapter 4.1, Section 56084 for those applicants seeking vendorization as a family home agency (FHA).

(b) The applicant shall sign and date Form DS 1890 (7/2011), which includes a certification that the information is true, correct and complies with Title 17, Section 54310(a).

(1) The name, title, business address and telephone number of each officer and member of the governing board;

(A) The application packet shall include copies of the corporation's articles of incorporation; by-laws, which shall include provisions for control by a responsible governing board; annual statement filed with the Secretary of State; corporate charter, if applicable; and evidence certifying the corporation's nonprofit status.

(B) The application packet shall contain a written resolution from the governing board stating that the board shall operate the FHA in full conformity with all applicable statutes and regulations.

(2) Name, address and telephone number of the owner of the facility premises if the applicant is leasing or renting;

(3) Disclosure of:

(A) Any board member's or officer's prior or present service as an administrator, general partner, corporate officer or director of any health facility certified by the Department of Health Services or community care facility licensed by the Department of Social Services' Community Care Licensing Division; and

(B) Any revocation or other action taken, or in the process of being taken, against any community care facility license or health facility certification held or previously held by the applicant or any officer or member of the governing board.

(4) A financial statement and budget which demonstrate the applicant's ability to cover the costs of operating the FHA to provide the level of services and supports necessary to maintain consumers for whom the regional center is responsible in family homes;

(5) A written statement that no FHA employee, Board of Directors member or officer shall be a family home provider of the FHA;

(6) A written statement that no family home shall be approved by the FHA as a residence for a consumer who is a relative of the family home provider except when: (1) the residence is consistent with the services and supports referenced in the consumer's IPP; and (2) the relative has no legal obligation to support the consumer;

(7) Any other information required by the regional center which is pertinent to vendorization of the FHA.

(d) Habilitation services providers who, on July 1, 2004, are providing services to consumers shall be deemed to be an approved vendor. Each approved vendor shall submit to the vendoring regional center, and a copy to the Department, a completed Vendor Application, DS 1890 (12/03) and a completed Annual Habilitation Services Provider Profile, DS 1970 (4/04) by July 31, 2004.

(e) Habilitation Services providers not deemed approved vendors pursuant to (d), and approved vendors seeking vendorization as Habilitation Services providers in a new location, shall, in addition to meeting the general requirements of this section and of Title 17, Sections 58800 through 58882, meet the following requirements as a condition of vendorization:

(1) The applicant shall:

(A) If currently accredited, supply a copy of its last accreditation report and indicate the date its next accreditation review is due.

(B) If not currently accredited, supply a copy of certification by the Department of Rehabilitation and shall become accredited within 3 years of the date of their certification.

(f) The following applicants shall be required to submit only Form DS 1890 (7/2011) and, if applicable, a copy of any license, credential, registration, certificate, permit, or academic degree required for the performance or operation of the service, or any waiver from licensure, registration, certification, credential, or permit from the responsible controlling agency. If the proposed service is eligible for Medi-Cal reimbursement, the applicant shall also sign the Home and Community Based Services Provider Agreement (6/99), and submit the original of the signed agreement to the vendoring regional center.

(1) Public transit authorities, dial-a-ride, rental car agencies, or taxis;

(2) Out-of-state manufacturers or distributors who are eligible for vendorization pursuant to Section 54318 of these regulations;

(3) Retail/wholesale stores; and

(4) Generic agencies specified in Section 54316(a)(2) of these regulations.

(g) Family members or consumers who desire to be vendored in the following categories shall be required to submit to the vendoring regional center Form DS 1890 (7/2011), and, if the vouchered family member or consumer is also the provider of the vouchered service, a copy of any license, credential, registration, certificate, permit, or academic degree required for the performance or operation of the service, or any waiver from licensure, registration, certification, credential, or permit from the responsible controlling agency, if applicable. If a proposed service is eligible for Medi-Cal reimbursement, the applicant shall also sign the Home and Community-Based Services Provider Agreement (6/99) and submit it to the vendoring regional center.

(1) Respite service--family member;

(2) Nursing service--family member;

(3) Transportation--family member;

(4) Day care--family member; and

(5) Diaper and nutritional supplements--family member.

(h) For the purposes of subsections (a) and (b) of this section, the documentation provided to the dentist by the Department of Health Care Services (DHCS) approving the dentist's enrollment in the Denti-Cal program, including the dentist in the Provider Master File and providing the dentist with a Medi-Cal provider number, constitutes vendorization for the purposes of providing services to consumers under Dentistry -- Service Code 715. The dentist's status as a Denti-Cal provider is under the oversight of DHCS.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4648(a), 4648.12(c)(1)(A) and 4689.1, Welfare and Institutions Code; and Section 11152, Government Code; and Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4502, 4631, 4648(a), 4648.12, 4690, 4691 and 12305.81(a)(2), Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Editorial correction of printing error in article 2 heading (Register 91, No. 30).

4. Amendment of section heading, subsections (a), (a)(5)(b) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section heading, subsections (a), (a)(5)(b) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendment of section heading and text transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of subsections (a)(10)(H), (c) and (d) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

9. Amendment of subsections (d)(1)-(5) and new subsections (e)-(e)(8) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

10. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

11. New subsections (a)(10)(I) and (c)-(c)(7), subsection relettering and amendment of Note filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

12. New subsection (a)(10)(H), subsection relettering and amendment of Note filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

13. New subsections (a)(10)(I) and (c)-(c)(7), subsection relettering and amendment of Note refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

14. New subsection (a)(10)(H), subsection relettering and amendment of Note refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

15. Certificate of Compliance as to 7-24-95 order including new subsection (a)(10)(H) and subsection relettering transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

16. Certificate of Compliance as to 6-20-94 order, including amendment of subsections (a)(10)(I), (d) and (e) and repealer of subsections (f)-(f)(8), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

17. Editorial correction of History 12 and History 14 (Register 96, No. 15).

18. New subsection (a)(10)(H), subsection relettering and amendment of Note refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

19. Certificate of Compliance as to 8-14-95 order transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

20. Change without regulatory effect amending subsection (e) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

21. New subsections (a)(10)(G) and (d)-(f), subsection relettering and amendment of Note filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

22. Amendment of subsections (a), (a)(5), (a)(10)(J), (b), (g) and (i) and amendment of Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

23. Reinstatement of section as it existed prior to 7-22-2004 emergency amendment by operation of Government Code section 11346.1(f) (Register 2004, No. 49).

24. New subsections (a)(10)(G) and (d)-(f), subsection relettering and amendment of Note refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

25. Refiling of 8-27-2004 order, including relettering of subsection (i) to subsection (h), 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

26. New subsections (a)(10)(G) and (d)-(f), subsection relettering and amendment of Note refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

27. Certificate of Compliance as to 12-22-2004 order, including further amendment of subsections (a)(2) and (h), transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

28. Certificate of Compliance as to 3-30-2005 order, including redesignation of former subsections (f)-(f)(2) as new (e)(1)-(e)(1)(B) and subsection relettering, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

29. Amendment of subsections (a), (b), (c)(1)(A)-(B), (f) and (g), new subsection (h) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54311. Disclosure Requirements.

Note • History

(a) The applicant or vendor shall disclose all the information required by Title 42, Code of Federal Regulations (CFR), Sections 455.104, 455.105 and 455.106, as of March 25, 2011, and shall complete and submit to the regional center the Applicant/Vendor Disclosure Statement, Form DS 1891 (7/2011), hereby incorporated by reference, which shall include, but not be limited to all of the following:

(1) The name, address, title and percentage of ownership or control interest of each person(s) with an ownership or control interest, as defined in Section 54302(b)(5), in the applicant or vendor or in any subcontractor in which the applicant or vendor has direct or indirect ownership of 5 percent of more.

(2) Whether any of the persons named in subsection (a)(1), above, is related to another as spouse, parent, child or sibling.

(3) The name and address of any other disclosing entity as defined in 42 CFR Section 455.101 with an ownership or control interest in the applicant or vendor. This requirement applies to the extent that the applicant or vendor can obtain this information by requesting it in writing from the disclosing entity. The applicant or vendor shall:

(A) Keep copies of all disclosure information submitted to the regional center at vendorization and upon request.

(B) Make the disclosure information available to the regional center upon request.

(4) The name and address of each person(s) with an ownership or control interest in any subcontractor with whom the applicant or vendor has had business transactions totaling more than $25,000 during the 12-month period either immediately preceding the date of the vendor application or immediately preceding the date of the regional center request for such information.

(5) Any significant business transactions between the applicant or vendor and any wholly owned supplier, or between the applicant or vendor and any subcontractor, at the time of the application, or during the 5-year period ending on the date of the written request by the regional center for such information.

(6) The name, title and address of any person(s) who, as applicant or vendor, or who has ownership or control interest in the applicant or vendor, or is an agent, director, member of the board of directors, officer, or managing employee of the applicant or vendor, has within the previous ten years:

(A) Been convicted of any felony or misdemeanor involving fraud or abuse in any government program, or related to neglect or abuse of an elder or dependent adult or child, or in any connection with the interference with, or obstruction of, any investigation into health care related fraud or abuse; or

(B) Been found liable any civil proceeding for fraud or abuse involving any government program; or

(b) Each applicant or vendor shall submit a new signed and dated DS 1891 (7/2011) to the regional center within 30 days of any change in the information previously submitted pursuant to this section or upon a written request by the regional center for such information.

(c) All current vendors shall submit a signed and dated DS 1891 (7/2011) to the vendoring regional center within 120 days of the effective date of these regulations for review by regional center by June 30, 2012.

(d) In addition to (c) above, the vendor shall supply the information in subsection (a) above upon written request to the vendoring regional center, Department of Developmental Services, the State Medicaid Agency, Department of Health Care Services, any State survey team, the Secretary of the United States Department of Health and Human Services, or any duly authorized representatives of the above-named entities.

NOTE

Authority cited: Sections 4648.12(c)(1)(A) and 14043.75, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4648.12 and 12305.81(a)(2), Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

1. New section filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54312. Applicants Exempted from the Application Process. [Repealed]

Note • History

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(1) filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

4. Amendment of section heading, subsections (a), (a)(2)-(4), repealer of subsection (b) and new subsections (b)-(c), and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section heading, subsections (a), (a)(2)-(4), repealer of subsection (b), and new subsections (b)-(c), and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Repeal of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

§54314. Ineligibility for Vendorization.

Note • History

(a) The following applicants shall not be vendored:

(1) Any officer or employee of the State of California;

(2) Any applicant in which an officer or employee of the State of California has a financial interest, as defined in the Government Code, Section 87103, except as permitted by Public Contract Code, Section 10430(g), effective January 1, 1992;

(3) Employees and board members of any regional center with a conflict of interest pursuant to Title 17, Sections 54500 through 54525, unless the conflict is eliminated or a waiver is obtained pursuant to Title 17, Sections 54522 through 54525;

(4) Any applicant in which the regional center employee or board member has a relationship which creates a conflict of interest pursuant to Title 17, Sections 54500 through 54525, unless the conflict is eliminated or a waiver is obtained pursuant to Title 17, Sections 54522 through 54525;

(5) Consumers, to provide services for, or to, themselves except to:

(A) Provide transportation services to themselves as specified in Section 54355(g)(5); and

(B) Serve as their own Supported Living Service vendors as specified in Title 17, Section 58616.

(6) Except as specified in Section 54318 of these regulations, any applicant located outside the state.

(7) Any applicant that has been determined to be an excluded individual or entity as defined in Section 54302(b)(1).

NOTE

Authority cited: Sections 4405, 4648(a), 4648.12(c)(1)(A) and 4689, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4626, 4627, 4631, 4648(a), 4648.1(d), 4648.12 and 4689(a)(1), Welfare and Institutions Code; Section 10430(g), Public Contract Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(5) filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

4. Amendment of subsection (a)(2) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsection (a)(2) refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendment of text and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of subsection (a)(5)(A) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Amendment of subsections (a)(5)-(a)(5)(A), new subsection (a)(5)(B) and amendment of Note filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

11. Amendment of subsections (a)(5)-(a)(5)(A), new subsection (a)(5)(B) and amendment of Note refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

13. Amendment of subsections (a)(5)-(a)(5)(A), new subsection (a)(5)(B) and amendment of Note refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 8-14-95 order, including further amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

15. New subsection (a)(7) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54316. Generic Agencies.

Note • History

(a) Any service operated by a generic agency shall be:

(1) Ineligible for vendorization if the generic agency is statutorily mandated to provide the services to the general public and/or to consumers, except as specified in (a)(2) below;

(2) Eligible for vendorization and subject to the vendorization process specified in Section 54310(d) and (e) of these regulations, if the generic agency:

(A) Provides services to the general public; and

(B) Charges a fee; however, the amount charged for consumers is the same as the amount charged to the general public for the same type of service.

(3) Eligible for vendorization and subject to the entire vendorization process specified in Section 54310(a) of these regulations, if the generic agency:

(A) Operates a service which is not mandated to provide to the general public;

(B) Has designed the service specifically for consumers; and

(b) For purposes of (a) above, fees shall not include:

(1) Shares of cost under the Medi-Cal program pursuant to the Welfare and Institutions Code, Section 14009;

(2) Annual deductibles under the uniform patient fee schedule for community mental health services pursuant to the Welfare and Institutions Code, Sections 5717 and 5718; or

(3) Repayment obligations under the California Children Services program pursuant to the Health and Safety Code, Section 255.

(c) Any generic agency meeting the requirements specified in (a)(2) above may request an exemption from the vendorization process by submitting a written statement to the vendoring regional center which includes:

(1) A description of the services to be provided; and

(2) The reasons it believes it qualifies for the exemption.

(d) Upon receipt of the written statement specified in (c) above:

(1) The vendoring regional center shall submit the request to the Department within 15 days of its receipt; and

(2) Within 15 days of receipt of the request from the regional center, the Department shall review the request and notify the vendoring regional center and the generic agency, in writing, that the exemption has been:

(A) Approved, along with the service code assigned pursuant to Section 54358(b) of these regulations; or

(B) Denied, along with the basis for the denial and an explanation of the appeal rights pursuant to Sections 54380 through 54390 of these regulations.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4644, 4648(a) and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(2) and (a)(3) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(2) and (a)(3) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(2)-(3) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsections (a)(2) and (3) and (c) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsection (a)(2) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (a)(2), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending subsections (a)(1), (a)(2), (a)(2)(B) and (a)(3)(B) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54318. Vendorization of Out-of-State Applicants and Manufacturers or Distributors.

Note • History

(a) A regional center may approve for vendorization an applicant not located and licensed, certified, or registered in California if the applicant meets all of the following requirements:

(1) Meets the requirements in California for the specific type of service, or meets the requirements for the specific service as specified by the appropriate controlling agency in the jurisdiction in which the applicant is located;

(2) Meets either of the following two criteria:

(A) Is located in a state bordering California and has an office or facility located within 50 miles of the California border: or

(B) Receives prior approval by the Director of the Department of the Director's designee pursuant to the Welfare and Institutions Code, Sections 4519(a) through (c).

(b) Manufacturers and distributors of merchandise which are located outside of California shall only be vendored if:

(1) The specific item is not available in California; or

(2) It is more economical to purchase the item outside of California.

(1) Submit a vendor application pursuant to Section 54310(d)(2) of these regulations; and

(2) Receive a service code pursuant to Sections 54342 through 54354 of these regulations, as applicable, providing they meet California requirements for a specific type of service; or

(3) Be vendored through miscellaneous services pursuant to Section 54356 of these regulations, providing they do not meet California requirements for a specific type of service.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4519, 4631, 4648(a) and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c)(1) and Note filed as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (c)(1) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (c)(1) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (c)(1) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsection (c)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54319. Group Practices.

Note • History

(a) Services which shall apply to both individuals and group practices include:

(1) Adaptive Skills Trainer -- Service Code 605;

(2) Art Therapist -- Service Code 691;

(3) Associate Behavior Analyst -- Service Code 613;

(4) Attorney -- Service Code 610;

(5) Behavior Analyst -- Service Code 612;

(6) Behavior Management Consultant -- Service Code 620;

(7) Counseling Services -- Service Code 625;

(8) Dance Therapist -- Service Code 692;

(9) Developmental Specialist -- Service Code 670;

(10) Educational Psychologist -- Service Code 672;

(11) Music Therapist -- Service Code 693;

(12) Recreational Therapist -- Service Code 694;

(13) Teacher -- Service Code 674;

(14) Teacher of Special Education -- Service Code 678;

(15) Tutor -- Service Code 680;

(16) Dentistry -- Service Code 715;

(17) Dietary Services (Dietitian only) -- Service Code 720;

(18) Laboratory and Radiologic Services -- Service Code 735;

(19) Occupational Therapy -- Service Code 773;

(20) Orthoptic Services -- Service Code 745;

(21) Orthotic and Prosthetic Services -- Service Code 750;

(22) Other Medical Equipment or Supplies -- Service Code 750;

(23) Other Medical Services -- Service Code 760;

(24) Pharmaceutical Services -- Service Code 765;

(25) Physical Therapy -- Service Code 772;

(26) Physicians or Surgeons -- Service Code 775;

(27) Psychiatrist -- Service Code 780;

(28) Clinical Psychologist -- Service Code 785; and

(29) Genetic Counselor -- Service Code 800.

(b) Group practices which provide more than one service shall be vendored separately for each service.

(c) The name of the group practice shall appear on the statewide vendor panel if all persons providing services as a group practice:

(1) Require no license, registration, and/or certificate; or

(2) Have the appropriate license, registration, and/or certificate.

(d) If some of the persons providing services within a group practice are assistants or trained aides who are not licensed, registered, or certified as appropriate to the service, the name of the group practice and the licensed/registered/certified applicant shall both appear on the statewide vendor panel.

(e) Except as specified in (f)(3) below, the following person shall sign the vendor application pursuant to Section 54310(b) of these regulations:

(1) Any person in the group practice for those services that do not require licensing, registration or certification; or

(2) A licensed/registered/certified person in the group practice for those services that require licensing, registration or certification.

(f) Any group practice which is incorporated shall:

(1) Possess corporation papers issued by the Secretary of State or other appropriate agency;

(2) Possess the appropriate license, certificate, and/or registration for all persons providing services as a group practice, if applicable; and

(3) Ensure that the corporation president sign the vendor application pursuant to Section 54310(b) of these regulations.

(g) The name of the corporation shall appear on the vendor panel for any group practice which is incorporated.

NOTE

Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code; and Section 11152, Government Code. References: Sections 4631 and 4648(a), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(1) and (a)(9) and subsection renumbering, amendment of subsections (c) and (f) and Note and repealer and new subsection (e) filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (a)(1) and (a)(9) and subsection renumbering, amendment of subsections (c) and (f) and NOTE, repealer of subsection (e) and new subsection (e) refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (e) and (f)(3) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Repealer of subsection (a)(14) and subsection renumbering filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

10. Change without regulatory effect amending subsections (a)(1)-(a)(27) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

11. New subsection (a)(4) and subsection renumbering filed 5-3-2001; operative 6-2-2001 (Register 2001, No. 18).

12. New subsection (a)(3) and subsection renumbering filed 7-11-2005; operative 8-10-2005 (Register 2005, No. 28).

§54320. Regional Center Review of Vendor Application.

Note • History

(a) The vendoring regional center shall review the vendor application identified in Section 54310(a) and, as applicable, (d) or (e) within 45 days after receipt from the applicant, to ensure all of the following:

(1) The vendor application is complete;

(2) The applicant has complied with provisions of Sections 54342 through 54355 of these regulations, as applicable;

(3) Any required license, credential, registration, accreditation, certificate or permit:

(A) Is current,

(B) Has been issued for the service to be vendored, and

(4) Staffing ratios and qualifications as specified in Section 56724, and 56770, if applicable, and Section 56756 or 56772 of these regulations are consistent with the program design as required in Section 56712 and Section 56762 of these regulations, if applicable, for applicants seeking vendorization as community-based day programs.

(5) The applicant has signed the Home and Community Based Services Provider Agreement (6/99), if applicable pursuant to Section 54310.

(6) That the applicant or person(s) disclosed pursuant to Section 54311 has not been determined to be an excluded individual or entity as defined in Section 54302(b)(1) and is not under investigation pursuant to the criteria in Section 54311(a)(6).

(b) If an applicant submits an incomplete vendor application, the regional center shall provide written notification to the applicant of the missing items within 45 days of receipt of the vendor application. The regional center shall take no further action until all required information is received, and any investigation pursuant to (a)(6) above is resolved. At that time, the vendoring regional center shall consider the vendor application completed.

(c) No provision of this section shall preclude the regional center from completing the vendorization process, up to the point of approval for those applicants which have applied for the appropriate license, credential, registration, certificate, or permit. However, the regional center shall not approve vendorization, nor refer consumers, until the appropriate license, credential, registration, certificate or permit is received.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4648(a) and 4648.12(c)(1)(A), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4502, 4631, 4648(a) 4648.12 and 4691, Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section heading and text filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section heading and text refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (a) and (d) and subsection relettering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (a)(5) filed 4-22-94; operative 4-22-94. Submitted to printing only (Register 94, No. 16).

8. Amendment of subsections (a)(2) and (5) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (a)(5), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending subsections (a)(5) and (c) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

12. Amendment of subsection (a) filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

13. Amendment of subsection (a)(5) and amendment of Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 7-22-2004 emergency amendment by operation of Government Code section 11346.1(f) (Register 2004, No. 49).

15. Amendment of subsection (a) refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

16. Amendment of subsection (a)(5) and amendment of Note refiled 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

17. Amendment of subsection (a) refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

18. Certificate of Compliance as to 12-22-2004 order transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

19. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (a)(3), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

20. Amendment of subsections (a)(1), (a)(3)(A)-(C) and (a)(5), new subsection (a)(6), amendment of subsection (b) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54322. Regional Center Approval/Denial of Vendorization.

Note • History

(a) The vendoring regional center shall approve vendorization within 45 days of receipt of all information which specifies that the applicant is in compliance with Section 54320(a).

(b) The vendoring regional center shall select criteria to apply in vendoring family home agencies (FHAs), including but not limited to, the following:

(1) The FHA's potential for providing cost-effective quality services and supports;

(2) The degree to which consumer choice regarding the provision of services and supports is identified as a factor in the FHA's program design;

(3) The experience of the FHA or key agency personnel in providing the same or comparable services;

(4) The reasonableness of the FHA's overhead;

(5) The capability of the regional center to monitor and evaluate the FHA; and

(6) The need for service.

(c) The regional center shall not approve vendorization of the FHA until completion of the criminal record review required by Title 17, Section 56085(a) and (b).

(d) The vendoring regional center shall issue an approval letter pursuant to (a) above to the vendor specifying all of the following:

(1) That the vendor is approved to provide the specified vendored services to consumers;

(2) That the statewide vendor panel reflects (1) above;

(3) The vendor identification number pursuant to Section 54340 of these regulations;

(4) The approved service code pursuant to Sections 54342 through 54358 of these regulations;

(5) The subcode, if applicable, pursuant to Section 54340 of these regulations;

(6) The approved staffing ratio for community-based day programs pursuant to Section 56756 or 56772 of these regulations;

(7) The approved facility service type and/or service level for residential services, as applicable;

(8) The process by which consumers are referred to the vendor and authorized to receive services;

(9) That vendorization is valid during the effective period of any license, credential, registration, certificate or permit required, and that vendorization shall not continue if the required document is suspended or revoked; and

(10) That vendorization does not guarantee that any consumers will be placed or referred to the vendor by the regional center.

(e) A vendoring regional center shall deny an application for vendorization within 45 days of receipt of a completed vendor application if the applicant fails to comply with the requirements of Section 54320(a) of these regulations, as applicable.

(f) The vendoring regional center shall notify the applicant, in writing, of the denial pursuant to (e) above and the reason for such denial. The notification shall also include:

(1) A statement that the applicant may appeal the action pursuant to Section 54380(a) of these regulations;

(2) A statement that failure to file an appeal within 30 days shall result in denial of the appeal pursuant to Sections 54380(b) and (d) of these regulations; and

(3) An explanation of the appropriate appeal procedures pursuant to Sections 54380 through 54390 of these regulations.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648(a), 4689.1 and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4631, 4648(a), 4689.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90, No. 35). A Certificate of Compliance must be transmitted to OAL by 10-29-90 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (a), (b)-(b)(5) and (d)(1) and subsection relettering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Editorial correction of subsections (b)(3)-(4) (Register 95, No. 30).

9. New subsections (b)-(c), subsection relettering, amendment of newly designated subsection (f) and amendment of Note filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

10. New subsections (b)-(c), subsection relettering, amendment of newly designated subsection (f) and amendment of Note refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 7-24-95 order including amendment of subsection (b)(4)-(5), new subsection (b)(6) and amendment of subsection (c) transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

12. Change without regulatory effect amending subsections (d)(1), (d)(8) and (d)(10) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54324. Emergency Vendorization.

Note • History

(a) The regional center is authorized to approve emergency vendorization for an applicant prior to the receipt of a completed vendor application if the regional center determines that the health or safety of a consumer is in jeopardy and no current vendor is available to provide the needed service.

(b) If emergency vendorization is approved, the applicant may provide services for no more than 45 days.

(c) The applicant shall meet all applicable requirements pursuant to Section 54320(b)(2) through (5) of these regulations.

(d) The applicant shall submit a completed vendor application pursuant to Section 54310(a), (d) or (e) of these regulations within 30 days of the authorization by the vendoring regional center to provide the service.

(e) Within 15 days after receipt of the vendor application, the regional center shall:

(1) Review the vendor application as required in Section 54320(a) of these regulations; and

(2) Notify the vendor of vendorization approval pursuant to Section 54322(d) of these regulations; or

(3) Notify the applicant of vendorization denial pursuant to Section 54322(f) of these regulations.

(f) The emergency vendorization shall lapse if the vendor application is not properly submitted or if the regional center does not approve the application within 45 days of the initial authorization.

(g) If a lapse of emergency vendorization occurs pursuant to (f) above, in no case shall the regional center allow the vendor to reapply for emergency vendorization.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4502, 4631, 4648(a) and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a) and (c)-(f) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 91, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a) and (c)-(f) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a), (c)-(d) and (e)(1)-(2) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (d) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Editorial correction of History 3 (Register 95, No. 18).

10. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (d), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending subsections (a), (d), (e)(2) and (e)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54326. General Requirements for Vendors and Regional Centers.

Note • History

(a) All vendors shall:

(1) Be prohibited from transferring vendorization of their service to another person or entity;

(2) Provide access to regional center and/or Department staff, on an announced or unannounced basis, for the purposes specified in the Welfare and Institutions Code, Section 4648.1;

(3) Maintain records of services provided to consumers in sufficient detail to verify delivery of the units of service billed:

(A) Such records shall be maintained for a minimum of five years from the date of final payment for the State fiscal year in which services were rendered or until audit findings have been resolved, whichever is longer. This requirement may be satisfied by retaining an electronic record of the information in the record, if the record reflects accurately the information set forth in the record at the time it was first generated in its final form as an electronic record or otherwise, and the electronic record remains accessible for later reference.

(B) Records must include for each consumer the information specified in Section 50604(d)(3)(A), (B), (C), (D), (E) or (F), as applicable.

(C) Data, as specified in Section 50604(d)(3)(A), (B), (C), (D), (E) or (F), as applicable, for the billing period shall be submitted to the regional center with the billings/invoices.

(4) Make available any books and records pertaining to the vendored service, including those of the management organization and disclosure information required in Section 54311, if applicable, for audit, inspection or authorized agency representatives. This shall also include only those portions of any personnel records that are necessary to ensure staff qualifications comply with the requirements contained in Section 56724, and Section 56770 or 56792 of these regulations, if applicable, in order to comply with the monitoring of program standards pursuant to the Welfare and Institutions Code, Section 4691(f);

(5) Utilize and be bound by Title 17, Sections 50700 through 50767, and the Welfare and Institutions Code, Section 4648.2, should the vendor elect to appeal any audit findings;

(6) Comply with the provisions contained in the Fair Labor Standards Act (29 U.S.C., Sections 201 through 219);

(7) Not discriminate in the provision of services to consumers on the basis of race, religion, age, disability, sex, or national origin of the consumer, or his/her parents, guardian, or conservator;

(8) Be vendored separately for each type of service provided, as specified in Sections 54342 through 54356 of these regulations unless the regional center waives separate vendorization pursuant to Section 54342(a)(37) or 54342(a)(78)(A);

(9) Provide certification consistent with the Public Contract Code, Sections 10410 and 10411, that the vendor and the agents or employees of the vendor, in the performance of the contracts, are independent contractors and are not officers or employees of the State of California;

(10) Bill only for services which are actually provided to consumers and which have been authorized by the referring regional center. When the vendor is receiving payment for a consumer from the Department of Rehabilitation and/or the Department of Health Services for a portion of the program day, and the vendor's rate of reimbursement is based on costs reported pursuant to Section 57422(c)(2), the vendor shall only bill the prorate share of the daily rate.

(11) Not bill for consumer absences for nonresidential services. The Department shall authorize payment for absences which are the direct result of situations and/or occurrences for which a State of Emergency has been declared by the Governor. If payment for absences due to a State of Emergency is authorized by the Department, the vendor shall bill only for absences in excess of the average number of absences experienced by the vendor during the 12-month period prior to the month in which the disaster occurred;

(12) Agree to accept the rate established, revised or adjusted by the Department as payment in full for all authorized services provided to consumers and not bill the consumer nor the consumer's family, conservator, guardian or authorized consumer representative for a supplemental amount regardless of the cost of providing the authorized service. This shall not preclude the vendor from billing the consumer or consumer's family for services provided which were authorized by the consumer or family and which were not authorized by the regional center;

(13) Comply with all applicable staffing ratio requirements;

(14) Be prohibited from being vendored by more than one regional center for the same service at the same location; and

(15) Comply with conflict of interest requirements as determined by the criteria established by Title 17, Sections 54500 through 54525 and the Welfare and Institutions Code, Sections 4626 through 4628.

(16) Sign the Home and Community-Based Services Provider Agreement (6/99), if applicable pursuant to Section 54310. If the Home and Community-Based Services Provider Agreement (6/99) is required and has not been signed, the regional center shall:

(A) For new applicants requesting vendorization, deny vendorization pursuant to Section 54322(c); or

(B) For existing vendors, notify in writing, the vendor and utilizing regional center(s), if any, that the signed Home and Community-Based Services Provider Agreement (6/99) is required and that payment of the vendor's rate will be suspended, the effective date of the suspension, and that payment shall remain suspended until the signed Home and Community-Based Services Provider Agreement (6/99), is received.

(1) The effective date for suspension of payment of the vendor's rate shall be 15 days from the date of the letter notifying the vendor that payment will be suspended.

(2) If the signed Home and Community-Based Services Provider Agreement (6/99), is submitted within the time specified, no further action will be taken.

(3) If the Home and Community-Based Services Provider Agreement (6/99), is submitted after the date when payment of the vendor's rate has been suspended, the vendoring regional center shall notify the vendor and utilizing regional center(s) that payment of the vendor's rate is reinstated as of the date payment was suspended.

(17) Notify the vendoring regional center of any additions or changes in the information disclosed on the DS 1891 (7/2011) and submit the information pursuant to requirements of Section 54311(c).

(18) Notify the vendoring regional center of:

(A) Any conviction for any felony or misdemeanor, within the previous ten years, involving fraud or abuse in any government program, or related to neglect or abuse of an elder or dependent adult or child, or in connection with the interference with, or obstruction of, any investigation into health care related fraud or abuse, or that has been found liable, within the previous ten years, in any civil proceeding for fraud or abuse in any government program;

(B) Any settlement in lieu of conviction involving fraud or abuse in any government program within the previous ten years; or

(C) Any loss of license, certificate or credential, or failure to maintain any valid licenses, certificates or credentials required for the performance or operation of the vendored service.

(b) The vendor shall maintain a written description of its organizational structure and operations at the vendor's business office in accordance with the following:

(1) All descriptions shall include:

(A) An identification of the legal entity serving as the governing body or board of directors;

(B) The policies of operation that are established by the governing body or board of directors; and

(2) In addition to the information specified in (b)(1) above, if the vendor:

(A) Operates more than one service, the description shall also include:

1. The names, addresses and vendor numbers of the other services; and

2. Whether any of the services share staff or facility space.

(B) Has a management organization, the description shall also include a diagram depicting the relationships among the management organization, the vendor, and any other services under the management organization.

(c) Regional centers shall submit the information specified in subsection (a)(3)(C) above to the Department on a monthly basis, and no later than 30 days after the end of the previous month.

(d) Regional centers shall not:

(1) Use purchase of service funds to purchase services for a minor child without first taking into account, when identifying the minor child's service needs, the family's responsibility for providing similar services to a minor child without disabilities. In such instances, the regional center must provide for exceptions, based on family need or hardship.

(2) Use purchase of service funds to purchase services for those executive/management services, legal services for the benefit of the regional center, service coordination, and administrative service and support functions that are funded through the regional center operations budget. Funding of specialized clinical and diagnostic assessment services and other services for the benefit of a consumer through purchase of service funds is permissible.

(3) Charge vendors or consumers for providing representative payee services.

(4) Except as specified in Section 54324 of these regulations:

(A) Refer any consumer to an applicant until the vendor application is approved; or

(B) Reimburse a vendor for services provided before vendorization.

(e) Compliance with the standards and requirements specified in these regulations does not exempt a vendor from compliance with existing statutes and regulations or with any other applicable standards or requirements promulgated by the controlling agencies for the service provided by the vendor.

(f) Regional centers shall take routine action to ensure that vendors have no convictions and have not been found liable as described in (a)(18)(A) above, have not entered into any settlement agreements in lieu of convictions involving fraud or abuse in any government program as described in (a)(18)(B), and are serving consumers with the valid licenses, certificates or credentials required for the performance or operation of the vendored service.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Section 4648.12(c)(1)(A), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4500, 4501, 4502, 4641.5, 4648, 4648.1, 4648.12 and 4742, Welfare and Institutions Code: and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(9) and (d)(1)(A) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(9) and (d)(1)(A) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a)(9) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsections (a)(17), (a)(17)(B) and (a)(17)(B)2-3 filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsections (a)(12) and (17) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of subsections (a)(9), (a)(12), (a)(17), (a)(17)(B) and (a)(17)(B)(2)-(3), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

12. Repealer of subsection (a)(2), subsection renumbering, and amendment of Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

13. Repealer of subsection (a)(2), subsection renumbering, and amendment of Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

15. Amendment of subsection (a)(3)(B), new subsections (a)(3)(C) and (c), subsection relettering and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

16. Amendment of subsection (a)(3)(B), new subsections (a)(3)(C) and (c), subsection relettering and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

17. Amendment of subsection (a)(3)(B), new subsections (a)(3)(C) and (c), subsection relettering and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

18. Amendment of subsections (a)(3)(A), (a)(16), (a)(16)(B) and (a)(16)(B)(2)-(3) and amendment of Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

19. Certificate of Compliance as to 6-1-2004 order, including amendment of subsections (a)(3)(B)-(C), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

20. Amendment of subsections (a)(3)(A), (a)(16), (a)(16)(B) and (a)(16)(B)(2)-(3) and amendment of Note refiled 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

21. Certificate of Compliance as to 12-22-2004 order, including further amendment of subsection (a)(16), transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

22. Amendment of subsections (a)(4) and (a)(16), new subsections (a)(17)-(a)(18)(C) and (f) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

23. Amendment of subsection (a)(3)(A) and Note filed 1-17-2012; operative 2-16-2012 (Register 2012, No. 3).

§54327. Requirements for Special Incident Reporting by Vendors and Long-Term Health Care Facilities.

Note • History

(a) Parent vendors, and consumers vendored to provide services to themselves, are exempt from the special incident reporting requirements set forth in this Article.

(b) All vendors and long-term health care facilities shall report to the regional center:

(1) The following special incidents if they occurred during the time the consumer was receiving services and supports from any vendor or long-term health care facility:

(A) The consumer is missing and the vendor or long-term health care facility has filed a missing persons report with a law enforcement agency;

(B) Reasonably suspected abuse/exploitation including:

1. Physical;

2. Sexual;

3. Fiduciary;

4. Emotional/mental; or

5. Physical and/or chemical restraint.

1. Provide medical care for physical and mental health needs;

2. Prevent malnutrition or dehydration;

3. Protect from health and safety hazards;

4. Assist in personal hygiene or the provision of food, clothing or shelter or

5. Exercise the degree of care that a reasonable person would exercise in the position of having the care and custody of an elder or a dependent adult.

(D) A serious injury/accident including:

1. Lacerations requiring sutures or staples;

2. Puncture wounds requiring medical treatment beyond first aid;

3. Fractures;

4. Dislocations;

5. Bites that break the skin and require medical treatment beyond first aid;

6. Internal bleeding requiring medical treatment beyond first aid;

7. Any medication errors;

8. Medication reactions that require medical treatment beyond first aid; or

9. Burns that require medical treatment beyond first aid.

(E) Any unplanned or unscheduled hospitalization due to the following conditions:

1. Respiratory illness, including but not limited, to asthma; tuberculosis; and chronic obstructive pulmonary disease;

2. Seizure-related;

3. Cardiac-related, including but not limited to, congestive heart failure; hypertension; and angina;

4. Internal infections, including but not limited to, ear, nose and throat; gastrointestinal; kidney; dental; pelvic; or urinary tract;

5. Diabetes, including diabetes-related complications;

6. Wound/skin care, including but not limited to, cellulitis and decubutus;

7. Nutritional deficiencies, including but not limited to, anemia and dehydration; or

8. Involuntary psychiatric admission;

(2) The following special incidents regardless of when or where they occurred:

(A) The death of any consumer, regardless of cause;

(B) The consumer is the victim of a crime including the following:

1. Robbery, including theft using a firearm, knife, or cutting instrument or other dangerous weapons or methods which force or threaten a victim;

2. Aggravated assault, including a physical attack on a victim using hands, fist, feet or a firearm, knife or cutting instrument or other dangerous weapon;

3. Larceny, including the unlawful taking, carrying, leading, or riding away of property, except for motor vehicles, from the possession or constructive possession of another person;

4. Burglary, including forcible entry; unlawful non-forcible entry; and, attempted forcible entry of a structure to commit a felony or theft therein;

5. Rape, including rape and attempts to commit rape.

(c) The report pursuant to subsection (b) shall be submitted to the regional center having case management responsibility for the consumer.

(d) When the regional center with case management responsibility is not the vendoring regional center, the vendor or long-term health care facility shall submit the report pursuant to subsection (b) to both the regional center having case management responsibility and the vendoring regional center.

(e) The vendor's or long-term health care facility's report to the regional center pursuant to subsection (b) shall include, but not be limited to:

(1) The vendor or long-term health care facility's name, address and telephone number;

(2) The date, time and location of the special incident;

(3) The name(s) and date(s) of birth of the consumer(s) involved in the special incident;

(4) A description of the special incident;

(5) A description (e.g., age, height, weight, occupation, relationship to consumer) of the alleged perpetrator(s) of the special incident, if applicable;

(6) The treatment provided to the consumer(s), if any;

(7) The name(s) and address(es) of any witness(es) to the special incident;

(8) The action(s) taken by the vendor, the consumer or any other agency(ies) or individual(s) in response to the special incident;

(9) The law enforcement, licensing, protective services and/or other agencies or individuals notified of the special incident or involved in the special incident; and

(10) The family member(s), if applicable, and/or the consumer's authorized representative, if applicable, who have been contacted and informed of the special incident.

(f) The report pursuant to subsection (b) shall be submitted to the regional center by telephone, electronic mail or FAX immediately, but not more than 24 hours after learning of the occurrence of the special incident.

(g) The vendor or long-term health care facility shall submit a written report of the special incident to the regional center within 48 hours after the occurrence of the special incident, unless a written report was otherwise provided pursuant to subsection (e). The report pursuant to this subsection may be made by FAX or electronic mail.

(h) When a vendor makes a report of an event to the Department of Social Services' Community Care Licensing Division pursuant to Title 22, California Code of Regulations, Section 80061(b) the vendor shall simultaneously report the event to the regional center by telephone, FAX or electronic mail.

(1) The vendor shall concurrently submit to the regional center a copy of any subsequent written report regarding the event that is submitted to the Department of Social Services' Community Care Licensing Division.

(i) When a long-term health care facility reports an unusual occurrence to the Department of Health Services' Licensing and Certification Division pursuant to Title 22, California Code of Regulations, Sections 72541, 75339, 76551 or 76923, the long-term health care facility shall simultaneously report the unusual occurrence to the regional center immediately by telephone, FAX or electronic mail.

(1) The long-term health care facility shall concurrently submit to the regional center a copy of any subsequent report, or any written confirmation of the unusual occurrence, that is submitted to the Department of Health Services' Licensing and Certification Division.

(j) The vendor or long-term health care facility may submit to the regional center a copy of the report submitted to a licensing agency when the report to the licensing agency contains all the information specified in subsection (d)(1) through (10).

(k) These regulations shall not remove or change any reporting obligations under the Elder and Dependent Adult Abuse Reporting Act commencing with Welfare and Institutions Code Section 15600 or the Child Abuse and Neglect Reporting Act commencing with Penal Code Section 11164.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4500, 4501, 4502, 4648, 4648.1 and 4742, Welfare and Institutions Code.

HISTORY

1. New section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-20-98 order, including further amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

4. Amendment filed 6-27-2001 as an emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-29-2001 or emergency language will be repealed by operation of law on the following day.

5. Reinstatement of section as it existed prior to 6-27-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 43).

6. Amendment filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 10-25-2001 order, including further amendment of section, transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

8. Change without regulatory effect amending subsection (b)(2)(B)5. filed 5-27-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 22).

§54327.1. Requirements for Special Incident Reporting by Regional Centers.

Note • History

(a) The regional center shall submit an initial report to the Department of any special incident, as defined in Section 54327(b), within two working days following receipt of the report pursuant to Section 54327(b).

(b) When a regional center has knowledge of a special incident for which the vendor or long-term health care facility is responsible for reporting but has not submitted a report to the regional center within the required time period, the regional center shall submit an initial report to the Department within two working days of learning of the occurrence.

(c) The initial report shall include the following information, to the extent the information is available at the time of the initial report:

(1) The consumer(s) name and date of birth;

(2) The vendor or long-term health care facility's name, address and telephone number;

(3) The name and telephone number of the regional center contact person regarding the special incident;

(4) The consumer(s) Unique Consumer Identifier (UCI);

(5) Name of the consumer's conservator or guardian, if applicable;

(6) Date, time and location of the incident;

(7) Date the incident was reported to the regional center;

(8) Name of the person preparing the report;

(9) Date the report was prepared;

(10) Type of incident;

(11) Any medical care or treatment required as a result of the special incident;

(12) Relationship of the alleged perpetrator to the consumer;

(13) Identification of any persons or entities notified about the incident and the date they were notified;

(14) A description of the special incident;

(15) If the special incident was a death, indication if the death was disease related; non-disease related; or, unknown;

(16) A description of any actions/outcomes taken by any of the following persons or entities in response to the special incident:

(A) Regional center(s);

(B) Vendor(s);

(D) Department of Social Services Community Care Licensing;

(E) Child Protective Services;

(F) Adult Protective Services;

(G) Long Term Care Ombudsman;

(H) Law enforcement; and/or

(I) Coroner.

(17) Any additional information that the regional center determines is necessary to explain or describe the special incident.

(d) Any required information that is not submitted with the initial report in (c) shall be submitted within 30 working days following receipt of the report of the special incident pursuant to Section 54327(b).

(e) The regional center shall comply with all Department requests for initial and follow-up information pertaining to a special incident.

(f) The report shall be considered complete when the regional center has submitted all the information required by this section.

(g) Effective January 1, 2002, all reports of special incidents prepared by the regional center shall be transmitted to the Department utilizing the Department's Electronic Data Reporting System.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 10-20-98 order, including further amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

5. Reinstatement of section as it existed prior to 6-27-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 43).

7. Certificate of Compliance as to 10-25-2001 order, including further amendment of section, transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

8. Change without regulatory effect relettering subsections and the internal cross-references thereto filed 5-27-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 22).

§54327.2. Regional Center Risk Management, Assessment and Planning Committee and Risk Management and Mitigation Plans.

Note • History

(a) Each regional center shall establish a Risk Management, Assessment and Planning Committee that, at a minimum, includes a representative from the regional center's clinical, quality assurance and training staff.

(b) The Risk Management, Assessment and Planning Committee shall develop the regional center's Risk Management and Mitigation Plan which shall address, at a minimum:

(1) The process and procedures for ensuring accurate and timely handling and reporting of special incidents by regional center staff, vendors, and long-term health care facilities;

(2) The provision of training and technical assistance to regional center staff, vendors and long-term health care facility staff and others on the legal obligations of abuse reporting, special incident reporting, risk assessment, developing and implementing an incident prevention plan and proactive accident/safety planning through the individualized program planning process;

(3) Coordination and communication with local licensing, protective service and law enforcement agencies relative to investigative actions and findings;

(4) A process for reviewing individual and aggregate special incident report data to identify trends and unusual patterns which may require regional center action, and;

(5) A process for reviewing medical records and coroner reports, as appropriate, associated with special incidents to ensure that appropriate medical attention was sought and/or given.

(1) Monitor the regional center's Risk Management and Mitigation Plan to ensure it is being implemented;

(2) Annually review the regional center's internal special incident reporting and risk management systems; and

(3) Update the Risk Management and Mitigation Plan as necessary.

(d) The Risk Management, Assessment and Planning Committee shall meet at least semi-annually.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions Code.

HISTORY

1. New section filed 6-27-2001 as an emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-29-2001 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2001, No. 43).

3. New section filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-25-2001 order, including amendment of subsection (b)(2), transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

§54330. Changes in Vendor Ownership, Location, or Program/Service Design.

Note • History

(a) The vendor shall notify the vendoring regional center 30 days prior to any change in any of the following:

(1) Ownership. A new vendor application shall be completed by the new owners and be approved by the vendoring regional center prior to provision of services to consumers. If necessary, a new license shall be obtained prior to approval of the vendor application and the provision of services to consumers;

(2) Location. If a license is applicable, the new location shall be licensed prior to the provision of services to regional center consumers; and

(3) The vendor's required license, certificate, registration, credential or permit.

(b) The vendor shall notify the vendoring regional center and all user regional centers:

(1) In writing at least 60 days before it discontinues providing services. The regional center shall delete the vendor from the vendor panel; or

(2) Of any modification to the program design or service design pursuant to Section 56712(b), 56762(c) or 56780(b) of these regulations, if applicable.

NOTE

Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a) and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Repealer of subsections (a)(1) and new subsections (a)(1)-(B) and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Repealer of subsection (a)(1) and new subsections (a)(1)-(B) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Editorial correction of printing error in HisTory 3 (Register 92, No. 25).

6. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a)(1) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsections (a)(1)-(a)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54332. Regional Center Files.

Note • History

(a) The vendoring regional center shall maintain a file for each vendor which includes copies of:

(1) The vendor application as described in Section 54310(a) of these regulations;

(2) Any required certificate, credential, license, degree, permit or registration;

(3) Statement of current vendor status;

(4) The regional center approval letter;

(5) The program design or service design as described in Sections 56712, 56762 and 56780 of these regulations, if applicable;

(6) The staff qualifications and duty statements as described in Sections 56722, 56724, 56752, 56754, 56770, 56790 and 56792 of these regulations, if applicable;

(7) Notification of established rate and all documentation submitted pursuant to Sections 57422, 57433 through 57439, 58020, and 58033 through 58039 of these regulations, for a rate determination, if applicable;

(8) The signed Home and Community Based Services Provider Agreement, (6/99) if applicable.

(9) Agreements negotiated pursuant to Section 57300(d) or (e), if applicable;

(10) Service contracts negotiated pursuant to Section 57540, if applicable;

(11) Agreements negotiated pursuant to Section 58140, if applicable.

(b) Regional centers shall review, at least biannually or sooner upon notification by the Department of Developmental Services, Department of Health Services, or any governing licensing or certification board or entity, all vendor files maintained by the regional center to determine that:

(1) The information required for vendorization is current, completed and accurate;

(2) At least one consumer has been provided services by the vendor within the last 24 months;

(3) The service currently provided by the vendor is the same service approved for vendorization;

(4) Vendors meet the minimum program standards as specified in Sections 56710 through 56802 of these regulations, if applicable;

(5) The vendor has signed the Home and Community Based Services Provider Agreement (6/99), if applicable; and

(6) The vendor is not in violation of the requirement stated in Section 54314(a)(7).

(c) If, after a review of the vendor files, the vendoring regional center determines that the vendored service has not been provided to any consumer within the last 24 months, the vendoring regional center shall:

(1) Send the vendor a written notice stating that vendorization will be terminated in 30 days unless the vendoring regional center receives notification from the vendor expressing an interest to continue as a vendor; and

(2) Make the changes to the statewide vendor panel required by Section 54334(d) of these regulations if the vendor does not respond in accordance with (c)(1) above.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4648(a) and 4648.12(c)(1)(A), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a), 4648.12, 4691 and 4791, Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection (a) and subsection relettering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsections (a)(8) and (b)(5) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsections (b)(2) and (c) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

10. Amendment of subsection (a)(9) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

11. Amendment of subsections (a)(8) and (b)(5) and amendment of Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

12. Amendment of subsections (a)(8) and (b)(5) and amendment of Note refiled 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 12-22-2004 order transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

14. Amendment of subsections (b), (b)(1) and (b)(3)-(5), new subsection (b)(6) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54334. Statewide Vendor Panel.

Note • History

(a) The statewide vendor panel shall include the following information for all vendors:

(1) Vendor's name and telephone number;

(2) Vendor's Social Security Number or Federal tax ID number;

(3) Vendor's mailing address, including the county;

(4) Location of vendor's facility;

(5) The vendor identification number, service code, and subcode;

(6) The vendor's area of specialty, if any;

(7) A description of the service provided;

(8) Licensed capacity, if applicable;

(9) The effective date of vendorization;

(10) The vendoring and all user regional centers; and

(11) The name of the management organization, if any.

(b) Any regional center utilizing a service within the vendoring regional center's catchment area shall notify the vendoring regional enter, in writing, within 15 days from the day the vendor begins to serve, or ceases to serve, the utilizing regional center's consumers.

(1) Input all applicable information for each vendor into the statewide vendor panel;

(2) Transmit this information to the Department via the centralized automated regional center accounting system. This information shall be maintained on a master file by the Department; and

(3) Ensure that all the information contained in the statewide vendor panel is current by updating the panel any time a change to any of the items specified in (a) above, is reported by a vendor or a regional center utilizing the service.

(d) The vendoring regional center shall delete a vendor's name from the vendor panel and shall send the vendor written notification, along with an explanation of the appeal rights pursuant to Sections 54380 through 54390 of these regulations, that vendorization has been terminated, if any of the following conditions exist:

(1) The vendor notifies the vendoring regional center of its intent to discontinue providing services;

(2) The vendor has not responded to the 30-day notice pursuant to Section 54332(c)(1) of these regulations; or

(3) Vendorization is being terminated for noncompliance pursuant to Sections 54370 or 54372.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a), 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (b)-(b)(6) and (e) and subsection relettering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Vendor Numbers and Service Codes

§54340. Vendor Identification Numbers, Service Codes, and Subcodes.

Note • History

(a) The Department shall issue a block of numbers to each regional center to use in assigning vendor identification numbers. The vendoring regional center shall assign a vendor identification number to each vendor in accordance with this section. The vendor identification number shall be used by all regional centers purchasing the vendored service from that specific vendor. Vendors shall be assigned vendor identification numbers as follows:

(1) Vendor identification numbers beginning with the letter “H” shall be assigned to adult day programs, mobility training services agencies, acute care hospitals, day treatment centers, infant development programs, camping services vendors, day care vendors, home health agencies, homemaker services, in-home respite services agencies, out-of-home respite services vendors, supported employment programs -- group, supported employment programs -- individual, work activity programs, transportation companies, transportation/additional component vendors, residential facilities, intermediate care facilities and nursing facilities:

(A) A separate vendor identification number shall be assigned for each location at which the vendor provides the service, with the exception of in-home respite services agency vendors which have received a waiver pursuant to Section 54342(a)(37) of these regulations;

(B) If a single vendor has more than one service of the same type at the same location, the regional center shall assign each service a separate vendor identification number; and

(C) Location, pursuant to paragraphs (a)(1)(A) and (B) above, shall be the business address for those vendors who offer services solely in the community and have no specific facility or building site.

(2) Vendor identification numbers beginning with the letter “P” shall be assigned to all vendors not listed in (a)(1) above, or (a)(3) , (a)(4) or (a)(5) below;

(3) A vendor identification number beginning with the letter “Z” shall be assigned to:

(A) The following vendors when the rate charged for consumers is the same charged to the general public for the same service:

1. Out-of-state manufacturers or distributors;

2. Retail/wholesale stores;

3. Public transit authorities;

4. Dial-a-ride;

5. Rental care agencies;

6. Taxis; and

7. Generic agencies.

(4) A vendor identification number beginning with the letter “V” shall be assigned to:

(A) Respite service - family member, nursing service - family member, day care - family member, transportation - family member, diaper and nutritional supplements - family member.

(B) Vendors who provide vouchered and non-vouchered services shall be assigned two vendor identification numbers:

1. a vendor identification number beginning with the letter “V” shall be assigned for vouchered services; and

2. A vendor identification number shall be assigned pursuant to (a)(1) through (3) above, as applicable, for non-vouchered services.

3. Regional centers may issue only one number to a vendor which shall be preceded by the letter “V” for vouchered services and the letter “H”, “P”, or “Z”, as appropriate pursuant to (a)(1) through (3) above, for non-vouchered services.

(5) A vendor identification number beginning with the letter “S” shall be assigned to vendors with whom the regional center negotiates and enters into a service contract pursuant to Section 57540.

(b) The Department shall assign vendor identification numbers to:

(1) Regional centers:

(A) When an emergency arises which affects the health or safety of a consumer and requires the regional center to provide services; and

(B) To facilitate payment for services pursuant to agreements between regional centers.

(2) Developmental centers to provide a mechanism for a regional center to pay a developmental center when the developmental center is providing services to a consumer residing in the community.

(c) The vendoring regional center shall assign a service code to the vendor based upon the program design and/or the services provided.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)-(a)(6) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)-(a)(6) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (a)(1) and (a)(5)-(6) and subsection relettering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsections (a)(1)(A) and (a)(4)(A), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

10. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

11. Amendment of subsection (a)(1) filed 8-1-2005; operative 8-31-2005 (Register 2005, No. 31).

§54342. Types of Services.

Note • History

(a) The following service codes shall be assigned to the following types of services:

(1) Activity Center -- Service Code 505. Activity Centers shall meet the requirements in Sections 56710 through 56756 of these regulations for the specific service being vendored.

(2) Acute Care Hospitals -- Service Code 700. A regional center shall classify a vendor as an acute care hospital if the vendor is either:

(A) An acute care hospital which is validly licensed as such by DHS, and which provides inpatient care 24-hours per day; or

(B) An acute psychiatric hospital which is validly licensed as such by DHS, and which provides care for the mentally disordered, incompetent persons referred to in Welfare and Institutions Code, Sections 5000 to 5550.

(3) Adaptive Skills Trainer -- Service Code 605. A regional center shall classify a vendor as an adaptive skills trainer if the vendor possesses the skills, training and education necessary to enhance existing consumer skills. An adaptive skills trainer may also remedy consumer skill deficits in communication, social function or other related skill areas and shall meet the following requirements:

(A) Possess a Master's Degree in one of the following: education, psychology, counseling, nursing, social work, applied behavior analysis, behavioral medicine, speech and language, or rehabilitation; and

(B) Have at least one year of experience in the design and implementation of adaptive skills training plans.

(4) Adult Day Care -- Service Code 855.

(A) A regional center shall classify a vendor as an adult day care facility if the vendor:

1. Possesses a valid day care license for adults issued by DSS or an agency authorized by DSS to assume specific licensing responsibilities; and

2. Provides nonmedical care and supervision to adults 18 years of age or older on less than a 24-hour per day basis.

(B) Adult day care does not include adult day programs as identified in (a)(1), (6), (12), (33), and (72).

(5) Adult Day Health Center -- Service Code 702. A regional center shall classify a vendor as an adult day health center if the vendor has a signed adult day health care provider agreement with the Department of Health Services to provide the services described in Title 22, Chapter 5 to Medi-Cal beneficiaries who are eligible for and voluntarily elect to participate in an adult day health care program.

(6) Adult Development Center -- Service Code 510. Adult Development Centers shall meet the requirements in Sections 56710 through 56756 of these regulations for the specific service being vendored.

(7) Art Therapist -- Service Code 691. A regional center shall classify a vendor as an art therapist if the vendor possesses a current registration issued by the American Art Therapy Association and works with an individual using art media as a means of expression and communication to promote the individual's perceptive, intuitive, affective, and expressive experiences which lead to the individual's personal growth or personality reintegration.

(8) Associate Behavior Analyst -- Service Code 613. A regional center shall classify a vendor as an Associate Behavior Analyst if the vendor assesses the function of a behavior of a consumer and designs, implements, and evaluates instructional and environmental modifications to produce socially significant improvements in the consumer's behavior through skill acquisition and the reduction of behavior, under direct supervision of a Behavior Analyst or Behavior Management Consultant. Associate Behavior Analysts engage in descriptive functional assessments to identify environmental factors of which behavior is a function. Associate Behavior Analysts shall not practice psychology, as defined in Business and Professions Code Section 2903. A regional center shall classify a vendor as an Associate Behavior Analyst if an individual is recognized by the National Behavior Analyst Certification Board as a Board Certified Associate Behavior Analyst.

(9) Attorney -- Service Code 610. A regional center shall classify a vendor as an attorney if the vendor:

(A) Is an active member in good standing of the State Bar of California;

(B) Advises individuals of their legal rights; and

(10) Audiology -- Service Code 706.

(A) A regional center shall classify a vendor as a provider of audiology services if the vendor is:

1. An audiologist who is validly licensed as an audiologist by the Speech Pathology and Audiology Examining Committee of the Medical Board of California; and

2. Uses techniques to identify and evaluate hearing disorders and to develop methods of improving hearing disorders involving speech, language, auditory behavior, and other aberrant behavior related to hearing loss.

(B) A vendored audiologist shall not dispense hearing aids to consumers, or be additionally vendored as an audiology center or hearing aid dispenser.

(11) Behavior Analyst -- Service Code 612. Behavior Analyst means an individual who assesses the function of a behavior of a consumer and designs, implements, and evaluates instructional and environmental modifications to produce socially significant improvements in the consumer's behavior through skill acquisition and the reduction of behavior. Behavior Analysts engage in functional assessments or functional analyses to identify environmental factors of which behavior is a function. A Behavior Analyst shall not practice psychology, as defined in Business and Professions Code section 2903. A regional center shall classify a vendor as a Behavior Analyst if an individual is recognized by the national Behavior Analyst Certification Board as a Board Certified Behavior Analyst.

(12) Behavior Management Assistant -- Service Code 615. A regional center shall classify a vendor as a behavior management assistant if the vendor designs and/or implements behavior modification intervention services under the direct supervision of a behavior management consultant; or if the vendor assesses the function of a behavior of a consumer and designs, implements, and evaluates instructional and environmental modifications to produce socially significant improvements in the consumer's behavior through skill acquisition and the reduction of behavior, under direct supervision of a Behavior Analyst or Behavior Management Consultant, and meets either of the following requirements:

(A) Possesses a Bachelor of Arts or Science Degree and has either:

1. Twelve semester units in applied behavior analysis and one year of experience in designing and/or implementing behavior modification intervention services; or

2. Two years of experience in designing and/or implementing behavior modification intervention services.

(B) Is registered as either:

1. A psychological assistant of a psychologist by the Medical Board of California or Psychology Examining Board; or

2. An Associate Licensed Clinical Social Worker pursuant to Business and Professions Code, Section 4996.18.

(13) Behavior Management Consultant -- Service Code 620.

(A) A regional center shall classify a vendor as a behavior management consultant if the vendor designs and/or implements behavior modification intervention services and meets the following requirements:

1. Individuals vendored as a behavior management consultant prior to, or as of, December 31, 2006, that have not previously completed twelve semester units in applied behavior analysis, shall have until December 31, 2008 to complete twelve semester units in applied behavior analysis and possess a license and experience as specified in 3. through 7. below.

2. Individuals vendored as a behavior management consultant on, or after, January 1, 2007, shall, prior to being vendored, have completed twelve semester units in applied behavior analysis and possess a license and experience as specified in 3. through 7. below.

3. Possesses a valid license as a psychologist from the Medical Board of California or Psychology Examining Board; or

4. Is a Licensed Clinical Social Worker pursuant to Business and Professions Code, Sections 4996 through 4998.7; or

5. Is a Licensed Marriage and Family Therapist pursuant to Business and Professions Code, Sections 4980 through 4984.7; or

6. Is any other licensed professional whose California licensure permits the design and/or implementation of behavior modification intervention services.

7. Have two years experience designing and implementing behavior modification intervention services.

(B) Behavior management consultants shall follow the requirements of Title 17, Sections 50800 through 50823, when using planned behavior modification interventions that cause pain or trauma.

(14) Behavior Management Program -- Service Code 515. Behavior Management Programs shall meet the requirements in Sections 56710 through 56756 of these regulations for the specific service being vendored.

(15) Camping Services -- Service Code 850. A regional center shall classify a vendor as a provider of camping services if the vendor has staff that possesses demonstrated competence to supervise safety of camp activities and is:

(A) A day camp which:

1. Provides a creative experience in outdoor living for a limited period of hours per day and days per year; and

2. Contributes to the individual's mental, physical, and social growth by using the resources of the natural surroundings;

(B) A residential camp which:

1. Possesses a valid fire clearance issued by the California State Fire Marshal, city fire department, or local fire district;

2. Complies with the requirements of Title 17, Sections 30700 through 30753;

3. Has a registered nurse on staff at all hours of operation; or

4. Has received a waiver issued by the appropriate agency if any of the requirements specified in 1. through 3. above are not met; and

5. Provides:

a. A creative experience in outdoor living on a 24-hour per day basis for a limited period of time;

b. Services which use the resources of the natural surroundings to contribute to the individual's mental, physical, and social growth; and

c. Other consistent services; or

(C) A traveling camp which provides camping or vacation experiences by traveling to various campgrounds or other tourist areas.

(16) Child Day Care -- Service Code 851. A regional center shall classify a vendor as child day care if the vendor:

(A) Possesses a valid family day care license issued by DSS or by an agency authorized by DSS to assume specified licensing responsibilities, and provides nonmedical care and supervision to children under 18 years of age on a less than 24-hour per day basis in the vendor's own home; or

(B) Possesses a valid day care license for children issued by DSS or by an agency authorized by DSS to assume specific licensing responsibilities, and provides personal care, protection, supervision and assistance to children under 18 years of age with special developmental needs in a nonresidential facility; or

(C) Possesses a preschool license issued by the Department of Education or a valid child care center license issued by DSS or an agency authorized by DSS to assume specified licensing responsibilities, and aids children in developing pre-academic skills, group training, and social skills in a nonresidential facility.

(17) Clinical Psychologist -- Service Code 785. A regional center shall classify a vendor as a clinical psychologist if the vendor:

(A) Is validly licensed as a clinical psychologist by the Psychology Examining Committee of the Medical Board of California; and

(B) Provides:

1. Diagnosis and psychotherapy of mental and emotional disorders; or

2. Individual and group testing and counseling in order to assist individuals achieve more effective personal, social, educational, and vocational development and adjustment.

(18) Counseling Services -- Service Code 625. The services included within this service code shall be provided by the following persons:

(A) Family Counselor -- A regional center shall classify a vendor as a family counselor if the vendor possesses a valid Marriage and Family Therapist license issued by the California Board of Behavioral Science Examiners, and provides support and counseling to help the individual maintain and maximize the use of his or her current functioning patterns; and

(B) Social Worker -- A regional center shall classify a vendor as a social worker if the vendor possesses a valid Clinical Social Worker's license issued by the California State Board of Behavioral Science Examiners, and provides the following services:

1. Social assessments;

2. Counseling; and

3. Other case work functions for the benefit of the individual.

(19) Dance Therapist -- Service Code 692. A regional center shall classify a vendor as a dance therapist if the vendor is validly registered as a dance therapist by the American Dance Therapy Association, and provides the following services:

(A) Teaches the individual to use body movement and dance as the process in therapeutic intervention directed toward gaining insight into the consumer's problematic behavior, and expanding the consumer's freedom of movement, flexibility, and coordination;

(B) Provides opportunities for the individual to express and communicate feelings, needs, and conflicts; and

(20) Day Treatment Centers -- Service Code 710. A regional center shall classify a vendor as a day treatment center if the vendor provides services to outpatients at an acute care hospital or acute psychiatric hospital.

(21) Dentistry -- Service Code 715. A regional center shall classify a vendor as a dentist if the vendor is validly licensed by the California Board of Dental Examiners and practices the branch of medicine which specializes in the diagnosis, prevention, and treatment of diseases of the teeth and their associated structures.

(22) Developmental Specialist -- Service Code 670. A regional center shall classify a vendor as a developmental specialist if the vendor possesses valid certification by an accredited hospital as having successfully completed a one-year developmental specialist training program, or if the vendor possesses a Master's Degree in Developmental Therapy from an accredited college or university.

(23) Diaper Service -- Service Code 627. A regional center shall classify a vendor as a provider of diaper service if the vendor:

(A) Supplies cloth diapers for the consumer; and

(B) Provides pick-up, laundering, and delivery of the diapers to the consumer's home.

(24) Dietary Services -- Service Code 720. A regional center shall classify a vendor as a provider of dietary services if the vendor is:

(A) A dietitian who is validly registered as a member of the American Dietetic Association and who prescribes or modifies a person's diet to meet the person's nutritional needs; or

(B) a nutritionist who evaluates an individual's nutritional needs and meets one of the following requirements:

1. Possesses a Master's Degree in one of the following:

a. Food and Nutrition;

b. Dietetics; or

c. Public Health Nutrition; or

2. Is employed as a nutritionist by a county health department.

(25) Driver Trainer -- Service Code 630. A regional center shall classify a vendor as a driver trainer if the vendor possesses the skills and training necessary to teach other individuals to drive automobiles and meets the following requirements:

(A) Possesses a current certification by the California Department of Motor Vehicles as a driver instructor; and

(B) Possesses a current and valid California driver's license.

(26) Durable Medical Equipment Dealer -- Service Code 725. A regional center shall classify a vendor as a durable medical equipment dealer if the vendor possesses a valid business license, and operates a business which manufactures, individually tailors, or sells durable medical equipment as defined in Title 22, California Code of Regulations, Section 51160.

(27) Educational Psychologist -- Service Code 672. A regional center shall classify a vendor as an educational psychologist if the vendor possesses a valid educational psychologist's license issued by the California Board of Behavioral Science Examiners, and provides evaluation and counseling to assist individuals in achieving more effective educational development.

(28) Family Home Agency (FHA) -- Service Code 904. A regional center shall classify a vendor as a family home agency (FHA) if the agency:

(A) Recruits, approves, trains, and monitors family home and family teaching home providers;

(B) Provides services and supports to family home and family teaching home providers; and

(29) Genetic Counselor -- Service Code 800. A regional center shall classify a vendor as a genetic counselor if the vendor:

(A) Has successfully completed training in an accredited genetic counseling program at the master or doctoral level;

(B) Is eligible for certification, or is certified by the National Board of Human Genetics; and

(C) Advises and counsels persons and families concerning a genetic and medical diagnosis and the probability that they carry and may transmit genetically determined characteristics to their offspring.

(30) Hearing and Audiology Facilities -- Service Code 730. A regional center shall classify a vendor as a hearing or audiology facility if the vendor is:

(A) A hearing facility which provides the following services:

1. Diagnosis of the individual's hearing loss; and

2. Treatment for individuals whose hearing loss does not require multi-disciplined diagnostic services; or

(B) An audiology facility which:

1. Treats the individual whose hearing loss requires multi-disciplined diagnostic services;

2. Provides a diagnosis of the individual's hearing loss;

3. Provides services intended to help the individual compensate for the hearing loss;

4. Does not dispense hearing aids to the individual;

5. Employs at least one audiologist who is licensed by the Speech Pathology and Audiology Examining Committee of the Medical Board of California; and

6. Employs individuals, other than (B)5. above, who perform services, all of whom shall be:

a. Licensed audiologists; or

b. Obtaining required professional experience, and whose required professional experience application has been approved by the Speech Pathology and Audiology Examining Committee of the Medical Board of California.

(31) Home Health Agency -- Service Code 854. A regional center shall classify a vendor as a home health agency if the vendor possesses a valid home health agency license issued by DHS, or meets the requirements established by DHS for providing home health services, and is primarily engaged in providing skilled nursing services and at least one of the following:

(A) Physical therapy;

(B) Occupational therapy;

(D) Medical social work; or

(E) Home health aide services.

(32) Home Health Aide -- Service Code 856. A regional center shall classify a vendor as a home health aide if the vendor possesses a valid home health aide license issued by DHS or meets the requirements established by DHS for providing home health services, and who:

(A) Provides services to the individual in order to maintain a safe and healthful home environment;

(B) Performs personal services directed toward adequate nutrition and personal cleanliness;

(D) Other services consistent with the duties specified in (a)(31)(A) through (C) above.

(33) Homemaker -- Service Code 858. A regional center shall classify a vendor as a homemaker if the vendor maintains, strengthens, or safeguards the care of individuals in their homes.

(34) Homemaker Service -- Service Code 860. A regional center shall classify a vendor as a homemaker service if the vendor employs, trains, and assigns personnel who maintain, strengthen, or safeguard the care of individuals in their homes.

(35) Independent Living Program -- Service Code 520. Independent Living Programs shall meet the requirements in Sections 56710 through 56756 of these regulations for the specific service being vendored.

(36) Independent Living Specialist -- Service Code 635. A regional center shall classify a vendor as an independent living specialist if the vendor possesses the skill, training, or education necessary to teach consumers to live independently and/or provide the supports necessary for the consumer to maintain a self-sustaining, independent-living situation in the community.

(37) Infant Development Program -- Service Code 805. Infant development programs shall meet the appropriate requirements in Sections 56710 through 56734 and 56760 through 56774 of these regulations.

(38) Infant Development Specialist -- Service Code 810. A regional center shall classify a vendor as an infant development specialist if the vendor has at least one year of experience working with parents and children with disabilities and possesses either of the following:

(A) A valid license or certification in one of the following disciplines:

1. Occupational therapy;

2. Physical therapy;

3. Special education;

4. Psychology;

5. Nursing; or

6. Speech and language therapy; or

(B) A Masters degree in child development/early childhood education which includes a minimum of 15 units of formal instruction in at least one of the following areas:

1. Typical and atypical infant development;

2. Infant assessment;

3. Infant intervention techniques; or

4. Family involvement in infant treatment.

(39) In-home Respite Services Agency -- Service Code 862. A regional center shall classify a vendor as an in-home respite services agency if the vendor meets the appropriate requirements in Sections 56780 through 56802 of these regulations. Separate vendorization may be waived at the vendor's request for existing in-home respite services agency vendors requesting to provide new in-home respite services at an additional business address.

(40) In-home Respite Worker -- Service Code 864. A regional center shall classify a vendor as a provider of in-home respite worker services if the vendor is an individual who:

(A) Has received Cardiopulmonary Resuscitation (CPR) and First Aid training from agencies offering such training, including, but not limited to, the American Red Cross;

(B) Has the skill, training, or education necessary to perform the required services; and

(41) Intermediate Care Facility/Developmentally Disabled (ICF/DD) -- Service Code 925. A regional center shall classify a vendor as an intermediate care facility/developmentally disabled if the vendor possesses a valid ICF/DD health facility license issued by the Department of Health Services.

(42) Intermediate Care Facility/Developmentally Disabled-Habilitative (ICF/DD-H) -- Service Code 930. A regional center shall classify a vendor as an intermediate care facility/developmentally disabled-habilitative if the vendor possesses a valid ICF/DD-H health facility license issued by the Department of Health Services.

(43) Intermediate Care Facility/Developmentally Disabled-Nursing (ICF/DD-N) -- Service Code 935. A regional center shall classify a vendor as an intermediate care facility/developmentally disabled-nursing if the vendor possesses a valid ICF/DD-N health facility license issued by the Department of Health Services.

(44) Interpreter -- Service Code 642. A regional center shall classify a vendor as an interpreter if the vendor demonstrates:

(A) Fluency in both English and in sign language; and

(B) Proficiency in facilitating communication between hearing-impaired and hearing persons using American sign language and spoken language.

(45) Laboratory and Radiologic Services -- Service Code 735. The following types of services are included within this service code:

(A) A regional center shall classify a vendor as a clinical laboratory if the vendor:

1. Is validly licensed by DHS as a clinical laboratory, and examines and tests specimens.

(B) A regional center shall classify a vendor as a provider of radiological services if the vendor:

1. Possesses a valid license as a technologist or radiologist issued by DHS;

2. Uses x-ray equipment which is validly registered with DHS; and

3. Provides services which involve the use of x-rays or radioactive materials for medical, diagnostic, or treatment procedures.

(46) Licensed Vocational Nurse -- Service Code 742. A regional center shall classify a vendor as a licensed vocational nurse if the vendor:

(A) Is validly licensed as a licensed vocational nurse by the California State Board of Vocational Nurse and Psychiatric Technician Examiners; or

(B) Is a nurse registry from whom the services of a licensed vocational nurse are obtained; and

(47) Mobility Training Services Agency -- Service Code 645. A regional center shall classify a vendor as a provider of mobility training services if the vendor is an agency which employs staff who possess the skill, training, or education necessary to teach individuals how to use public transportation or other modes of transportation which will enable them to move about the community independently.

(48) Mobility Training Services Specialist -- Service Code 650. A regional center shall classify an individual as a vendor of mobility training services if the vendor possesses the skill, training, or education necessary to teach individuals how to use public transportation or other modes of transportation which will enable them to move about the community independently.

(49) Music Therapist -- Service Code 693. A regional center shall classify a vendor as a music therapist if the vendor possesses a valid registration issued by the National Association for Music Therapy, and uses music media and activities to effect change or growth in the individual's:

(A) Self-awareness;

(B) Gross motor development;

(D) Eye-hand coordination and visual tracking;

(E) Visual, auditory, and tactile awareness and perception;

(F) Language development and communication skills;

(G) Emotional expression;

(H) Self-esteem and body image;

(I) Socialization and community awareness; and

(J) Sterotypical behaviors.

(50) Nurse Anesthetist -- Service Code 741. A regional center shall classify a vendor as a nurse anesthetist if the vendor:

(A) Is a nurse anesthetist who is validly licensed by the California State Board of Registered Nurses and certified by the American Association of Nurse Anesthetists; or

(B) Is a nurse registry from whom the services of a nurse anesthetist are obtained.

(51) Nurse's Aide or Assistant -- Service Code 743. A regional center shall classify a vendor as a nurse's aide or assistant if the vendor:

(A) Is certified as a nurse's aide or a home health aide by DHS; or

(B) Is a nurse registry from whom the services of a nurse's aide or assistant are obtained; and

(52) Nursing Facility -- Service Code 940. A regional center shall classify a vendor as a nursing facility if the vendor possesses a valid nursing facility license issued by the Department of Health Services.

(53) Occupational Therapy -- Service Code 773. A regional center shall classify a vendor as a provider of occupational therapy if the vendor is:

(A) An occupational therapist validly licensed by the California Board of Occupational Therapy and who, based on the written prescription of a physician, dentist or podiatrist, provides occupational therapy evaluation, treatment planning, treatment, instruction and consultative services; or

(B) An occupational therapist assistant validly certified by the California Board of Occupational Therapy and who provides occupational therapy evaluation, treatment planning, treatment, instruction and consultative services while under the direct supervision of a registered occupational therapist.

(54) Orthoptic Services -- Service Code 745. A regional center shall classify a vendor as a provider of orthoptic services if the vendor is:

(A) An orthoptic technician who is validly certified by the American Orthoptic Council and provides the following services:

1. Treats an individual's defective visual habits.

2. Treats defects of binocular vision and muscle imbalance by exercise and visual training, and re-educating the individual's visual habits.

(B) An optometrist who is validly licensed as an optometrist by the California State Board of Optometry and provides the following services:

1. Examines the eye for defects and faults of refraction; and

2. Prescribes correctional lenses or exercises.

(55) Orthotic and Prosthetic Services -- Service Code 750. A regional center shall classify a vendor as a provider of orthotic and prosthetic services if the vendor is:

(A) An orthotist who makes or fits orthopedic braces and who is either:

1. Validly certified by any of the following:

a. American Board for Certification in Orthotics and Prosthetics;

b. Academy of Orthotics and Prosthetics;

c. American Orthotics and Prosthetics Association;

d. California Children's Services Association; or

e. Veteran's Administration; or

2. A member of the California Orthotic and Prosthetic Association which employs only those orthotists who are eligible for certification.

(B) A prosthetist who makes or fits artificial limbs or other parts of the body, and who is either:

1. Validly certified by any of the following:

a. American Board for Certification in Orthotics and Prosthetics;

b. Academy of Orthotics and Prosthetics;

c. California Children's Services Association; or

d. Veteran's Administration; or

2. A member of the California Orthotic and Prosthetic Association which employs only those prosthetists who are eligible for certification.

(C) An individual who is validly licensed as a pharmacist by the California State Board of Pharmacy and who fits orthotic or prosthetic devices.

(56) Other Medical Equipment or Supplies -- Service Code 755. A regional center shall classify a vendor as a provider of other medical equipment or supplies if the vendor is:

(A) A dispensing optician who is validly registered as a dispensing optician by the Division of Allied Health Professions of the Medical Board of California, and who:

1. Fills prescriptions of physicians or optometrists for prescription lenses and related products;

2. Fits and adjusts such lenses and spectacle frames; and

3. Fits contact lenses under the advice, direction, and responsibility of a physician or optometrist;

(B) A hearing aid dispenser who is validly licensed as a hearing aid dispenser by the Hearing Aid Dispensers' Examining Committee of the Medical Board of California, and who:

1. Performs audiometric pure tone and speech testing;

2. Tests hearing in order to fit, dispense, or repair hearing aids; and

3. Is not vendored separately as an audiology center or individually as an audiologist; or

(C) A prosthetic and orthotic appliance factory which fits and sells orthotic and prosthetic appliances necessary for the restoration of function or replacement of body parts.

(57) Other Medical Services -- Service Code 760. A regional center shall classify a vendor as a provider of other medical services if the vendor provides any medical services not included otherwise in this section, and services provided by clinics or other medical facilities which are not included in another service code.

(58) Out-of-home Respite Services -- Service Code 868. A regional center shall classify a vendor as a provider of out-of-home respite services if the vendor:

(A) Is licensed by DSS or by an agency authorized by DSS or is licensed by DHS to provide out-of-home care to persons with developmental disabilities; and

(B) Is vendored by the regional center and provides services under the following service codes:

1. Service Code 855 -- Adult Day Care; or

2. Service Code 851 -- Child Day Care; or

3. Service Code 905 or 915 -- Residential Facility Serving Adults; or

4. Service Code 910 or 920 -- Residential Facility Serving Children; or

5. Service Code 930 -- Intermediate Care Facility/Developmentally Disabled -- Habilitative (ICF/DD-H); or

6. Service Code 935 -- Intermediate Care Facility/Developmentally Disabled -- Nursing (ICF/DD-N).

(C) Has staff who have received Cardiopulmonary Resuscitation (CPR) and First Aid training from agencies offering such training, including, but not limited to, the American Red Cross;

(D) Has the training, education, and skill to perform the required services; and

(E) Provides out-of-home respite services which consist of intermittent or regularly scheduled temporary care to individuals in a licensed facility and which:

1. Are designed to relieve families of the constant responsibility of caring for a member of that family who is a consumer;

2. Meet planned or emergency needs;

3. Are used to allow parents or the individual the opportunity for vacations and other necessities or activities of family life; and

4. Are provided to individuals away from their residence.

(59) Out-of-state Manufacturer or Distributor - Service Code 655. A regional center shall classify a vendor as an out-of-state manufacturer or distributor of merchandise if the vendor provides a specific item that is not available in California, or it is more economical to purchase the item outside of California.

(60) Pharmaceutical Services -- Service Code 765. A regional center shall classify a vendor as a provider of pharmaceutical services if the vendor is:

(A) A person who is validly licensed as a pharmacist by the California State Board of Pharmacy, and who identifies, prepares, or preserves compounds and dispenses drugs; or

(B) A pharmacy which is validly licensed as a pharmacy by the California State Board of Pharmacy, and which is a facility where medicines are compounded or dispensed.

(61) Physical Therapy -- Service Code 772. A regional center shall classify a vendor as a provider of physical therapy services if the vendor is:

(A) A physical therapist who is validly licensed by the Physical Therapy Examining Committee of the Medical Board of California and who, under medical supervision, treats individuals to relieve pain, develop or restore motor function, and maintain performance by using a variety of physical means; or

(B) A physical therapist assistant who is registered as a physical therapist assistant by the Physical Therapy Examining Committee of the Medical Board of California and who provides physical therapy while under the direct supervision of the licensed physical therapist.

(62) Physicians or Surgeons -- Service Code 775. A regional center shall classify a vendor as a physician or surgeon if the vendor provides professional services to individuals and is validly licensed by the Medical Board of California as a physician or surgeon.

(63) Psychiatric Technician -- Service Code 790. A regional center shall classify a vendor as a psychiatric technician if the vendor:

(A) Under medical direction, provides psychotherapeutical services; and

(B) Possesses a valid psychiatric technician's license issued by the California State Board of Vocational Nurse and Psychiatric Technician Examiners.

(64) Psychiatrist -- Service Code 780. A regional center shall classify a vendor as a psychiatrist if the vendor:

(A) Is validly licensed as a physician and surgeon by the Medical Board of California;

(B) Is validly certified by the American Board of Psychiatry and Neurology; and

(65) Recreational Therapist -- Service Code 694. A regional center shall classify a vendor as a recreational therapist if the vendor possesses a valid registration issued by either the National Council for Therapeutic Recreation Certification or the California Board of Recreation and Park Certification and provides the following services:

(A) Uses self-motivating recreational activities to develop the individual's motor skills, social skills, sensory functioning, or acceptable behavior;

(B) Counsels the individual in recreation and leisure pursuits; and

(66) Registered Nurse -- Service Code 744. A regional center shall classify a vendor as a registered nurse if the vendor:

(A) Is an individual who is validly licensed as a registered nurse by the California State Board of Registered Nurses; or

(B) Is a nurse registry from whom the services of a registered nurse are obtained.

(67) Residential Facility Serving Adults -- Owner Operated -- Service Code 905. A regional center shall classify a vendor as an owner-operated residential facility serving adults if:

(A) The facility serves adults;

(B) The vendor possesses a valid community care facility license as required by Health and Safety Code, Sections 1500 through 1569.87; and

(C) The facility is the residence of the licensee or a member of the corporate board (board of directors). The licensee may perform all of the activities necessary to operate the facility, or he/she may employ staff, which may include members of his/her family, to assist.

(68) Residential Facility Serving Children -- Owner Operated -- Service Code 910. A regional center shall classify a vendor as an owner-operated residential facility serving children if:

(A) The facility serves children;

(B) The vendor possesses a valid community care facility license as required by Health and Safety Code, Sections 1500 through 1569.87; and

(C) The facility is the residence of the licensee or a member of the corporate board (board of directors). The licensee may perform all of the activities necessary to operate the facility, or he/she may employ staff which may include members of his/her family, to assist.

(69) Residential Facility Serving Adults -- Staff Operated -- Service Code 915. A regional center shall classify a vendor as a staff-operated residential facility serving adults if:

(A) The facility serves adults;

(B) The vendor possesses a valid community care facility license as required by Health and Safety Code, Sections 1500 through 1569.87; and

(C) The facility is not the residence of the licensee or a member of the corporate board (board of directors) and the licensee employs personnel to provide direct care and training to individuals.

(70) Residential Facility Serving Children -- Staff Operated -- Service Code 920. A regional center shall classify a vendor as a staff-operated residential facility serving children if:

(A) The facility serves children;

(B) The vendor possesses a valid community care facility license as required in the Health and Safety Code, Section 1500 through 1569.87; and

(C) The facility is not the residence of the licensee or a member of the corporate board (board of directors) and the licensee employs personnel to provide direct care and training to individuals.

(71) Respiratory Therapist -- Service Code 793. A regional center shall classify a vendor as a respiratory therapist if the vendor:

(A) Provides respiratory therapy services; and

(B) Possesses a valid respiratory care practitioner certificate issued by the Respiratory Care Board of California of the Department of Consumer Affairs.

(72) Respite Facility -- Service Code 869. A regional center shall classify a vendor as a respite facility if the vendor:

(A) Is licensed as a residential facility by DSS or by an agency authorized by DSS;

(B) Provides only out-of-home respite services in accordance with (a)(58)(E)1. through 4. above.

(D) Is not vendored by the regional center to provide services under the following service codes:

1. Service Code 905 or 915 -- Residential Facility Serving Adults; or

2. Service Code 910 or 920 -- Residential Facility Serving Children.

(73) Retail/Wholesale Stores -- Service Code 660. A regional center shall classify a vendor as a retail/wholesale store if the facility provides goods for purchase and possesses a valid business license to operate that facility.

(74) Social Recreation Program -- Service Code 525. Social Recreation Programs shall meet the requirements in Sections 56710 through 56756 of these regulations for the specific service being vendored.

(75) Speech Pathology -- Service Code 707. A regional center shall classify a vendor as a provider of speech pathology services if the vendor is:

(A) A speech pathologist who is validly licensed as a speech pathologist by the Speech Pathology and Audiology Examining Committee of the Medical Board of California; and provides:

1. Diagnostic screening; and

2. Preventative and corrective therapy for persons with speech or language disorders.

(76) Teacher -- Service Code 674. A regional center shall classify a vendor as a teacher if the vendor possesses a valid California teaching credential issued by the California Commission on Teacher Credentialing or an instruction credential such as a “Life Diploma” or “California Community Colleges Certificate” issued by the California Commission on Teacher Credentialing. A teacher provides the following services:

(A) Conducts lessons;

(B) Prepares instructional materials;

(D) Provides other services consistent with the duties specified in (A) through (C) above.

(77) Teacher's Aide -- Service Code 676. A regional center shall classify a vendor as a teacher's aide if the vendor works under the supervision of a teacher and possesses the training, education, and/or skill to perform the services specified in (a)(76)(A) through (D) above.

(78) Teacher of Special Education -- Service Code 678. A regional center shall classify a vendor as a teacher of special education if the vendor possesses a valid California teaching credential in Special Education issued by the California Commission on Teacher Credentialing and provides the services specified in (a)(76)(A) through (D) above.

(79) Translator -- Service Code 643. A regional center shall classify a vendor as a translator if the vendor demonstrates:

(A) Fluency in both English and a language other than English; and

(B) The ability to read and write accurately in both English and a language other than English.

(80) Transportation -- Additional Component -- Service Code 880. A regional center shall classify a vendor as a provider of transportation services -- additional component if the vendor:

(A) Is vendored separately from the primary service. The vendoring regional center may waive separate vendorization as a transportation services--additional component if the vendor is a community-based day program vendor, who conducts its curriculum solely in natural environments, and the regional center determines that it would be more cost effective to include the cost of transportating consumers, which occurs between the first and last training site as specified in Section 57434(a)(3)(N). The cost of transporting consumers shall be considered more cost effective if the cost of including the transportation service in determining the rate of reimbursement for the community-based day program is less than the cost of providing the transportation service pursuant to separate vendorization as a provider of transportation services -- additional component;

(B) Provides services by employees of the primary service agency; and

(C) Provides the regional center with proof of adequate insurance as designated by the vendoring regional center in accordance with the Welfare and Institutions Code, Section 4648.3.

(81) Transportation Assistant -- Service Code 882. A regional center shall classify a vendor as a provider of transportation assistant services if the vendor:

(A) Is vendored separately from the transportation service vendor;

(B) Assists and monitors regional center consumers while the consumers are being transported; and

(82) Transportation Auto Driver -- Service Code 890. A regional center shall classify a vendor as transportation auto driver if the vendor provides the transportation to authorized services identified in the consumer's IPP and the vendor:

(A) Is an individual who is actually providing the transportation service;

(B) Possesses a valid California driver's license; and

(83) Transportation Broker -- Service Code 883. A regional center shall classify a vendor as a transportation broker if the vendor:

(A) Is not the transportation service provider; and

(B) Develops routing and time schedules for the transport of consumers to and from their day program;

1. Conduct monitoring and quality assurance activities; and/or

2. Perform safety reviews; and/or

3. Assist the regional center in implementing contracted transportation services.

(84) Transportation Companies -- Service Code 875. A regional center shall classify a vendor as a transportation company if the vendor possesses a current business license as a transportation company and:

(A) Provides the regional center with proof of adequate insurance as designated by the vendoring regional center in accordance with the Welfare and Institutions Code, Section 4648.3; and

(B) Will be employed to transport individuals to and from their community-based day programs or other vendored services for the regional center.

(85) Transportation -- Medical -- Service Code 885. A regional center shall classify a vendor as a provider of medical transportation if the vendor:

(A) Provides medical transportation services; and

(B) Meets the standards specified in Title 22, California Code of Regulations, Sections 51231, 51231.1 or 51231.2, for Litter Vans, Wheelchair Vans, or Medical Transportation Services.

(86) Transportation -- Public Transit Authority, Dial-A-Ride, Rental Car Agency or Taxi -- Service Code 895. A regional center shall classify a vendor as a public transit authority, dial-a-ride rental car agency or taxi provider if the vendor is licensed to perform such services, and if the rate charged in the use of these services to consumers is the same as that charged to the general public for the same service.

(87) Tutor -- Service Code 680. A regional center shall classify a vendor as a tutor if the vendor possesses the training, education, and/or skill necessary to provide the in-home individualized instruction to the individual which is supplementary to, or independent of, instruction provided by the classroom teacher.

(b) The following service code shall be assigned to the following type of service: Behavior Management Technician (Paraprofessional) -- Service Code 616. A regional center may vendor a group practice, vendored pursuant to Section 54319(d), for the above service. The Behavior Management Technician (Paraprofessional) shall practice under the direct supervision of a certified Behavior Analyst or a Behavior Management Consultant who is within the same vendored group practice. The Behavior Management Technician (Paraprofessional) implements instructional and environmental modifications to produce socially significant improvements in the consumer's behavior through skill acquisition and the reduction of behavior. The Behavior Management Technician (Paraprofessional) shall meet the following requirements:

(1) Has a High School Diploma or the equivalent, has completed 30 hours of competency-based training designed by a certified behavior analyst, and has six months experience working with persons with developmental disabilities; or

(2) Possesses an Associate's Degree in either a human, social, or educational services discipline, or a degree or certification related to behavior management, from an accredited community college or educational institution, and has six months experience working with persons with developmental disabilities.

NOTE

Authority cited: Sections 4405, 4648(a) and 4686.3, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a) and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section, including incorporation and amendment of former section 54344, filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

6. Amendment of subsection (a)(37), (a)(52)(B)2., (a)(54)(A)1., (a)(54)(B), (a)(58)(A), (a)(72), (a)(75) and (a)(81)(B), new subsections (a)(81)(C)1.-3. and amendment of (a)(83)(B) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

7. New subsection (a)(10) and subsection renumbering filed 5-3-2001; operative 6-2-2001 (Register 2001, No. 18).

8. Change without regulatory effect amending subsections (a)(52)(A)-(B) filed 6-12-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 24).

9. New subsection (a)(8), subsection renumbering, amendment of newly designated subsections (a)(12) and (a)(13)(A), new subsection (a)(13)(A)1. and amendment of newly designated subsections (a)(13)2.-4., (a)(18)(A), (a)(32)(D), (a)(72)(B)-(C), (a)(76) and (a)(77) filed 4-29-2004; operative 5-29-2004 (Register 2004, No. 18).

10. Amendment of subsections (a)(28)(A)-(C) filed 11-7-2006; operative 12-7-2006 (Register 2006, No. 45).

11. Repealer and new subsection (a)(13)(A)1., new subsection (a)(13)(A)2., subsection renumbering and new subsection (a)(13)(A)7. filed 6-27-2007; operative 7-27-2007 (Register 2007, No. 26).

12. New subsections (b)-(b)(2) and amendment of Note filed 9-19-2011 as an emergency; operative 9-19-2011 (Register 2011, No. 38). A Certificate of Compliance must be transmitted to OAL by 9-19-2013 pursuant to Welfare and Institutions Code section 4686.3 or emergency language will be repealed by operation of law on the following day.

§54344. Other Services: Nonmedical Services. [Repealed]

Note • History

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order including editorial correction to subsection (n)(4) transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (g) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (g) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Editorial correction of History 3 (Register 92, No. 25).

6. Certificate of Compliance as to 3-4-92 order including amendment of subsection (e)(1) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of section and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect incorporating former section 54344 into section 54342, including amendments, and repealing former section 54344, filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54346. Other Services: Medical Services. [Repealed]

Note • History

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (h)-(h)(2) and subsection relettering and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (h)-(h)(2) and subsection relettering and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection (h)(1)(B) and subsection relettering, adoption of new subsections (h)(2) and (n) and subsection renumbering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of section and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (s)(2), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

10. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54348. Prevention Services/Infant Development Services. [Repealed]

Note • History

NOTE

Authority cited: Sections 4405 and 4648 (a), Welfare and Institutions Code and Section 11152, Government Code. Reference: Sections 4631, 4648 (a) and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54349. Supported Living Service.

Note • History

The following service codes are included within “Supported Living Service,” and shall be accessed only by providers who are vendored as Supported Living Service vendors, pursuant to Title 17, Section 58612.

(a) Personal Support Service -- Service Code: 891. A regional center shall classify a vendor as a provider of Personal Support Service for any services the vendor provides prior to July 1, 2000, pursuant to Title 17, Section 58614(b) to meet the consumer's need for assistance with common daily living and routine household activities, accessing medical services, and animal companions. Personal Support Service must be tailored to meet those specific needs of an individual consumer which can not be met by the unassisted consumer because of the nature or severity of the consumer's physical or developmental challenges. Personal Support Service differs from Training and Habilitation Service as defined in (b), in that the immediate result of the service (e.g., successful preparation of a meal) is the primary objective of the service, while any training or habilitation that may result is an incidental and unanticipated consequence. Beginning July 1, 2000, all services previously provided under Service Code 891 shall be provided only in accordance with (d).

(b) Training and Habilitation Service -- Service Code: 892. A regional center shall classify a vendor as a provider of Training and Habilitation Service for any services the vendor provides prior to July 1, 2000, pursuant to Title 17, Section 58614(b) to meet the training and habilitation needs of the consumer. Training and Habilitation Service must be tailored to the specific training and habilitation needs and capacities of an individual consumer, and is intended to result in an increased ability on the part of the consumer to establish and maintain constructive human relationships, assume and exercise membership in the community, and meet his/her needs without assistance. Training and Habilitation Service is accessed only in accordance with the determination made through the consumer's IPP process of its appropriateness in consideration of the consumer's cognitive or physical challenges, and only when any corresponding Personal Support Service alternative, as defined in (a), is determined to be less appropriate in consideration of the consumer's cognitive or physical challenges. Training and Habilitation differs from any corresponding Personal Support Service in that the immediate result of the service (e.g., successful preparation of a meal) is always consequential to, but never the primary objective of, the training. Beginning July 1, 2000, all services previously provided under Service Code 892 shall be provided only in accordance with (d).

(c) 24-Hour Emergency Assistance -- Service Code: 893. A regional center shall classify a vendor as a provider of 24-Hour Emergency Assistance Service for any services the vendor provides prior to July 1, 2000, pursuant to Title 17, Section 58614(b)(16). Beginning July 1, 2000, all services previously provided under Service Code 893 shall be provided only in accordance with (d).

(d) Supported Living Service -- Service Code: 896. Beginning July 1, 2000, a regional center shall classify a vendor as a provider of Supported Living Service if the vendor provides services enumerated in Title 17, Section 58614.

(e) Supported Living Service Vendor Administration -- Service Code: 894. A regional center shall classify a vendor as a provider of Supported Living Service Vendor Administration if the vendor:

(1) Pursuant to Title 17, Section 58660(b)(2), is paid for any direct services referenced in (a); and

(2) Provides administrative services as specified in Section 58614(c), in support of the delivery of direct services.

(f) Vendors shall bill for services included in (a) through (d) under the following subcodes:

(1) Subcode “HA” when billing at an hourly rate negotiated pursuant to Title 17, Section 58660(b)(1);

(2) Subcode “MA” when billing at a monthly rate negotiated pursuant to Title 17, Section 58660(b)(1);

(3) Subcode “OA” when billing at other than an hourly or monthly rate negotiated pursuant to Title 17, Section 58660(b)(1);

(4) Subcode “H” when billing at an hourly rate negotiated pursuant to Title 17, Section 58660(b)(2);

(5) Subcode “M” when billing at a monthly rate negotiated pursuant to Title 17, Section 58660(b)(2);

(6) Subcode “O” when billing at other than an hourly or monthly rate negotiated pursuant to Title 17, Section 58660(b)(2).

(g) A regional center shall authorize a SLS vendor to provide a service only if such service:

(1) Is cost-effective; and

(2) Can not feasibly be provided without cost, or at a lesser cost, through generic or natural supports available in the community.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648, 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Section 4640.7(b), 4648(a)(2), 4689(c) and 4689.7(c), Welfare and Institutions Code.

HISTORY

1. New section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including further amendment of subsections (b), (d)(2), (e)(3), (e)(5)-(6) and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of section and Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§54350. Supportive Services. [Repealed]

Note • History

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code. Reference: Sections 4631, 4648(a) and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (b)(2), new subsection (b)(4), amendment of subsections (g) and (i) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (b)(2), new subsection (b)(4), amendment of subsections (g) and (i) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including adoption of subsection (c) and subsection renumbering and amendments transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsections (i)(1), (j)(1)(C) and (k)(3) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54351. Habilitation Services.

Note • History

The following service codes are included within “Habilitation Services”:

(a) Supported Employment Program -- Group Services -- Service Code 950. A regional center shall classify a vendor as a provider of Supported Employment -- Group Services if the vendor meets all the requirements of the vendorization process, including proof of certification of nonprofit status and provides supported employment services with a single job coach to a group of individuals engaged in paid work that is integrated in the community.

(b) Supported Employment Program -- Individual Services -- Service Code 952. A regional center shall classify a vendor as a provider of Supported Employment -- Individual Services if the vendor meets all the requirements of the vendorization process, including proof of certification of nonprofit status and provides supported employment services including job coaching services to a single individual with developmental disabilities engaged in paid work in an community setting.

(c) Work Activity Program -- Service Code 954. A regional center shall classify a vendor as a provider of Work Activity Program services if the vendor provides support to consumers engaged in paid work in a work activity center or similar setting.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4857 and 4860, Welfare and Institutions Code.

HISTORY

1. New section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (b), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§54352. Transportation Services.

Note • History

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648(a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a), 4690.1 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsection (c), amendment of former subsection (e) (now subsection (f)) and subsection renumbering filed 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

4. Amendment of subsections (b)(1) and (e) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsections (b)(1) and (e) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendment of subsection (b)(1) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of section and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54354. Service Codes for Residential, Intermediate Care and Nursing Facility Services. [Repealed]

Note • History

NOTE

Authority cited: Sections 4405, 4648 (a) and 4689.1, Welfare and Institutions Code; and Section 11152, Government Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 1500 through 1569.87 and 1250 through 1338.3, Health and Safety Code; and Sections 4631, 4648 (a) and 4689.1, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. New subsections (a)(1)(A)-(C), subsection renumbering, and amendment of Note filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

6. New subsections (a)(1)(A)-(C), subsection renumbering, and amendment of Note refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

8. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§54355. Vouchers.

Note • History

(a) A regional center may offer vouchers to family members or adult consumers to allow the families and consumers to procure their own diaper/nutritional supplements, day care, nursing, respite, and/or transportation services. When vouchers are issued they shall:

(1) Be used in lieu of, and shall not exceed the cost of services the regional center would otherwise provide; and

(2) Be issued only for services which are unavailable from generic agencies.

(b) The regional center shall provide prospective voucher recipients with information to assist them in determining liabilities they may incur by participating in a voucher program. Information provided shall include, but need not be limited to:

(1) Identification of the following areas of potential impact:

(A) Impact of vouchers on Supplemental Security Income (SSI) and/or other benefits;

(B) Voucher recipient's status as an employer and employer responsibilities;

(D) Potential increase in insurance needs; and

(E) Voucher recipient's responsibility for worker's compensation; and

(F) Voucher recipient's responsibility to withhold and pay the appropriate Federal, State and local taxes; and

(2) Identification of the appropriate agency(ies), including the Internal Revenue Service and the Employment Development Department, which the voucher recipient may contact to obtain information and/or technical assistance regarding the areas of potential impact specified in (1)(A) through (F) above.

(3) The requirement to maintain records for at least 5 years, pursuant to Section 50604(d)(3)(A) through (E), as applicable.

(4) The requirement to submit to the regional center on form DS 1811, Respite Services Billing Form (7/04) data as specified in (A) through (O) below with billings/invoices for the billing period:

(A) Name and Unique Client Identifier (UCI) number of consumer receiving respite service;

(B) Vendored family member name;

(D) Vendor address;

(E) Vendor phone number;

(F) Date of service;

(G) Address where respite services were provided;

(H) Start and end times of service provided;

(I) Number of hours respite worker worked;

(J) Amount billed to the regional center;

(K) Name of respite worker, agency or facility used;

(L) Respite worker's social security number or any document pursuant to Section 50604(d)(3), if individual worker is used;

(M) Respite worker's address, if individual worker is used;

(N) Respite worker's phone number, if individual worker is used; and

(O) Respite worker's signature, if individual worker is used.

(5) The requirement of the vendored family member to sign, with original signature, and date Form DS 1811 (8/04), which includes a certification that the information provided on the form is true and correct, and that the person signing the form is the only person who employed, supervised, and assigned duties to the respite worker(s) listed on the form, in addition to having read and followed all respite service program requirements and the terms and conditions pursuant to Title 17, Sections 50604(a), 50604(d), 54326(a)(10), 54355(b)(1) through (3), 54355(g)(4)(B), 54355(g)(4)(C)1. and 54355(g)(4)(C)2.

(c) If a family member or adult consumer accepts a voucher to procure their own service, the regional center shall assist the consumer or family member, as appropriate, in identifying providers of services and supports.

(d) Voucher recipients shall be legally responsible for the selection and supervision of the services provided under any voucher issued pursuant to this section. It is the responsibility of the voucher recipient to ensure that the requirements specified in (g)(1) through (5) below for the actual provider of the vouchered service are met by the individual/entity selected to provide the service.

(e) If a family member or adult consumer accepts a voucher to procure their own service, as listed in (a) above, the regional center shall vendor either:

(1) The vouchered family member or adult consumer pursuant to (g) below; or

(2) The provider of the vouchered service pursuant to Section 54342.

The regional center shall not vendor the voucher recipient and the voucher service provider for the same service.

(f) Family members or adult consumers to whom the voucher is issued shall only be vendored as the provider of the service for which the voucher is issued if specifically authorized pursuant to (g)(1) through (5) below.

(g) If the vouchered family member or adult consumer is to be vendored to procure their own service, the family member or adult consumer shall meet the specified criteria and be vendored pursuant to the following:

(1) Day Care -- Family Member -- Service Code 405.

(A) A regional center shall classify a vendor as day care - family member if the vendor:

1. Is a family member;

2. Is not the direct provider of the day care service; and

3. Selects the day care service for the consumer from:

a. An individual who possesses the skill, training, or education necessary to provide the day care service; or

b. An agency that meets the criteria specified in Section 54342(a)(4)(A)1. and 2., or (a)(15)(A), (B), or (C).

(B) Vouchers for day care for children shall only be issued by regional centers for day care costs and/or hours exceeding the cost of providing day care services provided to a child without disabilities. The regional center may pay in excess of this amount when a family can demonstrate a financial need and when doing so will enable the children to remain in the family home.

(2) Diaper and Nutritional Supplements -- Family Member -- Service Code 410.

(A) A regional center shall classify a vendor as diaper and nutritional supplements -- family member if the vendor is a family member who is authorized by the regional center to directly purchase diapers and/or nutritional supplements for a consumer in the family member's home.

(B) Vouchers for diapers shall only be issued for the procurement of diapers for children three years of age or older. A regional center may purchase diapers for children under three years of age when a family can demonstrate a financial need and when doing so will enable the child to remain in the family home.

(3) Nursing Service -- Family Member -- Service Code 415.

(A) A regional center shall classify a vendor as nursing service - family member if the vendor:

1. Is a family member; and

2. Selects, assigns, and monitors an individual who provides nursing services for a consumer.

(B) The family member may be the direct provider of the nursing service if the service is not intended to provide respite to the family member.

(C) The individual or family member who provides the nursing service shall possess the qualifications specified in Section 54342(a)(46), (51), or (66).

(4) Respite Service -- Family Member -- Service Code 420. A regional center shall classify a vendor as respite service - family member if the vendor:

(A) Is a family member;

(B) Is not the direct provider of the respite service; and

1. An individual who:

a. Is at least 18 years of age. Individuals currently providing in-home respite service shall have 90 days from the effective date of these regulations to comply; and

b. Possesses the skill, training, or education necessary to provide the respite service. The vendored family member shall be responsible for ensuring that the individual selected to provide the respite service will possess the skill, training, or education necessary to provide the respite service. In addition, the vendored family member is responsible for ensuring that the person providing respite care is familiar with the consumer's daily routines and needs, and is trained in any specialized supports necessary for the consumer. To the extent that these specialized support needs require additional training or certification in such things as First Aid, Cardiopulmonary Resuscitation (CPR), etc., these needs and requirements will be included as part of the description of respite care needs in the consumer's Individual Program Plan (IPP) or Individualized Family Service Plan (IFSP); or

2. An agency that meets the criteria specified in Section 54342(a)(38); or

3. For out-of-home respite services, a facility which meets the standards specified in Section 54342(a)(58) or (72). A relative who provides out-of-home respite in the relative's own house is exempt from licensure pursuant to Title 22, California Code of Regulations, Section 80007.

(5) Transportation -- Family Member -- Service Code 425.

(A) A regional center shall classify a vendor as transportation - family member if the vendor secures the transportation to and/or from authorized services identified in the consumer's IPP and the vendor:

1. Is a family member or adult consumer. The family member or adult consumer may either provide the transportation service or secure an individual to provide the transportation services identified in the consumer's IPP;

(B) The individual who is actually providing the transportation service shall:

1. Possess a driver's license which is valid in California; and

2. Have evidence of maintenance of adequate insurance coverage pursuant to Welfare and Institutions Code, Section 4648.3.

(C) Vouchers for transportation shall only be issued by regional centers to cover transportation costs which exceed the transportation costs that the family member would incur for a minor child without disabilities. The regional center may pay in excess of this amount when a family can demonstrate a financial need and when doing so will enable the consumer to remain in the family home.

(h) The voucher recipient shall maintain records of services provided to the consumer pursuant to Section 54326(a)(4).

(i) Effective October 1, 2011, for the services in (g)(1), (3), (4), and (5) above, when funded with federal financial participation through Medicaid programs, the consumers and family members of consumers shall:

(1) Be vendored for the services pursuant to California Code of Regulations, Title 17, Section 58886; or

(2) Use another vendored service provider.

NOTE

Authority cited: Sections 4405, 4648(a) and 4648.12(c)(1)(B), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a) and 4648.12(c), Welfare and Institutions Code.

HISTORY

1. New section filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

2. Certificate of Compliance as to 6-20-94 order, including amendment of section, transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Redesignation of subsections (b)1.-2. to (b)(1)-(2) and amendment of newly designated subsection (b)(2) and subsections (e) and (e)(2) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

5. Change without regulatory effect amending subsections (g)(1)(A)3.b., (g)(3)(C) and (g)(4)(C)1.-3. filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

6. Amendment of section and Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2004 or emergency language will be repealed by operation of law on the following day.

7. Amendment of section and Note refiled 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 12-22-2004 order, including further amendment of subsections (b)(4) and (b)(4)(L), transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

9. Change without regulatory effect amending subsection (g)(4)(C)3. filed 11-10-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 45).

10. Change without regulatory effect amending subsection (g)(3)(C) filed 4-21-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 17).

11. New subsections (i)-(i)(2) and amendment of Note filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54356. Miscellaneous Services.

Note • History

(a) A regional center shall classify a vendor as a miscellaneous service provider only if the vendor does not provide goods or services which are similar to any of the descriptions of goods or services contained within sections 54342 through 54355 of these regulations.

(b) The regional center shall obtain a service code from the Department for the vendors specified in (a) above.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Amendment of subsection (a) and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

§54358. Exempted Services.

Note • History

(a) For all vendors identified in Section 54310(d)(1) through (3) and (e) of these regulations, the vendoring regional center shall issue a service code consistent with the service codes identified in Sections 54342 through 54355 of these regulations.

(b) For generic agencies specified in Section 54310(d)(4) of these regulations, the vendoring regional center shall obtain a service code from the Department.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (b) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsection (a) and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (a)(3), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Vendor Compliance and Prohibitions

§54370. Termination of Vendorization for Noncompliance.

Note • History

(a) The vendoring regional center shall be responsible for ensuring that vendors within its service catchment area comply with the vendorization requirements. Except as specified in section 54372 of these regulations, the regional center shall take the actions as appropriate for the violations specified in (b) and (c) below.

(b) Vendorization shall be terminated at the end of the first working day after written notification is received from the vendoring regional center if any of the following conditions exist:

(1) The vendor is serving consumers without a current license, credential, registration, accreditation, certificate, degree or permit that is required for the performance or operation of the service;

(2) Vendorization has been transferred to another person or entity;

(3) The vendor has refused to make available any books and records pertaining to the vendored service, including those of the management organization, for audit, inspection or reproduction by regional center, Department or authorized agency representative staff;

(4) The service currently provided is not the same service that was approved for vendorization;

(5) The vendor is using planned behavior modification interventions that cause pain or trauma without meeting the conditions specified in title 17, sections 50800 through 58023.

(6) The vendor is transporting consumers using a driver who does not possess a valid driver's license appropriate for the vehicle being driven.

(7) The regional center has determined that continued utilization of the vendor threatens the health and safety of the consumer(s).

(8) The vendor knowingly and willfully makes or causes to be made a false statement or representation, including omissions, of any vendor application information specified in Section 54310 upon initial application or request for information from the regional center.

(9) The vendor or any person with an ownership or control interest in the vendor, or person who is a director, officer, or managing employee of a vendor, has been determined to be an excluded individual or entity as defined in Section 54302(b)(1).

(c) If a vendor is not in compliance with any requirement, other than those specified in (b) above, vendorization shall be terminated 30 days after written notification from the vendoring regional center.

(d) The written notification pursuant to (b) or (c) above shall:

(1) Be sent by registered return receipt requested mail with a copy to any user regional center(s); and

(2) Include all of the following:

(A) A description of the specific violation(s);

(B) A reference to the statute(s) or regulation(s) with which the vendor is not complying; and

(C) The date on which vendorization will be terminated unless action pursuant to (e) or (f) below is taken by the vendor.

(e) Termination pursuant to (b) above shall not occur if the vendor notifies the vendoring regional center, in writing, prior to the expiration of the period specified in the notice, of the vendor's intent to take either of the following actions:

(1) Correct the violation(s) and provide documentation of the correction to the vendoring regional center within 30 days from receipt of the notice; or

(2) File an appeal within 30 days from receipt of the notice in accordance with section 54380 of these regulations.

(3) If, within the 30-day period, the vendor fails to correct the violation and provide documentation pursuant to (1) above or to file an appeal pursuant to (2) above, vendorization will be terminated effective immediately.

(f) Termination pursuant to (c) above shall not occur if the vendor takes either of the following actions prior to the expiration of the period specified in the notice:

(1) Corrects the violation(s) and provides documentation of the correction to the vendoring regional center; or

(2) Files an appeal in accordance with section 54380 of these regulations.

(g) Action taken by the vendor pursuant to (e) or (f) above shall not preclude the vendoring regional center nor any user regional center from withdrawing purchase of service authorizations if necessary to protect the health, safety and welfare of the consumers.

(h) Regional Centers may place a moratorium on new referrals during the appeal process or until such violations have been corrected.

(i) No provision of this section shall be construed to supersede or replace the monitoring or corrective action plan provisions for residential facilities contained in title 17, sections 56550 through 56610.

NOTE

Authority cited: Sections 4405, 4648(a), 4648.12(c)(1)(A) and 4866, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a), 4648.12 and 4861(c), Welfare and Institutions Code; and Title 42, Code of Federal Regulations, Sections 455.104, 455.105 and 455.106.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (b)(1), (b)(6) and (e)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

6. Amendment of subsection (a), new subsection (b)(7) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

7. Amendment of subsection (a), new subsection (b)(7) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

8. Amendment of subsection (a), new subsection (b)(7) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

9. Amendment of subsection (b)(1) and amendment of Note filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (d)(1)(C), new subsections (e)-(e)(3) and (h), subsection relettering and amendment of newly designated subsections (f) and (g), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

11. Reinstatement of section as it existed prior to 7-22-2004 emergency amendment by operation of Government Code section 11346.1(f) (Register 2004, No. 49).

12. Amendment of subsection (b)(1) and amendment of Note refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

13. Amendment of subsection (b)(1) and amendment of Note refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (b)(1), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

15. Amendment of subsection (b)(5), new subsections (b)(8)-(9), amendment of subsection (d)(1) and amendment of Note filed 12-27-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 12-27-2011 (Register 2011, No. 52). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§54372. Review of Existing Vendors. [Repealed]

Note • History

NOTE

Authority cited: Sections 4405 and 4648 (b), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4648 (b), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Repeal of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54374. Use of Planned Behavior Modification Interventions That Cause Pain or Trauma.

Note • History

Vendors and regional centers shall follow the requirements of title 17, sections 50800 through 50823, when using planned behavior modification interventions that cause pain or trauma.

NOTE

Authority cited: Sections 4405 and 4648 (a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4502 and 4648 (a), Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

Article 5. Vendorization Appeal

§54380. Vendorization Appeal.

Note • History

(a) A vendor or an applicant for vendorization may appeal any of the following actions to the director of the vendoring regional center:

(1) Denial of a vendorization application;

(2) Failure of the vendoring regional center to comply with the provisions of these regulations; or

(3) Findings of noncompliance as specified in section 54370 of these regulations.

(b) The vendor shall file an appeal with the director of the vendoringregional center within 30 days after the receipt of written notification of the action of the regional center, or within 30 days after the failure of the vendoring regional center to comply with these regulations.

(c) Notwithstanding the provisions of (b) above, if a vendor wishes to have the termination of vendorization pursuant to section 54370 (b) of these regulations stayed pending appeal, such appeal must be made prior to the end of the first working day after receipt of written notification of the proposed termination from the vendoring regional center.

(d) If an appeal is not filed within the time specified, it shall be denied unless good cause pursuant to section 54388 of these regulations is established for the late submission. Good cause shall be determined by the director of the vendoring regional center or his or her designee in accordance with section 54388 of these regulations. If good cause for late submission is established, the director or his or her designee shall proceed to decide the appeal in accordance with section 54382 of these regulations.

NOTE

Authority cited: Sections 4440 and 4648 (a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Section 4648 (a), Welfare and Institutions Code; U.S Constitution, Amendment XIV, Section 1 and California Constitution, Article I, Section 7.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54382. Contents of Appeal and Decision.

Note • History

(a) The appeal filed pursuant to section 54380 of these regulations shall be in writing and shall include the following:

(1) The appellant's:

(A) Name, business address, and telephone number; and

(B) Vendor identification number, service code, subcode, and type of service provided as specified in sections 54340 through 54356 of these regulations, if applicable.

(2) Identification of the action being appealed;

(3) The specific basis for the appeal; and

(4) All supporting documentation and any other information necessary to substantiate and/or justify the appeal, including the specific regulation used as the basis for the appeal.

(b) Within 15 days after receipt of the appeal, the director of the vendoring regional center or his or her designee shall review the appeal to determine whether it contains the information required by (a) above.

(1) If all required information has been submitted, the director or his or her designee shall render a decision pursuant to (c) below.

(2) If all the required information has not been submitted and/or additional information is needed, the director of the vendoring regional center or his or her designee shall request the information in writing from the appellant. The appellant shall submit the information within 15 days after receipt of the request:

(A) If the information is not submitted within the time specified, the appeal shall be deemed withdrawn and no further action will be taken unless the appellant established good cause pursuant to section 54388 of these regulations for the later submission. Good cause shall be determined by the director of the vendoring regional center or his or her designee in accordance with section 54388 of these regulations:

1. If good cause for late submission is established, the director of the vendoring regional center or his or her designee shall proceed with the appeal and render a decision pursuant to (c) below.

(B) If the information is submitted but does not comply with the request, the appeal shall be deemed withdrawn and no further action will be taken.

(c) The director of the vendoring regional center or his or her designee shall render a decision on the appeal within 60 days after receipt of all required and/or requested information. The decision shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling;

(4) Specify the statutes and regulations upon which each ruling is based; and

(5) Specify the procedure for appealing the vendoring regional center's decision to the Director of the Department.

(d) A written copy of the decision shall be mailed to the appellant within 15 days after the decision is rendered.

(e) If the appellant does not appeal the decision to the Director of the Department, pursuant to section 54384 of these regulations, it shall be deemed final, and the vendoring regional center shall send a copy of the decision to all regional center(s) utilizing the service.

NOTE

Authority cited: Sections 4405 and 4648 (a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Section 4648 (a), Welfare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and California Constitution, Article I, Section 7.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54384. Appeal of the Regional Center's Decision.

Note • History

(a) The appellant may appeal the decision of the vendoring regional center's director to the Director of the Department within 15 days after receipt of the written decision. The appeal must be filed with the director of the vendoring regional center who shall forward the appeal to the Director of the Department in accordance with (c) below.

(b) The appeal shall be in writing and shall include the following:

(1) All information submitted to the vendoring regional center pursuant to section 54382 (a) of these regulations;

(2) A copy of the vendoring regional center's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting authority identifying why the appellant believes the decision of the director of the vendoring regional center should be reversed by the Director.

(c) Within 15 days after receipt of the appeal, the director of the vendoring regional center or his or her designee shall ensure that the appeal includes all information required by (b) above, and forward the appeal to the Director. The vendoring regional center shall not forward an incomplete appeal or an appeal filed after the time specified unless the appellant establishes good cause pursuant to section 54388 of these regulations.

(d) Within 30 days after receipt of the appeal, the Director of the Department or the Director s designee shall review the appeal and determine whether additional information upon which to base a decision is needed from the appellant, or the vendoring regional center.

(1) If no additional information is needed, the Director of the Department or the Director's designee shall render a decision pursuant to (e) below.

(2) If additional information is required, the Director of the Department or the Director's designee shall request the information from the appellant or the regional center. The appellant or the regional center shall submit the information within 15 days after receipt of the request.

(A) If the appellant does not submit the information within that time, the appeal shall be deemed withdrawn and no further action taken unless the appellant establishes good cause pursuant to section 54388 of these regulations for the late submission. Good cause shall be determined by the Director of the Department or the Director's designee pursuant to section 54388 of these regulations.

1. If good cause for late submission is established, the Director of the Department or the Director's designee shall proceed with the appeal and render a decision pursuant to (e) below.

(B) If the information is submitted, but does not comply with the request, the appeal shall be deemed withdrawn and no further action will be taken.

(C) If the regional center does not submit the requested information, the Director of the Department or the Director's designee shall proceed with the appeal and render a decision pursuant to (e) below.

(e) The Director of the Department or the Director's designee shall render a decision within 60 days after receipt of all required and/or requested information. The decision shall:

(1) Identify the specific issues in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is based.

(f) A written copy of the decision shall be sent to the appellant, the vendoring regional center and all regional center(s) utilizing the service within 15 days after the decision is rendered.

(g) The decision of the Director is the final administrative decision.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54386. Effective Date of Decision.

Note • History

The effective date of the director of the vendoring regional center's and the Director of the Department's decisions shall be stated in the decisions.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54388. Good Cause.

Note • History

(a) For the purposes of sections 54380 through 54386 of these regulations, good cause for a failure to act is limited to:

(1) A violent act of nature including but not limited to, flood, earthquake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by individuals other than the appellant which preclude the appellant from filing a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days after the incident giving rise to its claim of good cause, submit to the director of the regional center or the Director of the Department, whichever is appropriate, the basis for its claim of good cause and all supporting documents or other evidence substantiating its claim. The director of the regional center, the Director of the Department or the Director's designee, whichever is appropriate, shall, within 30 days of receipt of the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(c) The director of the regional center, the Director of the Department or the Director's designee, whichever is appropriate, shall notify the appellant in writing of the decision and shall specify what action will be taken, if any, pursuant to sections 54380 through 54386 of these regulations.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4648 (a) and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4648 (a) and 4791, Welfare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and California Constitution, Article I, Section 7.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54390. Review of Documents Only.

Note • History

An appeal made pursuant to sections 54380 through 54386 of these regulations shall be decided only on the documents submitted. There shall be no oral testimony or argument; however, the vendoring regional center and the appellant may hold an informal conference at any time to discuss or resolve the disputed issues.

NOTE

Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Section 4648(a), Welfare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and California Constitution, Article I, Section 7.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Repealer of Appendix and new Appendices A and B filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New Appendices A and B refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of Appendix A and repealer of Appendix B transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Certificate of Compliance as to 6-20-94 order, including new form, transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

9. Repealer of Appendix A filed 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 12-22-2004 order transmitted to OAL 4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

Subchapter 3. Regional Center Administrative Practices and Procedures

Article 1. Regional Center Conflict of Interest Standards and Procedures

§54500. Authority and Scope.

Note • History

These regulations prescribe conflict of interest standards and procedures for all members of the regional center governing boards and employees of the regional center to ensure that such persons make decisions relative to the regional center which are in the best interests of the center's clients and families pursuant to authority provided in Section 4627 of the Welfare and Institutions Code. Members serving on the governing board of a regional center on January 1, 1982 are subject to these regulations to the extent not prohibited by Welfare and Institutions Code, Section 4626.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Sections 4626 and 4627, Welfare and Institutions Code.

HISTORY

1. Editorial redesignation and renumbering of former Chapter 3 (Articles 1-3, Sections 50301-50327, not consecutive) to Chapter 3 (Subchapter 2, Article 1, Sections 54500-54529, not consecutive) filed 9-28-83 (Register 83, No. 40). For prior history, see Register 76, No. 51.

2. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87. No. 1).

§54505. Definitions.

Note • History

As used in this subchapter, the following words and phrases have the specified meanings:

(a) “Area Board” means the organization of individuals established and constituted according to Welfare and Institutions Code, Section 4570 et seq.

(b) “Board Member” or “Member of the Governing Board” means an individual serving on a governing board of a regional center.

(c) “Business Entity, Entity or Provider” means any individual or business venture from whom or from which the regional center purchases/obtains goods or services to conduct its operations. These entities or providers include, but are not limited to, residential facilities, intermediate care facilities, skilled nursing facilities, hospitals, medical groups, activity centers, independent living facilities, infant programs, clinics, laboratories, pharmacies, drug stores, ambulance services, furniture stores, equipment and supply stores, physicians, psychologists, nurses, therapists, teachers, social workers, and contract case managers.

(d) “Client” means the individual described in Section 56551(e), Chapter 3, Subchapter 4, Article 1, Title 17, California Administrative Code.

(e) “Decision or Policy-Making Authority” means the authority an individual possesses whenever the individual:

(1) makes a final decision; or

(2) may compel a decision or may prevent a decision either by reason of an exclusive power to initiate the decision or by reason of a veto which may or may not be overridden; or

(3) makes substantive recommendations which are, and over an extended period of time have been, regularly approved without significant amendment or modification by another person or entity or provider; or

(4) votes on matters, appoints or hires people, obligates or commits his or her agency to any course of action, or enters into any contractual agreement on behalf of his or her agency.

This authority does not include actions of the individuals which are solely secretarial or clerical.

(f) “Department” means the Department of Developmental Services.

(g) “Governing Board” means the board of directors of a private nonprofit corporation which contracts with the State for the purpose of establishing and operating a regional center and which is constituted in accordance with Section 4622 of the Welfare and Institutions Code.

(h) “Potential Conflict of Interest” means a situation which, based upon circumstances reasonably expected to occur at a point in the future, may result in a conflict of interest, as specified in Sections 54520 or 54521 of these regulations, at that time.

(i) “Present Conflict of Interest” means a conflict of interest, as specified in Sections 54520 or 54521 of these regulations, which currently exists.

(j) “Prospective Client” means any person who has presented himself or herself, at the regional center, as requiring services for the developmentally disabled but who has not yet gone through the initial intake and assessment process.

(k) “Regional Center” means a diagnostic, counseling, and service coordination center for persons with developmental disabilities and their families which is established and operated pursuant to Chapter 5 of Division 4.5 of the Welfare and Institutions Code by a private nonprofit corporation acting as a contracting agency.

(l) “Regional Center Employee” means any person who performs services for wages, salary or a fee under a contract of employment, express or implied, with the regional center. For purposes of these regulations, a business entity, entity or provider as defined in Section 54505(c) herein, is not a regional center employee.

(m) “Regional Center Operations” means those activities or services which regional centers are required by law, regulation, or contract with the State to provide, obtain, or purchase. Such activities include, but are not limited to: case finding, outreach, prevention, intake and assessment, individual program planning, case management, community programs, program development, and client advocacy and protection.

(n) “State Council” means the organization of individuals established and constituted pursuant to Welfare and Institutions Code, Section 4520 et seq.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Sections 4512, 4520 et seq., 4570 et seq., 4620, 4621, 4626, 4627, 4641, 4642, 4643, 4644, 4646, 4647 and 4648, Welfare and Institutions Code.

HISTORY

1. New section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54510. Regional Center.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54511. Contracting Agency.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54512. Regional Center Employee.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54520. Conflict of Interest Standards for Regional Center Governing Board Members.

Note • History

(a) The following constitute conflicts of interest for regional center governing board members:

(1) A conflict of interest exists when a member of the governing board or a family member of such person is a director, officer, owner, partner, shareholder, trustee or employee of any business entity or provider, holds any position of management in any business entity or provider, or has decision or policy-making authority in such an entity or provider, except to the extent permitted by Welfare and Institutions Code, Section 4626(a)(3) and (b). These conflict of interest provisions are in addition to those stated in Welfare and Institutions Code, Sections 4622(a)(9) and 4626.

(2) A conflict of interest exists when the advisory committee board member, appointed pursuant to Welfare and Institutions Code, Section 4622(a)(7), is an employee or member of the governing board of a provider from which the regional center purchases client services and engages in the activities prescribed in Welfare and Institutions Code Section 4622(a)(9). Such member is therefore prohibited from serving as an officer of the regional center governing board and from voting on the matters or issues described in Section 4622(a)(9). Furthermore, the member is subject to disclosure under Section 54522 of these regulations in addition to providing a list of his or her financial interests, as defined in Government Code Section 87103. Fiscal matters, as used in Welfare and Institutions Code Section 4622(a)(9) include, but are not limited to, setting purchase of service priorities, transferring funds to the purchase of service budget, and establishing policies and procedures with respect to payment for services.

(3) A conflict of interest exists when a governing board member is any individual described in Welfare and Institutions Code Section 4626. A financial interest in regional center operations, as used in Welfare and Institutions Code Section 4626(a)(4), exists if it is reasonably foreseeable that the member's interest, or the member's decision regarding that interest, will have a material financial effect, on the board member's interest in, or relationship with, the business entity or provider pursuant to Government Code, Section 87103. The financial effect is material if the decision will result in a benefit, detriment, gain, loss or profit to the member, entity or provider.

(b) The regional center governing board shall not enter or authorize the regional center to enter into any contract or any other type of agreement for pecuniary gain with any entity or provider in which a member has a conflict of interest as set forth in subsection (a)(1) and (a)(3) above, nor shall the board or board member allow the regional center to refer a client or prospective client to such an entity or provider.

(c) No regional center governing board member who has a conflict of interest shall continue to serve as a board member in violation of these provisions unless the board member has eliminated the conflict of interest or obtained a waiver pursuant to these regulations. This prohibition does not apply to the extent it is precluded by Welfare and Institutions Code, Sections 4626(a)(3) and (b).

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4622, 4626, 4627 and 4791(i), Welfare and Institutions Code. Reference: Sections 4622, 4626, 4627 and 4791, Welfare and Institutions Code and Section 87103, Government Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB484 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54521. Conflict of Interest Standards for Regional Center Employees.

Note • History

(a) The following constitute conflicts of interest for regional center employees:

(1) A conflict of interest exists when a regional center employee or a family member of such person is a governing board member, director, officer, owner, partner, shareholder, trustee, or employee of any business entity or provider, holds any position of management in any business entity or provider, or has decision or policy-making authority in such an entity or provider, or makes a decision regarding regional center operations involving a business entity or provider in which he or she has a financial interest.

For the purpose of this section, an employee has a financial interest in regional center operations if it is reasonably foreseeable that the employee's interest or the employee's decision regarding that interest will have a material financial effect, as distinguished from its effect on the regional center's clients and/or their families generally, on:

(A) Any business entity or provider in which the employee has a direct or indirect investment worth more than one thousand dollars ($1000).

(B) Any real property in which the employee has a direct or indirect interest worth more than one thousand dollars ($1000).

(C) Any source of income, other than loans by a commercial lending institution in the regular course of business on terms available to the public without regard to employee status, aggregating two hundred fifty dollars ($250) or more in value provided to, received by or promised to the employee within 12 months prior to the time when the decision is made.

For purposes of this section, “indirect investment” or “interest” means any investment or interest owned by the spouse or dependent child of an employee, by an agent on behalf of an employee, or by a business entity or provider or trust in which the employee, the employee's agent, spouse, or dependent children own directly, indirectly, or beneficially a ten percent interest or greater.

The financial effect is material if it will result in a benefit, detriment, gain, loss, or profit to the employee, entity, or provider.

(2) A conflict of interest exists when a regional center employee devotes less than his or her full-time attention and effort to his or her regional center employment for that period for which he or she is being reimbursed.

(3) A conflict of interest exists when a regional center employee provides services for salary, honorarium, or compensation of any kind in such fashion that the employee is receiving dual compensation for the same period of time. This subsection does not apply to regional center employees while officially off duty.

(4) A conflict of interest exists when a regional center employee participates in the evaluation of an application for employment at the regional center when the applicant is a member of the employee's family, or when an employee acts as a supervisor of another regional center employee who is a member of the supervisor's family.

(A) For the purpose of this subsection, supervisors shall include those individuals who serve as reviewing officer for reports of performance.

(B) For the purpose of this subsection, family members shall include: spouse, children, stepchildren, parents, stepparents, brothers, sisters, grandchildren, grandparents, or inlaws.

(b) No regional center employee shall continue employment with the regional center where the employee has a conflict of interest in violation of those provisions, unless the employee eliminates the conflict of interest or obtains a waiver pursuant to these regulations.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Section 4627, Welfare and Institutions Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54522. Conflict of Interest Disclosure--Content of Statements, Procedures and Actions Required for Resolution.

Note • History

(a) Within 60 calendar days of the effective date of this Article, each regional center employee who has decision or policy-making authority, as defined in Section 54505(e) herein, and each member of the governing board, including the board member designated by the regional center provider advisory committee pursuant to Welfare and Institutions Code, Section 4622(a)(7), shall prepare and file an initial conflict of interest statement pursuant to these regulations. Employees shall file their statements with their respective regional center and governing board members shall file their statements with their regional center governing board. Subsequent statements shall be filed thereafter whenever a change in status would create a present or potential conflict of interest situation as defined in these regulations. Individuals serving in any capacity under a waiver granted pursuant to Section 54523 of these regulations shall be required to file a conflict of interest statement with each waiver renewal as required pursuant to Section 54524(b)(3) of these regulations. The regional center and governing board shall designate the individual who is responsible for receiving, processing, and maintaining the initial and subsequent annual statements for their own respective agency. Such individual, however, may not review his or her own filed statement. The initial conflict of interest statement and all subsequent annual statements shall be dated, signed, and contain a declaration, under penalty of perjury, that the governing board member or employee has:

(1) No present or potential conflict of interest;

(2) A present conflict of interest; or

(3) A potential conflict of interest pursuant to these regulations.

The individual shall specify the factual basis for that determination and provide full and complete disclosure relative to any present or potential conflict of interest, including a description of the nature of the conflict of interest. For the board member designated by the regional center provider advisory committee pursuant to Welfare and Institutions Code, Section 4622(a)(7), the disclosure shall include, to the extent not otherwise disclosed, a list of the member's financial interest as required by Welfare and Institutions Code, Section 4622(a)(9)(C).

(b) If a present or potential conflict of interest exists, the statements of regional center employees and governing board members, including the board member designated by the regional center provider advisory committee pursuant to Welfare and Institutions Code, Section 4622(a)(7), shall if desired by the governing board member or regional center employee, also contain a request for waiver of the prohibitions of any present or potential conflict of interest, and a suggested plan of action for resolution of the present or potential conflict of interest, including limitations on the governing board member or regional center employee which will enable him or her to avoid actions involving the conflict of interest during the period the waiver request is being reviewed pursuant to Section 54523 of these regulations.

(c) The regional center or regional center governing board shall review, respectively, the waiver requests of all regional center employees and governing board members, and determine, in its discretion, whether to submit the request pursuant to the regulations, or require the individual to eliminate the conflict of interest or resign his or her position as stated therein.

(d) If a present or potential conflict of interest exists and no waiver is requested, or if the regional center or regional center governing board elects not to submit such a request in accordance with these regulations, the regional center employee or governing board member, and the board member designated by the regional center provider advisory committee pursuant to Welfare and Institutions Code, Section 4622(a)(7), shall have thirty (30) calendar days from the date of filing the conflict of interest statement or the date of notification by the regional center or its governing board in which to either take whatever action is necessary to eliminate the conflict of interest, or resign his or her position as a regional center employee or governing board member. During the thirty (30) calendar day period, the employee or board member shall avoid all involvement with or participation in regional center activities involving the conflict of interest in question.

(e) If no conflict of interest is declared at the time of filing the initial statement or subsequent statements, no further action is required by the governing board member or regional center employee unless or until such time as that individual's status changes, so that he or she is in a present or potential conflict of interest situation. Upon such a change in status, a new statement shall be filed immediately with the member's governing board or the employee's regional center, specifying the factual basis for that determination and providing full and complete disclosure relative to the present or potential conflict of interest in accordance with provisions of subsection (a) above.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4627 and 4791(i), Welfare and Institutions Code. Reference: Sections 4622, 4626, 4627 and 4791, Welfare and Institutions Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§54523. Requests for Waiver.

Note • History

(a) If the conflict of interest statement filed by the regional center governing board member or the regional center employee indicates that a present or potential conflict of interest exists and a waiver is being requested, then within thirty (30) calendar days of receipt of such a statement, the governing board or regional center shall, unless it has elected to do otherwise pursuant to Section 54522(c), submit the request for waiver packet in accordance with the procedures set forth in this section.

(b) All requests for waiver packets must be submitted to the Department. In addition, copies of requests for waiver packets involving governing board members must also be sent to the area board in the area and to the State Council.

(1) A copy of the board member's or employee's conflict of interest statements;

(2) The request for waiver;

(3) The plan of action for resolution of his or her conflict of interest and the time frames for doing so; and

(4) Any limitations proposed by the governing board or regional center to be applied to the board member or employee during the term of the waiver. Limitations may include, but are not limited to:

(A) Abstention by the person from voting on the conflict of interest situations;

(B) Nonparticipation by the person, individually or as part of a group, in the preparation, presentation, formulation or approval of reports, plans, policies, analyses, opinions or recommendations regarding the conflict of interest situation, when the exercise of judgement is required and the purpose is to influence the decision;

(C) Noninvolvement of the person in the negotiation, obligation, or commitment of the regional center to a course of action involving the conflict of interest situation;

(D) Reassignment of the person to duties or responsibilities where no conflict of interest exists; and

(E) Establishment of an independent review and prior approval procedure by supervisors or administrative staff regarding purchase of service and other decisions made by the person with respect to the conflict of interest situation.

(5) The individual(s) responsible for ensuring that the above plan of action or limitations are applied and monitored;

(6) Any other information which the employee or board member feels is pertinent to his or her request.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Sections 4627 and 4628, Welfare and Institutions Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54524. Response to Requests for Waiver.

Note • History

(a) Within twenty (20) calendar days after the area board in the area and the State Council receive copies of a request for waiver packet regarding a regional center governing board member, the area board in the area and the State Council, respectively, shall provide to the Department their written approval or disapproval of such request. The Department may not approve the request for waiver of a regional center governing board member without the approval of both the area board in the area and the State Council.

(b) Within sixty (60) calendar days after the Department receives a request for waiver packet the Department will respond to the request for waiver in writing:

(1) Explaining the outcome of its review including approval or denial of the request, where appropriate, and the rationale for the decision;

(2) Specifying the actions, if any, by the governing board or regional center which the Department deems necessary in order to resolve the conflict of interest; and

(3) Stating the duration of the waiver, if approved, according to the following:

(A) For the members of the governing boards who are subject to those regulations, the duration of the waiver may not exceed one year;

(B) For the regional center employee, the duration of the waiver will be determined by the Department.

(c) If the request for waiver is denied by the Department and/or the State Council or area board in the area pursuant to subsections (a) and (b) herein, the governing board member or regional center employee shall have thirty (30) calendar days from the date of receipt of the denial in which to either take whatever action is necessary to eliminate the conflict of interest or resign his or her position as a governing board member or regional center employee. During this thirty (30) calendar day period, the board member or employee shall avoid all involvement with and participation in the conflict of interest in question.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Sections 4627 and 4628, Welfare and Institutions Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87. No. 1).

§54525. Sanctions.

Note • History

(a) If the Department finds a governing board, a board member, a regional center or a center employee, in violation of any of the sections set forth in this Article, the Department shall:

(1) Immediately inform the party or parties in writing of such violation, including the supporting facts or information upon which determination of violation was made; and

(2) Require that the party or parties take appropriate action, within thirty (30) calendar days of the notice of violation, to resolve the conflict of interest or otherwise eliminate the violation. The Department may extend this thirty-day period only once and for a period not to exceed thirty (30) calendar days.

(b) If the violation is not resolved or eliminated within the thirty (30) calendar days as herein provided, and no extension of time has been granted by the Department, the Department may take immediate action to:

(1) Withhold part of the funding for that regional center; or

(2) Commence procedures for termination or nonrenewal of the regional center contract pursuant to Welfare and Institutions Code, Section 4635.

The area board in the area and the State Council shall be notified of the above action.

NOTE

Authority cited: Section 4627, Welfare and Institutions Code. Reference: Sections 4627 and 4635, Welfare and Institutions Code.

HISTORY

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54526. Purchases.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54527. Records.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54528. Board Meetings.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§54529. Sanctions.

History

HISTORY

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

Subchapter 3.5. Regional Center Budget Deficit Controls

Article 1. Definitions

§54600. Definitions.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session; and Sections 4646, 4647, 4648 and 4693, Welfare and Institutions Code.

HISTORY

1. New Subchapter 3 (Sections 54600-54676, not consecutive) filed 8-24-83 as an emergency; effective upon filing (Register 83, No. 40). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 12-22-83.

2. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5)

3. Order of Repeal of subsections (l) and (m) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

4. Editorial relettering only of subsections (a)-(p) organizing text in alphabetical order (Register 84, No. 15).

5. Amendment filed 2-22-84 as an emergency; effective upon filing. Certificate of Compliance included (Register 84, No. 15).

6. Order of Repeal of subsections (g) and (h) filed 3-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 15).

7. Expired by own terms (Register 88, No. 25).

§54601. Expiration.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Editorial correction adding new Section filed 1-23-84 (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Article 2. Service Authorization and Review

§54620. Service Purchase Authorizations.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Sections 4646, 4647 and 4648(b), Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsections (b)-(c) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. Editorial correction of HISTORY NOTE No. 2 and reprinting of subsection (d) inadvertently deleted in Register 84, No. 5 (Register 84, No. 15).

4. New subsections (b) and (c) filed 2-22-84 as an emergency; effective upon filing. Certificate of Compliance included (Register 84, No. 15).

5. Order of Repeal of subsections (b) and (c) filed 3-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 15).

6. Expired by own terms (Register 88, No. 25).

§54621. Review of Service Authorizations.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes o 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session; and Sections 4646, 4647 and 4648(b), Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including new subsection (c) transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Article 3. Plans of Action

§54640. Projecting Deficits.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (d) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. Editorial correction adding HISTORY NOTE Nos. 1 and 2 (Register 84, No. 15).

4. New subsection (d) filed 2-22-84 as an emergency; effective upon filing. Certificate of Compliance included (Register 84, No. 15).

5. Expired by own terms (Register 88, No. 25).

§54641. Content of Plans of Action.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§54642. Review of Plans of Action.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Editorial correction adding HISTORY NOTE No. 1 (Register 84, No. 15).

3. Expired by own terms (Register 88, No. 25).

§54643. Modification and Implementation of Plans of Action.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Editorial correction adding HISTORY NOTE No. 1 (Register 84, No. 15).

3. Expired by own terms (Register 88, No. 25).

§54644. Noncompliance.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session.

HISTORY

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Editorial correction adding HISTORY NOTE No. 1 (Register 84, No. 15).

3. Expired by own terms (Register 88, No. 25).

Article 4. Service Standards

§54660. Early Intervention Services.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session; and Sections 4642, 4644, 4648 and 4693, Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§54661. Preschool Services.

Note • History

NOTE

HISTORY

1. Expired by own terms (Register 88, No. 25).

§54662. Education.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§54663. Day Program Services.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (b)(3) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. Expired by own terms (Register 88, No. 25).

§54664. Independent Living Skills Training.

Note • History

NOTE

HISTORY

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (c) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. New subsection (c) filed 2-22-84 as an emergency; effective upon filing. Certificate of Compliance included (Register 84, No. 15).

4. Order of Repeal of subsection (c) filed 3-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 15).

5. Expired by own terms (Register 88, No. 25).

§54665. Extended Day Programs.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (a) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. New subsection (a) filed 2-22-84 as an emergency; effective upon filing. Certificate of Compliance included (Register 84, No. 15).

4. Expired by own terms (Register 88, No. 25).

§54666. Social Recreation Services.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§54667. Special Services.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including repealer of Section 54667 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54668. Behavior Modification.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (a)(2) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

3. Expired by own terms (Register 88, No. 25).

§54669. Sensory Motor Development.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including repealer of Section 54669 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54670. Education Training.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including repealer of Section 54670 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54671. Independent Living Skills Training.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including repealer of Section 54671 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54672. Vocational Training.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including repealer of Section 54672 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54673. Work Activity.

Note • History

NOTE

Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Section. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Extraordinary Session; and Section 4648, Welfare and Institutions Code.

HISTORY

1. Certificate of Compliance including repealer of Section 54673 transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

§54674. Respite Care.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§54675. Transportation.

Note • History

NOTE

HISTORY

1. Editorial correction of subsection (b) filed 9-7-83 (Register 83, No. 40).

2. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

3. Order of Repeal of subsections (b) and (d)(3) filed 1-23-84 by OAL pursuant to Government Code Section 11349.6; effective thirtieth day thereafter (Register 84, No. 5).

4. Expired by own terms (Register 88, No. 25).

§54676. Exceptions.

Note • History

NOTE

HISTORY

1. Certificate of Compliance including amendment transmitted to OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Subchapter 4. Residential Services and Quality Assurance Regulations

Article 1. Definitions

§56001. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning.Words used in their present tense include the future tense; words in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct; “may” denotes permissive conduct.

NOTE

Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4681.1 and 4748, Welfare and Institutions Code.

HISTORY

1. Repealer of former subchapter 4 (articles 1-2, sections 56550-56610) and new subchapter 4 (articles 1-11, sections 56001-56067), article 1 (sections 56001-56002) and section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correction of History 1 (Register 98, No. 27).

§56002. Definitions.

Note • History

(a) The following definitions shall apply to the regulations used in this subchapter:

(1) “Administrator” means the licensee, or the adult designated by the licensee to act in his/her behalf who assumes responsibility for facility operations.

(2) “Admission Agreement” means the agreement required pursuant to Title 22, California Code of Regulations, Sections 80068, 85068 and 87568.

(3) “Authorized Consumer Representative” means the parent, or guardian of a minor, conservator of an adult, or person who is legally entitled to act on behalf of the consumer.

(4) “Child With Special Health Care Needs” means a child with a developmental disability who: 1) is receiving services and service coordination from a regional center; 2) is placed in a foster family home, small family home or group home; and 3) has a medical condition that can rapidly deteriorate, resulting in permanent injury or death; or who has a medical condition that requires specialized in home health care, including an internal feeding tube, total parenteral feeding, a cardiorespiratory monitor, intervenous therapy, a ventilator, urinary catheterization, ministrations imposed by tracheostomy, colostomy, ileostomy, or other medical or surgical procedures; or special medication regimens, including injection, areosol treatment, and intravenous or oral medication which requires specialized in-home health care.

(5) “Consumer” means an individual who has been determined by a regional center to meet the eligibility criteria of the Welfare and Institutions Code Section 4512, and of Title 17, California Code of Regulations, Sections 54000, 54001 and 54010, and for whom the regional center has accepted responsibility.

(6) “Consumer Notes” means those ongoing notations made in the individual consumer file at the facility which are incidental to specific events in the consumer's life, and which are made at the time of occurrence and are not a part of the quarterly or semi-annual report.

(7) “Consumer Services” means those services which the residential service provider is responsible for implementing as a part of the program design and the consumer's IPP.

(8) “Consumers' Rights” means the rights of regional center consumers residing in facilities, as specified in Welfare and Institutions Code Sections 4502, 4502.1, 4503, 4504, 4705 and 4710.6; and Title 17, California Code of Regulations, Division 2, Chapter 1, Subchapter 5, Sections 50510, 50515(a)(2), (b)(2) and (c), 50520(b), 50530, 50532, 50534, 50536, 50540 and 50960.

(9) “Contact” means any communication between two or more persons or entities by means of face-to-face meetings, phone conversations, or letters.

(10) “Days” means calendar days unless otherwise stated.

(11) “Department” means the State Department of Developmental Services.

(12) “Direct Care Staff” means facility staff, in Service Level 2, 3 and 4 facilities, who personally provide direct supervision and special services to consumers and is synonymous with “Direct Support Professionals”. The term includes the licensee, the administrator, management and supervisory staff during that time when they are providing direct supervision and special services to consumers or are involved in performing program preparation functions.

(13) “Director” means the Director of the Department of Developmental Services or his/her designee.

(14) “Direct Supervision” means those activities in which direct care staff provide care, supervision, training and support to promote the consumer's functioning in the areas of self-care, daily living skills, physical coordination, mobility, behavioral self-control, choice-making, community integration, accessing community resources and participating in leisure time activities.

(15) “Facility” means a licensed community care facility as defined in Health and Safety Code Section 1502(a)(1), (4), (5) or (6); or a licensed residential care facility for the elderly as defined in Health and Safety Code Section 1569.2(k), which has been vendorized as a residential facility by a regional center pursuant to the requirements of Title 17, California Code of Regulations, Division 2, Chapter 3, Subchapter 2.

(16) “Facility Liaison” means the person, or his or her designee, assigned by the regional center as the principal coordinator between the regional center and the facility.

(17) “Facility Staff” means the administrator and direct care staff employed by the facility who provide direct supervision and special services to consumers residing in the facility, and consultants employed by the facility who provide support to direct care staff.

(18) “Immediate Danger” means conditions which constitute an impending threat to the health and safety of a consumer(s) and which require immediate action by the regional center to safeguard the health and safety of the consumers in the facility.

(19) “Individual Life Quality Outcomes” means desired outcomes for individual life quality and represent life conditions that people have identified as being important in their everyday lives.

(20) “Individual Program Plan (IPP)” means a written plan that is developed by a regional center Interdisciplinary Team, in accordance with the provisions of Welfare and Institutions Code Sections 4646 and 4646.5.

(21) “Interdisciplinary Team (ID Team)” means the group of persons convened, in accordance with Welfare and Institutions Code Sections 4646 and 4645.5, for the purpose of preparing a consumer's IPP.

(22) “Licensee” means the person who is identified as the licensee on the license to operate as a community care facility which is issued to the facility by the Department of Social Services' Community Care Licensing Division.

(23) “Looking at Service Quality Provider's Handbook” means the publication so entitled and developed by the Department to help administrators and direct care staff increase the quality of their services through a self-assessment of their direct supervision and special services to consumers. The self-assessment is based upon twenty-five individual life quality outcomes. The publication entitled “Looking at Service Quality Provider's Handbook,” original edition which bears no revision or publication date, is hereby incorporated by this reference as though fully set forth herein.

(24) “Medication” means any drug or other agent ordered by a physician, and over-the-counter medications used to treat symptoms of illness or injury.

(25) “Natural Environment” means places and social contexts commonly used by individuals without developmental disabilities.

(26) “Noncompliance” means failure to comply with any of the requirements of Title 17, California Code of Regulations, Division 2, Chapter 3, Subchapter 4 or 6.

(27) “Normalization” means life conditions which enable consumers to lead more independent, productive and normal lives which approximate the pattern of daily living of non-disabled persons of the same age and reflect personal choice.

(28) “Personal and Incidental Allowance” means that portion of the Supplemental Security Income/State Supplemental Program (SSI/SSP) payment designated for the personal expenses of the consumer.

(29) “Placement” means the process the regional center and the consumer complete to assist the consumer to locate and make an initial move to a facility.

(30) “Program Design” means the description of consumer services offered by a facility, the functional characteristics of the consumers the facility will serve, and the resources available to meet individual service needs consistent with the facility's service level.

(31) “Program Preparation Functions” means ancillary activities performed by direct care staff or administrators, including, but not limited to, data collection and analysis, development of training plans, staff meetings, consumer meetings and parent conferences.

(32) “Quality Assurance (QA) Coordinator” means that person who is knowledgeable in, and designated by the regional center to be responsible for, managing all elements of the Quality Assurance Plan.

(33) “Quality Assurance (QA) Evaluation” means the process of assessing a specific facility's ability to provide the minimum acceptable level of service required by these regulations and the effects of those services upon the consumers served.

(34) “Quality Assurance Evaluation Team” means a group of two or more persons who perform a QA evaluation and have knowledge of residential services for persons with a developmental disability by virtue of personal, professional or academic experience or training.

(35) “Quality Assurance (QA) Plan” means the written plan developed by each regional center to coordinate the QA evaluation process, ongoing monitoring, and necessary training and technical assistance to assure implementation of these regulations.

(36) “Regional Center” means a diagnostic, counseling and service coordination center for developmentally disabled persons and their families which is established and operated pursuant to Welfare and Institutions Code Sections 4620 through 4669, by a private nonprofit community agency or corporation acting as a contracting agency. As used in these regulations, any reference to the regional center shall, by reference, be applicable to those agencies or persons with which the regional center contracts or employs to provide service coordination to consumers under the provisions of Welfare and Institutions Code Section 4647.

(37) “Regional Center Director” means the Director of the Regional Center or his/her designee.

(38) “Regional Center Representative” means a person who is employed or designated by the regional center to represent that agency.

(39) “Relocation” means the process the regional center and the consumer complete to enable a consumer to move from one facility to another.

(40) “Residential Service(s)” means the direct supervision and special services which facility staff provide to a consumer during the process of implementing the program design and achieving the objectives of the Individual Program Plan (IPP) for which the residential service provider is responsible.

(41) “Residential Service Provider” means an individual or entity which has been licensed by the Department of Social Services as a community care facility pursuant to Health and Safety Code Section 1502(a)(1), (4), (5) or (6); or is defined as a licensed facility for the elderly in Health and Safety Code Section 1569.2; has completed the vendorization process pursuant to Title 17, California Code of Regulations, Division 2, Subchapter 2; and has been assigned a vendor identification number beginning with the letter “H” pursuant to Title 17, California Code of Regulations, Section 54340(a)(1).

(42) “Self Care” means providing for, or meeting, a consumer's own physical and personal needs in the areas related to eating, dressing, toileting, bathing and personal hygiene.

(43) “Service Coordinator” means the regional center or designee agency employee, or his/her designee, who has responsibility for providing or ensuring service coordination as specified in Welfare and Institutions Code Section 4647.

(44) “Service Level” means one of a series of 4 levels which has been approved for each facility by a regional center. Service Levels 2, 3 and 4 have a specified set of requirements that a facility must meet which addresses the direct supervision and special services for consumers within that facility.

(45) “Service Needs” means those consumer needs which require direct supervision and special services, which are identified through the ID Team assessment process.

(46) “Service Outcomes” means the results, for the consumer, of direct supervision and special services provided by the facility's program.

(47) “Special Incident Report (SIR)” means a special incident report as defined in Title 17, California Code of Regulations, section 54327(b).

(48) “Special Services” means specialized training, treatment, and/or supervision which are required by the consumer's IPP and provided by direct care staff in addition to direct supervision.

(49) “Submit” means the postmarking or hand delivery of the item required no later than the last day of the timeline allowed.

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4501, 4502, 4503, 4504, 4646, 4646.5, 4647, 4648, 4681.1, 4695, 4695.2, 4705, 4740 through 4748 and 17710, Welfare and Institutions Code; Sections 1502(a) and 13131, Health and Safety Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (a)(2) and (24) and capitalizing “S” of “Section” throughout (Register 95, No. 18).

6. Change without regulatory effect amending subsection (a)(21) and Note filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

7. Repealer of subsection (a)(1), subsection renumbering, and amendment of newly designated subsections (a)(20), (a)(38), (a)(40), (a)(41) and (a)(45) and amendment of Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

8. New subsections (a)(19) and (a)(22) and subsection relettering filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

9. New subsections (a)(19) and (a)(22) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

10. Repealer of subsection (a)(1), subsection renumbering, amendment of newly designated subsections (a)(20), (a)(38), (a)(40), (a)(41) and (a)(45) and amendment of Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to first 10-20-98 order, including further amendment of subsection (a)(22), transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

12. Certificate of Compliance as to second 10-20-98 order, including further amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

13. Amendment of subsection (a)(12), new subsection (a)(13), repealer of subsection (a)(14), renumbering and amendment of former subsection (a)(13) to subsection (a)(14), amendment of subsections (a)(41) and (a)(48) and amendment of Note filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

15. Amendment of subsection (a)(12), new subsection (a)(13), repealer of subsection (a)(14), renumbering and amendment of former subsection (a)(13) to subsection (a)(14), amendment of subsections (a)(41) and (a)(48) and amendment of Note filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

16. Refiling of 7-26-2000 order, including further amendment of subsection (a)(12), new subsection (a)(22), subsection renumbering and amendment of newly designated subsections (a)(23) and (a)(42), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

17. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

18. Change without regulatory effect amending subsection (a)(48) filed 8-28-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 35).

19. Repealer of subsection (a)(43), subsection renumbering, and amendment of newly designated subsection (a)(47) filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

20. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

21. Certificate of Compliance as to 10-25-2001 order transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

22. Change without regulatory effect repealing subsection (a)(42), renumbering subsections and adopting new subsection (a)(47) filed 5-27-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 22).

23. Change without regulatory effect amending subsection (a)(2) filed 11-10-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 45).

Article 2. General Requirements

§56003. Residential Services Orientation.

Note • History

(a) The regional center shall provide a residential services orientation for all persons who wish to become vendorized to provide services pursuant to Subchapter 4. The residential services orientation shall occur no less than every six months and shall include the following information:

(1) An overview of Title 17, California Code of Regulations requirements applicable to residential facilities, including:

(A) Record maintenance requirements pursuant to Title 17, California Code of Regulations, Section 50604.

(B) Vendorization procedures pursuant to Title 17, California Code of Regulations, Sections 54310 through 54374;

(D) Regional center evaluation and monitoring processes pursuant to Sections 56046 through 56052;

(E) Access requirements as specified in Title 17, California Code of Regulations, Section 50603;

(F) Consumers' Rights as defined in Section 56002(a)(9);

(G) Elements of the program design pursuant to Section 56013.

(2) An overview of the self-assessment process and the individual life quality outcomes identified in the “Looking at Service Quality Provider's Handbook”.

(3) Copies of sections of Title 17, California Code of Regulations applicable to residential facilities, and “Looking at Service Quality Provider's Handbook,” supplied by the Department.

(b) The administrator shall complete the residential services orientation:

(1) Before the admission of the first regional center consumer; or

(2) When two or more years have elapsed since he/she last served as an administrator.

NOTE

Authority cited: Chapter 157, Statutes of 2003; and Sections 4648.1, 4681.1, 4742 and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4681.1, 4740, 4742 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Change without regulatory effect amending designation of subsection (a) filed 11-17-93 pursuant to title 1, section 100, California Code of Regulations (Register 93, No. 47).

4. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

5. Editorial correction of History 2 (Register 94, No. 47).

6. Editorial correction capitalizing “S” of “Section” throughout (Register 95, No. 18).

7. New subsections (a)(2) and (a)(3) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

8. New subsections (a)(2)-(3) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment of subsections (a)(2) and (a)(3) and amendment of Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

10. New subsection (a)(1)(A), subsection relettering, amendment of newly designated subsection (a)(1)(B) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

11. New subsection (a)(1)(A), subsection relettering, amendment of newly designated subsection (a)(1)(B) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

12. New subsection (a)(1)(A), subsection relettering, amendment of newly designated subsection (a)(1)(B) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 6-1-2004 order transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§56004. Facility Service Levels.

Note • History

(a) Service Level 1 through 4 facilities shall possess a valid Community Care Facility license issued by the Department of Social Services' Community Care Licensing Division pursuant to Health and Safety Code Sections 1500 et seq., and Title 22, California Code of Regulations, Division 6, Sections 80000 et seq.

(b) Service Level 1 through 4 facilities shall be vendorized by a regional center pursuant to the requirements of Title 17, California Code of Regulations, Chapter 3, Subchapter 2.

(1) Direct supervision and special services pursuant to Welfare and Institutions Code Sections 4681.1(b)(2) and (b)(3) as needed to provide services in accordance with, and to meet the requirements of, the approved program design pursuant to Section 56005 and the consumer's IPP objectives.

(2) A basic staffing level of no less than one direct care staff person at all times when consumers are under the supervision of facility staff. This basic staffing level shall be the total direct supervision and special services required of the facility up to a maximum number of consumers as follows:

(A) For Service Level 2, one direct care staff person for up to six consumers in the facility;

(B) For Service Levels 3, 4A, and 4B, one direct care staff person for up to three consumers in the facility;

(D) For Service Levels 4F, 4G, 4H, and 4I, one direct care staff person for the first consumer in the facility.

(d) In addition to the basic level of staffing described in subsection (c)(2)(A) through (D) above, facilities providing residential services to a greater number of consumers shall provide a cumulative number of additional weekly direct care staff hours for consumers based upon the facility's service level, as specified in the table below:

*Consumer(s)

(1) A facility with seven or more consumers shall provide the number of weekly direct care staff hours for each additional consumer as specified in the table above.

(e) A facility may include within the total number of additional direct care staff hours required pursuant to subsection (d) above, hours of program preparation functions which shall be counted as follows:

(1) Service Level 2 facilities: Up to 2 hours per consumer per week.

(2) Service Level 3 facilities: Up to 2 hours per consumer per week.

(3) Service Level 4A, 4B, 4C facilities: Up to 3 hours per consumer per week.

(4) Service Level 4D, 4E, 4F, 4G facilities: Up to 4 hours per consumer per week.

(5) Service Level 4H facilities: Up to 5 hours per consumer per week.

(6) Service Level 4I facilities: Up to 7 hours per consumer per week.

Program preparation function hours shall not be used as a basis for increasing a service level.

Staff schedules which were part of the facility's program design as approved by the regional center pursuant to Section 56005 prior to September 20, 1993 shall remain in effect.

(f) In addition to the above direct care staff hours requirements, Service Level 4 facilities shall provide a cumulative number of consultant hours consisting of no less than the number of hours indicated below during each consecutive six-month period after the effective date of these regulations based upon the number of consumers in the facility.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4646, 4646.5, 4648, 4681.1, 4748, 4786 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsection (b) filed 1-18-91 pursuant to section 100, title 1, California Code of Regulations; operative 2-13-91 pursuant to Government Code section 11346.2(d) (Register 91, No. 14).

3. Amendment of Table, new subsection (d) and subsection renumbering, and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of Table, new subsection (d) and subsection renumbering and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

7. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

8. Editorial correction of History 6 (Register 94, No. 47).

9. Editorial correction of subsection (c)(1) (Register 95, No. 18).

10. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56005. Facility Service Level Approval Process.

Note • History

(a) A residential service provider shall submit a written request to the regional center to establish an approved Service Level 2, 3 or 4. The written request shall include the following:

(1) A statement of the administrator's qualifications pursuant to Section 56037;

(2) A program design pursuant to Section 56013 which is consistent with the proposed service level; and

(3) Specification of the proposed facility service level pursuant to the requirements in Section 56004.

(b) Within 45 days of receipt of a request to establish an approved Service Level 2, 3 or 4, the regional center shall review the request and provide written notification to the applicant of the:

(1) Approval of the requested service level and the effective date for the approved service level which shall be the date of issuance of written notification to the applicant; or

(2) Disapproval of the requested service level specifying the reason(s) for disapproval.

(c) The requirements specified in subsections (a) and (b) above shall also apply to those facilities which have an approved service level and are submitting a request to establish another approved service level.

(1) A facility's written request to be established as another approved service level shall be considered only when there is a change in the facility's ownership or the ID Teams of a majority of the facility's consumers have identified, pursuant to Section 56022(a) and (b), that the consumers need a new service level.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (c)(1) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (c)(1) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (c)(1) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56009. Regional Center Compliance.

Note • History

NOTE

Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4631, 4635, 4648.1, 4681.1 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

2. Repealer filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

3. Editorial correction of History 2 (Register 94, No. 47).

Article 3. Program Design

§56013. Program Design Requirements.

Note • History

(a) Each facility applying for Service Level 2, 3 or 4 approval shall submit a written program design to the regional center pursuant to Section 56005 which is based upon the principles of normalization as measured by consumer participation in a variety of integrated, age-appropriate activities which take place in natural environments, at home, at work, in the community and during leisure time.

(b) The program design shall include:

(1) An organizational chart for the facility;

(2) A statement of purpose, a description of consumer services to be provided, and expected service outcomes for consumers to be served;

(3) Facility entrance and exit criteria which identify the characteristics of the consumer population the facility intends to serve, including age range, gender, ambulatory status, medical conditions, self-help skills and behavioral characteristics;

(4) A description of program preparation functions to be performed by facility staff which is consistent with the requirements specified in Section 56004(e)(1) through (6);

(5) A description of staff qualifications and a duty statement for each staff position in the facility;

(6) A sample staff schedule; and

(7) A staff training plan.

(c) In addition to subsection (b) the program design for each facility applying for Service Level 3 approval shall include:

(1) A description of services designed to enhance the capabilities of consumers including those with:

(A) Significant deficits in self-help skills; and/or

(B) Some limitations in physical coordination and mobility; and/or

(d) In addition to subsection (b) the program design for each facility applying for Service Level 4 approval shall include:

(1) A description of services designed to enhance the capabilities of consumers including those with:

(A) Severe deficits in self-help skills; and/or

(B) Severe impairment in physical coordination and mobility; and/or

(2) A description of consultant qualifications, hours and duties;

(3) A specific description of the instructional methods and techniques to be utilized to achieve the desired service outcomes; and

(4) A methodology for measurement of consumer progress toward achievement of IPP objectives which includes:

(A) Types of data to be collected;

(B) Data collection systems;

(D) Methods and intervals for summarizing data and reporting on progress made toward achieving IPP objectives.

NOTE

Authority cited: Sections 4648(a), 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4501, 4646, 4648, 4681.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsections (a)(1)(A) and (a)(4), and amendment of renumbered subsections (a)(4)-(7) and NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsections (a)(1)(A) and (a)(4), and amendment of renumbered subsections (a)(4)-(7) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including repealer of subsections (a)(1)(A) and (d)(3) and amendment of subsections (a)(4) and (d)(2) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsections (a) and (d)(4)(D) (Register 95, No. 18).

9. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

Article 4. Consumer Placement and Relocation

§56016. Placement and Relocation Requirements.

Note • History

(a) The regional center shall, to the extent feasible, provide opportunities for each consumer or authorized consumer representative to have a choice among appropriate, available living arrangements.

(b) The regional center shall provide placement and relocation assistance to each consumer as specified in Welfare and Institutions Code Sections 4647, 4648 and 4747.

(c) The administrator may refuse to admit a consumer who has been referred to the facility by a regional center representative if the facility cannot meet the identified needs of the consumer.

(d) No consumer shall be placed into or relocated to a facility where a license revocation action is pending or the license renewal application has been denied.

(e) When the administrator determines that the facility can no longer meet the needs of the consumer, the administrator shall immediately notify the regional center, the consumer and/or the consumer's authorized representative.

(1) The administrator shall put verbal notification in writing and forward to the regional center within 24 hours.

(f) Upon notification as required in subsection (e), the regional center shall relocate the consumer within 30 days or within a time frame which has been mutually agreed-upon by the regional center, the administrator and the consumer and/or the consumer's authorized representative.

(g) Within a reasonable period of time based on the health and safety considerations for the consumer and no longer than the time frame for relocation pursuant to subsection (f) the regional center shall convene the consumer's I.D. Team to assess the consumer's needs and to determine:

(1) The services and supports to be provided to the consumer before, during and after the relocation; and

(2) Any additional measures necessary to meet the consumer's health and safety needs until the relocation has been accomplished.

NOTE

Authority cited: Sections 4681.1 , 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4647, 4648, 4652, 4681.1, 4741, 4744, 4746, 4747, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of article heading and section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction inserting subsection (c) and amending History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b) and Authority cite (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56017. Consumer Placement and Relocation Assistance.

Note • History

(a) When the consumer or the consumer's authorized representative requests assistance to relocate, or the administrator or regional center finds it necessary for a consumer to move from his/her current residential location, the ID Team, shall determine the living arrangement appropriate to the consumer's needs.

(b) When the appropriate living arrangement is determined to be a facility, the regional center shall release written information to the prospective administrator(s) for the purpose of determining if the residential service provider can meet the consumer's service needs. The information shall include:

(1) The current IPP;

(2) A description of the consumer's service needs;

(3) A statement of the consumer's ambulatory or nonambulatory status;

(4) Known information regarding individual likes and dislikes, abilities, interests and activities;

(5) Known information related to any history of aggressive or dangerous behavior of the consumer towards self or others;

(6) Identified needs for training and treatment of behaviors which interfere with, or prevent participation in, activities;

(7) Identified medical needs including special dietary requirements;

(8) When the consumer has an authorized representative, the name, address and telephone number of the consumer's authorized representative; and

(9) When the consumer has a parent(s) or other relative and the parent(s) or other relative has been actively involved in the provision of the services and supports specified in the consumer's IPP, the parent(s) or other relative(s) name, address and telephone number.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4514, 4646, 4646.5, 4648, 4681.1, 4710, 4741, 4744, 4747, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section heading and text filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56018. Preadmission Visits.

Note • History

(a) The service coordinator shall advise the consumer, or the consumer's authorized representative, of the opportunity to arrange a preadmission visit to a facility for the purpose of determining the suitability of the facility as a living environment for the consumer.

(b) When the consumer or the consumer's authorized representative requests a preadmission visit, the service coordinator or the consumer or the consumer's authorized representative shall contact the facility administrator to establish an agreed-upon date and time for a preadmission visit.

(1) Be available to discuss the facility and its services pursuant to Section 56013; and

(2) Determine if the facility can meet the service needs of the consumer.

(d) The service coordinator shall provide information to the administrator in accordance with Section 56017(b)(1)-(9), when the consumer is on an overnight visit or is under the direct supervision of the facility during a day visit.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1, 4747, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (c)(1) and (d) (Register 95, No. 18).

§56019. Consumer Admission.

Note • History

(a) When the consumer or the consumer's authorized representative, administrator and the service coordinator have reached an agreement regarding consumer placement or relocation to a specific facility, the administrator shall:

(1) Establish with the consumer or the consumer's authorized representative and the service coordinator a date and time for the consumer's admission to the facility;

(2) Explain any facility rules and the facility grievance procedure to the consumer and the consumer's authorized representative via methods appropriate to the communication skills of the consumer, and document such explanation in the consumer notes;

(3) Determine, with the service coordinator, and consumer or the consumer's authorized representative, how the consumer's personal and incidental allowance shall be dispensed and recorded; and

(4) Meet with the consumer and the consumer's family or the consumer's authorized representative on the day of admission.

(b) The service coordinator shall:

(1) For a consumer who is 18 years of age or younger, and as appropriate, up to 22 years of age:

(A) Identify the person responsible for representing the interests of the consumer for educational and related services, and provide this information in writing to the administrator;

(B) Notify the special education administrator for the school district in which the facility is located of the date the consumer will be admitted to the facility and any special educational services required.

(2) Document in the consumer's regional center record that the administrator was provided with the information specified in Section 56017(b)(1)-(9);

(3) Accompany the consumer to the facility at the time of admission unless other arrangements have been made with the consumer, or the consumer's authorized representative, and the administrator;

(A) The service coordinator shall, when not present on the day of admission, make a personal or telephone contact with the consumer, or the consumer's authorized representative and the administrator within five working days of the admission and meet with both the administrator and consumer and/or the consumer's authorized representative when requested by the administrator, consumer or the consumer's authorized representative.

(4) Provide and explain to the consumer or the consumer's authorized representative, information regarding the consumer's rights as specified in Section 56002(a)(9); and

(5) Provide a telephone number to the consumer or the consumer's authorized representative where he/she can contact the service coordinator.

(1) The admission agreement shall include statements certifying that:

(A) No objection has been made to admission of the consumer to the facility;

(B) The consumer or the consumer's authorized representative has been informed of the consumer's rights as defined in Section 56002(a)(9); and

(2) The admission agreement shall be:

(A) Signed by the facility administrator, the regional center and the consumer or the consumer's authorized representative; and

(B) Effective on the date the consumer is admitted to the facility.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4659, 4681.1, 4741, 4742, 4747, 4748, 4803 and 4791, Welfare and Institutions Code; Sections 56026(c)(4) and 56156, Education Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section heading and text filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (b)(2) and (4) and Reference cite (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56020. Emergency Placement and Relocation.

Note • History

Each regional center shall develop and maintain procedures to be implemented in the event of emergency situations requiring consumer placement(s) or relocation(s).

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4681.1, 4741, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

Article 5. Consumer Services

§56022. Consumer IPP Objectives.

Note • History

(a) Within 30 days after the consumer's admission, the service coordinator shall review jointly with the ID Team the consumer's IPP objectives as necessary pursuant to Welfare and Institutions Code Sections 4646.5 and 4647.

(1) The service coordinator shall invite the administrator to meet with the ID Team to provide information concerning the consumer.

(2) It shall be the responsibility of the administrator to notify the service coordinator when there has been a change in the consumer's service needs which may necessitate a reassessment of the type and amount of services which are necessary to achieve the IPP objectives.

(b) The consumer's IPP shall include:

(1) The date of the IPP meeting;

(2) A determination of the type and amount of services which shall be provided by the facility to meet the consumer's service needs;

(3) An identification of the appropriate service level which is necessary to implement the IPP; and

(4) A list of all participants present at the IPP meeting.

(c) The service coordinator shall provide the administrator and the consumer, or the consumer's authorized representative and all persons responsible for the implementation of the IPP with a copy of the IPP within 30 days of the review specified in subsection (a) above.

(d) Administrators for all service levels shall provide services which are consistent with the program design and the consumer's IPP objectives for which the facility is responsible.

NOTE

Authority cited: Sections 4681.1, 4748, and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4646, 4647, 4681.1, 4740, 4743, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (a)(2) filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

3. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

4. Amendment of article heading, section heading and text filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

5. Editorial correction of History 3 (Register 94, No. 47).

6. Editorial correction of subsection (a) (Register 95, No. 18).

7. Change without regulatory effect amending Note filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

8. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56026. Consumer Notes, Quarterly and Semi-Annual Reports.

Note • History

(a) The administrator for each Service Level 2, 3 or 4 facility shall be responsible for ensuring preparation and maintenance of on-going, written consumer notes which shall include:

(1) Community and leisure activities;

(2) Overnight visits away from the facility;

(3) Illness;

(4) SIRs as defined in Section 54327(b);

(5) Medical and dental visits; and

(6) The date and signature of the staff person making the entry.

(b) The administrator for each Service Level 2 and 3 facility shall be responsible for ensuring the preparation and maintenance of a written semi-annual report of consumer progress toward achievement of each IPP objective for which the facility is responsible. The report shall include the date of completion of the report and signature of the person preparing the report.

(c) The administrator for each Service Level 4 facility shall be responsible for ensuring the preparation and maintenance of a written quarterly report of consumer progress toward achievement of each IPP objective for which the facility is responsible.The report shall include:

(1) A summary of the data collected for each consumer as specified in Section 56013(d)(4);

(2) Identification of barriers to consumer progress and actions taken in response to these barriers; and

(3) The date of completion of the report and signature of the person preparing the report.

(d) The administrator for each Service Level 4 facility shall submit the quarterly report required in subsection (c) above to the service coordinator within 30 days of the end of the quarter.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4646, 4646.5, 4681.1, 4742, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsections (e) and (f) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsections (e) and (f) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of section heading, and subsections (b)-(d) and repealer of subsections (c)(3), (e) and (f) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section heading and text filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (a) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

9. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

10. Certificate of Compliance as to 10-25-2001 order, including amendment of subsection (a)(4) transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

§56027. Special Incidents.

Note • History

(a) Each regional center shall report special incidents to the Department pursuant to Title 17, California Code of Regulations, Section 54327.1.

NOTE

Authority cited: Section 11152, Government Code. Reference: Sections 4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (c)(1) (Register 95, No. 18).

6. Amendment of subsection (a), repealer of subsections (b)-(d) and amendment of Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

7. Amendment of subsection (a), repealer of subsections (b)-(d) and amendment of Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

Article 6. Welfare and Institutions Code Section 4695.2 Direct Care Staff Training Regulations

§56031. Definitions.

Note • History

(a) When used in this article, the following words and phrases shall have the following meanings:

(1) “Certified Family Home” means a family residence which is certified by a licensed Foster Family Agency (FFA) and is issued a certificate or approved by that FFA as meeting licensing standards, and is used only by that FFA for the placement of children.

(2) “Certified Parent” means the adult(s) residing in a home which has been certified by a Foster Family Agency to provide care and supervision to children placed exclusively by that FFA.

(3) “Challenge Test” means a Department-approved test which, if passed, substitutes for and satisfies the requirement of one of the two 35-hour competency-based training segments required by Welfare and Institutions Code Section 4695.2(a), (b) and (c).

(4) “Competency-based Training and Testing” means the two 35-hour competency-based training courses and related competency tests which direct care staff are required by Welfare and Institutions Code Section 4695.2(a), (b) and (c) to complete satisfactorily.

(5) “Foster Family Agency (FFA)” means a foster family agency as defined in Health and Safety Code Section 1502(a)(4).

(6) “Satisfactory Completion” means attendance at each of the two 35-hour training courses required by Section 56033(a)(1) and (2), completion of the training and taking the Department-approved competency test for the applicable training segment.

NOTE

Authority cited: Section 4695.2(e), Welfare and Institutions Code. Reference: Section 4695.2, Welfare and Institutions Code.

HISTORY

1. New article 6 (sections 56031-56034) and section filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

2. New article 6 (sections 56031-56034) and section refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

3. New article 6 (sections 56031-56034) and section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

5. New article 6 (sections 56031-56034) and section filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

6. Amendment of article heading, repealer of article 6 (sections 56031-56034), new article 6 (sections 56031-56035) and repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

8. Amendment of article heading, repealer of article 6 (sections 56031-56034), new article 6 (sections 56031-56035) and repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

9. Refiling of 7-26-2000 order, including repealer of subsection (a)(5), subsection renumbering and new subsection (a)(6), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

11. Change without regulatory effect amending article heading, subsections (a)(3)-(4) and Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56032. Purpose.

Note • History

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4681.4 and 4681.5, Welfare and Institutions Code.

HISTORY

1. New section filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

5. New section filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

6. Repealer filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

7. Repealer refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

§56033. Direct Care Staff Competency-Based Training and Testing Requirements.

Note • History

(a) The following competency-based training and testing requirements apply only to those direct care staff who are employed in Service Level 2, 3, and 4 facilities.

(1) Direct care staff employed in Service Level 2, 3, and 4 facilities before January 1, 2001 shall have until:

(A) January 1, 2002 to satisfactorily complete the first 35-hour competency-based training course and pass the competency test applicable to that training segment, or to pass a challenge test applicable to that training segment; and

(B) January 1, 2003 to satisfactorily complete the second 35-hour competency-based training course and pass the competency test applicable to that training segment, or to pass a challenge test applicable to that training segment.

(2) Direct care staff hired in Service Level 2, 3, and 4 facilities on or after January 1, 2001 shall have:

(A) One year from the date on which the direct care staff was hired to satisfactorily complete the first 35-hour competency-based training course and pass the competency test applicable to that training segment, or to pass a challenge test applicable to that training segment; and

(B) Two years from the date on which the direct care staff was hired to satisfactorily complete the second 35-hour competency-based training course and pass the competency test applicable to that training segment, or to pass a challenge test applicable to that training segment.

(b) After the direct care staff completes a challenge test for either of the two 35-hour training segments, the Department shall provide the direct care staff with written notification of the results of the challenge test.

(1) A direct care staff who elects to take but does not pass the challenge test shall take the applicable competency-based training and competency test required by subsection (a)(1) or (2).

(2) A direct care staff may take only one challenge test for each of the two 35-hour training segments prior to attending the related competency-based training segment.

(c) After completing either 35-hour training segment, each direct care staff shall take a competency test to assess the direct care staff's competency in specific knowledge areas.

(d) Within 60 days of a direct care staff taking the competency test for either of the 35-hour training segments, the Department shall provide the direct care staff and his/her administrator with written notification that the direct care staff has:

(1) Satisfactorily completed the competency testing requirement for the applicable 35-hour training segment; or

(2) Satisfactorily completed the competency testing requirement for the applicable 35-hour training segment with knowledge area(s) identified as needing improvement; or

(3) Failed to satisfactorily complete the competency testing requirement for the applicable 35-hour training segment.

(e) The administrator shall be responsible for ensuring that any direct care staff who has knowledge area(s) identified pursuant to subsection (d)(2) as needing improvement obtains the additional training.

(f) Direct care staff who fail to satisfactorily complete the testing requirement may continue to provide direct supervision and special services to consumers only when the administrator ensures that the direct care staff:

(1) Repeats the applicable 35-hour training segment and retakes the competency test for that training segment; and

(2) Provides direct supervision and special services only in the presence of another direct care staff who has satisfactorily completed the applicable 35-hour training segment or has passed the challenge test applicable to that training segment.

(A) If the facility is unable to satisfy the requirement in subsection (f)(2), the administrator shall comply with any condition(s) that the regional center may require to protect consumer health and safety.

(g) The requirement of subsection (f)(2) shall remain in effect until such time as the direct care staff has satisfactorily completed the competency test for the applicable 35-hour training segment.

(h) Upon written notification of satisfactory completion of the first 35-hour competency-based training and competency testing requirement pursuant to subsection (d), the direct care staff who has previously failed to satisfactorily complete the competency test for the first 35-hour training segment shall have:

(1) One year from the date of written notification to satisfactorily complete the second 35-hour training segment; and

(2) No more than two years from the date the direct care staff was hired to satisfactorily complete the competency test for the second 35-hour training segment.

(i) The administrator shall enroll direct care staff in the training required by subsection (a)(1) or (2) on a schedule which ensures the opportunity for satisfactory completion of the training by all of the facility's direct care staff who are required to complete the training.

NOTE

Authority cited: Section 4695.2(e), Welfare and Institutions Code. Reference: Section 4695.2, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

6. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

8. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

9. Refiling of 7-26-2000 order, including amendment of subsections (a)(1)-(a)(2), (b)(1) and (h)(1)-(i), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

11. Amendment of subsections (a)(1)-(2) filed 10-11-2001 as an emergency; operative 10-11-2001 (Register 2001, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-8-2002 or emergency language will be repealed by operation of law on the following day.

12. Reinstatement of section as it existed prior to 10-11-2001 emergency amendment pursuant to Government Code section 11346.1(f) (Register 2002, No. 9).

13. Change without regulatory effect amending subsections (a)(1)-(2) and (b) and amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56034. Waiver Requirements for Facilities.

Note • History

(a) A facility may apply in writing to the regional center for a waiver of the competency-based training and competency testing requirements specified in Section 56033(a)(1) and (2) when the facility:

(1) Has a consumer population of less than one third (33.3%) regional center consumers as defined in Section 56002(a)(5); and

(2) Is able to document in its written application to the regional center that the granting of a waiver will not create an adverse impact on consumer health and safety.

(b) To apply for a waiver pursuant to subsection (a), the facility shall submit a training plan to the regional center which shall include, but not be limited to:

(1) A description of how the facility's training program meets the requirements for competency-based training required by Welfare and Institutions Code Section 4695.2;

(2) The titles of all facility staff who are required to attend the facility's training;

(3) The number of hours of training required by the facility's training plan;

(4) The period of time over which the facility's training is to be provided;

(5) A training schedule for facility staff who are currently employed and another training schedule for facility staff who are hired following the effective date of these regulations;

(6) The titles and qualifications of the individuals who will conduct the facility's training; and

(7) A methodology for assessing individual competency in the knowledge area(s) included in the training.

(c) Within 45 days of receiving a complete training plan from a facility, the regional center shall either approve or deny the facility's request for a waiver and notify the facility in writing, by certified mail, of the regional center's approval or denial.

(d) If the facility's request for a waiver is denied by the regional center, the facility may, within fifteen days of receipt of the regional center's denial of the facility's request for a waiver, appeal the regional center's denial of the facility's request for a waiver to the Department.

(e) To file an appeal, the facility shall send to the Department:

(1) A copy of the training plan which was submitted to the regional center by the facility;

(2) A copy of the regional center's written denial of the facility's request for a waiver; and

(3) Any other information which the facility considers appropriate to the appeal.

(f) The Department shall render a written decision to uphold or deny the regional center's denial of the facility's request for a waiver within forty-five days of receipt of the information submitted pursuant to subsection (e)(1) through (3).

(1) The Department's written decision shall be sent to the residential facility and the regional center via certified mail within 15 days of the decision being rendered.

(g) The Department's decision is final.

NOTE

Authority cited: Section 4695.2(e), Welfare and Institutions Code. Reference: Section 4695.2, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

9. Refiling of 7-26-2000 order, including repealer and new section, 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

11. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

12. Change without regulatory effect amending subsection (b)(1) filed 9-21-2011 pursuant to section 100, title 1, California Code of Regulations (Register 2011, No. 38).

§56034.1. Foster Family Agency Waiver Requirements.

Note • History

(a) The regional center may waive the requirement for certified parents and FFA staff, who provide direct supervision and special services to children who are regional center consumers to complete the direct care staff competency-based training and testing requirements described in Section 56033(a)(1) and (2).

(b) To request a waiver pursuant to subsection (a), the FFA shall submit a training plan to the regional center which shall include, but not be limited to:

(1) A description of how the FFA's training program meets the requirements for competency-based training required by Welfare and Institutions Code Section 4681.5;

(2) The titles of all FFA staff who are required to attend the FFA's training;

(3) The number of hours of training required by the FFA's training plan;

(4) The period of time over which the FFA's training is to be provided;

(5) A training schedule for FFA staff who are currently employed and another training schedule for FFA staff who are hired following the effective date of these regulations;

(6) The titles and qualifications of the individuals who will conduct the FFA's training; and

(7) A methodology for assessing individual competency in the knowledge area(s) included in the training.

(c) Within 45 days of receiving a complete training plan from an FFA, the regional center shall either approve or deny the FFA's request for a waiver and notify the FFA in writing, by certified mail, of the regional center's approval or denial.

(d) If the FFA's request for a waiver is denied by the regional center, the FFA may, within fifteen days of receipt of the regional center's denial of the FFA's request for a waiver, appeal the regional center's denial of the FFA's request for a waiver to the Department.

(e) To file an appeal, the FFA shall send to the Department:

(1) A copy of the training plan which was submitted to the regional center by the FFA;

(2) A copy of the regional center's written denial of the FFA's request for a waiver; and

(3) Any other information which the FFA considers appropriate to the appeal.

(f) The Department shall render a written decision to uphold or deny the regional center's denial of the FFA's request for a waiver within forty-five days of receipt of the information submitted pursuant to subsection (e)(1) through (3).

(1) The Department's written decision shall be sent to the FFA and the regional center via certified mail within 15 days of the decision being rendered.

(g) The Department's decision is final.

NOTE

Authority cited: Section 4695.2(e), Welfare and Institutions Code. Reference: Section 4695.2, Welfare and Institutions Code.

HISTORY

1. New section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 30).

3. New section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

4. New section refiled 11-27-2000 as an emergency, including amendment of subsection (b)(1); operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 7-26-2000 order, including amendment of subsection (a), transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

6. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56035. Waiver for Prevailing Rate Facilities.

Note • History

A facility which is paid a prevailing rate pursuant to Title 17, California Code of Regulations, Section 56919, is waived from the training and competency testing requirements specified in Section 56033(a)(1) and (2).

NOTE

Authority cited: Section 4695.2(e), Welfare and Institutions Code. Reference: Section 4695.2, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 30).

4. New section refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

6. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

Article 7. Personnel

§56036. Training Plans.

Note • History

(a) Service Level 2, 3 and 4 administrators shall assure the development, implementation and maintenance of a written facility staff training plan.

(b) The plan shall include a description of how each of the following training components will be provided:

(1) The on-site orientation for direct care staff specified in Section 56038(a)(1);

(2) The on-the-job training for direct care staff specified in Section 56038(a)(2);

(3) Continuing education requirements as specified in Sections 56037(a) and 56038(a)(3); and

(4) Any additional training in any knowledge area(s) which is identified as needing improvement in the written notice pursuant to Section 56033(d)(2).

(A) The written facility staff training plan shall specify a time frame for completing the additional training which shall be no more than one year from the receipt of the written notification pursuant to Section 56033(d)(2).

NOTE

Authority cited: Sections 4681.1 and 4695.2(e), Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4681.1, 4695, 4695.2, 4740 and 4843, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (a)(1) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (a)(1) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including repealer of subsection (a)(1) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Editorial correction of History 5 (Register 94, No. 47).

7. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

8. New subsection (d) and amendment of Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

9. New subsection (d) and amendment of Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

10. New subsection (d) and amendment of Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

11. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

12. New subsection (d) and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

13. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

15. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

16. Repealer and new section refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

17. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

18. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56037. Administrator Qualifications and Continuing Education.

Note • History

(a) Administrators for Service Level 2, 3 and 4 facilities shall fulfill requirements for continuing education in one or more of the following areas, as they relate to the administration and management of residential services for persons with developmental disabilities:

(1) Consumer services as described in the program design;

(2) Promotion of consumers' rights, health, safety and social and physical integration; and

(3) The ID Team process, including development and implementation of IPPs.

(b) An administrator of an adult residential facility may meet the requirements for continuing education specified in this section by meeting the requirements for continuing education specified in Health and Safety Code Section 1562.3(f)(1).

(c) The regional center shall count the hours required for the renewal of the administrator certification as required by Health and Safety Code Section 1562.3(f)(1), to the maximum extent allowed by that section, toward the continuing education requirements specified in this section when the administrator provides documentation to the regional center that the hours have been completed.

(1) Hours shall be counted on an hour-for-hour basis.

(d) Service Level 2 administrators shall:

(1) Have a minimum of six months of prior experience providing direct supervision and special services to persons with developmental disabilities;

(A) The regional center shall be permitted to waive the above requirement if the regional center determines that it is necessary to meet consumer needs.

(2) Complete a minimum of eight hours of continuing education in the areas specified in subsection (a) above within each twelve-month period following the assumption of the duties of an administrator.

(e) Service Level 3 administrators shall:

(1) Have a minimum of nine months of prior experience providing direct supervision and special services to persons with developmental disabilities;

(A) The regional center shall be permitted to waive the above requirement if the regional center determines that it is necessary to meet consumer needs.

(2) Complete a minimum of 12 hours of continuing education in the areas specified in subsection (a) above within each twelve-month period following the assumption of the duties of an administrator.

(f) Service Level 4 administrators shall:

(1) Have a minimum of 12 months of prior experience providing direct supervision and special services to persons with developmental disabilities;

(A) The regional center shall be permitted to waive the above requirement if the regional center determines that it is necessary to meet consumer needs.

(2) Complete a minimum of 12 hours of continuing education in the areas specified in subsection (a) above within each twelve-month period following the assumption of the duties of an administrator.

(g) Service Level 2, 3 and 4 administrators providing direct supervision and special services shall complete any additional training in a specific knowledge area(s) which has been identified as needing improvement in the written notification pursuant to Section 56033(d)(2).

(h) Successful completion of the competency-based training and passage of the competency test required by Section 56033(a)(1) or (2) shall satisfy the continuing education requirements specified in this section for an administrator for the year in which the training is satisfactorily completed.

(i) For administrators, passing the challenge test without attending the competency-based training required by Section 56033(a)(1) or (2) shall not satisfy the continuing education requirements specified in this section.

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4681.1, 4695, 4695.2, 4748, 4833 and 4843, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (b)(2)(A) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (b)(2)(A) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsections (b)(2), (c)(2) and (d)(2) and repealer of subsection (b)(2)(A) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsection (d)(2) and Reference cite (Register 95, No. 18).

9. Change without regulatory effect amending subsections (b)(1)(A), (c)(1)(A) and (d)(1)(A) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

10. New subsections (e)-(g) and amendment of Note filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

11. New subsections (b)-(c)(1), relettering of former subsection (b) to subsection (d), relettering of former subsection (c)-(d) to first pair of subsections (e)-(f) and amendment of Note filed 3-23-2000; operative 4-22-2000 (Register 2000, No. 12).

12. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

13. New subsections (e)-(g) and amendment of Note filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

14. Refiling of 7-26-2000 order, including relettering of duplicate subsections (e)-(g) as (g)-(i) and amendment of Note, 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

15. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

16. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56038. Direct Care Staff Qualifications and Continuing Education Requirements.

Note • History

(a) Service Level 2, 3 and 4 administrators shall ensure that each direct care staff person meets applicable requirements as follows:

(1) Within the first 40 hours of providing consumer services in the facility, all new direct care staff shall complete an on-site orientation which addresses the following:

(A) The facility's program design;

(B) Consumer IPPs;

(D) Assistance to consumers with prescribed medications, if applicable;

(E) Health and emergency procedures, including fire safety;

(F) Identification and reporting of Special Incidents, as required by Title 17, California Code of Regulations, Section 54327(a); and

(G) Identification and reporting of consumer abuse.

(2) Receive on-the-job training as necessary to implement consumer IPPs.

(3) Receive continuing education in one or more of the following areas, as they relate to planning and implementation of residential services for persons with developmental disabilities:

(A) Consumer services as described in the program design;

(B) Promotion of consumers' rights, health, safety, and social and physical integration; and

(b) Service Level 2 direct care staff shall complete a minimum of eight hours of continuing education, as described in subsection (a)(3), above within each twelve-month period following the assumption of the duties of direct care staff.

(c) Service Level 3 direct care staff shall complete a minimum of 12 hours of continuing education specified in subsection (a)(3) above within each twelve-month period following the assumption of the duties of direct care staff.

(d) Service Level 4 direct care staff shall:

(1) Have a minimum of six months of prior experience providing direct supervision and special services; or

(2) Within six months of beginning to provide direct supervision and special services in the facility, complete at least 12 additional hours of continuing education as specified in subsection (a)(3) above.

(3) Complete a minimum of 12 hours of continuing education which meets the requirements specified in subsection (a)(3) above within each twelve-month period following the assumption of the duties of direct care staff.

(e) Direct care staff shall complete any additional training in a specific knowledge area(s) which has been identified as needing improvement in the written notification pursuant to Section 56033(d)(2).

(f) Successful completion of the competency-based training and passage of the competency test required by Section 56033(a)(1) or (2) shall satisfy the direct care staff continuing education requirements specified in this section for a direct care staff for the year in which the training is satisfactorily completed.

(g) For direct care staff, passing the challenge test without attending the competency-based training required by Section 56033(a)(1) or (2) shall not satisfy the direct care staff continuing education requirements specified in this section.

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4681.1, 4695, 4695.2, 4791, 4833 and 4843, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (b)(1) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (b)(1) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsections (b), (c), (d)(3) and repealer of subsection (b)(1) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Amendment of subsection (a)(1)(F) and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

9. Amendment of subsection (a)(1)(F) and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

11. Amendment of subsection (d)(2), new subsections (e)-(g) and amendment of Note filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

12. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

13. Amendment of subsection (d)(2), new subsections (e)-(g) and amendment of Note filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

14. Refiling of 7-26-2000 order, including further amendment of subsection (b) and Note, 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

15. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

16. Change without regulatory effect amending subsections (a)(1)(F)-(G) and amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56040. Consultant Qualifications.

Note • History

(a) Consultant services provided by Service Level 4 facilities shall be appropriate to meet individual consumer service needs.

(b) Consultants shall be individuals or groups eligible for vendorization in accordance with Title 17, California Code of Regulations, Chapter 3, Subchapter 2:

(1) Section 54319, Group Practices; and/or

(2) Section 54342, Types of Services;

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4681.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

7. Change without regulatory effect amending subsections (b)(1)-(2) and repealing subsections (b)(3)-(4) filed 11-10-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 45).

Article 8. Monitoring and Evaluation

§56046. Quality Assurance Plans.

Note • History

(a) The regional center shall develop, implement, and maintain a Quality Assurance (QA) Plan to ensure Service Level 2, 3 and 4 facility compliance with these regulations.

(b) The QA Plan shall include, but not be limited to, the following:

(1) A schedule of evaluations which ensures that each facility is evaluated a minimum of once every three years;

(2) The composition of the QA evaluation teams;

(3) The methods to be utilized by the service coordinator for monitoring the facility's implementation of consumer IPP objectives for which the facility is responsible;

(4) The methods to be utilized by the facility liaison for QA monitoring of the facility's compliance with these regulations and provision of technical assistance to the facility;

(5) The methods, forms, and instruments, to be utilized by the regional center for QA evaluations; and

(6) A description of training to be offered to persons who will participate in QA evaluations which includes familiarization with these regulations and the individual life quality outcomes identified in the “Looking at Service Quality Provider's Handbook”, and an overview of the QA evaluation process.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4501, 4648, 4648.1, 4681.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (a)(1)(A) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (a)(1)(A) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including repealer of subsection (a)(1)(A) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Relocation of article heading and amendment of section filed 9-20-93 as an emergency; operative 9-20-93. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed, as appropriate.

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Amendment of subsection (b) filed 6-6-96 as an emergency; operative 6-6-96. Submitted to OAL for printing only (Register 96, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-4-96 or emergency language will be repealed by operation of law on the following day.

9. Editorial correction of History 8 (Register 96, No. 38).

10. Certificate of Compliance as to 6-6-96 order, including amendment of Note, transmitted to OAL 9-11-96 and filed 9-18-96. This filing was submitted to OAL for printing only and is not subject to OAL review pursuant to Chapter 722, Statutes of 1992, section 147 (Register 96, No. 38).

11. Amendment of subsections (a)(4)-(a)(6) and repealer of subsection (b) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

12. Amendment of subsections (a)(4)-(6) and repealer of subsection (b) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 10-20-98 order, including further amendment of section and Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56047. Regional Center Monitoring of the IPP Objectives.

Note • History

(a) The regional center representative shall meet with the consumer at least quarterly to review the consumer's progress towards achieving IPP objectives.

(1) At least two of the quarterly meetings required by subsection (a) shall take place at the consumer's residence and a representative of the facility shall be present at these meetings.

(2) Other quarterly meetings may take place at a site other than the consumer's residence that is acceptable to the consumer.

(3) Quarterly meetings pursuant to subsection (a) may be conducted during an unannounced visit pursuant to Welfare and Institutions Code Section 4648.1, provided the requirements specified in subsection (a) are met.

(4) When the consumer has a consumer's authorized representative, the regional center representative shall notify the consumer's authorized representative of the date and time of the meeting required by subsection (a) if the meeting is announced.

(5) When the consumer's authorized representative is unable to attend the meeting, the regional center representative shall confer with the consumer's authorized representative regarding the consumer's progress toward achieving IPP objectives.

(b) When the consumer is a child with special heath care needs, the regional center representative shall meet with the representative of the facility and the consumer at the facility at least quarterly to review the consumer's progress toward achieving IPP objectives pursuant to the requirements specified in subsection (a)(1) through (5).

(1) Review implementation of the consumer's IPP objectives, including any related consumer notes and quarterly or semi-annual reports; and

(2) Meet privately with the consumer, when requested by the consumer or the consumer's authorized representative.

(d) The regional center representative may review the facility's records and accounts of the consumer's cash resources, personal property and valuables for compliance with Title 22, California Code of Regulations, Section 80026(e) through (l).

(e) Upon completing the review specified in subsection (a) or (b) above, the regional center representative shall compile a progress report which shall include:

(1) The date of the visit specified in subsection (a) or (b) above;

(2) Documentation of the meeting required by subsection (a) or (b);

(3) Changes in consumer service needs, and actions taken in response to these changes;

(4) An assessment of the provision of services in relation to the IPP; and,

(5) The signature of the regional center representative.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4405, 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4502, 4646, 4646.5, 4647, 4648, 4648.1, 4681.1 and 4742, Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of first paragraph, new subsections (a)(1), (a)(2), (b)(1)(A) and (b)(1)(B) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of first paragraph, new subsections (a)(1), (a)(2), (b)(1)(A) and (b)(1)(B) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a) and (b)(1) and repealer of subsections (a)(1)-(2) and (b)(1)(A)-(B) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section heading and text filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (b) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

9. Amendment of subsection (a) and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

10. Amendment of subsection (a) and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 10-20-98 order, including additional amendment of section heading and section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56048. Facility Liaison Quality Assurance (QA) Monitoring of the Facility.

Note • History

(a) The regional center shall designate a facility liaison for each Service Level 2, 3 and 4 facility in the regional center's service catchment area, in which consumers of the regional center reside.

(b) The regional center shall assign a facility liaison to each facility in such a way as to minimize the number of staff responsible for monitoring consumer services and providing technical assistance to the facility.

(1) Establish, with the facility liaison, an agreeable date and time for the monitoring visit;

(2) Provide access to all records pertaining to the provision of consumer services.

(d) The facility liaison shall:

(1) Complete a minimum of one monitoring visit, which may be unannounced pursuant to Welfare and Institutions Code Section 4648.1, to each facility each year;

(2) Review staff schedules for compliance with the approved service level requirements;

(3) Review personnel training files to assure compliance with Sections 56033, 56034, 56034.1, and 56036 through 56038;

(4) Select and review a randomly chosen sample of 20 percent, rounded up to the nearest whole number, of the consumer records, to ensure that:

(A) Services are provided in accordance with the program design and IPP;

(B) All documents pursuant to Section 56059(a) and (b) are complete and current.

(5) Provide a copy of “Looking at Service Quality Provider's Handbook” bearing no publication or revision date, to and review the individual life quality outcomes and self-assessment process with, the administrator.

(6) Review the Service Level 4 program design with the administrator to determine program effectiveness in achieving the IPP objectives for which the facility is responsible.

(e) In conducting facility liaison monitoring visits, the facility liaison may inspect the residential service provider's grounds, buildings, and services.

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4422, 4646.5, 4648, 4648.1, 4681.1, 4695.2, 4740, 4742, 4743, 4745, 4746, 4748 and 4750, Welfare and Institution Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (c)(1), new subsection (c)(2) and subsection (c) renumbering, repealer of subsection (e), and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (c)(1), new subsection (c)(2) and subsection (c) renumbering, repealer of subsection (e), and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Editorial correction of subsection (d)(3) (Register 92, No. 15)

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections (c)(1) and (e) and amendment of newly designated subsection (c)(1) and renumbering of following subsections and amendment of subsection (d)(3) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

7. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

8. Editorial correction of History 6 (Register 94, No. 47).

9. Amendment of subsection (b), new subsection (d)(6) and subsection renumbering filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

10. Amendment of subsection (b), new subsection (d)(6) and subsection renumbering refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

11. Amendment of subsection (d)(4) and Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 10-20-98 order, including further amendment of section and Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

13. Amendment of subsection (d)(4) and Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

14. Amendment of subsection (d)(4) and Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

15. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

16. Amendment of subsection (d)(3) and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

17. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

18. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

19. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

20. Refiling of 7-26-2000 order, including amendment of subsection (d)(5) and further amendment of Note, 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

21. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

22. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56049. Quality Assurance Evaluation Team.

Note • History

(a) The Quality Assurance (QA) Evaluation Team shall complete the QA Evaluations of facilities.

(b) Each regional center shall designate a QA Coordinator who shall implement a QA Plan for the regional center. The QA Coordinator shall:

(1) Assure that each facility is evaluated in accordance with section 56046(a)(1)-(6);

(2) Select the QA Evaluation Team chairperson and members utilizing the following criteria:

(A) The team shall consist of at least 2 members;

(B) The chairperson shall be a regional center employee.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1, 4740 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. New subsection (b)(2)(C) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

5. New subsection (b)(2)(C) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56050. Preparation for the Quality Assurance Evaluation.

Note • History

(a) All Service Level 2, 3 and 4 facilities providing residential services shall participate in a Quality Assurance (QA) Evaluation conducted by the regional center.

(b) The chairperson of the QA Evaluation Team shall:

(1) Confirm the date and time of the on-site evaluation with the administrator;

(2) Assign duties to the Evaluation Team members;

(3) Obtain consumer consent for QA Evaluation Team members who are not regional center employees to review consumer records.

(c) Members of the QA Evaluation Team who are not regional center employees shall be instructed in the confidentiality of consumer information in accordance with Welfare and Institutions Code Sections 4514 and 4515, and sign a statement of confidentiality. Consumer consent shall also be obtained for review of consumer records by any team member who is not a regional center employee.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1, 4740 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b)(3) (Register 95, No. 18).

6. Amendment of subsection (b)(3) and new subsection (c) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

7. Amendment of subsection (b)(3) and new subsection (c) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-20-98 order, including further amendment of subsections (b)(3) and (c), transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56051. Quality Assurance Evaluation.

Note • History

(a) During the evaluation, the QA Evaluation Team members shall:

(1) Review facility records both at the facility and at the regional center for compliance with documentation requirements specified in sections 56059 and 56060 respectively;

(2) Review randomly selected consumers' records, both at the facility and at the regional center for compliance with documentation requirements specified in sections 56059 and 56060 respectively, and management of personal and incidental allowance;

(3) Observe consumer activities during regularly scheduled daily activities for compliance with the program design, and the IPP objectives;

(4) Talk to consumers living in the facility and authorized representatives, when appropriate, to determine their satisfaction with facility services;

(5) Assess the effectiveness of the facility in assisting consumers in achieving the individual life quality outcomes.

NOTE

Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4501, 4648, 4648.1, 4681.1, 4740, 4742 and 4746, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. New subsections (a)(4)-(a)(5)(C) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(3) and new subsections (a)(4)-(a)(5)(C) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 10-20-98 order, including further amendment of subsection (a)(5), repealer of subsections (a)(5)(A)-(C) and amendment of Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56052. Post-Evaluation Activities.

Note • History

(a) After completion of the on-site QA Evaluation in accordance with Section 56051(a)(1) through (5), the QA Evaluation Team chairperson shall:

(1) Within five days, conduct an exit interview with the administrator, which includes:

(A) Presentation of preliminary findings of compliance and/or noncompliance with the provisions of these regulations including the effectiveness of and consumer(s') satisfaction with, the assistance provided by the facility to help consumers achieve the individual life quality outcomes;

(B) An opportunity for the administrator to discuss and respond to the findings and provide additional information, if any; and

(2) Within 30 days, provide the administrator with written results of the evaluation which shall include, but not be limited to:

(A) Findings of compliance and/or noncompliance, with the provisions of these regulations including the effectiveness of and consumer's satisfaction with the assistance provided by the facility to help consumers achieve the individual life quality outcomes, and any requirement(s) for action(s) or follow-up; and

(B) The process for securing needed technical assistance and/or training.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4648.1, 4681.1, 4742, 4745, 4746 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (b) and NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsection (b) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsection (b) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Editorial correction of History 5 (Register 94, No. 47).

7. Amendment of subsections (a), (a)(1)(A) and (a)(2)(A)-(B) and repealer of subsections (b)-(b)(1) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

8. Amendment of subsections (a), (a)(1)(A) and (a)(2)(A)-(B) and repealer of subsections (b)-(b)(1) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment of subsections (a)(1)(A) and (a)(2)(A) and amendment of Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

Article 9. Corrective Action Plans and Sanctions

§56053. Immediate Danger.

Note • History

(a) Situations which come to the attention of, or are reported to, the regional center and which appear to constitute an immediate danger shall be investigated immediately following the notification. Situations which shall be investigated include but are not limited to:

(1) Life threatening structural conditions;

(2) Suspicion or allegations of abuse of a consumer;

(3) A consumer(s) in the facility with no direct supervision unless there is an IPP objective and waiver or exception, approved pursuant to Title 22, California Code of Regulations, Section 80024;

(4) Failure to provide a consumer(s) with a medically prescribed special diet(s); or

(5) The presence of an individual exhibiting aggressive or assaultive behavior which is life threatening to self or others.

(b) When the regional center determines that the purpose of the visit would be thwarted if advance notice were given, the regional center shall have the authority to make an unannounced visit to the facility to verify the existence of the immediate danger.

(1) Immediately forward any allegations regarding consumer abuse to the applicable protective services agency; and

(2) Cooperate with the investigating agency as requested.

(d) Immediately after verifying that a situation exists which constitutes an immediate danger, the regional center shall take the following actions:

(1) Meet with the administrator to describe the situation(s) which constitutes the immediate danger; and

(2) Notify the Department of Social Services' Community Care Licensing Division district office of the conditions which constitute the immediate danger.

(e) The regional center shall determine whether the immediate danger can be corrected within 24 hours of verification.

(1) When the immediate danger cannot be corrected within 24 hours of verification, the regional center shall initiate the emergency relocation of the consumer(s) subject to the immediate danger.

(2) When the immediate danger can be corrected within 24 hours of verification, and the safety of the consumer(s) can be assured, the regional center shall verify that the correction of the immediate danger has occurred.

(A) The regional center shall verify the correction of the immediate danger within 24 hours of notification by the facility that the immediate danger has been corrected.

(f) The regional center shall document all actions taken pursuant to subsections (a) through (e) above.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4502, 4648, 4648.1, 4681.1, 4741, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (a)(3) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56054. Substantial Inadequacies.

Note • History

(a) Substantial inadequacies are the following:

(1) Conditions posing a threat to the health and safety of any consumer, that are not considered an immediate danger as specified in Section 56053;

(2) Provision of fewer direct care staff hours than are required by the facility's approved service level;

(3) Violations of consumers' rights as defined in Section 56002(a)(8);

(4) Failure to provide consumer services as specified in the consumer's IPP;

(5) Failure to comply with the terms of the consumer's Admission Agreement;

(6) Deficiencies or irregularities in the handling of the consumer's cash resources, personal property, and valuables;

(7) Failure to comply with the requirements for administrator and staff qualifications and/or administrator and staff training;

(8) Failure of a Service Level 4 facility to utilize the instructional methods and techniques which are specified in the facility's program design;

(9) Failure of a Service Level 4 facility to utilize the methodology for measurement of consumer progress toward achievement of IPP objectives which is specified in the facility's program design;

(10) Failure to take a required action pursuant to Section 56052 within the specified timeframe;

(11) Failure to:

(A) File an accurate and complete report verifying the use of rate increase funds authorized by Welfare and Institutions Code Section 4681.4(a) or (b) as required by Title 17, California Code of Regulations, Section 56934(a);

(B) Utilize Welfare and Institutions Code Section 4681.4 (a) or (b) rate increase funds for the purposes specified in Title 17, California Code of Regulations, Section 56932(a)(1) through (3);

(C) Utilize Welfare and Institutions Code Section 4681.4 (a) or (b) rate increase funds for a purpose which has been approved by the Department pursuant to Title 17, California Code of Regulations, Section 56932(a)(4); or

(12) Failure to ensure that a direct care staff:

(A) Completes the competency-based training and testing required by Section 56033(a)(1) or (2); or

(B) Completes any additional training required by Section 56033(d)(2); or

(C) Complies with Section 56033(f)(1) or (2) when the direct care staff has failed to satisfactorily complete the competency-based training and competency testing.

(13) Failure to report special incidents pursuant to Section 54327.

(b) When the regional center receives a report that there are substantial inadequacies in the services of a facility, or when the regional center discovers that there are substantial inadequacies in the services of a facility, the regional center shall have the authority to make an unannounced visit(s) to the facility.

NOTE

Authority cited: Section 11152, Government Code; Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4646.5, 4647, 4648, 4648.1, 4681.1, 4681.4, 4695.2, 4742, 4743, 4745, 4746, 4747 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (a)(1) (Register 95, No. 18).

6. Amendment of subsections (a)(8) and (a)(9) and new subsection (a)(10) filed 6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emergency language will be repealed by operation of law on the following day.

7. Amendment of subsections (a)(8) and (a)(9) and new subsection (a)(10) refiled 10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-17-99 or emergency language will be repealed by operation of law on the following day.

8. New subsections (a)(11)-(a)(12)(C) and amendment of Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment of subsection (a)(10), new subsection (a)(13) and amendment of Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

10. New subsections (a)(11)-(a)(12)(C) and amendment of Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

11. New subsections (a)(11)-(a)(12)(C) and amendment of Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

12. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

13. New subsections (a)(11)-(a)(12)(C) and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

14. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

15. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

16. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

17. Refiling of 7-26-2000 order, including amendment of subsections (a)(3) and (a)(10), new subsection (a)(13) and amendment of subsection (b), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

18. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

19. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56055. Insufficiencies.

Note • History

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4681.1, 4742, 4745 and 4746, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

§56056. Corrective Action Plan (CAP).

Note • History

(a) The regional center and the administrator shall meet to develop a written corrective action plan (CAP) within 10 working days of the identification and verification of a substantial inadequacy.

(b) The CAP shall describe:

(1) The substantial inadequacy and cite the statute, regulation, IPP, or Admission Agreement requirement for which noncompliance is identified and shall inform the administrator of the right to appeal the findings; and

(2) The method(s) by which the administrator is to correct the substantial inadequacy.

(c) Correction of the substantial inadequacy shall occur within a period not to exceed 30 days of the development of the CAP unless the regional center determines that correction cannot be accomplished within the specified time frame.

(1) When correction will take longer than 30 days from the development of the CAP, the CAP shall specify interim dates by which specific steps toward correction of the substantial inadequacy will take place, with the total time period not to exceed six months.

(d) Within two working days of meeting with the administrator, the regional center shall provide a copy of the CAP to the administrator.

(e) The regional center is authorized to send a copy of the CAP to the appropriate Department of Social Services' Community Care Licensing Division district office.

(f) The regional center shall send a copy of the CAP to any other regional center which has consumers residing in the facility who are affected by the substantial inadequacy.

(g) The administrator shall return the signed and dated CAP to the regional center within seven days of its receipt, with any areas of disagreement noted in writing.

(h) The facility liaison shall:

(1) Visit the facility to review and document actions taken by the administrator to implement the CAP; and

(2) Document any substantial inadequacy(ies) which is not corrected within the specified time frame.

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4647, 4648.1, 4742, 4745, 4746 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56057. Sanctions.

Note • History

(a) The regional center shall apply sanction(s) to the facility when:

(1) A substantial inadequacy is not corrected within the time frame specified in the CAP developed pursuant to Section 56056; or

(2) There are two findings of substantial inadequacy in the same facility within any twelve-month period.

(b) If the regional center determines that the substantial inadequacy(ies) is related to the basic staffing level or the additional weekly direct care staff hours being provided by a facility, the regional center may reduce the approved service level to the level associated with the total number of staff hours actually being provided by the facility.

(c) In determining the number of staff hours being provided by a facility, the regional center shall determine the basic staffing level and the average number of direct care staff hours provided by the facility during a minimum of four one-week periods during the previous 12 months.

(d) In all findings of substantial inadequacy, the regional center may:

(1) Meet with the consumer, or the consumer's authorized representative, to discuss the situation, recommend relocation, and discuss the consequences of refusing to relocate; or

(2) Not place consumers into the facility until the facility complies with the CAP.

(e) In addition to the actions specified in subsection (d), the regional center may, upon discovering that a finding of substantial inadequacy pursuant to Section 56054(a)(11)(A) through (C) has not been corrected within the time frame specified in the CAP developed pursuant to Section 56056, take one of the following actions:

(1) Recover any misused, undocumented or unreported portion of the Welfare and Institutions Code Section 4681.4(a) or (b) rate increase funds; or

(2) Offset an amount equal to the misused, undocumented or unreported portion of the Welfare and Institutions Code Section 4681.4(a) or (b) rate increase funds from future reimbursements to the licensee.

(f) When the regional center determines the appropriate sanction, the regional center shall provide written notification to the administrator, by certified mail, return receipt requested, of the following:

(1) The action(s) to be taken;

(2) The reason(s) for such action(s); and

(3) The administrator's appeal rights pursuant to Sections 56061 through 56067.

NOTE

Authority cited: Section 11152, Government Code; Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4648.2, 4695.2, 4745, 4746 and 4747, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (e)(3) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

7. Repealer of subsections (d)(1) and (d)(1)(A), redesignation of former subsection (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection relettering, and amendment of Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

8. Repealer of subsections (d)(1) and (d)(1)(A), designation of former subsection (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection relettering, and amendment of Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

9. Repealer of subsections (d)(1) and (d)(1)(A), redesignation of former subsection (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection relettering, and amendment of Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

10. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

11. Repealer of subsections (d)(1) and (d)(1)(A), redesignation of former subsection (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection relettering, and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

12. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

13. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

14. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

15. Refiling of 7-26-2000 order, including amendment of subsections (d)-(d)(1) and (e)(1)-(2), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

16. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

17. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

Article 10. Records Maintenance

§56058. Confidentiality.

Note • History

NOTE

Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4514, 4515, 4516 and 4744, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

§56059. Residential Services Records.

Note • History

(a) Each Service Level 2, 3 and 4 facility shall maintain individual consumer files, and a facility file.

(b) Individual consumer files shall contain the following:

(1) Current emergency information, including names, addresses and telephone numbers of the consumer's authorized representative and pharmacy;

(2) Recent consumer photograph and physical description;

(3) Consumer inoculation records and TB clearance;

(4) Consumer allergy record;

(5) Signed consent for release of information form(s), if any;

(6) Current IPP in accordance with Section 56022;

(7) Consumer notes pursuant to Section 56026;

(8) Quarterly or semi-annual reports pursuant to Section 56026;

(9) Copies of SIRs prepared as required by Title 17, California Code of Regulations, Section 54327(b); and

(10) Current information provided by the regional center pursuant to Section 56017(b).

(1) All items specified in Section 56013;

(2) QA Evaluation reports pursuant to Section 56052;

(3) CAPs, pursuant to Section 56056;

(4) A weekly staff schedule which specifies the number of staff in the facility during each hour of each day;

(5) A weekly schedule which specifies the number of consumers in the facility during each hour of each day;

(6) Personnel and training records that verify compliance with Sections 56033, 56034 and, if applicable, 56034.1 which shall include, but not be limited to:

(A) The date on which the direct care staff was hired;

(B) The date on which the direct care staff's employment was terminated.

(7) A copy of any direct care staff's written notification regarding challenge or competency testing pursuant to Section 56033(b) or (d).

(8) Each written approval issued by the Department authorizing the use of Welfare and Institutions Code Section 4681.4(a) or (b) rate increase funds for a purpose other than those specified in Section 56932(a)(1) through (3); and

(9) For a Foster Family Agency (FFA):

(A) A copy of any approved FFA request for a waiver required by Section 56034.1;

(B) A copy of the regional center's written approval of the FFA's request for a waiver; and

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4648.1, 4681.1, 4695.2, 4742 and 4745, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (b)(11)(A) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (b)(11)(A) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsection (b)(11) and repealer of subsection (b)(11)(A) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsections (a), (b)(7) and (c)(3) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

9. Amendment of subsection (b)(9) and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

10. Amendment of subsection (b)(9) and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

11. Amendment of subsections (c)(5) and (c)(6), new subsections (c)(6)(A)-(c)(9), and amendment of Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

13. Amendment of subsections (c)(5) and (c)(6), new subsections (c)(6)(A)-(c)(9), and amendment of Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

14. Amendment of subsections (c)(5) and (c)(6), new subsections (c)(6)(A)-(c)(9), and amendment of Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

15. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

16. Amendment of subsections (c)(5) and (c)(6), new subsections (c)(6)(A)-(c)(9), and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

18. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

20. Repealer and new section refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

21. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

22. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§56060. Regional Center Records.

Note • History

(a) The regional center shall maintain records which document:

(1) Facility service level approval;

(2) Quality assurance evaluations;

(3) Regional center monitoring of consumer IPP objectives;

(4) Facility liaison (QA) monitoring;

(5) Special Incident Reports (SIRs);

(6) Finding of Immediate Danger;

(7) Substantial Inadequacies;

(8) Corrective Action Plans;

(9) Sanctions;

(10) Facility appeals;

(11) Quarterly reports from Service Level 4 facilities; and

(12) The Department's approval of the use of Welfare and Institutions Code Section 4681.4(a) or (b) rate increase funds for a purpose other than those specified in Section 56932(a)(1) through (3).

NOTE

Authority cited: Sections 4681.1, 4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4502-4504, 4646.5, 4648, 4648.1, 4681.1, 4695.2, 4742, 4743, 4745 and 4746, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsections (b)(1)(C) and (c)(5) and repealer of subsection (b)(6) and subsection renumbering filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

4. Change without regulatory effect amending subsection (a)(4) filed 11-17-93 pursuant to title 1, section 100, California Code of Regulations (Register 93, No. 47).

5. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

6. Editorial correction of History 3 (Register 94, No. 47).

7. Editorial correction of subsection (a)(3) (Register 95, No. 18).

8. Change without regulatory effect amending subsections (a)(10)-(11) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

9. New subsections (a)(12) and (a)(13) and amendment of Note filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

10. New subsections (a)(12)-(a)(13) and amendment of Note refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

11. New subsections (a)(12)-(a)(13) and amendment of Note refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

12. Reinstatement of section as it existed prior to 9-9-99 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 2).

13. New subsections (a)(12)-(a)(13) and amendment of Note filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

14. Editorial correction of History 13 (Register 2000, No. 11).

15. Repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

16. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

17. Repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

18. Repealer and new section refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

19. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

20. Change without regulatory effect amending Note filed 2-28-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

Article 11. Facility Appeals Process

§56061. Appeal Process.

Note • History

(a) The administrator may appeal to the director of the regional center the following specific actions taken by the regional center:

(1) Findings of substantial inadequacy pursuant to Section 56054;

(2) Findings of immediate danger pursuant to Section 56053;

(3) Sanctions pursuant to Section 56057;

(4) Service level disapproval pursuant to Section 56005; and

(5) Enforcement of any requirement by the regional center which is not contained in Title 17, California Code of Regulations, Division 2, Chapter 3, Subchapters 4 and 6.

NOTE

Authority cited: Sections 4405, 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4648.1, 4681.1, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction capitalizing “S” of “Section” throughout (Register 95, No. 18).

§56062. Contents of Appeal and Hearing.

Note • History

(a) The administrator's written appeal request shall be submitted to the regional center director within 30 days after the receipt of written notification from the regional center of the action specified in Section 56061 and shall:

(1) Indicate the name and address of the facility;

(2) Identify the specific action being appealed;

(3) Describe the potential adverse impact on the facility;

(4) Describe the specific basis of the appeal;

(5) Include information necessary to substantiate the legal and factual basis of the appeal;

(6) Be signed by the administrator; and

(7) Be deemed filed on the date submitted to the regional center.

(b) Within 15 days of receipt of the appeal, the regional center director shall review the appeal to determine whether it includes the information required by subsection (a) above.

(1) If all the required information has not been included and/or additional information is needed, the regional center director shall request, in writing, the additional information from the appellant.

The request shall be made no later than 20 days from receipt of the appeal.

(A) The appellant shall submit the required information no later than 15 days from the receipt of the request in subsection (b)(1) above.

(B) If the information requested is not submitted within the time specified, the appeal shall be deemed withdrawn and no further action will be taken unless the appellant establishes good cause for the late submission. Good cause shall be determined by the regional center director in accordance with Section 56067.

(2) If all the required information has been received, notice of a hearing date shall be sent to the administrator by certified mail, return receipt requested, within 15 days of receipt of the information, specifying the date, time, and place of the hearing and the matter(s) to be heard.

(A) The hearing date shall be set no later than 25 days from receipt of all required information.

(B) All parties to the appeal must agree to any extension of the hearing date.

(c) The appeal process does not preclude the administrator from terminating the proceeding at any time prior to the hearing date if the matter is settled.

(d) With regard to the hearing, the administrator shall have the right to:

(1) Examine, prior to the hearing, all documents on file pertaining to the subject of the appeal, which are not confidential or otherwise not discoverable under existing statutes and regulations;

(2) Be represented by counsel;

(3) Attend the hearing and present written and/or oral evidence;

(4) Cross-examine witnesses; and

(5) Access documents at the hearing not previously accessed under subsection (1) above.

NOTE

Authority cited: Sections 4405, 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4648.1, 4648.2, 4681.1, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Repealer of subsection (e) filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

4. Editorial correction of History 3 (Register 94, No. 47).

5. Editorial correction of subsections (a) and (b)(1)(A) and (B) (Register 95, No. 18).

§56063. Decision.

Note • History

(a) Within 60 days after the date of the hearing, the regional center director shall:

(1) Render a decision; and

(2) Submit a written notification of the decision to the administrator by certified mail, return receipt requested.

(b) The written notification shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue(s);

(3) State the facts supporting each ruling;

(4) Specify the statute(s) and regulation(s) upon which each ruling is based; and

(5) Specify the procedure for appealing the regional center director's decision to the Director.

NOTE

Authority cited: Sections 4405, 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4681.1 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of Note filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Editorial correction of subsection (c) (Register 95, No. 18).

§56064. Appeal of the Regional Center's Decision.

Note • History

(a) The administrator, if dissatisfied with the decision rendered by the regional center director, may appeal the decision to the Director. The written appeal to the Director shall:

(1) Be submitted within 15 days from receipt of the written decision in Section 56063(a)(2); and

(2) Be in writing and include the following information:

(A) A copy of the regional center director's written decision;

(B) A copy of all information submitted to the regional center pursuant to Section 56062(a)(1)-(7) and (b)(2); and

(C) A statement of the issue(s), facts and any supporting statute(s) and regulation(s) identifying why the appellant believes the decision of the regional center director should be reversed by the Director.

(b) Within five days of receipt of the appeal, the Director shall request, in writing, from the regional center a copy of the appeal file.

(c) The regional center director shall submit a copy of the complete appeal file to the Director no later than 15 days from the submission of the request for the copy of the appeal file.

(d) Within 30 days of submission of the record forwarded pursuant to subsection (c) above, the Director shall review the record to determine if additional information on which to base a decision is needed from the appellant or the regional center.

(1) If no additional information is needed, the Director shall render a decision pursuant to Section 56065(a).

(2) If additional information is required, the Director shall request in writing, within 35 days of submission of the record pursuant to subsection (c) above, the material from the appellant and/or the regional center.

(3) The appellant and/or the regional center shall submit the additional information to the Director no later than 15 days from the submission of the request in subsection (2) above.

(A) If the appellant does not submit the information requested within the time specified, the appeal shall be deemed withdrawn and no further action taken unless the appellant establishes good cause for late submission pursuant to Section 56067. Good cause shall be determined by the Director.

(B) If the regional center does not submit the requested information within the time specified, the Director shall proceed with the appeal and render a decision based upon the available record pursuant to Section 56065(a).

NOTE

Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4648.1, 4745, 4748 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction capitalizing “S” of “Section” throughout (Register 95, No. 18).

5. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56065. Decision by the Director.

Note • History

(a) The Director shall, within 60 days of the final submission of all required and/or requested information:

(1) Render a decision; and

(2) Submit a written copy of the decision to the appellant, with a copy to the regional center.

(b) The written notification shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue(s);

(3) State the facts supporting each ruling; and

(4) Specify the statutes and regulations upon which each ruling is based.

(d) The decision of the Director is the final level of appeal in the administrative process.

(1) This does not preclude any other judicial remedies.

NOTE

Authority cited: Sections 4405, 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4648.2, 4681.1 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsection (b) and renumbering second subsection (b) to subsection (c) and subsection (c) to subsection (d) filed 3-21-91 pursuant to section 100 Title 1, California Code of Regulations (Register 91, No. 14).

§56066. Implementation of Regional Center Actions During Appeal.

Note • History

(a) Implementation of regional center actions during the appeal process shall occur as follows:

(1) In the case of immediate danger, the action of the regional center shall remain in effect throughout the appeal process;

(2) In the case of substantial inadequacies, corrective action shall be suspended until the appeal process is complete, except in situations specified in Section 56054(a)(1);

(A) Nothing in the foregoing shall preclude the regional center from taking immediate action if conditions in the facility deteriorate into an immediate danger because the substantial inadequacy has not been corrected.

(3) In the case of a disputed service level the rate paid during the appeal shall be for the service level approved by the regional center and appealed by the administrator.

NOTE

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction of subsection (a)(2) (Register 95, No. 18).

§56067. Good Cause.

Note • History

(a) For the purposes of Section 56061 through 56066 of these regulations, good cause for failure to act is limited to:

(1) A violent act of nature, including but not limited to, flood, earthquake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by individuals other than the appellant which precludes the appellant from filing a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days after the incident giving rise to its claim of good cause, submit to the regional center director or the Director, whichever is appropriate, the documents or other evidence substantiating its claim. The regional center director or the Director, whichever is appropriate, shall, within 30 days of receipt of the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(c) The director of the regional center or the Director, whichever is appropriate, shall notify the appellant in writing of the decision and shall specify what action will be taken, if any, pursuant to Sections 56061 through 56066 of these regulations.

NOTE

Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4745 and 4748, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of Note filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Editorial correction of subsections (a) and (c) (Register 95, No. 18).

4. Change without regulatory effect amending Note filed 12-2-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 49).

Subchapter 4.1. Family Home Agency (FHA) Regulations

Article 1. Definitions

§56075. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense. Words in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct. “May” denotes permissive conduct.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New subchapter 4.1, article 1 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New subchapter 4.1, article 1 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56076. Definitions.

Note • History

(a) As used in this Subchapter, the following phrase shall have the meaning specified in Title 17, Section 54000:

(1) Developmental Disability

(b) As used in this Subchapter, the following words and phrases shall have the meanings specified in Title 17, Section 54302:

(1) Applicant;

(2) Vendor;

(3) Vendorization.

(c) As used in this Subchapter, the following words and phrases shall have the meanings specified in Title 17, Section 56002:

(1) Authorized Consumer Representative;

(2) Consumers' Rights;

(3) Department;

(4) Director;

(5) Individual Program Plan (IPP);

(6) Interdisciplinary Team (ID Team);

(7) Regional Center;

(8) Service Coordinator.

(d) As used in this Subchapter, the following words and phrases shall have the meaning specified in Title 17, Section 58501:

(1) Cost Effective;

(2) Submit.

(e) The following definitions shall apply to the regulations used in this Subchapter:

(1) “Certificate of Approval” means the certificate issued to a family home upon approval by an FHA.

(2) “Consumer” means a person with a developmental disability who is at least 18 years of age and who does not require continuous skilled nursing care.

(3) “Continuous Skilled Nursing Care” means nursing care which is provided to a consumer whose condition cannot be classified as chronic or stable; or for whom performance of nursing care cannot be termed routine; or for whom the performance of nursing tasks by unlicensed persons would pose potential harm.

(4) “Conviction” means a plea or verdict of guilty or a conviction following a plea of nolo contendere.

(5) “Family Home” means a home that has been approved by an FHA and is owned, leased, or rented by, and is the family residence of, the family home provider and in which services and supports are provided to a maximum of two consumers regardless of their degree of disability, except for those consumers who require continuous skilled nursing care as defined in subsection (e)(3). As used in this subchapter, this term shall be understood to include the term “family teaching home.”

(6) “Family Home Agency (FHA)” means a private, not-for-profit agency that is vendored to do all of the following: 1) recruit, approve, train, and monitor family home providers; 2) provide services and supports to family home providers; and 3) assist consumers in moving into or relocating from family homes.

(7) “Family Home Provider” means a person who has been recruited, approved, and trained by an FHA to provide services and supports to a consumer residing in a family home.

(8) “Family Teaching Home” means a home that has been approved by an FHA and is owned, leased, or rented by the family home agency, wherein the family home provider and the consumer(s) have independent residences, either contiguous or attached, and in which services and supports are provided to a maximum of three consumers regardless of their degree of disability, except for those consumers who require continuous skilled nursing care as defined in subsection (e)(3). All requirements in this subchapter applicable to family homes shall apply equally to family teaching homes.

(9) “Person-Centered Planning” means the planning process for consumers as specified in Welfare and Institutions Code Sections 4646 and 4646.5.

(10) “Positive Behavioral Supports” means the systematic application of proactive and preventative behavioral interventions, excluding interventions which utilize pharmaceuticals or medications to achieve behavioral change, and which result in lasting positive changes in the consumer's behavior, are based upon the positive reinforcement of appropriate consumer behavior, and are designed to support consumers with challenging behaviors and ensure the consumer's right to reside in the least restrictive environment.

(11) “Relative” means spouse, parent, stepparent, son, daughter, brother, sister, stepbrother, stepsister, half-brother, half-sister, uncle, aunt, niece, nephew, first cousin, or any such person denoted by the prefix “grand” or “great” or the spouse of any of the persons specified in this definition.

(12) “Seclusion” means the physical isolation of the consumer.

(13) “Service Catchment Area” means the geographical area in which a regional center provides services.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code. Reference: Sections 4502 and 4689.1, Welfare and Institutions Code.

HISTORY

1. New section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

4. New subsections (e)(11) and (e)(13), subsection renumbering, and amendment of Note filed 6-24-98 as an emergency; operative 6-24-98 (Register 98, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-22-98 or emergency language will be repealed by operation of law on the following day.

5. New subsections (e)(11) and (e)(13), subsection renumbering, and amendment of Note refiled 10-22-98 as an emergency; operative 10-22-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-19-99 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-22-98 order, including repealer of subsection (a)(13), transmitted to OAL 12-31-98 and filed 2-16-99 (Register 99, No. 8).

7. Amendment of subsection (e)(5), new subsection (e)(8) and subsection relettering filed 11-7-2006; operative 12-7-2006 (Register 2006, No. 45).

Article 2. Competitive Procurement

§56077. Determination of Need.

Note • History

(a) The regional center shall determine the need for FHA services based upon the following criteria:

(1) Whether there is a sufficient number of FHA's currently providing services;

(2) Whether the FHA will meet an unmet need which has been identified in a consumer's IPP; and

(3) Whether there is an anticipated future need for FHA services within the regional center's service catchment area.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 2 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 2 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (a)(1), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56078. Public Notice.

Note • History

(a) When the regional center has determined the need for FHA services pursuant to Section 56077, the regional center shall give public notice of the intent to contract for FHA services.

(1) More than one contract may be announced in a public notice.

(b) The public notice shall be published in at least one newspaper of general circulation in the regional center's service catchment area.

(1) The name, title, address and telephone number of the regional center employee responsible for the public notice and for providing the information required by Section 56079;

(2) A summary of the services and supports for which the regional center intends to contract; and

(3) The deadline for submission of written applications and the address to which applications should be mailed.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (c)(1)-(2), repealer of subsections (c)(3)-(8) and subsection renumbering, transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56079. Application.

Note • History

(a) An application for intent to contract submitted in response to the public notice required by Section 56078 shall include, but not be limited to:

(1) The name, address and telephone number of the prospective FHA administrator;

(2) The prospective FHA's program design as specified in Section 56084;

(3) The signature of the prospective FHA administrator and the date on which the application was signed; and

(4) Any additional format or procedural requirements deemed necessary by the regional center.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a) and (a)(4), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56080. Selection of FHA.

Note • History

(a) The regional center shall utilize the following criteria to select the prospective FHA:

(1) The prospective FHA's potential for providing cost-effective quality services and supports as referenced in the program design pursuant to Section 56084;

(2) The degree to which consumer choice regarding the provision of services and supports is identified as a factor in the program design;

(3) The experience of the prospective FHA or key agency personnel in providing the same or comparable services;

(4) The reasonableness of the prospective FHA's overhead; and

(5) The capability of the regional center to monitor and evaluate the prospective FHA.

(b) The regional center shall not discriminate in the selection of an FHA on the basis of race, color, creed, national origin, ancestry, sex, marital status, disability, religious or political affiliation, age or sexual orientation.

(c) The regional center may require the revision of an application prior to, and as a condition of, further consideration by the regional center.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4646, 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (a)(5) and new subsections (b)-(c), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56081. Notice of Intent.

Note • History

(a) Within 30 days following the regional center's selection of an FHA pursuant to Section 56080, the regional center shall give public notice of its intent to contract with the selected FHA by posting a notice of its selection in an area of the regional center which is accessible to the general public.

(b) The regional center shall notify, in writing, those not selected under Section 56080.

(1) Notification shall include, but not be limited to, the right to appeal the contract decision pursuant to subsection (c).

(c) The regional center shall develop a written appeal procedure for those not selected under Section 56080 which includes, but is not limited to, the following:

(1) The format and content of the appeal;

(2) The grounds for the appeal;

(3) The process for submission of the appeal;

(A) The appeal shall be filed with the regional center within a reasonable period of time not to exceed 15 days following receipt of the notification pursuant to subsection (b).

(4) The process for resolution of the appeal;

(A) The regional center shall resolve the appeal within a reasonable period of time not to exceed 15 days following the regional center's receipt of the appeal submitted pursuant to subsection (c)(3).

(d) If the appeal is upheld, the prospective FHA which submitted the appeal shall be eligible to enter into contract negotiations with the regional center pursuant to Section 56082(a).

(e) Nothing shall prevent the regional center from contracting with, and vendoring, the selected FHA during the pendency of the appeal.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a) and (b)(1), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 3. Contract and Vendorization

§56082. Contract and Vendorization.

Note • History

(a) The regional center shall negotiate a contract with the FHA selected pursuant to Section 56080 which includes, but is not limited to:

(1) A rate(s) of reimbursement for the FHA; and

(2) A requirement that the vendor maintain service records to support all billing/invoicing as specified in Section 50604(d)(1) through (3)(F), as applicable; and

(3) A requirement that the vendor submit to the regional center with their billings/invoices the information specified in (2) above for the billing period.

(b) Regional center reimbursement to FHAs shall not exceed rates for similar individuals when residing in other types of out-of-home care established pursuant to Welfare and Institutions Code Section 4681.1.

(1) The FHA shall ensure that family homes receive a sufficient portion of the rate of reimbursement to provide the services and supports specified in a consumer's IPP.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Section 4689.1, Welfare and Institutions Code; and Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 3 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 3 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a) and (c), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

4. Redesignation and amendment of portion of subsection (a) as new subsection (a)(1), new subsections (a)(2)-(3) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

5. Redesignation and amendment of portion of subsection (a) as new subsection (a)(1), new subsections (a)(2)-(3) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

6. Redesignation and amendment of portion of subsection (a) as new subsection (a)(1), new subsections (a)(2)-(3) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (a)(2), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§56083. Residential Services Orientation and Training.

Note • History

(a) Prior to a consumer residing in a family home, the following FHA staff shall attend the residential services orientation provided by the vendoring regional center pursuant to the requirements of Title 17, Section 56003(a)(1)(A), (C), (D) and (E):

(1) The FHA administrator;

(2) All FHA staff responsible for the direct supervision of other FHA staff; and

(3) All FHA staff who have frequent and routine contact with the consumer.

(b) When there is a change in the FHA's administrator or staff as specified in subsection (a)(1) through (3), the new administrator or staff shall attend the next scheduled residential services orientation provided by the regional center.

(c) The vendoring regional center may require further training in addition to that specified in Section 56084(b)(6) and (7).

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

3. Certification of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 4. Program Design

§56084. Program Design Requirements.

Note • History

(a) The program design shall detail how the FHA will achieve and monitor the following outcomes:

(1) That the consumer will live in a family home where he/she will receive respect and support and involvement in the normal routines of family life;

(2) That the FHA and the family home will provide services and supports which will be consistent with the consumer's needs and preferences for services and supports as specified in the consumer's IPP;

(3) That the FHA and the family home will provide services and supports which are designed to encourage and support the consumer in the formation of relationships with peers without disabilities and in participation in the community;

(4) That the FHA and the family home will provide services and supports which will respect the consumer's personal and cultural preferences and values;

(5) That the FHA will ensure an appropriate match between the needs and preferences of the consumer and the family home;

(6) That the FHA will assist the consumer in building and maintaining relationships with others, including, but not limited to, marital and interpersonal relationships; family relationships; and friendships and social networks;

(7) That the FHA will ensure that services and supports which are chosen by the consumer and provided by the FHA will be satisfactory to the consumer, or the consumer's authorized representative, if applicable; and

(8) That FHA staff will be suited by experience, sensitivity, education and training to achieve the outcomes specified in subsections (a)(1) through (7) and to perform the duties specified in subsection (b)(4)(A) through (O) and Section 56086(a)(1) through (7).

(b) In addition to subsection (a), the program design shall include, but not be limited to:

(1) Complete job descriptions of all FHA positions, including number of employees, classification, qualifications and duties;

(2) Information specifying lines of authority, reporting relationships and staff responsibilities and an organizational chart for the FHA; and

(3) The FHA's proposed staffing ratio which pertains to the number of specified staff to be maintained relative to:

(A) The number of homes which will serve consumers; and

(B) The number of, and specific needs of, consumers who will be placed in family homes approved by the FHA.

(4) Written statements specifying the FHA's policies and procedures for:

(A) Recruiting family homes;

(B) Assessing the qualifications of prospective family home providers;

(D) Assuring that the match between the consumer and the family home takes into account the consumer's individual health and safety needs as specified in the consumer's IPP;

(E) Utilizing and coordinating with community resources;

(F) Providing assistance to consumers in moving into, or out of, family homes;

(G) Reporting and investigation of complaints concerning the FHA or the family home(s);

(H) FHA monitoring of the family home(s);

(I) Providing or arranging for emergency or unanticipated termination of services to, and relocation of, the consumer, including coordination with the family home provider when the consumer terminates residence pursuant to Section 56094(a);

(J) Assuring that each family home has a contingency plan in the event of a disaster or emergency;

(K) Assuring that ancillary services and supports, including, but not limited to, respite care, will be provided or arranged for by the FHA;

(L) Determining the portion of the FHA's rate of reimbursement to be paid to the family home pursuant to Section 56082(b)(1);

(M) Providing technical assistance to the family home;

(N) Obtaining liability insurance; and

(O) Providing evidence that, when the family home provider has been appointed as the consumer's representative payee for the consumer's Supplemental Security Income (SSI) and State Supplemental Program (SSP) payment, or the consumer has entrusted funds and/or property to the care of the family home provider, the family home provider has filed with the FHA a bond, issued by a surety company to the State of California as principal, in an amount sufficient to cover the amount of funds and/or property entrusted to the family home provider.

(5) Written descriptions of the following:

(A) The range of services and supports to be provided to consumers and family homes by the FHA to support and maintain the consumer in a family home; and

(B) The 24-hour emergency response services to be provided, or arranged for, by the FHA including weekends, holidays and situations in which the consumer requires immediate temporary or permanent living alternative.

(6) A proposed training plan which addresses the initial and ongoing training needs for FHA staff and the family home. The training plan shall include, but not be limited to, the following topics:

(A) Health and safety in the FHA and the family home, including first aid, CPR and nutrition;

(B) Positive behavioral supports and crisis intervention techniques;

(D) Fostering consumer participation in, and integration into, the community;

(E) Adjustment issues for consumers and families, including cultural diversity and sensitivity to the needs of persons with developmental disabilities;

(F) Building a new or extended family and fostering personal relationships;

(G) Values and philosophy of the developmental disabilities service system pursuant to Welfare and Institutions Code Section 4501;

(H) Person-centered planning, consumer choice and the IPP process, including implementation of consumer IPP objectives for which the FHA or family home is responsible;

(I) Identification and reporting of adult abuse; and

(J) Record-keeping.

(7) The proposed training plan shall specify:

(A) The frequency of the training to be provided, which shall occur with sufficient frequency and regularity to enable FHA staff and family home providers to keep abreast of changes and developments in the field of developmental disabilities and to meet the needs of individual consumers;

(B) The FHA's procedures for assessing the training needs of FHA staff and the family home;

(C) The FHA's procedures for assessing the training plan's effectiveness and making necessary revisions to the training plan; and

(D) That new FHA staff will be trained prior to providing services and supports to consumers.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 4 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 4 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a)(6), (b), (b)(4)(K), (b)(4)(O), (b)(6)(G), (b)(7)(A)-(C), and (c), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 5. Criminal Record Clearance

§56085. Fingerprints and Criminal History.

Note • History

(a) The Department shall conduct a criminal record review of all persons specified in Welfare and Institutions Code Section 4689.2(c) and shall have the authority to approve or deny an application for vendorization as an FHA, or employment, residence, or presence in the family home based upon the results of such a review.

(1) All completed, signed and dated Department of Justice fingerprint cards (BID-7) shall be submitted directly to the Department.

(2) Fingerprint cards shall be provided by the Department.

(b) When the person who is subject to the criminal record review specified in subsection (a) has not resided continuously in California for the past two years, the criminal record review required by subsection (a) shall include criminal history record information (CHRI) maintained by the Federal Bureau of Investigation (FBI).

(d) Subsequent to vendorization of the FHA, all persons subject to criminal record review pursuant to Welfare and Institutions Code Section 4689.2(c) shall, prior to employment by the FHA, or residence or initial presence in the family home, be fingerprinted and sign, under penalty of perjury, a DS 5407 (New 5/95) regarding any prior criminal convictions.

(1) The FHA shall submit fingerprint cards to the Department within four calendar days following employment, residence or initial presence in the family home.

(2) The original signed and dated DS 5407 (New 5/95) shall be retained by the FHA.

(A) A copy of the signed and dated DS 5407 (New 5/95) shall be submitted to the Department within four calendar days following the employment, residence or initial presence of the declarant in the family home.

(B) A copy of the signed and dated DS 5407 (New 5/95) shall be retained by the regional center.

(e) If the criminal record transcript discloses that any person specified in Welfare and Institutions Code Section 4689.2(c) has been convicted at any time of a crime, except a minor traffic violation, the Department is authorized to:

(1) For an applicant for vendorization as an FHA, deny the application for vendorization pursuant to Welfare and Institutions Code Section 4689.4.

(2) For an FHA, terminate the vendorization of the FHA.

(3) For a family home, terminate the approval of the family home.

(f) If the criminal record transcript of a current or prospective employee of the FHA discloses that a current or prospective employee of an FHA has been convicted at any time of a crime, except a minor traffic violation, the FHA, upon notification by the Department, shall act immediately to do the following:

(1) For current or prospective employees, terminate the current employee's employment or bar the prospective employee from entering the family home; or

(2) Seek an exemption pursuant to Welfare and Institutions Code Section 4689.2(f).

(g) If the criminal record transcript of any adult person, other than the consumer, residing in the family home discloses that the person has been convicted at any time of a crime, except a minor traffic violation, the FHA, upon notification by the Department, shall:

(1) Remove the consumer from the family home; or

(2) Remove the adult person from the family home; or

(3) Bar the adult person from entering the family home; or

(4) Seek an exemption for the adult person pursuant to Welfare and Institutions Code Section 4689.2(f).

(h) After a review of the criminal record transcript, the Director shall have the authority to grant an exemption from subsections (e), (f) and (g) when:

(1) The Director has substantial and convincing evidence to support a reasonable belief that the applicant for vendorization, or other person specified in Welfare and Institutions Code Section 4689.2(c), is of such good character as to justify approval of vendorization or an exemption.

(A) The Director shall have the authority to consider factors, including the following, as evidence of good character and rehabilitation:

1. The nature of the crime;

2. The period of time since the crime was committed and the number of offenses;

3. The circumstances surrounding the commission of the crime that would demonstrate the unlikelihood of repetition;

4. Activities since conviction, including employment or participation in therapy or education, that would indicate changed behavior;

5. The granting of a full and unconditional pardon by the Governor;

6. Character references; or

7. A certificate of rehabilitation from a superior court.

(2) Any person specified in Welfare and Institutions Code Section 4689.2(c) who has been rehabilitated as provided in Penal Code Section 4852.03 has maintained the conduct required in Penal Code Section 4852.05 for at least 10 years and has the recommendation of the district attorney representing the employee's county of residence.

(3) The applicant for vendorization or, other person specified in Welfare and Institutions Code Section 4689.2(c), has received a certificate of rehabilitation pursuant to Chapter 3.5 (commencing with Section 4852.01) of Title 6 of Part 3 of the Penal Code.

(i) Following the receipt of all information which will enable the Director to grant or deny an exemption from subsections (e), (f) and (g), the Director shall either grant or deny the exemption within a period of time which shall not exceed 30 days.

(j) The Director shall specify, in writing, the reasons for any exemption granted.

(k) Any person specified in Welfare and Institutions Code Section 4689.2(c) shall be permitted to transfer a current criminal record clearance pursuant to subsection (b), from one FHA or family home to another as long as the criminal record clearance has been processed through the Department.

(l) Except as otherwise provided in Welfare and Institutions Code Section 4689.2(f), no exemption shall be granted if the conviction was for an offense specified in Penal Code Sections 220, 243.4, 264.1, paragraph (1) of subdivision (a) of 273a, 273d, 288, 289 or 368(a) or (b), or for another crime against an individual specified in Penal Code Section 667.5(c).

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4689.1, 4689.2, 4689.3, 4689.4, 4689.5, 4689.6 and 4741, Welfare and Institutions Code.

HISTORY

1. New article 5 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 5 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (h)(1)(A)5., new subsection (i) and subsection relettering, transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 6. The FHA

§56086. The FHA.

Note • History

(a) The FHA shall employ sufficient staff with the combined experience, training and education to perform the following duties:

(1) Administration of the FHA;

(2) Recruitment of family homes;

(3) Training of FHA staff and family homes;

(4) Ensuring an appropriate match between the needs and preferences of the consumer and the family home;

(5) Monitoring of family homes;

(6) Provision of services and supports to consumers and family homes which are consistent with the consumer's preferences and needs and the consumer's IPP; and

(7) Coordination with the regional center and members of the consumer's family and/or the consumer's authorized representative, if applicable, as necessary to ensure consumer satisfaction and the stability of the family home.

(b) In order to accomplish the duties specified in subsection (a)(1) through (7) and Section 56084(b)(4)(A) through (O), the FHA shall consider selection criteria for hiring purposes, which shall include, but not be limited to:

(1) Education in the fields of social work, psychology, education, or related areas;

(2) Experience, either personal or professional, working or living with persons with developmental disabilities;

(3) Experience and training in program management, fiscal management, and organizational development;

(4) Training in any related areas that augment the individual's education and experience; or

(5) Any combination of the above.

(c) A new FHA administrator shall meet with the regional center director or his/her designee within 14 days of assuming the duties of administrator.

(d) No FHA administrator, staff member, Board of Directors member or officer shall be a family home provider of the FHA with which he/she is affiliated.

(e) No person employed by the FHA shall enter into any independent financial relationship or transaction with a family home provider, including but not limited to, rental agreements, personal cash loans, or sale, trade or transfer of property.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Section 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 6 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 6 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 7. The Family Home

§56087. Home Visit.

Note • History

(a) Prior to approval, the FHA shall visit each prospective family home to:

(1) Interview all adults who reside in the home;

(2) Interview or see all family members who reside in the home;

(3) Provide the prospective family home with copies of these regulations and the Lanterman Developmental Disabilities Services Act;

(4) Discuss the content of Section 56088(b)(8)(A) through (C) with the prospective family home provider; and

(5) Discuss the training specified in Sections 56083(c) and 56084(b)(6) and (7); and

(6) Determine that the family home provides:

(A) A safe, clean, and pleasant living environment;

(B) Age-appropriate living space; and

(C) Accommodations for ensuring safe and reasonable accessibility for entrance to, movement within and exit from the family home.

(7) Determine, pursuant to subsections (a)(1) through (6), that the prospective family home providers have the experience, knowledge, cooperation, history and interest to become an approved family home.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 7 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 7 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (a)(5), new subsection (a)(6), repealer of subsection (b) and redesignation of former (b)(1)-(3) as new (a)(6)(A)-(C), and new subsection (a)(7), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56088. Certificate of Approval.

Note • History

(a) The FHA shall issue a Certificate of Approval to each family home which has:

(1) Completed the criminal record review required by Section 56085(a);

(2) Been visited by the FHA as required by Section 56087(a); and

(3) Met the criteria specified in Section 56087(a)(6) and (7).

(b) The Certificate of Approval shall include, but not be limited to:

(1) The name, address and telephone number of the FHA;

(2) The name, address, location and telephone number of the family home provider;

(3) The number of consumers for which the family home has been approved;

(4) Any limitations of the home, including ambulatory status of consumers to be served;

(5) The date of issuance of the certificate;

(6) The date of expiration of the certificate which shall not exceed one year from the date of issuance;

(7) A statement that the family home shall be used exclusively as a residence by the FHA which issued the Certificate of Approval;

(8) A statement which shall include, but not be limited to, the following information:

(A) The relationship between the consumer and the family home is voluntary and may be terminated by any party to the agreement at any time subject to the requirements of Section 56094.

(B) The Department and the regional center shall enforce applicable provisions of law and regulation, investigate allegations of abuse or neglect, and impose sanctions on FHAs, including the following:

1. Requiring movement of a consumer from a family home; and/or

2. Requiring termination of the approval of a family home; and/or

3. Requiring termination of the FHA's vendorization.

(C) The Department and the regional center shall monitor services and supports provided by the family home in accordance with Welfare and Institutions Code Section 4648.1(a) and (b) as necessary to implement the consumer's IPP.

(9) The date and signature of the FHA's administrator.

(1) The original shall be maintained on the premises of the family home; and

(2) A copy of the original shall be maintained by the FHA.

(d) Within 10 working days of the issuance of a Certificate of Approval pursuant to subsection (a), the FHA shall send written notice to the regional center of the family home provider's name, address, telephone number and location.

(e) A Certificate of Approval shall not be transferable and shall be void upon a change of location of the family home.

(f) The family home provider shall immediately notify the regional center and the FHA of a change in the location of a family home.

(1) Verbal notification shall be put in writing within 5 working days.

(g) The family home provider shall notify the regional center and the FHA in writing at least 30 days prior to a non-emergency change in the location of a family home.

(h) The FHA shall conduct a site visit to the new location of the family home within 5 working days of notification as required by subsections (f) and (g) for the purpose of:

(1) Approving the new location; and

(2) Issuing a new Certificate of Approval.

(i) When the FHA does not approve the new location pursuant to subsection (h)(1), the FHA shall notify the family home and the regional center in writing of the FHA's decision not to approve the family home.

(1) The notification required by subsection (i) shall occur within a reasonable period of time not to exceed 5 working days following the site visit required by subsection (h).

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a)(3), (b), (b)(8) and (b)(8)(B)1.-2., new subsection (g) and subsection relettering, and amendment of newly designated subsections (h), (i) and (i)(1), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56089. Prohibited Interventions and Treatment.

Note • History

(a) All behavior modification interventions that cause pain or trauma, as specified in Title 17, Division 2, Chapter 1, Subchapter 8, are prohibited.

(b) Electroconvulsive therapy (ECT) as defined in Title 17, Division 2, Chapter 1, Subchapter 8, Section 50801(j) is a prohibited treatment procedure.

(c) A consumer who resides in a family home shall be free from corporal or unusual punishment, infliction of pain, humiliation, intimidation, ridicule, coercion, threat, mental abuse, restraint or other actions of a punitive nature, including, but not limited to: interference with the daily living functions, including eating, sleeping, or toileting; or withholding of shelter, clothing, medication or aids to physical functioning.

(d) A consumer who resides in a family home shall not be placed in seclusion.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code. Reference: Sections 4502 and 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a) and (b), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

4. New subsections (c)-(e) and amendment of Note filed 6-24-98 as an emergency; operative 6-24-98 (Register 98, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-22-98 or emergency language will be repealed by operation of law on the following day.

5. New subsections (c)-(e) and amendment of Note refiled 10-22-98 as an emergency; operative 10-22-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-19-99 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-22-98 order, including repealer of subsection (e), transmitted to OAL 12-31-98 and filed 2-16-99 (Register 99, No. 8).

Article 8. Referral for Service

§56090. Referral for Service.

Note • History

(a) When the consumer and the consumer's authorized representative, if applicable, has expressed an interest in the services and supports provided by an FHA, the regional center shall coordinate with the FHA for a meeting between the FHA, the consumer and/or the consumer's authorized representative, if applicable.

(b) Prior to the meeting required in subsection (a), the regional center shall obtain the consent of the consumer, or the consumer's authorized representative, if applicable, to release information to the FHA which includes, but is not limited to:

(1) The consumer current Individual Program Plan (IPP);

(2) A statement of the consumer's ambulatory or nonambulatory status as determined by the consumer's ID Team;

(3) A statement that the consumer does not require continuous skilled nursing care;

(4) Known information regarding the consumer's likes and dislikes, strengths and needs, interests and activities;

(5) A medical history which includes any identified medical and/or special care needs, including special dietary requirements;

(6) Any health and safety requirements which are specific to the needs of the consumer;

(7) When the consumer has an authorized representative, the authorized representative's name, address and telephone number;

(8) When a conservator has been appointed for the consumer, a statement that the regional center has obtained the consent of the consumer's conservator, if the conservator has been granted the legal authority to fix residence, for the consumer to reside in a family home; and

(9) The name and telephone number of the regional center service coordinator who is responsible for the implementation of the consumer's IPP.

(c) No consumer shall reside in a family home in which the family home provider is a relative of the consumer as defined in Section 56076(e)(10).

(1) The regional center may make an exception to the requirement of subsection (c) when:

(A) The residence is consistent with the services and supports referenced in the consumer's IPP; and

(B) The relative has no legal obligation to support the consumer.

(d) When the FHA has identified an appropriate family home, the FHA shall coordinate at least one visit to the family home by the consumer and the consumer's authorized representative, if applicable.

(e) When the consumer has made a decision to reside in the family home, the FHA shall execute a residence agreement which specifies the following:

(1) The portion of the FHA's rate of reimbursement to be paid to the family home provider by the FHA pursuant to Section 56082(b)(1); and

(2) The services and supports which the FHA and the family home will provide to the consumer.

(f) The residence agreement shall be signed by the:

(1) Consumer;

(2) Consumer's authorized representative, if applicable;

(3) FHA;

(4) Regional center; and

(5) Family home provider.

(g) The original residence agreement shall be maintained by the family home provider.

(h) Copies of the signed residence agreement shall be maintained by the entities specified in subsection (f)(1) through (4).

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4689.1 and 4648, Welfare and Institutions Code.

HISTORY

1. New article 8 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 8 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (b)(8), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 9. Consumer Funds and Property

§56091. Consumer Funds and Property.

Note • History

(a) When the family home provider has been appointed as the consumer's representative payee for the consumer's Supplemental Security Income (SSI) and State Supplemental Program (SSP) payment or the consumer has entrusted funds and/or property to the care of the family home provider, the following shall apply:

(1) A consumer's funds and property shall be used only for the consumer's benefit;

(2) A consumer's funds and property shall be free of any liability incurred by the FHA or the family home provider;

(3) Consumer funds and/or property shall be maintained separate and intact and shall not be commingled with family home or FHA funds and/or property, or the funds and/or property of other consumers; and

(4) Except for that portion of the consumer's SSI/SSP benefit which is designated for the consumer's room, board, care and supervision, the FHA or the family home provider shall not make expenditures from consumers' funds for any services or supports required by this Subchapter. Consumers' SSI/SSP benefits are also deemed to include any income used to determine the SSI/SSP payment.

(b) The family home provider shall maintain accurate records of accounts of funds and/or property entrusted to the family home provider's care which include, but not be limited to:

(1) Personal possessions and/or funds received by or entrusted to the family home provider;

(2) Disbursements made to, or for, the consumer; and

(3) All transactions on behalf of a consumer as specified in subsections (c) (d) and (e).

(c) All consumer funds which are entrusted to the family home provider and which are not kept on the premises of the family home shall be deposited in the consumer's name in an interest-bearing account in a local bank, savings and loan or credit union authorized to do business in California, the deposits of which are insured by a branch of the Federal Government.

(d) The family home provider shall provide access to the consumer's cash resources when requested by the consumer or the consumer's authorized representative, if applicable.

(e) All interest accruing to funds deposited by the family home provider in an account pursuant to subsection (c) shall be the property of the consumer.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 9 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 9 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (b), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 10. Health-Related Services

§56092. Health-Related Services.

Note • History

(a) The FHA and the family home shall provide, or arrange for, any health-related services which are:

(1) Referenced in the consumer's IPP and for which the FHA or the family home provider is responsible; or

(2) Prescribed for the consumer; or

(3) Needed by the consumer.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 10 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 10 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24 -95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 11. Abuse and Special Incident Reporting

§56093. Abuse and Special Incident Reporting.

Note • History

(a) The family home provider shall report any occurrence or allegation of consumer abuse to the FHA and either the adult protective services agency or the local law enforcement agency pursuant to Welfare and Institutions Code Section 15630.

(1) In addition to (a), the family home provider shall also report any occurrence or allegation of neglect or exploitation to the FHA.

(b) The report in subsection (a) shall be:

(1) By telephone, FAX or electronic mail immediately, but in no case more than 24 hours after the occurrence; and

(2) Submitted in writing within 48 hours after the occurrence.

(c) Upon receipt of the report in subsection (b)(1), or upon the FHA's independent suspicion or knowledge of abuse, the FHA shall notify:

(1) The regional center pursuant to Title 17, California Code of Regulations, Section 54327(b);

(2) The consumer's authorized representative, if applicable;

(3) The applicable protective services agency or local law enforcement agency; and

(4) Any person designated in the consumer's IPP to receive information regarding any occurrence of consumer abuse or allegations of consumer abuse.

(d) The notification in subsection (c) shall be:

(1) By telephone, FAX or electronic mail immediately, but in no case later than the end of the FHA's business day; and

(2) Submitted in writing within 48 hours after the occurrence.

(e) The regional center, the FHA and the family home provider shall cooperate as requested by any agency which has the responsibility for investigating the occurrence.

(f) The Family home provider shall report to the FHA the following special incidents in which consumers are involved:

(1) Incidents as defined in Section 54327(b);

(2) Incidents which may result in criminal charges or legal action;

(3) Incidents which may result in the denial of a consumer's rights;

(4) Poisonings;

(5) Catastrophes;

(6) Emergency treatment;

(7) Fires or explosions; or

(8) Any other incident which appears to have a negative effect on the consumer's health, safety and well-being.

(g) The report in subsection (f) shall be:

(1) By telephone, FAX or electronic mail immediately, but in no case more than 24 hours after the incident; and

(2) Submitted in writing within 48 hours after the incident.

(h) Upon receipt of the report in subsection (g), or upon the FHA's independent suspicion or knowledge of a special incident, the FHA shall notify:

(1) The regional center pursuant to Title 17, California Code of Regulations, Section 54327(b);

(2) The consumer's authorized representative, if applicable;

(3) Any person designated in the consumer's IPP to receive such information.

(i) The report required by subsection (h) shall be:

(1) By telephone, FAX or electronic mail immediately, but in no case later than the end of the FHA's business day; and

(2) In writing within 48 hours after the incident.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 11 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 11 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsection (a), new subsection (a)(1), amendment of subsections (c)(3) and (f), repealer of subsection (g), new subsections (g)-(h) and subsection relettering, redesignation of former subsections (g)(1)-(3) as (h)(1)-(3), and amendment of newly designated subsection (i), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8)

4. Amendment of subsections (b)(1), (c)(1), (c)(4), (d)(1), (g)(1), (h)(1) and (i)(1) and amendment of Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsections (b)(1), (c)(1), (d)(1), (g)(1), (h)(1) and (i)(1) and amendment of Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

7. Amendment filed 6-27-2001 as an emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-29-2001 or emergency language will be repealed by operation of law on the following day.

8. Reinstatement of section as it existed prior to 6-27-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 43).

9. Amendment filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 10-25-2001 order, including amendment of subsections (c)(1), (f)(1) and (h)(1), transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

Article 12. Termination of Residency

§56094. Termination of Residency.

Note • History

(a) The consumer may terminate residency at any time with or without cause.

(1) The family home provider shall notify the FHA and the regional center when the consumer decides to terminate residency as specified in subsection (a).

(b) The notification required in subsection (a)(1) shall be:

(1) By telephone immediately; and

(2) In writing within 24 hours after the termination of residence.

(c) When the consumer's decision to terminate residency is unanticipated by the family home provider or the FHA or the consumer's decision to terminate residency is due to an emergency, the FHA shall provide or arrange for services pursuant to Section 56084(b)(4)(I).

(d) Upon notification as required by subsection (a)(1), the regional center shall convene the consumer's ID Team within a reasonable period of time not to exceed 5 working days following receipt of the notification required by subsection (b) to assess the consumer's residence in terms of subsection (h)(1) through (3).

(e) When a family home provider determines that the family home is unable to continue to meet the needs of the consumer as specified in the consumer's IPP, the family home provider shall notify the following, in writing, at least 30 days prior to the date of termination of residency:

(1) The consumer;

(2) The regional center;

(3) The FHA; and

(4) The consumer's authorized representative, if applicable.

(f) When an FHA determines that it is unable to continue to meet the needs of the consumer as specified in the consumer's IPP, the FHA shall notify the following, in writing, at least 30 days prior to the date of termination of residency:

(1) The consumer;

(2) The regional center;

(3) The family home provider; and

(4) The consumer's authorized representative, when applicable.

(g) When the regional center determines that the FHA or the family home provider is unable to continue to meet the needs of the consumer as specified in the consumer's IPP, the regional center shall notify the following, in writing, at least 30 days prior to the date of termination of residency:

(1) The consumer;

(2) The FHA;

(3) The family home provider; and

(4) The consumer's authorized representative, if applicable.

(h) Upon the determination in subsections (e), (f), or (g), the regional center shall convene the consumer's ID Team to assess:

(1) The need for additional or different services and supports in order for the consumer to remain in the family home; or

(2) If a move becomes necessary, the consumer's choices and needs for services and supports before, during and after the move to a new residence; and

(3) Any additional measures necessary to meet the consumer's health and safety needs until the move has been accomplished.

(i) A place of residence shall be selected by the regional center and the FHA within a reasonable period of time based upon concerns for the health and safety of the consumer.

(j) The FHA shall provide the services and supports necessary to enable the consumer to continue to reside in the family home until a new residence is selected pursuant to subsection (i).

(k) If a new residence is not available by the designated termination date, the regional center shall coordinate with the FHA to ensure that the services and supports necessary to enable the consumer to continue to reside in the family home are provided until a new residence is available.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 12 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 12 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (d) and (h)-(h)(2), new subsection (h)(3), amendment of subsection (i), repealer of subsections (i)(1)-(2) and new subsection (k), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 13. Monitoring and Sanctions

§56095. Monitoring and Sanctions.

Note • History

(a) The FHA's social service staff shall monitor family homes on at least a monthly basis to ensure:

(1) Consistency between the services and supports being provided by the family home and the services and supports specified in the consumer's IPP;

(2) Consistency between the services and supports being provided by the family home and the FHA's program design;

(3) Consumer satisfaction;

(4) Appropriateness of the match between the needs of the consumer and the family home;

(5) Consumer health and safety; and

(6) Accountability of consumer funds and property.

(b) The FHA's social service staff shall report deficiencies identified pursuant to subsection (a) to the regional center.

(1) That the services and supports referenced in the consumer's IPP are being provided as specified;

(2) That the consumer is achieving the outcomes specified in the consumer's IPP;

(3) That the consumer's health and safety are not endangered;

(4) That the consumer is satisfied as a resident in the family home, as determined by the consumer, the consumer's authorized representative, if any, the consumer's family, or significant others, or all of these; and

(5) That the consumer's funds and property are accounted for.

(d) When the meeting pursuant to subsection (c) is announced, the regional center representative shall provide advance notice to the consumer's authorized representative, if any, of the date and time of the meeting.

(1) A maximum of two of the quarterly meetings per year may be conducted during an unannounced visit pursuant to Welfare and Institutions Code Section 4648.1 provided that the regional center representative also satisfies the requirements of (c).

(e) At least two of the quarterly meetings required by subsection (c) shall take place at the family home and a representative of the FHA shall be present.

(1) Other quarterly meetings may take place at a place other than the consumer's residence at a site acceptable to the consumer.

(f) When the consumer's authorized representative, if any, is unable to attend the meeting, or the meeting is unannounced pursuant to Welfare and Institutions Code Section 4648.1(a), the regional center representative shall confer with the consumer's authorized representative regarding the consumer's progress toward achieving his/her Lanterman Act IPP objectives.

(g) A regional center representative shall monitor the FHA on at least an annual basis to ensure:

(1) That services and supports provided by the FHA and the family home conform to applicable laws and regulations;

(2) That the administration of the FHA is consistent with the contract negotiated between the FHA and the regional center pursuant to Section 56082(a); and

(3) That the services and supports provided by the FHA and the family home are consistent with the FHA's program design as required by Section 56084.

(h) In the event that the regional center learns of or identifies a deficiency pursuant to subsections (a) through (c) and (g), the regional center shall require the FHA to implement a written plan of corrective action which specifies:

(1) A description of the condition(s) or complaint(s) which led to the need for corrective action;

(2) The method(s) by which the administrator is required to correct the condition(s) or complaint(s);

(3) The technical assistance to be provided by the regional center or the Department; and

(4) The time frame for the correction of the condition(s) or complaint(s).

(i) When the FHA fails to make the required corrections specified in subsection (h), the regional center shall impose any or all of the following sanctions on the FHA by requiring:

(1) Movement of a consumer from a family home;

(2) Termination of approval of a family home and revocation of the family home's Certificate of Approval; and

(3) Termination of the FHA's vendorization.

(j) When the regional center imposes a sanction pursuant to subsection (i), the regional center shall inform the FHA in writing of the following:

(1) The sanction to be imposed;

(2) The deficiency which led to the sanction; and

(3) The effective date of the sanction.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4405 and 4689.1, Welfare and Institutions Code. Reference: Sections 4501, 4646.5, 4648.1(a), 4689.1 and 4742, Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

1. New article 13 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New article 13 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a)(3) and (c)(4), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

4. Amendment of subsection (c) and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsection (c) and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98, disapproved by OAL and order of repeal of 10-20-98 order filed on 2-17-99 (Register 99, No. 8).

7. Amendment of subsections (c)-(c)(1) and (c)(4), new subsections (d)-(f), subsection relettering, amendment of newly designated subsections (h), (i) and (j) and amendment of Note filed 9-20-99; operative 10-20-99 (Register 99, No. 39).

Article 14. Appeals

§56096. Appeals.

Note • History

(a) The FHA may appeal the denial of an application for vendorization pursuant to Title 17, Section 54380.

(b) The FHA may appeal sanctions imposed pursuant to Section 56095(f)(1) through (3) to the Director.

(c) The FHA shall file a written appeal with the Director within 30 days after notification of the imposition of a sanction.

(d) If the appeal is not filed within the time specified in subsection (c), it shall be denied unless good cause pursuant to Section 56098 is established for the late submission.

(1) Good cause shall be determined by the Director.

(2) If good cause for late submission is established, the Director shall proceed to decide the appeal in accordance with Section 56097(c).

(e) Appeals of the denial of an application for vendorization or the termination of vendorization pursuant to Welfare and Institutions Code Section 4689.4 shall be filed and conducted pursuant to Welfare and Institutions Code Section 4689.5.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New article 14 and section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

. 2. New article 14 and section refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56097. Content of Appeal and Decision.

Note • History

(a) The appeal filed pursuant to Section 56096(c) shall be in writing and shall include, but not be limited to, the following:

(1) The appellant's:

(A) Name, business address, and telephone number; and

(B) Vendor identification number, service code and subcode, if applicable.

(2) Identification of the action being appealed;

(3) The specific basis for the appeal; and

(4) All supporting documentation and any other information necessary to substantiate and/or justify the appeal, including the specific regulation used as the basis for the appeal.

(b) Within 15 days after receipt of the appeal, the Director shall review the appeal to determine whether the appeal contains the information required by subsection (a)(1) through (4).

(1) If all the required information has been submitted, the Director shall render a decision pursuant to subsection (c).

(2) If all the required information has not been submitted and/or additional information is needed, the Director shall request the information in writing from the appellant.

(3) The appellant shall submit the required or additional information to the Director within 15 days after receipt of the request.

(A) If the information is not submitted within the time specified in subsection (b)(3), the appeal shall be deemed to be withdrawn and no further action will be taken unless the appellant establishes good cause pursuant to Section 56098.

1. If good cause for late submission is established, the Director shall proceed with the appeal and render a decision pursuant to subsection (c).

(B) If the information is submitted but does not comply with the request, the appeal shall be deemed withdrawn and no further action will be taken.

(c) The Director shall render a decision on the appeal within 60 days after receipt of all required and/or requested information. The decision shall include, but not be limited to:

(1) Date of the decision;

(2) Identify the specific issue(s) in dispute;

(3) Rule on each issue identified;

(4) State the facts supporting each ruling; and

(5) Specify the statutes and/or regulations upon which each ruling is based.

(d) A written copy of the decision shall be mailed to the appellant within 15 days after the decision is rendered.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsections (a) and (c), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56098. Good Cause.

Note • History

(a) For the purposes of Sections 56096(d) and 56097(b)(3)(A), good cause for a failure to act includes but is not limited to:

(1) A violent act of nature, including, but not limited to, flood, earthquake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by individuals other than the appellant which preclude the appellant from filing a timely appeal.

(b) The appellant shall, within 60 days after the incident giving rise to its claim of good cause, submit to the Director the basis for the claim of good cause and all supporting documents or other evidence substantiating the claim.

(c) The Director shall, within 30 days of receipt of the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(d) The Director shall notify the appellant in writing of the decision.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§56099. Review of Documents Only.

Note • History

(a) An appeal made pursuant to this Article shall be decided only on the merits of the documents submitted.

(b) There shall not be oral testimony or argument.

(c) Nothing in Sections 56096 through 56099 shall preclude the regional center and the appellant from holding an informal conference at any time to discuss or resolve the issues in dispute.

NOTE

Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Institutions Code.

HISTORY

1. New section and form DS5407 filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-21-95 or emergency language will be repealed by operation of law on the following day.

2. New section and form DS5407 refiled 11-14-95 as an emergency; operative 11-14-95 (Register 95, No. 46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Subchapter 4.2. Intermediate Care Facility (ICF); Intermediate Care Facility/Developmentally Disabled (ICF/DD); Intermediate Care Facility/Developmentally Disabled-Habilitative (ICF/DD-H); Intermediate Care Facility/Developmentally Disabled-Nursing (ICF/DD-N); Skilled Nursing Facility (SNF) Monitoring Requirements

Article 1. Definitions

§56100. Meaning of Words.

Note • History

A word or a phrase shall have its usual meaning unless the context or a definition clearly indicates a different meaning. Words and phrases used in their present tense include the future tense. Words and phrases in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct. “May” denotes permissive conduct.

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4648.1 and 4742, Welfare and Institutions Code.

HISTORY

1. New subchapter 4.2 (articles 1-2), article 1 (sections 56100-56101) and section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day. For prior history of article 1 (sections 56550-56609) see Register 91, No. 14.

2. New subchapter 4.2 (articles 1-2), article 1 (sections 56100-56101) and section refiled 10-26-98 as an emergency; operative 10-26-98 (Register 98, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-23-99 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-26-98 order, including amendment of subchapter heading, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56101. Definitions.

Note • History

(a) The following definitions shall apply to the regulations set forth in this subchapter:

(1) “Consumer” means a person who has a disability which meets the definition of “developmental disability” as specified in Welfare and Institutions Code, Section 4512(d).

(2) “Consumer's Authorized Representative” means a person who meets any of the qualifications for an “authorized representative” as set forth in Welfare and Institutions Code Section 4701.6.

(3) “Facility Representative” means a person who is employed or designated by the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF to represent that facility.

(4) “Immediate Danger” means an immediate and serious threat having a high probability that serious harm or injury to the consumer's health and safety could occur at any time, or already has occurred and may occur again if the consumer(s) is not protected effectively from the harm or injury or the threat to the consumer's health and safety is not removed.

(5) “Intermediate Care Facility (ICF)” means an Intermediate Care Facility as defined in Health and Safety Code Section 1250(d).

(6) “Intermediate Care Facility/Developmentally Disabled (ICF/DD)” means an Intermediate Care Facility/Developmentally Disabled as defined in Health and Safety Code Section 1250(g).

(7) “Intermediate Care Facility/Developmentally Disabled/Habilitative (ICF/DD-H)” means an Intermediate Care Facility/Developmentally Disabled-Habilitative as defined in Health and Safety Code Section 1250(e).

(8) “Intermediate Care Facility/Developmentally Disabled/Nursing (ICF/DD-N)” means an Intermediate Care Facility/Developmentally Disabled-Nursing as defined in Health and Safety Code Section 1250(h).

(9) “Lanterman Act Individual Program Plan (IPP)” means a written plan for consumer services developed by the consumer's planning team in accordance with the provisions of Welfare and Institutions Code Sections 4646 and 4646.5.

(10) “Regional Center” means a private nonprofit diagnostic, counseling and service coordination center for developmentally disabled persons and their families which is established and operated pursuant to Welfare and Institutions Code Sections 4620 through 4669.

(11) “Regional Center Representative” means a person who is employed or designated by the regional center to represent that agency.

(12) “Skilled Nursing Facility (SNF)” means a skilled facility as defined in Title 22, California Code of Regulations, Section 51121.

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4502 and 4742, Welfare and Institutions Code; Section 1250, Health and Safety Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

2. New section refiled 10-26-98 as an emergency; operative 10-26-98 (Register 98, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-23-99 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-26-98 order, including amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

Article 2. Monitoring

§56102. State Developmental Centers.

Note • History

The requirements of Subchapter 4.2 shall not apply to State Developmental Centers.

NOTE

HISTORY

1. New article 2 (sections 56102-56104) and section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

2. New article 2 (sections 56102-56104) and section refiled 10-26-98 as an emergency; operative 10-26-98 (Register 98, No. 44). A Certificate of Compliance must be transmitted to OAL by 2-23-99 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-26-98 order, including renumbering of former section 56102 to section 56103 and new section 56102, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§56103. Service Delivery Monitoring.

Note • History

(a) The regional center representative shall meet with the consumer at least quarterly to review the consumer's progress toward achieving his/her Lanterman Act IPP objectives.

(1) At least two of the quarterly meetings per year required by subsection (a) shall take place in the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF and a facility representative shall be present at these meetings.

(2) Other quarterly meetings may take place at a location other than the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF at a site acceptable to the consumer.

(3) A maximum of two of the quarterly meetings per year pursuant to subsection (a) may be conducted during an unannounced visit pursuant to Welfare and Institutions Code Section 4648.1(a), provided the requirement specified in subsection (b) is met.

(4) The regional center representative shall provide advance notification to the facility, the consumer's authorized representative, if any, and the consumer of the date and time of the meeting required by subsection (a) if the meeting is to be announced.

(5) When the consumer's authorized representative is unable to attend the meeting required by subsection (a), or the meeting is unannounced pursuant to Welfare and Institutions Code 4648.1(a), the regional center representative shall confer with the consumer's authorized representative regarding the consumer's progress toward achieving his/her Lanterman Act IPP objectives.

(b) The regional center representative shall review the documentation of the implementation and progress toward achievement of the consumer's Lanterman Act IPP objectives.

(c) When the meeting is announced, and the notification requirements of (a)(4) have been met, the regional center representative shall meet privately with the consumer when requested by the consumer or the consumer's authorized representative, if any.

(d) The regional center representative may review the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF's records and accounts of the consumer's cash resources, personal property and valuables.

(e) Upon completing the reviews specified in subsections (a) and (b), the regional center representative shall complete a written progress report which includes, but is not limited to:

(1) The date of the meeting(s) required by subsection (a) and the review required by subsection (b);

(2) Documentation of the meeting(s) required by subsection (a);

(3) Any changes in the consumer's needs for services and supports and all actions taken in response to those changes;

(4) A summary of the provision of services and supports to the consumer pursuant to the consumer's Lanterman Act IPP; and

(5) The signature of the regional center representative.

(f) The written progress report shall be retained by the regional center in the consumer's file.

(g) If the regional center representative finds any evidence of suspected licensing violations during a review, he/she shall report such violations immediately to the appropriate California Department of Public Health's Licensing and Certification district office.

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4502, 4648.1(a) and 4742, Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

1. New section filed 5-10-2000; operative 6-9-2000 (Register 2000, No. 19). For prior history, see Register 99, No. 8.

2. Change without regulatory effect amending subsection (g) filed 9-24-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 39).

§56104. Suspension of Placements.

Note • History

(a) The regional center shall not place new consumers into an ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF when any of the following circumstances exist at the facility:

(1) The ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF's license has been suspended;

(2) A revocation action against the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF's license is pending or has been referred to the Attorney General;

(3) The court has been petitioned for a receiver, or a receiver has been appointed, for the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF; or

(4) The Department of Health Care Services has issued written notice to the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF that the facility's certification for Medi-Cal funding will not be renewed or is being suspended.

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4501, 4502, 4502.1, 4646.5, 4648.1 and 4742, Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

3. Certificate of Compliance as to 10-26-98 order, including renumbering and amendment of former section 56103 to section 56104, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

4. Change without regulatory effect amending subsection (a)(4) filed 9-24-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 39).

§56105. Termination of Consumer(s) Residence.

Note • History

(a) The regional center shall have the authority to relocate a consumer residing in an ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF when:

(1) The consumer or the consumer's authorized representative asks for the consumer to be moved.

(2) No other agency has jurisdiction to act or an agency with jurisdiction is unable to do so in a timely manner, and the regional center has determined that:

(A) The consumer is in immediate danger; or

(B) The consumer's health or safety would be compromised by continued residence in the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF.

NOTE

HISTORY

1. Renumbering and amendment of former section 56104 to section 56105 filed 2-17-99; operative 2-17-99 (Register 99, No. 8).

§56610. Compliance.

Note • History

NOTE

Authority cited: Section 4748, Welfare and Institutions Code. Reference: Sections 4746 and 4748, Welfare and Institutions Code.

HISTORY

1. Repealer filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

Subchapter 5. Standards for Nonresidential Services

Article 1. Definitions

§56702. Terms Defined in Other Subchapters.

Note • History

(a) As used in this subchapter, the following words and phrases have the meanings specified in section 54302 of these regulations;

(1) Activity Center

(2) Adult Day Programs

(3) Adult Development Center

(4) Authorized Consumer Representative

(5) Behavior Management Program

(6) Community-based Day Programs

(7) Community Integration

(8) Consumer

(9) Days

(10) Department

(11) Direct Care Staff

(12) Direct Services

(13) Functional Skills

(14) Generic Agency

(15) Independent Living Program

(16) Individual Program Plan (IPP)

(17) In-home Respite Services

(18) Infant Development Program

(19) Interdisciplinary Team (ID Team)

(20) Natural Environment

(21) Program Preparation Functions

(22) Regional Center

(23) Self-Care

(24) Social Recreation Program

(25) Special Incident Report

(26) Staffing Ratio

(27) Vendor

NOTE

Authority cited: Sections 4648, 4690, 4690.2 and 4691, Welfare and Institutions Code. Reference: Sections 4646, 4648, 4690, 4690.2 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(4), repealing subsection (a)(6), renumbering subsections, and adding new subsection (a)(8) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56704. Additional Terms Defined.

Note • History

(a) As used in this subchapter, the following words and phrases have the following meanings:

(1) “Care Giver” means an adult, other than a parent, who has primary responsibility for the care and custody of a child. A care giver may be a relative, such as an aunt, uncle, or grandparent, or an unrelated adult, such as a foster care parent;

(2) “Center-Based Environment” means within a day care facility or on the grounds of such a facility;

(3) “Consumer Program Coordinator” means the individual specified in Welfare and Institutions Code, section 4648 (a) who has the responsibility for, implementing, overseeing, and monitoring, the consumer's IPP and for maintaining the consumer's case management or service coordination file. Consumer program coordinator is synonymous with regional center case manager, counselor or service coordinator;

(4) “Employment Training” means individually planned activities and instruction which enable adults with developmental disabilities to obtain and maintain paid work and which can occur in group or individual situations. This term is synonymous with vocational training;

(5) “Non-mobile Persons” means persons who are confined to wheelchairs or gurneys, and who are unable to move from one place to another place independently;

(6) “Personal Needs”, means a condition or situation pertaining to one s own intimate and immediate care, such as eating, toileting, personal hygiene;

(7) “Program Curriculum” means the array of consumer training services offered by a vendor; and

(8) “Self-Help” means those skills and abilities which are considered as normal developmental milestones for non disabled children.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. Standards for All Community-Based Day Programs

§56710. General Requirements.

Note • History

(a) Community-based day program vendors shall adopt and review, annually, a written internal grievance procedure for consumers pursuant to Welfare and Institutions Code, Section 4705.

(b) A community-based day program vendor may subcontract for provision of a portion of the direct service if both of the following conditions are met:

(1) The unique needs of the consumer(s) require an intermittent service for a portion of the direct service day which can only be provided by a licensed professional not available within the program staff; and

(2) Written approval of the regional center is obtained.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4705 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (c)-(c)(2) and amendment of Note filed as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (c)-(c)(2) and amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection (c) and amendment of Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Change without regulatory effect amending subsections (a) and (b)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56711. Waiver of Service Standards.

Note • History

(a) Regional centers, in negotiating service contracts pursuant to Section 57540 or a lower level of payment pursuant to 57300(d), may waive or modify any of the following program standards for the duration of the service contract or lower level of payment:

(1) Personnel functions and qualifications specified in Sections 56724(a), (b), (c) and (e), 56754, and/or 56770;

(2) Staff training requirements specified in Section 56726 and/or 56774; and/or

(3) Program evaluation requirements specified in Section 56732.

(b) Regional centers may waive or modify any of the program standards pursuant to (a) above only if waiver or modification of the program standard(s) will not adversely affect the health and safety of the consumers or place the consumers in a more restrictive environment.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147 and Section 4791(i), Welfare and Institutions Code. Reference: Section 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Amendment of subsection (a)(1) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsection (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56712. Program Design.

Note • History

(a) The program design shall include the following items:

(1) A program description which includes:

(A) The purpose and goals of service;

(B) Anticipated consumer outcomes resulting from participation in the program stated in measurable terms;

(D) Description of the location(s) in which consumer training occurs, such as a center-based environment, the consumer's place of residence or a natural environment;

(E) Consumer attendance policy which includes the following:

1. The requirement for the vendor to notify the regional center on or before a consumer's fifth consecutive day of unplanned absence;

2. The attendance requirements for consumers to remain enrolled in the program; and

3. The efforts the program will make to assure attendance at the program as frequently as determined necessary by the ID Team.

(F) Statement of the staffing ratio required pursuant to Section 56756 or 56772 of these regulations;

(G) Schedule of the vendor's direct service operating hours including a sample of a current weekly schedule; and

(H) A staff training plan, if developed pursuant to Sections 56726 and 56774 of these regulations, if applicable.

(2) A description of the entrance/exit criteria pursuant to Sections 56714 and 56746 of these regulations, if applicable, including the intake procedure and any screening processes used by the vendor;

(3) A description of the process used to determine how the vendor will assist each consumer served in achieving his/her IPP objectives for which the vendor is responsible including:

(A) Consumer assessment procedures, timelines, and instruments used, including an explanation of how each instrument is applicable in assessing the consumer's needs;

(B) Utilization of assessment data for determining the specific activity and program services that consumers receive; and

(C) Evaluation procedures used to determine the extent of a consumer's progress toward achieving the specific outcomes in each IPP objective for which the vendor is responsible.

(4) A description of the method of evaluating program effectiveness in accordance with Section 56732 of these regulations; and

(5) A description of the internal consumer grievance procedures required pursuant to Section 56710(a) of these regulations.

(b) When modifications are made to the program design which constitute a change in the type of services provided, the vendor must, at least 30 days prior to the change, notify the consumers or their authorized consumer representatives and submit to the vendoring regional center, a revised program design as described in (a) above. A revised program design is required when any of the following elements of the program design are changed:

(1) Locations in which consumer training occurs;

(2) Curriculum training components;

(3) Existing approved staffing ratio;

(4) Approved service code;

(5) Entrance and/or exit criteria;

(6) Hours of operation.

(c) A rate adjustment request which results from a program design change shall be submitted to the vendoring regional center prior to December 1 of the current calendar year in accordance with section 57922 of these regulations.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Section 4691, Welfare and Institutions Code. Reference: Chapter 1011, Statutes of 1992, Section 11, Sections 4646, 4646.5, 4648, 4691, 4690.2, 4705 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Amendment of subsections (a)(1)(A)-(a)(5) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56714. Vendor Entrance and Exit Criteria for Consumers.

Note • History

(a) The vendor shall have written entrance and exit criteria that shall be used by a consumer's ID Team to determine the appropriateness of the vendor's program for meeting the objective(s) of an individual consumer's IPP. The criteria shall include all of the following:

(1) Ages of consumers to be served;

(2) Any other prerequisites required for participation in the program; and

(3) The level of skills and ability development which would indicate that placement in the vendor's program may no longer meet the consumer's needs.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56716. Consumer Placement Procedures.

Note • History

(a) Interdisciplinary Teams shall identify community-based day programs which can meet the objectives of the consumer's IPP developed pursuant to Welfare and Institutions Code, section 4646.5 and which are located as close to the consumer's residence as possible as required by Welfare and Institutions Code, section 4501.

(b) Placement in a program shall occur providing all of the following conditions exist:

(1) The consumer or authorized consumer representative consents to the placement;

(2) The regional center concurs that the placement is appropriate;

(3) The consumer's needs can be met within the staffing ratio approved for the program pursuant to section 56756 or 56772 of these regulations;

(4) The consumer meets the vendor's entrance, criteria; and

(5) The vendor agrees to the consumer's placement in the program.

(c) A consumer's continued placement in a community-based day program shall be based upon a determination by the ID Team during the IPP review that:

(1) There is documentation that all of the conditions in paragraph (b) above exist; and

(2) The consumer has been assisted by the program in making reasonable progress toward the IPP objective(s) for which the consumer was originally placed into the program.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Chapter 1011, Statutes of 1992, Section 11; and Sections 4501, 4646, 4646.5, 4648, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56718. Consumer Placement and Funding Termination Procedures.

Note • History

(a) Funding of a consumer's placement in a vendor's program shall be terminated when one or more of the following occur:

(1) The regional center issues a written determination stating that continued participation jeopardized the consumer's health and safety;

(2) The consumer or authorized consumer representative makes a written or oral request to the regional center to discontinue participation or the consumer can no longer attend the program due to an unanticipated change in residence;

(3) The ID Team has determined through a consumer evaluation that the vendor's program no longer meets the consumer's needs;

(4) The vendor determines that its program may no longer meet the consumer's needs; or

(5) The consumer, or authorized consumer representative acting on behalf of the consumer, consents to an alternate placement identified by the ID Team as being able to meet the consumer's needs and as being more cost effective. The alternate placement shall be considered more cost effective if the combined cost of the alternate placement and the cost of transporting the consumer to and from the alternate placement is less than the combined cost of the consumer's current placement and the cost of transporting the consumer to and from the current placement.

(b) When a determination is made pursuant to (a)(1), (3), (4) or (5) above, the basis for the determination shall be documented in writing in the consumer's case file by the regional center for (a)(1) and/or (3) and/or (5) and by the vendor for (a)(4). The regional center shall also include written documentation in the consumer's file that the consumer or authorized consumer representative has been informed of the fair hearing rights pursuant to Welfare and Institutions Code, Sections 4701, 4705 and 4710 when the determination is made pursuant to (a)(1), (3) or (5) above.

(c) When the regional center or the vendor proposes to terminate the consumer's placement in the vendor's program, other than in accordance with (a)(1) or (a)(2) above, the initiating party shall notify the other party and the consumer in writing at least 30 days prior to the proposed termination date. Such notice shall include a written statement of reasons for the termination. If the regional center terminates the placement prior to the end of the 30 day notice period, except as specified in (a)(1) and (a)(2) above, the vendor shall be paid for those days of program services during that 30 days period for which the consumer would have been authorized to receive services as identified in the IPP. Funding shall not continue under either of the following circumstances:

(1) There is agreement between the regional center, vendor, and the consumer or authorized consumer representative for an earlier termination date. In this instance, funding shall be provided through the date the consumer leaves the program.

(2) The consumer's vacated place in the program has been filled by another consumer. In this instance, funding for the consumer who is no longer in the program shall cease on the date the substitute consumer begins attending.

(d) When the conditions specified in (a)(1) above exist, termination shall be immediate and no further payment shall be made, except as specified in (e) below.

(e) When the conditions specified in (a)(1), (a)(3) or (a)(5) above exist, termination of funding shall not be made if the consumer files a fair hearing request pursuant to Welfare and Institutions Code, Sections 4700 through 4730.

(f) When the conditions specified in (a)(2) above exist, funding shall terminate immediately upon the consumer's nonparticipation. The regional center shall notify the vendor in writing of the reason that the consumer no longer wishes to participate in the program. Such notification shall be made within 10 days of the date the regional center is notified by the consumer or authorized consumer representative.

(g) A vendor may exclude a consumer from participation in the program during periods when the vendor determines that the consumer is a threat to the health and safety of other individuals in the program. Such exclusion shall be followed by a meeting scheduled by the vendor within three working days to include the consumer program coordinator, the consumer and authorized consumer representative to discuss the basis of the exclusion and any program changes that may be required. The provisions of this paragraph shall not apply to exclusions that are made in accordance with a prior written agreement with the regional center pertaining to the individual consumer.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4691, and 4700 through 4730, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(4) and Note and new subsection (a)(5) filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(4) and Note and new subsection (a)(5) refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(5), (b) and (e) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56720. Consumer IPP Documentation.

Note • History

(a) The vendor shall be responsible for establishing, maintaining, and modifying, as necessary, documentation regarding the manner in which it will assist each consumer served in achieving his/her IPP objective(s) for which the vendor is responsible.

(b) The following time lines shall be followed in establishing, maintaining, and modifying the documentation required in (a) above.

(1) The regional center shall provide the vendor a written copy of the consumer's IPP within 30 days following:

(A) The consumer's admission to the vendor's program; and

(B) Any modification made by the ID Team to the consumer's IPP.

(2) The vendor shall prepare the documentation required in (a) above within 30 days of receipt of the IPP pursuant to (b)(1)(A) or (B) above.

(1) Review the consumer's performance and progress in relation to each IPP objective for which the vendor is responsible; and

(2) Submit written documentation to the regional center which includes all of the following:

(A) An evaluation of the consumer's performance and progress based upon the review conducted pursuant to (c)(1) above;

(B) Identification of the barriers to the consumer's success in achieving the IPP objective(s) for which the vendor is responsible and how such barriers shall be overcome in the future; and

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646, 4648, 4648.1 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (c) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56722. Personnel Requirements.

Note • History

(a) Each vendor shall maintain current written job descriptions, or interagency agreements with the generic agency providing the staff, for all personnel, including staff whose wages are not paid by regional center purchase of service funds.

(b) Each job description shall include:

(1) Position title;

(2) Role and responsibility of the position within the organizational structure of the program;

(3) Duty statement;

(4) Work hours;

(5) Minimum qualifications

(6) Positions supervised, if applicable; and

(7) Reporting supervisor.

(d) Volunteers shall not be used to replace paid staff, but may be used to augment such staff, pursuant to Section 56724 of these regulations.

(e) Staff whose wages are not paid by regional center purchase of service funds shall demonstrate the minimum qualifications as identified in Section 56724 of these regulations necessary for each job function performed.

(f) The vendor is authorized to utilize consultants to develop the program design pursuant to Section 56712 of these regulations, and to develop and carry out staff development and training.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a) and (d) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (b)(4) and amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§56724. Personnel Functions and Qualifications.

Note • History

(a) Each vendor shall assign staff to carry out the duties described herein. The vendor is authorized to designate positions by different titles than those listed, but is responsible for assuring the functions described are carried out. Staff who are hired by the vendor to carry out the functions listed shall meet the minimum qualifications listed in this section.

(b) The vendor shall assign a director to carry out the administrative responsibilities for the program.

(1) The director shall have primary responsibility for the following functions:

(A) Organizing and supervising the program in accordance with the program's established policies;

(B) Overseeing the areas of budgeting, program design and implementation, project planning, staff development and training, evaluation and the direction of program services; and

(2) The vendor is authorized to delegate to the director additional functions not identified in (b)(1) above and which are directly related to the overall administration of the program; and

(3) The director shall possess the minimum qualifications specified in section 56754 (a) or 56770 (a) of these regulations.

(1) The supervisor shall have primary responsibility for one or more of the following functions:

(A) Selection, training, and supervision of assigned staff;

(B) Planning, managing, coordinating and evaluating, assigned staff efforts to achieve the program's objectives and consumer outcomes;

(C) Coordinating with the regional center the implementation of consumer IPP objectives for which the vendor is responsible;

(D) Assessing the program's effectiveness in achieving consumer IPP objectives; and

(E) Identifying barriers to consumer success in obtaining the IPP objective(s) and how those shall be overcome pursuant to section 56720(c)(2)(B) of these regulations.

(2) The vendor is authorized to delegate to the supervisor additional functions not identified in (c)(1) above and which are directly related to the supervision of the program.

(3) The supervisor shall possess the minimum qualifications specified in section 56754 (b) or 56770 (b) of these regulations.

(d) The vendor shall assign staff to carry out direct service and program preparation functions for the program.

(1) Each direct care staff person shall be responsible for the following functions:

(A) Implementing program curricula;

(B) Directly delivering individual and group learning experiences to assist each consumer served in obtaining his/her IPP objective(s) for which the vendor is responsible;

(D) Participating in consumer assessment, planning and evaluation processes.

(2) The vendor shall not assign other duties to the direct care staff from the above noted functions during hours when direct service is provided.

(3) The direct care staff shall possess the following minimum qualifications:

(A) Education and experience required in the job description; and

(B) The ability to perform the functions required in the program design.

(e) The vendor shall assign staff to carry out administrative support functions, including clerical, janitorial, and bookkeeping or accounting.

(1) The vendor is authorized to hire staff directly to carry out such functions or to secure the performance of such functions from other entities.

(2) The administrative support staff shall demonstrate experience and the ability to perform the functions described in the job description.

(f) The vendor is authorized to use volunteers to augment paid staff providing the conditions in sections 56722 (a) through (d) of these regulations are met.

(g) The vendor is authorized to assign staff to operate a motor vehicle for the purpose of carrying out assigned functions. The vendor shall assure that such staff possess a current valid driver's license which is appropriate for the type of vehicle to be driven.

(h) The vendor shall assure that any consultant it utilizes shall comply with all California licensing, certification, registration and vendorization requirements applicable to the functions to be carried out.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (c)(1)(B)-(c)(1)(E) and (d)(1)(B)-(d)(1)(D) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56726. Staff Training.

Note • History

(a) A vendor may develop and implement a written staff training plan for new employee orientation and ongoing employee staff training.

(b) If a training plan is developed pursuant to (a) above, it shall at a minimum:

(1) Describe the amount, type, subject, and frequency of training for different categories of staff, including staff who are not paid by regional center purchase of service funds or who are volunteers;

(2) Describe training curricula and techniques, including training in consumer safety procedures to be used in the event of an emergency; and

(3) Indicate time frames for accomplishing the training.

(1) Be provided within the first two weeks of employment;

(2) Be based on the prior experience and qualifications of the employee and the needs of the vendor; and

(3) Use a curriculum that includes, but is not limited to:

(A) Welfare and Institutions Code, sections 4502, 4504, 4518, 4646.5, 4648, 4655, 4705, 4710 and 4710.5;

(B) Consumer's rights as defined in title 17, section 50510;

(D) The policies, procedures and practices of the vendor's program; and

(E) Specific job requirements for that employee.

(d) If ongoing staff training is developed pursuant to (a) above, it shall at a minimum:

(1) Be provided for all direct care staff and supervisors on an annual basis; and

(2) Use a curriculum that addresses the particular instructional methodology and techniques used by the vendor in training consumers to meet their IPP objectives for which the vendor is responsible.

(e) The vendor shall document all training provided to employees.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Chapter 1011, Statutes of 1992, Section 11; and Sections 4646.5, 4648.1, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsection (a)(1) and amendment of Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsections (b)(2), (c)(3)(B) and (d)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56728. Program Records.

Note • History

(a) A vendor shall develop the following records and maintain them at its business office:

(1) The program design as required in Section 56712(a) of these regulations and changes made to the program design;

(2) Employee time sheets specifying each employee's shift hours;

(3) Employee payroll records;

(4) Consumer attendance, maintained daily, indicating the date of service;

(5) Documentation of all training attended by each employee;

(6) All records used by the vendor in completing the DS 1897 (12/92) submitted to the Department for a rate determination pursuant to Sections 57430 through 57534 of these regulations;

(7) All written approvals from regional centers or the Department required by these regulations;

(8) The program evaluation required by Section 56732 of these regulations; and

(9) The written description of the vendor's organizational structure as specified in Section 54326(b) of these regulations.

(b) Records required pursuant to (a)(2) through (a)(7) above shall be retained for five years from the date of origination or until audit adjustments have been resolved, whichever is longer.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648, 4648.1, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(6) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(6) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a)(6) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a)(4) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56730. Consumer Records.

Note • History

(a) Vendors shall maintain consumer information and records as confidential documents pursuant to Welfare and Institutions Code, sections 4514 through 4518, and shall also maintain consumer confidentiality as required in Health and Safety Code, sections 199.20 through 199.27.

(b) Vendors shall maintain an individual consumer case file for each consumer admitted to the program.

(1) The most current copies of:

(A) Emergency and personal identification information, including the consumer's address, telephone number, names and telephone numbers of residential care provider, relatives, and/or guardian or conservator, physician's name(s) and telephone number(s), pharmacy name, address and telephone number, and health plan if appropriate;

(B) A medical history which includes:

1. Current medications;

2. Known allergies;

3. Medical disabilities;

4. Infectious, contagious or communicable conditions;

5. Special nutritional needs; and

6. Immunization records.

(C) Any consumer medical, psychological, and social evaluations identifying the consumer's ability and functioning level, which shall be supplied by the regional center;

(D) Authorization for emergency medical treatment;

(E) Documentation that the consumer and/or the authorized consumer representative has been informed of his/her personal rights;

(F) The IPP as prepared and forwarded by the regional center; and

(G) Consumer IPP documentation as required by section 56720 of these regulations.

(2) All copies of:

(A) Special incident reports, if any;

(B) Case notes reflecting important events or information not documented elsewhere;

(D) Documentation of reviews conducted pursuant to section 56732 (c) of these regulations, including summaries of the data collection that indicate consumer performance and progress toward consumer outcomes for which the vendor is responsible.

(3) Documentation of attempts to obtain required information not contained in the consumer record.

(d) Records pertaining to the consumer shall be stored at the program site in a secure and locked place which shall be readily accessible. The vendor is authorized to keep pertinent consumer data, including, but not limited to, emergency telephone numbers, important medical data, current IPP objectives, and data collection sheets with the consumer when the consumer is participating in an activity or training at a location which is away from the program's central filing area.

(e) The individual consumer, case file shall be retained for five years following the consumer's termination from the program.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4514, 4646, 4646.5, 4648, 4648.1 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56732. Program Evaluation.

Note • History

(a) Each fiscal year the vendor shall conduct an annual review of its program's effectiveness in relation to the program design. This shall include a documented review of:

(1) The program's objectives as required in Section 56712(a)(1)(B) of these regulations; and

(2) Aggregate data on progress in relation to the IPP objectives for which the vendor is responsible.

(b) The vendor shall have a written evaluation design specifying:

(1) The purpose of the evaluation;

(2) The type of data to be collected and used;

(3) The frequency of data collection;

(4) Data collection and analysis methods;

(5) A description of the distribution, communication of, and actions taken upon the results of the evaluation;

(6) The frequency of evaluations; and

(7) The reason this particular evaluation design was selected and how it relates to program objectives.

(c) The vendor shall submit to the vendoring regional center, user regional centers and the Department a written summary of the annual program evaluation which shall be maintained in the vendor file at the vendoring regional center and at the Department. The vendor shall maintain on file pursuant to Section 56728 of these regulations the full program evaluation for review by the regional center and the Department.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (a)(1) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56734. Effective Date of Compliance.

Note • History

(a) The effective date of compliance of community-based day programs with the provisions of sections 56710 through 56734, 56740 through 56756, and 56760 through 56774 of these regulations shall be as follows:

(1) Programs vendored after the effective date of these regulations shall be in compliance with these provisions upon the date of vendorization.

(2) Programs vendored prior to the effective date of these regulations which:

(A) Do not meet one or more provision(s) specified in sections 56710 through 56734, 56740 through 56756, and 56760 through 56774 of these regulations, except for the licensing provisions in sections 56740 and 56760 of these regulations, shall have a maximum of one year from the effective date of these regulations to come into compliance with the applicable provision(s).

(B) Equal or exceed any provision(s) specified in sections 56710 through 56734, 56740 through 56756, and 56760 through 56774 of these regulations, shall be deemed in compliance with the applicable provision(s) upon the effective date.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 3. Additional Standards for Adult Day Programs

§56740. General Requirements.

Note • History

In addition to the general requirements specified in section 56710 of these regulations, adult day program vendors shall comply with applicable licensing requirements pursuant to the Health and Safety Code, sections 1500 through 1569.87.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§56742. Program Curriculum and Components.

Note • History

(a) The program curriculum shall:

(1) Be developed by the vendor based upon:

(A) The program's philosophy and goals as stated in the program design; and

(B) The needs of the consumer population to be served.

(2) Reflect a pattern of activities similar to those of non-disabled adults; and

(3) Be designed to develop and maintain the consumer's functional skills.

(b) The program curriculum shall be developed as follows:

(1) Activity centers, adult development centers, and behavior management programs shall have at least one of the training components specified in (b)(1)(A) through (D) below and shall be conducted in center-based and/or natural environments:

(A) Self-advocacy;

(B) Employment training;

(D) Self-care.

(2) Social recreation programs shall provide community integration and self-advocacy training as they relate to recreation and leisure pursuits. Social recreation programs shall be conducted in center-based and/or natural environments.

(3) Independent living programs shall have all of the functional skills training components specified in (b)(3)(A) through (M) below, and shall not be conducted in a center-based environment:

(A) Cooking;

(B) Cleaning;

(D) Menu planning;

(E) Meal preparation;

(F) Money management, including check cashing and purchasing activities;

(G) Use of public transportation in natural environments;

(H) Personal health and hygiene;

(I) Self-advocacy training;

(J) Independent recreation and participation in natural environments;

(K) Use of medical and dental services, as well as other community resources;

(L) Community resource awareness such as police, fire, or emergency help; and

(M) Home and community safety.

(4) Independent living programs may also, or in lieu of (b)(3) above, provide the supports necessary for a consumer to maintain a self-sustaining, independent living situation in the community.

(c) The curriculum for all programs shall describe the location(s) pursuant to Section 56712(a)(1)(D) of these regulations in which consumers will receive instruction and perform those skills taught.

(d) The curriculum for all programs shall describe:

(1) The schedule of consumer training activities which is designed to ensure that the entire direct services time is focused toward the achievement of the individual objectives contained in the IPP;

(2) Consumer training activities;

(3) Age appropriate materials and activities which shall be used; and

(4) Specific consumer outcomes which are anticipated from participation in each training component.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Section 11346.1, Government Code; and Sections 4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4501, 4646, 4646.5, 4648, 4651, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsection (b)(4) and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsection (b)(4) and amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (c) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56744. Consumer Eligibility for Services.

Note • History

(a) A consumer shall be eligible for an Adult Day Program pursuant to a determination of the ID Team that the consumer meets all of the following criteria:

(1) The consumer is at least 18 years of age;

(2) The consumer is not eligible for the same or similar services from a generic agency that is funded to provide the service to the general public with the exception of programs jointly funded by generic agencies and the regional center; and

(3) The consumer's IPP includes an objective(s) which can be met by an adult day program.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646, 4646.5, 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56746. Vendor Entrance and Exit Criteria for Consumers.

Note • History

(a) In addition to the criteria specified in section 56714 of these regulations, adult day program vendor entrance and exit criteria shall also include a description of the level of all of the following attributes required for participation in the vendor's program:

(1) Self-care skills;

(2) Physical and medical conditions; and

(3) Behavioral characteristics.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4648 and 4691, Welfare and Institutions Code.

HISTORY

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90, No. 36). Certificate of Compliance must be transmitted to OAL by 10-29-90 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56748. Consumer Placement Procedures.

Note • History

(a) Notwithstanding sections 56716 (b)(3) and/or (4) of these regulations, a consumer shall be eligible for placement in an adult day program pursuant to a determination of the ID Team that, while the consumer's needs exceed the level of service provided by the program, the IPP objective(s) can be addressed in such program. The ID Team shall include all of the following as documentation for the determination:(1) The factual basis and rationale leading to the decision for the alternate placement including a statement that a more appropriate program is not available;

(2) The duration of the alternate placement; and

(3) A statement that:

(A) The program provides the least restrictive environment;

(B) The health and safety of the consumer and others will not be jeopardized by the alternate placement;

(D) The conditions specified in (b) below are met.

(b) When a placement pursuant to paragraph (a) above occurs:

(1) A copy of the documentation shall be:

(A) Placed in the consumer's regional center record; and

(B) Provided to the vendor who shall maintain the copy in accordance with section 56728 of these regulations.

(2) The consumer's IPP shall be reviewed by the ID Team no less than once every six months to determine the continued appropriateness of the alternate placement.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646, 4646.5, 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56750. Consumer Placement and Funding Termination Procedures.

Note • History

In addition to the reasons specified in section 56718 (a), of these regulations, funding of a consumer's placement in a vendor's program shall also be terminated when a more appropriate program becomes available for consumers placed pursuant to section 56748 of these regulations. When such a termination occurs, the procedures specified in section 56718 (c) of these regulations shall apply.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646, 4646.5, 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56752. Personnel Requirements.

Note • History

(a) In addition to the requirements specified in section 56722 of these regulations, if consumers perform chores or work for the vendor beyond the secondary tasks resulting from a planned activity during the vendor's direct service hours, both of the following conditions shall be met:

(1) Such chores or work are identified in the consumer's IPP documentation as activities relevant to his/her achievement of specific IPP objectives; and

(2) The consumer is compensated pursuant to the requirements of the California Labor Code, sections 1191 through 1193 and 29 United States Code, sections 211 and 214.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646.5 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56754. Personnel Functions and Qualifications.

Note • History

(a) The director of an adult day program shall possess the following minimum qualifications:

(1) A bachelor's degree and a minimum of 18 months of experience in the management of a human services delivery system; or

(2) Five years of experience in a human services delivery system, including at least two years in a management or supervisory system.

(b) The supervisor of an adult day program shall possess the following minimum qualifications:

(1) Three years of experience in a human services delivery system, including at least one year in a comparable program or a bachelor's degree in a human services related field; and

(2) The demonstrated ability to provide staff training, supervision and planning.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(1)-(2) and (b)(1)-(2) and relettering and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (a)(1)-(2) and (b)(1)-(2) and relettering and amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(1)(B) and (b)(1)(A) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56756. Staffing Ratio.

Note • History

(a) A staffing ratio shall be approved for each adult day program by the Department pursuant to this section. This ratio shall be based on the program design, the curriculum as vendored, the characteristics and needs of the consumers to be served, and the number of consumers enrolled.

(b) For activity centers, adult development centers, behavior management programs, and social recreation programs, the vendor may supplement direct care staff by one staff person, six hours per day, for every ten non-mobile consumers attending. Programs serving more or less than ten non-mobile consumers shall have their supplemental staff calculated on a proportionate basis. For the purpose of this section, non-mobile means persons who are confined to wheelchairs or gurneys and who are unable to independently move from one place to another place.

(1) Vendors shall submit requests for supplemental staff in writing to the regional center.

(2) Regional centers shall notify vendors in writing that they are authorized to receive payment to maintain the staffing ratio specified in (b) above for non-mobile consumers.

(c) The vendoring regional center shall provide the Department with its recommendations for those vendors requesting a staffing ratio pursuant to (d)(1) or (e)(1) below.

(d) Activity centers shall provide a direct care staff-to-consumer ratio of 1:8.

(1) The vendor is authorized to request Department approval for modification of the staffing for an Activity Center to an overall direct care staff-to-consumer ratio of 1:7 or 1:6. A written request and justification shall be submitted to the Department by the regional center which documents the findings pursuant to the criteria listed below. The overall direct care staffing ratio shall be determined by averaging the specific staff-to-consumer ratio needed for each individual consumer. The regional center shall consider whether the activity center meets at least one of the following criteria for modification of the direct care staffing ratio of 1:8:

(A) The activity center is providing community integration or employment training in natural environments to groups of three or fewer consumers for at least two hours in duration on a daily basis.

1. If each group of consumers receives at least one two-hour session per week, then the staffing ratio shall be 1:7.

2. If each group of consumers receives at least two-hour sessions per week, then the staffing ratio shall be 1:6.

(B) The activity center is providing services to consumers whose IPPs include an objective to modify behaviors that may represent a threat to the individual, others, and/or property.

1. If consumers require intermittent spontaneous/unplanned behavior intervention to prevent or minimize disruption of activities or injury to persons or property, the staffing ratio shall be 1:7. For purposes of this paragraph and (d)(1)(C)1. below, “intermittent” means more often than once a week, but less than once per day.

2. If consumers require frequent spontaneous/unplanned behavior intervention to prevent or minimize disruption of activities or injury to persons or property, the staffing ratio shall be 1:6. For purposes of this paragraph and (d)(1)(C)2. below, “frequent” means at least once per day.

3. Such behaviors may include:

a. Physical aggression resulting in physical injury to others;

b. Displays of self-injurious behavior that could result in serious injury;

c. Causing severe damage to property;

d. Running or wandering away;

e. Smearing of feces;

f. Displays of inappropriate sexual behavior.

1. If consumers require intermittent, as defined in (d)(1)(B)1. above, assistance or supervision in eating, toileting or caring for their personal hygiene needs, then the staffing ratio shall be 1:7.

2. If consumers require frequent, as defined in (d)(1)(B)2.above, assistance or constant supervision in eating, toileting or caring for their personal hygiene needs, then the staffing ratio shall be 1:6.

(2) If a given consumer meets more than one criterion as specified in (d)(1)(A) through (d)(1)(C) above, the staffing ratio which provides the most direct care staff for the vendor shall prevail.

(3) Modifications approved under (d)(1) above shall be reviewed at least annually by the regional center to assure that the condition on which the modification was approved continues.

(e) Adult development centers shall provide a direct care staff to-consumer ratio of 1:4.

(1) The vendor is authorized to request Department approval for modification of the staffing for an Adult Development Center to an overall direct care staff-to-consumer ratio of 1:3. A written request and justification shall be submitted to the Department by the regional center which documents the findings pursuant to the criteria listed below. The overall direct care staffing ratio shall be determined by averaging the specific staff-to-consumer ratio needed for each individual consumer. The regional center shall consider whether the Adult Development Center meets the following criteria for modification of the direct care staffing ratio of 1:4.

(A) The Adult development center is providing community integration or employment training in natural environments to groups of three or fewer consumers for at least two hours duration on a daily basis with each group of consumers receiving at least two two-hour sessions per week; and

(B) The consumers receiving community integration or employment training require constant assistance and constant supervision. For purposes of this section, “constant assistance” means providing direct physical aid and help with self-care needs at all times during service hours. For purposes of this section “constant supervision” means maintaining visual or physical proximity to an individual consumer during all service hours.

(2) Modifications approved under (e)(1) above, shall be reviewed at least annually by the regional center to assure that the conditions on which modifications were approved continue.

(f) Behavior management programs shall provide a direct care staff-to-consumer ratio of 1:3.

(g) Social recreation programs shall provide a direct care staff-to-consumer ratio of 1:10.

(h) Independent living programs shall provide a direct care staff-to-consumer ratio of:

(1) 1:1 when the service is conducted on an individual basis;

(2) 1:2 when the service is provided to two consumers; or

(3) 1:3 when the service is conducted on a group basis.

(i) The vendor shall maintain the approved staffing ratio during its direct service hours. The vendor shall not be required to schedule the ratio with each subgroup of consumers at all times, but shall maintain both:

(1) The ratio of staff on duty to consumers in attendance during all service hours which shall be determined by a numerical comparison of the number of individuals on duty as direct care staff with the number of consumers in attendance. If the numerical comparison results in a fraction, more than one-half of a staff person shall be rounded up to the next whole number. Less than one-half of a staff person shall be rounded up to the next one-half of a whole number. One-half of a staff person shall not be rounded.

(2) Sufficient supervision for each subgroup to protect the health and safety of the consumers.

(j) The vendor shall not count consumers, or subcontractors authorized pursuant to section 56710 (b) of these regulations, as staff for the purpose of computing the direct care staff-to-consumer ratio or for rate-setting purposes.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsection (h)(2), subsection redesignation and amendment of Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Additional Standards for Infant Development Programs

§56760. General Requirements.

Note • History

(a) In addition to the general requirements specified in section 56710 of these regulations, infant development program vendors shall:

(1) Comply with applicable licensing requirements pursuant to Health and Safety Code, sections 1596.70 through 1596.894; and

(2) Make the grievance procedure specified in section 56710(a) of these regulations available to the consumer's parent, care giver or authorized consumer representative.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648, 4691 and 4705, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56762. Program Design.

Note • History

(a) In addition to the items specified in section 56712 (a) of these regulations, the program design for infant development programs shall also include the written procedures used by the vendor for review of consumer assessment information. Such information shall include the following areas if applicable to the consumer's IPP:

(1) Audiology services;

(2) Medical services;

(3) Nursing services;

(4) Nutritional evaluation;

(5) Occupational and/or physical therapy;

(6) Psychological services;

(7) Social work services;

(8) Speech pathology; and

(9) Visual screening.

(b) In addition to the items specified in Section 56712(a) of these regulations, the program design for infant development programs shall also include the expected level of participation and attendance by parents, care givers or authorized consumer representatives in the infant development program.

(c) When modifications are made to the program design which constitute a change in the type of services provided, the vendor must, at least 30 days prior to the change, notify the consumer's parents, care givers or authorized consumer representatives and submit to the vendoring regional center a revised program design as described in (a) above. A revised program design is required when any of the following elements of the program design are changed:

(1) Locations in which consumer training occurs;

(2) Curriculum training components;

(3) Existing approved staffing ratio;

(4) Approved service code;

(5) Entrance and/or exit criteria;

(6) Hours of operation.

(d) A rate adjustment request which results from a program design change shall be submitted to the vendoring regional center prior to December 1 of the current calendar year in accordance with section 57922 of these regulations.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4514 through 4518, 4646.5, 4648, 4685, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (a), (b), (c) and (c)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56764. Program Curriculum and Components.

Note • History

(a) The program curriculum for infant development programs shall be developed by the vendor based upon the program's philosophy and goals and the needs of the population to be served.

(b) The program curriculum for infant development programs shall include the following items:

(1) Intervention activities which promote development in all of the following areas according to basic principles of child growth and development:

(A) Physical development;

(B) Cognitive development;

(D) Psychosocial development; and

(E) Self-help and feeding.

(2) Activities which:

(A) Increase parent, care giver or authorized consumer representative and child interaction by training parents, care givers or authorized consumer representatives to recognize and respond to the child's unique characteristics, temperament, and non-verbal communication signaling distress or the need for interaction;

(B) Increase and develop parents, care givers or authorized consumer representatives and child interpersonal relationships through the day-to-day activities, such as bathing, dressing, feeding and comforting.

(3) Parenting skills relating to the parents' givers' care or authorized consumer representatives' ability to care for the special needs of the child including:

(A) Demonstrations of developmentally appropriate activities for the child;

(B) Training and consultation; and

(C) Access to various developmentally appropriate equipment and material, and the use of play as a vehicle for intervention.

(c) The curriculum for all programs shall describe the location(s) pursuant to Section 56712 (a)(1)(D) of these regulations in which consumers will receive instruction and perform those skills taught.

(d) The curriculum for all programs shall describe:

(1) The schedule of training activities which is designed to ensure that the entire direct services time is focused toward the achievement of the individual objective(s) contained in the IPP;

(2) Training activities;

(3) Age appropriate materials and activities which shall be used; and

(4) Specific consumer outcome(s) which are anticipated from participation in each training component.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147, and Sections 4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648, 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Amendment of subsection (c) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsections (b)(2)(A)-(b)(3), (c) and (d)(4) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56766. Consumer Eligibility for Services.

Note • History

(a) A consumer shall be eligible for an infant development program pursuant to a determination of the ID Team that the consumer meets all of the following criteria:

(1) The consumer is under age five;

(2) The consumer either does not qualify for services from a publicly supported local school program or, if qualified, is awaiting service because the local school program is inactive or there are no current vacancies. Services jointly funded by Special Education and the regional center are exempted from this provision; and

(3) The consumer's IPP includes an objective(s) which can be met by an infant development program.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4646.5, 4648, 4685 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56768. Consumer Placement Termination Procedures.

Note • History

(a) When a vendor makes a determination to exclude a consumer from participation in the infant development program pursuant to section 56718 (g) of these regulations, a meeting need not be scheduled if the exclusion is for routine health problems associated with infancy and early childhood.

(b) A meeting or consultation shall be held between the vendor, parent, care giver, or authorized consumer representative and the consumer program coordinator when a consumer is between the ages of two years and six months and two years and nine months and prior to discharge of the consumer from the infant development program. The purpose of the meeting or consultation shall be to discuss the consumer's entrance into local public special education programs in order to provide for continuity of services. The consumer program coordinator shall initiate the meeting or consultation.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56770. Personnel Functions and Qualifications.

Note • History

(a) The director of an infant development program shall possess the following minimum qualifications:

(1) A bachelor's degree and a minimum of 18 months of experience in the management of a human services delivery system; or

(2) Five years of experience in a human services delivery system, including at least two years in a management or supervisory position.

(b) The supervisor of an infant development program shall possess the following minimum qualifications:

(1) Three years of experience in a human services delivery system, including at least one year in a comparable program or a bachelor's degree in child development, early childhood education, developmental disability education, or a closely related child-focused specialty; and

(2) The demonstrated ability to provide staff training, supervision and planning.

NOTE

Authority cited: Sections 4648 and 4691, Welfare and Institutions Code. Reference: Sections 4648 and 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§56772. Staffing Ratio.

Note • History

(a) A staffing ratio shall be approved for each infant development program by the Department pursuant to this section. This ratio shall be based on the program's design, the curriculum as vendored, the characteristics and needs of the consumers to be served and the number of consumers enrolled.

(b) Infant development programs shall provide a direct care staff-to-consumer ratio of:

(1) 1:1 when the service is conducted on an individual basis;

(2) 1:2 when the service is conducted on both an individual and group basis and the proportion of consumers receiving direct services on an individual basis when averaged with the consumers receiving direct services on a group basis yields a staffing ratio of 1:2; or

(3) 1:3 when the service is conducted on a group basis.

(c) The vendor shall maintain the approved staffing ratio during its direct service hours, which shall be determined by a numerical comparison of the number of individuals on duty as direct care staff with the number of consumers in attendance. If the numerical comparison results in a fraction, more than one-half of a staff person shall be rounded up to the next whole number. Less than one-half of a staff person shall be rounded up to the next one-half of a whole number. One-half of a staff person shall not be rounded. The vendor shall not count subcontractors authorized pursuant to section 56710 (b) of these regulations as staff for the purpose of computing the direct care staff-to-consumer ratio for rate-setting purposes.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56774. Staff Training.

Note • History

(a) In addition to the requirements of section 56726 of these regulations:

(1) Training plans shall also describe child development intervention curricula and techniques; and

(2) The curriculum for new employee orientation shall include:

(A) The early intervention service system for at-risk and/or handicapped children; and

(B) Philosophy and models of early intervention.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 5. Standards for In-Home Respite Services Agencies

§56776. Definitions.

Note • History

(a) As used in this article, the following words and phrases have the meanings specified in section 54302 of these regulations:

(1) Authorized Consumer Representative

(2) Consumer

(3) Days

(4) Department

(5) Family Member

(6) Generic Agency

(7) Individual Program Plan (IPP)

(8) In-home Respite Services

(9) Interdisciplinary Team (ID Team)

(10) Regional Center

(11) Self-Care

(12) Service Contract

(13) Special Incident Report

(14) Vendor

(b) As used in this article, the following words and phrases have the meanings specified in section 56704 of these regulations:

(1) Consumer Program Coordinator

(2) Personal Needs

(3) Self Help

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4648, 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4646, 4646.5, 4648, 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (a)(1), (a)(2) and (b)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

6. Amendment of article heading filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§56778. Waiver of Service Standards.

Note • History

(a) Regional centers, in negotiating service contracts pursuant to Section 57540 or a lower level of payment pursuant to Section 57300(d), may waive or modify any of the following program standards for the duration of the service contract or lower level of payment:

(1) Personnel requirements specified in Section 56790;

(2) Personnel functions and qualifications specified in Section 56792(a), (b), (c), (d) and (f);

(3) Staff training requirements specified in Section 56794;

(4) In-home respite service evaluation requirements specified in Section 56800;

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Section 4791(i), Welfare and Institutions Code. Reference: Section 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Amendment of subsection (a)(2) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsection (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56780. Service Design.

Note • History

(a) The service design of an in-home respite services agency shall include the following items in the order listed below:

(1) An in-home respite service description which includes:

(A) The purpose and goals of the service;

(B) Anticipated consumer outcomes from participation in the service stated in measurable terms;

(D) Schedule of the vendor's service operating hours including days and times when the service is available;

(E) A staff training plan, if developed, pursuant to Section 56794 of these regulations;

(2) A description of the consumers served pursuant to Section 56784 of these regulations;

(3) A description of the process used by the vendor to organize and carry out the requested services from the point of first contact by the person requesting services through the provision of the service;

(4) A description of the method of evaluating the in-home respite service's effectiveness in accordance with Section 56800 of these regulations; and

(5) A written internal grievance procedure for consumers pursuant to Welfare and Institutions Code, Section 4705.

(b) When modifications are made to the service design which constitute a change in the type of consumer served or the times when the service is available, the vendor shall, at least 30 days prior to the change, notify the consumers scheduled to receive in-home respite services or their authorized consumer representatives and submit to the vendoring regional center a revised service design as described in (a) above.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4646, 4646.5, 4648, 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(4) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(4) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. New subsection (a)(4) and subsection redesignation and amendment of subsection (a)(3) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56782. Consumer Eligibility for Services.

Note • History

(a) A consumer shall be eligible for services from an in-home respite services agency pursuant to a determination by the ID Team that:

(1) The consumer resides with a family member(s) as described in 54302(a)(22) and the need for the service is agreed by the family member(s) and the ID Team.

(2) The consumer's IPP includes an objective which can be met by an in-home respite services agency.

NOTE

Authority cited: Section 11346.1, Government Code; and Section 4690.2, Welfare and Institutions Code. Reference: Sections 4646.5, 4648, 4685 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a)(1) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56784. Identification of Consumers Served.

Note • History

(a) The vendor shall have a written description of the population served that shall be used by a consumer's ID Team to determine the appropriateness of the vendor's agency for meeting the consumer's need for in-home respite services and shall include all of the following:

(1) Ages of consumers to be served;

(2) A description of the range of consumer needs in the following areas that the vendor is able to meet:

(A) Self-care skills;

(B) Physical and medical condition;

(D) Any other prerequisites.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4646.5 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56786. Procedures for Service Authorization.

Note • History

(a) Interdisciplinary Teams shall identify in-home respite, services agencies which can meet the objectives of the consumer's IPP developed pursuant to Welfare and Institutions Code, section 4646 and 4646.5.

(b) Authorization for services from an in-home respite services agency shall occur providing all of the following conditions exist:

(1) The consumer or authorized consumer representative consents to receive the service from the agency;

(2) The regional center concurs that the agency's services are appropriate;

(3) The consumer meets the vendor's service criteria pursuant to section 56784 of these regulations; and

(4) The vendor agrees to provide the service.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Chapter 1011, Statutes of 1992, Section 11; and Sections 4646, 4646.5, 4648, 4685, 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56788. Service Termination Procedures.

Note • History

(a) Funding for a consumer's services from an in-home respite services agency shall be terminated when one or more of the following occur:

(1) The regional center issues a determination that continued receipt of services from the agency jeopardizes the consumer's health or safety;

(2) The consumer or authorized consumer representative makes a written or oral request to the regional center to discontinue receipt of the agency's service;

(3) The consumer moves to an area outside the vendor's service area;

(4) The ID Team determines that in-home respite services are no longer required to meet consumer needs;

(5) The vendor, determines that its agency no longer meets the consumer's need.

(b) When a determination is made pursuant to (a)(1), (4) or (5) above, the basis for, the determination shall be documented in writing in the consumer's case file by the regional center for (a)(1) and/or (4) and by the vendor for (a)(5). The regional, center shall also include written documentation in the consumer's case file that the consumer or authorized consumer representative has been informed of the fair hearing rights pursuant to Welfare and Institutions Code, sections 4700 through 4730, when the determination is made pursuant to (a)(1) or (a)(4) above.

(c) When the conditions specified in (a)(1) or (a)(4) above exist, termination of funding shall not be made if the consumer files a fair hearing request pursuant to Welfare and Institutions Code, sections 4700 through 4730.

(d) A vendor may terminate in-home respite services during periods when the vendor determines that serving the consumer presents a threat to the health and welfare of the consumer, other individuals in the home, or the vendor agency's staff. The basis of such termination shall be documented within three working days by the vendor in the consumer case file maintained pursuant to section 56798 of these regulations.

(e) A vendor shall take action to assure consumer safety when the circumstances specified in (d) above, or any other circumstances, prevent the carrying out or completion of in-home respite services during the time of authorized service delivery. Such actions shall include instructing the agency's respite worker to immediately contact:

(1) The consumer's family member or authorized consumer representative;

(2) The director or supervisor of the in-home respite services agency; and

(3) The consumer program coordinator.

(f) In addition to the persons specified in (e)(1) through (e)(3) above, actions to assure consumer safety may also include immediately contacting the local law enforcement, fire or public health authorities.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4648, 4690.2 and 4700 through 4730, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56790. Personnel Requirements.

Note • History

(a) Each vendor shall maintain current written job descriptions for all personnel, including staff whose wages are not paid by the regional center purchase of service funds.

(b) Each job description shall include:

(1) Position title;

(2) Role and responsibility of the position;

(3) Duty statement;

(4) Work hours;

(5) Minimum qualifications;

(6) Positions supervised; and

(7) Reporting supervisor.

(c) Staff whose wages are not paid by regional center purchase of service funds shall demonstrate the minimum qualifications, as identified in Section 56792 of these regulations, necessary for each job function performed.

(d) The vendor is authorized to utilize consultants to develop the in-home respite service description required in Section 56780(a)(1) of these regulations, and to develop and carry out staff development and training.

NOTE

Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code. Reference: Sections 4648 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

4. Amendment of subsection (a) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§56792. Personnel Functions and Qualifications.

Note • History

(a) Each vendor shall assign staff to carry out the duties described. The vendor is authorized to designate positions be different titles than those listed but is responsible for assuring the functions described are carried out. Staff who are hired by the vendor to carry out the functions listed shall meet the minimum qualifications listed in this section.

(b) The vendor shall assign a director to carry out the administrative responsibilities for the in-home respite services agency.

(1) The director shall have primary responsibility for the following functions:

(A) Organizing and supervising the agency in accordance with the agency's established policies;

(B) Overseeing the areas of budgeting, service design and implementation, project planning, staff development and training, evaluation and the direction of the in-home respite services;

(D) Assuring that individual respite service workers are matched with consumers based on respite worker skill and experience and consumer supervision needs.

(2) The vendor is authorized to delegate to the director additional functions to those listed in (b)(1) above, related to the overall administration of the in-home respite service.

(3) The director shall possess the following minimum qualifications:

(A) A bachelor's degree and a minimum of 18 months of experience in the management of a human services delivery system; or

(B) Five years of experience in a human services delivery system, including at least two years in a management or supervisory position.

(1) The vendor is authorized to delegate to the supervisor the following functions:

(A) Selection and supervision of assigned staff; and

(B) Matching individual respite service workers with consumers based on respite worker experience and consumer supervision needs.

(2) The vendor is authorized to delegate to the supervisor additional functions to those listed in (c)(1) above directly related to supervision of the in-home respite services.

(3) The supervisor shall possess the following minimum qualifications:

(A) Three years of experience in a human services related field; and

(B) The demonstrated ability to provide staff training, supervision and planning.

(d) A vendor may assign staff to carry out scheduling responsibilities for the in-home respite services agency.

(1) The vendor is authorized to delegate to the scheduler the function of arranging the times and dates for service delivery.

(2) The vendor is authorized to delegate to the scheduler additional functions to those listed in (d)(1) above.

(3) The scheduler shall possess the following minimum qualifications:

(A) Education and experience required in the job description; and

(B) The ability to perform the functions required in the service design.

(e) The vendor shall assign staff to carry out in-home respite services.

(1) Each respite worker shall be responsible for the following functions:

(A) Performing the in-home respite services;

(B) Maintaining information as required in Sections 56796(a)(4) and 56798(c)(2)(B) of these regulations;

(C) Obtaining information concerning any specific care needs unique to the individual consumer at the time, or prior to the time, when services are delivered.

(D) Obtaining phone numbers and locations where family members can be contacted during the provision of in-home respite services.

(2) The vendor shall not assign other duties to the respite worker from the above noted functions during hours the that worker is providing in-home respite services.

(3) The respite worker shall possess the following minimum qualifications:

(A) Has received Cardiopulmonary Resuscitation (CPR) and First Aid training from agencies offering such training, including, but not limited to, the American Red Cross;

(B) Education and experience required in the job description; and

(f) The vendor may assign staff to carry out administrative support functions, including clerical, janitorial, and bookkeeping or accounting.

(1) The vendor is authorized to hire staff directly to carry out or to secure the performance of such functions from other entities.

(2) The administrative support staff shall demonstrate experience and the ability to perform the functions described in the job description.

(h) The vendor shall assure that any consultants it utilizes shall comply with all California licensing, certification, registration and vendorization requirements applicable to the functions to be carried out.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4648, 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648, 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (b)(3)(A)-(B) and (c)(3)(A)-(B) with renumbering of following subsections (A)-(B) to 1.-2., repealer of subsection (g) and relettering and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (b)(3)(A)-(B) and (c)(3)(A)-(B) with renumbering of following subsections (A)-(B) to 1.-2., repealer of subsection (g) and relettering and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (b)(3)(A)2. and (c)(3)(A)1. transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (e)(3)(A) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56793. Staffing Ratio.

Note • History

(a) The vendor shall maintain a staff-to-consumer ratio of 1:1 during its direct service hours.

(b) When a respite service is provided to more than one consumer at the same time and location, regional centers may allow a staff-to-consumer ratio other than 1:1 only if the modification of the staffing ratio is agreed to by each consumer and, where appropriate, each consumer's family and if the modification will not adversely affect the health and safety of the consumers or result in placing the consumers in a more restrictive environment.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2 and 4691, Welfare and Institutions Code.

HISTORY

1. New section filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§56794. Staff Training.

Note • History

(a) A vendor may develop and implement a written staff training plan for new employee orientation and ongoing employee staff training.

(b) If a training plan is developed pursuant to (a) above, it shall at a minimum:

(2) Describe contents of training, including training in consumer safety procedures to be used in event of an emergency.

(1) Be provided within the first two weeks of employment;

(2) Be based on the prior experience and qualifications of the employee and needs of the vendor;

(3) Use a curriculum that includes but is not limited to:

(A) Welfare and Institutions Code, sections 4502, 4504, 4518, 4646.5, 4648, 4655, 4710 and 4710.5;

(B) Consumer's rights as defined in title 17, section 50510;

(D) The policies, procedures and practices of the vendor's in-home respite services agency; and

(E) Specific job requirements for that employee.

(d) If ongoing staff training is developed pursuant to (a) above, it shall at a minimum:

(1) Be provided for all respite workers and supervisors on an annual basis; and

(2) Use curriculum that addresses the particular activities used by the vendor in assisting consumer to meet the consumer's in-home respite service needs.

(e) The vendor shall document all training provided to employees.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Chapter 1011, Statutes of 1992, Section 11; and Sections 4646.5, 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Editorial correction of subsection (d)(2) (Register 95, No. 49).

6. Change without regulatory effect amending subsections (a)(2), (c)(3)(B) and (d)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56796. Required Agency Records.

Note • History

(a) A vendor shall develop the following records and maintain them at its business office:

(1) Service design as required in Section 56780(a) of these regulations and changes made to the service design;

(2) Employee time sheets specifying each employee's work hours;

(3) Employee payroll records;

(4) Consumer(s) served, indicating the dates and hours of service;

(5) Documentation of all training attended by each employee;

(6) All records used by the vendor in developing the DS 1897B (12/92) submitted to the Department for a rate determination;

(7) All written approvals from regional centers or the Department required by these regulations; and

(8) The In-home Respite Service evaluation required by Section 56800 of these regulations; and

(9) The written descriptions of the vendor's organizational structure as specified in Section 54326(b) of these regulations.

(b) Records required pursuant to (a)(2) through (7) above, shall be retained for five years from the date of origination or until audit adjustments have been resolved, whichever is longer.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(7) and (a)(8) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(7) and (a)(8) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(1) and (a)(6) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(4) and (a)(8) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56798. Consumer Records.

Note • History

(b) Vendors shall maintain an individual consumer case file for each consumer served by the in-home respite services agency.

(1) The most current copies of:

(A) Any emergency and personal identification information, which may effect the delivery of services, including the consumer's address, telephone number, names and telephone numbers of relative's, and/or guardian or conservator, physician's name(s) and telephone number, and health plan, if appropriate;

(B) Pertinent information related to consumer respite needs including:

1. Known medications;

2. Known allergies;

3. Medical disabilities;

4. Infectious, contagious or communicable conditions;

5. Special nutritional needs; and

6. Specific care needs unique to the individual consumer.

(C) Any other available medical, psychological, and social information which may effect the delivery of In-home Respite Services, including the consumer's ability and functioning level; and

(D) Authorization for emergency medical treatment.

(2) All copies of:

(A) Special incident reports; and

(B) Case notes reflecting important events or information not documented elsewhere.

(3) Documentation of attempts to obtain required information not contained in the consumer record.

(d) Records pertaining to the consumer shall be stored in a secure and locked place which shall be readily accessible when needed. The vendor is authorized to keep pertinent consumer data, including, but not limited to, emergency telephone numbers, and important medical data with the consumer when services are rendered.

(e) The individual consumer case file shall be retained for five years from the time a consumer no longer receives services from the agency.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4646.5, 4648, 4648.1 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56800. In-Home Respite Services Evaluation.

Note • History

(a) The vendor shall conduct an annual review of its effectiveness in relation to the service design. This shall include a review of:

(1) The ability of the vendor to meet the in-home respite needs of consumers served;

(2) The aggregate data on:

(A) The number of consumers served;

(B) The different type of consumer needs encountered during service delivery; and

(C) Outcomes in relation to the expectations identified in the service design as required in Section 56780(a)(1)(B) of these regulations; and

(3) The degree to which family members were satisfied with the service as provided by the in-home respite services agency.

(b) The vendor shall have a written evaluation design specifying:

(1) The purpose of the evaluation;

(2) The type of data to be collected and used;

(3) The frequency of data collection;

(4) The role of consumers, families or authorized consumer representatives in the evaluation process;

(5) Data collection and analysis methods;

(6) A description of the distribution, communication of, and actions taken upon the results of the evaluation;

(7) The frequency of evaluations; and

(8) A description of how the particular evaluation design chosen by the vendor relates to the service design.

(c) The vendor shall submit to the vendoring regional center, user regional centers and the Department a written summary of the annual in-home respite service evaluation which shall be maintained in the vendor file at the regional center and at the Department. The vendor shall maintain on file, pursuant to Section 56796 of these regulations, the full in-home respite service evaluation for review by the vendoring regional center and the Department.

NOTE

Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code. Reference: Sections 4501, 4648, 4648.1 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a), (a)(1), (a)(2)(A), (a)(2)(B) and (b)(4) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§56802. Effective Date of Compliance.

Note • History

(a) The effective date of compliance by in-home respite services agencies with the provisions of this article shall be as follows:

(1) Agencies vendored after the effective date of these regulations shall be in compliance with these provisions upon the date of vendorization.

(2) Agencies vendored prior to the effective date of these regulations which:

(A) Do not meet one or more provision(s) specified in sections 56780 through 56802 shall have a maximum of one year from the effective date of these regulations to come into compliance with the applicable provision(s).

(B) Equal or exceed any provision(s) specified in sections 56780 through 56802 shall be deemed in compliance with the applicable provision(s) upon the effective date of these regulations.

NOTE

Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code. Reference: Sections 4648 and 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Subchapter 6. Ratesetting Procedures for Residential Services

HISTORY

1. Change without regulatory effect renumbering subchapter 6 (filed 1-14-91 but not printed) sections 56100 through 56119 to sections 56900 through 56919. (Register 91, No. 14).

Article 1. Definitions

§56900. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense; words in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct; “may” denotes permissive conduct.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

§56901. Definitions.

Note • History

(a) As used in this Subchapter, the following words and phrases have the meanings specified in Section 56002.

(1) Administrator;

(2) Consumer;

(3) Days;

(4) Department;

(5) Direct Care (DC) Staff;

(6) Facility;

(7) Individual Program Plan (IPP);

(8) Personal and Incidental Allowance;

(9) Residential Service Provider; and

(10) Regional Center.

(b) When used in this subchapter, the following words and phrases have the following meanings:

(1) “Administrative Duties” means those tasks performed by facility staff which pertain to the management of the facility and are not considered direct care.

(2) “California Consumer Price Index (California CPI)” means the historical index of the cost of living in California published by the Department of Industrial Relations, Division of Labor Statistics and Research, under the authority of California Labor Code Section 150, and the projected California CPI published by the Department of Finance.

(3) “Conserve” means an action taken by a regional center which has been appointed as a consumer's representative payee, to save or invest consumer funds pursuant to Title 20, Code of Federal Regulations, Section 416.645(a).

(4) “Cost Components” means the sublisting under cost items listed in Section 56908(b).

(5) “Cost Elements” means Basic Living Needs, Indirect Costs, Direct Supervision and Special Services and Proprietary Fee.

(6) “Cost Items” means the major headings (Items 1 through 14) listed under Section 56908(b).

(7) “Cost Study Facility” means a facility which participates in the triennial survey to determine facility costs.

(8) “Customary Fee” means a fee that is within the range of usual fees charged and received by providers of similar training for the same service within the geographic location.

(9) “Direct Program Costs” means facility costs related to the provision of residential services.

(10) “Enrolled” means the days in which a resident is in placement in a facility during the cost study reporting period.

(11) “Established Rate” means the proposed rate after any adjustment pursuant to Section 56902(b) and (c).

(12) “Facility Cost Study” means the triennial collection and analysis of facility cost data.

(13) “Facility Size” means the licensed capacity of a facility.

(14) “Fixed Asset” means an item of tangible property which is used for a period of more than one year and must be depreciated, rather than expensed, pursuant to generally accepted accounting principles.

(15) “Geographic Location” means a county or group of counties which share a common cost of living.

(16) “Housekeeping Duties” means tasks which pertain to cooking, housecleaning, and laundry services.

(17) “Live-in Staff” means wage-earning facility employees who reside in the facility, such as house parents who meet the definition of an “employee residing on the employer's premises” pursuant to Section 785.23 of “Interpretive Bulletin, Part 785: Hours Worked Under the Fair Labor Standards Act of 1938, As Amended,” published by the U.S. Department of Labor.

(18) “Maintenance and Repair Duties” means tasks which pertain to the upkeep of facility premises.

(19) “Management Organization” means a separate and distinct corporation or entity which operates two or more programs or services.

(20) “Mandated Minimum Wage” means the higher wage required by federal or state law.

(21) “Median” means the fiftieth percentile of a statistical distribution.

(22) “Occupant” means any individual living in the facility, including consumers and non-consumers, the owner/operator and his/her family members, and live-in staff.

(23) “Occupant Day” means a day that one occupant resides in a facility.

(24) “Operation Type” means owner operated or staff operated.

(25) “Operative Rate” means the rate being paid on June 30 of the current fiscal year.

(26) “Out-of-home Respite Services” means regional center approved intermittent or regularly scheduled temporary non-medical care and supervision, provided by a residential service provider.

(27) “Owner operated” means that the facility is the residence of the licensee or a member of the corporate board of directors.

(28) “Prevailing Rate” means the rate of payment which is being paid to a residential service provider by other governmental agencies to provide services to residents.

(29) “Proprietary Fee” means the amount which reflects a reasonable rate of return on the net value of a facility's fixed assets.

(30) “Proposed Rate” means the residential rate proposed by the Department pursuant to Section 56902.

(31) “Regional Center Supplement” means that portion of the established rate which the regional center uses to pay the portion of the residential rate that exceeds the amount of the consumer's SSI/SSP payment.

(32) “Reporting Period” means the period of time specified by the Department for the purpose of a facility cost study.

(33) “Resident” means a person placed in a licensed facility to receive care and supervision pursuant to Title 22, California Code of Regulations (CCR), Division 6. Resident includes both regional center and non-regional center consumers.

(34) “Resident Day” means any portion of a day in which a resident is placed in the facility.

(35) “Residential Respite Services” means intermittent or regularly scheduled temporary non-medical care and supervision provided to the consumer in an out-of-home setting.

(36) “Service Code” means a number which is assigned by the vendoring regional center to a residential service provider which indicates the type of authorized service to be provided.

(37) “Staffing Standards (SS)” means the average number of staff hours per consumer per month allowed for each service level and step which includes hours for direct care, and relief coverage for vacations, holidays, night coverage, and training.

(38) “Staff Operated” means that the facility is not the residence of the licensee or a member of the corporate board of directors, and the licensee employs personnel to provide direct care to consumers.

(39) “Subcode” means a series of a maximum of five numbers and/or letters which is assigned by the vendoring regional center to a residential service provider for billing purposes.

(40) “Target Fiscal Year” means the fiscal year in which the Department recommends that a proposed rate be implemented.

(41) “Usual Fee” means the fee which is regularly charged and received for a given service by an individual provider. If more than one fee is charged for a given service, the fee determined to be the usual fee shall not exceed the lowest fee which is regularly charged.

(42) “Vehicle Miles” means the miles a facility vehicle is used for administrative functions, to transport residents for direct services, or for other facility operations.

(43) “Vendoring Identification Number” means the unique number which is assigned to each residential service provider in order to establish a record-keeping and tracking system for regional centers' billing purposes.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsections (a)(8), (b)(3) and (b)(31) and subsection renumbering filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

4. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

5. Editorial correction of History 3 (Register 94, No. 47).

6. Editorial correction of subsections (b)(4), (6), (11) and (30) (Register 94, No. 50).

7. Editorial correction of subsections (a) and (b)(11) and (26) and capitalizing “S” of “Section” and “D” of “Division” throughout (Register 95, No. 18).

Article 2. General Provisions

§56902. General Provisions.

Note • History

(a) Proposed residential rates shall be determined for a specific target fiscal year in accordance with generally accepted accounting principles pursuant to Article 5.

(b) Payment of proposed rates is subject to appropriation of sufficient funds for that purpose in the Budget Act.

(c) Absent specific direction from the Legislature, when sufficient funds are not appropriated in the Budget Act to fully provide for payment of the proposed rates, in lieu of the proposed rates, the Department shall increase operative rates on a pro rata basis if the amount appropriated is sufficient for an increase.

(d) Once the vendor has received notice of the maximum rate established by the Department for the facility's approved service level, each regional center, or its designee, which has placed consumers in the facility may negotiate with the vendor a level of payment for its consumer(s) that is lower than the rate established by the Department.

(1) A payment at the lower level may only occur after both the regional center and the vendor mutually agree in writing:

(A) To the negotiated level of payment; and

(B) To the effective date and termination date for the regional center to reimburse the vendor at the negotiated level of payment.

(2) Upon termination of the level of payment negotiated by the regional center and a vendor, the regional center shall resume reimbursements to the vendor for services at the maximum rate established by the Department for the facility's approved service level.

(3) The negotiated level of payment between each regional center and the vendor shall not modify any other requirement specified in Subchapters 4 and 6.

(4) The negotiated level of payment between each regional center and the vendor may be renegotiated or terminated at any time upon the request of either party.

(5) Each regional center shall provide the Department and the vendor with a copy of the agreement specified in subsection (d)(1).

NOTE

Authority cited: Sections 4680, 4681.1, 4786 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4680, 4681.1, 4786 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (e) and amendment of NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. New subsection (e) and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including repealer of subsections (e)-(e)(6) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

Article 3. Cost Studies

§56903. Facility Cost Study.

Note • History

(a) The Department shall conduct a facility cost study every three years pursuant to Welfare and Institutions Code Section 4681.1(b).

(b) In conducting the facility cost study, the Department shall make every reasonable effort to:

(1) Design a facility sample to produce estimates which are statistically valid at the 95% confidence interval;

(2) Ensure the cost data utilized is reliable; and

(3) Analyze the cost data utilizing standard accepted statistical methods.

(c) When a facility is selected to participate in a cost study, the administrator shall provide data from the facility's financial records for the specified reporting period, as requested by the Department or its designee, pursuant to this subchapter.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Change without regulatory effect amending article 3 heading filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56904. Cost Study Records Maintenance Requirements.

Note • History

(a) The administrator shall make available to the Department for the cost study, all financial and service records. Such records shall include the California Revenue and Taxation Code (R&TC) and Internal Revenue Codes (IRC) information statements or returns and all pertinent documentation for a reporting period specified by the Department.

(b) Facility financial records shall be maintained in a manner consistent with:

(1) A single method of accounting, clearly reflecting the nature and amounts of all cost (expenses) and all income;

(2) The Internal Revenue Code (IRC) and the California Revenue and Taxation Code (R&TC) information statements; and

(3) Title 17, CCR, Sections 50604 and 56908.

(1) For all individuals living in the facility, the total number of occupant days, including the following:

(A) Resident days;

(B) Live-in staff days; and

(2) The number of staff hours performing the following functions:

(A) Direct care pursuant to Section 56004;

(B) Housekeeping;

(D) Supervision and management; and

(E) Administration.

(3) Allowable expenses pursuant to Section 56908;

(4) A description of all donated goods and services, including the fair market value at the time of donation, and the date of donation;

(5) For each fixed asset:

(A) A description including a serial number or other identifying information;

(B) A description of whether the item is to be used for administrative purposes or for basic living needs;

(6) The program design requirements pursuant to Title 17, CCR, Section 56013(a);

(7) Vendoring identification number, service code and subcode;

(8) Name of the vendoring regional center and any other regional centers utilizing the facility;

(9) Name of the management organization, if any;

(10) A reasonable estimate of the square footage of the facility as follows:

(A) Living space used by residents;

(B) Administrative functions; and

(11) Vehicle miles related to:

(A) Direct services to residents;

(B) Administrative functions; and

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Sections 4648.1 and 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correction of subsections (b)(3) and (c)(3) (Register 94, No. 50).

3. Editorial correction capitalizing “S” of “Section” throughout (Register 95, No. 18).

§56905. Depreciation.

Note • History

(a) In conducting a cost study pursuant to Section 56903, the Department shall utilize depreciation costs of all assets which are:

(1) Directly related to the facility's operations as a facility; and

(2) Recognized as an allowable business expense in accordance with federal and state income tax guidelines and actually reported as such on the residential service provider's state and federal tax returns for the date year of the cost study. In the event of inconsistencies between state and federal income tax depreciation guidelines, the California State Franchise Tax Board requirements shall prevail for the purpose of data collection for the cost study.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction of subsection (a) (Register 94, No. 50).

§56906. Cost Allocation Methods.

Note • History

(a) To allocate cost items in a facility cost study, the Department shall review the data presented to determine:

(1) That allowable costs are directly identified with the cost study facility (CSF) or specific cost element; or

(2) That allowable costs are combined with the allowable costs of other facilities, cost elements, or a management organization.

(b) When the nature of the allowable cost of the accounting records provided by the facility permits, allowable costs shall be directly allocated to each CSF or cost element.

(c) When any allowable cost cannot be directly identified with a CSF or a cost element, the Department shall allocate a percentage of the cost to the CSF or cost element using the following steps:

(1) Determine a percentage which reflects that portion of time, number of residents, hours of direct service, space, or vehicle miles which is attributable to the CSF.

(2) Multiply the total cost by the percentage determined in (1) above.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

§56908. Allowable Costs.

Note • History

(a) In order to propose rates of reimbursement, the Department shall include in the facility cost study only those costs which are:

(1) Directly related to the operation of the facility;

(2) Recognized as an allowable business expense in accordance with federal and state income tax guidelines and reported as such on the residential service provider's state and federal tax returns for the data year of the cost study; and

(3) As otherwise specified in subsection (b) below. In the event of inconsistencies between state and federal tax reporting guidelines, the California State Franchise Tax Board requirements shall prevail for the purpose of data collection for the cost study.

(b) In order for the Department to conduct the cost study in accordance with state law, it is necessary for the Department to organize the data collected for the cost study in a manner not entirely consistent with state and federal tax reporting formats. The Department shall organize its cost study and include the following cost items if they are allowable business expenses consistent with subsections (a)(1) and (2) above and are incurred by the residential service provider and necessary for the operation of the facility. The cost components presented under each cost item are presented only as examples of allowable costs and are not intended to be exclusive.

(1) Staff wages and fringe benefits which include the following cost components:

(A) Expenditures for wages and salaries paid to all facility employees performing housekeeping, direct care, administration and management, staff supervision, clerical, accounting/bookkeeping, maintenance and repair functions;

(B) Expenditures for fringe benefits including the residential service provider's share of Old Age Security Disability Insurance (OASDI), Workers' Compensation, Unemployment Insurance, Employment Training Tax, health insurance, dental insurance, vision insurance, life insurance, disability insurance, and retirement.

(2) Housing expenses which include the following cost components:

(A) Rent or lease for the facility building;

(B) Depreciation and interest for the facility building, additions and mandated or other capital and leasehold improvements; and

(3) Furniture and equipment expenses which include the following cost components:

(A) Rent or lease payments; and

(B) Depreciation and interest.

(4) Insurance expenses which include the following cost components:

(A) Property insurance, including fire, theft and earthquake;

(B) Flood insurance;

(D) Director's and officer's liability insurance; and

(E) Surety bonds.

(5) Utilities expenses which include the following cost components:

(A) Energy including gas, electricity, wood, coal, and oil;

(B) Water;

(D) Garbage and refuse disposal.

(6) Food expenses which include the following cost components:

(A) Groceries for food prepared at home for occupants; and

(B) Restaurant meals for residents and the facility staff who accompany them.

(7) Expenses for housekeeping supplies and services including the following cost components:

(A) Housekeeping, cleaning, paper products, and maintenance supplies; and

(B) Payments to external housekeeping or laundry services.

(8) Clothing and personal care expenses, which are not purchased with a resident's personal and incidental allowance funds, and which include the following cost components:

(A) Resident clothing, toiletries, and other personal items; and

(B) Over-the-counter medications and prescriptions.

(9) Transportation expenses which include the following cost components:

(A) Costs of the facility vehicle, including:

1. Rental and lease payments;

2. Depreciation and interest;

3. Insurance;

4. Gasoline and oil;

5. Maintenance and repair; and

6. License fees.

(B) Public transportation fares including bus, light rail, and taxi; and

(10) Program supply expenses for resident use or for the care or training of residents.

(11) Consultant expense for activities pursuant to Section 56040(a).

(12) Other professional consultant expenses including:

(A) The costs of legal, accounting, clerical, or managerial services not provided by facility staff; and

(B) Consultants other than those required by Section 56040(a).

(13) Facility repair and maintenance expenses including the following cost components:

(A) Materials and supplies; and

(B) Contract labor for maintenance or repair of the facility, furniture, and equipment.

(14) General and administrative expenses including the following cost components:

(A) Dues/Subscriptions which shall include:

1. Dues for professional organizations related to residential care;

2. Subscriptions for publications which are used in the operation of the facility, for residents, or for the purpose of staff development.

(B) Business taxes that must be paid as a condition of operating a facility, excluding property taxes, business income taxes and personal income taxes;

(C) Fees for licenses, certifications, registrations, or permits required in order to operate a community care facility providing residential care;

(D) Staff recruitment and other personnel costs including advertising, charges and fees for screening prospective employees, such as fingerprinting, driving record checks performed by the Department of Motor Vehicles, and physical examinations or other health and safety checks required prior to employment; costs for inoculations or clinical tests of employees for the health and safety of staff or consumers;

(E) Staff training expenses related to the requirements of Sections 56036 through 56038;

(F) Communications expenses including telephone charges and long distance charges related to facility business, postage, telegraph, teletype, centrex, telepak, message services, facsimiles, and TDD; and

(G) Office supplies including paper products, pens, typewriter, computer, printer and other equipment and supplies.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of subsection (b)(14)(D) filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (b)(11) and (b)(14)(E) (Register 95, No. 18).

6. Change without regulatory effect amending subsections (a)(3) and (b) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56909. Costs Not to Be Reported.

Note • History

(a) The Department shall exclude from the facility cost study those costs which are not:

(1) Directly related to the operation of the facility;

(2) Recognized as an allowable business expense in accordance with federal and state income tax guidelines.

(b) In order to comply with state laws, the following costs shall not be included in the facility cost study, in addition to those cost items excluded in accordance with the provisions of subsection (a) above:

(1) Personal expenses of the owner-operator and his/her family which include those items, activities, or services that are used strictly by occupants who are not residents and are unrelated to facility business, including but not be limited to:

(A) Personal clothing;

(B) Use of facility vehicles for personal business; and

(2) Expenses of an activity other than residential care, such as any other business or non-residential program which uses space, equipment, or supplies on the facility grounds;

(3) Camperships or other expense of sending a resident to summer camp;

(4) Resident relocation expense;

(5) Donations to public or private agencies or organizations;

(6) Fund raising expenses;

(7) Gifts to employees;

(8) Legal fees directly related to a resident or employee, or expenses for the prosecution of claims against a regional center or state agency;

(9) Public relations expenses;

(10) Refundable deposits;

(11) The following management organization expenses:

(A) Services which duplicate those provided by the facility;

(B) Those applicable to, associated with, or claimed by other facilities operated by the management organization; and

(C) Costs which do not support facility operations and which cannot be allocated to any of the direct program cost items in Section 56908.

(12) The value of capital improvements, except as allowed pursuant to Section 56905.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction of subsections (b)(11)(C) and (b)(12) (Register 94, No. 50).

5. Editorial correction of subsection (b)(11)(C) (Register 95, No. 18).

6. Change without regulatory effect amending subsection (b) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

Article 4. Rates Development Methodology

§56910. General Provisions for Rate Proposals.

Note • History

(a) The Department shall utilize a rate development methodology to determine the amounts for the cost elements for the proposed rates.

(b) The Department shall develop proposed rates pursuant to Section 56902 which shall:

(1) Be based upon median cost per consumer per month;

(2) Vary by Service Levels 2, 3 and 4(A-I); and

(3) Vary by geographic location.

(c) The proposed rates shall be the sum of the cost elements pursuant to Sections 56911 through 56914, updated pursuant to Section 56915.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Editorial correction of subsections (b) and (c) (Register 94, No. 50).

4. Editorial correction of subsection (c) (Register 95, No. 18).

5. Change without regulatory effect amending subsection (b)(2) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56911. Basic Living Needs.

Note • History

(a) The basic living needs (BLN) cost element represents the cost of meeting consumers' basic living needs, allocated pursuant to Section 56906, and shall include the following:

(1) Wages and fringe benefits of staff performing housekeeping duties;

(2) Housing;

(3) Furniture and equipment;

(4) Insurance;

(5) Utilities;

(6) Food;

(7) Housekeeping supplies and services;

(8) Clothing and personal care items which are not purchased with a resident's personal and incidental allowance; and

(9) Transportation.

(b) The following steps shall be completed by the Department to determine the proposed amount for BLN:

(1) For each CSF, calculate the total BLN costs as follows:

(A) To derive the BLN cost per occupant day, calculate the costs per day for subsections (a)(1) through (7) above using the following formula:

COST PER OCCUPANT DAY = Dollar amount per cost item

total number of occupant days

(B) To derive the BLN cost per resident day, calculate the costs per day for subsections (a)(8) and (9) above using the following formula:

COST PER RESIDENT DAY = Dollar amount per cost item

total number of resident days

enrolled

(2) Using generally accepted statistical techniques:

(A) Analyze the total BLN cost for all CSFs to determine if there are any significant differences by:

1. Service Levels 2, 3 and 4;

2. Operation type;

3. Facility size; and

4. Geographic location.

(B) Group together those with a significant similarity, except geographic locations;

(C) Group together those that are similar by geographic location, regardless of whether or not the differences between locations are significant;

(D) Where the distinct groups have been identified in subsections (B) and (C) above, determine the median total BLN cost for each group.

(3) Convert each median cost identified in subsection (2)(D) above to the cost per resident per month using the following formula:

MEDIAN COST PER RESIDENT MONTH = Median cost per day for each item X 30.44 days

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (a) filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Editorial correction of subsection (a) (Register 94, No. 50).

4. Editorial correction of subsections (a), (b)(1)(B), and (b)(3) (Register 95, No. 18).

5. Change without regulatory effect amending subsections (b)(1)(A)-(C), (b)(2)(A)1., (b)(2)(D) and (b)(3) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56912. Indirect Costs.

Note • History

(a) The indirect costs cost element represents that portion of indirect, overhead, and administrative costs allocated pursuant to Section 56906, and includes the following:

(1) Wages and fringe benefits to staff performing facility administration and management, clerical, bookkeeping/accounting, staff supervision, maintenance and repair duties;

(2) Housing;

(3) Furniture and equipment;

(4) Insurance;

(5) Utilities;

(6) Housekeeping supplies and services;

(7) Transportation;

(8) Program supplies;

(9) Other professional consultant services;

(10) Repair and maintenance; and

(11) General and administrative costs.

(b) The following steps shall be completed by the Department to determine the proposed amount for indirect costs:

(1) Calculate total costs per resident day using the following formula:

Dollar amount per cost item

Total number of resident days enrolled

(2) Using generally accepted statistical techniques:

(A) Analyze the total indirect cost per resident day for all CSFs to determine if there are any significant differences by:

1. Service Levels 2, 3 and 4;

2. Operation type;

3. Facility size; and

4. Geographic location.

(B) Group together those with a significant similarity, except geographic locations;

(C) Group together those that are similar by geographic location, whether or not the differences between locations are significant;

(D) Where distinct groups have been identified in subsections (B) and (C) above, determine the median total indirect costs per resident day for each group.

(3) Convert each median cost per resident day identified in subsection (1) or (2)(D) above to the cost per resident month using the formula for median cost per resident month in Section 56911(b)(3).

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correction of subsections (a) and (b)(3) (Register 94, No. 50).

3. Change without regulatory effect amending subsections (b)(2)(A)1., (b)(2)(D) and (b)(3) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56913. Direct Supervision and Special Services.

Note • History

(a) The direct supervision and special services cost element represents the expenditures for personnel who provide direct services to residents, allocated pursuant to Section 56906, and includes the following:

(1) Wages and fringe benefits for direct care staff; and

(2) Consultant expense.

(b) The following steps shall be completed by the Department to determine the proposed amount for direct supervision for all CSFs:

(1) For each staff-operated CSF, identify the following DC staff costs:

(A) Wages for DC staff;

(B) Fringe benefits for DC staff.

(2) Calculate DC staff hourly wages for each CSF using the following formula:

DC STAFF HOURLY WAGE = Total DC staff wages

Total DC staff hours

(A) If the DC staff hourly wage in subsection (b)(1)(A) above for any CSF is below the state minimum wage, the Department shall substitute the state minimum wage in lieu of the actual wage.

(3) Using generally accepted statistical techniques, analyze the DC staff wages for all CSFs, determined in subsection (b)(1)(A) above, to:

(A) Group together, by service level, those with a significant similarity;

(B) Group together those that are similar by geographic location, whether or not the differences between the locations are significant;

(4) Calculate the DC staff fringe benefit ratio for all CSFs by completing the following steps:

(A) For each staff-operated facility participating in the study, calculate the fringe benefit ratio for DC staff, stated as percentage of wages, using the following formula with the data for the wages and fringe benefits costs in subsections (b)(1)(A) and (B) above:

DC STAFF FRINGE BENEFIT RATIO = Fringe benefits for DC staff

DC staff wages

(B) Determine the median fringe benefit ratio from the data developed in step (A) above;

(C) Determine a mandated fringe benefit ratio for the reporting period that includes all required staff fringe benefits including OASDI, Unemployment Insurance, Employment Training Tax, and Worker's Compensation; and

(D) Compare the median fringe benefit ratio determined in subsection (B) above with the mandated fringe benefit ratio determined in subsection (C) above, and select the higher ratio.

(5) Calculate the total median hourly compensation for DC staff using the following formula:

TOTAL MEDIAN HOURLY COMPENSATION = median hourly wage for each group in subsection (3)(C) above + median hourly wage x fringe benefit ratio in subsection (4)(D) above.

(6) Determine the DC staff cost per consumer per month for Service Levels 2, 3 and 4 as follows:

DC STAFF COST PER CONSUMER PER MONTH = [Total hourly compensation produced in step (5)] x the residential services staffing standard (SS) per consumer per month.

(A) The chart below shows the staffing standard in terms of level of service and facility operation type:

Facility level Owner/operated Staff operated

hours/cl/mo. hours/cl/mo.

Level 2 55.1 71.2

Level 3 87.7 103.8

Level 4

A -- 140.0

B -- 153.7

C -- 167.7

D -- 181.7

E -- 200.0

F -- 218.6

G -- 236.8

H -- 260.0

I -- 292.2

(c) The following steps shall be completed by the Department to determine the proposed amount for consultant expenses for all Service Level 4 CSFs:

(1) Calculate the consultant cost per hour for each Service Level 4 CSF utilizing the following formula:

Total expenditures for

COST PER CONSULTANT HOUR = consultant services

total hours of

consultant service delivered

(2) Determine the median hourly cost for consultant services for all Service Level 4 CSFs.

(3) Determine the consultant cost per consumer per month by multiplying the hourly cost produced in subsection (1) above by the consultant hours required below:

Step Consultant

Hrs/Consumer/Month

4A 2

4B 2

4C 2

4D 3

4E 3

4F 3

4G 4

4H 4

4I 4

(d) The amount for direct supervision and special services for Service Levels 2 and 3 is the amount determined in subsection (6) above.

(e) The amount for direct supervision and special services for Service Level 4 (A-I) is the sum of subsections (b)(6)and (c)(2) above.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Editorial correction of subsection (a) (Register 94, No. 50).

4. Editorial correction of subsections (b)(6)(A) amd (c)(3) (Register 95, No. 18).

5. Change without regulatory effect amending section filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56914. Proprietary Fee.

Note • History

(a) The proprietary fee cost element shall be calculated for each CSF as follows:

(1) Identify the amount of the allowable, unrecovered basis for depreciation of all fixed assets to determine the total net fixed asset value;

(2) Divide the total net fixed asset value by the average number of residents residing at the facility during the reporting period to get total net fixed asset value per resident.

(b) Using generally accepted statistical techniques:

(1) Analyze total net fixed asset value per resident to determine if there are any significant differences by:

(A) Service level;

(B) Operation type;

(D) Geographic location.

(2) Group together those with a significant similarity, except geographic locations;

(3) Group together those that are similar by geographic location, whether or not the differences between locations are significant;

(4) Where distinct groups have been identified in subsections (2) and (3) above, determine the median total net fixed asset value per resident for each group.

(c) Determine the pre-tax rate of return on assets for residential care facilities (Standard Industrial Code 8361) using Dun and Bradstreet data reports; and

(d) For each median identified in subsection (b)(4) above, calculate the monthly amount for the proprietary fee cost element utilizing the following formula:

Median total net fixed asset value per

PROPRIETARY FEE = consumer x [rate of return identified in (c) above]

the number of months in the reporting period

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (d) filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

3. Change without regulatory effect amending subsections (b)(4) and (d) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56915. Cost Data Update Methodology.

Note • History

(a) The Department shall update the amounts of the cost elements by the California Consumer Price Index (CPI) as follows:

(1) Identify the amount for the reporting period (ARP);

(2) Determine the mid-point of the reporting period used for the cost study;

(3) Determine the mid-point of the target fiscal year;

(4) Obtain the historical and projected California CPI for subsections (2) and (3) above;

(5) Update each amount using the following formula:

UPDATED COST = CPI for mid-point of target fiscal year x ARP in (1) above

CPI for mid-point of reporting period

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsection (a)(4) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

Article 5. Rate Proposals

§56916. Proposed Rates.

Note • History

(a) The Department shall update the cost elements resulting from its most recent cost study as follows:

(1) The BLN amount determined in Section 56911(b)(3) shall be updated by the California CPI pursuant to Section 56915;

(2) The Indirect Costs amount determined in Section 56912(b)(3) shall be updated by the California CPI pursuant to Section 56915;

(3) The Direct Supervision and Special Services shall be updated by:

(A) Updating the median hourly wage amount determined in Section 56913(b)(3)(C) by:

1. Any federal or state minimum wage changes with an effective date between the cost study reporting period and the target fiscal year; and

2. By the California CPI pursuant to Section 56915.

(B) Updating the ratio determined in Section 56913(c)(4)(D) for any mandated changes in employer's contributions for fringe benefits between the cost study reporting period and the target fiscal year;

(4) The Proprietary Fee amount determined in Section 56914(d) shall be updated to reflect the most recent Dun and Bradstreet data.

(b) Each cost element shall be adjusted to reflect any additional costs identified by the Department since the time of the reporting period which were not captured by the cost study data.

(c) The rates to be proposed pursuant to Section 56910 shall be the sum of the cost elements determined in subsection (a) above after adjusting according to subsection (b) above.

NOTE

Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction of subsections (a)(1)-(4) and (c) (Register 94, No. 50).

5. Editorial correction capitalizing “S” of “Section” throughout (Register 95, No. 18).

6. Change without regulatory effect amending subsection (c) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

Article 6. Reimbursement Policies

§56917. Payment of Established Rates.

Note • History

(a) Regional centers shall pay residential service providers monthly at the rate established by the Department pursuant to Section 56902(b) and (c).

(b) The source of funds for the monthly payment of residential service providers shall consist of the Regional Center Supplement and, where appropriate, any Supplemental Security Income (SSI) and State Supplemental Program (SSP) funds for which the consumer is eligible minus the consumer's Personal and Incidental Allowance as defined in Title 17, California Code of Regulations, Section 56002(a)(26).

(c) When the regional center has been appointed as the consumer's representative payee for the consumer's SSI/SSP payment, the regional center shall:

(1) Forward that portion of the consumer's Personal and Incidental Allowance which is not conserved by the regional center on the consumer's behalf to the consumer no later than the 10th day of the month in which the regional center receives the consumer's SSI/SSP payment; and

(2) Forward the consumer's SSI/SSP payment to the residential service provider no later than the 10th day of the month following the month in which the regional center receives the consumer's SSI/SSP payment.

(d) The regional center shall reimburse the residential service provider in arrears with funds from the Regional Center Supplement for that portion of the residential rate which exceeds the amount of the consumer's SSI/SSP payment.

(1) The regional center shall not increase the amount of the Regional Center Supplement when:

(A) The residential service provider has been appointed as the consumer's representative payee for the consumer's SSI/SSP payment; and

(B) The amount of the consumer's SSI/SSP payment is temporarily reduced or terminated due to:

1. The representative payee's failure to submit required documentation; and/or

2. The accumulation of consumer funds to the extent that the amount of the consumer's SSI/SSP payment is reduced or the consumer's eligibility for SSI/SSP is terminated.

(e) All consumer SSI/SSP funds which have been conserved by the regional center shall be deposited in an interest-bearing account in a local bank, savings and loan or credit union authorized to do business in California, the deposits of which are insured by a branch of the Federal Government. The account shall meet the following requirements:

(1) The account shall be maintained as a trust account separate from the accounts of the regional center; and

(2) The account title shall clearly note that the account contains consumer cash resources.

(f) The regional center shall provide access to the consumer's cash resources when requested by the consumer or his/her authorized representative.

(g) All interest accruing to funds conserved by the regional center on behalf of a consumer in an account pursuant to Section 56917(e) shall be the property of the consumer.

(h) The established rate shall be paid for the full month when the consumer is temporarily absent from the facility 14 days or less per month.

(1) When the consumer's temporary absence is due to the need for inpatient care in a health facility as defined in Health and Safety Code Section 1250(a), or (c) the regional center shall continue to pay the established rate as long as no other consumer occupies the vacancy created by the consumer's temporary absence, or until the ID Team has determined that the consumer will not return to the facility.

(i) The established rate shall be prorated for a partial month of service in all other cases by dividing the established rate by 30.44, then multiplying by the number of days the consumer resided in the facility.

NOTE

Authority cited: Sections 4648, 4681.1 and 4791(i), Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648, 4659(a), 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsections (a) and (b) and NOTE filed 11-4-91 as an emergency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL 3-3-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsections (a) and (b) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a), designation of former text of subsection (a) to subsection (b), new subsections (c)-(g), renumbering and amendment of former subsection (b) to (h), new subsection (h)(1) and renumbering of former subsection (c) to (i) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsection (a) (Register 94, No. 50).

9. Editorial correction of subsection (g) (Register 95, No. 18).

10. Change without regulatory effect amending subsection (b) filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

§56918. Reimbursement for Residential Respite Services.

Note • History

A provider of residential respite services shall be reimbursed pursuant to Title 17, California Code of Regulations, Section 57332(c)(6).

NOTE

Authority cited: Sections 4648 and 4681.1, Welfare and Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4418.6, 4648, 4681.1 and 4791(i), Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 11-23-94; operative 11-23-94 (Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction (Register 95, No. 18).

6. Change without regulatory effect amending section filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 25).

7. Change without regulatory effect amending section filed 11-10-2005 pursuant to section 100, title 1, California Code of Regulations (Register 2005, No. 45).

§56919. Usual and Customary Fees and Prevailing Rates.

Note • History

(a) The regional center shall request approval by the Department for the payment of usual and customary fees or prevailing rates.

(b) At the Department's discretion, usual and customary fees or prevailing rates may be approved for facilities which meet the criteria in Section 56004(a) and have a rate established by another governmental agency.

NOTE

Authority cited: Section 4681.1, Welfare and Institutions Code. Reference: Section 4681.1, Welfare and Institutions Code.

HISTORY

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correction of subsection (b) (Register 95, No. 18).

Article 7. Verification of Use of Rate Increase Funds

§56931. Definitions.

Note • History

(a) When used in this article, the following words and phrases shall have the following meanings:

(1) “Benefits” means health insurance, dental insurance, vision insurance, life insurance, long-term disability insurance, retirement plans, sick leave, bonus, paid vacation, holidays, employee assistance programs, employment-related education and training, social security, workers' compensation, unemployment insurance, and any other mandatory state and federal employer taxes.

(2) “Compensation” means the total of:

(A) Benefits as defined in subsection (a)(1);

(B) Salaries as defined in subsection (a)(7);

(D) The fair market value of all payments in kind, including, but not limited to, lodging and meals.

(3) “Competency-based Training and Testing” means competency-based training and testing as defined in Title 17, California Code of Regulations, Section 56031(a)(4).

(4) “Coverage” means employing qualified substitute direct care staff to provide direct supervision and special services to consumers while direct care staff are attending competency-based training and competency testing or taking a challenge test.

(5) “Direct Care Staff” means direct care facility staff in Service Level 2, 3 and 4 facilities who personally provide direct supervision and special services to consumers and is synonymous with “Direct Support Professionals”. The term includes the licensee, the administrator, management and supervisory staff during that time when they are providing direct supervision and special services to consumers.

(6) “Licensee” means the adult, firm, partnership, association or corporation, having the authority and responsibility for the operation of a licensed community care facility.

(7) “Salaries” means a fixed dollar amount of pay per pay period paid to direct care staff on a regular basis.

(8) “Wages” means an hourly rate of pay which is paid to direct care staff.

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code.

HISTORY

1. New article 7 (sections 56931-56937) and section filed 12-31-98 as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99 or emergency language will be repealed by operation of law on the following day.

2. New article 7 (sections 56931-56937) and section refiled 5-11-99 as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99 or emergency language will be repealed by operation of law on the following day.

3. New article 7 (sections 56931-56937) and section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000 or emergency language will be repealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

5. New article 7 (sections 56931-56937) filed 1-14-2000 as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-15-2000 or emergency language will be repealed by operation of law on the following day.

6. Repealer and new article 7 (sections 56931-56937) and repealer and new section filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-11-2000 or emergency language will be repealed by operation of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

8. Repealer and new article 7 (sections 56931-56937) and repealer and new section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-27-2000 or emergency language will be repealed by operation of law on the following day.

9. Refiling of 7-26-2000 order, including amendment of subsection (a)(5), 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§56932. Purposes.

Note • History

(a) Rate increase funds received pursuant to Welfare and Institutions Code Section 4681.4 (a) or (b) shall be used only for the following purposes:

(1) Increasing direct care staff salaries, wages and benefits.

(2) Reducing turnover of direct care staff and improving the overall quality of consumer care by increasing direct care staff salaries, wages and benefits in a manner which fairly and equitably allocates the rate increase funds derived from Welfare and Institutions Code Section 4681.4(a) or (b) among direct care staff employees with consideration for job tenure, duties, and relative number of hours worked.

(3) Providing coverage while direct care staff are attending competency-based training and testing or taking a challenge test.

(4) Other purposes which have been approved by the Department.

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

9. Repealer and new section refiled 11-27-2000 as an emergency; operative 11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§56933. Verification Requirement.

Note • History

Each licensee of a Service Level 2, 3, or 4 facility who receives rate increase funds authorized by Welfare and Institutions Code Section 4681.4 (a) or (b) for the purposes specified in Section 56932 shall provide to the regional center verification of the use of any rate increase funds received by the licensee.

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§56934. Rate Increase Funds Verification Procedures.

Note • History

(a) Each licensee who receives rate increase funds authorized by Welfare and Institutions Code Section 4681.4(a) during the 1999 calendar year shall report in writing the use of those rate increase funds to the regional center.

(b) Each licensee who receives rate increase funds authorized by Welfare and Institutions Code Section 4681.4(b) during the 2000 calendar year shall report in writing the use of those rate increase funds to the regional center.

(1) Not less than 30 days prior to the date specified in subsection (c), the regional center shall notify the licensee in writing of the necessity to report the use of rate increase funds.

(c) The licensee's written report, pursuant to subsection (a) or (b), shall be postmarked no later than March 1 of the calendar year following the year in which the rate increase funds were received by the licensee.

(d) The licensee's written report, pursuant to subsection (a) or (b), shall contain, but not be limited to, the following information:

(1) The name, address and telephone number of the facility submitting the report;

(2) The licensee's vendor identification number;

(3) The amount of rate increase funds the licensee received during the calendar year for which the written report is being submitted;

(4) A signed statement that the licensee declares under penalty of perjury under the laws of the State of California that the licensee:

(A) Has read and understands the requirements of Sections 56932 through 56935;

(B) Has increased direct care staff salaries, wages and benefits in a manner which fairly and equitably allocates the increased funds derived from Welfare and Institutions Code Section 4681.4(a) or (b) among direct care staff with consideration for job tenure, duties, and relative number of hours worked, if applicable; and

(C) Has spent the entire amount of rate increase funds received for the calendar year exclusively and entirely for the purposes authorized pursuant to Welfare and Institutions Code Section 4681.4(c)(1) through (3);

(e) The licensee's written report, pursuant to subsection (a) or (b), for those facilities where the licensee has received the Department's approval to use the rate increase funds for a purpose other than those specified in Section 56932(a)(1) through (3) shall contain, but not be limited to, the following:

(1) The information required by subsection (d)(1) through (3); and

(2) A signed statement that the licensee declares under penalty of perjury under the laws of the State of California that the licensee has spent the entire amount of rate increase funds received for the prior calendar year exclusively and entirely for the purposes approved by the Department pursuant to Section 56937.

(f) The regional center shall review a sample of the reports submitted by the licensees pursuant to subsection (a) and (b) to verify that the rate increase funds were spent in accordance with the requirements specified in Section 56932(a)(1) through (4).

(g) Verification of the use of rate increase funds shall include, but is not limited to, reviewing any of the work records employers are required to maintain by the Employment Development Department's regulations at Title 22, California Code of Regulations, Section 1085-2.

(h) The regional center shall retain one copy of each report filed pursuant to subsection (a) and (b) as well as documentation of findings of regional center reviews of verification reports pursuant to subsection (g) for a three year period.

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code; and Section 1085-2, Title 22, California Code of Regulations.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§56935. Failure to File.

Note • History

NOTE

Authority cited: Section 11152, Government Code; and Section 4405, Welfare and Institutions Code. Reference: Sections 4681.4 and 4681.5, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Repealer of 1-14-2000 and 3-13-2000 emergency orders by operation of Government Code section 11346.1, subsections (f) and (g) (Register 2000, No. 48).

§56936. Criteria for Approving Rate Increase Funds Use for Other Purposes.

Note • History

(a) A licensee who receives rate increase funds authorized by Welfare and Institutions Code Section 4681.4(b) may apply to the Department for approval to use the rate increase funds for purposes other than those specified in Section 56932(a)(1) through (3) when the licensee can document that, effective December 31, 1999, all direct care staff with a minimum of six (6) months of experience were receiving compensation at least equivalent to two-hundred and ten percent (210%) of California's minimum wage which was in effect on December 31, 1998 ($12.08 per hour).

(b) When the licensee has complied with subsection (a), compensation of direct care staff with a minimum of six (6) months of experience shall be maintained at an amount equivalent to an hourly rate of no less than two-hundred and ten percent (210%) of California's minimum wage which was in effect on December 31, 1998 ($12.08 per hour).

(c) The use of rate increase funds for purposes other than those specified in Section 56932(a)(1) through (3) shall be limited to expenditures which improve the quality of care provided to a consumer(s).

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§56937. Procedures for Approving the Use of Rate Increase Funds for Other Purposes.

Note • History

(a) To request the Department's approval to use rate increase funds received during calendar year 2000 for purposes other than those specified in Section 56932(a)(1) through (3), the licensee shall submit to the Department all of the following:

(1) Payroll records and other relevant documentation which establish the compensation paid to every direct care staff member for the pay period including December 31, 1999, and which clearly demonstrate that on an hourly basis, the compensation of each direct care staff member with a minimum of six months of experience, for every hour worked that pay period, equaled or exceeded two hundred and ten percent (210%) of California's minimum wage in effect on December 31, 1998 ($12.08 per hour).

(2) Work records which employers are required to maintain by Title 22, California Code of Regulations, Section 1085-2 for all employees; and

(3) A description of the proposed use of the rate increase funds and an explanation of how the proposed use of rate increase funds is consistent with the criteria specified in Section 56936.

(b) The licensee's application shall be received by the Department no later than April 30, 2000.

(c) The proposed use of rate increase funds for a purpose other than those specified in Section 56932(a)(1) through (3) shall not be implemented until the licensee is notified in writing of the Department's approval.

(1) The Department's written approval for the use of rate increase funds for a purpose other than those specified in Section 56932(a)(1) through (3) shall be sent to the licensee and the regional center via certified mail within 60 days of the receipt of the information required by subsections (a)(1) through (3).

(d) The Department's decision is final.

NOTE

Authority cited: Section 4681.4(e), Welfare and Institutions Code. Reference: Section 4681.4, Welfare and Institutions Code; and Section 1085-2, Title 22, California Code of Regulations.

HISTORY

4. Repealed by operation of Government Code section 11346.1(g) (Register 2000, No. 2).

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amendment by operation of Government Code section 11346.1(f) (Register 2000, No. 30).

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

Subchapter 7. Nonresidential Service Vendor Rate-Setting Provisions

Article 1. Definitions

§57200. Terms Defined In Other Subchapters.

Note • History

(a) As used in Sections 57300 through 57948, the following words and phrases have the meanings specified in Sections 54302 and 56704:

(1) Activity Center

(2) Adult Development Center

(3) Authorized Consumer Representative

(4) Behavior Management Program

(5) Community-Based Day Programs

(6) Consumer

(7) Days

(8) Department

(9) Direct Care Staff

(10) Direct Services

(11) Director

(12) Family Member

(13) Generic Agency

(14) Independent Living Program

(15) Infant Development Program

(16) Management Organization

(17) Non-mobile Consumers

(18) Nonresidential Services

(19) Regional Center

(20) Service Code

(21) Service Contract

(22) Social Recreation Program

(23) Staffing Ratio

(24) Subcode

(25) Units of Service

(26) User Regional Center or Utilizing Regional Center

(27) Vendor

(28) Vendor Identification Number

(29) Vendoring Regional Center

(30) Voucher

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691, 4691.5 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(12) and (a)(24) and subsection renumbering and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (a)(12) and (a)(24) and subsection renumbering and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a)(3), repealing subsection (a)(5), renumbering subsections, adding new subsection (6), and amending subsection (a)(16) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57210. Additional Terms Defined.

Note • History

(a) As used in Sections 57300 through 57948, the following words and phrases have the following meanings:

(1) “Allowable Range” means the distance from the lower limit to the upper limit in a distribution of amounts among like programs determined pursuant to Step four, Section 57513;

(2) “Cost-of-Living Adjustment” or “COLA” means an amount of funds appropriated in the Budget Act for increases in rates established by the Department which is representative of an overall increase in the cost of providing services to consumers;

(3) “Direct Service Hours” means the number of hours during which direct services are provided to consumers by direct care staff to meet the objectives of the program design pursuant to Section 56712 or 56762 and, for vendors reimbursed for absences pursuant to Section 54326(a)(11), the number of direct service hours for which reimbursement was received shall also be included;

(4) “Fiscal Year” means the 12-month period which begins July 1 of one calendar year and ends June 30 the following calendar year;

(5) “Gap” means the difference between the amount determined for each vendor in Step five, Section 57514(a)(1) and the amount determined for each vendor in Step two, Section 57511(a)(1) based upon allowable cost and consumer attendance reported to the Department;

(6) “Gap Funding” means an amount of funds appropriated in the Budget Act pursuant to Section 57820;

(7) “Like Programs” means programs that are assigned the same service code and have the same approved staffing ratios;

(8) “Level of Payment” means the total amount which a regional center reimburses a vendor for services provided to its consumers;

(9) “Lower Limit” means the lowest amount allowed in the distribution of amounts among like programs, without an increase in the amount pursuant to Step six, Section 57515;

(10) “Permanent Payment Rate” means a rate established by the Department subsequent to the effective date of Sections 57200 through 57948, which is based upon each vendor's program, allowable cost, consumer attendance, vendor income, and as applicable, regional center payment information;

(11) “Profit”, for profit organizations, or “Surplus”, for not-for-profit organizations, means the amount remaining after all allowable costs related to services for consumers are deducted from a vendor's reimbursement received for those consumers;

(12) “Public Agency” means federal, state, and local government, including school districts, colleges and/or universities supported by public funds;

(13) “Regional Center Payments” means the total amount of income which the vendor received from the vendoring regional center and/or utilizing regional center(s), if any, for services provided to consumers;

(14) “Schedule of Maximum Allowances (SMA)” means the schedule of the maximum allowable rate for the service provided as established by the Department of Health Services (DHS) for services reimbursable under the Medi-Cal program. If the vendor's usual and customary rate is less than the maximum rate allowed pursuant to the SMA, the regional center shall pay the vendor's usual and customary rate.

(15) “Staff Relief Time” means time worked by substitute staff for direct care staff who are absent because of vacation, illness, staff training, jury duty, military leave or administrative leave;

(16) “Straight-line Depreciation” means a depreciation method where the cost of property or equipment is deductible in equal annual amounts over the estimated useful life of the property or equipment;

(17) “Temporary Payment Rate” means a rate established by the Department subsequent to the effective date of Sections 57200 through 57948, for vendors who do not have an actual cost history which the Department can use to establish a permanent payment rate;

(18) “Upper Limit” means the highest amount allowed in the distribution of amounts among like programs, without a decrease in the amount pursuant to Step six, Section 57515;

(19) “Usual and Customary Rate” means the rate which is regularly charged by a vendor for a service that is used by both regional center consumers and/or their families and where at least 30% of the recipients of the given service are not regional center consumers or their families. If more than one rate is charged for a given service, the rate determined to be the usual and customary rate for a regional center consumer and/or family shall not exceed whichever rate is regularly charged to members of the general public who are seeking the service for an individual with a developmental disability who is not a regional center consumer, and any difference between the two rates must be for extra services provided and not imposed as a surcharge to cover the cost of measures necessary for the vendor to achieve compliance with the Americans With Disabilities Act. New programs applying for vendorization shall provide a written declaration to the vendoring regional center that it is their intent to comply with this subsection, and will be allowed up to 12 months to achieve compliance. The vendoring regional center may audit a vendor's records to determine compliance with this subsection and, if the vendor is found not to be in compliance, shall revoke the vendor's usual and customary rate and negotiate a rate pursuant to Section 57300; and

(20) “Vendor Income” means all income received from any public agency, with the exception of the Department, regional centers, or the Department of Rehabilitation and/or the Department of Health Services if the vendor reported costs pursuant to Section 57422(c)(2), for services to consumers pursuant to Section 57438.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including new subsection (a)(21) and subsection renumbering transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (a)(21) filed 4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsection (a)(3) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

12. Amendment of subsection (a)(3) and (a)(19) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

13. Change without regulatory effect amending subsection (a)(3) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

Article 2. General Provisions

§57300. Rate-Setting Requirements Applicable to All Nonresidential Service Vendors.

Note • History

(a) In order for the Department to establish a rate of reimbursement for nonresidential service vendors, each vendor shall:

(1) Be approved as a vendor by a regional center pursuant to Section 54322(d)(1);

(2) Submit complete and accurate information and documentation; and

(3) Comply, if applicable, with the submission requirements specified in:

(A) Sections 57422 through 57439 for community-based day programs; or

(B) Sections 58020 through 58039 for in-home respite service agencies.

(b) Vendors shall not charge regional centers more for services to consumers than they charge for comparable services to any other person served by the vendor, solely because the consumer is a person with a developmental disability whose services are publicly rather than privately funded.

(1) Unless they have a rate established pursuant to these regulations which is currently in effect; nor

(2) For services in an amount greater than the rate established pursuant to these regulations.

(d) For those vendors for whom the Department establishes a rate, once the vendor has received notice of the rate established by the Department, any regional center, or its designee, purchasing or intending to purchase services from the vendor may negotiate with the vendor the level of payment for services provided to its consumers for a specified period of time. The level of payment may be less than but shall not exceed the maximum reimbursement possible during the period specified, using the rate established by the Department and the units of service used by the vendor to charge and invoice the regional center for services provided to consumers as the basis for determining the maximum reimbursement possible.

(1) Each regional center and vendor shall mutually agree in writing upon the level of payment and the effective date for commencing and terminating payment at the agreed upon amount.

(2) Upon termination of the level of payment negotiated by a regional center and vendor, the vendor shall be reimbursed for services at the rate established by the Department.

(3) Within the limitations specified in this section, the level of payment negotiated by a regional center and vendor may be renegotiated.

(4) Each regional center shall provide the Department and vendor with a copy of the written agreement specifying the terms of the level of payment.

(e) If a vendor does not have a rate established by the Department, and if the SMA is not applicable to the service provided by the vendor, and if the vendor does not have an established usual and customary rate as defined in Section 57210(a)(19), the vendoring regional center shall negotiate with the vendor the level of payment for services provided to consumers for a specified period of time.

(1) Once the vendor has received written notice of vendorization and rate approval from the vendoring regional center, any regional center purchasing or intending to purchase services from the vendor may utilize the approved rate or negotiate with the vendor for a level of payment for a specified period of time.

(f) Rates of reimbursement established pursuant to the Schedule of Maximum Allowances (SMA) or the vendor's usual and customary rate or rates set by negotiation with a regional center in accordance with this section do not require approval by the Department.

(g) For nonresidential rate-setting purposes, a change in ownership, pursuant to Section 54330, will not result in a change in the vendor's rate if the staffing ratio and program activities, as identified in the program design, remain unchanged.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690, 4690.1, 4690.2, 4691, 4691.5 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690, 4690.1, 4690.2, 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (d)-(d)(5) and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (d)-(d)(5) and amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection (d)(5) and amendment of subsections (a)(1) and (a)(3)(B) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(1), (b) and (d) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsections (c)(1)-(d), new subsection (e)-(e)(1), subsection relettering and amendment of subsection (f) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Article 3. Vouchers

§57310. Method of Reimbursement for Voucher Services.

Note • History

(a) Each regional center may offer vouchers to family members or adult consumers to allow the families and consumers to procure the following services:

(1) Nursing Service - Family Member - Service Code 415; and/or

(2) Day Care - Family Member - Service Code - 405; and/or

(3) Respite Service - Family Member - Service Code 420; and/or

(4) Transportation - Family Member - Service Code 425; and/or

(5) Diapers and Nutritional Supplements - Family Member - Service Code 410.

(b) If a voucher is issued, the maximum reimbursement authorized by the regional center for the service provided shall be specified in the voucher and shall not exceed the maximum rate of reimbursement as specified below:

(1) Nursing Service - Family Member - Service Code 415 - the Schedule of Maximum Allowances for the Home and Community Based Services, In-Home Medical Care Waiver Program, as developed by the Department of Health Services;

(2) Day Care - Family Member - Service Code 405 - the usual and customary rate, as defined in Section 57210(a)(19), which the direct provider of the service charges or, if the direct provider of the service does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e);

(3) Respite Service - Family Member - Service Code 420 - $10.71 per consumer per hour, including fringe benefits, effective January 1, 2008;

(4) Transportation - Family Member - Service Code 425 - the standard rate schedule developed by the regional center pursuant to Title 17, California Code of Regulations, Section 58543; and

(5) Diaper and Nutritional Supplements - Family Member - Service Code 410 - the usual and customary rate charged by the supplier.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690, 4690.1 and 4690.2, Welfare and Institutions Code. Reference: Sections 4690, 4690.1, 4690.2 and 4690.5, Welfare and Institutions Code; Budget Act of 2000-01, Item 4300-101-0001.

HISTORY

3. Certificate of Compliance as to 3-4-92 order including amendment of text and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. New article 3 heading and amendment of section heading, text and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order, including amendment of subsections (a) and (a)(5), repealer of subsections (a)(6)-(13), amendment of subsection (b)(5) and repealer of subsections (b)(6)-(13), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (a) and (b)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Change without regulatory effect amending subsection (b)(3) filed 3-6-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 10).

10. Change without regulatory effect amending subsection (b)(3) filed 1-15-99 pursuant to section 100, title 1, California Code of Regulations (Register 99, No. 3).

11. Amendment of subsection (b)(2) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

12. Amendment of subsection (b)(3) and amendment of Note filed 3-14-2001 as an emergency; operative 3-14-2001 (Register 2001, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-12-2001 or emergency language will be repealed by operation of law on the following day.

13. Amendment of subsection (b)(3) and amendment of Note refiled 7-12-2001 as an emergency, including further amendment of subsection (b)(3) and Note; operative 7-12-2001 (Register 2001, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-9-2001 or emergency language will be repealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 7-12-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 47).

15. Amendment of subsection (b)(3) and amendment of Note filed 11-19-2001 as an emergency; operative 11-19-2001 (Register 2001, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-19-2002 or emergency language will be repealed by operation of law on the following day.

16. Certificate of Compliance as to 11-19-2001 order transmitted to OAL 3-15-2002 and filed 3-27-2002 (Register 2002, No. 13).

17. Change without regulatory effect amending subsection (b)(3) and Note filed 10-4-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 40).

18. Amendment of subsection (b)(3) filed 11-16-2007; operative 11-16-2007 pursuant to Government Code section 11343.4 (Register 2007, No. 46).

19. Amendment of subsection (b)(3) filed 7-14-2008; operative 7-14-2008 pursuant to Government Code section 11343.4 (Register 2008, No. 29).

Article 5. Rates of Reimbursement Based on the Schedule of Maximum Allowances or the Vendor's Usual and Customary Rate

§57330. Generic Agencies.

Note • History

(a) The maximum rate of reimbursement shall be the usual and customary rate charged by the generic agency to all participants in the program.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690, and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57331. Group Practices.

Note • History

(a) The rate of reimbursement for group practices shall be determined based on the method of reimbursement established, pursuant to Sections 57332 through 57335, for an individual providing the same service.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690, and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57332. Maximum Rates of Reimbursement for Non-Residential Services.

Note • History

(a) The maximum rate of reimbursement for the following services shall be the vendor's usual and customary rate as defined in Section 57210(a)(19) or, if the vendor does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e):

(1) Adaptive Skills Trainer -- Service Code 605

(2) Adult Day Care -- Service Code 855

(3) Art Therapist -- Service Code 691

(4) Associate Behavior Analyst -- Service Code 613.

(5) Attorney -- Service Code 610

(6) Behavior Analyst -- Service Code 612

(7) Camping Services -- Service Code 850 (Day Camp, Residential Camp, and Traveling Camp)

(8) Child Day Care -- Service Code 851

(9) Counseling Services -- Service Code 625 (Family Counselors and Social Workers)

(10) Dance Therapist -- Service Code 692

(11) Developmental Specialist -- Service Code 670

(12) Diaper Service -- Service Code 627

(13) Dietary Services -- Service Code 720 (Dietician and Nutritionist)

(14) Driver Trainer -- Service Code 630

(15) Educational Psychologist -- Service Code 672

(16) Homemaker -- Service Code 858

(17) Homemaker Service -- Service Code 860

(18) Independent Living Specialist -- Service Code 635

(19) Interpreter -- Service Code 642

(20) Mobility Training Services Agency -- Service Code 645

(21) Mobility Training Services Specialist -- Service Code 650

(22) Music Therapist -- Service Code 693

(23) Psychiatric Technician -- Service Code 790

(24) Recreational Therapist -- Service Code 694

(25) Retail/Wholesale Stores -- Service Code 660

(26) Teacher -- Service Code 674

(27) Teacher of Special Education -- Service Code 678

(28) Teacher's Aide -- Service Code 676

(29) Translator -- Service Code 643

(30) Tutor -- Service Code 680

(b) The maximum rate of reimbursement for the following medical services shall be in accordance with the Schedule of Maximum Allowances (SMA):

(1) Acute Care Hospitals -- Service Code 700

(Acute Care Hospitals and Acute Psychiatric Hospital)

(2) Adult Day Health Center -- Service Code 702

(3) Audiology -- Service Code 706

(4) Clinical Psychologist -- Service Code 785

(5) Day Treatment Centers -- Service Code 710

(6) Dentistry -- Service Code 715

(7) Durable Medical Equipment Dealer -- Service Code 725

(8) Genetic Counselor -- Service Code 800

(9) Hearing and Audiology Facilities -- Service Code 730

(10) Home Health Agency -- Service Code 854

(11) Home Health Aide -- Service Code 856

(12) Infant Development Specialist -- Service Code 810

(13) Laboratory and Radiology Services -- Service Code 735

(14) Nurse Anesthetist -- Service Code 741

(15) Occupational Therapy -- Service Code 773

(16) Orthoptic Services -- Service Code 745

(Orthoptic Technician and Optometrist)

(17) Orthotic and Prosthetic Services -- Service Code 750

(Orthotist and Prosthetist)

(18) Other Medical Equipment or Supplies -- Service Code 755

(Dispensing Optician, Hearing Aid Dispenser, and Prosthetic and Orthoptic Appliance Factory)

(19) Other Medical Services -- Service Code 760

(20) Pharmaceutical Services -- Service Code 765

(Pharmacist and Pharmacy)

(21) Physical Therapy -- Service Code 772

(22) Physicians or Surgeons -- Service Code 775

(23) Psychiatrist -- Service Code 780

(24) Respiratory Therapist -- Service Code 793

(25) Speech Pathology -- Service Code 707

(1) Behavior Management Assistant -- Service Code 615

(A) The usual and customary rate, as defined in Section 57210(a)(19), charged for the behavior management assistant services or, if the vendor does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e), not to exceed the rate of reimbursement established for the licensed professional with whom the Behavior Management Assistant is registered.

(2) Behavior Management Consultant -- Service Code 620

(A) The maximum rate of reimbursement shall be based on the method of reimbursement established, pursuant to Section 57332, for an individual with the same licensed classification.

(3) In-Home Respite Worker -- Service Code 864

(A) Effective January 1, 2008, the maximum rate of reimbursement for in-home respite workers shall not exceed $10.71 per consumer per hour, including fringe benefits, except:

1. When the family member has more than one consumer residing with them who has been authorized by the regional center to receive in-home respite services, the maximum level of payment shall be determined pursuant to Section 58140 of these regulations.

(4) Licensed Vocational Nurse -- Service Code 742

(A) The rate of reimbursement shall be in accordance with the Schedule of Maximum Allowances (SMA) for the Home and Community- Based Services, In-Home Medical Care Waiver Program.

(5) Nurse's Aide or Assistant -- Service Code 743

(A) The rate of reimbursement shall be in accordance with the Schedule of Maximum Allowances (SMA) for the Home and Community-Based Services, In-Home Medical Care Waiver Program.

(6) Out-of-Home Respite Services -- Service Code 868

(A) Day care homes providing out-of-home respite services shall be reimbursed in accordance with the vendor's usual and customary rate, as defined in Section 57210(a)(19) or, if the vendor does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e).

(B) Licensed residential facilities providing out-of-home respite services, for whom the Department of Social Services or the Department of Health Services has established a rate, shall be reimbursed in accordance with the rate of reimbursement as established by the appropriate Department.

(C) Licensed residential facilities providing out-of-home respite services, for whom the Department of Social Services has not established a rate, shall be reimbursed at 1/21 of the monthly rate established by the regional center for the facility's service level as approved pursuant to Title 17, California Code of Regulations, Section 56005.

(7) Out-of-State Manufacturer or Distributor -- Service Code 655

(A) Out-of-State Manufacturers or Distributors supplying products that are reimbursable under the Medi-Cal program shall be reimbursed in accordance with the Schedule of Maximum Allowances (SMA).

(B) Out-of-State Manufacturers or Distributors supplying products that are not reimbursable under the Medi-Cal program shall be reimbursed according to the vendor's usual and customary rate.

(8) Registered Nurse -- Service Code 744.

(A) The rate of reimbursement shall be in accordance with the Schedule of Maximum Allowances (SMA) for the Home and Community-Based Services, In-Home Medical Care Waiver Program.

(9) Respite Facility -- Service Code 869

(A) Vendors classified as a respite facility shall be reimbursed as follows:

1. Either 1/21 of the established monthly rate for the facility's service level as approved pursuant to Title 17, California Code of Regulations, Section 56005; or

2. The agreed-upon level of payment for a service contract negotiated pursuant to Section 57540(b) through (f).

a. Effective January 1, 2008, the level of payment shall not exceed $10.71 per consumer per hour, including fringe benefits, authorized by the Department for an In-Home Respite Worker, Service Code 864, for the same units of service.

(10) Genetic Counselor -- Service Code 800

Genetic counselors to whom the SMA does not apply shall be reimbursed in accordance with the vendor's usual and customary rate, as defined in Section 57210(a)(19) or, if the vendor does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e).

(11) Infant Development Specialist -- Service Code 810

Infant development specialists to whom the SMA does not apply shall be reimbursed in accordance with the vendor's usual and customary rate, as defined in Section 57210(a)(19) or, if the vendor does not have an established usual and customary rate, a negotiated rate pursuant to Section 57300(e).

(12) Behavior Management Technician (Paraprofessional) -- Service Code 616

Regional centers shall contract for Behavior Management Technician (Paraprofessional) services at no more than 75% of the regional center's median hourly rate for Behavior Management Assistant -- Service Code 615 or the statewide median rate for Behavior Management Assistant -- Service Code 615, whichever is lower.

NOTE

Authority cited: Sections 4690 and 4686.3, Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4691.6, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. New subsections (a)(4), (a)(11)(A)-(D) and (a)(12) and subsection redesignation filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect amending section, including incorporation and amendment of former section 57333, filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

6. Change without regulatory effect amending subsections (c)(3)(A) and (c)(9)(A)2.a. filed 3-6-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 10).

7. Editorial correction of subsection (a)(3) (Register 97, No. 21).

8. Change without regulatory effect amending subsections (c)(3)(A) and (c)(9)(A)2.a. filed 1-15-99 pursuant to section 100, title 1, California Code of Regulations (Register 99, No. 3).

9. Amendment of subsections (a), (c)(1)(A), (c)(6)(A) and (c)(10)-(11) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

10. Amendment of subsections (c)(3)(A), (c)(6)(A) and (c)(9)(A)2.a. and amendment of Note filed 3-14-2001 as an emergency; operative 3-14-2001 (Register 2001, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-12-2001 or emergency language will be repealed by operation of law on the following day.

11. New subsection (a)(5) and subsection renumbering filed 5-3-2001; operative 6-2-2001 (Register 2001, No. 18).

12. Amendment of subsections (c)(3)(A), (c)(6)(A) and (c)(9)(A)2.a. and amendment of Note refiled 7-12-2001 as an emergency, including further amendment of Note; operative 7-12-2001 (Register 2001, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-9-2001 or emergency language will be repealed by operation of law on the following day.

13. Reinstatement of section as it existed prior to 7-12-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 47).

14. Amendment of subsections (c)(3)(A), (c)(6)(A) and (c)(9)(A)2.a. and amendment of Note filed 11-19-2001 as an emergency; operative 11-19-2001 (Register 2001, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-19-2002 or emergency language will be repealed by operation of law on the following day.

15. Certificate of Compliance as to 11-19-2001 order transmitted to OAL 3-15-2002 and filed 3-27-2002 (Register 2002, No. 13).

16. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. and amendment of Note filed 8-29-2002 as an emergency; operative 8-29-2002 (Register 2002, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-27-2002 or emergency language will be repealed by operation of law on the following day.

17. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. and amendment of Note refiled 12-19-2002 as an emergency; operative 12-27-2002 (Register 2002, No. 51). A Certificate of Compliance must be transmitted to OAL by 4-28-2003 or emergency language will be repealed by operation of law on the following day.

18. Certificate of Compliance as to 12-19-2002 order transmitted to OAL 4-25-2003 and filed 6-5-2003 (Register 2003, No. 23).

19. New subsection (a)(4) and subsection renumbering filed 4-29-2004; operative 5-29-2004 (Register 2004, No. 18).

20. Change without regulatory effect amending subsections (c)(3)(A) and (c)(9)(A)2.a. and amending Note filed 10-4-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 40).

21. Amendment of subsections (c)(3)(A) and (c)(9)(A)2. filed 11-16-2007; operative 11-16-2007 pursuant to Government Code section 11343.4 (Register 2007, No. 46).

22. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. filed 7-14-2008; operative 7-14-2008 pursuant to Government Code section 11343.4 (Register 2008, No. 29).

23. New subsection (c)(12) and amendment of Note filed 9-19-2011 as an emergency; operative 9-19-2011 (Register 2011, No. 38). A Certificate of Compliance must be transmitted to OAL by 9-19-2013 pursuant to Welfare and Institutions Code section 4686.3 or emergency language will be repealed by operation of law on the following day.

§57334. Prevention Services/Infant Development Services. [Repealed]

Note • History

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57335. Supportive Services. [Repealed]

Note • History

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Amendment of subsection (b)(2) and new subsections (b)(2)(A)-(B) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsections (c)(3)(A)2. and (c)(3)(A)2.a., transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57336. Miscellaneous Services.

Note • History

(a) The maximum rates of reimbursement for Miscellaneous Services shall be established in accordance with the following:

(1) Schedule of Maximum Allowances (SMA); or

(2) The vendor's usual and customary rate, as defined in Section 57210(a)(19), if the SMA does not apply to the services provided; or

(3) A negotiated rate pursuant to Section 57300(e) if the vendor does not have an established usual and customary rate, as defined in Section 57210(a)(19), and the SMA does not apply to the services provided.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648(a), 4690 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

3. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Subchapter 8. Rate-Setting Procedures for Community-Based Day Programs

Article 1. (Reserved)

Article 2. General Provisions

§57422. General Requirements.

Note • History

(a) If a vendor serves both consumers and persons other than consumers, the vendor shall:

(1) Report only the program, cost and vendor income information related to services to consumers; and

(2) Allocate its costs and vendor income to consumers and to other persons served by the vendor based upon:

(A) Actual days of attendance if the service is an activity center, adult development center or behavior management program; and

(B) Actual hours of attendance if the service is a social recreation program, independent living program, or infant development program.

(b) If a vendor operates more than one service and the services share costs and/or vendor income, the vendor shall allocate these costs and/or vendor income based upon each service's representative share of the cost and/or vendor income.

(c) If a vendor provides services to consumers for the Department of Rehabilitation and/or the Department of Health Services, the vendor shall:

(1) Report only the allowable program, cost and vendor income information related to the program activities vendored by the regional center; or

(2) Report the total allowable program, cost and vendor income information, including the costs associated with services provided for the Department of Rehabilitation and/or the Department of Health Services. Only those allowable costs which would otherwise be funded by the Department shall be included.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (a)-(a)(2) and (c) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Submission of Required Information

§57430. Submission of Information.

Note • History

(a) Each community-based day program vendor shall submit the program, cost and vendor income information specified in Sections 57433 through 57438, and as applicable, the regional center payment information specified in Section 57439, on Form DS1897, dated 12/92, entitled Community-Based Day Program: Program, Cost and Vendor Income Statement, for each service for which the vendor is requesting that a rate be established. The vendor shall sign and date Form DS1897 which includes a certification that the information is true and correct and complies with Sections 57422 through 57439. The vendor shall submit the original document to the Department with a copy of this document submitted to the vendoring regional center at the same time the original document is submitted to the Department.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order including amendment transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57431. Reporting Periods for Submission of Information.

Note • History

(a) Information submitted pursuant to Sections 57433 through 57439 shall cover the following reporting periods:

(1) For vendors receiving a temporary payment rate and whose temporary payment rate will be converted to a permanent payment rate, the reporting period shall be 12 consecutive months of representative actual allowable cost information, incurred within 18 months from the date the temporary payment rate became effective. The Department may grant an extension of the temporary payment rate for a period of up to six months if the vendor is unable to submit the required cost information due to delayed consumer enrollment into the program; and

(2) For vendors receiving a permanent payment rate and whose permanent payment rate will be established in Fiscal Year 1997-98, and each alternate fiscal year thereafter, the reporting period shall be Fiscal Year 1995-96, and each alternate fiscal year thereafter.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691, 4691.5 and 4791, Welfare and Institutions Code. Reference: Sections 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsection (a)(1) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§57432. Required Due Dates for Submission of Information.

Note • History

(a) The required dates for submission are as follows:

(1) Within 18 months from the date the temporary payment rate became effective, for vendors whose temporary payment rate is being converted to a permanent payment rate, unless an extension of the temporary payment rate has been granted pursuant to Section 57431(a)(1);

(2) Prior to expiration of the temporary payment rate for those vendors who received an extension pursuant to Section 57431(a)(1);

(3) September 30, 1996, and each alternate September 30 thereafter, for vendors whose permanent payment rate is being established in Fiscal Year 1997-98, and each alternate fiscal year thereafter; and

(4) At the time the vendor requests establishment of a temporary payment rate, for vendors requesting a temporary payment rate.

(b) If the information is received by the dates specified in (a), the vendoring regional center and the Department shall review the information pursuant to Sections 57440 and 57442.

(c) If the information is not received by the dates specified in (a), the Department shall, within 15 days, notify in writing, the vendor, the vendoring regional center, and utilizing regional center(s), if any, as follows:

(1) For the following vendors, that payment of the vendor's rate was suspended, the effective date of the suspension and that payment shall remain suspended until the information is received:

(A) For vendors required to submit information pursuant to (a)(1), suspension is effective at the end of 18 months, unless an extension of the temporary payment rate has been granted pursuant to Section 57431(a)(1); and

(B) For vendors required to submit information pursuant to (a)(2), suspension is effective upon expiration of the extension; and

(C) For vendors required to submit information pursuant to (a)(3), suspension is effective on September 30, 1996, and each alternate September 30, thereafter.

(2) This provision does not apply to vendors requesting a temporary payment rate, since the Department cannot initiate any action until the vendor submits its request for establishment of a temporary payment rate.

(d) If the information is submitted after the dates specified in (a) when payment of the vendor's rate has been suspended, the vendoring regional center and the Department shall review the information pursuant to Sections 57440 and 57442, and the Department shall authorize the vendoring regional center and utilizing regional center(s), if any, to reinstate payment of the vendor's rate as of the date payment was suspended.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§57433. Required Program Information.

Note • History

(a) In order for the Department to establish a temporary payment rate or permanent payment rate, the vendor shall submit the following program information:

(1) Vendor name, and name of the management organization, if any, vendor identification number, service code and subcode;

(2) Facility or office telephone number, business and mailing addresses;

(3) Name of the service director;

(4) Name of the vendoring regional center and utilizing regional center(s), if any; and

(5) A copy of the program design which was submitted to the vendoring regional center pursuant to Section 54310(a)(10)(D).

(b) In addition to the information in (a), vendors requesting a permanent payment rate shall also submit for each month of the reporting period:

(1) The total number of direct service hours actually provided to consumers. For vendors reimbursed for absences pursuant to Section 54326(a)(11), the total number of direct service hours actually provided to consumers shall also include direct service hours for which the vendor received reimbursement;

(2) For activity centers, adult development centers or behavior management programs the:

(A) Maximum number of consumers enrolled;

(B) Actual number of days of attendance for all consumers, which shall also include the actual number of consumer days for which the vendor was reimbursed for absences pursuant to Section 54326(a)(11);

(C) Number of days in which service was actually provided, which shall also include the actual number of days for which the vendor was reimbursed for absences pursuant to Section 54326(a)(11); and

(D) Number of direct service hours operated per-day.

(3) For social recreation programs, independent living programs or infant development programs the:

(A) Authorized number of direct service hours for all consumers;

(B) Number of consumers scheduled to receive services within the hours identified in (A);

(C) Number of consumers who actually received services within the hours identified in (A), which shall also include the number of consumers for whom the vendor was reimbursed for absences pursuant to Section 54326(a)(11); and

(D) Actual number of hours of attendance for all consumers identified in (C), which shall also include the actual number of hours for which the vendor was reimbursed for absences pursuant to Section 54326(a)(11).

(1) The date that the vendor began, or intends to begin, providing services to consumers; and

(2) A copy of the vendorization approval letter specified in section 54322(d).

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147 and Sections 4691, 4691.5 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(5) and (c)(2) filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsections (b)(1), (b)(2)(B)-(C) and (b)(3)(C)-(D) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Change without regulatory effect amending subsections (b)(1), (b)(2)(B)-(C) and (b)(3)(C)-(D) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§57434. Required Cost Information.

Note • History

(a) In order for the Department to establish a permanent payment rate, the vendor shall submit information for the following allowable costs for the reporting period, if they are incurred by the vendor and are necessary for the vendored service.

(1) Salary and wage expense which shall include:

(A) The total gross salary and wages, including overtime and staff relief time, for the staff functions specified in Section 56724; and

(B) The average hourly salary and wage and fringe benefit cost for the direct service function specified in section 56724(d).

(2) Fringe benefit costs associated with the salary and wage costs for the staff functions identified in (1)(A) which shall be limited to the following:

(A) Old Age Security Disability Insurance (OASDI) or Federal Insurance Compensation Act (FICA);

(B) Workers' compensation;

(D) Life insurance;

(E) Health insurance;

(F) Dental insurance;

(G) Retirement;

(H) Vision insurance;

(I) Employee Training Tax, as specified in the California State Unemployment Insurance Code Section 976.6; and

(J) Long-term disability insurance.

(3) Operating expenses which shall not duplicate other allowable costs and shall be limited to the following cost categories:

(A) Accounting fees of the vendor for the establishment and maintenance of accounting records and other information systems required for the fiscal management of the vendored service;

(B) Bank service fees of the vendor;

(C) Communication costs for services including telephone, telegraph, teletype, centrex, telepak, postage, message services, facsimiles and TDD;

(D) Contractual/consultant fees for program operation that do not have a specific cost category;

(E) Depreciation costs, except for vehicles which are covered under (P). The following items shall be depreciated using the straight-line depreciation method and the useful life of the item. The useful life of an item shall be that used for federal tax purposes.

1. Facilities which have been purchased by the vendor;

2. Furniture and equipment which has been purchased by the vendor and has a unit acquisition cost of at least $500 and a normal useful life of at least four years; and

3. Capital improvements that add to the value or useful life of the facility or equipment. Capital improvements shall be treated as a permanent investment to be added to the cost basis of the facility or equipment and charged to depreciation.

(F) General expense costs for the following items only:

1. Furniture and equipment which do not meet the criteria specified in (E)2.;

2. Interest on loans attributable to the vendored service;

3. Subscriptions for periodicals which are used in the operation of the vendored service or for the purpose of staff development;

4. Staff recruitment costs; staff screening costs, such as fingerprinting prospective employees; and staff hiring costs which shall include the costs for physical examinations or other health and safety costs that may be required prior to employment;

5. Fees for licenses, certifications, registrations or permits, if necessary for vendorization or the continued operation of the service subsequent to vendorization;

6. Accreditation fees;

7. Association dues or fees;

8. Costs for providing or preparing information related to the vendored service which is used as general information to the consumers or to the authorized consumer representatives;

9. Local business fees or taxes;

10. Costs related to inoculations or clinical tests of an employee, for the employee's or consumer's health and safety; and

11. Fuel and oil.

(G) Insurance costs;

(H) Janitorial fees;

(I) Legal fees;

(J) Maintenance costs for repair and upkeep of furniture and equipment, vehicles, facilities and grounds which neither adds to the permanent value nor prolongs its useful life, but maintains it in an efficient operating condition;

(K) Office and program supply costs for items which are expendable or consumable and are used by or on behalf of the consumers in the vendored service. Food supply items shall only be included for consumers when used to reinforce positive behaviors, as a necessary item for instruction only when supported by the program design pursuant to Section 56712 or 56762, or as required by the appropriate licensing agency;

(L) Rental and lease costs. On a lease-purchase, while the item is being leased, the cost shall be reported under this category. When the option-to-purchase has been exercised, the residual value of the item shall be depreciated and shall be reported, as applicable, under category (E) or (P). Rental and lease costs shall apply to the following items:

1. Furniture and equipment;

2. Vehicles; and

3. Facilities, including rental costs for vacant apartments which are used for independent living programs.

(M) Staff training costs for in-service training and employee development which meet the requirements specified in Section 56726 or 56744. Staff training costs which were incurred shall be allowable to the extent the vendor implemented the staff training plan specified in Section 56726(a)(1);

(N) Travel costs for consumer or staff travel that is a part of the program curriculum.

1. When the program curriculum is conducted solely in natural environments, only consumer travel which occurs between the first and last training site shall be included, unless the regional center, pursuant to Section 54342(a)(78)(A), also approves inclusion of travel associated with transporting consumers to the first and from the last training site as part of the operating expenses of the vendored service;

2. Consumer travel shall also include travel costs for travel to and from the vendored service site on an emergency basis when the consumer's health or safety is at risk.

(O) Utility costs such as gas, electricity, water, garbage, sewer fees or other utility expenses which occur at the vendored service site;

(P) Vehicle depreciation costs for owned vehicles shall be calculated by using the straight-line depreciation method and the minimum normal service life specified below. Vehicles which have been purchased using a combination of funds obtained through Section 16(b)(2) of the Urban Mass Transportation Act of 1964, 49 United States Code, Section 1612(b), and funds from the vendor, shall only be depreciated for the portion of the costs incurred by the vendor. The minimum normal service life for:

1. Standard size heavy duty (approximately 35'-40') transit busses is at least twelve years of service or an accumulation of at least 500,000 total miles on the vehicle;

2. Medium size heavy duty (approximately 30') transit busses is at least ten years of service or an accumulation of at least 350,000 total miles on the vehicle;

3. Small medium duty (under 30') transit busses is at least seven years of service or an accumulation of at least 200,000 total miles on the vehicle. A 16-passenger bus shall be considered a small medium duty transit bus and not a van; and

4. Other vehicles such as regular and specialized vans and cars is at least four years of service or an accumulation of at least 100,000 total miles on the vehicle.

(4) Management organization costs which:

(A) Shall include for staff functions of the management organization, the allowable costs specified in (a)(1) through (3) of this section.

(B) Shall not include:

1. More than 100 percent of the allocated costs of the management organization;

2. Costs applicable to or claimed by other services operated by the vendor;

3. Any non-allowable costs pursuant to Section 57436; and

4. Costs for staff relief time and direct care staff.

(C) Shall be allocated on a basis consistent with the administrative support provided to each separate service, and each vendor shall:

1. Indicate whether the methodology used to allocate the costs of the management organization is based upon:

a. Actual days of attendance if the service is an activity center, adult development center, or behavior management program; or actual hours of attendance if the service is a social recreation program, independent living program, or infant development program; or

b. The total costs of each service.

2. Include the total allowed costs of the management organization for the reporting period.

(b) Cost information submitted pursuant to (a) shall not include salaries and wages and fringe benefits for staff hired to supplement staffing ratios for non-mobile consumers, pursuant to Section 56756(b). These costs shall be reimbursed pursuant to Sections 57530 through 57534.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(3)(N) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(3)(N) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(3)(M) and (a)(3)(N)1. and 2. transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsection (a)(3)(F)2. and redesignation of subsection (a)(4)(C)(1) to (a)(4)(C)1. filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§57436. Costs Not to Be Reported.

Note • History

(a) Non-allowable costs shall not be reported and are limited to the following:

(1) Camperships, student aid funds and scholarships;

(2) Consumer entertainment and admission fees;

(3) Consumer moving expenses,

(4) Contractual/consultant fees for individual services which can be obtained through a generic agency and which the generic agency is legally responsible to provide;

(5) Depreciation costs for furniture, equipment, facilities or vehicles that are donated, secured or purchased through government grants;

(6) Depreciation costs for owned land;

(7) Donated services, facilities, furniture, equipment, or vehicles;

(8) Donations to other agencies;

(9) Employee bonuses and commissions;

(10) Facility, furniture, equipment, or vehicle rental or lease costs associated with items which are owned by a management organization, its affiliates or a commonly owned entity; and are leased or rented back to the management organization, its affiliates or a commonly owned entity, or the services it operates, when submission of such costs would result in the vendor being reimbursed twice for the same costs;

(11) Federal/state income tax and penalties or fees associated with payment of federal or state income taxes;

(12) Fund raising costs;

(13) Gifts for consumers or employees;

(14) Legal fees directly related to a consumer, or expenses for the prosecution of claims against the regional center or state agencies;

(15) Management organization costs pursuant to Section 57434(a)(4)(B);

(16) Payroll tax penalties

(17) Profit;

(18) Public relations costs;

(19) Refundable deposits;

(20) Supplements to consumers for their daily living needs;

(21) Surplus as defined in Section 57210(a)(11); and

(22) Travel costs associated with transporting consumers to or from the vendored service site, or to the first and from the last training site for programs which conduct their curriculum solely in natural environments, except as specified in Section 57434(a)(3)(N).

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(21) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(21) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a)(20) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. New subsection (a)(16) and subsection renumbering filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§57438. Required Vendor Income Information.

Note • History

(a) In order for the Department to establish a permanent payment rate, the vendor shall submit the following vendor income information:

(1) The name of each vendor income source;

(2) The total amount of vendor income received from each source; and

(3) The duration of funding provided by each vendor income source.

(b) Vendor income shall not include income:

(1) Received from private sources;

(2) Used for non-allowable costs or for persons other than consumers;

(3) Received from the Department or regional centers; and

(4) Received from the Department of Rehabilitation and/or the Department of Health Services for services to consumers.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (b)(2) and (b)(4) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57439. Required Regional Center Payment and Vendor Cost Reduction Information.

Note • History

(a) In order for the Department to establish a permanent payment rate for vendors whose temporary payment rate is being converted to a permanent payment rate, or for vendors whose permanent payment rate is being established, each vendor who agreed, pursuant to Section 57300(d), to a negotiated level of payment shall submit regional center payment information for each regional center with whom the vendor agreed to a negotiated level of payment as follows:

(1) The total amount of the actual regional center payments which the vendor received for services provided to consumers during the reporting period; and

(2) The maximum amount of the regional center payment which the vendor would have received during the reporting period, had the vendor not agreed to a negotiated level of payment. The maximum amount of the regional center payment shall be computed by multiplying the vendor's established temporary payment rate or permanent payment rate for the reporting period, by the actual number of consumers days or hours of attendance which the vendor charged and invoiced the regional center for services provided to consumers.

(b) In addition to the information specified in (a) above, each vendor who agreed, pursuant to Section 57300(d), to a negotiated level of payment shall submit the total amount of cost reductions implemented as a result of the agreed upon lower level of payment.

(c) Each vendor who agreed, pursuant to Section 57540, to enter into a service contract may report regional center payment information and cost reduction information pursuant to (a) and (b) above if the method of payment agreed to in the service contract results in a reduced level of payment to the vendor.

NOTE

HISTORY

3. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. New subsection (c) filed 6-28-96; operative 6-28-96 (Register 96, No. 26).

7. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Review Requirements

§57440. Vendoring Regional Center Review Procedures.

Note • History

(a) Vendoring regional center review procedures shall apply only to the establishment of permanent payment rates, including conversion of temporary payment rates to a permanent payment rate.

(b) Within 30 days from the date of the Department's written notification pursuant to Section 57442(a)(1)(A), the vendoring regional center shall:

(1) Review the information submitted by the vendor to determine the following:

(A) That services being provided are consistent with the program design, pursuant to Section 56712 or 56762;

(B) That the staffing ratio is consistent with that specified in Section 56756 or 56772;

(C) That the information submitted by the vendor is complete and complies with Sections 57422, and 57433 through 57439; and

(D) Any known inconsistencies in the vendor's reporting of cost and/or vendor income and/or, as applicable, regional center payment information.

(2) Forward a written copy of the review results to the Department and the vendor.

(c) If the vendoring regional center does not notify the Department of the results of its review pursuant to (b), the Department shall proceed with its review procedures pursuant to Section 57442.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (b)(1)(C)-(D) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (b)(1)(C)-(D) and Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57442. Department Review Procedures.

Note • History

(a) Department review procedures are as follows:

(1) For vendors whose temporary payment rates are being converted to permanent payment rates, and for vendors whose permanent payment rate is being established, the Department shall:

(A) Within five days from receipt of the information required from the vendor, send a written notification to the vendoring regional center which shall indicate that the Department has received the information; and

(B) Upon receipt of the information required from the vendoring regional center pursuant to Section 57440, or within 50 days of receipt of the information required from the vendor:

1. Review the information to determine if it is complete and complies with the requirements of Sections 57422, and 57433 through 57439; and

2. Determine the annual number of direct service hours allowed or required in order to maintain the approved staffing ratio pursuant to Section 57444.

(2) For vendors who are requesting a temporary payment rate, the Department shall, within 30 days of receipt of the information required from the vendor, review the information to determine if it is complete and complies with the requirements of Section 57433.

(b) If the information is complete and complies with the requirements of:

(1) Sections 57422, and 57433 through 57439, the Department shall, for those vendors identified in (a)(1), establish a permanent payment rate pursuant to Sections 57500 through 57519; or

(2) Section 57433, the Department shall, for those vendors identified in (a)(2), establish a temporary payment rate pursuant to Sections 57520 and 57522.

(c) If the information is not complete or does not comply with the requirements of Sections 57422, and 57433 through 57439, for establishment of a permanent payment rate, or Section 57433, for establishment of a temporary payment rate:

(1) The Department shall, within the time specified in (a)(1)(B) or (a)(2):

(A) Make a written request to the vendor for any additional or clarifying information; and

(B) Send a copy of the request to the vendoring regional center and utilizing regional center(s), if any.

(2) The vendor shall submit the required information to the Department with a copy to the vendoring and utilizing regional center(s), if any, within 15 days from receipt of the Department's written request:

(A) If the vendor submits the required information within the time specified, and it is complete and complies with the requirements of:

1. Sections 57422, and 57433 through 57439, the Department shall, for those vendors identified in (a)(1), establish a permanent payment rate pursuant to Sections 57500 through 57519; or

2. Section 57433, the Department shall, for those vendors identified in (a)(2), establish a temporary payment rate pursuant to Sections 57520 and 57522.

(B) If the vendor fails to submit the required information within the time specified, the Department shall notify, in writing, the vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

1. For those vendors identified in (a)(1):

a. That unless their rate has expired, payment of their rate shall be suspended within 15 days from the date of the Department's written notification; and

b. That payment shall remain suspended until the required information is received.

2. For those vendors identified in (a)(2), that the Department shall take no further action on their rate request until all required information has been received.

(C) If the required information is received after the vendoring regional center and utilizing regional center(s), if any, have suspended payment of the vendor's rate pursuant to (B)1. or 2. and the information is complete and it complies with the requirements of:

1. Sections 57422, and 57433 through 57439, the Department shall, for those vendors identified in (a)(1) :

a. Establish a permanent payment rate pursuant to Sections 57500 through 57519; and

b. Authorize the vendoring regional center and utilizing regional center(s), if any, to reinstate payment of the vendor's rate as of the date payment was suspended. The reinstated rate shall be effective until the new permanent payment rate is effective.

2. Section 57433, the Department shall, for those vendors identified in (a)(2), establish a temporary payment rate pursuant to Sections 57520 and 57522.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(1)(B)1, (b)(1), (c), (c)(2)(A)1, (c)(2)(c)1 and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(1)(B)1, (b)(1), (c), (c)(2)(A)1, (c)(2)(C)1 and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57444. Determination of the Direct Service Hours Allowed or Required to Maintain the Approved Staffing Ratio.

Note • History

(a) For determining the mean and allowable range of rates, the Department shall review the program information reported pursuant to section 57433 to determine if the vendor's annual number of direct service hours actually provided to consumers is greater or less than the direct service hours allowed or required in order to maintain the staffing ratio approved by the Department, pursuant to section 56756 or 56772.

(b) The Department shall determine the annual number of direct service hours allowed using the program information reported pursuant to section 57433, the approved staffing ratio and the total number of consumers enrolled:

(1) For activity centers, adult development centers, and behavior management programs:

(A) For each month in the reporting period determine the total monthly direct service hours by:

1. Multiplying the reported number of direct service hours operated per-day, by the reported number of days in which service was actually provided; and

2. Multiplying the amount computed in 1. by the reported consumer enrollment.

(B) Add together the total computed for each month pursuant to (A); and

(C) Divide the total computed in (B) by the approved staffing ratio to compute the annual number of direct service hours allowed, based on the approved staffing ratio.

(2) For social recreation programs, independent living programs, and infant development programs:

(A) Determine the total number of direct service hours authorized by adding together the authorized direct service hours reported for each month of the reporting period; and

(B) Divide the total computed in (A) by the approved staffing ratio to compute the annual number of direct service hours allowed, based on the approved staffing ratio.

(c) The Department shall determine the annual number of direct service hours required using the program information reported pursuant to section 57433, the approved staffing ratio and the number of consumers in attendance:

(1) For activity centers, adult development centers, and behavior management programs:

(A) For each month of the reporting period determine the total monthly direct services hours by multiplying the reported number of actual days of attendance by the reported number of direct service hours operated per-day;

(B) Add together the total computed for each month pursuant to (A); and

(C) Divide the total computed in (B) by the approved staffing ratio to compute the annual number of direct service hours required to maintain the approved staffing ratio.

(2) For social recreation programs, independent living programs, and infant development programs:

(A) Determine the total number of direct service hours actually provided by adding together the total reported hours of attendance for each month of the reporting period; and

(B) Divide the total computed in (A) by the approved staffing ratio to compute the annual number of direct service hours required to maintain the approved staffing ratio.

(d) Determine the annual number of direct service hours actually provided by direct care staff by adding together the reported number of direct service hours for each month of the reporting period.

(e) The annual number of direct service hours actually provided by direct care staff, as computed in (d), shall be compared with the annual number of direct service hours allowed, based on the approved staffing ratio, as computed in (b)(1) or (2), and with the annual number of direct service hours required, based on the approved staffing ratio, as computed in (c)(1) or (2).

(1) If the amount computed in (d) exceeds the amount computed in (b)(1) or (2), then the number of direct service hours provided exceeds the number of direct service hours allowed, and the Department shall decrease the total salary and wage and fringe benefit costs, reported pursuant to sections 57434 (e)(1)(A) and (a)(2), by the cost of the excess direct service hours, as follows:

(A) Determine the excess direct service hours by subtracting the amount computed in (b)(1) or (2) from the amount computed in (d);

(B) Multiply the amount computed in (A) by the average hourly salary and wage and fringe benefit costs reported pursuant to section 57434 (a)(1)(B); and

(C) Subtract the amount computed in (B) from the total salary and wage and fringe benefit costs reported pursuant to sections 57434 (a)(1)(A) and (a)(2). This amount shall then be used in step two, section 57511 (a)(2).

(2) If the amount computed in (d) is less than the amount computed in (c)(1) or (2), then the number of direct service hours provided is less than the number of direct service hours, required, and the Department shall exclude the vendor's costs in determining the mean and allowable range of rates pursuant to step three, section 57512 (a)(1)(B).

(3) If the amount computed in (d) is equal to or exceeds the amount computed in (c)(1) or (2), but does not exceed the amount computed in (b)(1) or (2), then the number of direct service hours provided is within the number of direct service hours allowed and required to maintain the approved staffing ratio, and the Department shall make no adjustment to the total salary and wage and fringe benefit costs reported pursuant to sections 57434 (a)(1)(A) and (a)(2), except for non-allowable costs identified in section 57436.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a), (b), (b)(1)(A), (c) and (e)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 9. Rate-Setting Methodology for Community-Based Day Programs

Article 1. Permanent Payment Rates

§57500. General Provisions.

Note • History

(a) The methodology for computing permanent payment rates is based on program, cost, vendor income, and as applicable, regional center payment information submitted by all vendors receiving permanent payment rates. The Department shall use each vendor's program, cost, vendor income, and as applicable, regional center payment information to establish that vendor's permanent payment rate pursuant to this methodology.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57510. Step One: Grouping of Like Program Vendors.

Note • History

(a) Step one in the process of determining a permanent payment rate is the grouping of like program vendors. Each vendor shall be grouped with like program vendors, according to their service code and staffing ratio approved by the Department pursuant to Section 56756 or 56772.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Editorial correction inserting inadvertently omitted section 57510 (Register 2000, No. 18).

§57511. Step Two: Computing an Amount Using Allowable Costs and Consumer Attendance.

Note • History

(a) Step two in the process of determining a permanent payment rate is to compute an amount or amounts, as applicable, for each vendor within the group of like programs, based on allowable costs and consumer attendance as follows;

(1) For each vendor, the Department shall compute an amount by:

(A) Determining the total allowable costs as follows:

1. Add together the total costs reported by the vendor identified in Section 57434;

2. Subtract from the amount computed in 1. the amount of any non-allowable costs specified in Section 57436, which were identified by the Department or vendoring regional center during their review of the information submitted by the vendor; and

3. For vendors who agreed to a negotiated level of payment, as specified in Section 57300(d), and whose temporary payment rate is being converted to a permanent payment rate, or whose permanent payment rate is being established, the Department shall increase the amount computed in 2. by:

a. Subtract the total amount of the actual regional center payments which the vendor received for services provided, as reported pursuant to Section 57439(a)(1), from the maximum amount of the regional center payment which the vendor would have received, as reported pursuant to Section 57439(a)(2); and

b. Adding the amount computed in a. or the total amount of cost reductions reported pursuant to Section 57439(b), whichever is less, to the amount computed in 2.

(B) Dividing the total allowable costs computed in (A) by the vendor's actual hours or days of consumer attendance, identified in Section 57433(b)(2)(B) or (3)(D); and

(C) Increasing or decreasing, if applicable, the amount computed in (B) for any of the following that has occurred from July 1 through September 30 following the reported period, and which have not been included in the total allowable costs reported by the vendor:

1. Increase the amount computed in (B) by the amount of any COLA authorized in the Budget Act for the fiscal year following the reporting period;

2. Increase the amount computed in (B) by the amount of any rate increase granted by the Department, as a result of a rate adjustment pursuant to Sections 57920 through 57924, and/or audit adjustment pursuant to Section 57930, and/or rate appeal pursuant to Sections 57940 through 57948; and/or

3. Decrease the amount computed in (B) by the amount of any rate decrease issued by the Department, as a result of a rate adjustment pursuant to Sections 57920 through 57924, and/or audit adjustment pursuant to Section 57930, and/or rate appeal pursuant to Sections 57940 through 57948.

(2) For each vendor included in (a)(1), whose annual number of direct service hours results in excess direct service hours, as determined pursuant to Section 57444(e)(1), the Department shall compute an additional amount using that vendor's allowable costs and consumer attendance and the steps specified in (a)(1), except the Department shall reduce the total allowable costs determined in (a)(1)(A) by the costs of the excess direct service hours computed in Section 57444(e)(1). This additional amount shall only be used in the computation of the mean and allowable range of rates, for those vendors with excess direct service hours.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(1)(A)1-2 and new subsection (a)(1)(A)3-b and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(1)(A)1-2 and new subsection (a)(1)(A)3-b and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(1)(A)3 and (a)(1)(A)3b transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and subsections (a), (a)(1)(B) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57512. Step Three: Computing the Mean for Each Like Program.

Note • History

(a) Step three in the process of determining a permanent payment rate is the computation of the mean for all like programs. In making this computation, the Department shall:

(1) Use the amount computed for each vendor in step two, section 57511 (a)(1), except that:

(A) For each vendor with excess direct service hours, the Department shall substitute the amount computed in section 57511 (a)(1) with the amount computed in section 57511 (a)(2); and

(B) For each vendor whose direct service hours are less than required, as identified in section 57444 (e)(2), the Department shall exclude that vendor's allowable costs, as determined in step two, in the computation of the mean.

(2) Add together the amount specified in (1) for each vendor within each like program; and

(3) Divide the sum computed in (2) by the number of vendors included in calculating the sum.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§57513. Step Four: Determination of the Allowable Range of Rates for Each Like Program.

Note • History

(a) Step four in the process of determining a permanent payment rate is the computation of an allowable range of rates for each like program. The Department shall determine the upper and lower limits of the allowable range of rates as follows:

(1) For Fiscal Year 1997-98, and each alternate fiscal year thereafter:

(A) Multiply the mean computed in section 57512 for Fiscal Year 1993-94, by 50 percent to determine the range;

(B) Subtract the lower limit from the upper limit of the allowable range of rates established for Fiscal Year 1991-92, and adjusted for any COLA for Fiscal Year 1992-93, to determine the existing range;

(D) The lesser of the two ranges compared in (C) shall be divided by two;

(E) The upper limit shall be determined by adding the amount computed in (D) to the mean computed pursuant to section 57512 for Fiscal Year 1997-98, and each alternate fiscal year thereafter; and

(F) The lower limit shall be determined by subtracting the amount computed in (D) from the mean computed pursuant to section 57512 for Fiscal Year 1997-98, and each alternate fiscal year thereafter.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (b)-(b)(3) and amendment of Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (b), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57514. Step Five: Adjusting the Amount Computed in Step Two for Gap Funding.

Note • History

(a) Step five in the process of determining a permanent payment rate is to adjust the amount computed in step two, section 57511 (a)(1), for any money appropriated pursuant to the Budget Act, to fund the gap computed in Section 57820. The Department shall:

(1) Convert the vendor's current permanent payment rate into an amount as follows:

(A) Add back any vendor income subtracted out when the Department computed the vendor's current permanent payment rate. The increased rate shall become the amount for use in this step;

(B) If no vendor income was used in computing the vendor's current permanent payment rate, that rate shall become the amount for use in this step.

(2) If the amount computed in (1):

(A) Is below, or within the allowable range of rates, the gap adjustment combined with the amount computed in (1) shall not exceed the upper limit of the allowable range of rates; or

(B) Exceeds the upper limit of the allowable range of rates, the vendor shall not be eligible for a gap adjustment.

(3) For those vendors eligible for a gap adjustment pursuant to (2)(A), the Department shall:

(A) Increase to the upper limit, the difference between the amount computed in (1) and the amount computed in step two, Section 57511 (a)(1), if the appropriation in the Budget Act is sufficient to fully cover the statewide fiscal impact of the gap computed in Section 57820; or

(B) Increase the amount computed in (1) up to the upper limit, based upon the percentage of available funds, if the appropriation in the Budget Act is insufficient to fully cover the statewide fiscal impact of the gap computed in Section 57820. The Department shall, for those eligible vendors:

1. Determine the percentage of available funds by dividing the statewide fiscal impact of the gap computed in Section 57820, by the amount appropriated in the Budget Act;

2. Determine the difference between each vendor's amount as computed in Step two, section 57511 (a)(1), and their amount as computed in (1);

3. Multiply the difference computed in 2. by the percentage of available funds computed in 1.; and

4. Increase the amount computed in (1) by the amount computed in 3.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57515. Step Six: Adjusting the Amount Computed in Step Five by the Upper and Lower Limit of the Allowable Range of Rates.

Note • History

(a) Step six in the process of determining a permanent payment rate is to adjust the amount computed in step five, section 57514, by the upper and lower limit of the allowable range of rates:

(1) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, the upper and lower limit adjustment shall be computed as follows:

(A) For vendors whose amount, as determined in step five, is within the allowable range of rates, the Department shall make no change to that amount;

(B) For vendors whose amount, as determined in step five, is above the upper limit of the allowable range of rates, the Department shall reduce that amount to the upper limit;

(C) For vendors whose amount, as determined in step five, is below the lower limit of the allowable range of rates, the Department shall increase the amount to the lower limit, based upon available funds pursuant to (a)(1)(C)1. through 3.

1. The amount of available funds to increase amounts computed in step five shall be determined as follows:

a. Multiply each vendor's reduction computed pursuant to (1)(B) by their consumer attendance identified in section 57433 (b)(2)(B) or (3)(D);

b. Add the amount computed in a. for each vendor to determine the total available funds from the upper limit reduction pursuant to (1)(B); and

c. Add to the amount determined in b. any gap funding appropriated pursuant to the Budget Act, for those vendors specified in section 57810 (a)(1)(A) and (B).

2. The amount of funds needed to increase amounts computed in step five to the lower limit, shall be determined as follows:

a. Determine the difference between, the lower limit and each vendor's amount as computed in step five;

b. Multiply the difference computed in a. by consumer attendance identified in section 57433 (b)(2)(B) or (3)(D); and

c. Add the amounts computed in b. to determine the total amount of needed funds.

3. The total amount of available funds, as determined in (C)1., shall be compared to the total amount of funds needed, as determined in (C)2.

a. If there are sufficient funds to fully fund the lower limit increase, the Department shall increase amounts computed in step five to the lower limit.

b. If there are insufficient funds to fully fund the lower limit increase, the Department shall adjust the difference computed in (C)2.a. by the percentage of available funds. The Department shall:

(1.) Calculate the percentage of available funds, by dividing the total amount of available funds computed in (C)1.c. by the total amount of funds needed computed in (C)2.c.;

(2.) Multiply the percentage of available funds, by the difference computed in (C)2.a. for each vendor; and

(3.) Increase amounts computed in step five by the amount computed in (C)3.b.(2.).

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57517. Step Seven: Adjusting the Amount Computed in Step Six by Vendor Income.

Note • History

(a) Step seven in the process of determining a permanent payment rate is to adjust the amount computed in step six, section 57515, if applicable, by the amount of any vendor income reported by the vendor pursuant to section 57438 as follows. The Department shall:

(1) Divide vendor income by the vendor's actual consumer attendance identified in section 57433 (b)(2)(B) or (3)(D); and

(2) Subtract the amount computed in (1) from the amount computed in step six.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57518. Step Eight: Adjusting the Amount Computed in Step Seven for Budget Act Adjustment.

Note • History

(a) Step eight in the process of determining a permanent payment rate is to adjust the amount computed in step seven, section 57517, if applicable, for the following that will occur in the fiscal year for which the permanent payment rate is established:

(1) COLA authorized in the Budget Act; and/or

(2) Legislative adjustment, for any item of cost(s), specified in the Budget Act.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§57519. Adjusting the Rate Methodology for COLAs.

Note • History

(a) For each fiscal year in which a COLA is granted in the Budget Act, the Department shall increase the mean, computed in step three, section 57512, and upper and lower limits of the existing allowable range of rates, computed in step four, section 57513, by the percentage of the COLA.

(b) If the COLA is granted in a fiscal year in which the Department does not calculate a mean and an allowable range of rates, the COLA shall be applied to the mean and allowable range of rates calculated in the previous fiscal year.

(c) The effective date of the adjustment to the mean and allowable range of rates for a COLA pursuant to (a) or (b), shall be the effective date of the COLA as specified in the Budget Act.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 2. Temporary Payment Rate

§57520. General Provisions.

Note • History

(a) The methodology for computing temporary payment rates is based on program, cost, vendor income, and as applicable, regional center payment information submitted by all vendors receiving permanent payment rates. The Department shall use each vendor's program information to establish that vendor's temporary payment rate pursuant to this methodology.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed 6-17-93 as an emergency; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57522. Establishment of the Temporary Payment Rate.

Note • History

(a) The temporary payment rate is determined using the same information and steps specified in sections 57510, 57511, 57512 and 57519 for establishing a permanent payment rate.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (b), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect repealing subsections (b)-(b)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Non-Mobile Supplemental Rate

§57530. Supplemental Rate for Community-Based Day Programs Serving Non-Mobile Consumers.

Note • History

(a) Vendors of activity centers, adult development centers, behavior management programs and social recreation programs, may supplement their direct care staffing ratios for non-mobile consumers as specified in section 56756 (b).

(b) For vendors specified in (a), effective July 1, 2000, the maximum rate of reimbursement shall not exceed $.76 per consumer per hour, or one-tenth of the prevailing minimum wage, as mandated by State and Federal laws, plus fringe benefits at 20% of the prevailing minimum wage, whichever is greater. This rate shall be in addition to the vendor's permanent or temporary payment rate.

(1) The per-consumer, per-hour rate, as specified in (b), is based on a 1:10 staff-to-consumer ratio for a maximum of six hours per day.

(2) The Department shall authorize regional centers to pay up to six hours per-day, per-consumer in the amount established in (b).

(3) The amount in (b) shall be increased by any COLA included in the Budget Act for that purpose.

(4) If there is an increase in the prevailing minimum wage, the Department shall only, if applicable, increase the existing hourly supplemental rate up to the amount of the new prevailing minimum wage.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code; Budget Act of 2000-01, Item 4300-101-0001.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections (a), (b)(1) and (b)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment of subsections (b)-(b)(3) and amendment of Note filed 3-14-2001 as an emergency; operative 3-14-2001 (Register 2001, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-12-2001 or emergency language will be repealed by operation of law on the following day.

5. Amendment of subsections (b)-(b)(3) and amendment of Note refiled 7-12-2001 as an emergency; operative 7-12-2001 (Register 2001, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-9-2001 or emergency language will be repealed by operation of law on the following day.

6. Reinstatement of section as it existed prior to 7-12-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 47).

7. Amendment of subsections (b)-(b)(3) and amendment of Note filed 11-19-2001 as an emergency; operative 11-19-2001 (Register 2001, No. 47). A Certificate of Compliance must be transmitted to OAL by 3-19-2002 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 11-19-2001 order transmitted to OAL 3-15-2002 and filed 3-27-2002 (Register 2002, No. 13).

§57532. Effective Date.

Note • History

(a) The effective date for funding of staff who provide a 1:10 staff-to-consumer ratio for non-mobile consumers shall be the date the community-based day program began incurring the additional cost.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57534. Written Notification of the Supplemental Rate Established for Community-Based Day Programs Serving Non-Mobile Consumers.

Note • History

(a) For vendors receiving a supplemental rate established in section 57530 (b), the Department shall notify the regional center in writing of the supplemental rate. The regional center shall notify each vendor eligible for this supplemental rate.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Service Contracts

§57540. Service Contracts Between the Regional Center and Community-Based Day Program Vendors.

Note • History

(a) Once the Department has established a rate of reimbursement for community-based day program vendors pursuant to Sections 57500 through 57519 for vendors whose temporary payment rate is being converted to a permanent payment rate and vendors whose permanent payment rate is being established or reestablished, or pursuant to Sections 57520 through 57522, for vendors who are requesting a temporary payment rate, a regional center and a vendor may negotiate a service contract for provisions of the vendored service.

(b) The service contract shall commence on the date agreed to by the regional center and vendor, and shall terminate on the expiration date specified by the Department in its written notification to the vendor of the established rate, or earlier, if an earlier termination date has been mutually agreed to by the regional center and vendor.

(1) If the service contract terminates on the expiration date specified in the Department's written notification to the vendor of the established rate, the Department shall:

(A) For those vendors whose established rate is a temporary payment rate, establish a permanent payment rate, as applicable, pursuant to Section 57642 or 57652; or

(B) For those vendors whose established rate is a permanent payment rate:

1. Reestablish the permanent payment rate during Fiscal Year 1996-97, and each alternate fiscal year thereafter, as specified in Section 57640; or

2. Establish a permanent payment rate during Fiscal Year 1997-98, and each alternate fiscal year thereafter, as specified in Section 57650.

(2) If the service contract terminates prior to the expiration date specified in the Department's written notification to the vendor of the established rate, the vendor shall be reimbursed at the rate established by the Department until the expiration of the established rate.

(1) Level of payment;

(2) Effective date for commencing and terminating payment as determined by the regional center and vendor pursuant to (b) above;

(3) Units of service which the vendor shall use to charge and invoice the regional center for services provided to consumers. The units of service shall include the minimum and maximum number of units of service to be provided during the period specified. Units of service for contracts reimbursed other than a daily or hourly rate shall also be maintained pursuant to Section 50604(d)(3)(A) through (F), as applicable.

(d) The level of payment agreed to under the service contract may be less than but shall not exceed the maximum reimbursement possible during the contract period, using the rate established by the Department and the units of service actually provided by the vendor as the basis for determining the maximum reimbursement possible.

(e) In addition to the items specified in (a) through (d) above, service contracts negotiated pursuant to the provisions of this section shall include:

(1) The provisions specified in Sections 50607 through 50611; and

(2) A statement that the vendor shall agree to maintain service and program information in accordance with the provisions of Section 50604(d)(1) through (3)(F), as applicable, and Section 57433(b)(1), (2), and (3).

(3) A provision requiring the vendor to submit to the regional center with their billings/invoices the information specified in Section 50604(d)(3)(A) through (F), as applicable, for the billing period.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4648(a), 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4648(a), 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 3-4-92 order including amendment of subsections (c)(3)(A) and (B) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Editorial correction of printing error inserting article heading (Register 92, No. 34).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Amendment of section heading, section and Note filed 8-28-95 as an emergency; operative 8-28-95 (Register 95, No. 35). This amendment is deemed an emergency, is not subject to OAL review, and shall remain in effect until revised or repealed by the Department pursuant to Stats. 1992, ch. 722, sec. 147.

8. Certificate of Compliance as to 8-28-95 order transmitted to OAL 5-16-96 and filed 6-28-96 (Register 96, No. 26).

9. Change without regulatory effect amending subsections (b)(1)(A)-(b)(1)(B)2. and (c)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

10. Amendment of subsections (c)(3) and (e)(2), new subsection (e)(3) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

11. Amendment of subsections (c)(3) and (e)(2), new subsection (e)(3) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

12. Amendment of subsections (c)(3) and (e)(2), new subsection (e)(3) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 6-1-2004 order, including amendment of subsections (c)(3), (e)(2) and (e)(3), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

Subchapter 10. Schedule of Payment Rates for Community-Based Day Programs

Article 1. General Provisions

§57600. General Provisions for Schedule of Payment Rates for All Fiscal Years.

Note • History

(a) Each fiscal year, the Department shall establish a payment rate for each vendor.

(b) The appropriate like program for each vendor shall be determined based upon their service code and the staffing ratio approved by the Department pursuant to Section 56756 or 56772.

(c) Each vendor shall submit information, as applicable, pursuant to Sections 57433 through 57439. The vendoring regional center and the Department shall review the information pursuant to Sections 57440 and 57442.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

4. Amendment of subsection (c) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

Article 2. Schedule of Payment Rates for Fiscal Year 1990-91

§57620. Vendors Receiving Permanent Rates.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 2 (sections 57620-57624) and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57622. Vendors Receiving Provisional Rates.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57624. New Vendors.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Schedule of Payment Rates for Fiscal Year 1991-92

§57630. Vendors Receiving Permanent Rates.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 3 (sections 57630-57636) and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57632. Vendors Receiving Temporary Payment Rates.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (b) and (d)(1) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (b) and (d)(1) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57634. Vendors Receiving Provisional Rates.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57636. New Vendors.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Schedule of Payment Rates for Fiscal Year 1996-97 and Each Alternate Fiscal Year Thereafter

§57640. Vendors Receiving Permanent Payment Rates.

Note • History

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter, the Department shall reestablish permanent payment rates that were established the previous fiscal year by adjusting those rates pursuant to sections 57515 and 57518.

(b) The effective date of the reestablished permanent payment rate shall be September 1, 1996, for Fiscal Year 1996-97, and September 1 for each alternate fiscal year thereafter.

(c) The expiration date of the reestablished permanent payment rate shall be August 31, 1997, for Fiscal Year 1996-97, and August 31 for each alternate fiscal year thereafter.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending article heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57642. Vendors Receiving Temporary Payment Rates.

Note • History

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter, the temporary payment rate established the previous fiscal year shall continue until the Department converts it to a permanent payment rate pursuant to Section 57652(b) through (e).

(b) If the mean is adjusted for a COLA pursuant to section 57519 (b), the Department shall adjust the temporary payment rate established the previous fiscal year, by the amount of the COLA.

(c) The effective date of the adjustment of the temporary payment rate, as specified in (b), shall be the effective date of the COLA as specified in section 57519 (c).

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57644. New Vendors.

Note • History

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter, new vendors requesting a rate shall receive the temporary payment rate established the previous fiscal year, adjusted for a COLA, if applicable, pursuant to section 57519. The Department shall use the program information specified in section 57433, submitted by each new vendor by the date specified in section 57432(a)(3), to establish the vendor's temporary payment rate.

(b) The temporary payment rate shall be effective on the date the vendor begins providing services to consumers.

(1) The Department converts the temporary payment rate to a permanent payment rate pursuant to Section 57652; or

(2) It expires, which shall be twenty-one months from the date it became effective.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 5. Schedule of Payment Rates for Fiscal Year 1997-98 and Each Alternate Fiscal Year Thereafter

§57650. Vendors Receiving Permanent Payment Rates.

Note • History

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, the Department shall establish permanent payment rates pursuant to Sections 57500 through 57519, based upon the program, cost and vendor income information specified in Sections 57433 through 57438, and as applicable, the regional center payment information specified in Section 57439, submitted by vendors receiving permanent payment rates, by the date specified in Section 57432(a)(2) for the reporting period specified in Section 57431(a)(2).

(b) The effective date of the established permanent payment rate shall be September 1, 1997, for Fiscal Year 1997-98, and September 1 for each alternate fiscal year thereafter.

(c) The expiration date of the established permanent payment rate shall be August 31, 1998, for Fiscal Year 1997-98, and August 31 for each alternate fiscal year thereafter.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending article heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57652. Vendors Receiving Temporary Payment Rates.

Note • History

(a) The temporary payment rate shall continue until the Department converts it to a permanent payment rate pursuant to (b) through (e).

(b) All vendors converting from a temporary payment rate to a permanent payment rate shall submit the program, cost and vendor income information specified in Sections 57433 through 57438, and as applicable, the regional center payment information specified in Section 57439 by the dates specified in Section 57432(a)(1) for the reporting period specified in Section 57431(a)(1).

(c) The Department shall convert the temporary payment rate to a permanent payment rate pursuant to Sections 57500 through 57519, with the following exceptions:

(1) The amount computed in Step five, Section 57514, shall not be adjusted for gap funding;

(2) The permanent payment rate shall not exceed the upper limit; and

(3) If the amount computed in Step five is below the lower limit of the allowable range of rates, the Department shall increase that amount to the lower limit based upon available funds from the upper limit reduction process for vendors with a permanent payment rate pursuant to Section 57515.

(d) The effective date of the conversion of the temporary payment rate to a permanent payment rate shall be:

(1) Thirty days from the date the Department receives the program, cost and vendor income information that complies with Sections 57422, and 57433 through 57438, and as applicable, the regional center payment information specified in Section 57439; or

(2) No later than 21 months from the date the temporary payment rate was initially established, if the vendor did not receive an extension of the temporary payment rate pursuant to Section 57431(a)(1).

(e) Temporary payment rates which are converted to a permanent payment rate shall expire August 31, following the effective date.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing and adding new section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment of subsection (d)(2) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§57654. New Vendors.

Note • History

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, new vendors requesting a rate shall receive a temporary payment rate established pursuant to sections 57520 and 57522, using the program information specified in section 57433 submitted by each new vendor by the date specified in section 57432(a)(3). The temporary payment rate shall be based upon the program, cost and vendor income information submitted by vendors receiving permanent payment rates pursuant to section 57650(a).

(b) The temporary payment rate shall be effective on the date specified in Section 57644(b).

(c) Once the temporary payment rate is established, the vendor shall continue to receive that rate until it is converted or it expires as specified in Section 57644(c).

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 6. Timelines for Rate Establishment and Written Notification

§57660. Timelines for Continuation of the Permanent Rate and Written Notification.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57662. Timelines for Extension of the Provisional Rate and Written Notification.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57664. Timelines for Establishment of the Permanent Payment Rate and Written Notification.

Note • History

(a) For vendors receiving a permanent payment rate, the Department shall, upon receipt of the information which complies with Sections 57422, and 57433 through 57439, and by September 1, of each year, establish or reestablish the permanent payment rate and notify, in writing, each vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The permanent payment rate;

(2) The effective date and expiration date of the permanent payment rate;

(3) The service code and staffing ratio used to determine the permanent payment rate;

(4) Any Budget Act adjustments;

(5) The next required reporting period, and submission date pursuant to Sections 57431(a)(2) and 57432(a)(2) for the program, cost, vendor income, and as applicable, regional center payment information;

(6) That payment of the permanent payment rate shall be suspended pursuant to Section 57432(c)(1)(B) if the required information specified in (a)(5) is not submitted; and

(7) The vendor's right to appeal the permanent payment rate pursuant to Sections 57940 through 57948.

(b) For vendors converting their temporary payment rates to a permanent payment rate, the Department shall establish the permanent payment rate and provide the notification specified in (a) within 30 days of receipt of program, cost and vendor income information that complies with Sections 57422, and 57433 through 57438, and as applicable, the regional center payment information specified in Section 57439 for vendors with a temporary payment rate that is converted to a permanent payment rate.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a), (a)(5), and (b)(3) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a), (a)(5), and (b)(3) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57666. Timelines for Establishment of the Temporary Payment Rate and Written Notification.

Note • History

(a) For vendors requesting a temporary payment rate, the Department shall within 30 days from receipt of program information that complies with section 57433, establish a temporary payment rate and notify, in writing, each vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The temporary payment rate;

(2) The effective date and expiration date of the temporary payment rate;

(3) The service code and staffing ratio used to determine the temporary payment rate;

(4) Any cost-of-living adjustment;

(5) The next required reporting period, and submission date pursuant to sections 57431(a)(1) and 57432(a)(1) for the program, cost and vendor income information;

(6) That payment of the temporary payment rate shall be suspended pursuant to section 57432(c)(1)(A) if the required information specified in (a)(5) is not submitted;,and

(7) The vendor's right to appeal the temporary payment rate pursuant to sections 57940 through 57948.

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(5) and (a)(6) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 11. Reporting Requirements for Community-Based Day Programs

Article 1. Annual Report to the Legislature

§57810. The Department's Annual Report to the Legislature.

Note • History

(a) By April 15, 1997, for Fiscal Year 1997-98, and by April 15 for each alternate fiscal year thereafter, the Department shall report the following to the Legislature:

(1) The amount needed to fund the statewide fiscal impact of the gap including identification of the amount attributed to vendors who are:

(A) Not eligible for a gap adjustment pursuant to section 57514 (a)(2)(B); or

(B) Eligible only for a partial gap adjustment pursuant to section 57514 (a)(2)(A).

(2) Any other known pertinent costs or rate information which the Department deems necessary, in order to show cost-of-living increases to an allowable cost item that affects all vendors, and which has not been:

(A) Funded in the current fiscal year's Budget Act; nor

(B) Included in the next fiscal year's Governor's Budget.

(b) By April 15, 1998, for Fiscal Year 1998-99, and by April 15 for each alternate fiscal year thereafter, the Department shall report:

(1) The amount determined in (a)(1) that was unfunded in the previous year; and

(2) The information specified in (a)(2).

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a) and (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57812. The Joint Report to the Legislature for Fiscal Year 1996-97.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. Calculation of the Statewide Fiscal Impact of the Gap

§57820. Determination of the Statewide Fiscal Impact of the Gap for Fiscal Year 1997-98, and Each Alternate Fiscal Year Thereafter.

Note • History

(a) For vendors with a permanent payment rate whose amount computed in step two, section 57511(a)(1), is below the upper limit of the allowable range of rates computed in section 57513 the Department shall:

(1) For each vendor, calculate the difference between step two, section 57511(a)(1) and step five, section 57514(a)(1);

(2) Multiply the amount computed in (1) for each vendor by each vendor's actual consumer attendance identified in section 57433(b)(2)(B) or (3)(D); and

(3) Add the amounts computed in (2) to determine the statewide gap.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections (a) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57822. Determination of the Statewide Fiscal Impact of the Gap for Fiscal Year 1993-94, and Each Alternate Fiscal Year Thereafter.

Note • History

NOTE

Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code. Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 12. Rate Adjustments, Audit Adjustments and Rate Appeals for Community-Based Day Programs

Article 1. General Provisions

§57910. General Provisions.

Note • History

(a) A permanent payment rate may be adjusted pursuant to this article, by the Department, only for the following:

(1) A rate adjustment pursuant to section 57920(b) and (c); and/or

(2) An audit adjustment pursuant to section 57930(a)(1)(A); and/or

(3) A rate appeal pursuant to sections 57940 through 57948.

(b) A temporary payment rate may be adjusted pursuant to this article, by the Department, only for the following:

(1) A rate adjustment pursuant to section 57920(b)(1); and/or

(2) An audit adjustment pursuant to section 57930(a)(1)(B); and/or

(3) A rate appeal pursuant to sections 57940 through 57948.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a), repealing subsections (c)-(c)(3) and relettering remaining subsection filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. Rate Adjustments

§57920. General Provisions.

Note • History

(a) Once a payment rate for each community-based day program has been established by the Department, adjustments to that rate shall be considered by the Department, for either anticipated or unanticipated program changes, in accordance with (b) and (c).

(b) Anticipated program changes are service modifications which the vendor and/or the vendoring regional center can plan for and expect to occur in the next fiscal year. Anticipated program changes shall be submitted to the Department and the vendoring regional center prior to December 1 of the year previous to the fiscal year in which the changes are expected to occur. Any requests submitted after December 1 shall not be considered by the Department. Anticipated program changes shall be limited to the following:

(1) A modification in the program design pursuant to section 56712 or 56762 which results in a change in the approved existing staffing ratio or approved service code. Changes in the approved existing staffing ratio or approved service code shall be based upon the characteristics and needs of the consumers served and/or the program curriculum as specified in section 56756 or 56772;

(2) Relocation of the service due to expiration of the vendor's facility lease or tenancy arrangement; and/or

(3) A loss or gain of any vendor income used to compute the vendor's rate.

(c) Unanticipated program changes shall be submitted by the vendor to the Department and the vendoring regional center no later than 60 days from the date the change has occurred. Unanticipated program changes received after the 60 days shall not be considered by the Department. Unanticipated program changes shall be limited to the following:

(1) Mandated service adjustments due to changes in, or additions to, existing statutes, laws, regulations or court decisions; and/or

(2) Emergency relocations as required to protect the health and safety of the consumers.

(d) Anticipated program changes shall be funded by the Department only if there are funds made available in the Budget Act appropriation to the Department for that purpose.

(e) Unanticipated program changes shall be funded effective the date the Department approves them pursuant to section 57924.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (b)(1), repealing subsections (b)(2)-(b)(2)(B), renumbering subsections, and amending subsection (c)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§57922. Submission Requirements for Rate Adjustments.

Note • History

(a) Any community-based day program vendor requesting a rate adjustment due to anticipated or unanticipated program changes pursuant to the requirements of section 57920 shall submit the following information in writing to the Department with a copy to the vendoring regional center:

(1) Vendor program information specified in section 57433(a)(1) through (4);

(2) The specific reason for the adjustment request;

(3) All supporting documentation and any other information necessary to substantiate and/or justify the request;

(4) Program, cost and vendor income information for only those items relatingto the rate adjustment request; and

(5) The date the additional cost was incurred or is expected to be incurred.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§57924. Review Procedures for Rate Adjustments.

Note • History

(a) Within five days of receipt of the rate adjustment request from the vendor, the Department shall send a written notification to the vendoring regional center which shall indicate that the Department has received the rate adjustment request from the vendor.

(b) Within 30 days from the date of the Department's written notification pursuant to (a), the vendoring regional center shall:

(1) Review all information submitted by the vendor to determine if it complete and complies with the requirements of sections 57920 and 57922; and

(2) Notify the Department in writing, with a copy to the vendor, of the vendoring regional center's recommendation, including supporting rationale for their recommendation. The vendoring regional center's supporting rationale shall include:

(A) The specific regulatory basis for the request;

(B) A statement that the circumstances necessitating the request have been verified by the regional center; and

(c) If the vendoring regional center does not notify the Department of the results of its review and recommendation pursuant to (b), the Department shall proceed with its review procedures pursuant to (d) through (g).

(d) Within 50 days of receipt of the rate adjustment request from the vendor, the Department shall review the request to determine if it is complete and complies with the requirements of sections 57920 and 57922.

(1) If the vendor's rate adjustment request is complete and complies with the requirements of sections 57920 and 57922, the Department shall approve the vendor's rate adjustment request within 60 days of receipt of the request. However, requests for anticipated program changes shall only be approved contingent upon funds being available pursuant to section 57920(d).

(2) If the vendor's rate adjustment request is not complete or does not comply with the requirements of sections 57920 and 57922, the Department shall make a written request to the vendor for additional information, as required, and send a copy of the request to the vendoring regional center. The vendor shall submit the required additional information to the Department within 15 days from receipt of the written request.

(A) If the vendor fails to submit the required additional information within 15 days, the Department shall deny the vendor's rate adjustment request.

(B) If the vendor submits the required additional information within the 15 days and it is complete and complies with the requirements of sections 57920 and 57922, the Department shall approve the vendor's rate adjustment request within 60 days of receipt of the required additional information. However, requests for anticipated program changes shall only be approved contingent upon funds being available pursuant to section 57920(d).

(C) If the vendor submits the required additional information within 15 days and it is not complete and does not comply with the requirements of sections 57920 and, 57922, the Department shall deny the vendor's rate adjustment request.

(e) The Department shall notify, in writing, the vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The decision to approve or deny the vendor's rate adjustment request pursuant to (d). Notification shall be as follows:

(A) Within,the time specified in (d)(1) if the vendor's rate adjustment request, when initially received by the Department, is complete and complies with sections 57920 and 57922;

(B) Within 15 days from the date any required additional information from the vendor is due, if the vendor fails to submit the required additional information within the time specified in (d)(2)(A);

(C) Within the time specified in (d)(2)(B) if the vendor submits the required additional information within 15 days and it is complete and complies with sections 57920 and 57922; or

(D) Within 60 days of receipt of any required additional information which is not complete and does not comply with sections 57920 and 57922, as specified in (d)(2)(C).

(2) The availability of funds in the Budget Act, to fund previously approved anticipated program changes pursuant to section 57920(d). The notification shall be by September 1.

(f) The effective date for all approved rate adjustments due to anticipated program changes, pursuant to section 57920(b), shall be September 1 of the subsequent fiscal year, or later, depending upon when the cost relating to the change actually occurs.

(g) The effective date for all approved rate adjustments due to unanticipated program changes pursuant to section 57920(c) shall be the date the community-based day program began incurring the additional cost.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 3. Audit Adjustments

§57930. Rate Adjustments Resulting From Audit Findings.

Note • History

(a) If the Department or regional center conducts an audit of the vendor, and an adjustment to the rate is required as a result of the audit, the Department shall adjust the vendor's rate as follows:

(1) The audit report shall be utilized by the Department in determining whether an adjustment to the vendor's rate is required. This determination shall be made prior to issuance of the audit report.

(A) For vendors reimbursed at a permanent payment rate, the vendor's rate shall be adjusted if the program, cost, vendor income, and as applicable, regional center payment information, used as a basis for determining the rate, does not substantiate or support the rate established by the Department.

(B) For vendors reimbursed at a temporary payment rate, the vendor's rate shall be adjusted if any of the program information used as a basis for determining the rate, does not substantiate or support the rate established by the Department.

(2) The revised rate and the effective date of the revised rate shall be determined as follows:

(A) For vendors reimbursed at a permanent payment rate, the vendor's program, cost, vendor income, and as applicable, regional center payment information used as a basis for determining the vendor's rate, adjusted for any findings in the final audit report, shall be used to determine the revised rate and its effective date.

(B) For vendors reimbursed at a temporary payment rate, the vendor's program information used as a basis for determining the vendor's rate, adjusted for any findings in the final audit report, shall be used to determine the revised rate and its effective date.

(b) If an adjustment to the vendor's rate was made pursuant to (a), the Department shall include, with the final audit report released to the vendor, written notification of the following:

(1) The revised rate and its effective date;

(2) The vendor's right to defer implementation of the revised rate and/or its effective date, pending the results of an audit appeal, if the vendor appeals the audit pursuant to Title 17, Sections 50700 through 50767;

(3) That if the vendor appeals the audit, the results of the audit appeal shall be used by the Department in accordance with (a) to determine the revised rate and its effective date; and

(4) The vendor's right to appeal errors by the Department in calculating its revised rate and/or the effective date of the revised rate pursuant to Sections 57940 through 57948.

(c) Vendors shall not appeal issues pertaining to the audit through the rate appeal process specified in Sections 57940 through 57948.

(d) A copy of the written notification and final audit report specified in (b) shall be sent to the vendoring regional center, and utilizing regional center(s), if any, at the same time the original notice and audit report are sent to the vendor. The Department shall provide the vendor, the vendoring regional center, and the utilizing regional center(s), if any, with written notification of the results of any audit appeal and revisions, if any, in the vendor's rate and its effective date.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(1)(A) and (a)(2)(A) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(1)(A) and (a)(2)(A) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Rate Appeals

§57940. General Provisions.

Note • History

(a) A vendor may appeal the following to the Department's Deputy Director who has the responsibility for setting rates:

(1) Errors in program and/or cost and/or vendor income and/or, as applicable, regional center payment information submitted by the vendor which was utilized by the Department to establish the vendor's rate;

(2) Errors by the Department in calculating the vendor's rate, including revised rates based on a final audit report or the results of an appeal of a final audit report;

(3) The effective date of the rate, including revised rates based on a final audit report or the results of an appeal of a final audit report; and/or

(4) A rate adjustment request denied by the Department pursuant to Sections 57920 through 57924, except anticipated program changes that were not approved because funding was not appropriated for that purpose.

(b) The vendor shall file the appeal with the Deputy Director within 12 months after the receipt of written notification from the Department of the vendor's rate.

(c) If an appeal is not filed within the time specified, it shall be denied unless good cause pursuant to Section 57946 is established for the late submission. Good cause shall be determined by the Deputy Director in accordance with Section 57946. If good cause for late submission is established, the Deputy Director shall proceed to decide the appeal in accordance with Section 57941.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(1) and Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. Amendment of subsection (a)(1) and NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of forms transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57941. Contents of Appeal and Decision.

Note • History

(a) The appeal filed pursuant to section 57940 shall be in writing and shall include the following:

(1) Vendor program information specified in section 57433(a)(1) through (4);

(2) Identification of the rate error or effective date being appealed;

(3) The specific basis of the appeal; and

(4) All supporting documentation and any other information necessary to substantiate and/or justify the appeal including the specific regulation used as the basis for the appeal.

(b) At the time the vendor files the appeal with the Deputy Director, a copy shall be mailed to the vendoring regional center, and utilizing regional center(s), if any.

(c) Within 15 days after receipt of the appeal, the Deputy Director shall review the appeal to determine whether it complies with sections 57940 and 57941(a).

(1) If all required information has been submitted, the Deputy Director shall render a decision pursuant to (d);

(2) If all required information has not been submitted and/or additional information is needed, the Deputy Director shall request the additional information, in writing, from the appellant within 15 days after receipt of the appeal. The appellant shall submit the additional information within 15 days after receipt of the request.

(A) If the information is not submitted within the time specified, the appeal shall be deemed withdrawn and no further action shall be taken unless the appellant establishes good cause pursuant to section 57946, for the late submission. Good cause shall be determined by the Deputy Director, in accordance with section 57946. If good cause for late submission is established and the information is submitted, the Deputy Director shall proceed with the appeal and render a decision pursuant to (d);

(B) If the information is submitted but does not comply with the request, the appeal shall be deemed withdrawn and no further action shall be taken.

(d) The Deputy Director shall render a decision on the appeal within 60 days after receipt of all required and/or requested information. The decision shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is based.

(e) A written copy of the decision shall be mailed to the appellant, the vendoring regional center, and utilizing regional center(s), if any, within 15 days after the decision is rendered.

(f) If the appellant does not appeal the decision to the Director, pursuant to section 57942, it shall be deemed final.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§57942. Appeal of Deputy Director's Decision.

Note • History

(a) The appellant may appeal the Deputy Director's decision to the Director within 15 days after receipt of the written decision. The appeal shall be in writing and shall include the following:

(1) All information submitted to the Deputy Director pursuant to section 57941(a);

(2) A copy of the Deputy Director's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting authority identifying why the appellant believes the decision of the Deputy Director should be reversed by the Director.

(b) Within 30 days after receipt of the appeal, the Director or the Chief Deputy Director shall review the appeal and determine whether additional information upon which to base a decision is needed from the appellant utilizing the process specified in section 57941(c).

(c) Within 60 days of receipt of all required and/or requested information, the Director or the Chief Deputy Director shall render a decision utilizing to the process specified in section 57941(d).

(d) A written copy of the decision shall be sent to the appellant, the vendoring regional center, and utilizing regional center(s), if any, within 15 days after the decision is rendered.

(e) An appeal filed with the Director is the final level of appeal. The decision rendered by the Director or the Chief Deputy Director shall be deemed final.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147 and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57944. Effective Date of Decision.

Note • History

The effective date of the decision rendered pursuant to Sections 57941 and 57942 shall be stated in the decision. The effective date shall be the date the Department received the appeal pursuant to Section 57940 or the date the costs are incurred, whichever is later.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57946. Good Cause.

Note • History

(a) For the purposes of sections 57940 through 57944, good cause for a failure to act is limited to:

(1) A violent act of nature, including, but not limited to, flood, earthquake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property, by individuals other than the appellant, which preclude the appellant from filing a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days after the vendor has notice of the incident giving rise to its claim of good cause, submit to the Deputy Director or the Director, as appropriate, the basis for its claim of good cause and all supporting documents or other evidence to substantiate its claim. The Deputy Director, Director or Chief Deputy Director, whichever is appropriate, shall, within 30 days of receipt of, the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(c) The Deputy Director, Director or Chief Deputy Director, as appropriate, shall notify the appellant in writing of the good cause determination, and shall specify what action shall be taken, if any, pursuant to sections 57941 through 57944.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§57948. Review of Documents Only.

Note • History

An appeal made pursuant to sections 57940 through 57946 shall be decided only on the documents submitted. There shall be no oral testimony or argument.

NOTE

Authority cited: Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of forms filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of forms filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of form DS1897 Instructions filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Editorial correction of form (Register 96, No. 13).

8. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

Subchapter 13. Rate-Setting Procedures for In-Home Respite Services Agency Vendors

Article 1. Definitions

§58000. Terms Defined In Other Subchapters.

Note • History

(a) As used in Sections 58020 through , the following words and phrases have the meanings specified in Sections 54302 and 57210:

(1) Authorized Consumer Representative

(2) Consumer

(3) Cost-of-Living Adjustment or COLA

(4) Days

(5) Department

(6) Director

(7) Family Member

(8) Fiscal Year

(9) Generic Agency

(10) In-Home Respite Services

(11) Level of Payment

(12) Like Programs

(13) Management Organizations

(14) Profit or Surplus

(15) Public Agency

(16) Regional Center

(17) Regional Center Payments

(18) Service Code

(19) Straight-line Depreciation

(20) Subcode

(21) User Regional Center or Utilizing Regional Center

(22) Vendor

(23) Vendor Identification Number

(24) Vendoring Regional Center

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Section 4690.2, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(7) and (a)(11) and subsection renumbering and amendment of Note filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

4. New subsections (a)(7) and (a)(11) and subsection renumbering and amendment of NOTE refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including adoption of subsection (a)(17) and subsection renumbering transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58010. Additional Terms Defined.

Note • History

(a) As used in sections 58020 through 58448, the following words and phrases have the following meanings:

(1) “Allowable Range” means the distance from the lower limit to the upper limit in a distribution of amounts among like programs determined pursuant to step four, section 58113;

(2) “Direct Service Hours” means the number of hours during which a respite worker provides care to a consumer in the consumer's place of residence and, for vendors reimbursed for absences pursuant to Section 54326(a)(12), the number of direct service hours for which reimbursement was received shall also be included;

(3) “Gap” means the difference between the amount determined for each vendor in step five, section 58114 (a)(1) and the amount determined for each vendor in step two, section 58111 based upon allowable cost and direct consumer service hours reported to the Department;

(4) “Gap Funding” means an amount of funds appropriated in the Budget Act pursuant to Section 58320;

(5) “Lower Limit” means the lowest amount allowed in the distribution of amounts among like programs, without an increase in the amount pursuant to step six, section 58115;

(6) “Permanent Payment Rate” means a rate established by the Department subsequent to the effective date of sections 58000 through 58448, which is based upon each vendor's service, allowable cost, direct service hours, vendor income, and as applicable, regional center payment information;

(7) “Temporary Payment Rate” means a rate established by the Department subsequent to the effective date of sections 58000 through 58448, for vendors who do not have an actual cost history which the Department can use to establish a permanent payment rate;

(8) “Upper limit” means the highest amount allowed in the distribution of amounts among like programs, without a decrease in the amount pursuant to step six, section 58115; and

(9) “Vendor Income” means all income received from any public agency, with the exception of the Department or regional centers, for services to consumers pursuant to section 58038.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(6) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsection (a)(2) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (a)(2)-(a)(4), repealing subsections (a)(7) and (a)(8), renumbering subsections, and amending newly designated subsection (a)(11) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. General Provisions

§58020. General Requirements.

Note • History

(a) If a vendor serves both consumers and persons other than consumers, the vendor shall:

(1) Report only the service, cost and vendor income information related to services to consumers; and

(2) Allocate its costs and vendor income to consumers and to other persons served by the vendor based upon the total actual number of direct service hours.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Section 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)-(a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Submission of Required Information

§58030. Submission of Information.

Note • History

(a) Each in-home respite services agency vendor shall submit the service, cost and vendor income information specified in Sections 58033 through 58038, and as applicable, the regional center payment information specified in Section 58039, on Form DS1897B, dated 12/92, entitled In-Home Respite Services Agency: Service, Cost and Vendor Income Statement, for each service for which the vendor is requesting that a rate be established. The vendor shall sign and date Form DS1897B which includes a certification that the information is true, correct and complies with Sections 58020 through 58039. The vendor shall submit the original document to the Department with a copy of this document submitted to the vendoring regional center at the same time the original document is submitted to the Department.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2, 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58031. Reporting Periods for Submission of Information.

Note • History

(a) Information submitted pursuant to sections 58033 through 58039 shall cover the following reporting periods:

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791, Welfare and Institutions Code. Reference: Sections 4690.2, 4691, 4691.5 and 4791, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

7. Amendment of subsection (a)(1) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58032. Required Due Dates for Submission of Information.

Note • History

(a) The required dates for submission are as follows:

(2) Prior to expiration of the temporary payment rate for those vendors who received an extension pursuant to Section 58031(a)(1);

(4) At the time the vendor requests establishment of a temporary payment rate, for vendors requesting a temporary payment rate.

(b) If the information is received by the dates specified in (a), the vendoring regional center and the Department shall review the information pursuant to Sections 58040 and 58042.

(c) If the information is not received by the dates specified in (a), the Department shall within 15 days, notify in writing, the vendor, the vendoring regional center, and utilizing regional center(s), if any, as follows:

(1) For the following vendors that payment of the vendor's rate was suspended, the effective date of the suspension and that payment shall remain suspended until the information is received:

(A) For vendors required to submit information pursuant to (a)(1), suspension is effective at the end of 18 months, unless an extension has been granted pursuant to Section 58031(a)(1); and

(B) For vendors who have received an extension of their temporary payment rate pursuant to Section 58031(a)(1), suspension is effective upon termination of the extension;

(C) For vendors required to submit information pursuant to (a)(3), suspension is effective on September 30, 1996, and each alternate September 30 thereafter.

(2) This provision does not apply to vendors requesting a temporary payment rate since the Department cannot initiate any action until the vendor submits its request for establishment of a temporary payment rate.

(d) If the information is submitted after the dates specified in (a) when payment of the vendor's rate has been suspended, the vendoring regional center and the Department shall review the information pursuant to Sections 58040 and58042 and the Department shall authorize the vendoring regional center and utilizing regional center(s), if any, to reinstate payment of the vendor's rate as of the date payment was suspended.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58033. Required Service Information.

Note • History

(a) In order for the Department to establish a temporary payment rate or permanent payment rate, the vendor shall submit the following service information:

(1) Vendor name, and name of the management organization, if any, vendor identification number, service code and subcode;

(2) Office telephone number, business and mailing addresses;

(3) Name of the service director;

(4) Name of the vendoring regional center and utilizing regional center(s), if any; and

(5) A copy of the service design which was submitted to the vendoring regional center pursuant to section 54310(a)(10)(F).

(b) In addition to the information in (a), vendors requesting a permanent payment rate shall also submit the total actual number of direct service hours for all consumers and, for vendors reimbursed for absences pursuant to Section 54326(a)(11), the number of direct service hours for which reimbursement was received shall also be included.

(1) The date that the vendor began, or intends to begin, providing services to consumers; and

(2) A copy of the vendorization approval letter specified in section 54322(d).

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(5) and (c)(2) filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsection (b) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (b), (c)(1) and (c)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Change without regulatory effect amending subsection (b) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

§58034. Required Cost Information.

Note • History

(a) In order for the Department to establish a permanent payment rate, the vendor shall submit information for the following allowable costs if they are incurred by the vendor and are necessary for the vendored service.

(1) Total gross salary and wages including overtime for the staff functions specified in Section 56792.

(2) Fringe benefit costs associated with the salary and wage costs for the staff functions identified in (1) which shall be limited to the following:

(A) Old Age Security Disability Insurance (OASDI) or Federal Insurance Compensation Act (FICA);

(B) Workers' compensation;

(D) Life insurance;

(E) Health insurance;

(F) Dental insurance;

(G) Retirement;

(H) Vision insurance;

(I) Employee Training Tax as specified in the California State Unemployment Insurance Code Section 976.6; and

(J) Long-term disability insurance.

(3) Operating expenses which shall not duplicate other allowable costs and shall be limited to the following cost categories:

(A) Accounting fees of the vendor for the establishment and maintenance of accounting records and other information systems required for the fiscal management of the vendored service;

(B) Bank service fees of the vendor;

(C) Communication costs for services including telephone, telegraph, teletype, centrex, telepak, postage, message services, facsimiles and TDD;

(D) Contractual/consultant fees for service operation that do not have a specific cost category;

1. Buildings which have been purchased by the vendor;

2. Furniture and equipment which has been purchased by the vendor and has a unit acquisition cost of at least $500 and a normal useful life of at least four years; and

3. Capital improvements that add to the value or useful life of the building or equipment. Capital improvements shall be treated as a permanent investment to be added to the cost basis of the building or equipment and charged to depreciation.

(F) General expense costs for the following items only:

1. Furniture and equipment which do not meet the criteria specified in (E) 2;

2. Interest on loans attributable to the vendored service;

3. Subscriptions for periodicals which are used in the operation of the vendored service or for the purpose of staff development;

5. Fees for licenses, certifications, registrations or permits, if necessary for vendorization or the continued operation of the service subsequent to vendorization;

6. Accreditation fees;

7. Association dues or fees;

8. Costs for providing or preparing information related to the vendored service which is used as general information to the consumers or to the authorized consumer representatives;

9. Local business fees or taxes;

10. Costs related to inoculations or clinical tests of an employee, for the employee's or consumer's health and safety; and

11. Fuel and oil.

(G) Insurance costs;

(H) Janitorial fees;

(I) Legal fees;

(J) Maintenance costs for repair and upkeep of furniture and equipment, vehicles, buildings and grounds which neither adds to the permanent value nor prolongs its useful life, but maintains it in an efficient operating condition;

(K) Office supply costs;

1. Furniture and equipment;

2. Vehicles; and

3. Buildings.

(M) Staff training costs for in-service training and employee development which meet the requirements specified in Section 56794;

(N) Staff travel costs which are specifically related to the administration of the vendored service.

(O) Utility costs such as gas, electricity, water, garbage, sewer fees or other utility expenses which occur at the vendored service site;

(P) Vehicle depreciation cost for owned vehicles shall be calculated by using the straight-ling depreciation method and the minimum normal service life which is allowed by the Urban Mass Transportation Administration. The minimum normal service life for vehicles such as regular and specialized vans and cars is at least four years for service or an accumulation of at least 100,000 total miles on the vehicle.

(4) Management organization costs which:

(A) Shall include for staff functions of the management organization, the allowable costs specified in (a)(1) through (3) of this section.

(B) Shall not include:

1. More than 100 percent of the allocated costs of the management organization;

2. Costs applicable to or claimed by other services operated by the vendor.

3. Any non-allowable costs pursuant to Section 58036; and

4. Costs for respite worker staff.

(C) Shall be allocated on a basis consistent with the administrative support provided to each separate service, and each vendor shall:

1. Indicate whether the methodolgy used to allocate the costs of the management organization is based upon.

a. Direct service hours; or

b. The total costs of each service.

2. Include the total allowed costs of the management organization for the reporting period.

(b) Cost information submitted pursuant to (a) shall not include respite worker travel costs. These costs shall be reimbursed pursuant to Sections 58130 and 58132.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(3)(F)8. and (a)(3)(F)10. filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment of subsections (a)(1), (a)(2)(I), (a)(3)(F)2., (a)(3)(F)9., (a)(4)(B)3. and (b) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58036. Costs Not to Be Reported.

Note • History

(a) Non-allowable costs shall not be reported, and are limited to the following:

(1) Camperships, student aid funds and scholarships;

(2) Consumer entertainment and admission fees;

(3) Consumer moving expenses;

(4) Contractual/consultant fees for individual services which can be obtained through a generic agency and which the generic agency is legally responsible to provide;

(5) Depreciation costs for furniture, equipment, buildings or vehicles that are donated, secured or purchased through government grants;

(6) Depreciation costs for owned land;

(7) Donated services, buildings, furniture, equipment or vehicles;

(8) Donations to other agencies;

(9) Employee bonuses and commissions;

(10) Office furniture, equipment, or vehicle rental or lease costs associated with items which are owned by a management organization, its affiliates or a commonly owned entity; and are leased or rented back to the management organization, its affiliates or a commonly owned entity, or the services it operates, when submission of such costs would result in the vendor being reimbursed twice for the same costs;

(11) Federal/state income tax and penalties or fees associated with payment of federal or state income taxes;

(12) Fund raising costs;

(13) Gifts for consumers or employees;

(14) Legal fees directly related to a consumer, or expenses for the prosecution of claims against the regional center or state agencies;

(15) Management organization costs pursuant to Section 58034 (a)(4)(B);

(16) Payroll tax penalties;

(17) Profit;

(18) Public relations costs;

(19) Refundable deposits;

(20) Supplements to consumers for their daily living needs;

(21) Surplus as defined in Section 57210(a)(11); and

(22) Travel costs associated with transporting consumers to or from the vendored service site except for emergencies when the consumer's health and safety is at risk.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(20) filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

5. Amendment of subsection (a)(15), new subsection (a)(16), subsection renumbering and amendment of newly designated subsection (a)(21) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58038. Required Vendor Income Information.

Note • History

(a) In order for the Department to establish a permanent payment rate, the vendor shall submit the following vendor income information:

(1) The name of each vendor income source;

(2) The total amount of vendor income received from each source; and

(3) The duration of funding provided by each vendor income source.

(b) Vendor income shall not include income:

(1) Received from private sources;

(2) Used for non-allowable costs or for persons other than consumers; and

(3) Received from the Department or regional centers.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (b)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58039. Required Regional Center Payment and Vendor Cost Reduction Information.

Note • History

(a) In order for the Department to establish a permanent payment rate for vendors whose temporary payment rate is being converted to a permanent payment rate, or for vendors whose permanent payment rate is being established, each vendor who agreed, pursuant to Section 57300(d) or Section 58140, to a negotiated level of payment shall submit regional center payment information for each regional center with whom the vendor agreed to a negotiated level of payment as follows:

(1) The total amount of the actual regional center payments which the vendor received for services provided to consumers during the reporting period; and

(2) The maximum amount of the regional center payment which the vendor would have received during the reporting period, had the vendor not agreed to a negotiated level of payment. The maximum amount of the regional center payment shall be computed by multiplying the vendor's established temporary payment rate or permanent payment rate for the reporting period, by the actual number of direct service hours which the vendor charged and invoiced the regional center for services provided to consumers.

(b) In addition to the information specified in (a) above, each vendor who agreed, pursuant to Section 57300(d) or Section 58140, to a negotiated level of payment shall submit the total amount of cost reductions implemented as a result of the agreed upon lower level of payment.

(c) The provisions of this section shall not apply to respite services provided to family members as a result of a voucher as specified in Section 57310(a)(3), (a)(12), (b)(3) and (b)(12).

NOTE

HISTORY

1. New section filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Amendment of subsection (c)(1) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

6. Change without regulatory effect amending subsections (a)(1), (a)(2) and (b)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

7. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Article 4. Review Requirements

§58040. Vendoring Regional Center Review Procedures.

Note • History

(a) Vendoring regional center review procedures shall apply only to the establishment of permanent payment rates, including conversion of temporary payment rates to a permanent payment rate.

(b) Within 30 days from the date of the Department's written notification pursuant to section 58042 (a)(1)(A), the vendoring regional center shall:

(1) Review the information submitted by the vendor to determine the following:

(A) That services being provided are consistent with the service design, pursuant to section 56780;

(B) That the information submitted by the vendor is complete and complies with sections 58020, and 58033 though 58038; and

(C) Any known inconsistencies in the vendor's reporting of cost and/or vendor income and/or, as applicable, regional center payment information.

(2) Forward a written copy of the review results to the Department and the vendor.

(c) If the regional center does not notify the Department of the results of its review pursuant to (b), the Department shall proceed with its review procedures pursuant to section 58042.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (b)(1)(C) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58042. Department Review Procedures.

Note • History

(a) Department review procedures are as follows:

(1) For vendors whose temporary payment rates are being converted to permanent payment rates, and for vendors whose permanent payment rate is being established, the Department shall:

(B) Upon receipt of the information required from the vendoring regional center pursuant to section 58040, or within 50 days of receipt of the information required from the vendor, review the information to determine if it is complete and complies with the requirements of sections 58020, and 58033 through 58039.

(b) If the information is complete and complies with the requirements of:

(1) Sections 58020, and 58033 through 58039, the Department shall, for those vendors identified in (a)(1), establish a permanent payment rate pursuant to sections 58100 through 58119; or

(2) Section 58033, the Department shall, for those vendors identified in (a)(2), establish a temporary payment rate pursuant to sections 58120 and 58122.

(c) If the information is not complete or does not comply with the requirements of sections 58020, and 58033 through 58039, for establishment of a permanent payment rate, or section 58033, for establishment of a temporary payment rate,

(1) The Department shall, within the time specified in (a)(1)(B) or (a)(2):

(A) Make a written request to the vendor for any additional or clarifying information; and

(B) Send a copy of the request to the vendoring regional center and utilizing regional center(s), if any.

(2) The vendor shall submit the required information to the Department with a copy to the vendoring and utilizing regional centers, if any, within 15 days from receipt of the Department's written request:

(A) If the vendor submits the required information within the time specified, and it is complete and complies with the requirements of:

1. Sections 58020, and 58033 through 58039, the Department shall, for those vendors identified in (a)(1), establish a permanent payment rate pursuant to sections 58100 through 58119; or

2. Section 58033, the Department shall, for vendors identified in (a)(2), establish a temporary payment rate pursuant to sections 58120 and 58122.

1. For those vendors identified in (a)(1):

a. That unless their rate has expired, payment of their rate shall be suspended within 15 days from the date of the Department's written notification; and

b. That payment shall remain suspended until the required information is received.

2. For those vendors identified in (a)(2), that the Department shall take no further action on their rate request until all required information has been received.

(C) If the required information is received after the vendoring regional center and utilizing regional center(s), if any, have suspended payment of the vendor's rate pursuant to (B)l. or 2. and the information is complete and it complies with the requirements of:

1. Sections 58020, and 58033 through 58039, the Department shall, for those vendors identified in (a)(1):

a. Establish a permanent payment rate pursuant to sections 58100 through 58119; and

2. Section 58033, the Department shall, for those vendors identified in (a)(2), establish a temporary payment rate pursuant to sections 58120 and 58122.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of text and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsection (a)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 14. Rate-Setting Methodology for In-Home Respite Services Agency Vendors

Article 1. Permanent Payment Rates

§58100. General Provisions.

Note • History

(a) The methodology for computing permanent payment rates is based on service, cost, vendor income, and as applicable, regional center payment information submitted by all vendors receiving permanent payment rates. The Department shall use each vendor's service, cost, vendor income, and as applicable, regional center payment information to establish that vendor's permanent payment rate pursuant to this methodology.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58111. Step Two: Computing an Amount Using Allowable Costs and Direct Service Hours.

Note • History

(a) Step two in the process of determining a permanent payment rate is to compute an amount for each vendor within the group of like programs, based on allowable costs and direct service hours. For each vendor, the Department shall compute an amount by:

(1) Determining the total allowable costs as follows:

(A) Add together the total costs reported by the vendor pursuant to section 58034;

(B) Subtract from the amount computed in (A) the amount of any non-allowable costs specified in section 58036, which were identified by the Department or vendoring regional center during their review of the information submitted by the vendor; and

(C) For vendors who agreed to a negotiated level of payment , as specified in Section 57300(d), and whose temporary payment rate is being converted to a permanent payment rate, or whose permanent payment rate is being established, the Department shall increase the amount computed in (B) by:

1. Subtracting the total amount of the actual regional center payments which the vendor received for services provided during the reporting period, as reported pursuant to Section 58039(a)(1), from the maximum amount of the regional center payment which the vendor would have received during the reporting period, as reported pursuant to Section 58039(a)(2); and

2. Adding the amount computed in 1. or the total amount of cost reductions reported pursuant to Section 58039(b), whichever is less, to the amount computed in (B).

(2) Dividing the total allowable costs computed in (1) by the vendor's actual direct service hours pursuant to section 58033 (b) .

(3) Increasing or decreasing, if applicable, the amount computed in (2) for any of the following that has occurred from July 1 through September 30 following the reporting period, and which have not been included in the total allowable costs reported by the vendor:

(A) Increase the amount computed in (2) by the amount of any COLA authorized in the Budget Act for the fiscal year following the reporting period;

(B) Increase the amount computed in (2) by the amount of any rate increase granted by the Department, as a result of a rate adjustment pursuant to sections 58420 through 58424, and/or audit adjustment pursuant to section 58430, and/or rate appeal pursuant to sections 58440 through 58448; and/or

(C) Decrease the amount computed in (2) by the amount of any rate decrease issued by the Department, as a result of a rate adjustment pursuant to sections 58420 through 58424, and/or audit adjustment pursuant to section 58430, and/or rate appeal pursuant to sections 58440 through 58448.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(1)(C)-(C)2. and amendment of subsections (a)(1)(A)-(B) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58112. Step Three: Computing the Mean.

Note • History

(a) Step three in the process of determining a permanent payment rate is the computation of the mean using the amount determined in step two, section 58111:

(1) Add together the amount computed in step two for each vendor; and

(2) Divide the sum computed in (1) by the number of vendors included in calculating the sum.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§58113. Step Four: Determination of the Allowable Range of Rates.

Note • History

(a) Step four in the process of determining a permanent payment rate is the computation of an allowable range of rates. The Department shall determine the upper and lower limits of the allowable range of rates as follows:

(1) For Fiscal Year 1997-98 and each alternate fiscal year thereafter:

(A) Multiply the mean computed in section 58112 for Fiscal Year 1993-94, by 50 percent to determine the range;

(D) The lesser of the two ranges compared in (C) shall be divided by two;

(E) The upper limit shall be determined by adding the amount computed in (D) to the mean computed pursuant to section 58112 for Fiscal Year 1997-98, and each alternate fiscal year thereafter; and

(F) The lower limit shall be determined by subtracting the amount computed in (D) from the mean computed pursuant to section 58112 for Fiscal Year 1997-98, and each alternate fiscal year thereafter.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58114. Step Five: Adjusting the Amount Computed in Step Two for Gap Funding.

Note • History

(a) Step five in the process of determining a permanent payment rate is to adjust the amount computed in step two, section 58111, for any money appropriated pursuant to the Budget Act, to fund the gap computed in Section 58320. The Department shall:

(1) Convert the vendor's current permanent payment rate into an amount as follows:

(A) Add back any vendor income subtracted out when the Department computed the vendor's current permanent payment rate. The increased rate shall become the amount for use in this step;

(B) If no vendor income was used in computing the vendor's current permanent payment rate, that rate shall become the amount for use in this step.

(2) If the amount computed in (1):

(A) Is below, or within the allowable range of rates, the gap adjustment combined with the amount computed in (1) shall not exceed the upper limit of the allowable range of rates; or

(B) Exceeds the upper limit of the allowable range of rates, the vendor shall not be eligible for a gap adjustment.

(3) For those vendors eligible for a gap adjustment pursuant to (2)(A), the Department shall:

(A) Increase to the upper limit, the difference between the amount computed in (1) and the amount computed in step two, section 58111 if the appropriation in the Budget Act is sufficient to fully cover the statewide fiscal impact of the gap computed in Section 58320; or

(B) Increase the amount computed in (1) up to the upper limit, based upon the percentage of available funds, if the appropriation in the Budget Act is insufficient to fully cover the statewide fiscal impact of the gap computed in Section 58320. The Department shall, for those eligible vendors:

1. Determine the percentage of available funds by dividing the statewide fiscal impact of the gap computed in Section 58320, by the amount appropriated in the Budget Act;

2. Determine the difference between each vendor's amount as computed in step two, section 58111, and their amount as computed in (1);

3. Multiply the difference computed in 2. by the percentage of available funds computed in 1.; and

4. Increase the amount computed in (1) by the amount computed in 3.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)-(a)(1)(B) and (a)(3)(A)-(a)(3)(B)1. filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58115. Step Six: Adjusting the Amount Computed in Step Five by the Upper and Lower Limit of the Allowable Range of Rates.

Note • History

(a) Step six in the process of determining a permanent payment rate is to adjust the amount computed in step five, section 58114, by the upper and lower limit of the allowable range of rates:

(1) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, the upper and lower limit adjustment shall be computed as follows:

(A) For vendors whose amount, as determined in step five, is within the allowable range of rates, the Department shall make no change to that amount;

(B) For vendors whose amount, as determined in step five, is above the upper limit of the allowable range of rates, the Department shall reduce that amount to the upper limit;

(C) For vendors whose amount, as determined in step five, is below the lower limit of the allowable range of rates, the Department shall increase the amountto the lower limit, based upon available funds pursuant to (a)(1)(C)1. through 3.

1. The amount of available funds to increase the amounts computed in step five shall be determined as follows:

a. Multiply each vendor's reduction computed pursuant to (1)(B) by their direct service hours identified in section 58033 (b);

b. Add the amount computed in a. for each vendor to determine the total available funds from the upper limit reduction pursuant to (1) (B); and

c. Add to the amount determined in b. any gap funding appropriated pursuant to the Budget Act, for those vendors specified in section 58310 (a)(1)(A) and (B).

2. The amount of funds needed to increase amounts computed in step five to the lower limit, shall be determined as follows:

a. Determine the difference between the lower limit and each vendor's amount as computed in step five;

b. Multiply the difference computed in a. by each vendor's direct service hours identified in section 58033 (b); and

c. Add the amounts computed in b. to determine the total amount of needed funds.

3. The total amount of available funds, as determined in (C) 1., shall be compared to the total amount of funds needed, as determined in (C)2.

a. If there are sufficient funds to fully fund the lower limit increase, the Department shall, increase amounts as determined in step five to the lower limit.

b. If there are insufficient funds to fully fund the lower limit increase, the Department shall adjust the difference computed in (C)2.a. by the percentage of available funds. The Department shall:

(1.) Calculate the percentage of available funds by dividing the total amount of available funds, computed in (C)1.c. by the total amount of funds needed computed in (C)2.c.;

(2.) Multiply the percentage of available funds, by the difference computed in (C)2.a. for each vendor; and

(3.) Increase amounts computed in step five by the amount computed in (C)3.b.(2).

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(1) and (a)(1)(B) and repealing subsections (a)(1)(C)4.-(a)(2)(B) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58117. Step Seven: Adjusting the Amount Computed in Step Six by Vendor Income.

Note • History

(a) Step seven in the process of determining a permanent payment rate is to adjust the amount computed in step six, section 58115, if applicable, by the amount of any vendor income reported by the vendor pursuant to section 58038 as follows. The Department shall:

(1) Divide vendor income by the vendor's actual direct service hours identified in section 58033 (b); and

(2) Subtract the amount computed in (1) from the amount computed in step six.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§58118. Step Eight: Adjusting the Amount Computed in Step Seven for Budget Act Adjustment.

Note • History

(a) Step eight in the process of determining a permanent payment rate is to adjust the amount computed in step seven, section 58117, if applicable, for the following that will occur in the fiscal year for which the permanent payment rate is established:

(1) COLA authorized in the Budget Act; and/or

(2) Legislative adjustment, for any item of cost(s), specified in the Budget Act.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§58119. Adjusting the Rate Methodology for COLAs.

Note • History

(a) For each fiscal year in which a COLA is granted in the Budget Act, the Department shall increase the mean, computed in step three, section 58112, and upper and lower limits of the existing allowable range of rates, computed in step four, section 58113, by the percentage of the COLA.

(c) The effective date of the adjustment to the mean and allowable range of rates for a COLA pursuant to (a) or (b), shall be the effective date of the COLA specified in the Budget Act.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 2. Temporary Payment Rate

§58120. General Provisions.

Note • History

(a) The methodology for computing temporary payment rates is based on service, cost, vendor income, and as applicable, regional center payment information submitted by all vendors receiving permanent payment rates. The Department shall use each vendor's service information to establish that vendor's temporary payment rate pursuant to this methodology.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58122. Establishment of the Temporary Payment Rate.

Note • History

(a) The temporary payment rate is determined using the same information and steps specified in sections 58110, 58111, 58112, and 58119 for establishing a permanent payment rate.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 3. Supplemental Rate for Respite Worker Travel Costs

§58130. Supplemental Rate for Respite Worker Travel Costs.

Note • History

(a) Regional centers shall reimburse the in-home respite service agency for respite worker travel costs for private vehicle travel or public transportation which is required in order for the respite worker to travel to and from and between respite sites. Travel costs shall also include costs for consumer travel which is necessary in order for the respite worker to carry out assigned functions.

(b) Respite worker travel costs shall be authorized pursuant to minimum state of California travel reimbursement rates for state employees pursuant to Welfare and Institutions Code, section 4690.2 (b)(5).

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58132. Written Notification of the Supplemental Rate for Respite Worker Travel Costs.

Note • History

(a) For vendors receiving a supplemental rate for respite worker travel cost pursuant to section 58130, the Department shall notify the regional center in writing of the reimbursement rate. The regional center shall notify each vendor eligible for this supplemental rate.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 4. Negotiating the Level of Payment When Serving More than One Consumer

§58140. Negotiating the Level of Payment When Serving More Than One Consumer.

Note • History

(a) Once the Department has established a rate of reimbursement pursuant to Sections 58100 through 58119, for vendors whose temporary payment rate is being converted to a permanent payment rate and vendors whose permanent payment rate is being established or reestablished, or Sections 58120 through 58122 for vendors who are requesting a temporary payment rate, a regional center, or its designee, and a vendor may negotiate the level of payment when a family member has more than one consumer residing with them who has been authorized by the regional center to receive in-home respite services. The amount of the level of payment may be less than but shall not exceed the per-consumer per-hour rate established by the Department and shall only apply to the additional consumer(s) receiving services.

(b) Each regional center and vendor shall mutually agree in writing upon the level of payment and the effective date for commencing and terminating payment at the agreed upon amount.

(c) The level of payment negotiated by a regional center and vendor shall commence on the date agreed to by the regional center and vendor, and shall terminate on the expiration date specified by the Department in its written notification to the vendor of the established rate, or earlier, if an earlier termination date has been mutually agreed to by the regional center and vendor.

(1) If the level of payment agreed to by the regional center and vendor terminates on the expiration date specified in the Department's written notification to the vendor of the established rate, the Department shall:

(A) For those vendors whose established rate is a temporary payment rate, establish a permanent payment rate, as applicable, pursuant to Section 58242 or 58252; or

(B) For those vendors whose established rate is a permanent payment rate:

1. Reestablish the permanent payment rate during Fiscal Year 1996-97, and each alternate fiscal year thereafter, as specified in Section 58240; or

2. Establish the permanent payment rate during Fiscal Year 1997-98, and each alternate fiscal year thereafter, as specified in Section 58250.

(2) If the level of payment agreed to by the regional center and vendor terminates prior to the expiration date specified in the Department's written notification to the vendor of the established rate, the vendor shall be reimbursed at the rate established by the Department until the expiration of the established rate.

(d) Within the limitations specified in this section, the level of payment negotiated by a regional center and a vendor may be renegotiated.

(e) Each regional center shall provide the Department and vendor with a copy of the written agreement specifying the terms of the level of payment.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 3-4-92 order including amendment of subsection (a) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending article heading, section heading, and subsections (a), (c)(1)(A) and (c)(1)(B)1. and 2. filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 5. Payment Rates for Existing In-Home Respite Services Agency Vendors

§58150. Payment Rates for Existing In-Home Respite Services Agency Vendors.

Note • History

(a) Existing in-home respite services agency vendors requesting a payment rate to provide new in-home respite services at an additional business address shall receive:

(1) A temporary payment rate as specified in Section 58236, 58244 or 58254 if separate vendorization of the additional business address was not waived pursuant to Section 54342(a)(37); or

(2) The permanent payment rate established for the existing in-home respite services agency if separate vendorization of the additional business address was waived pursuant to Section 54342(a)(37).

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections 4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2 and 4791, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 3-4-92 order including amendment of subsections (a)(1)-(2) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsections (a)(1)-(2) and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 15. Schedule of Payment Rates for In-Home Respite Services Agency Vendors

Article 1. General Provisions

§58210. General Provisions for Schedule of Payment Rates for All Fiscal Years.

Note • History

(a) Each fiscal year, the Department shall establish a payment rate for each vendor.

(b) The appropriate like program for each vendor shall be determined based upon their service code.

(c) Each vendor shall submit information, as applicable, pursuant to sections 58033 through 58039. The vendoring regional center and the Department shall review the information pursuant to sections 58040 and 58042.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

Article 2. Schedule of Payment Rates for Fiscal Year 1990-91

§58220. Vendors Receiving Permanent Rates.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 2 (sections 58220-58224) and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58222. Vendors Receiving Provisional Rates.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58224. New Vendors.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Schedule of Payment Rates for Fiscal Year 1991-92

§58230. Vendors Receiving Permanent Rates.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 3 (sections 58230-58236) and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58232. Vendors Receiving Temporary Payment Rates.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (b) and (d)(1) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58234. Vendors Receiving Provisional Rates.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58236. New Vendors.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Schedule of Payment Rates for Fiscal Year 1996-97 and Each Alternate Fiscal Year Thereafter

§58240. Vendors Receiving Permanent Payment Rates.

Note • History

(b) The effective date of the reestablished permanent payment rate shall be September 1, 1996, for Fiscal Year 1996-97, and September 1 for each alternate fiscal year thereafter.

(c) The expiration date of the reestablished permanent payment rate shall be August 31, 1997, for Fiscal Year 1996-97, and August 31 for each alternate fiscal year thereafter.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending article heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58242. Vendors Receiving Temporary Payment Rates.

Note • History

(b) If the mean is adjusted for a COLA pursuant to section 58119 (b), the Department shall adjust the temporary payment rate established the previous fiscal year, by the amount of the COLA.

(c) The effective date of the adjustment to the temporary payment rate, as specified in (b), shall be the effective date of the COLA as specified in section 58119 (c).

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58244. New Vendors.

Note • History

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter, new vendors requesting a rate shall receive the temporary payment rate established the previous fiscal year, adjusted for a COLA, if applicable, pursuant to section 58119. The Department shall use the service information specified in section 58033, submitted by each new vendor by the date specified in Section 58032(a)(3), to establish the vendor's temporary payment rate.

(b) The temporary payment rate shall be effective on the date the vendor begins providing services to consumers.

(1) The Department converts the temporary payment rate to a permanent payment rate pursuant to Section 58252; or

(2) It expires, which shall be twenty-one months from the date it became effective.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 5. Schedule of Payment Rates for Fiscal Year 1997-98 and Each Alternate Fiscal Year Thereafter

§58250. Vendors Receiving Permanent Payment Rates.

Note • History

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, the Department shall establish permanent payment rates pursuant to sections 58100 through 58119, based upon the service, cost and vendor income information specified in sections 58033 through 58038, and as applicable, the regional center payment information specified in Section 58039, submitted by vendors receiving permanent payment rates by the date specified in Section 58032(a)(2) for the reporting period specified in Section 58031(a)(2).

(b) The effective date of the established permanent payment rate shall be September 1, 1997, for Fiscal Year 1997-98, and September 1 for each alternate fiscal year thereafter.

(c) The expiration date of the established permanent payment rate shall be August 31, 1998, for Fiscal Year 1997-98, and August 31 for each alternate fiscal year thereafter.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending article heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58252. Vendors Receiving Temporary Payment Rates.

Note • History

(a) The temporary payment rate shall continue until the Department converts it to a permanent payment rate pursuant to (b) through (e).

(b) All vendors converting from a temporary payment rate to a permanent payment rate shall submit the service, cost and vendor income information specified in Sections 58033 through 58038, and as applicable, the regional center payment information specified in Section 58039 by the dates specified in Section 58032(a)(1) for the reporting period specified in Section 58031(a)(1).

(c) The Department shall convert the temporary payment rate to a permanent payment rate pursuant to Sections 58100 through 58119, with the following exceptions:

(1) The amount computed in Step five, Section 58114 shall not be adjusted for gap funding;

(2) The permanent payment rate shall not exceed the upper limit; and

(d) The effective date of the conversion of the temporary payment rate to a permanent payment rate shall be:

(1) Thirty days from the date the Department receives the service, cost and vendor income information that complies with Sections 58020 and 58033 through 58038, and as applicable, the regional center payment information specified in Section 58039; or

(2) No later than 21 months from the date the temporary payment rate was initially established.

(e) Temporary payment rates which are converted to a permanent payment rate shall expire August 31, following the effective date.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing and adding new section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58254. New Vendors.

Note • History

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter, new vendors requesting a rate shall receive a temporary payment rate established pursuant to sections 58120 through 58122, using the service information specified in section 58033 submitted by each new vendor by the date specified in Section 58032(a)(3). The temporary payment rate shall be based upon the service, cost and vendor income information submitted by vendors receiving permanent payment rates-pursuant to section 58250 (a).

(b) The temporary payment rate shall be effective on the date specified in Section 58244(b).

(c) Once the temporary payment rate is established, the vendor shall continue to receive that rate until it is converted, or it expires, as specified in Section 58244(c).

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 6. Timelines for Rate Establishment and Written Notification

§58260. Timelines for Continuation of the Permanent Rate and Written Notification.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58262. Timelines for Extension of the Provisional Rate and Written Notification.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58264. Timelines for Establishment of the Permanent Payment Rate and Written Notification.

Note • History

(a) For vendors receiving a permanent payment rate, the Department shall, upon receipt of the information which complies with sections 58020, and 58033 through 58039, and by September 1, of each year, establish or reestablish a permanent payment rate and notify, in writing, each vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The permanent payment rate;

(2) The effective date and expiration date of the permanent payment rate;

(3) The service code used to determine the permanent payment rate;

(4) Any Budget Act adjustments;

(5) The next required reporting period, and submission date pursuant to Section 58031(a)(2) and 58032(a)(2) for the service, cost, vendor income, and as applicable, regional center payment information;

(6) That payment of the permanent payment rate shall be suspended pursuant to section 58032 (c)(1)(B) if the required information specified in (a)(5) is not submitted; and

(7) The vendor's right to appeal the permanent payment rate pursuant to sections 58440 through 58448.

(b) For vendors converting their temporary payment rates to a permanent payment rate, the Department shall establish the permanent payment rate and provide the notification specified in (a) within 30 days of receipt of the service, cost and vendor income information that complies with sections 58022, and 58033 through 58038, and as applicable, the regional center payment information specified in Section 58039 for vendors with a temporary payment rate that is converted to a permanent payment rate.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a), (a)(5) and (b)(3) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58266. Timelines for Establishment of the Temporary Payment Rate and Written Notification.

Note • History

(a) For vendors requesting a temporary payment rate, the Department shall, within 30 days from receipt of the service information, that complies with section 58033, establish a temporary payment rate and notify, in writing, each vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The temporary payment rate;

(2) The effective date and expiration date of the temporary payment rate;

(3) The service code used to determine the temporary payment rate;

(4) Any cost-of-living adjustment;

(5) The next required reporting period, and submission date, pursuant to Sections 58031(a)(1) and 58032(a)(1) for the service, cost and vendor income information;

(6) That payment of the temporary payment rate shall be suspended pursuant to Section 58032(c)(1)(A) if the required information specified in (a)(5) is not submitted; and

(7) The vendor's right to appeal the temporary payment rate pursuant to sections 58440 through 58448.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(5) and (a)(6) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 16. Reporting Requirements for In-Home Respite Services Agency Vendors

Article 1. Annual Report to the Legislature

§58310. The Department's Annual Report to the Legislature.

Note • History

(a) By April 15, 1997, for Fiscal Year 1997-98, and by April 15 for each alternate fiscal year thereafter, the Department shall report the following to the Legislature:

(1) The amount needed to fund the statewide fiscal impact of the gap including identification of the amount attributed to the vendors who are:

(A) Not eligible for a gap adjustment pursuant to section 58114 (a)(2)(B); or

(B) Eligible only for a partial gap adjustment pursuant to section 58114 (a)(2)(A).

(A) Funded in the current fiscal year's Budget Act; nor

(B) Included in the next fiscal year's Governor's Budget.

(b) By April 15, 1998, for Fiscal Year 1998-99, and by April 15 for each alternate fiscal year thereafter, the Department shall report:

(1) The amount determined in (a)(1) that was unfunded in the previous year; and

(2) The information specified in (a)(2).

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a) and (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58312. The Joint Report to the Legislature for Fiscal Year 1996-97.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. Calculation of the Statewide Fiscal Impact of the Gap

§58320. Determination of the Statewide Fiscal Impact of the Gap for Fiscal Year 1997-98, and Each Alternate Fiscal Year Thereafter.

Note • History

(a) For vendors with a permanent payment rate whose amount computed in step two, section 58111, is below the upper limit of the allowable range of rates computed in section 58113, the Department shall:

(1) For each vendor, calculate the difference between step two, section 58111 and step five, section 58114 (a)(1);

(2) Multiply the amount computed in (1) for each vendor by each vendor's actual direct consumer service hours identified in section 58033 (b); and

(3) Add the amounts computed in (2) to determine the statewide gap.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections (a) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58322. Determination of the Statewide Fiscal Impact of the Gap for Fiscal Year 1993-94, and Each Alternate Fiscal Year Thereafter.

Note • History

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Subchapter 17. Rate Adjustments, Audit Adjustments and Rate Appeals for In-Home Respite Services Agency Vendors

Article 1. General Provisions

§58410. General Provisions.

Note • History

(a) A permanent payment rate may be adjusted pursuant, to this article, by the Department, only for the following:

(1) A rate adjustment pursuant to section 58420 (b) and (c); and/or

(2) An audit adjustment pursuant to section 58430 (a)(1)(A); and/or

(3) A rate appeal pursuant to sections 58440 through 58448.

(b) A temporary payment rate may be adjusted pursuant to this article, by the Department, only for the following:

(1) An audit adjustment pursuant to section 58430 (a)(1)(B); and/or

(2) A rate appeal pursuant to sections 58440 through 58448.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 2. Rate Adjustments

§58420. General Provisions.

Note • History

(a) Once a payment rate for each in-home respite services agency vendor has been established by the Department, adjustments to that rate shall be considered by the Department, for either anticipated or unanticipated changes, in accordance with (b) and (c).

(b) Anticipated changes are service modifications which the vendor and/or the vendoring regional center can plan for and expect to occur in the next fiscal year. Anticipated changes shall be submitted to the Department and the vendoring regional center prior to December 1 of the year previous to the fiscal year in which the changes are expected to occur. Any requests submitted after December 1 shall not be considered by the Department. Anticipated changes shall be limited to the following:

(1) Relocation of the vendor's office due to expiration of the vendor's office lease or tenancy arrangement; and/or

(2) A loss or gain of any vendor income used to compute the vendor's rate;

(3) An increase or decrease in the units of service purchased by regional centers, where such change equals 25% or more annually from the units of service used in the cost statement upon which their rate was based.

(c) Unanticipated changes shall be submitted by the vendor to the Department and the vendoring regional center no later than 60 days from the date the change has occurred. Unanticipated changes received after the 60 days shall not be considered by the Department. Unanticipated changes shall include mandated service adjustments due to changes in, or additions to, existing statutes, laws or regulations or court decisions.

(d) Anticipated changes shall be funded by the Department only if there are funds made available in the Budget Act appropriation to the Department for that purpose.

(e) Unanticipated changes shall be funded effective the date the Department approves them pursuant to section 58424.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 8-30-2001 as an emergency; operative 8-30-2001 (Register 2001, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-28-2001 or emergency language will be repealed by operation of law on the following day.

4. Reinstatement of section as it existed prior to 8-30-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2002, No. 15).

5. Amendment filed 4-11-2002 as an emergency; operative 4-11-2002 (Register 2002, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-9-2002 or emergency language will be repealed by operation of law on the following day.

6. Amendment refiled 8-8-2002 as an emergency; operative 8-8-2002 (Register 2002, No. 32). A Certificate of Compliance must be transmitted to OAL by 12-6-2002 or emergency language will be repealed by operation of law on the following day.

7. Amendment refiled 12-5-2002 as an emergency; operative 12-5-2002 (Register 2002, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-4-2003 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 12-5-2002 order transmitted to OAL 4-4-2003, and withdrawn from OAL review on 5-15-2003.

9. Amendment filed 5-15-2003 as an emergency; operative 5-15-2003 (Register 2003, No. 20). A Certificate of Compliance must be transmitted to OAL by 9-12-2003 or emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 5-15-2003 order transmitted to OAL 6-23-2003 and filed 7-28-2003 (Register 2003, No. 31).

§58422. Submission Requirements for Rate Adjustments.

Note • History

(a) Any in-home respite services agency vendor requesting a rate adjustment due to anticipated or unanticipated program changes pursuant to the requirements of section 58420 shall submit the following information in writing to the Department with a copy to the vendoring regional center:

(1) Vendor service information specified in section 58033 (a)(1) through (4);

(2) The specific reason for the adjustment request;

(3) All supporting documentation and any other information necessary to substantiate and/or justify the request;

(4) Service, cost and vendor income information for only those items relating to the rate adjustment request; and

(5) The date the additional cost was incurred or is expected to be incurred.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§58424. Review Procedures for Rate Adjustments.

Note • History

(b) Within 30 days from the date of the Department's written notification pursuant to (a), the vendoring regional center shall:

(1) Review all information submitted by the vendor to determine if it complies with the requirements of sections 58420 and 58422; and

(2) Notify the Department, in writing, with a copy to the vendor, of the regional center's recommendation, including supporting rationale for their recommendation. The regional center's supporting rationale shall include:

(A) The specific regulatory basis for the request;

(B) A statement that the circumstances necessitating the request have been verified by the regional center; and

(c) If the regional center does not notify the Department of the results of its review and recommendation pursuant to (b), the Department shall proceed with its review procedures pursuant to (d) through (g).

(d) Within 50 days of the receipt of the rate adjustment request from the vendor, the Department shall review the request to determine if it is complete and complies with the requirements of sections 58420 and 58422.

(1) If the vendor's rate adjustment request is complete and complies with the requirements of sections 58420 and 58422, the Department shall approve the vendor's rate adjustment request within 60 days of receipt of the request. However, requests for anticipated program changes shall only be approved contingent upon funds being available pursuant to section 58420 (d).

(2) If the vendor's rate adjustment request is not complete or does not comply with the requirements of sections 58420 and 58422, the Department shall make a written request to the vendor for additional information, as required, and send a copy of the request to the vendoring regional center. The vendor shall submit the required additional information to the Department within 15 days from receipt of the written request.

(A) If the vendor fails to submit the required additional information within 15 days, the Department shall deny the vendor's rate adjustment request.

(B) If the vendor submits the required additional information within the 15 days and it is complete and complies with the requirements of sections 58420 and 58422, the Department shall approve the vendor's rate adjustment request within 60 days of receipt of the required additional information. However, requests for anticipated program changes shall only be approved contingent upon funds being available pursuant to section 58420 (d).

(C) If the vendor submits the required additional information within 15 days and it is not complete and does not comply with the requirements of sections 58420 and 58422, the Department shall deny the vendor's rate adjustment request.

(e) The Department shall notify, in writing, the vendor, the vendoring regional center, and utilizing regional center(s), if any, of the following:

(1) The decision to approve or deny the vendor's rate adjustment request pursuant to (d). Notification shall be as follows:

(A) Within the time specified in (d)(1) if the vendor's rate adjustment request, when initially received by the Department, is complete and complies with sections 58420 and 58422;

(B) Within 15 days from the date any required additional information from the vendor is due, if the vendor fails to submit the required additional information within the time specified in (d)(2)(A);

(C) Within the time specified in (d)(2)(B) if the vendor submits the required additional information within 15 days and it is complete and complies with sections 58420 and 58422; or

(D) Within 60 days of receipt of any required additional information which is not complete and does not comply with sections 58420 and 58422, as specified in (d)(2)(C).

(2) The availability of funds in the Budget Act, to fund previously approved anticipated program changes pursuant to section 58420 (d). The notification shall be by September 1.

(f) The effective date for all approved rate adjustments due to anticipated program changes pursuant to section 58420 (b) shall be September 1 of the subsequent fiscal year, or later, depending upon when the cost relating to the change actually occurs.

(g) The effective date for all approved rate adjustments due to unanticipated program changes pursuant to section 58420 (c) shall be the date the service began incurring the additional cost.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

Article 3. Audit Adjustments

§58430. Rate Adjustments Resulting from Audit Findings.

Note • History

(a) If the Department or regional center conducts an audit of the vendor, and an adjustment to the rate is required as a result of the audit, the Department shall adjust the vendor's rate as follows:

(1) The audit report shall be utilized by the Department in determining whether an adjustment to the vendor's rate is required. This determination shall be made prior to issuance of the audit report.

(A) For vendors reimbursed at a permanent payment rate, the vendor's rate shall be adjusted if the service, cost, vendor income, and as applicable, regional center payment information, used as a basis for determining the rate, does not substantiate or support the rate established by the Department.

(B) For vendors reimbursed at a temporary payment rate, the vendor's rate shall be adjusted if any of the service information used as a basis for determining the rate, does not substantiate or support the rate established by the Department.

(2) The revised rate and the effective date of the revised rate shall be determined as follows:

(A) For vendors reimbursed at a permanent payment rate, the vendor's service, cost, vendor income, and as applicable, regional center payment information used as a basis for determining the vendor's rate, adjusted for any findings in the final audit report, shall be used to determine the revised rate and its effective date.

(B) For vendors reimbursed at a temporary payment rate, the vendor's service information used as a basis for determining the vendor's rate, adjusted for any findings in the final audit report, shall be used to determine the revised rate and its effective date.

(b) If an adjustment to the vendor's rate was made pursuant to (a), the Department shall include, with the final audit report released to the vendor, written notification of the following:

(1) The revised rate and its effective date;

(2) The vendor's right to defer implementation of the revised rate and/or its effective date, pending the results of an audit appeal, if the vendor appeals the audit pursuant to title 17, section 50700 through 50767;

(3) That if the vendor appeals the audit, the results of the audit appeal shall be used by the Department in accordance with (a) to determine the revised rate and its effective date; and

(4) The vendor's right to appeal errors by the Department in calculating its revised rate and/or the effective date of the revised rate pursuant to sections 58440 through 58448.

(c) Vendors shall not appeal issues pertaining to the audit through the rate appeal process specified in sections 58440 through 58448.

(d) A copy of the written notification and final audit report specified in (b) shall be sent to the vendoring regional center, and utilizing regional center(s), if any, at the same time the original notice and audit report are sent to the vendor. The Department shall provide the vendor, the vendoring regional center, and utilizing regional center(s), if any, with written notification of the results of any audit appeal and revisions, if any, in the vendor's rate and its effective date.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(1)(A) and (a)(2)(A) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsections (a)(1)(A)-(B) and (a)(2)(A)-(B) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Rate Appeals

§58440. General Provisions.

Note • History

(a) A vendor may appeal the following to the Department's Deputy Director who has the responsibility for setting rates:

(1) Errors in service and/or cost and/or vendor income and/or, as applicable, regional center payment information submitted by the vendor which was utilized by the Department to establish the vendor's rate;

(2) Errors by the Department in calculating the vendor's rate, including revised rates based on a final audit report or the results of an appeal of a final audit report;

(3) The effective date of the rate, including revised rates based on a final audit report or the results of an appeal of a final audit report; and/or

(4) A rate adjustment request denied by the Department pursuant to sections 58420 through 58424, except anticipated program changes that were not approved because funding was not appropriated for that purpose.

(b) The vendor shall file the appeal with the Deputy Director within 12 months after the receipt of written notification from the Department of the vendor's rate.

(c) If an appeal is not filed within the time specified, it shall be denied unless good cause pursuant to section 58446 is established for the late submission. Good cause shall be determined by the Deputy Director in accordance with section 58446. If good cause for late submission is established, the Deputy Director shall proceed to decide the appeal in accordance with section 58441.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(1) and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58441. Contents of Appeal and Decision.

Note • History

(a) The appeal filed pursuant to section 58440 shall be in writing and shall include the following:

(1) Vendor service information specified in section 58033 (a)(1) through (4);

(2) Identification of the rate error or effective date being appealed;

(3) The specific basis of the appeal; and

(4) All supporting documentation and any other information necessary to substantiate and/or justify the appeal, including the specific regulation used as the basis for the appeal.

(b) At the time the vendor files the appeal with the Deputy Director, a copy shall be mailed to the vendoring regional center, and utilizing regional center(s), if any.

(c) Within 15 days after receipt of the appeal, the Deputy Director shall review the appeal to determine whether it complies with sections 58440 and 58441 (a).

(1) If all required information has been submitted, the Deputy Director shall render a decision pursuant to (d);

(2) If all required information has not been submitted, and/or additional information is needed, the Deputy Director shall request the additional information, in writing, from the appellant within 15 days after receipt of the appeal. The appellant shall submit the additional information within 15 days after receipt of the request.

(A) If the information is not submitted within the time specified, the appeal shall be deemed withdrawn, and no further action shall be taken unless the appellant establishes good cause, pursuant to section 58446, for the late submission. Good cause shall be determined by the Deputy Director, in accordance with section 58446. If good cause for late submission is established, and the information is submitted, the Deputy Director shall proceed with the appeal and render a decision pursuant to (d);

(B) If the information, is submitted but does not comply with the request, the appeal shall be deemed withdrawn and no further action shall be taken.

(d) The Deputy Director shall render a decision on the appeal within 60 days after receipt of all required and/or requested information. The decision shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is based.

(e) A written copy of the decision shall be mailed to the appellant, the vendoring regional center, and utilizing regional center(s), if any, within 15 days after the decision is rendered.

(f) If the appellant does not appeal the decision to the Director, pursuant to section 58442, it shall be deemed final.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

§58442. Appeal of Deputy Director's Decision.

Note • History

(a) The appellant may appeal the Deputy Director's decision to the Director within 15 days after receipt of the written decision. The appeal shall be in writing and shall include the following:

(1) All information submitted to the Deputy Director pursuant to section 58441(a);

(2) A copy of the Deputy Director's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting authority identifying why the appellant believes the decision of the Deputy Director should be reversed by the Director.

(c) Within 60 days of receipt of all required and/or requested information, the Director or the Chief Deputy Director shall render a decision utilizing the process specified in section 58441 (d).

(d) A written copy of the decision shall be sent to the appellant, the vendoring regional center and utilizing regional center(s), if any, within 15 days after the decision is rendered.

(c) An appeal filed with the Director is the final level of appeal. The decision rendered by the Director or the Chief Deputy Director shall be deemed final.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58444. Effective Date of Decision.

Note • History

The effective date of the decision rendered pursuant to Sections 58441 and 58442 shall be stated in the decision. The effective date shall be the date the Department received the appeal pursuant to Section 58440 or the date the costs are incurred, whichever is later.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58446. Good Cause.

Note • History

(a) For the purposes of sections 58440 through 58444, good cause for a failure to act is limited to:

(1) A violent act of nature, including, but not limited to, flood, earthquake, blizzard or fire; and/or

(2) Arson, vandalism, and/or theft of records and/or property, by individuals other than the appellant, which preclude the appellant from filing a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days after the vendor has notice of the incident giving rise to its claim of good cause, submit to the Deputy Director, or the Director, as appropriate, the basis for its claim of good cause and all supporting documents or other evidence to substantiate its claim. The Deputy Director, Director, Chief Deputy Director, as appropriate, shall, within 30 days of receipt of the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(c) The Deputy Director, Director or Chief Deputy Director, as appropriate, shall notify the appellant in writing of the good cause determination, and shall specify what action will be taken, if any, pursuant to sections 58441 through 58444.

NOTE

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58448. Review of Documents Only.

Note • History

An appeal made pursuant to sections 58440 through 58446 shall be decided only on the documents submitted. There shall be no oral testimony or argument.

NOTE

Authority cited: Section 4690.2, Welfare and Institutions Code. Reference: Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and filed 10-29-90 (Register 90, No. 46).

3. Amendment of forms filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of forms filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of form DS 1897B Instructions filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Editorial correction of form (Register 96, No. 13).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

Subchapter 18. Transportation Service

Article 1. Definitions

§58500. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense. Words used in the singular form include the plural form. Use of the word “shall” denotes mandatory conduct and “may” denotes permissive conduct.

NOTE

Authority cited: Sections 4405 and 4631, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4690 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58501. Definitions.

Note • History

(a) The following definitions shall apply to the regulations contained in this subchapter:

(1) “Basis for Payment” means the method used to calculate and determine the rate of payment;

(2) “Bid” means all the documents submitted by the bidder to the regional center in response to a Request for Proposal (RFP);

(3) “Bidder” means an individual or entity who submits a bid to the regional center in response to an RFP;

(4) “Bidders' Conference” means a meeting held by the regional center after an RFP is issued to respond to questions from potential bidders;

(5) “Bid Form” means that part of the bid which contains the bid price and all supporting cost information;

(6) “Cost Effective” means obtaining the optimum results for the expenditure;

(7) “Rate of Payment” means the price charged to a regional center by a vendor for each unit of service;

(8) “Route Miles” means the number of miles driven, while consumers are in the vehicle, during the provision of transportation service;

(9) “Submit” means the postmarking or hand delivery of the item required;

(10) “Transportation Aide” means a person who assists and monitors regional center consumers while the consumers are receiving transportation service;

(11) “Transportation Service” means the conveyance of a consumer including boarding and exiting the vehicle.

NOTE

Authority cited: Sections 4405, 4631, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(8), (a)(10) and (a)(11) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58502. Terms Defined in Other Subchapters.

Note • History

(a) As used in this subchapter, the following words and phrases have the meanings specified in Subchapter 2, Section 54302.

(1) Authorized Consumer Representative

(2) Community-based Day Programs

(3) Consumer

(4) Department

(5) Individual Program Plan (IPP)

(6) Interdisciplinary (ID) Team

(7) Management Organization

(8) Regional Center

(9) Service Code

(10) Special Incident Report

(11) Subcode

(12) Unit of Service

(13) Vendor

(14) Vendor Identification Number

(15) Vendoring Regional Center

(b) As used in this subchapter, the following words and phrases have the meanings specified in Subchapter 7, Section 57210:

(1) Straight-line Depreciation

(2) Vendor Income

NOTE

Authority cited: Sections 4405, 4631, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (a)(1), repealing subsection (a)(2), renumbering subsections, and adding new subsection (a)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. General Provisions

§58510. General Requirements Applicable to Regional Centers.

Note • History

(a) The regional center shall purchase transportation service only when:

(1) The transportation service is included in the consumer's IPP;

(2) The vendor has a rate approved by the Department or the regional center;

(3) Provision of the transportation service is not the responsibility of any public agency which receives public funds for providing the transportation service;

(4) Provision of the transportation service is not part of the consumer's community-based day program; and

(b) The regional center shall purchase transportation service by using, at its discretion, any of the following processes:

(1) Competitive procurement utilizing a Request for Proposal (RFP) pursuant to Sections 58530 through 58535;

(2) Noncompetitive procurement, which is limited to:

(A) Negotiated rate, pursuant to Section 58540;

(B) Cost statement, pursuant to Sections 58550 through 58555;

(D) Standardized rates pursuant to Section 58542; and

(E) Standard Rate Schedule pursuant to Section 58543.

(1) Establish the level of liability insurance coverage to be obtained by each vendor, for damages for bodily injuries or death and for damages to or destruction of property;

(2) Provide monthly records of services provided to each consumer, including the date, city or county where service was provided, and the number of miles driven, or number of trips provided, by vendor. Units of service for contracts reimbursed other than a per mile, per day, or per trip rate shall also be maintained and reported as specified above. The above information must be submitted to the Department on a monthly basis, and no later than 30 days after the end of the previous month;

(3) At least annually inform the local transportation planning agency designated pursuant to Government Code Section 29532 of the transportation needs of its consumers; and

(4) Determine the necessity for transportation assistant and transportation aide services.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4646 4646.5, 4648, 4648.3, 4690 and 4690.1, Welfare and Institutions Code; and 42 U.S.C. Section 1396m.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of subsections (b)(2)(C) and Note and new subsections (b)(2)(E) and (b)(3) filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency language will be repealed by operation of law on the following day.

3. Amendment of subsections (b)(2)(C) and NOTE and new subsections (B)(2)(E) and (b)(3) refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Change without regulatory effect amending subsections (a)(1), (a)(4), (c)(2) and (c)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

8. Repealer of subsection (b)(3), amendment of subsection (c)(2) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

9. Repealer of subsection (b)(3), amendment of subsection (c)(2) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

10. Repealer of subsection (b)(3), amendment of subsection (c)(2) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

11. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (c)(2), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§58511. Release of Consumer Information.

Note • History

(a) The regional center shall provide, in writing, the consumer information specified in Section 58521(b)(1) through (3) to the following transportation vendors:

(1) Transportation Companies--Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82);

(2) Transportation--Additional Component--Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

(b) If any information specified in Section 58521(b)(1) through (3) changes, the regional center shall;

(1) Notify the vendor of the change within one working day after it learns of the change; and

(2) Provide written confirmation to the vendor any such change within five working days after it learns of the change.

NOTE

Authority cited: Sections 4405, 4631, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending section heading and subsections (a)-(a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58512. Record Retention.

Note • History

(a) The regional center shall retain, for three years after the termination of each contract for transportation service, a copy of the following documentation, as applicable:

(1) The executed contract, if a written contract is required;

(2) The RFP;

(3) Each opened bid;

(4) Documentation indicating the:

(A) Number of bids received;

(B) Number of bids that meet the format and bid submission requirements specified in the RFP;

(D) Names of bidders, and vendor identification number, if any;

(5) Each completed evaluation form and supporting documentation used during the bid evaluation process;

(6) Name and vendor identification number of selected bidder;

(7) Selected bidder's rate of payment and basis for payment;

(8) A copy of any protest received, all documents relating to it, and the resolution of the protest;

(9) The evaluation committee's explanation and supporting documentation for the award of the contract;

(10) For negotiated rate contracts and contracts in which the rate of payment is based on a cost statement:

(A) A written explanation for the selection of the vendor; and

(B) A written analysis showing that transportation service will be provided in a cost-effective manner;

(11) The vendor's insurance policy pursuant to Title 17, California Code of Regulations, Section 54342(a)(78)(C) and (82)(A);

(12) A copy of any contract amendments;

(13) A written explanation of the necessity to amend the contract;

(14) Documentation indicating that the needs of the consumers will appropriately be met;

(15) Documentation showing that the transportation service will be provided in a cost-effective manner; and

(16) The Form DS2 (7/91), entitled Transportation Cost Statement.

NOTE

Authority cited: Sections 4405, 4631, 4648, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648, 4648.3 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (a)(6) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment of section and Note filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58513. General Requirements Applicable to Transportation Service Vendors.

Note • History

(a) The vendor shall comply with Title 17, California Code of Regulations, Sections 54310 through 54390, prior to the regional center purchase of transportation service from the vendor.

(b) The vendor shall not charge regional centers more for providing transportation service to consumers than the vendor charges any other person for the same service.

NOTE

Authority cited: Sections 4405, 4631, 4648, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690 and 4690.1 Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (b) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3. Standards for Transportation Service Vendors

§58520. Standards for Drivers and Transportation Aides.

Note • History

(a) The following vendors shall meet the applicable standards in subsectors (b), (c) and (d) below:

(1) Transportation Companies--Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82);

(2) Transportation--Additional Component--Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

(b) The vendor shall require that each driver and transportation aide:

(1) Is at least 18 years of age; and

(2) Is competent in the use of wheelchairs, hydraulic lifts, ramps and other equipment used for transporting, boarding and exiting consumers from the vehicle, if applicable.

(c) The vendor shall require that each driver has a valid California driver's license pursuant to Vehicle Code Section 12500, and, if applicable, a valid special driver certificate pursuant to Vehicle Code Section 12523.6, and, if applicable, a medical certificate pursuant to Vehicle Code Section 12804.

(d) The vendor shall require that each driver has not been convicted of driving under the influence of alcoholic beverage or any drug or a combination of the two pursuant to Vehicle Code Sections 23152 and 23153 within five years immediately preceding and during employment, or reckless driving, pursuant to Vehicle Code Sections 23103 and 23104, or speed contest pursuant to Vehicle Code Section 23109 within three years immediately preceding and during employment.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631 and 4690, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsections (a)(1), (a)(2) and (b)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

5. Change without regulatory effect amending subsections (c) and (d) and amending Note filed 5-4-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 19).

§58521. Consumer Information.

Note • History

(a) The vendor shall maintain, and keep confidential, the consumer information received from the regional center pursuant to Section 58511.

(b) The vendor shall release the following consumer information only to the driver and only when necessary to protect the health and/or safety of the consumer, driver, transportation aide or other passengers:

(1) The name, address, and telephone number of the consumer, authorized consumer representative and/or physician;

(2) The consumer's disabilities, medication needs, allergies, and/or other conditions which may affect the vendor's provision of transportation services; and

(3) Additional consumer information determined necessary by the regional center.

NOTE

Authority cited: Sections 4405, 4631 and 4690, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4514, 4631 and 4690, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending section heading and section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58522. Refusal to Transport.

Note • History

(a) A vendor may refuse to transport a consumer only if the transportation of the consumer poses a threat to the health and/or safety of the consumer, driver, transportation aide or other passengers.

(b) The vendor shall, within one working day following the refusal to transport the consumer, notify the regional center responsible for the consumer.

(c) The vendor shall, within five working days following the refusal to transport the consumer, submit a written explanation of the refusal to the regional center responsible for the consumer.

NOTE

Authority cited: Sections 4405, 4631 and 4690, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58523. Vendor Records.

Note • History

(a) The following vendors shall retain the records specified in (b) below:

(1) Transportation Companies--Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82);

(2) Transportation--Additional Component--Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

(b) The vendors specified in (a) above shall retain for three years copies of the following records:

(1) Those required for audits pursuant to Title 17, California Code of Regulations, Section 50604;

(2) The contract, if a written contract is required;

(3) Special incident reports pursuant to Title 17, California Code of Regulations, Section 54326(a)(2);

(4) The safety compliance rating issued by the California Highway Patrol pursuant to Title 13, California Code of Regulations, Section 1233;

(5) All maintenance records of vehicles used in providing transportation service to regional center consumers; and

(6) For each driver;

(A) A valid driver's license issued by the Department of Motor Vehicles pursuant to Vehicle Code Section 12500;

(B) A Traffic Point Count as produced by the Department of Motor Vehicles in accordance with Vehicle Code Section 12810; and

NOTE

Authority cited: Sections 4405, 4631 and 4690, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(1), (a)(2) and (b)(5) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58524. Transportation Service Contracts.

Note • History

(a) A contract for transportation service between a regional center and a vendor shall be in writing, except as provided in subsection (b) below, and shall not exceed five years including all amendments.

(b) The following shall not require written contracts:

(1) Temporary transportation service purchased pursuant to Section 58541; or

(2) Transportation service purchased using standardized rates pursuant to Section 58542.

(1) The provisions specified in Title 17, California Code of Regulations, Sections 50607 through 50611;

(2) A provision that the schedules and routes for regional center consumers shall be subject to the approval of the regional center;

(3) The amount of the vendor's liability insurance coverage;

(4) A stipulation that the vendor shall not subcontract any part of the service to be provided without prior written approval of the vendoring regional center;

(5) A stipulation that both parties shall be excused from performance during the time and to the extent that either party is prevented from performing by acts of God, strikes, commandeering of vehicles, materials, products, plants or facilities by the government when evidence thereof is presented to the other party;

(6) A stipulation that the vendor shall not deny services or employment to any person on the basis of religion, color, ethnic group identification, sex, sexual preference, age, physical or mental disability;

(7) A stipulation that the contract is subject to any additional restrictions, or conditions enacted by the Legislature and contained in the Budget Act or any other statute enacted by the Legislature which may affect the provisions, terms or funding of this contract in any manner; and

(8) A stipulation that the contract may be amended as specified in Section 58525.

NOTE

Authority cited: Sections 4405, 4631, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (c)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58525. Transportation Service Contract Amendments.

Note • History

NOTE

Authority cited: Sections 4405, 4631, 4648 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4646, 4648 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (c)(1) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Repealer filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Article 4. Competitive Procurement

§58530. Eligibility Requirements.

Note • History

(a) Entities that are vendored, or meet the requirements for the following types of vendors, shall be eligible to submit a bid through the competitive procurement process:

(1) Transportation Companies--Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82);

(2) Transportation--Additional Component--Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

NOTE

Authority cited: Sections 4405, 4631, 4648, 4690 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648, 4690 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58531. Regional Center Requirements.

Note • History

(a) For each competitive procurement, the regional center shall:

(1) Develop and utilize an RFP pursuant to Section 58533;

(2) Develop a bid form with instructions that shall include a requirements that the form be submitted in a sealed envelope, separate from the remainder of the bid;

(3) Establish an RFP evaluation committee which shall be composed of at least five members, the majority of whom shall have experience in evaluating, procuring, or providing transportation service; and

(4) Develop a written protest procedure which allows unsuccessful bidders to protest the notice of intent to award the contract. This procedure shall specify the:

(A) Format and content of the protest;

(B) Grounds for the protest;

(D) Process and time frame for awarding the contract once the protest has been resolved, as specified in Section 58534(c).

NOTE

Authority cited: Sections 4405, 4631, 4648 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58532. Public Notice of RFP.

Note • History

(a) The regional center shall give public notice of its intent to issue an RFP. The notice shall be published in a newspaper of general circulation in the area for which service is to be provided at least ten, but not more than 90, days before the RFP is issued.

(b) The regional center shall give notice to the following of its intent to issue an RFP by mail within ten days after publication of the notice specified in subsection (a) above:

(1) Providers of transportation service known by the regional center to be operating in the area for which service is to be provided; and

(2) Other individuals or entities that have requested the notification.

(1) Method of obtaining a copy of the RFP;

(2) Date on which the RFP will be available;

(3) Place, date, and time of bidders' conference, if scheduled;

(4) Deadline for submission of bids; and

(5) Place, date, and time of opening the sealed envelopes containing the bid form pursuant to Section 58534(a)(3).

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58533. Contents of RFP.

Note • History

(a) Each RFP shall include:

(1) Background information including a description of the following:

(A) Services provided by the regional center; and

(B) Consumers to be served.

(2) Format and submission requirements including:

(A) Standard format in which the bids shall be submitted;

(B) Instructions on how and where to submit bids;

(D) Place, date, and time of bidders' conference, if scheduled;

(E) Place, date, and time of bid opening;

(F) Bid form developed by the regional center pursuant to Section 58531(a)(2); and

(G) Form DS 1890 (7/90), entitled Vendor Application Form.

(3) The scope of work;

(4) The resources and technical expertise required of bidders;

(5) The criteria necessary to establish the bidders' qualifications, competency, experience, financial resources and business integrity;

(6) The following specifications:

(A) Any requirements for performance bonds or letters of credit;

(B) Liability insurance requirements;

(D) Any requirements for transportation aide services;

(E) Basis for payment; and

(F) A sample contract format.

(7) Evaluation criteria for use by the evaluation committee including:

(A) Basis for determining which bidders meet the criteria specified in subsections (a)(4) and (5) above;

(B) Quality of service;

(D) The process for selection of the successful bidder which shall be based, at the regional center's discretion, on either:

1. The lowest bid; or

2. The highest score using a scoring process with specified criteria which includes a requirement that at least 75% of the total possible score shall be based upon the bid price.

a. The scoring process specified in the RFP must identify the total maximum score possible, each of the criteria for which a score will be assigned and the maximum score possible for each of the criteria.

(E) Composition and qualifications of the RFP evaluation committee pursuant to Section 58531(a)(3).

(F) The regional center shall notify all prospective bidders, in writing at least ten days in advance of the due date for submission of bids, of any additional evaluation criterion which was not included in the RFP and which will be utilized in evaluating bids.

(8) The contract award process as specified in Section 58534; and

(9) A copy of the protest procedure developed in accordance with Section 58531(a)(4).

NOTE

Authority cited: Sections 4405, 4631, 4648 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (a)(1)(B) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58534. Contract Award Process.

Note • History

(a) The regional center's RFP evaluation committee shall complete the following in the sequence indicated:

(1) Review all bids to determine which bids, if any, meet the format and bid submission requirements specified in the RFP;

(2) Review each bid which meets the format and bid submission requirements specified in the RFP to determine which bidders meet the criteria specified in Section 58533(a)(4) and (5);

(3) Open the sealed envelope containing the bid form for each bid that meets the criteria specified in Section 58533(a)(4) and (5) at the time and place stated in the RFP, and read them publicly. Opened bid forms shall be made available for public review;

(4) Evaluate, in writing, each opened bid form pursuant to the process for selection of the successful bidder specified in Section 58533(a)(7)(B); and

(5) Select the bidder who is the successful bidder based upon the specific criteria announced by the regional center in the RFP pursuant to Section 58533(a)(7)(B)(1) and (2).

(b) Within 30 days from the day of opening the sealed envelope containing the bid forms pursuant to (a)(3) above, the regional center shall give public notice of intent to award the contract. The notice shall identify the bidder selected pursuant to (a)(5) above and specify the contract award date. The notice shall be posted in a visible location of the main entrance of the regional center that issued the RFP. The notice shall be posted for ten working days prior to the award and shall be sent to all bidders.

(c) If, prior to the award, any bidder files a written protest in accordance with the protest procedure developed pursuant to Section 58531(a)(4), the regional center shall follow either step (1) or (2) below:

(1) Not award the contract until:

a. The protest has been withdrawn; or

b. The regional center has resolved the protest.

(2) Terminate the RFP process pursuant to (d) below.

(d) The regional center may terminate the contract award process at any time by rejecting all bids submitted. If the RFP process is terminated, the regional center shall:

(1) Notify all bidders in writing within ten working days after the decision to terminate the contract award process; and

(2) Correct the disputed items and rebid the contract utilizing the process specified in Sections 58530 through 58535; or

(3) Allow all interested bidders to participate in the negotiated rate contract process.

(e) Pending resolution of a dispute and/or award of a contract, if the regional center determines that the health or safety of a consumer(s) is in jeopardy and no current vendor is available to provide the needed transportation service, the regional center may approve emergency vendorization utilizing the process specified in Section 54324, except the emergency vendorization may be approved for a maximum of 60 days. The emergency vendorization shall lapse if the vendor application is not properly submitted or if the regional center does not approve the application within 60 days of the initial authorization.

(f) All bids with unopened bid forms shall be returned to the respective bidder after the contract is awarded.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of section and Note filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58535. Reporting Requirements for Competitive Process. [Repealed]

Note • History

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Repealer filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Article 5. Noncompetitive Procurement

§58540. Negotiated Rates.

Note • History

(1) Transportation Companies - Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82); or

(2) Transportation - Additional Component - Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

(3) Transportation Broker - Service Code 883, pursuant to Title 17, California Code of Regulations, Section 54342(a)(81).

(b) The proposed rate negotiated between the regional center and the vendor shall not be subject to the review and approval of the Department.

(1) A written explanation for the selection of the vendor; and

(2) A written analysis showing that transportation service will be provided in a cost-effective manner.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631, 4690.1 and 4791(i), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. New subsection (a)(3) and amendment of Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

3. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

4. Change without regulatory effect amending subsections (a)(1)-(a)(3) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

5. Amendment of subsections (b)-(c), repealer of subsections (c)(1) and (d)-(f) and subsection renumbering filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58541. Temporary Provision of Transportation Services.

Note • History

(a) When transportation service is terminated because of unforeseen circumstances, the regional center may purchase transportation service including transportation aide service, if any, from an individual or entity eligible to be vendored as:

(1) Transportation Companies - Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82);

(2) Transportation - Additional Component - Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78);

(3) Transportation Auto Driver - Service Code 890, pursuant to Title 17, California Code of Regulations, Section 54342(a)(80);

(4) Transportation - Public Transit Authority, Dial-a-ride, Rental Car Agency or Taxi - Service Code 895, pursuant to Title 17, California Code of Regulations, Section 54342(a)(84); or

(5) Miscellaneous service provider to purchase bus passes, taxi rides, or other transportation services for regional center consumers, including vehicle rental.

(b) The rate of payment for transportation service provided on a temporary basis shall be determined by the regional center and shall meet the following standards:

(1) The transportation service will be provided in a cost-effective manner;

(2) For those vendors specified in subsection (a)(1) above, the rate shall not exceed the amount the vendor charges to the general public; and

(3) For those vendors specified in subsections (a)(3) and (4) above, the rate shall be determined in accordance with Section 58542.

(d) The regional center shall maintain, pursuant to Section 58512, the following information:

(1) An explanation of the circumstances that resulted in the need to purchase transportation service on a temporary basis;

(2) The rate and duration of payment; and

(3) The vendor name and identification number.

(e) The rate of payment for transportation service provided on a temporary basis shall not be subject to the review and approval of the Department.

NOTE

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of subsections (a)(3)-(4) and Note filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

3. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

4. Change without regulatory effect amending subsections (a)(1)-(a)(5) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

5. Amendment of subsections (a)(3)-(4) and (d), repealer of subsections (e)-(e)(4) and subsection relettering filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58542. Standardized Rates.

Note • History

(a) Transportation Assistant - Service Code 882, as described in Title 17, California Code of Regulations, Section 54342(a)(79), shall be paid a rate in accordance with the vendor's usual and customary rate.

(b) Transportation - Medical - Service Code 885, as described in Title 17, California Code of Regulations, Section 54342(a)(83), shall be paid in accordance with the Schedule of Maximum Allowances (SMA).

(c) Transportation - Public Transit Authority, Dial-A-Ride, Rental Car Agency, or Taxi - Service Code 895, pursuant to Title 17, California Code of Regulations, Section 54342(a)(84) shall be paid at a rate or fare not to exceed the amount charged to the general public for the same service.

(d) Transportation Auto Drivers - Service Code 890, pursuant to Title 17, California Code of Regulations, Section 54342(a)(80) shall be paid on a per mile basis at a rate not to exceed the travel rate paid by the regional center to its own employees.

(e) Persons who are vendored as miscellaneous service providers by the regional center to purchase bus passes, taxi rides, or other transportation services for regional center consumers, including vehicle rental, shall be paid at a rate not to exceed the rate charged to the general public for those services or rental vehicles.

(f) The rate of payment for transportation services established pursuant to Subsections (a) through (c) above, shall not be subject to the review and approval of the Department.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631, 4690.1 and 4791, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4690.1 and 4791, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

4. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

6. Amendment of subsections (b)-(d) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

8. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

§58543. Standard Rate Schedule.

Note • History

(a) A regional center may enter into a contract for the provision of transportation service in which the rate of payment, including the rate for transportation aide services, if any, is based upon a Standard Rate Schedule (SRS). The regional center may enter into such contracts only with an individual or entity vendored as a Transportation -- Additional Component -- Service Code 880, pursuant to Section 54342(a)(78), Transportation -- Auto Driver -- Service Code 890, pursuant to Section 54342(a)(80), Transportation -- Family Member -- Service Code 425, pursuant to Section 54355(g)(5), or Participant-Directed Transportation -- Family Member -- Service Code 470, pursuant to 58886(e)(4).

(1) The SRS shall be established by the regional center based upon the cost effectiveness of providing specific transportation services. The regional center shall also adopt a Standardized Contract, to be used with the SRS, which complies with Sections 58500 through 58525 of these regulations;

(2) The regional center shall submit the proposed SRS, the Standardized Contract, and a written explanation of the cost effectiveness of the SRS and Standardized Contract to the Department for review and approval. Within 30 days after receipt of the information, the Department shall:

(A) Review the information and approve the SRS and Standardized Contract only upon a showing by the regional center that the transportation service, procured pursuant to the SRS and Standardized Contract, will be provided in a cost-effective manner and that the Standardized Contract complies with Sections 58500 through 58525 of these regulations;

(B) Notify the regional center of the approval or denial of the SRS and Standardized Contract. If approved, the notification shall include the effective date of the SRS or, if denied, the reason for the denial.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405, 4631, 4648.12(c)(1)(B) and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648.12(c) and 4690.1, Welfare and Institutions Code.

HISTORY

3. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsection (a) filed 6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order, including amendment of subsection (a), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsection (a) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsection (a) and Note filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

Article 6. Noncompetitive Procurement Based on Cost Statement

§58550. Cost Statement.

Note • History

(a) A regional center may enter into a contract for the provision of transportation service in which the rate of payment is based on a cost statement. The regional center may enter into such contracts only with an entity vendored or eligible to be vendored as either:

(1) Transportation Companies - Service Code 875, pursuant to Title 17, California Code of Regulations, Section 54342(a)(82); or

(2) Transportation Additional Component - Service Code 880, pursuant to Title 17, California Code of Regulations, Section 54342(a)(78).

(b) The rate of payment based on a cost statement shall be effective for at least one year. If the term of the contract exceeds one year, the rate shall be effective for the full term of the contract unless amended.

(c) When a proposed contract for transportation service is based on a cost statement, the vendor shall submit Form DS2 (7/91), entitled Transportation Cost Statement, to the regional center. Within 30 days after receipt of Form DS2 (7/91) from the vendor, the regional center shall:

(1) Review the Form DS2 (7/91) for compliance with Sections 58551, 58552, 58553 and 58555 of these regulations; and

(2) Calculate a proposed rate of payment pursuant to Section 58554, based on the information contained on the Form DS2 (7/91).

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment of subsection (b) and repealer of subsections (c)(3)-(f) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58551. Vendor Information.

Note • History

(a) The vendor shall submit the following information to the regional center on the Form DS2 (7/91), entitled Transportation Cost Statement:

(1) Vendor name;

(2) Business telephone number;

(3) Vendor identification number;

(4) Service code and subcode;

(5) Business and mailing addresses;

(6) Name of management organization, if any;

(7) Name and telephone number of the contact person;

(8) Name of the vendoring and contracting regional center;

(9) Proposed effective date of service; and

(10) Signature of the vendor or designee and the date signed.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58552. Cost Information.

Note • History

(a) The vendor shall submit the following information for the projected allowable costs for a 12 month period to the regional center on the Form DS2 (7/91), entitled Transportation Cost Statement, if the costs will be incurred by the vendor and are necessary for the provision of transportation service:

(1) Salary and wage expense which shall include:

(A) Total gross salaries and wages, including overtime; and

(B) Cash outlays for employees' accrued vacation.

(2) Fringe benefit costs which shall be limited to the following:

(A) Old Age Security Disability Insurance (OASDI) or Federal Insurance Compensation Act (FICA);

(B) Workers' Compensation;

(D) Life insurance;

(E) Health insurance;

(F) Dental insurance;

(G) Retirement;

(H) Vision insurance;

(I) Employee Training Tax as specified in the California State Unemployment Insurance Code Section 976.6; and

(J) Long-term disability insurance.

(3) Operating expenses which shall not duplicate other projected allowable costs and shall be limited to the following cost categories:

(A) Accounting fees of the vendor for the establishment and maintenance of accounting records and other information systems required for the fiscal management of the vendored service;

(B) Bank service fees of the vendor;

(C) Communication costs for services including telephone, telegraph, teletype, centrex, telepak, postage, message services, facsimiles and Telecommunications Devices for the Deaf (TDD);

(D) Contractual/consultant fees for transportation service operations that do not have a specific cost category;

(E) Depreciation costs, except for vehicles which are covered under subsection (a)(6) below. The following items shall be depreciated using the straight-line depreciation method and the useful life of the item. The useful life of an item shall be the same as that which is used for federal tax purposes.

1. Facilities or buildings purchased by the vendor, which are directly related to providing transportation services to regional center consumers;

2. Furniture and equipment which has been purchased by the vendor, and is associated with the provision of transportation services to regional center consumers, has a unit acquisition cost of at least $500 and a normal useful life of at least four years; and

3. Capital improvements that add to the value or useful life of the building, facility or equipment. Capital improvements shall be treated as a permanent investment to be added to the cost basis of the building or equipment and charged to depreciation.

(F) General expense costs for the following items, only if projected to be incurred as a result of providing transportation services to regional center consumers:

1. Furniture and equipment which do not meet the criteria specified in subsection (E)2. above;

2. Interest on loans attributable to the vendored service;

3. Subscriptions for periodicals which are used in the operation of the transportation services or for the purpose of staff development;

4. Staff recruitment costs including:

a. Staff screening costs, such as fingerprinting prospective employees; and

b. Staff hiring costs which shall include the costs for physical examinations or other health and safety costs that may be required prior to employment.

5. Fees for licenses, certifications, registrations or permits, if necessary for vendorization or the continued operation of the transportation service subsequent to vendorization;

6. Association dues or fees;

7. Costs for providing or preparing information requested by the regional center which is related to the transportation service and is used as general information to the consumers or to the authorized consumer representatives;

8. Local business fees or taxes;

9. Costs related to inoculations or clinical tests of an employee, for the employee's or consumer's health and safety; and

10. Fuel and oil.

(G) Janitorial fees;

(H) Legal fees;

(I) Office supply costs;

(J) Rental and lease costs. On a lease-purchase, while the item is being leased, the cost shall be reported under this category. When the option-to-purchase has been exercised, the residual value of the item shall be depreciated and shall be reported, as applicable, under subsection (E). Rental and lease costs shall apply to the following items:

1. Furniture and equipment;

2. Buildings and terminals; and

3. Vehicles.

(K) Staff training costs for in-service training and employee development which are related to transportation service;

(L) Staff travel costs which are specifically related to the administration of the transportation service;

(M) Utility costs such as gas, electricity, water, garbage, and sewer fees.

(4) Insurance costs which shall include all projected costs for liability insurance associated with conducting the transportation service. Insurance costs shall not include any cost specified in subsections (2)(A) through (J) above;

(5) Maintenance costs which shall include costs for repair or upkeep of furniture, equipment, vehicles, buildings or grounds when the repair or upkeep does not add to the permanent value but maintains the item in an efficient operating condition;

(6) Vehicle depreciation costs for vehicles owned by the vendor which shall be calculated by using the straight-line depreciation method and the minimum normal service life specified below. Vehicles which have been purchased using a combination of funds obtained through Section 16(b) 2 of the Urban Mass Transportation Act of 1964, 49 United States Code, Section 1612(b), and funds from the vendor, shall only be depreciated for the portion of the costs incurred by the vendor. The minimum service life for:

(A) Standard size heavy duty (approximately 35' - 40') transit buses is at least 12 years of service or an accumulation of at least 500,000 total miles on the vehicle;

(B) Medium size heavy duty (approximately 30') transit buses is at least ten years of service or an accumulation of at least 350,000 total miles on the vehicle;

(C) Small size heavy duty (under 30') transit buses is at least seven years of service or an accumulation of at least 200,000 total miles on the vehicle. A 16-passenger bus shall be considered a small medium duty transit bus and not a van; and

(D) Other vehicles such as regular and specialized vans and cars is at least four years of service or an accumulation of at least 100,000 total miles on the vehicle.

(7) Management organization costs which:

(A) Shall include the vendor's prorated portion of the projected allowable costs specified in subsections (a)(1) through (6) above.

(B) Shall not include:

1. More than 100 percent of the allocated costs of the management organization costs;

2. Costs applicable to or claimed by other services operated by the vendor.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(3)(E)1.-2., (a)(3)(F), (a)(3)(F)7. and (a)(3)(F)9. filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 3).

3. Amendment of subsections (a)(3)(F)2. and (a)(6)(A)-(C), redesignation of subsections (a)(7)(B)(1)-(2) to (a)(7)(B)1.-2. and amendment of newly designated subsection (a)(7)(B)2. filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58553. Vendor Income Information.

Note • History

(a) The vendor shall submit the following projected vendor information, for all income related to the transportation service being provided to the regional center on the Form DS2 (7/91), entitled Transportation Cost Statement:

(1) The name of each vendor income source;

(2) The duration of projected vendor income from each source; and

(3) The total amount of projected vendor income from each source.

(b) Vendor income shall not include:

(1) Donations;

(2) Income received form the Department or regional centers.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58554. Rate Calculation Based on Cost Statement.

Note • History

(a) A rate of payment based on a cost statement is computed using the following:

(1) Step One in the process is to compute a total amount for annual projected allowable costs by adding together the costs identified in Section 58552 which were reported by the vendor Form DS2 (7/91), entitled Transportation Cost Statement;

(2) Step Two in the process is to compute a total amount for annual projected vendor income identified in Section 58553 which were reported by the vendor on Form DS2 (7/91), entitled Transportation Cost Statement;

(3) Step Three in the process is to determine the annual net cost by subtracting the amount computed in Step Two from the amount computed in Step One; and

(4) Step Four in the process is to compute the rate of payment by dividing the annual net cost determined in Step Three by the total number of annual route miles which were reported by the vendor on Form DS2 (7/91), entitled Transportation Cost Statement.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58555. Rate of Payment for Transportation Aide Services.

Note • History

(a) When the regional center requires a transportation service vendor to employ a transportation aide, the rate of payment for transportation aide service shall be limited to the following hourly expenses as reported on the Form DS2 (7/91), entitled Transportation Cost Statement:

(1) Salary and wage expense pursuant to Section 58552(a)(1);

(2) Fringe benefit costs pursuant to Section 58552(a)(2); and

(3) Training costs pursuant to Section 58552(a)(3)(K).

(b) The regional center shall pay for transportation aide service on an hourly basis. The hourly rate for transportation aide service shall be computed by adding the hourly expenses reported in subsections (a)(1) and (a)(2) to the hourly expenses reported in subsection (a)(3) above.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

Article 7. Appeals

§58560. General Provisions.

Note • History

(a) A vendor may appeal the following decisions of the director of the contracting regional center to the Department's Deputy Director who has responsibility for setting rates:

(1) Denial of a request for an amendment to a written contract;

(2) Denial of a proposed rate based on a cost statement;

(3) Denial of a proposed negotiated rate; and/or

(4) Denial of a proposed contract based on noncompliance with Sections 58513 through 58524 or Sections 58540 through 58555 of these regulations.

(b) The vendor shall file the appeal with the Deputy Director within 30 days after the receipt of written notification of the regional center director's denial specified in (a)(1) through (3) above.

(c) If an appeal is not filed within the time specified, it shall be denied unless good cause pursuant to Section 58564 is established for the late submission. Good cause shall be determined by the Deputy Director in accordance with Section 58564. If good cause for late submission is established, the Deputy Director shall decide the appeal in accordance with Section 58561.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of subsections (a), (a)(4) and (b) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§58561. Contents of Appeal and Decision.

Note • History

(a) The appeal filed pursuant to Section 58560 shall be in writing and shall include the following:

(1) The vendor's:

(A) Name, business address, and telephone number; and

(B) Vendor identification number, service code and subcode.

(2) Identification of the denial being appealed;

(3) The specific basis of the appeal; and

(4) All supporting documentation and any other information necessary to substantiate and/or justify the appeal including the specific regulation used as the basis for the appeal.

(b) At the time the vendor files the appeal with the Deputy Director, a copy shall be mailed to the contracting regional center.

(c) Within 15 days after receipt of the appeal, the Deputy Director shall review the appeal to determine if all required documentation has been submitted and that the appeal complies with Sections 58560 and 58561.

(1) If all required documentation has been submitted, the Deputy Director shall render a decision pursuant to subsection (d) below;

(2) If all the required documentation has not been submitted and/or additional documentation is needed, the Deputy Director shall request the additional information in writing from the vendor within 15 days after receipt of the appeal. The vendor shall submit the additional information within 15 days after receipt of the Deputy Director's request.

(A) If the vendor fails to submit the additional information within the time specified, the appeal shall be deemed withdrawn and no further action shall be taken unless the vendor establishes good cause for late submission pursuant to Section 58564 of this article. Good cause shall be determined by the Deputy Director, in accordance with Section 58564. If good cause for late submission is established and the additional information is submitted as requested by the Deputy Director, the appeal process shall resume and the Deputy Director shall render a decision pursuant to subsection (d) below;

(B) If the additional information submitted by the vendor does not comply with the request the appeal shall be deemed withdrawn and no further action shall be taken.

(d) The Deputy Director shall render a decision on the appeal within 60 days after receipt of all required and/or requested information. The decision shall:

(1) Identify the name and address of the vendor(s);

(2) Identify the specific issue(s) in dispute;

(3) Rule on each issue identified;

(4) State the facts supporting each ruling; and

(5) Identify the statutes and regulations upon which each ruling is based, if applicable.

(e) A written copy of the decision shall be mailed to the vendor and the contracting regional center within 15 days after the decision is rendered.

(f) I the vendor does not appeal the decision to the Director, pursuant to Section 58562, it shall be deemed final.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58562. Appeal of Deputy Director's Decision.

Note • History

(a) The vendor may appeal the Deputy Director's decision to the Director within 15 days after receipt of the written decision. The appeal shall be in writing and shall include the following:

(1) All information submitted to the Deputy Director pursuant to Section 58561(a);

(2) A copy of the Deputy Director's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting authority identifying why the vendor believes the decision of the Deputy Director should be reversed by the Director.

(c) Within 60 days after receipt of all required and/or requested information, the Director or the Chief Deputy Director shall render a decision pursuant to Section 58561(d).

(d) A written copy of the decision shall be sent to the contracting regional center and the vendor within 15 days after the decision is rendered.

(e) An appeal filed with the Director is the final level of appeal. The decision rendered by the Director or the Chief Deputy Director shall be deemed final.

NOTE

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58563. Effective Date of Decision.

Note • History

(a) The effective date shall be stated in the decision and shall be:

(1) For the appeal of a denial of a request for amendment to a written contract, no earlier than the date the Department received the request for amendment;

(2) For the appeal of a denial of a proposed rate based on a cost statement, no earlier than the date the Form DS2 (7/91), entitled Transportation Cost Statement, was received by the Department; or

(3) For the appeal of a denial of a negotiated rate, no earlier than the date the information specified in 58540(c)(1) thru (3) was received by the Department.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

§58564. Good Cause.

Note • History

(a) For the purposes of Sections 58560 through 58563, good cause for a failure to acts limited to:

(1) A violent act of nature, including, but not limited to, flood, earthquake, blizzard or fire; or

(2) Arson, vandalism, and/or theft by individuals other than the vendor which preclude the vendor from filing a timely appeal.

(b) The vendor shall, within 60 days after receipt of the notice of the incident giving rise to its claim of good cause, submit to the Deputy Director or the Director, whichever is appropriate, the basis for its claim of good cause and all supporting documents or other evidence to substantiate its claim. The Deputy Director, Director or Chief Deputy Director, whichever is appropriate, shall within 30 days after receipt of the claim and supporting documentation, review the information and render a decision regarding whether good cause has been established.

(c) The Deputy Director, Director or Chief Deputy Director, whichever is appropriate, shall notify the vendor in writing of the good cause determination and shall specify what action shall be taken, if any, pursuant to Sections 58561 through 58563.

NOTE

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

§58565. Review of Documents Only.

Note • History

(a) An appeal made pursuant to Sections 58560 through 58565 shall be decided only on the documents submitted. There shall be no oral testimony or argument.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

Article 8. Transitory Provisions

§58570. General Provisions.

Note • History

(a) A contract for transportation serviced which was executed before the effective date of these regulations shall:

(1) Remain in effect unless it is terminated pursuant to the contract provisions or pursuant to subsection (3) below;

(2) Not be amended after the effective date of these regulations; and

(3) Be terminated by agreement of the parties.

NOTE

Authority cited: Sections 4405, 4631 and 4690.1, Welfare and Institutions Code and Section 11152, Government Code. Reference: Sections 4631 and 4690.1, Welfare and Institutions Code.

HISTORY

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code section 11346.2(d) (Register 92, No. 10).

Transportation Cost Statement - Page 1 Instructions

Instructions

Line Reference

1. Enter the vendor name and telephone number. 58551 (a)(1)(a)(2)

2. Enter vendor identification number, service code ad subcode. 58551 (a)(1)(a)(4)

3. Enter the address where the service is located. 58551 (a)(5)

4. Enter the mailing address of the service. 58551 (a)(5)

5. Enter the management organization name if the service is affiliated with a management organization. 58551 (a)(6)

6. Enter the name and telephone number of the contact person. 58551 (a)(7)

7. Enter the name of the vendoring regional center. 58551 (a)(8)

8. Enter the names of the contracting regional centers for which you provide service. 58551 (a)(8)

9. Enter the effective date of service. 58551 (a)(9)

10-16. On Lines 10-16, enter the projected costs for these items 58552 (a)(1)

through (a)(7)

17. To determine the subtotal, add all projected costs for line items 10-16, and enter on this line. 58554 (a)(1)

18. Enter the total vendor income from page 2, Section A, on this line. 58554 (a)(2)

19. To determine the annual net cost, subtract the vendor income, if any (line 18) from the subtotal of the 58554 (a)(3)

projected costs (line 17). Enter this amount on line 19 and on page 2, Section B, under annual net cost.

Instructions

Section Reference

A Enter information on vendor income received, including name of each source, duration of income, and 58533

amount of income received from each source. Add these amounts, and enter the total on page 1, line 18.

B To establish the proposed rate of payment, divide the annual net cost by the projected number of annual 58554 (a)(4)

route miles anticipated to be driven. The quotient shall be the proposed rate of payment.

C To determine the hourly rate of pay for Transportation Aides, add the hourly salaries and wages, hourly 58555 (a)

fringe benefits and hourly training cost. through (b)

Subchapter 19. Supported Living Service

Article 1. Definitions

§58600. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense. Words used in the singular form include the plural form. Use of the word “shall” indicates conduct that is required, and “may” indicates conduct that is permitted.

NOTE

Authority cited: Section 11152, Government Code; Sections 4689 and 4690, Welfare and Institutions Code. Reference: Section 4689, Welfare and Institutions Code.

HISTORY

1. New subchapter 19, article 1 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New subchapter 19, article 1 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New subchapter 19, article 1 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58601. Definitions.

Note • History

(a) The following definitions shall apply to the regulations contained in Subchapter 19:

(1) “Circle of Support” means an informal but identifiable and reliable group of people who, pursuant to Welfare and Institutions Code, Section 4512(f), meet and communicate regularly to offer support, at a frequency and in a manner consistent with and appropriate to the need, to the consumer for whose benefit it exists.

(2) “Direct Service(s)” means any service component enumerated in Section 58614.

(3) “Home” means, with respect to the home of a consumer receiving SLS, a house or apartment, or comparable dwelling space meeting community housing standards, which is neither a community care facility, health facility, nor a family home certified by a Family Home Agency, and in which no parent or conservator of the consumer resides, and which a consumer chooses, owns or rents, controls, and occupies as a principal place of residence.

(4) “Individual Program Plan (IPP)” means a written plan that is developed jointly by the consumer, one or more representatives of the regional center, and other persons pursuant to Welfare and Institutions Code, Section 4646(d), through a process which identifies the consumer's needs and preferences and adopts a cost-effective strategy for meeting them.

(5) “Internal Grievance Procedure” means the written set of procedures, established pursuant to Welfare and Institutions Code, Section 4705(a), a SLS vendor uses to achieve the communication and resolution of consumer dissatisfaction.

(6) “Personal Advocate” means a person chosen by the consumer to assist in representing and expressing the consumer's interests and preferences, or, when appropriate, means the conservator or other person legally authorized to act on the consumer's behalf.

(7) “Supported Living Arrangement” means the full array of regional center-funded services and supports received by a SLS consumer, including SLS, day program, transportation, and all other regional center services and supports.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648(a)(3), 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4648, 4689 and 4689.7(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Repealer of subsection (a)(2), subsection renumbering, amendment of newly designated subsections (a)(2)-(3) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58602. Terms Defined in Other Subchapters.

Note • History

(a) As used in this subchapter, the following terms have the meanings specified in Title 17, Section 50401:

(1) Department; and

(2) Regional Center.

(b) As used in this subchapter, the following terms have the meanings specified in Title 17, Section 50501:

(1) Community Care Facility; and

(2) Health Facility.

(1) Developmental Disability.

(d) As used in this subchapter, the following terms have the meanings specified in Title 17, Section 54302:

(1) Applicant;

(2) Consumer;

(3) Generic Support(s);

(4) Natural Supports;

(5) Service Design;

(6) Service Code;

(7) Special Incidents;

(8) Supported Living Service;

(9) Vendor; and

(10) Vendorization.

(e) As used in this subchapter, the following term has the meaning specified in Title 17, Section 56076(e):

(1) Family Home;

(2) Family Home Agency (FHA);

(3) Relative.

(f) As used in this subchapter, the following term has the meaning specified in Title 17, Section 58501:

(1) Cost Effective.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4689 and 4689.7(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including new subsections (d)-(e)(1), transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Editorial correction of Note (Register 97, No. 21).

6. New subsections (b)-(b)(2), subsection relettering, amendment of newly designated subsection (e)(1), new subsections (e)(2)-(3) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

Article 2. General Provisions

§58610. Regional Center Responsibilities.

Note • History

(a) Regional centers shall purchase SLS as defined in Title 17, Section 54349(a) through (e), only:

(1) From a SLS vendor; and

(2) Pursuant to a written contract as specified in Sections 58670, 58671, and 58672.

(b) The regional center shall make available to any consumer and, as appropriate, to any consumer's family members relevant and understandable information aimed at enhancing the recipients' general understanding of SLS and ability to make informed choices.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4685(c)(5), 4689(d) and 4689.7(c), Welfare and Institutions Code.

HISTORY

1. New article 2 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 2 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 2 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsections (b)-(c), new subsections (c)(1)-(3) and amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsection (a), repealer of subsections (c)-(c)(3) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58611. Housing Financial Involvement and Responsibilities.

Note • History

(a) A SLS vendor shall have no financial or fiduciary involvement in the home, or in any utility or service contract integral to the occupancy of the home, of a consumer to whom the SLS vendor provides services, whenever such involvement would inhibit the consumer's exercise of the rights enumerated in Section 58620, or be inconsistent with any requirement of Welfare and Institutions Code, Section 4689.

(1) Whenever a vendor proposes to have a financial or fiduciary involvement specified in (a), the vendor shall present the proposal in writing to the regional center. The proposal shall assure and demonstrate to the regional center's satisfaction, that:

(A) The involvement would serve the interests of the consumer better than a range of available alternatives;

(B) The consumer understands and approves of the vendor's proposed involvement; and

(b) The regional center shall not pay any costs incurred by a consumer receiving SLS in securing, occupying, or maintaining a home rented, leased, or owned by the consumer except when the executive director of the regional center has determined that:

(1) Payment of the cost would result in savings to the State with respect to the cost of meeting the consumer's overall services and supports needs;

(2) The costs can not be paid by other means, including available natural or generic supports; and

(3) The costs are limited to:

(A) Rental or utility security deposits;

(B) Rental or lease payments;

(D) Moving fees; and

(E) Non-adaptive and/or non-assistive household furnishings, appliances, and home maintenance or repair costs.

NOTE

Authority cited: Section 11152, Government Code; Sections 4689 and 4690, Welfare and Institutions Code. Reference: Section 1505(l), Health and Safety Code; and Sections 4512(b), 4620.1, 4689(a), 4689(b) and 4791(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsections (b)-(b)(3), new subsections (b)(3)(A)-(E), repealer of subsections (b)(4)-(10) and amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58612. Vendor Status Requirements.

Note • History

(a) A regional center shall grant initial SLS vendor status to an applicant for vendorization if the applicant:

(1) Meets all applicable general vendorization requirements specified in Title 17, Sections 54310 through 54330 with the exception specified in Section 58630(d), and also meets the additional requirements specified in Articles 4 through 6 of this subchapter, or

(2) Has provided direct services and supports which the regional center has identified as being the equivalent of, or essentially similar to SLS, immediately proceeding the effective date of this regulation.

(b) An applicant granted SLS vendor status pursuant to (a)(2) shall meet all requirements of (a)(1) not later than one year after the effective date of this regulation.

(1) The regional center shall terminate vendor status for a vendor failing to meet the requirements of (a)(1) without good cause.

NOTE

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of section and Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58613. Consumer Eligibility Determination.

Note • History

(a) A consumer shall be eligible for SLS upon a determination made through the IPP process that the consumer:

(1) Is at least 18 years of age;

(2) Has expressed directly or through the consumer's personal advocate, as appropriate, a preference for:

(A) SLS among the options proposed during the IPP process; and

(B) Living in a home that is not the place of residence of a parent or conservator of the consumer.

(b) Consumers shall not be denied eligibility for SLS solely because of the nature and severity of their disabilities.

NOTE

Authority cited: Section 11152, Government Code; Sections 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4512(b), 4646(b) and 4689(a)(8), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58614. Service and Support Components.

Note • History

(a) Supported Living Service, as referenced in Title 17, Section 54349(a) through (e), shall consist of any individually designed service or assessment of the need for service, which assists an individual consumer to:

(1) Live in his or her own home, with support available as often and for as long as it is needed;

(2) Make fundamental life decisions, while also supporting and facilitating the consumer in dealing with the consequences of those decisions; building critical and durable relationships with other individuals; choosing where and with whom to live; and controlling the character and appearance of the environment within their home.

(b) Supported Living Service(s) are tailored to meet the consumer's evolving needs and preferences for support without having to move from the home of their choice, and include but are not limited to the following:

(1) Assisting with common daily living activities such as meal preparation, including planning, shopping, cooking, and storage activities;

(2) Performing routine household activities aimed at maintaining a clean and safe home;

(3) Locating and scheduling appropriate medical services;

(4) Acquiring, using, and caring for canine and other animal companions specifically trained to provide assistance;

(5) Selecting and moving into a home;

(6) Locating and choosing suitable house mates;

(7) Acquiring household furnishings;

(8) Settling disputes with landlords;

(9) Becoming aware of and effectively using the transportation, police, fire, and emergency help available in the community to the general public;

(10) Managing personal financial affairs;

(11) Recruiting, screening, hiring, training, supervising, and dismissing personal attendants;

(12) Dealing with and responding appropriately to governmental agencies and personnel;

(13) Asserting civil and statutory rights through self-advocacy;

(14) Building and maintaining interpersonal relationships, including a Circle of Support;

(15) Participating in community life; and

(16) 24-hour emergency assistance, including direct service in response to calls for assistance. This service also includes assisting and facilitating the consumer's efforts to acquire, use, and maintain devices needed to summon immediate assistance when threats to health, safety, and well-being occur.

(c) Supported Living Service Vendor Administration, as referenced in Title 17, Section 54349(e), shall include, but is not limited to, the following:

(1) Administrative functions;

(2) Rental or leasing of administrative office(s) space;

(3) Office furniture, supplies, and equipment;

(4) Travel designated in the SLS vendor's contract as necessary for the performance of administrative functions;

(5) Accounting;

(6) Insurance designed to protect against loss by theft, fire, and similar calamities; professional liability; and automobile accident liability; and

(7) Discretionary background checks for paid staff, volunteers, and contractors as specified in the SLS vendor's contract.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648, 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4648(a)(2), 4689(c) and 4689.7(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of section and Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58615. Service Records.

Note • History

(a) SLS vendors shall maintain, and provide access to, records pursuant to all applicable requirements of Title 17, Sections 50603, 50604, and 50605.

(b) In addition to the requirements noted in (a), all SLS vendors shall maintain and provide access to all records relating to service design, service delivery, and employee service time records. These records shall include the following:

(1) Time sheets;

(2) Payroll records;

(3) Accounting records;

(4) Training records;

(5) Service evaluations;

(6) Internal grievance procedure records;

(7) Historical data documenting the actual delivery of service to consumers for which the SLS vendor has claimed payment, including the:

(A) Identification of the vendor by unique identifier;

(B) Location of the service;

(D) Inclusive dates of the service; and

(8) Other records as required by:

(A) The terms of the contract; and

(B) The regional center, for the purpose of conducting the evaluations specified in Sections 58671(c).

NOTE

Authority cited: Section 11152, Government Code; Sections 4648 and 4690, Welfare and Institutions Code. Reference: Sections 4648.1(a), 4648.1(b) and 4659(a)(1), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Editorial correction of Note (Register 97, No. 21).

§58616. Additional General Provisions.

Note • History

(a) A consumer shall have the right to qualify for SLS vendorization and to serve as his/her own SLS vendor.

(b) No relative or conservator of a consumer shall serve as the SLS vendor for that consumer except when a determination has been made through the IPP process that:

(1) Unpaid family-based, or other natural supports for the consumer will not be supplanted;

(2) Such service is consistent with the consumer's IPP goals and objectives;

(3) The relative or conservator proposing to serve as the SLS vendor has no legal obligation to support the consumer;

(4) The consumer's preference is for that relative or conservator to serve as the SLS vendor; and

(5) The service will be at least as cost effective as any available alternative.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648, 4688, 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4648.1(d), 4659(a), 4688(b)(5) and 4689(a)(1), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58617. Supported Living Arrangement Costs.

Note • History

(a) Before SLS is provided to a consumer, the projected annual cost of the consumer's SLA, as determined through the consumer's IPP process, shall not exceed the total annual cost of regional center funded services and supports that would be provided if the consumer were served in an appropriate licensed residential facility, as identified through the IPP process, provided:

(1) The total annual cost of services and supports shall include all regional center costs for residential placement (or costs incurred by the State for 24-hour long-term health care), community-based day program, transportation, and other services and supports; and

(2) The appropriate licensed facility for a consumer who is living in a licensed facility at the time of the cost comparison shall be that licensed facility.

(b) Notwithstanding (a), when the consumer does not reside in a licensed facility the projected annual cost of a consumer's SLA shall be deemed to have met the requirements of (a) when the cost is within the range of annual costs of SLAs for other consumers with comparable needs for regional center services and supports, who are currently receiving SLS from the regional center.

(c) Notwithstanding (a), the projected annual cost of a consumer's SLA shall be deemed to have met the requirements of (a) when the consumer is one of a group of consumers receiving, or projected to receive, SLS services from the same vendor, provided the aggregate cost to the regional center of the SLAs of the grouped consumers does not exceed the total cost to the regional center that would have resulted had the costs for services and supports for each of the grouped consumers been determined individually in accordance with (a).

NOTE

Authority cited: Sections 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4512(b), 4690 and 4791(b) and (c), Welfare and Instititions Code.

HISTORY

1. New section filed 9-20-96; operative 9-20-96 (Register 96, No. 38).

2. Editorial correction of Note (Register 97, No. 21).

Article 3. Consumer Rights

§58620. Consumer Preferences and Leadership.

Note • History

Consumers receiving SLS shall have the right to make decisions that shape the nature and quality of their lives in accordance with their preferences, and consistent with the goals of the consumer's IPP. These rights shall include, but are not limited to, the following:

(a) Choosing where and with whom to live;

(b) Controlling the character and appearance of the environment within their home;

(d) Participating actively in their IPP process so that the SLS they receive is based on their needs and preferences;

(e) Receiving services appropriate to their evolving needs and preferences for support without having to move from the home of their choice, for as long as SLS remains the preferred objective, as determined in the consumer's IPP process; and

(f) Informing the regional center about how satisfied they are with the services they are receiving, and to have this information taken into account in the regional center's periodic evaluation of the SLS vendor's service, pursuant to Section 58671(c).

NOTE

Authority cited: Section 11152, Government Code; Sections 4648, 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4646(a), 4648(a)(7), 4502, 4502.1, 4503(j), 4689(a) and 4689(e), Welfare and Institutions Code.

HISTORY

1. New article 3 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 3 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 3 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsection (e) and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58621. Right to Information.

Note • History

To assure opportunities for making informed decisions as people supported in community settings, SLS consumers shall have a right to information, in an understandable and accessible form. Such information shall include, but not be limited to:

(a) An explanation of the general concepts, purposes, and practices of SLS, pursuant to Section 58610(b);

(b) Training in the philosophy and objectives of SLS, available from the SLS vendor pursuant to Section 58653;

(c) Information from the SLS vendor describing any change in the SLS vendor's service design that would affect the services being received by the consumer, pursuant to Section 58630(b)(2)(B); and

(d) Notice in writing from the regional center when their SLS is affected by the termination of a contract with a SLS vendor, within 10 days of a notification of contract termination pursuant to Section 58672(a).

NOTE

Authority cited: Section 11152, Government Code; Sections 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4502.1, 4503(j) and 4689(d), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

Article 4. Service Design

§58630. General Requirements.

Note • History

(a) Except as specified in (d), an applicant for SLS vendor status shall develop a written service design that shall be approved by the regional center as a condition of vendorization.

(b) A SLS vendor shall modify or replace the approved service design only:

(1) In accordance with its contractual obligations, if any, to the regional center; and

(2) Upon 60 days' prior written notice to:

(A) The regional center; and

(B) Each consumer (or, when appropriate, the consumer's personal advocate) receiving SLS from the SLS vendor. The notice to each consumer shall communicate clearly the consequences the service design changes will have with respect to the SLS services being received by the consumer.

(1) Inform a vendor in writing of the regional center's approval or disapproval of a new or modified service design prior to the expiration of the notice specified in (b)(2); and

(2) Delete from the vendor panel any vendor whose service design has not been approved by the regional center.

(d) Notwithstanding the above, the regional center may waive the service design requirements, provided the:

(1) Applicant proposes to provide services to consumers at no more than one home; and

(2) Competence and suitability of the applicant has been established, using the requirements of Sections 58631 and 58632 as guidelines.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(C), 4689 and 4690, Welfare and Institutions Code. Reference: Section 4689(d), Welfare and Institutions Code.

HISTORY

1. New article 4 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 4 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 4 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58631. Service Design Components.

Note • History

A required service design shall include, but not be limited to, the following:

(a) A mission statement;

(b) A description of the range of approaches and strategies the SLS vendor is prepared to employ to achieve the aims specified in Section 58632;

(1) The SLS vendor shall specify for each aim whether and to what extent each of the associated services are available through the vendor.

(d) A description of the SLS vendor's internal grievance procedure;

(e) A description of the records the SLS vendor will maintain relating to the procedures for regional center SLS vendor performance evaluation referenced in Section 58671(c);

(f) A description of the SLS vendor's staff hiring criteria, including any minimum qualifications requirements; and

(g) A description of procedures and practices the agency will use to screen paid staff, consultants, and volunteers who will have direct contact with consumers.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(C) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(3)(C), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58632. Implementation of SLS Philosophy.

Note • History

A service design shall provide generalized examples sufficiently detailed to illustrate and demonstrate the SLS vendor's competence and suitability to implement the service orientation and principles of SLS stated in Welfare and Institutions Code, Section 4689(a)(1) through (a)(8). This demonstration shall include, but not be limited to, a general explanation of how the SLS vendor will achieve all of the following:

(a) Support of the consumer's assumption of responsibility for making life decisions on the basis of personal preference that enhance the prospects for increased independence, self-reliance, and self-esteem, and for implementing those decisions effectively;

(b) Provision of ongoing monitoring to help confirm, assure, or signal that:

(1) Significant changes in the needs and preferences of the consumer are reflected in the SLS component of the consumer's IPP;

(2) Supports and services remain responsive to the consumer's needs and preferences; and

(3) Risks of endangerment to health, safety, and well-being are minimized.

(c) Provision of necessary and appropriate assistance to the consumer, subject to the prohibitions on payments enumerated in Section 58611(b) in locating, securing, and maintaining a place to live;

(d) Assistance to the consumer in structuring and maintaining a:

(1) Social environment within the home typical of other non-institutional, non-licensed homes in the community, in which persons without disabilities live;

(2) Community-oriented life in which all generic and natural supports are accessed consistent with the needs and preferences of the consumer; and

(3) Network of critical and durable relationships with others, including a circle of support consisting of a majority of members who are not paid to support the consumer, and with appropriate family participation.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648(a)(3)(C), 4688, 4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4501, 4648(a), 4688, 4689, 4689.7(c) and 4750, Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsection (a), repealer of subsection (b)(3), subsection renumbering and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

Article 5. Standards for Vendors

§58640. General Requirements.

Note • History

(a) Each SLS vendor shall provide for the performance of the duties of director, direct service supervisor(s), and employees of the vendor who provide direct service to consumers.

(b) The SLS vendor may:

(1) Separate or combine, and provide for the discharge of, these duties as appropriate to the vendor's circumstances and internal organization; and

(2) Designate staff positions by titles different from those noted in (a).

(c) One individual may assume all the duties of the director, direct service supervisor(s), and direct service employees of the vendor, or any combination of such duties, provided:

(1) The individual meets the qualifications for any positions assumed; and

(2) No more than one full-time equivalent position is required for discharging such duties.

(d) Pursuant to Sections 58630(d), 58654, and 58671(c), a SLS vendor providing services to consumers at no more than one home may be required to meet service design, training, and/or service evaluation requirements that are less demanding than those required by the regional center of other SLS vendors.

(e) The SLS vendor shall assure that any consultant to the SLS vendor meets all licensing, certification, registration and SLS vendor status requirements applicable to the functions undertaken by the consultant.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(A) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(6)(A), Welfare and Institutions Code.

HISTORY

1. New article 5 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 5 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 5 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of section, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58641. Standards for Director Position.

Note • History

(a) The SLS vendor shall assign a director to carry out the administrative responsibilities for the SLS vendor's SLS operations, which shall include at least all of the functions noted in (b).

(b) The director shall have the ability, as a result of any combination of relevant training and experiemce, to competently and consistently organize and supervise the provision of services in accordance with the SLS vendor's established policies, including:

(1) Selecting, and exercising general supervision over, assigned staff; and

(2) Overseeing discharge of the vendor's contractual obligations, budgeting, service design and implementation, project planning, staff development, training, evaluation, and the direction of the SLS.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(A) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(6)(A), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsection (b), transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58642. Standards for Supervisory Position.

Note • History

(a) The SLS vendor shall assign direct service supervisory staff to supervise the delivery of SLS by direct service personnel.

(b) All direct service supervisory staff shall have the ability, as a result of any combination of relevant training and experience, to competently and consistently organize and supervise the direct provision of services to consumers in accordance with the SLS vendor's established policies, under the general supervision of the director.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(A) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(6)(A), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58643. Standards for Direct Service Staff.

Note • History

(a) The SLS vendor shall, subject to Section 58620(c), assign direct service staff to provide SLS directly to consumers. Such direct service staff shall have:

(1) The skill, training, or education necessary to:

(A) Establish and maintain a constructive and appropriate personal relationship with consumers;

(B) Minimize risks of endangerment to the health, safety, and well-being of consumers;

(C) Perform first aid and cardiopulmonary resuscitation (CPR), and operate 24-hour Emergency Assistance systems, as appropriate to the need with respect to any specific consumer; and

(D) Achieve the intended results of the service being performed.

(2) Current and valid licenses, certificates, or registrations that may be legally required to provide the service.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3)(A) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(6)(A), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

Article 6. Training Requirements

§58650. Regional Center Staff Orientation.

Note • History

(a) Each regional center shall provide SLS orientation for any regional center staff assigned to SLS-related responsibilities, including, but not limited to, the following:

(1) Regional center policy-making;

(2) Vendoring of SLS providers;

(3) Resource development;

(4) Supervising, evaluating, overseeing, or consulting with SLS vendors; and

(5) Service coordination to SLS consumers.

(b) Orientation shall:

(1) Focus on the philosophy, concepts, and practices of SLS; and

(2) Occur within three months following the assumption of SLS-related responsibilities.

NOTE

Authority cited: Section 11152, Government Code; Sections 4688 and 4690, Welfare and Institutions Code. Reference: Sections 4651(b), 4659(d) and 4688, Welfare and Institutions Code.

HISTORY

1. New article 6 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 6 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 6 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58651. Vendor Orientation Requirements.

Note • History

(a) Each SLS vendor shall be responsible for SLS orientation of the SLS vendor's paid and unpaid staff, whose duties include the direction or supervision of SLS, or direct service delivery of the services defined in Title 17, Section 54349(a), (b), and (c).

(b) SLS orientation for each staff member shall occur within the first two weeks of employment, and shall include:

(1) An overview of the SLS vendor's mission, policies, practices, and SLS philosophy as stated in the approved service design, pursuant to Section 58632, or as otherwise approved by the regional center pursuant to Section 58630(d);

(2) An understanding of the IPP objectives of each consumer with whom the staff member works directly;

(3) A focus on the practical use of SLS to promote a consumer's self-reliance;

(4) Consumers' protections and rights, including:

(A) The operation of the SLS vendor's internal grievance procedure;

(B) Fair hearing provisions, pursuant to Title 17, Sections 50900 through 50964;

(D) Rights of consumers specified in Sections 58620 and 58621; and

(E) Protection of consumers from abuse, neglect and financial exploitation, including requirements for documenting and reporting such occurences.

(5) A review of appropriate conduct of staff in establishing and maintaining personal relationships with consumers; and

(6) Participation of consumers in a teaching, consulting, or other instructional resource capacity.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(3)(C), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsections (b)(4)(E) and (b)(6) and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsection (b)(4)(C) filed 6-27-2001 as an emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Compliance must be transmitted to OAL by 10-29-2001 or emergency language will be repealed by operation of law on the following day.

6. Reinstatement of section as it existed prior to 6-27-2001 emergency amendment by operation of Government Code section 11346.1(f) (Register 2001, No. 43).

7. Amendment of subsection (b)(4)(C) filed 10-25-2001 as an emergency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-28-2002 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-25-2001 order transmitted to OAL 2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

§58652. Vendor Continuing Training Requirements.

Note • History

(a) Each SLS vendor, subsequent to orientation of staff, shall provide continuing training for all staff whose duties include the direction, supervision, or direct service delivery of the services defined in Title 17, Section 54349(a), (b), and (c).

(b) Such continuing SLS training for staff shall occur at least annually and shall focus on:

(1) Recent developments in the theory and practice of SLS;

(2) Policies, procedures, and practices of the SLS vendor targeted at meeting IPP objectives for SLS; and

(3) Identification of service delivery issues and challenges, and the accumulated experience of the SLS vendor's staff and others in dealing with them.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(3)(C), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58653. Vendor SLS Training for Consumers.

Note • History

Each SLS vendor shall be responsible for making SLS training available to each consumer receiving SLS from the SLS vendor and to the unpaid members of the consumer's circle of support. Such SLS training shall include, as appropriate to each consumer's preferences, all of the following:

(a) Philosophy of SLS;

(b) Consumers' rights;

(d) Internal grievance procedure of the SLS vendor; and

(e) Strategies for building and maintaining an effective circle of support.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648, 4689 and 4690, Welfare and Institutions Code. Reference: Section 4689(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsections (c) and (d), new subsection (e) and amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§58654. Waiver of Vendor Training Requirements.

Note • History

The regional center may waive any or all training requirements specified in Sections 58651 through 58652, provided the:

(a) Vendor provides services to consumers at no more than one home; and

(b) Regional center determines that no adverse impact on the quality of service delivery will result.

NOTE

Authority cited: Section 11152, Government Code; Sections 4688, 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4688 and 4651(a), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

Article 7. Rate Negotiation

§58660. General Requirements.

Note • History

(a) Rates for SLS shall be:

(1) Cost effective to the State; and

(2) Agreed upon through contract negotiation between the regional center and the SLS vendor in accordance with Sections 58661 through 58663.

(b) The regional center may negotiate a rate for the direct services referenced in Title 17, Section 54349(a) through (d), and specified in Section 58614(b). The negotiated rate for direct services shall be established using one of the following methods:

(1) The direct service rate includes compensation for all SLS vendor's administration services specified in Section 58614(c). No additional rate shall be negotiated for SLS Vendor Administration (Service Code 894), and the vendor shall receive no additional compensation for administration costs;

(2) The direct service rate excludes all SLS vendor's administration costs for the services specified in Section 58614(c). An additional rate may be negotiated separately for SLS Vendor Administration (Service Code 894), to compensate the vendor for necessary administration costs.

(1) Result in the regional center paying the vendor more for any service than the vendor would charge any other purchaser of the same or essentially similar service; nor

(2) Be subject to approval by the Department.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648(a)(3), 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4648(a)(3)(B), 4689.7(c), 4690 and 4791(c), Welfare and Institutions Code.

HISTORY

1. New article 7 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 7 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 7 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsections (b)-(b)(2) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58661. Direct Service Rates.

Note • History

(a) Direct Service rates shall be:

(1) Limited to the following service code categories:

(A) Personal Support Service (Service Code 891), pursuant to Title 17, Section 54349(a);

(B) Training and Habilitation Service (Service Code 892), pursuant to Title 17, Section 54349(b);

(D) Supported Living Service (Service Code 896), pursuant to Title 17, Section 54349(d);

(2) Negotiated separately for each service code category enumerated in (a)(1) until July 1, 2000, and based on any one or any combination of the following models that results in the most cost-effective purchase of services by the regional center:

(A) Hourly rates;

(B) Monthly rates;

(D) Rates based on anticipated average monthly costs;

(E) Rates based on the actual provision of services in a payment period;

(F) Rates applied to services to individual consumers, groups of consumers, or to all the consumers served by the SLS vendor.

(b) Rates may reflect, as appropriate to the applicable method of negotiation specified in Section 58660(b), any combination of the following:

(1) Salaries, wages, and benefits of all SLS staff and consultants to the vendor providing direct service;

(2) Travel and incidental costs designated in the contract as necessary for the provision of direct service; and

(3) Cost of the administration services specified in Section 58614(c), necessary to maintain the SLS vendor's direct service operation.

NOTE

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of subsections (a)(1)(A)-(C) and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of section and Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58662. SLS Vendor Administration Rates.

Note • History

(a) A separate SLS vendor administration rate shall be limited to SLS Vendor Administration (Service Code 894), pursuant to Title 17, Section 54349(e).

(b) The SLS vendor administration rate shall be:

(1) Negotiated only with SLS vendors whose direct service rates are negotiated pursuant to Section 58660(b)(2);

(2) A single fixed monthly rate; and

(3) Limited to the SLS vendor's costs of administration, as specified in Section 58614(c), which are required to maintain the SLS vendor's direct service operation.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4648(a)(3), 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4648(a)(3)(B) and 4689.7(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsections (a) and (b)(3) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

§58663. Rate Review and Renegotiation.

Note • History

(a) The regional center and contracting SLS vendor shall review all negotiated rates at the time of contract renewal, and at other times as specified in the contract.

(b) Regional centers shall, for at least three years from the date of the final payment to the SLS vendor in any State fiscal year, retain and make available to the Department upon request the cost data or analytical bases which the regional center relied upon during rate negotiation with the SLS vendor.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a) and 4690, Welfare and Institutions Code. Reference: Sections 4648(a)(3)(B) and 4648(a)(5), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

Article 8. SLS Contract Standards

§58670. General Provisions.

Note • History

(a) All contracts between a regional center and a SLS vendor for the delivery of SLS shall meet all the following applicable contracting regulatory requirements:

(1) Requirements specified in Title 17, Section 50607;

(2) Fiscal provisions specified in Title 17, Section 50609(a), (c), (d), and (e); and

(3) Audit provisions specified in Title 17, Section 50610.

(b) In addition to the requirements specified in (a), all contracts between a regional center and a SLS vendor for the delivery of SLS shall meet all requirements specified in this section, and in Sections 58671 and 58672.

(1) Adopted a required service design that has not been approved by the regional center; or

(2) Not signed the State Department of Health Care Services' Medi-Cal Provider Agreement.

(d) A regional center may, pursuant to Sections 58660 through 58662, contract with a SLS vendor for one or more of the SLS services referenced in Title 17, Section 54349, and specified as a SLS service component in Section 58614.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3) and 4690, Welfare and Institutions Code. Reference: Section 4648(a)(3), Welfare and Institutions Code.

HISTORY

1. New article 8 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 8 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 8 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Change without regulatory effect amending subsection (c)(2) filed 9-24-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 39).

§58671. Contract Requirements.

Note • History

In addition to the requirements set forth in Section 58670, all contracts shall include:

(a) The vendor's approved service design;

(b) Performance standards and service provision outcomes the SLS vendor is obligated to meet; and

(c) The procedures that will be used to monitor and evaluate the outcomes of the vendor's service provision, including but not limited to the requirements of Section 58680.

(d) Rates agreed upon through negotiation, pursuant to Sections 58660, 58661, and 58662;

(e) Limitations on the SLS services referenced in Title 17, Section 54349(a) through (e), which the SLS vendor is authorized to deliver;

(f) Disclosure by the vendor of any past, present or pending residential licensure revocation or denial, and/or any pending application(s) the vendor has filed for residential licensure in the State of California; and

(g) A description of the contract termination conditions specified in Section 58672.

(h) A requirement that the vendor maintain service records to support all billing/invoicing as specified in Section 50604(d)(1) through (3)(F), as applicable.

(i) A requirement that the vendor submit to the regional center with their billings/invoices the information specified in (h) above for the billing period.

NOTE

Authority cited: Chapter 157, Statutes of 2003; Section 11152, Government Code; and Sections 4648(a)(3), 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Sections 4648(a)(3)(B), 4689(e) and 4689.7(c), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of section and Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsections (e) and amendment of Note filed 4-18-2000; operative 5-18-2000 (Register 2000, No. 16).

6. New subsections (h)-(i) and amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emergency language will be repealed by operation of law on the following day.

7. New subsections (h)-(i) and amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency language will be repealed by operation of law on the following day.

8. New subsections (h)-(i) and amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emergency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 6-1-2004 order, including amendment of subsection (h), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§58672. Contract Termination.

Note • History

(a) The contract shall be subject to termination under any of the following conditions:

(1) For cause by the regional center, with notice, pursuant to Title 17, Section 50611(b);

(2) For cause by the regional center, with or without notice, when the regional center determines that either:

(A) The results of any evaluation of the SLS vendor's service delivery, conducted pursuant to Section 58671(c), warrant contract cancellation; or

(B) The SLS vendor's service contributes to life-threatening dangers to, or has resulted in abuse of, a consumer.

(3) Without cause by either party, provided:

(A) The parties to the contract mutually agree to the termination; or

(B) The party initiating the termination gives 60 days' written notice of intention to terminate.

(b) Upon termination of the contract, the vendor shall immediately cease providing services to, and remove any direct service staff from the home of, any consumer whose services were covered by the contract.

NOTE

Authority cited: Section 11152, Government Code; Sections 4648(a)(3) and 4690, Welfare and Institutions Code. Reference: Section 4648.1(d), Welfare and Institutions Code.

HISTORY

4. Certificate of Compliance as to 8-14-95 order, including amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

Article 9. Performance Evaluations

§58680. Regional Center Requirements.

Note • History

(a) The regional center shall, with respect to the procedures adopted pursuant to Section 58671(c) for monitoring and evaluating a SLS vendor's provision of service:

(1) Assure that the requirements of Welfare and Institutions Code, Section 4689(e)(1) through (5), are met;

(2) At least quarterly conduct a face-to-face meeting with each SLS consumer and, when appropriate, the consumer's personal advocate. The meeting shall occur in the consumer's home, except when the consumer withholds permission;

(3) Give significant weight to the evaluation results in any decision to renegotiate, terminate for cause, or renew an existing contract with the SLS vendor; and

(4) Retain and make available to the Department for a period of at least three years from the date of an evaluation, all records related to the evaluation.

NOTE

Authority cited: Section 11152, Government Code; Sections 4405, 4648, 4689 and 4690, Welfare and Institutions Code. Reference: Sections 4648.1(d) and 4689(e), Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

HISTORY

1. New article 9 and section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95 or emergency language will be repealed by operation of law on the following day.

2. New article 9 and section refiled 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL by 4-10-96 or emergency language will be repealed by operation of law on the following day.

3. New article 9 and section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-14-95 order, including new subsections (a)(1)-(2) and subsection renumbering and amendment of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

5. Amendment of subsection (a)(2) and Note filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or emergency language will be repealed by operation of law on the following day.

6. Amendment of subsection (a)(2) and Note refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

Subchapter 21. Habilitation Services Program

Article 1. Definitions

§58800. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense. Words used in the singular form include the plural form. Use of the word “shall” indicates conduct that is required, and “may” indicates conduct that is discretionary.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Section 4851, Welfare and Institutions Code.

HISTORY

1. New subchapter 21 (articles 1-9, sections 58800-58882), article 1 (sections 58800-58801) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New subchapter 21 (articles 1-9, sections 58800-58882), article 1 (sections 58800-58801) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New subchapter 21 (articles 1-9, sections 58800-58882), article 1 (sections 58800-58801) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58801. Definitions.

Note • History

(a) As used in this Subchapter, the following terms shall have the meanings specified in Title 17, Section 50602:

(1) Service Provider,

(b) As used in this Subchapter, the following terms shall have the meanings specified in Title 17, Section 54302

(1) Accreditation;

(2) CARF;

(3) Certification;

(4) Department

(5) Habilitation Services;

(6) Individual Program Plan (IPP)

(7) Management Organization

(8) Supported Employment;

(9) Supported Employment Program (SEP);

(10) Vendor;

(11) Vendorization; and

(12) Work Activity Program.

(d) As used in this Subchapter, the term “Cost-of-Living Adjustment” or “COLA” shall have the meaning specified in Title 17, Section 57210.

(e) As used in this Subchapter, the following terms shall mean:

(1) “Allowable supported employment services” means the services approved in the IPP and specified in the IHSP for the purpose of achieving supported employment outcomes, and may include any combination of the following:

(A) Job development to the extent authorized by the regional center;

(B) Program staff time for conducting job analysis of supported employment opportunities for a specific consumer;

(C) Program staff time for the direct supervision or training of a consumer or consumers while they engage in integrated work unless other arrangements for consumer supervision, including, but not limited to, employer supervision reimbursed by the Supported Employment Program, are approved by the regional center;

(D) Community-based training in adaptive functional and social skills necessary to ensure job adjustment and retention;

(E) Counseling with a consumer/family and/or authorized representative to ensure support of a consumer in job adjustment;

(F) Advocacy or intervention on behalf of a consumer to resolve problems affecting the consumer's work adjustment or retention; and

(G) Ongoing support services needed to ensure the consumer's retention of the job;

(2) “Audit, Desk” means a desk review by the Department used to calculate a daily rate based on the Cost Statement data submitted. This does not verify or guarantee that the data submitted or the daily rate are accurate or final;

(3) “Audit, Independent” means an external examination by a Certified Public Accountant (CPA) of a facility's year-end financial statements on which an opinion is issued;

(4) “Audit, Review” means an examination is an independent review by an accountant of a facility's year-end financial statements on which a statement is issued;

(5) “Common Area” means the space within a service provider's location that has no specific purpose related to the cost centers (e.g., lunchrooms, hallways, and rest rooms);

(6) “Consumer, Habilitation Services (consumer)” means an individual who is at least 18 years of age, with a developmental disability receiving habilitation services who has been referred by a Regional Center or by another agency (in accordance with Welfare and Institutions Code section 4850-4867) and is authorized to receive such services;

(7) “Consumer, Other” means an individual who is funded by a private or government source other than the regional center, Department of Rehabilitation or unfunded by any source (including unfunded sheltered employees);

(8) “Consumer, Vocational Rehabilitation” means an individual funded by the Vocational Rehabilitation Program (VRP) of the Department of Rehabilitation;

(9) “Consumer Productivity Rate” means the percentage of industrial standard that the consumer has produced in the work setting;

(10) “Consumer Stipend” means a monetary payment to a consumer, generally used as an incentive, for purposes other than a consumer wage (e.g., during training, class time, and other time spent in unpaid activities);

(11) “Consumer Subsidy” means that portion of wages exceeding the wages warranted by the consumer's productivity rate that must be paid to meet regulations for Department of Labor's certificate for regular work programs and/or applicable State labor laws, i.e. if a consumer produces at 40% but must be paid 50% of minimum wage;

(12) “Consumer Wage” means a monetary payment to a consumer in accordance with regulations for the Department of Labor certificate and/or any applicable State Labor laws for the production of goods/and or services;

(13) “Cost Center” means a grouping of revenues and expenses based on a similar purpose;

(14) “Cost Center, Administration” means those costs of a general nature that are applicable to all programs operated by the service provider and those specified in these regulations to be administrative in nature;

(15) “Cost Center, Fund Raising” means those costs related to producing income for the service provider from private sources other than production, fee-for-service, and/or grants;

(16) “Cost Center, Non-Program Activities” means those costs generated and incurred by the service provider for revenue generating activities in which no consumers are served (e.g., thrift stores in which no consumers participate, non-habilitation programs);

(17) “Cost Center, Other” means those costs generated and incurred by service providers serving consumers in other than work activity programs which are administered by the same service provider (e.g., day program, residential, camp);

(18) “Cost Center, Production” means those costs generated and incurred by the work activity program service provider from the production of goods and/or services;

(19) “Cost Center, Stores” means those costs incurred and generated by stores or other business operations in which consumers are trained for employment;

(20) “Cost Center, Transportation” means those costs incurred and generated by the ongoing transportation of consumers by the service provider to and from their place of residence and their habilitation services program;

(21) “Cost Center, Work Activity Programs (WAP)” means those costs generated and incurred by the provision of services to a consumer in the work activity program. These services include Habilitation/Rehabilitation which is a single set of services that incorporate work adjustment where the purpose is to enable consumers to develop, maintain, and increase proficiency in work skills and behaviors. Included may be supportive habilitation services which are non-vocational but support the consumer's vocational development and retention of work skills and behavior;

(22) “Cost Statement” means the information required biennially by the Department from the work activity program vendor for the establishment of the rate for Work Activity Programs.

(23) “Direct Production Expense” means those expenses or portion of expenses that are directly attributable to the production of goods or services, including, but not limited to raw materials, marketing, contract procurement, direct production labor, food in food service programs, and shipping and receiving expenses. This does not include expenses for stores and/or other non-program activities;

(24) “Direct Production Labor” means the salary or portion of salary paid to or for an employee for the production of goods and/or services for revenue to the service provider; which includes the cost of non-consumer production workers;

(25) “DOR” means the Department of Rehabilitation;

(26) “Extended services” means training, supervision and support services given to a consumer after transition from intensive services;

(27) “Facility” means a single unit vendored by a regional center that has at least one component of habilitation services that may be operated by a management organization;

(28) “Fee-For-Service” means a fee paid to a facility by a government or private source for a specific service or services provided to a consumer or group of consumers;

(29) “Fiscal Year” means that period of twelve consecutive-months selected and used by a vendor for organizing and reporting accounting records;

(30) “Government Source” means Federal, state, or local public agencies that are supported by public funds;

(31) “Group Services” means job coaching in a group supported employment where services are funded by the Regional Center or DOR. For consumers receiving group services, ongoing support shall be limited to job coaching at the work site;

(32) “Historical period” means the period of time upon which allowable costs for the Work Activity Program are based;

(33) “Holding Company” means a management organization of which the vendor is a subsidiary;

(34) “Income” means all revenue received by a vendor that is not a recovery;

(35) “Indirect Expenses” means vendor expenses that are related to providing services to consumers, and non-consumer related activities administered by the vendor;

(36) “Individual Habilitation Service Plan (IHSP)” means the service plan developed by the habilitation service vendor to meet the employment goals of the IPP;

(37) “Individualized Plan for Employment (IPE)” means an agreed-upon, approved, written plan of vocational rehabilitation program services that assists an individual with a disability eligible for Department of Rehabilitation services to achieve an employment outcome.

(38) “Individualized Services” means job coaching and other supported employment services, provided on or off the worksite, for regional center consumers in a supported employment placement at a job coach-to-consumer ratio of one-to-one. These services decrease over time;

(39) “Integrated work” means paid work by a consumer in a community setting in which the consumer interacts with individuals without disabilities, other than those providing services to the consumer, to the same extent that individuals without disabilities in comparable positions interact with other persons;

(40) “Intensive Services” means, except as noted in Section 58842, initial DOR funded ongoing support services as specified by the Code of Federal Regulations, and when related to individualized services, as defined in this section, decrease to stabilization;

(41) “Intervention” means job coaching services necessary for maintenance of employment;

(42) “Job Coaching” means employment-related services specified in the IPP and provided by a job coach, directly to or on behalf of consumers, for both group and individual placements;

(43) “Non-Consumer Production Worker” means a person who is not a consumer and who is hired specifically to produce goods and/or services for revenue for the Work Activity Program;

(44) “Order of Selection” for vocational rehabilitation services means the priority established by the Department of Rehabilitation for selecting eligible individuals to receive vocational rehabilitation services in the event these services cannot be provided to all eligible applicants.

(45) “Payment Year” means the year for which the daily rate is paid for habilitation services, beginning July 1 and ending June 30;

(46) “Percentage of Intervention” means supported employment program job coaching time expressed as a percentage of all the hours worked by the consumer;

(47) “Private Source” means any entity other than a government source;

(48) “Production Consumer” means a consumer who is receiving a wage for the production of goods and/or services under the supervision of the Work Activity Program staff;

(49) “Production Work Day” means a day of attendance in which any paid work is performed by a consumer or non-consumer production worker for the production of goods and/or services;

(50) “Production Work Hour” means an hour in which any paid work is performed during a day of attendance by a consumer or non-consumer production worker for the production of goods and/or services;

(51) “Productivity Rate” means the percentage of the industrial standard established with the Code of Federal Regulations, by the U. S. Department of Labor and the California Industrial Welfare Commission Orders, that the consumer has produced in either a supported Employment or Work Activity Program work setting and when sub-minimum wages apply;

(52) “Program Day” means the period of time during which a Work Activity Program provides services to consumers as established by the vendor in the approved program design;

(53) “Program Expansion” means the addition of a new service program, space at an existing site, or a new site by a vendor;

(54) “Rate” means the daily or hourly rate paid to service providers for their provision of services to habilitation consumers;

(55) “Rate, Base” means the daily or hourly fee based on the historical period and updated by a rate adjustment based on the State approved COLA, if any, through the current fiscal year;

(56) “Rate, Gross” means the base rate without deducting recoveries from indirect expenses;

(57) “Rate, Historical” means the total allowable Work Activity Program costs in the historical period divided by the total days or hours of attendance of consumers in the historical period;.

(58) “Rate, Interim” means the daily, statewide average rate, set by the Department for a new Work Activity Program prior to the establishment of a daily rate based on the historical period;

(59) “Rate Adjustment “ means a rate increase or decrease to adjust for cost changes not reflected in the historical period;

(60) “Rate Correction” means the increase or decrease in the rate following a Departmental review or onsite audit, based on source documentation;

(61) “Rate Revision” means a rate increase or decrease in consequence of a review or audit conducted by the Department or the regional center based on additional information provided by the vendor;

(62) “Reconciliation” means the explanation by the service provider of differences between year end financial statements (audited or unaudited) and Revenue Statement (Form DS1950 Work Activity Program Cost Statement [Rev 3/05], Tab C) and Expense Statement (Form DS1950 Work Activity Program Cost Statement [Rev 3/05], Tab D);

(63) “Recoveries” are defined primarily as funds provided to offset indirect expenses by reimbursing a service provider directly for expenses incurred or by direct payment (generally for staff) of such expenses. Rental income or revenue from sales when the production cost has been included as an indirect expense, are also included as recoveries.

(64) “Revenue” means all income and support, including cash, goods, and in-kind received by a service provider;

(65) “Service Delivery Staff” means the Work Activity Program staff working directly with the consumer;

(66) “Shipping and Receiving” means incoming and outgoing transportation and loading area expenses for production materials and supplies, used goods, and finished products;

(67) “Stabilization” means the consumer has reached the employment outcomes as specified in the Individualized Plan for Employment and IPP, the consumer has learned and maintained the job for a minimum of sixty (60) consecutive work days, and is expected to continue in the employment. Stabilization rates (the ratio of job coaching hours to the consumers work hours per month) for consumers receiving individualized services in supported employment requires the following percentages of intervention be achieved:

(A) 20% intervention or less for 60 days; or

(B) 25% intervention or less for 90 days; or

(68) “Staff-To-Consumer Ratio” means the number of service delivery staff to number of consumers in the Work Activity Program reported on the cost statement;

(69) “Staggered Work Schedule” means differing start and stop times for consumer work schedules in a supported employment group;

(70) “State” means the State of California;

(71) “Subsidy” means the funds from a government source (cash or in-kind) other than fee-for-service that offsets allowable indirect expenses;

(72) “Supported Employment Intake” means the process completed by a vendor for the purpose of the provision of Supported Employment services to a consumer, and must include;

(A) Initial meeting with the consumer and, when appropriate, the consumer's authorized representative.

(B) Review of the Job Placement Parameters form with the consumer, and

(73) “Supported Employment Placement” means the employment of an individual with a developmental disability in an individual placement by an employer in the community, directly or through contract with a supported employment program. This includes provision of ongoing support services necessary for the individual to retain employment.

(74) “Supported Employment Retention” means a consumer authorized for individual placement services who is placed in an integrated supported employment setting and has remained on the job for ninety (90) days.

(75) “Supportive Habilitation Services” means any combination of direct services to consumers to achieve personal safety practice training, housekeeping maintenance skills training development, health maintenance skills development, including hygiene skills, and other vocationally related activities identified in the vendor's program design and approved by the vendoring regional center, including but not be limited to self-advocacy training, consumer counseling, job club, peer vocational counseling, and career counseling;

(76) “Temporary Transfer” means a regional center-authorized reassignment of a consumer from one habilitation program type to another, for a period not exceeding sixty (60) consecutive days per occurrence, with one thirty (30) consecutive day extension;

(77) “Vocational Rehabilitation Program (VR)” means a statewide program administered by the Department of Rehabilitation to assess, plan, develop, and provide employment services for individuals with disabilities so that those individuals may prepare for and engage in employment opportunities and achieve employment outcomes consistent with their strengths, priorities, concerns, abilities, capabilities, interests, and informed choice. The VR program is an integral part of a statewide workforce investment system.

(78) “Work Adjustment Services” means any combination of direct services to consumers designed to develop physical capacities, psychomotor skills, interpersonal and communicative skills, work habits, vocationally appropriate dress and grooming, productive skills, work practices and work-related skills development, or preparation for a Vocational Rehabilitation referral.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Section 4851, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

Article 2. General Requirements for All Habilitation Services

§58810. General Vendorization Requirements for Habilitation Services.

Note • History

(a) Regional centers shall purchase Habilitation services, pursuant to Title 17, Section 54310, only from vendored work activity programs or supported employment programs, or both.

(b) Habilitation services providers who, on July 1, 2004, are engaged in providing work activity or supported employment services to consumers shall be deemed to be vendored by the appropriate regional center effective that date provided the habilitation program meets the requirements pursuant to Section 54310.

(c) Vendors approved pursuant to (b) shall have until July 1, 2005 to submit to the vendoring regional center an approved program design pursuant to Section 58811.

(d) Regional centers shall vendor additional Habilitation services providers, pursuant to the requirements of Title 17, Sections 54310 and 54351, upon verifying that an applicant for vendorization is appropriately accredited and/or certified.

(e) The regional center shall make available to existing, new and developing vendors information regarding the statutes and regulations, as developed by the Department.

(f) Within four (4) years of the effective date of vendorization, Habilitation services providers must become CARF accredited. The service provider shall distribute copies of any CARF accreditation reports to the vendoring regional center(s), DOR and the Department within thirty (30) days of receipt of such report(s). The regional center may purchase services from a service provider who is not CARF accredited if the service provider meets the following conditions:

(1) Demonstrates that the program is in compliance with the DOR certification standards, to allow a period for becoming CARF accredited: and

(2) Commits, in writing, to apply within three years for accreditation by CARF in the service categories appropriate to their program type(s) as a condition of continued vendorization.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4857.1, 4861(c) and 4861(d), Welfare and Institutions Code.

HISTORY

1. New article 2 (sections 58810-58812) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 2 (sections 58810-58812) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 2 (sections 58810-58812) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (f) and new subsections (f)(1)-(2), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58811. Program Design Requirements for Habilitation Services.

Note • History

(a) The general program design requirements that apply to both Work Activity Programs (addressing the specific program standards as defined in Sections 58820 through 58822) and Supported Employment Programs (addressing the specific program standards as defined in Section 58830 and 58831) and reflect current CARF requirements shall include the following:

(1) A description of the program including:

(A) Employment/Habilitation philosophy, including purpose and goals;

(B) The specific services and supports it typically provides;

(2) The methods used to inform consumers about the programs services and supports, employment, and career options;

(3) Desired consumer outcomes stated in measurable terms;

(4) A description of the entrance and exit criteria that includes all of the following:

(A) Ages of consumers to be served;

(B) Any other prerequisites required for entrance and continuing participation in the program;

1. Self-care skills,

2. Physical and medical conditions, and

3. Behavioral characteristics.

(5) A description of the process the program uses for evaluating and promoting consumer career/vocational development;

(6) A description of the person-centered planning process used to facilitate a consumer's vocational and career outcome(s);

(7) A staff-training plan;

(8) A description of the internal consumer grievance procedures pursuant to Welfare and Institutions Code, Section 4705;

(9) A description of the program's quality management system;

(b) Program design modifications:

(1) Must be approved by the vendoring regional center prior to implementation; and

(2) Require the vendor to notify, at least 30 days prior to the implementation of the modification, the consumer(s) or authorized representative(s), the Department, and the Department of Rehabilitation.

(c) In addition to the general program design requirements described in (a) and (b) above, the program design for Work Activity Programs (addressing the specific program standards as defined in Sections 58820 through 58822) shall include the following:

(1) Consumer attendance policy to include the following:

(A) The requirement for the vendor to notify the regional center on or before a consumer's fifth consecutive day of unplanned absence; and,

(B) The attendance requirements for a consumer to remain enrolled in the program;

(2) The length of the program day;

(3) A description of the methods utilized for contract procurement and product marketing;

(d) In addition to the general program design requirements described in (a) and (b) above; the program design for Supported Employment Programs, Group or Individual (addressing the specific program standards as defined in Sections 58830 and 58831) shall include the following:

(1) A description of the services and supports used to assist consumer(s) to meet employer requirements;

(2) The methods utilized for job development, placement and retention;

(3) The process used to determine either Individual or group placement.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4851(e) and 4861, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including repealer and new section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58812. General Planning Requirements.

Note • History

(a) Following regional center referral of a consumer to a Habilitation service provider, the service provider shall develop and submit for regional center review an initial IHSP within 90 days of the start date.

(1) The IHSP shall include the following:

(A) Service provider name, address and vendor number;

(B) Consumer name, UCI number and social security number;

(D) Objective, status and progress;

(E) Current vocational functioning;

(F) Goals and methods to measure progress

(G) Persons responsible for implementation

(H) Achievements summary;

(I) Attendance, wage statistics and percentage of intervention; and,

(J) Signature of consumer and/or conservator.

(b) Following development, and adoption of the consumer's initial IHSP, the vendor shall submit for regional center review an updated IHSP, within thirty (30) days of the consumer's birthday annually thereafter.

(c) The Habilitation services vendor, working collaboratively with the consumer and/or his or her family or authorized representative, shall review the IHSP, at least, semiannually, or as specified in the IHSP, and document progress achieved toward each IHSP objective.

(d) The IPP team of a consumer receiving Habilitation services shall meet whenever it is necessary to review:

(1) Job placement considerations, including the appropriateness of the placement;

(2) The efficacy of services at the consumer's Work Activity Program or Supported Employment Program; and

(3) The Individual Habilitation Service Plan.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854 and 4854.1, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (a), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

Article 3. Standards for Work Activity Programs

§58820. General Standards for Work Activity Programs.

Note • History

(a) Work Activity Program services include, but are not necessarily limited to, any combination of the following:

(1) Community-based work activity centers or essentially similar site-based programs and services certified by the Department of Rehabilitation and subject to CARF accreditation pursuant to Section 58810(f).

(2) Vocationally focused services to, and remunerative employment of, consumers, and related activities pursuant to Title 29, Part 525, Code of Federal Regulations.

(3) Paid training of consumers for the purpose of enhancing their ability to perform productive work, pursuant to Title 29, Part 785, Section 785.27, Code of Federal Regulations.

(4) Work environments providing payment to consumers commensurate with their level of productivity, based on productivity studies conducted in compliance with Title 29, Part 525, of the Code of Federal Regulations, and the requirement of Section 1191.5 of the California Labor Code, and Sections 6 and 7 of the California Industrial Welfare Commission Order, order number 1-2001, updated effective January 1, 2004.

(b) Work Activity Programs shall provide the requisite amount and variety of work sufficient to prepare each consumer served to attain his or her highest feasible level of functioning, in accordance with each consumer's IPP.

(c) Work Activity Programs shall assure that the aggregate percentage of the total time consumers average in program participation time over any six (6)-month period, shall be:

(1) Not less than fifty (50) percent in paid work;

(2) Not more than fifty (50) percent of the time in a combination of work adjustment services and supportive habilitation services.

(A) Work adjustment services consist of any appropriate combination of the following components:

1. Physical capacities development;

2. Psychomotor skills development;

3. Interpersonal and communicative skills development;

4. Work habits development;

5. Development of vocationally appropriate dress and grooming;

6. Productive skills development;

7. Work practices training;

8. Work-related skills development;

9. Orientation to and preparation for referral to the Department of Rehabilitation for vocational rehabilitation program services.

(B) Supportive habilitation services consist of any appropriate combination of the following components:

1. Personal safety practice training;

2. Housekeeping maintenance skills training development;

3. Health and hygiene maintenance skills development;

4. Self-advocacy training, consumer counseling, peer vocational counseling, career counseling and peer club participation;

5. Other vocationally related activities identified in the regional center-approved Work Activity Program design.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4851(e), 4854, 4854.1 and 4857, Welfare and Institutions Code.

HISTORY

1. New article 3 (sections 58820-58822) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Editorial correction of History 1 (Register 2004, No. 49).

3. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

4. New article 3 (sections 58820-58822) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

5. New article 3 (sections 58820-58822) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58821. Work Activity Program Day Length.

Note • History

(a) The approved Work Activity Program design shall specify the length of the program day during which consumers receive services, provided:

(1) No approved design shall define a program day of less than five (5) hours, exclusive of the meal period.;

(2) The program day shall not be reduced in length from what it had been in the historical period used in calculating the Work Activity Program rate, unless an exception pursuant to Welfare and Institutions Code, Section 4862, has been granted.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Section 4862(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58822. Work Activity Program Service Records Requirements.

Note • History

(a) All Work Activity Programs shall meet the requirements of Section 50604 and maintain consumer-specific records documenting daily service delivery in a manner that links regional center-paid services to the services specified in the consumer's IHSP.

(b) All Work Activity Programs shall submit to the Department and the billing regional center by the 15th day of each following month, a completed monthly Work Activity Program Consumer Monthly Report, DS 1971 (1/05) for the previous month, including the following information for each consumer served and aggregated calculations for:

(1) Name of the consumer;

(2) Wages earned by the consumer;

(3) Hours worked by the consumer;

(4) Monthly percentage of participation in paid work for each consumer;

(5) Productivity level for each consumer;

(5) Average percentage of participation in paid work for the aggregate of consumers; and

(7) Average wages and productivity level for the aggregate of consumers.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854, 4859 and 4865, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsection (b), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

Article 4. Standards for Supported Employment Programs

§58830. General Standards for Supported Employment Programs.

Note • History

(a) Supported Employment Program services consist of any combination of the allowable supports identified in the IPP and specified in the IHSP for a consumer as necessary to enable that consumer to perform integrated work for pay through a supported employment placement.

(b) Allowable supported employment services may include any of the following:

(1) Job development, as indicated in the IPP and the IHSP, and authorized by the regional center;

(2) Program staff time for conducting job analysis of supported employment opportunities for a specific consumer;

(3) Program staff time for the direct supervision or training of a consumer or consumers while they engage in integrated work unless other arrangements for consumer supervision, including, but not limited to, employer supervision reimbursed by the supported employment program, are approved by the regional center;

(4) Community-based training in adaptive functional and social skills necessary to ensure job adjustment and retention;

(5) Counseling with a consumer and or his or her family member or authorized representative to ensure support of a consumer in job adjustment;

(6) Advocacy or intervention on behalf of a consumer to resolve problems affecting the consumer's work adjustment or retention;

(7) Ongoing support services needed to ensure the consumer's retention of the job.

(8) Services and supports following a job loss;

(9) Job coach travel time for individual placement is billable as follows:

(A) Job coach travel time from the vendor's headquarters to the first consumer's work site is billable to the first consumer.

(B) The job coach travel time from the first consumer's worksite to the second consumer's worksite is billable to the second consumer.

(C) Job coach travel time for all subsequent consumers is billed in the same fashion until the job coach arrives at the last consumer's worksite. Travel from last consumer's worksite back to the vendor's headquarters is not billable.

(d) Group services shall be limited to:

(1) Job coaching provided at the worksite;

(2) Employment placements at a job coach-to-consumer ratio of not less than one-to-four nor more than one-to-eight except for those groups that may be authorized by the passage of the Trailer Bill to the Budget Act Fiscal Year 2004-05 to grand-father specific groups at a one-to-three consumer to job coach ratio:

(A) Services to a minimum of four consumers are funded by the regional center or the Department of Rehabilitation, and

(B) Consumers unable to participate due to illness or injury for a period not exceeding six (6) months are replaced by other consumers temporarily, for the purpose of maintaining the program's minimum coach-to-consumer ratio.

(C ) A newly approved group begins with a minimum of three (3) consumers and increased to four (4) within ninety (90) days of starting.

(e) Individualized services:

(1) May be provided on or off the jobsite;

(2) Shall consist of job coaching and other supported employment services for regional center-funded consumers in a supported employment placement at a job coach-to-consumer ratio of one-to-one;

(3) Shall decrease over time until stabilization in the employment is achieved.

(f) Consumers in Supported Employment Programs receiving less than the minimum wage shall be paid according to productivity level on the basis of appropriately conducted productivity studies in compliance with Title 29, Part 525, of the Code of Federal Regulations; Section 1191.5 of the California Labor Code; and Sections 6 and 7 of the Industrial Welfare Commission Order No. 1, updated effective January 1, 2004.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4851(j) and 4854, Welfare and Institutions Code.

HISTORY

1. New article 4 (sections 58830-58834) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 4 (sections 58830-58834) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 4 (sections 58830-58834) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including new subsections (b)(8)-(b)(8)(C) and amendment of subsections (d)(2) and (f), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58831. Supported Employment Program Records Requirements.

Note • History

(a) In addition to meeting the requirements of Section 50604, all Supported Employment Programs shall maintain service records that accurately and adequately link the services billed to the IHSP of each consumer receiving services, including:

(1) Consumer's name;

(2) Job coach's name;

(3) Date(s) of intervention;

(4) Start and end times of intervention;

(5) Purpose of intervention;

(6) Location of intervention; and

(7) Actions taken.

(b) In addition to (a), Supported Employment Individual Services Programs shall regularly submit to the Department and the billing regional center a completed Supported Employment Individualized Services Consumer Monthly Report, DS 1972 (1/05), no later than the 15th day of the following month. The report shall include for each consumer served and the aggregate calculation of the:

(1) Name of the consumer;

(2) Wages earned by each consumer and the average for the aggregate;

(3) Hours worked by each consumer and the average for the aggregate;

(4) Hours of intervention for each consumer and the average for the aggregate; and

(5) Percentage of intervention for each consumer and the average for the aggregate.

(1) Maintain records documenting:

(A) Occurrences or behaviors by a consumer that impede the progress of the group or the individual consumer; and

(B) Any unusual circumstances or events that impact the stability of the group and/or individual consumer.

(2) Regularly submit to the Department, the billing regional center and DOR (when one (1) or more consumers are in the Vocational Rehabilitation program and payment is required) a completed Supported Employment Group Services Consumer Monthly Report, DS 1964 (1/05), no later than the 15th day of the following month. The report shall include the following information:

(A) Employer name and location;

(B) Supported Employment Program name and vendor number;

(D) Name(s) of the job coach(es);

(E) Date(s) of service;

(F) Time in 15 minute increments of each consumer's workday, including lunch break;

(G) Hourly wages (reported each July and January) earned by each consumer;

(H) Monthly hours worked by each consumer;

(I) Monthly Report preparer's name;

(J) Each consumer productivity level;

(K) Indication of regional center authorization for each of the following:

1. meal time supervision; and

2. staggered start and stop time.

(L) Consumer Name;

(M) UCI Number; and

(N) Authorization Number.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854, 4859 and 4865, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58832. Supported Employment Group Formation and Change Requirements.

Note • History

(a) Supported Employment Programs offering group services may request permission to form new groups through submission to the Department of a completed Request for New SEP Groups, Form DS1962 (1/05),

(b) The Department shall, in consultation with the vendoring regional center, approve or disapprove the formation of new groups based upon consideration of the following factors:

(1) Number of consumers;

(2) Ratio of consumers to job coaches;

(3) Wages paid to consumers; and

(4) Necessity for staggered hours attributable to medical and transportation needs as identified in the consumer's IPP, job requirements as established by the employer, availability of transportation in the geographic location.

(c) Supported Employment Programs offering group services may request permission to change existing groups through submission to the Department and the vendoring regional center of a completed Notification of SEP Group Changes, Form DS 1963 (1/05). The following changes may be requested:

(1) Increase or decrease in work hours or work days;

(2) Implementation of or alteration to a staggered work schedule; and

(3) Termination of group and transfer of consumers to another Supported Employment Program.

(d) The Department and the regional center shall approve any proposed change to an existing program prior to implementation of the change by the Supported Employment Program.

NOTE

Authority cited: Section 11152, Government Code; Section 4866, Welfare and Institutions Code. Reference: Sections 4854, 4860 and 4861, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (a) and (c), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58833. Temporary Transfers Between Work Activity and Supported Employment Programs.

Note • History

The regional center shall approve the temporary transfer of a consumer between a Supported Employment -- Group Placement Program and a Work Activity Center, pursuant to the following:

(a) A finding by the consumer's IPP team of a prospective need for a temporary transfer, manifested in a written preauthorization for the transfer specifying the following:

(1) The criteria upon which the temporary transfer is preconditioned;

(2) The maximum number of days of the temporary transfer, not to exceed sixty (60) days; and

(3) Conditions, other than those specified in (c), under which an extension of the temporary transfer is to be granted, not to exceed thirty (30) days.

(b) Emergency authorization of a temporary transfer pursuant to Title 17, Section 50612.

(c) The regional center may grant an extension of a temporary transfer of up to thirty (30) days when not specified in accordance with (a)(3), provided one or more of the following adverse circumstances occurs:

(1) Temporary shutdown of the employer's operations due to good cause;

(2) Adverse weather conditions;

(3) Natural disasters.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854.1, 4857, 4860(b) and 4862(c)(1)(2), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58834. Additional Requirements for Supported Employment Programs.

Note • History

(a) Regional centers shall approve job coaching for consumer supervision during the meal period when previously approved by the Department of Rehabilitation or when specified in the consumer's IPP.

(b) Supported employment services above the stabilization level specified in the consumer's IPP shall be allowable as necessary, consistent with the determination of the consumer's IPP team, when:

(1) The consumer is learning new job skills or increasing his or her job responsibilities;

(2) There is a change in employer management;

(3) The consumer is experiencing a personal crisis.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854 and 4854.1, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

Article 5. Coordination of Services With the Department of Rehabilitation

§58840. Referrals to the Department of Rehabilitation.

Note • History

(a) Work Activity Programs shall at least once annually assess the service needs of each consumer served by the program to identify any consumers for whom vocational rehabilitation program services provided by the Department of Rehabilitation would be appropriate, provided the program shall inform the regional center at any time when a consumer expresses an interest in securing employment outside the Work Activity Program, or presents as an appropriate candidate for referral to the Department of Rehabilitation.

(1) The Work Activity Program shall inform the regional center whenever a consumer is identified as a candidate for vocational rehabilitation program services pursuant to this section, within thirty (30) days of the assessment or identification;

(2) Upon being informed of the need for services for any consumer, the regional center shall collaborate with the Work Activity Program to address the finding of need for vocational rehabilitation program services through the consumer's IPP process.

(3) Upon confirmation of the need for vocational rehabilitation program services through the consumer's IPP process, the regional center shall refer the consumer to the Department of Rehabilitation for the needed vocational rehabilitation program services, using Vocational Rehabilitation Referral, Form DS 1968 (4/04) to effect the referral.

(b) The regional center shall refer a consumer to the Department of Rehabilitation when:

(1) The consumer has no current job, and requests a job while meeting Department of Rehabilitation eligibility requirements for Vocational Rehabilitation Services, or:

(2) The consumer has a job, where ongoing job coach funding is provided by the regional center and he/she requests an additional job where DOR will provide funding of services for the new job. DOR VR program does not provide ongoing support for a consumer in a job after the consumer has stabilized. DOR would provide services for the new job only.

NOTE

Authority: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854.1, 4856(a), 4857 and 4858, Welfare and Institutions Code.

HISTORY

1. New article 5 (sections 58840-58842) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 5 (sections 58840-58842) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 5 (sections 58840-58842) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (b)-(b)(2) and repealer of subsection (b)(3), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58841. Transition to Habilitation Services Upon Achievement of Stabilization.

Note • History

(a) The regional center shall maintain communication with the Department of Rehabilitation to monitor the progress of any consumer referred by the regional center to the Department of Rehabilitation pursuant to Section 58840.

(b) When a consumer receiving supported employment services from the Department of Rehabilitation achieves stabilization, the regional center shall assure that consumer's timely transition from vocational rehabilitation intensive services to regional center-funded extended services, in accordance with the following requirements:

(1) Upon receiving notification from the Department of Rehabilitation that the consumer receiving supported employment intensive services has reached stabilization, the regional center shall implement the consumer's IPP determinations for Habilitation Service. Based upon the notification received from the Department of Rehabilitation, the planning team shall verify that:

(A) The consumer has performed the job satisfactorily for a minimum of sixty (60) days or longer;

(B) The consumer's job is expected to be stable and to continue; and

(C) The percentage of job coaching intervention for individual services meets the following criteria: no more than 20 percent for at least sixty (60) days; no more than 25 percent for at least ninety (90) days; no more than 30 percent for at least 120 days;

(2) Regional center funding for the consumer's extended services shall begin on the first billing day of the month following the regional center's approval of services, or according to a start time agreed upon by the IPP team in coordination with the Department of Rehabilitation.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854.1 and 4857, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58842. Denial of Services Pursuant to Order of Selection Criteria.

Note • History

Whenever the Department of Rehabilitation is unable to provide vocational rehabilitation services to all eligible applicants and invokes order of selection criteria to set priorities for accepting applicants, the regional center shall, as directed by the Department, provide on behalf of consumers denied services pursuant to the order of selection:

(a) Intensive services job coaching until stabilization is achieved; and

(b) Supported Employment Intake, Supported Employment Retention, and Supported Employment Placement fees.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854.1, 4856(a), 4857 and 4858, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

Article 6. Quality Assurance Monitoring and Corrective Actions for Habilitation Services Programs

§58850. Monitoring and Evaluation of Habilitation Program Services.

Note • History

(a) The Department and the vendoring regional center shall have the authority and responsibility for monitoring and evaluating Habilitation Services Programs for:

(1) Service quality.

(2) Protections as specified in Section 50510 of these regulations and the CARF standards for consumers receiving services.

(3) Verify ongoing CARF accreditation.

(b) The Department and the vendoring regional center shall coordinate the following monitoring and evaluation activities as may from time to time be necessary to avoid duplication or incompatibility of effort, and to achieve the most efficient and effective employment of staff resources in the implementation of this section:

(1) Review the initial and subsequent annual Individual Habilitation Service Plan prepared by the Habilitation Services Program for all consumers served by the program;

(2) Review each program's CARF accreditation report, upon initial accreditation and renewal, as appropriate; and

(3) Review for each Work Activity Program the information, as compiled by the Department, the amount of time consumers engaged in paid work as a percentage of the total time that the aggregate of consumers in the program received services over a selected period of six (6) months.

(c) The activities specified in (a) shall be undertaken at a frequency and in a manner to be determined by the Department and the vendoring regional center, provided that these reviews shall occur not less frequently than would achieve synchronization with the program's CARF accreditation renewal cycle.

(d) As necessary for the implementation of this section, all Habilitation Services Programs shall:

(1) Maintain and make available for inspection and review by the Department and the regional center, as appropriate, all records, reports, documents, and facilities related to the delivery of services to consumers; and

(2) Provide the Department and the vendoring regional center, as appropriate, direct access to program administrators, supervisors, and staff.

(e) In the event the Department and the vendoring regional center disagree upon a course of action pursuant to the monitoring and evaluating responsibilities of this section, the Department's position shall prevail.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Section 4856, Welfare and Institutions Code.

HISTORY

1. New article 6 (sections 58850-58851) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 6 (sections 58850-58851) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 6 (sections 58850-58851) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (a)(2)-(3), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58851. Noncompliance Sanctions and Corrective Action Plans.

Note • History

(a) Habilitation Services Programs determined by the Department and the vendoring regional center consequent to the monitoring and quality assurance activities specified in Section 58850, to be out of compliance with any relevant service provider requirement in this Subchapter, shall be subject to immediate sanctions proportional to the noncompliance condition(s).

(b) A finding of failure on the part of a Habilitation Services Program to comply with relevant service provider requirements shall require the development of a corrective action plan within thirty (30) days of notification by the Department or regional center of noncompliance, provided the sanction imposed is not termination of vendorization.

(1) A moratorium on new referrals.

(A) This sanction shall apply only in cases where consumers are not subject to, or at imminent risk of, abuse or other harm.

(B) The moratorium shall trigger development and implementation of a corrective action plan, and shall be rescinded only when the conditions that led to the moratorium have been corrected in accordance with the corrective action plan.

(2) Imposition of a corrective plan.

(A) A corrective action plan may be imposed in conjunction with a moratorium on new referrals, or as the sole sanction when a moratorium on referrals has not been imposed.

(B) The program shall develop a corrective action plan within thirty (30) days of notification by the Department or regional center of noncompliance, provided the sanction imposed does not include termination of vendorization.

(D) Failure of the Habilitation Services Program to comply with the conditions and timelines of the corrective action plan shall result in termination of vendorization, pursuant to Title 17, Section 54370.

(3) Removal of consumers from the habilitation services program.

(A) Removal of consumers shall be required only when dangerous or abusive conditions are present, or upon termination of vendorization.

(B) Upon correction by the Habilitation Services Program of the conditions found by the Department or the regional center to have threatened the health and safety of consumers, as determined by the Department or the regional center, consumers removed from the program may, at their option, return to the program or receive services from an alternate program.

(4) Termination of vendorization.

(d) A Habilitation Services Program sanctioned under subparagraph (A) of paragraph (3) of subdivision (c) may request an administrative review, pursuant to Welfare and Institutions Code, Section 4648.1.

(e) A Habilitation Services Program sanctioned under paragraph (4) of subdivision (c) shall have a right to a formal review by the Office of Administrative Hearings under Chapter 4 (commencing with Section 11370) of Part 1 of Division 3 of Title 2 of the Government Code.

(f) Any habilitation services program that has been sanctioned pursuant to former Title 9, Section 19354.5, the provider shall complete the requirements of the corrective action plan or any other terms or conditions imposed upon it as part of the sanctions. At the end of the term of the corrective action plan or other compliance requirements, the services provider shall be evaluated by the regional center and/or Department in light of the standards and requirements established for Habilitation Services Programs in this Subchapter.

(g) The Department and vendoring regional center(s) shall notify DOR if sanctions are being considered.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4856 and 4648.1, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (c) and (c)(3) and new subsection (g), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

Article 7. Work Activity Program Ratesetting Procedures

§58860. General Provisions.

Note • History

(a) The rates shall be based on the allowable costs inclusive of allowable staff time costs associated with the Work Activity Programs only and shall not include expenses for other programs such as Activity Centers, residential programs, camps, or transportation to and from the consumer's home. Staff cost will be determined by a semi-annual two-week time study.

(b) The Department shall establish rates which reflect the reasonable cost of both an overall habilitation service and each specific allowable service, activity, or administrative cost comprising that overall service. Direct costs related to services, provided in the areas of shipping/receiving, or business operations, such as stores, shall not be included in the computation of the Habilitation Service cost, but rates paid for consumers receiving services in these areas shall be based on the costs and consumer attendance of the primary work activity operation.

(c) For new Work Activity Programs, which have insufficient historical fiscal and consumer data, rates shall be set according to Section 4861 of the Welfare and Institutions Code.

(d) When an established habilitation service provider who has a historical period of costs for Work Activity Program services corresponding to that of service providers already vendorized requests a new vendorization, the Department shall:

(1) Base the rate on all allowable historical period costs relating to all cost centers, except those for other vendorized programs, and on the total attendance of all consumers served through those cost centers in the historical period, since the service provider cannot have served Habilitation consumers in the historical period; and

(2) Determine if the computed rate is comparable (within one standard deviation of the mean) to those of service providers already vendorized that are similar in size, area, and consumer services.

(e) Reasonable cost shall not be based on actual cost during a payment year, but on actual allowable costs in a historical period. The principle of reasonable cost, as distinct from actual cost, shall be based on the cost containment methods specified in Sections 58871.

(f) The policies and procedures the Department employs to establish rates shall be equitable. The Department shall require all vendors to submit the same type of cost statement data in the same form.

(g) The Department shall apply all of the ratesetting policies and procedures specified in these regulations in the same manner.

(h) The Cost Statement shall be used by the Department as a basis for establishing rates so that expenses for all services for which the vendor bills the regional center are reported separately for each service.

(i) The Department shall not reduce the rate of payment resulting from income, as defined in Section 58801(e)(34), received by vendors.

(j) The rate for Work Activity Program services shall be the sole rate paid for such services and shall not be paid if any other fee is paid by any government or private entity other than the regional center for a consumer for such Work Activity Program services.

(k) The historical rate for Work Activity Program services shall be based on allowable administrative, production, and service costs divided by the actual habilitation and vocational rehabilitation services consumer attendance during the historical period as reported on the Cost Statement required in Section 58870.

(1) Allowable costs include:

(A) Administrative -- costs allocated to service programs based on the percentage of indirect costs of each program.

(B) Production -- all indirect production costs are allowable to the extent that consumers are not working to the industry's production level. (Net of consumer productivity).

(l) This historical rate shall then be adjusted by any State approved COLA(s) to arrive at a daily or hourly rate. The amount of the COLA(s) shall depend directly upon the accounting fiscal year that is the historical period for the service provider (e.g., if the accounting fiscal year of the service provider begins two years prior to the payment year, a two-year COLA shall be added to the rate resulting from the historical period data).

(m) Days or hours billed during the historical period by the Work Activity Program and paid by the regional center, Department of Rehabilitation, and any other entity shall be considered to be days or hours of attendance for purposes of rate setting.

(n) Because the Legislature has expressed its intent that the Department assures service quality the ratesetting procedure shall seek to maintain an adequate level of habilitation services.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859, 4861(b) and 4863, Welfare and Institutions Code.

HISTORY

1. New article 7 (sections 58860-58864) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 7 (sections 58860-58864) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 7 (sections 58860-58864) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58861. General Ratesetting Requirements for Work Activity Programs.

Note • History

(a) Work Activity Programs requesting or receiving reimbursement from the regional center for the provision of Work Activity Program services shall submit all fiscal and consumer data as required by these regulations, to the Department and a copy to the vendoring regional center. Such data shall serve as the basis for setting rates, and is subject to audit. Failure to comply with the Department' s data submission policies shall result in a delay in processing of the current payment year invoices of that Work Activity Program.

(b) All vendors and Management Organizations shall use the instructions and procedures for reporting Cost Statement data detailed in this Subchapter. The data reported for the Management Organization shall then be allocated to the vendor(s) on a cost basis.

(c) Vendors that are part of a school, hospital, or any city or county operation may report only the data for the Work Activity Program.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4860, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58862. Reporting Period for Submission of Information.

Note • History

(a) For Fiscal Year 2006-07, and each alternate fiscal year thereafter, rates are based on the costs for the vendor's fiscal year of two (2) years prior.

(b) To aid in the vendors' preparation and the Department's desk audit and the Department's and/or regional center's field audit of Cost Statements, vendors shall use as a historical period their most recently completed fiscal year as the basis for reporting Cost Statement data. The historical period shall not end later than the last day of March preceding the payment year.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58863. Required Due Dates for Submission of Information.

Note • History

(a) Beginning September 30, 2005, the Cost Statement data and year-end financial statements, audited or un-audited, and any reconciliation shall be submitted to the Department and a copy to the vendoring regional center three months after the end of the vendors' fiscal year but no later than May 31, 2006 and no later than each alternate May 31st thereafter. This establishes the cost statement due date.

(b) An independent audit or review report of the historical period shall be submitted to the Department and a copy to the vendoring regional center within three months of the cost statement due date. Schools, hospitals and public agencies are exempt from this requirement.

(c) The Department may extend deadlines for submission of cost statements and audits or review reports if such extensions may be accommodated by the Department.

(d) The vendor shall request extensions at least two weeks prior to the due date set by the Department.

(e) Failure to submit the cost statement on required forms and audits or review reports, on time, shall result in Departmental action pursuant to California Code of Regulations, Section 58861(a).

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (a)-(b), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58864. Required Cost Statement Information.

Note • History

(a) The vendor shall report the following in the form and time period required by the Department utilizing the DS 1950 (3/2005), Work Activity Program Cost Statement and instructions incorporated in these regulations by reference, including Tab A (Staff Survey Report), Tab B (Space Utilization Report), Tab C (Revenue Statement), Tab D (Expense Statement), Tab E (Other Expense Statement), Tab F (Revenue and Expense Statement Reconciliation), Tab G (Consumer Survey Report), Tab H (Rate Computation Sheet), Tab I (General Information/Certification), Tab J (Allocation Guidelines), Tab K (Facility Questionnaire), Tab L (Adjustments):

(1) All revenue and expenses biennially;

(2) Actual attendance of all consumers and non-consumer production workers, and productivity rates of all habilitation and vocational rehabilitation consumers biennially; and

(3) Any request for rate adjustment.

(b) For each of the forms listed below the specified objective and required documentation which must be retained for review and audit are as follows:

(1) Staff Survey Report, Form DS 1950 (3/05), Tab A,

(A) Objective: To report staff salaries and wages and allocate them to the appropriate cost centers

(B) Required Documentation:

1. Payroll records, including W-2s, quarterly payroll tax returns, and canceled checks.

2. Time studies used as the basis for allocating salaries and wages;

(2) Space Utilization Report, Form DS 1950 (3/05), Tab B;

(A) Objective: To report, by cost center, the use of buildings owned or leased by the facility for use in allocating costs related to the building;

(B) Required Documentation: The floor plan identifying size and area;

(3) Revenue Statement, Form DS 1950 (3/05), Tab C;

(A) Objective: To report all revenue (cash and in-kind) received by the service provider;

(B) Required Documentation: All revenue records;

(4) Expense Statement, Form DS 1950 (3/05), Tab D;

(A) Objective: To report all expenses incurred by the facility.

(B) Required Documentation: All expense records, including ledgers, journals, invoices, and canceled checks, depreciation records, records of the basis for allocating all expenses.

(5) Revenue and Expenses Statement Reconciliation, Form DS 1950 (3/05), Tab F;

(A) Objective: To reconcile the year-end financial statements with the Revenue and Expense Statements (Forms DS 1950 (3/05), Tab C and DS 1950 (3/05), Tab D to ensure accuracy.

(B) Required Documentation: Year-end financial statements (audited or unaudited), annual reviews or independent audit reports, including management letters from independent auditors;

(6) Consumer Survey Report, Form DS 1950 (3/05), Tab G;

(A) Objectives: (i) To provide a basis for allocating work activity program costs based upon consumer and worker participation and HSP consumer productivity. (ii) To provide a basis for determining the unit cost for HSP consumers.

(B) Required Documentation: Consumer attendance records (should be summarized monthly), consumer payroll records, records of individual consumer productivity rates, consumer productivity rate calculations (should be summarized monthly), workdays or work hours for non-consumer production workers (should be summarized monthly);

(7) Rate Computation Sheet, Form DS 1950 (3/05), Tab H,

(A) Objective: To calculate daily or hourly rates for Work Activity Programs;

(8) General Information/Certification, Form DS 1950 (3/05), Tab I.

(A) Objective: This form is required and shall be completed after the ratesetting forms are completed. To provide an overview of the organization and to obtain assurance from the directors of the facilities that, to the best of their knowledge, all of the data submitted for the setting of the rate is accurate.

(c) The vendor shall consistently use the same headings or titles for services or programs on all reporting forms required by the Department.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Section 4859(a), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

Article 8. Ratesetting Methodology for Work Activity Programs

§58870. General Provisions.

Note • History

(a) Work Activity Program rates shall be established, as applicable, according to the following sequence:

(1) Applying, as appropriate, all cost containment policies in accordance with Section 58871.

(2) Setting of the historical rate from Cost Statement; Work Activity Program Cost Statement, DS 1950 (3/05), Tab A (Staff Survey Report); Tab B (Space Utilization Report),Tab C (Revenue Statement); Tab D (Expense Statement); Tab E (Other Expense Statement); Tab G (Consumer Survey Report); and Tab H (Rate Computation Sheet);

(3) Computing the base rate.;

(4) As appropriate, reducing the rate in accordance with the maximum daily rate policy specified in Section 58873.

(5) Adjusting the rate, as appropriate, in accordance with policies on rate adjustments specified in Section 58876.

(b) If vendor operations during the historical period are dependent upon grant funds which will terminate before the payment year for which the rate is being set, the Department shall not apply such grant funds as a recovery in its computation of the rate.

(c) When a vendor dependent on grant funds has not been in operation long enough to establish a historical period, the daily rate shall be the statewide average rate.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859, 4860 and 4866, Welfare and Institutions Code.

HISTORY

1. New article 8 (sections 58870-58879) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 8 (sections 58870-58879) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 8 (sections 58870-58879) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (a)(1)-(2) and (a)(5), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58871. Cost Containment Policies.

Note • History

(a) All cost containment policies shall be applied to historical period costs.

(b) Administrative costs of a Work Activity Program shall be determined by the Department to be excessive when, as a percentage of the total gross cost of the Work Activity Program in the historical period, such costs exceed the maximum of 32.12%. The procedure to determine administrative costs is:

(1) To determine the percentage of administrative cost to total gross cost of each Work Activity Program, the Department shall divide the gross administrative cost applicable to the Work Activity Program by the total gross cost of the Work Activity Program.

(2) If a Work Activity Program's administrative cost percentage exceeds the maximum allowable percentage, the Department shall reduce the administrative cost to the maximum level.

(3) The only exception to the above policy is that a service provider's cost of administration of the Work Activity Program shall not be reduced below the minimum cost necessary to support the salaries and overhead for the basic core administrative staff which is defined as the director, clerical, and fiscal support staff.

(1) The Department shall allow as an expense FICA contributions actually incurred during the historical period as described in (2) and (3) below. In addition, the contribution made by the employer to a qualified plan shall be allowed subject to the exceptions, conditions, and limitations contained herein.

(A) As used in this section, “Qualified Plan” means a pension, retirement, or other similar deferred compensation plan that has been approved, certified, and is legal as required by federal and state laws, regulations, and case law.

(B) As used in this section, “FICA Rate” means the employer's portion of the FICA contribution rate expressed as a percent of gross wages. The rate used shall be the rate in effect during the historical period.

(2) If the employee was covered by FICA during the historical period, the allowed percentage for the employer contributions to a qualified plan shall be five percent (5%).

(3) If the employee was not covered by FICA during the historical period, the allowed percentage shall be the sum of the FICA rate plus five percent (5%).

(4) The total allowable expense of this section shall not exceed the amount defined by either (2) or (3) above.

(5) Notwithstanding any other provision of this section, the maximum allowance for employer contributions to a qualified plan shall not exceed the lesser of either:

(A) The required employer contribution as determined by the trustee of the qualified plan; or

(B) The contribution required to keep the plan actuarially sound.

(6) To determine the percentage allowed for retirement plans, the Department shall divide the total amount reported for indirect expenses for retirement by the total amount reported for staff salaries.

(7) If the percentage is less than or equal to the allowed percentage, no adjustment shall be made.

(8) If the percentage is more than the allowed percentage, the expense applicable to the excess percentage not allowed shall be deducted from the amount reported for retirement on a prorated basis from each cost center.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section heading and section, renumbering and amendment of former section 58872 to section 58871(c)-(c)(8) and amendment of Note, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58872. Program Expansion Policy and Procedure.

Note • History

(a) Through its ratesetting procedure, the Department shall allow increased costs incurred in the historical period for program expansion only if such costs for expansion were approved by the Department, in writing, prior to the expenditure. This policy shall apply only to major line items (related to staff, occupancy, and equipment) and shall not apply to any costs incurred by a Work Activity Program prior to the date of the filing of these regulations.

(b) Work Activity Programs shall adhere to the following procedure to submit costs related to program expansion:

(1) A Work Activity Program planning to incur increased costs for program expansion which are likely to exceed the Consumer Price Index (CPI) percent increase as reported in California Abstract for “all items”, shall submit a written request for approval of those costs to the Department. The request shall include all applicable information as required for vendorization as a new service provider.

(2) In consultation with the regional center and the Department of Rehabilitation, the Department shall review and evaluate the request.

(3) The Department shall apply criteria as they are relevant to the pertinent policies and procedures relating to: local needs assessment, service capacity, standards, and evaluation of all alternative options to meet the identified need that apply to the vendorization of new service providers.

(4) The Department shall submit a written response to the director of the Work Activity Program within 45 days of the receipt of the request. The response shall specify the rationale applied for approval (in full or in part) or for denial of the request.

(5) If the request is approved, the director of the Work Activity Program shall include a copy of the written letter of approval with the Cost Statement for the historical period in which those costs were incurred.

(6) If the letter of approval does not accompany the Cost Statement, the Department, during the desk audit, shall compare current Cost Statement expense line items to those of the prior year. If increases have occurred above the CPI, the Department shall require the Work Activity Program to provide an explanation of the increased costs. If the increases were due to disapproved program expansion, the costs shall be disallowed in the computation of the rate.

NOTE

Authority: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including renumbering of former section 58872 to section 58871(c)-(c)(8) and new section, transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58873. Maximum Daily Rate.

Note • History

(a) The Department shall, biennially, set the maximum daily rate for Work Activity Program services.

(b) The Department shall set three (3) maximums, dependent on the total number of consumers served in the Work Activity Program during the historical period.

(c) The maximums shall be established biennially based on the Cost Statements submitted and received by the Department, in a form permitting such determination, by June 1 preceding the payment year for which they are submitted.

(d) For each vendor submitting a Cost Statement meeting the time constraints stated in (c) above, the Department shall calculate the gross rate.

(e) The Department shall group the above gross rates based on the number of all consumers served in the Work Activity Program during the historical period covered by the Cost Statements. The vendor groupings are as follows:

(1) Small vendors: 0 - 30 consumers;

(2) Medium vendors: 31 - 100 consumers;

(3) Large vendors: 101 or more consumers.

(f) For each grouping of gross rates calculated, the Department shall compute the mean (average) and standard deviation for that grouping.

(g) The mean plus one standard deviation shall be the maximum allowable rate for each grouping for the payment year.

(h) If a vendor's rate exceeds the maximum established for its number of consumers, following application of any other cost containment measures in Sections 58871 through 58872, the rate shall be reduced to the maximum for that grouping.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58874. Reporting Requirements.

Note • History

(a) To receive a rate based on allowable cost, in accordance with these regulations, a vendor shall establish a historical period. In the case of new vendors meeting all other criteria for vendorization, the historical period need not extend a full year, but it shall occupy at least three months ending no later than March 31 preceding the payment year for which the Work Activity Program's rate is being established. That historical period shall be representative of the vendor's ongoing operating costs excluding start-up costs.

(b) The vendor shall submit, as required by the Department, a completed Cost Statement for the historical period in accordance with the principles, policies, procedures, and instructions specified in Section 58864. Using representative cost and consumer data in the Cost Statement, the Department shall apply the policies and procedures in these regulations to establish the rate for the upcoming payment year. If service provider operations during the historical period are dependent upon establishment grant funds which will terminate before the payment year for which the rate is being set, the Department shall not apply such grant funds as a recovery in its computation of the rate.

(c) If the Department determines that the minimum required historical period is not sufficiently representative of cost and consumer data as the basis for establishing the rate, the policy set forth in Section 58860(c) shall be in effect. To be sufficiently representative, the historical period shall not contain costs that are essentially start-up costs (security deposits, moving expenses, etc.), and the consumer attendance during the historical period shall reasonably approximate the caseload level that had been anticipated in the service provider's request -for vendorization.

(d) Expenses for other programs not provided as part of the Work Activity Program shall be reported separately from the expenses of Work Activity Program services. However, such expenses may be consolidated under one cost center unless a portion of those expenses are allowable Work Activity Program expenses.

(e) An independent review of financial statements performed by an accountant may be submitted instead of an independent audit and shall cover at a minimum the following:

(1) An inquiry as to the vendor's accounting principles and practices and methods used in applying them;

(2) An inquiry as to the vendor's procedures for recording, classifying, and summarizing transactions and accumulating information;

(3) Analytical procedures designed to identify relationships or items that appear to be unusual;

(4) An inquiry about budgetary actions taken at meetings of board of directors or other comparable meetings;

(5) An inquiry about whether the financial statements have been properly prepared in conformity with Generally Accepted Accounting Principles and whether any events subsequent to the date of the financial statements would have a material effect on the statements under review;

(6) Working papers prepared in connection with a review of financial statements describing the items covered as well as any unusual items, including their disposition.

(f) An independent review report shall accompany the financial statements reviewed by an accountant and shall cover the following points:

(1) A review was performed in accordance with standards established by the American Institute of Certified Public Accountants;

(2) The statements are representations of management;

(3) The review consisted of inquiries and analytical procedures that are less in scope than those of an audit; thus, no opinion is expressed regarding the financial statements as a whole;

(4) The accountant is not aware of any material modifications that need to be made to the statements for them to be in conformity with Generally Accepted Accounting Principles.

(g) If there are material changes as the result of the independent review or independent audit report, the vendor shall revise the Cost Statement to reconcile with the review or audit and resubmit them. The Department shall revise the rate accordingly.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (b)-(c), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58875. Non-Allowable Costs.

Note • History

(a) The historical period shall not contain costs that are start-up costs, such as security deposits, moving expenses.

(b) The value of private donations or grants for rent, goods, services, assets, or staff shall not be reported either as an indirect expense or a recovery. The value of private donations shall be reported as income, the expense for which the donation was used shall be reported as a direct expense, when applicable, or as an item on the Work Activity Program Cost Statement -- Revenue and Expenses Statement Reconciliation, Form DS 1950 (3/05) Tab F.

(1) Bad debts of vendors;

(2) Bad debts to vendors;

(3) Donations from vendors to other parties;

(4) Sales discounts to other parties;

(5) Theft of materials, products, or assets;

(6) Federal and State tax penalties and interest;

(7) Breakage and spoilage of materials and products used in production only;

(8) Consumer stipends;

(9) Insurance to protect against ratesetting or funding decisions made by the Department;

(10) Losses from food service programs;

(11) Losses from sales of fixed assets;

(12) Other losses from business transactions or operations;

(13) Legal fees resulting from suits against the department or regional centers;

(14) All expenses related to the following in Work Activity Programs:

(A) Medical, psychological, and/or nursing services;

(B) Physical and/or occupational therapy services;

(D) Dietary services;

(E) Pharmacy services;

(F) Speech pathology services;

(G) Audiological services;

(H) Prosthetics and/or orthotics fitting;

(I) Dentistry services;

(J) Optometric services;

(K) Camps, field trips, recreational or social activities;

(L) Expenses for payment to holding companies for items such as occupancy, equipment, and vehicles that exceed the expense that would have been incurred by the vendor if the holding company did not exist.

(d) It is not necessary to allocate unallowable expenses. These shall be reconciling items between the Expense Statement, Form DS 1950 (3/05) Tab D and the Revenue and Expense Statement Reconciliation, Form DS 1950 (3/05) Tab F.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (b), (c)(8) and (d), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58876. Rate Adjustment and Rate Revision Provisions.

Note • History

(a) The Department shall adjust base rates following the addition of any State-approved COLA's except as provided in Section 58876(g)(7) and 58876(p).

(b) The Department shall make rate adjustments only before the payment year begins and make them effective July 1 of the payment year, except in cases of occupancy adjustments due to disasters such as earthquakes, floods, and fires pursuant to Section 58877.

(c) If the basis for the adjustment will not take effect until after the beginning of the payment year, the Department shall prorate the adjustment over the entire payment year effective July 1.

(d) In all cases the vendor shall actually incur the cost to be eligible for a rate adjustment.

(e) Documentation submitted by a vendor as the basis for an adjustment shall be subject to Departmental review and Departmental and/or regional center audit, as well as to all policies and procedures pertaining to such reviews and audits.

(f) No rate adjustment shall result in a rate exceeding the approved maximum daily rate for the vendor based on vendor grouping pursuant to section 58873(a) through (h).

(g) The Department shall take into account, as a basis for a rate adjustment, increases in occupancy cost (limited to rent, lease, mortgage interest, and building depreciation) from the historical period to the payment period, only if all of the following apply:

(1) The increase in rent, lease, mortgage interest, and/or building depreciation for the payment year exceeds the corresponding cost(s) in the historical period;

(2) The increased cost:

(A) Resulted in needed and more normalized or improved services to consumers and was approved in writing by the Department before it was incurred; or

(B) Was unavoidable, such as loss of lease or disaster, and the replacement vendor site, or portion thereof, was obtained at a cost consistent with the average cost paid for buildings in the area; or

(3) The vendor submits the request for adjustment in writing prior to July 1 of the payment year, except in cases of disasters such as earthquakes, floods, and fires, and in the form required by the Department;

(4) The vendor shall complete a Request for Rate Adjustment B Occupancy on a form specified by the Department and submit it to the Department with a copy to the vendoring regional center prior to July 1 of the payment year for which the adjustment is being requested, except in the case of disaster when the form shall be submitted before new occupancy commitments are made;

(5) If the cost increase meets all of the requirements specified in (g)(1) through (3) above, the Department shall deduct that amount from the historical period cost, and use the difference to compute the rate adjustment;

(6) If space utilization differs from that of the historical period, the vendor shall submit a Space Utilization Report, Form DS 1950 (3/05) Tab B, as a basis for distribution of the increased costs. If there is no change, the costs shall be distributed as in the historical period;

(7) The Department shall use all historical consumer data to calculate the adjustment for the payment year. However, because costs are payment year costs, no COLA increases shall be applied in the year of the adjustment.

(h) The Department shall make rate adjustments for staffing for the following reasons:

(1) If a vendor's Work Activity Program staff-to-consumer ratio in the historical period falls below the staffing level as defined here and the vendor elects to hire staff to attain this staffing level;

(A) The staffing level the Department will use as a basis for rate adjustments shall be applied to all consumers and staff in the combined programs offered by the Work Activity Program and is as follows:

(i) For direct service staff, three staff positions for the first ten consumers, and one additional staff position for each additional ten consumers;

(ii) These positions include the executive director, rehabilitation counselor, and all staff positions whose function is primarily to provide direct service to consumers including, but not limited to, supervision, training, and education;

(iii) The position(s) of executive director and/or rehabilitation counselor may be combined;

(B) For administrative support staff, one staff position to provide clerical support and one staff position to provide fiscal support.

(i) If the functions of the administrative support staff above are included in the duties of staff defined as service delivery staff, the position(s) shall be calculated on a pro rata basis between direct service and administrative support;

(ii) If the vendor's Work Activity Program staffing level is not maintained following payment of a rate adjustment for that purpose, no future adjustments shall be approved for this reason; and/or

(iii) If the vendor incurs a loss of subsidized staff, from the historical period, causing the staff-to-consumer ratio to fall below the staffing level above, and hires or retains staff to attain or maintain this staffing level;

(iv) If the vendor cannot confirm the loss of subsidized staff prior to the deadline for submission of a request for rate adjustment, the vendor shall obtain information from the source of subsidy, and on the basis of that information, submit a request if there is likelihood that substantial subsidy will be lost.

(i) The adjustment, if approved, shall be based on the information as known, and if the subsidy is not reduced, the adjustment, in full or in part, will be rescinded retroactively.

(j) In all cases, the vendor shall supply written documentation verifying the hiring or retention of the staff including the salary and fringe benefits to be paid to such staff.

(k) The vendor shall complete a Request for Rate Adjustment B Staffing on a form specified by the Department and submit it to the Department with a copy to the vendoring regional center prior to July 1 of any future payment years for which the adjustment is being requested.

(l) Following the request for a rate adjustment by the vendor, the Department shall review the data submitted on the Staff Survey Report(s), Form DS 1950 (3/05) Tab A, the Consumer Survey Report(s), Forms DS 1950 (3/05) Tab G for the historical period to determine if the vendor met the staffing level as defined in this Section during the historical period, or if the loss of subsidized staff caused it to fall below that level for that period.

(m) If the vendor did not meet the staffing level as defined in this Section, the Department shall prorate the annual salary and fringe benefits to staff to be hired, or retained, based on the date hiring or retention is to occur.

(n) The Department shall enter the cost in (d) above on the Rate Computation Sheet, Form DS 1950 (3/05) Tab H and distribute it based on the Staff Survey Report, Form DS 1950 (3/05) Tab A.

(o) The Department shall complete the rate calculation using all client data from the historical period.

(p) The Department shall add no COLA increases in the year of the adjustment because costs used in calculating the rate adjustment are for current payment year costs.

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including amendment of section heading and section, renumbering and amendment of former section 58877 to section 58876(g)-(g)(7) and renumbering and amendment of former section 58878 to section 58876(h)-(p), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58877. Rate Adjustment Due to an Increase in Occupancy Cost. [Renumbered]

Note • History

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including renumbering of former section 58877 to section 58876(g)-(g)(7), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58878. Rate Adjustment Due to a Change in Staff-to-Consumer Ratio. [Renumbered]

Note • History

NOTE

Authority cited: Section 11152, Government Code; and Sections 4857.1, 4859(a), 4860(b) and 4866, Welfare and Institutions Code. Reference: Sections 4859 and 4861(b), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order, including renumbering of former section 58878 to section 58876(h)-(p), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58879. Rate Appeals. [Renumbered]

Note • History

(a) Any vendor disputing a departmental decision affecting its rate for Work Activity Program services may appeal the decision pursuant to Sections 57940 through 57948.

NOTE

Authority cited: Chapter 722, Statutes of 1992, Section 147; and Section 4691, Welfare and Institutions Code. Reference: Section 4691, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

Article 9. Billing and Payment

§58880. Work Activity Programs.

Note • History

(a) For each payment year, the Department shall establish a maximum number of service days per year, which shall be based on a maximum of five days per week, minus the number of nationally observed holidays. At the beginning of each payment year, all Work Activity Programs shall submit to the applicable regional center, for approval a schedule of the number of days per month for which reimbursement will be requested for services provided; the total number of days in that schedule shall not exceed the maximum number of service days established by the Department.

(b) The regional center shall make payment for services using a daily rate as follows:

(1) A Work Activity Program may bill for a full day of service when the Work Activity Program has written documentation that the consumer has received allowable Work Activity Program services as specified in Section 4851(h) of the Welfare and Institutions Code;

(2) A Work Activity Program may bill for a half-day of service when the Work Activity Program has written documentation that the consumer has received services as specified in Section 4851(i) of the Welfare and Institutions Code;

(3) A Work Activity Program may not bill for a consumer who is absent or who receives services for less than two hours, excluding the lunch period, except that the Department may authorize payment for absences which are the direct result of situations or occurrences for which a state of emergency has been declared. If payment for absences due to a state of emergency is authorized, the Work Activity Program shall bill only for daily absences in excess of the average percentage of daily absences experienced by the Work Activity Program, per consumer, in the same month of the year previous to the year in which the state of emergency was declared. If the Work Activity Program was not in operation in the previous year, the average percentage of absences per consumer shall be based on the most recent comparable month, as determined by the Department, in which billing was made to the regional center;

(4) Payment using a daily rate shall be as follows:

(A) For full-day and half-day billing, the Work Activity Program shall add the approved full-days and half-days of service for each consumer for each month and invoice the regional center after the month's end for the total number of billing days for each consumer, not to exceed the maximum number of billing days for the billing month per the schedule submitted to regional center.

(c) The regional center may make payment for services using an hourly rate determined by the regional center and specified by a service contract pursuant to Section 57540. The Work Activity Program or regional center shall request this option from the other party not less than 60 (sixty) days prior to the month in which billing using an hourly rate is requested. The Work Activity Program or regional center may refuse the request. The service contract shall be effective for a minimum of one year unless the regional center discontinues payment for services on an hourly basis if it determines that the information submitted is not supported by sufficient documentation, or if it determines that the cost of using an hourly rate is greater than the cost of utilizing a daily rate or other terms of the contract are not met.

(d) The hours billed for each consumer for each month shall be determined by totaling the number of hours and minutes of services for each day. At the end of the month, the Work Activity Program shall round the total numbers of hours and minutes for each consumer to the nearest hour for the month, using simple rounding, i.e., round down for less than a half hour and round up for a half hour or more.

(e) The vendor shall maintain records for each consumer of all daily start and end times of the service, the daily lunch period, and any interruptions in the program day and as specified in Section 58822.

(f) The regional center shall make no payment for services to any person, including students of elementary or secondary schools, for whom any other agency has primary responsibility for providing such services according to Federal or State statute.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4863, 4864 and 4867, Welfare and Institutions Code.

HISTORY

1. New article 9 (sections 58880-58882) and section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be transmitted to OAL by 11-19-2004 or emergency language will be repealed by operation of law on the following day.

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

3. New article 9 (sections 58880-58882) and section refiled 11-29-2004 as an emergency; operative 11-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be transmitted to OAL by 3-29-2005 or emergency language will be repealed by operation of law on the following day.

4. New article 9 (sections 58880-58882) and section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by 7-28-2005 or emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of subsections (b)(3) and (b)(4)(A), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative 8-31-2005 (Register 2005, No. 31).

§58881. Supported Employment Programs.

Note • History

(a) Payment rates for Supported Employment Program services are specified in Welfare and Institutions Code 4860.

(b) Vendors must maintain adequate documentation to support the job coaching billed to the regional center as specified in Section 58831(a).

(c) A Supported Employment Program may not bill for group services when a job coach is not present, except that the Department may authorize payment for group services that were not provided when the work site was not accessible due to the direct result of situations or occurrences for which a state of emergency has been declared. If payment due to a state of emergency is authorized, the Supported Employment Program shall bill only for job coaching for days the work site was not accessible, as determined by the Department, in which billing was made to the regional center.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Section 4860, Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

§58882. Billing for Temporary Transfers.

Note • History

(a) Procedure for Authorization of a temporary transfer:

(1) Temporary transfers should be anticipated and planned for during the IPP. The pre-authorization of a temporary transfer should specify the criteria and maximum number of days of the temporary transfer.

(2) Emergency authorization of a temporary transfer pursuant to Section 50612.

(b) The regional center may grant an extension of a temporary transfer if there is a delay in the return date to the job beyond the original 60-calendar day authorization for the temporary transfer;

(1) Delays may include:

(A) Temporary employer closures, e.g. school breaks, inventory, natural disasters;

(B) Adverse weather conditions;

(1) From Supported Employment - Group Placement to a Work Activity Program shall be billed for the consumer utilizing the Work Activity Program Purchase of Service and not under the Supported Employment Program B Group Placement Purchase of Service;

(2) From a Work Activity Program to Supported Employment Group Placement shall be billed for the consumer utilizing the Supported Employment Program -- Group Placement Purchase of Service and not the Work Activity Program Purchase of Service.

NOTE

Authority cited: Section 11152, Government Code; and Section 4866, Welfare and Institutions Code. Reference: Sections 4854.1, 4857, 4860(b) and 4862(c)(1)(2), Welfare and Institutions Code.

HISTORY

2. Repealed by operation of Government Code section 11346.1(g) (Register 2004, No. 49).

5. Certificate of Compliance as to 3-30-2005 order transmitted to OAL 6-21-2005 and filed 8-1-2005 (Register 2005, No. 31).

Subchapter 22. Participant-Directed Services

Article 1. Definitions

§58883. Meaning of Words.

Note • History

Words shall have their usual meaning unless the context or a definition clearly indicates a different meaning. Words used in their present tense include the future tense. Words used in the singular form include the plural form. Use of the word “shall” indicates conduct that is required, and “may” indicates conduct that is permitted.

NOTE

Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631 and 4648(a), Welfare and Institutions Code.

HISTORY

1. New subchapter 22 (articles 1-3, sections 58883-58888), article 1 (sections 58883-58884) and section filed 8-29-2011 as an emergency; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL by 2-27-2012 or emergency language will be repealed by operation of law on the following day.

§58884. Definitions.

Note • History

(a) The following definitions shall apply to the language contained in Subchapter 22 of these regulations:

(1) Participant-Directed Services means those services described in California Code of Regulations, Title 17, Section 58886(a) and includes the adult consumer or family member exercising decision-making authority over specified services.

(2) Co-Employer means the vendored adult consumer or family member who manages employees that provide specified Participant-Directed Services and who works with the Financial Management Service Co-Employer. The Co-Employer makes recommendations to the Financial Management Services Co-Employer on who to hire to perform a specified Participant-Directed Service.

(3) Employer means the vendored adult consumer or family member who hires and engages an employee or procures an entity to perform a specified Participant-Directed Service.

(4) Financial Management Service Co-Employer (FMS Co-Employer) means a vendored entity that functions with the Co-Employer to hire an employee pursuant to the Co-Employer's recommendation and pays the employee to perform the Participant-Directed Services.

(5) Financial Management Service Fiscal/Employer Agent (FMS F/EA) means the vendored entity that functions as the adult consumer's agent or family member's agent in performing payroll duties according to IRS regulations, processing payments for the reimbursement of goods and services, and performing other employer responsibilities that are required by federal and state law. Under this arrangement the adult consumer or family member is the employer.

(6) Individual Family Service Plan (IFSP) has the meaning specified in California Code of Regulations, Title 17, Section 52100.

(b) As used in this subchapter, the following terms shall have the meanings specified in California Code of Regulations, Title 17, Section 54302:

(1) Adult;

(2) Consumer;

(3) Family member

(4) Individual Program Plan (IPP); and

(5) Vendor.

NOTE

Authority cited: Sections 4405, 4648(a), 4648.12(c)(1)(B) and 4688.21(d), Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a), 4648.12(c) and 4688.21, Welfare and Institutions Code; 42 U.S.C. Section 1396n(c) (Section 1915(c) of the Social Security Act).

HISTORY

1. Adoption of subsections (a)(2) and (a)(4) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4688.21; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 24 months or emergency language will be repealed by operation of law on the following day.

2. Adoption of subsections (a)(1), (a)(3), (a)(5)-(6) and (b) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

Article 2. General Requirements for Participant-Directed Services

§58886. General Requirements for Participant-Directed Services.

Note • History

(a) Effective October 1, 2011, for consumers and family members of consumers receiving the services in California Code of Regulations, Title 17, Section 54355 (g) (1), (3), (4), and (5), when these services are funded with federal financial participation through Medicaid programs, the regional center may offer Participant-Directed Services to allow the adult consumer and/or family member to procure their own community-based training service, day care, nursing, respite, and/or transportation services.

(b) When an adult consumer or family member makes the decision to use Participant-Directed Services the regional center shall:

(1) Provide information regarding their responsibilities and functions as either the Employer or Co-Employer;

(2) Provide information about the requirements regarding the use of a FMS Co-Employer or FMS F/EA;

(3) Assist the adult consumer or family member to identify and choose an FMS Co-Employer or FMS F/EA as follows:

(A) An adult consumer or family member who chooses to be the Employer as described in Section 58884(a)(3) shall make use of a FMS F/EA vendor pursuant to Section 58884(a)(5);

(B) An adult consumer or family member who chooses to be a Co-Employer as described in Section 58884(a)(2) shall make use of a FMS Co-Employer pursuant to Section 58884(a)(4); and

(4) Vendor the adult consumer or family member acting as Employer or Co-Employer for one or more Participant-Directed Services pursuant to (c), and a family member of more than one consumer shall only be vendored once.

(1) Recruits workers;

(2) Verifies worker qualifications;

(3) Specifies additional worker qualifications based on consumer needs and preferences;

(4) Determines worker duties;

(5) Schedules workers;

(6) Orients and instructs workers in duties;

(7) Supervises workers;

(8) Evaluates worker performance; and

(9) Verifies time worked by employees and approves time sheets.

(d) The Employer or Co-Employer has the following additional responsibilities:

(1) The adult consumer or family member in the capacity as an Employer pursuant to (b)(3)(A) above has independent authority to:

(A) Hire workers; and

(B) Terminate workers.

(2) The adult consumer or family member in the capacity as Co-Employer pursuant to (b)(3)(B) above has authority to make recommendations to the FMS Co-Employer for hiring and terminating workers.

(e) The regional center shall vendor the Employer and Co-Employer in accordance with vendor requirements contained in California Code of Regulations, Title 17, Sections 54310 and 54326, in addition to the following requirements:

(1) Participant-Directed Day Care Service -- Family Member -- Service Code 455.

(A) A regional center shall classify a vendor as Participant-Directed Day Care Service -- Family Member if the vendor:

1. Is a family member;

2. Is not the direct provider of the day care service; and

3. Selects the day care service for the consumer from:

a. An individual who possesses the skill, training, or education necessary to provide the day care service; or

b. An agency that meets the criteria specified in California Code of Regulations, Title 17, Section 54342(a)(4) or (a)(15)(A), (B), or (C).

(B) Participant-directed day care services for children shall only be authorized by regional centers for day care costs and/or hours exceeding the cost of providing day care services provided to a child without disabilities. The regional center may pay in excess of this amount when a family can demonstrate a financial need and when doing so will enable the children to remain in the family home.

(2) Participant-Directed Nursing Service -- Family Member -- Service Code 460.

(A) A regional center shall classify a vendor as a Participant-Directed Nursing Service -- Family Member if the vendor:

1. Is a family member; and

2. Selects, assigns, and monitors an individual who provides nursing services for a consumer.

(B) The family member may be the direct provider of the nursing service if the service is not intended to provide respite to the family member.

(C) The individual or family member who provides the nursing service shall possess the qualifications specified in California Code of Regulations, Title 17, Section 54342(a)(46), (51), or (66).

(3) Participant-Directed Respite Service -- Family Member -- Service Code 465.

(A) A regional center shall classify a vendor as Participant-Directed Respite Service -- Family Member if the vendor:

1. Is a family member;

2. Is not the direct provider of the respite service; and

3. Selects the respite service for the consumer from an individual who is at least 18 years of age and possesses the skill, training, or education necessary to provide the respite service. The vendored family member shall be responsible for ensuring that the individual selected to provide the respite service will possess the skill, training, or education necessary to provide the respite service. In addition, the vendored family member is responsible for ensuring that the person providing respite care is familiar with the consumer's daily routines and needs, and is trained in any specialized supports necessary for the consumer. To the extent that these specialized support needs require additional training or certification in such things as First Aid, Cardiopulmonary Resuscitation (CPR), etc., these needs and requirements will be included as part of the description of respite care needs in the consumer's IPP or IFSP; or

4. An agency that meets the criteria specified in California Code of Regulations, Title 17, Section 54342(a)(39); or

5. For out-of-home respite services, a facility which meets the standards specified in California Code of Regulations, Title 17, Section 54342(a)(58) or (72). A relative who provides out-of-home respite in the relative's own house is exempt from licensure pursuant to Title 22, California Code of Regulations, Section 80007.

(4) Participant-Directed Transportation -- Family Member -- Service Code 470.

(A) A regional center shall classify a vendor as Participant-Directed Transportation -- Family Member if the vendor secures the transportation to and/or from authorized services identified in the consumer's IPP and the vendor:

(B) The individual who is actually providing the transportation service shall:

1. Possess a driver's license which is valid in California; and

2. Have evidence of maintenance of adequate insurance coverage pursuant to Welfare and Institutions Code, Section 4648.3.

(C) Participant-Directed Transportation shall only be authorized by regional centers to cover transportation costs which exceed the transportation costs that the family member would incur for a minor child without disabilities. The regional center may pay in excess of this amount when a family can demonstrate a financial need and when doing so will enable the consumer to remain in the family home.

(5) Participant-Directed Community-Based Training Service for Adults -- Service Code 475, as established in Welfare and Institutions Code Section 4688.21(c)(1) through (12) is an adult day program service that assists the adult consumer in the development of skills required for community integrated employment and/or participation in volunteer activities and to secure employment and/or volunteer positions or pursue secondary education.

(A) A regional center shall classify a vendor as a Participant-Directed Community-Based Training Service for Adults if the vendor:

1. Is an adult consumer, family member, or conservator;

2. Is not the direct provider of the community-based training service for adults. A parent or conservator shall not be the direct support worker employed by the community-based training vendor; and

3. Selects the community-based training service for adults from an individual who is at least 18 years of age and possesses the skill, training, or experience necessary to provide the community-based training service for adults in accordance with the IPP. If the selected individual is required to transport the consumer, meets the requirements in (e)(4)(B) above.

(B) The Participant-Directed Community-Based Training Service for Adults shall be provided in natural environments in the community, separate from the consumer's residence.

(f) By September 30, 2011, adult consumers or family members vendored pursuant to California Code of Regulations, Title 17, Section 54355(g)(1), (3), (4) and (5) who choose to be an Employer or Co-Employer are not required to be re-vendored. The regional center shall:

(1) Ensure that the adult consumer or family member continues to meet vendor requirements in accordance with (b), (c), (d) and (e) above;

(2) Provide the adult consumer or family member with information regarding the requirements to use an FMS Co-Employer and/or FMS F/EA pursuant to (b) above when these services are funded with federal financial participation through Medicaid and about the requirements for the applicable Participant-Directed Services, pursuant to (e) above;

(3) Assist the adult consumer or family member to identify and choose an appropriate FMS Co-Employer or FMS F/EA pursuant to (b) above;

(4) Assign the applicable Participant-Directed Service code pursuant to (e) above, with services to be effective no sooner than October 1, 2011; and

(5) Continue to pay the existing rate of the voucher service(s) for the corresponding participant-directed services as described in (e) above.

NOTE

HISTORY

1. Adoption of article 2 (sections 58886-58887) and subsection (e)(5) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4688.21; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 24 months or emergency language will be repealed by operation of law on the following day.

2. Adoption of subsections (a)-(e)(4)(C) and (f)-(f)(5) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

§58887. Service Components for Participant-Directed Services.

Note • History

(a) Effective August 29, 2011, the FMS F/EA, pursuant to (b) below, and the FMS Co-Employer, pursuant to (c) below, shall be vendored to provide the following services to support the adult consumer or family member with the employment of workers to carry out authorized Participant-Directed Services:

(1) Collect and process timesheets of workers providing Participant-Directed Services;

(2) Assist the family member or adult consumer in verifying the worker's eligibility for employment as evidenced by a copy of the social security number or any document pursuant to California Code of Regulations, Title 17, Section 50604(d)(3), if individual worker is used;

(3) Process payroll, withholding, filing and payment of applicable federal, state and local employment related taxes and insurance for authorized Participant-Directed Services;

(4) Track, prepare and distribute monthly expenditure reports to the Employer or Co-Employer and the regional center;

(5) Maintain all source documentation related to the authorized service(s) and expenditures;

(6) Maintain a separate accounting of funds used for each adult consumer or family member Participant-Directed Service; and

(7) Ensure payments do not exceed the amounts and rates authorized by the regional center subject to the limits of California Code of Regulations, Title 17, Section 58888.

(b) FMS F/EA -- Service Code 490.

(1) A regional center shall classify an applicant as an FMS F/EA if the applicant meets vendor requirements described in California Code of Regulations, Title 17, Sections 54310 and 54326, and demonstrates the ability, skills, and knowledge to carry out both the responsibilities in (a) above and the following additional requirements of an FMS F/EA to assist an adult consumer or family member functioning as an Employer:

(A) For the purposes of processing payroll, apply for and obtain authorization under Section 3504 of the Internal Revenue Code to be an agent for each adult consumer or family member that the FMS F/EA represents;

(B) During the period from when the FMS F/EA makes application to the Secretary of the Internal Revenue Service (IRS) until receiving IRS approval, the FMS F/EA shall be responsible for applicable federal, state and local employment-related taxes and insurance; and

(C) Process payments for reimbursements to entities providing goods and services in accordance with applicable IRS regulations.

(2) The FMS F/EA may process payroll for services provided by individual workers, and reimbursements for services provided by other entities.

(1) A regional center shall classify an applicant as an FMS Co-Employer if the applicant meets vendorization requirements described in California Code of Regulations, Title 17, Section 54310 and demonstrates the ability, skills, and knowledge to carry out both the responsibilities in (a) above and the following additional requirements specific to assisting an adult consumer or family member functioning as a Co-Employer:

(A) Hiring of individual employees who have been selected by the adult consumer or family member to provide Participant-Directed Services;

(B) Providing other employer-related supports to the Co-Employer as specified in the consumer's IPP.

(2) The FMS Co-Employer shall process payroll for services provided by the employees.

(d) The FMS Co-Employer and the FMS F/EA shall submit billings/invoices to the regional center for reimbursement for expenditures for authorized Participant-Directed Services and meet the requirements of California Code of Regulations, Title 17, Section 50604.

(e) The FMS Co-Employer and the FMS F/EA shall reimburse the worker(s) who provide(s) the authorized Participant-Directed Service(s) at a rate not to exceed the specified rates in California Code of Regulations, Title 17, Section 58888.

NOTE

HISTORY

1. Adoption of subsections (a)-(a)(7) and (c)-(e) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4688.21; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 24 months or emergency language will be repealed by operation of law on the following day.

2. Adoption of subsections (b)-(b)(2) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

Article 3. Participant-Directed Services Rate-Setting Provisions

§58888. General Provisions for Rate-Setting and Reimbursements.

Note • History

(a) The Participant-Directed Service(s), and units of service shall be determined through the IPP process pursuant to Welfare and Institutions Code Sections 4646 and 4646.5. The rate of payment for the service shall not exceed the maximum rate of reimbursement as specified below:

(1) Participant-Directed Day Care Service -- Family Member -- Service Code 455 -- the usual and customary rate, as defined in California Code of Regulations, Title 17, Section 57210(a)(19), which the direct provider of the service charges or, if the direct provider of the service does not have an established usual and customary rate, a negotiated rate pursuant to California Code of Regulations, Title 17, Section 57300(e);

(2) Participant-Directed Nursing Service -- Family Member -- Service Code 460 -- the Schedule of Maximum Allowances for the Home and Community Based Services, In-Home Medical Care Waiver Program, as developed by the Department of Health Care Services;

(3) Participant-Directed Respite Service -- Family Member -- Service Code 465 -- the rate established pursuant to California Code of Regulations, Title 17, Section 57310(b)(3);

(4) Participant-Directed Transportation -- Family Member -- Service Code 470 -- the standard rate schedule developed by the regional center pursuant to California Code of Regulations, Title 17, Section 58543; and

(5) Participant-Directed Community-Based Training Service -- Service Code 475 -- $13.47 per consumer per hour up to a maximum of 150 hours per quarter. The rate includes employer-related taxes and all transportation needed to implement the service, except that the consumer shall also be eligible for a regional center-funded bus pass, if appropriate and needed.

(b) The regional center shall authorize a rate of payment for the FMS F/EA and FMS Co-Employer as follows:

(1) For FMS FE/A services as described in Section 58887(a) and (b):

(A) A rate not to exceed a maximum of $45.00 per consumer per month for one Participant-Directed Service; or

(B) A rate not to exceed a maximum of $70.00 per consumer per month for two or three Participant-Directed Services; or

(2) For FMS Co-Employer services as described in Sections 58887(a) and (c) a rate not to exceed a maximum of $95.00 per consumer per month for one to four Co-Employer services.

(c) The regional center shall name the FMS Co-Employer -- Service Code 491, and/or the FMS F/EA -- Service Code 490, as the vendor of record for the purchase of service authorizations for the Participant-Directed Services identified in the consumer's IPP. The authorization shall have an effective date for services or payments no sooner than October 1, 2011.

NOTE

Authority cited: Sections 4405, 4648(a), 4648.12(c)(1)(B), 4688.21(d) and 4690, Welfare and Institutions Code; and Section 11152, Government Code. Reference: Sections 4631, 4648(a) and 4648.12(c), Welfare and Institutions Code.

HISTORY

1. Adoption of article 3 (section 58888) and subsection (a)(5) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4688.21; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 24 months or emergency language will be repealed by operation of law on the following day.

2. Adoption of subsections (a)-(a)(4) and (b)-(c) filed 8-29-2011 as a deemed emergency pursuant to Welfare and Institutions Code section 4648.12; operative 8-29-2011 (Register 2011, No. 35). A Certificate of Compliance must be transmitted to OAL within 18 months or emergency language will be repealed by operation of law on the following day.

Chapter 4. Case Management

Subchapter 1. General

Article 1. Definitions

§59000. Meaning of Words.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

1. New section filed 7-17-91 as an emergency and submitted to OAL on 7-17- 91 for printing only pursuant to section 4 of chapter 14 of the Statutes of 1991; operative 7-17-91 (Register 91, No. 48). A Certificate of Compliance must be transmitted to OAL by 11-14-91 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing chapter 4, subchapter 1 (articles 1-4, sections 59000-59011), article 1 (sections 59000-59001) and section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59001. Definitions.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code. 42 USC Section 1396n.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

Article 2. Case Management Services

§59002. Case Management Services.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing article 2 (section 59002) and section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

Article 3. Assessment Procedures

§59003. Fee Determinations.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852, 4853 and 14170, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing article 3 (sections 59003-59007) and section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59004. Self-Declaration of Income (SDOI).

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Section 4852, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59005. Health Insurance/Benefit Plan.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4659, 4851, 4852, 4853 and 14170, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59006. Health Insurance/Benefit Plan (HIBP).

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4852 and 14170, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59007. Reports.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

Article 4. Billings and Collections

§59008. Statements.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing article 4 (sections 59008-59011) and section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59009. Billings.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59010. Delinquency.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

§59011. Collections.

Note • History

NOTE

Authority cited: Chapter 14, Statutes of 1991, Section 4. Reference: Sections 4851, 4852 and 4853, Welfare and Institutions Code.

HISTORY

2. Certificate of Compliance as to 7-17-91 order transmitted to OAL 11-13-91 and filed 12-10-91 (Register 92, No. 9).

3. Change without regulatory effect repealing section filed 5-2-96 pursuant to section 100, title 1, California Code of Regulations (Register 96, No. 18).

Division 3. Air Resources

Chapter 1. Air Resources Board

Subchapter 1. Administrative Procedures

Article 1. Board Meetings and Hearings

§60000. Purpose.

Note • History

The regulations set forth in this subchapter shall supplement provisions in the Mulford-Carrell Air Resources Act (Division 26 of the Health and Safety Code), the Administrative Procedure Act, and the California Environmental Quality Act with regard to meetings and hearings of the state board and the executive officer.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 39000, et seq., Health and Safety Code; Sections 11340, et seq., Government Code; and Section 21080.5, Public Resources Code.

HISTORY

1. Redesignation of Subchapter 1 (Sections 60100-70201, not consecutive) to Subchapter 1.5 (Sections 60100-70201, not consecutive) filed 6-5-78; effective thirtieth day thereafter (Register 78, No. 23).

2. New Subchapter 1 (Sections 60000-60013) filed 6-5-78; effective thirtieth day thereafter (Register 78, No. 23).

3. Repealer of Subchapter 1 (Articles 1-2, Sections 60000-60023) and new Subchapter 1 (Articles 1-2, Sections 60000-60023) filed 11-25-81; effective thirtieth day thereafter (Register 81, No. 48). For prior history, see Registers 80, No. 27 and 80, No. 9.

§60001. Scheduling of Meetings.

Note

Meetings shall be scheduled by the chairperson or the executive officer of the state board, who may with appropriate notice change the starting time of any proceeding or reschedule, cancel, or continue the proceeding.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 39513, 39515, 39516, and 39600, Health and Safety Code; Section 11129, Government Code.

§60002. Notice.

Note

In addition to providing notice of state board meetings and hearings as required by statute, notice shall be mailed to state and local government agencies having jurisdiction by law with respect to a proposed activity of the state board and to persons who request such notice in writing. For informational purposes, notice may be provided to newspapers of general circulation, to all persons believed to be interested in the proceeding, and to the State Clearinghouse for circulation to public agencies.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 39002, 41502 and 41650, Health and Safety Code; Sections 11125 and 11346.5, Government Code.

§60003. Quorum.

Note

The presence of a majority of the total appointed members of the state board shall constitute a quorum, and formal decisions shall be by vote of a majority of the quorum. No formal decision on any item shall be made in the absence of a quorum.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: FTC v. Flothill Products, 389 U.S. 179, 183 (1967); Vita-Pharmacals v. Board of Pharmacy, 110 Cal.App.2d 826 (1952); Robert's Rules of Order .

§60004. Record of Proceedings.

Note

(a) Board proceedings shall be recorded electronically, or by other appropriate means. The recording or transcript shall be made available to the public for review at the state board's main office. At the request of the state board, the executive officer, or any interested person, the proceedings shall be recorded by a certified court reporter and the cost thereof borne by the person making the request. Upon a showing of need, economic hardship, and the public interest to be served, any person may request, and the state board or executive officer may grant, a transcript of specified proceedings at state board expense.

(b) For every rulemaking proceeding, the secretary of the state board shall maintain a file as required by Government Code Section 11347.3.

NOTE

Authority cited: Section 39601, Health and Safety Code. Reference: Section 39600, Health and Safety Code; and 11347.3, Government Code.

§60005. Staff Reports.

Note

(a) Where a public hearing is required by law or where the action contemplated may have a significant effect on the environment, a staff report, together with the proposed rule, regulation, order, standard or plan shall be prepared and published by the staff of the state board. For rulemaking proceedings governed by the Administrative Procedure Act, the staff report shall be published at least 45 days before the date of the public hearing. For all other such proceedings, the staff report shall be published as early as reasonably practicable prior to the proceeding. Staff reports shall be available for public review and comment and shall be distributed to all governmental agencies having jurisdiction by law over the proposed activity and to persons who have requested such reports.

(b) It is the policy of the state board to prepare staff reports in a manner consistent with the environmental protection purposes of the state board's regulatory program and with the goals and policies of the California Environmental Quality Act (CEQA; Public Resources Code Sections 21000 et seq.). All staff reports shall contain a description of the proposed action, an assessment of anticipated significant long or short term adverse and beneficial environmental impacts associated with the proposed action and a succinct analysis of those impacts. The analysis shall address feasible mitigation measures and feasible alternatives to the proposed action which would substantially reduce any significant adverse impact identified.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 21080.5, Public Resources Code.

§60006. Environmental Alternatives.

Note

Any action or proposal for which significant adverse environmental impacts have been identified during the review process shall not be approved or adopted as proposed if there are feasible mitigation measures or feasible alternatives available which would substantially reduce such adverse impact. For purposes of this section, “feasible” means capable of being accomplished in a successful manner within a reasonable period of time, taking into account economic, environmental, social, and technological factors, and consistent with the state board's legislatively mandated responsibilities and duties.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 21080.5, Public Resources Code.

§60007. Response to Environmental Assessment.

Note

(a) If comments are received during the evaluation process which raise significant environmental issues associated with the proposed action, the staff shall summarize and respond to the comments either orally or in a supplemental written report. Prior to taking final action on any proposal for which significant environmental issues have been raised, the decision maker shall approve a written response to each such issue.

(b) Notice of the final action and the written response to significant environmental issues raised shall be filed with the Secretary of the Resources Agency for public inspection.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 21080.5, Public Resources Code.

§60008. Local District Amendment of Regulations Adopted by State Board.

Note

(a) For one year after the state board's adoption for a district of any program or portion thereof or rule, or regulation, any amendment by a district pursuant to its own regulations, of such program or portion thereof or rule, or regulation, shall not be effective for any purpose unless and until the state board finds that such amendment will not interfere with the district's ability to achieve and maintain the state's ambient air quality standards. The state board may at any time, by resolution adopted either on its own motion or at the request of an affected district, exempt from the provisions of this section any program or portion thereof or rule, or regulation adopted by it for a local district.

(b) Upon amendment by a district, within the one-year period provided in paragraph (a), of a program or portion thereof or rule, or regulation, adopted for it by the state board, the district shall file such amendment with the general counsel of the state board, accompanied by a request for review pursuant to this section. Within thirty (30) days of such filing, the board's executive officer shall review the amendment for the purpose of making the state board finding set forth in paragraph (a). In the event the executive officer finds that the amendments do not satisfy the requirements of paragraph (a), the executive officer shall notify the district in writing of such finding and set forth the specific reasons therefor. Unless the executive officer so notifies the district within the thirty-day period specified herein, the state board shall be deemed to have made the finding set forth in paragraph (a) of this section.

(c) The determination of the executive officer pursuant to paragraph (b) of this section shall be reviewable by the state board pursuant to the procedures set forth in Sections 60020-60023 of Title 17 of the California Administrative Code.

NOTE

Authority cited: Sections 39600, 39601 and 41504, Health and Safety Code. Reference: Sections 39002, 39500, 39600 and 41500, Health and Safety Code.

Article 2. State Board Review of Executive Officer Actions

§60020. Petition.

Note

(a) A petition to the state board for review of action taken by the executive officer relating to the matters set forth in Health and Safety Code Section 39515(c) must be received by the state board or postmarked no later than thirty (30) days from the date of the action sought to be reviewed.

(b) Any air pollution control district, air quality planning agency, or member of the public shall, upon written request to the board secretary, be mailed notice of such executive officer action at the time it is taken.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 39515, Health and Safety Code.

§60021. Scheduling of Board Review; Procedure for Stay.

Note • History

(a) Upon receipt of a petition for review of an executive officer action, the matter shall be placed on the agenda of the next regularly scheduled board meeting to take place at least ten (10) days following receipt of the petition. A notice shall be promptly mailed to the petitioner and to all parties who participated in any executive officer hearing on the action being reviewed.

(b) The executive officer action shall remain in full force and effect pending state board review unless petition for review demonstrates to the satisfaction of the executive officer that a stay of the action is needed to prevent irreparable injury to the public or an affected member thereof. If, in its initial consideration of a petition for review, the board does not take final action on the petition, or at any other time, the board may, at the request of the petitioner or on its own motion, grant a stay of the executive officer action pending final board action.

(c) The board or the executive officer shall have the power, on a showing of good cause by the petitioner, to continue the hearing on the petition to the next regularly scheduled board meeting following the meeting at which the petition is originally scheduled for hearing.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 39515, Health and Safety Code.

HISTORY

1. Editorial correction of subsection (a) filed 5-7-84; effective thirtieth day thereafter (Register 84, No. 19).

§60022. Record Before the State Board.

Note

(a) The state board shall review the executive officer action based upon (1) the record on which the executive officer action was based; and (2) the contents of the petition(s) requesting state board review. Additionally, where the state board determines that additional evidence is necessary to its review of the action of the executive officer, it may consider such new evidence, provided that all interested persons who participated in any proceeding before the executive officer are given at least fifteen (15) days to respond to any evidence accepted by the board. Any person desiring the board to consider new evidence shall submit such evidence in writing no later than three (3) days prior to the hearing. Where the executive officer acted pursuant to a hearing, only persons who participated in the hearing may submit new evidence to the board.

(b) At the hearing at which the board considers the petition, the petitioner shall be afforded the opportunity to comment in support of the petition.

NOTE

Authority cited: Sections 39600 an 39601, Health and Safety Code. Reference: Section 39515, Health and Safety Code.

§60023. State Board Action on Review.

Note

Upon completing its review of the executive officer action, the state board may:

(1) affirm the action of the executive officer; or

(2) set aside or modify the action of the executive officer; or

(3) direct the executive officer to take appropriate action as directed by the state board.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Section 39515, Health and Safety Code.

Article 3. Permit Procedures

§60030. Permit Application Review and Processing.

Note • History

(a) The procedures and time periods set forth in this subsection shall apply to all permit applications received by the board, except for those permit applications specified in subsection (b).

(1) Within 30 days of receipt of an application for a permit, as defined in Government Code Section 15375(a), the executive officer shall inform the applicant, in writing, either that the application is complete and accepted for filing or that the application is deficient and identify the specific information required to make the application complete.

(2) Within 15 days of receipt of additional information provided in response to a determination by the executive officer that an application is deficient, the executive officer shall inform the applicant, in writing, either that the new information is sufficient to make the application complete and that the application is accepted for filing, or that the application is deficient and shall identify the specific information required to make the application complete.

(3) Within 90 days after an application is accepted for filing, the executive officer shall act to approve or to disapprove the application.

(b) For the categories listed below, permit applications shall be processed as provided in the procedures specified in subsection (a), in accordance with the following time periods:

No. of days after No. of days after

receipt of appli- receipt of

cation within which additional infor-

executive officer mation within which

will inform the appli- executive officer No. of days after

cant either that the will determine application is

application is com- whether the infor- accepted for filing

plete or that addi- mation submitted within which

tional information makes the appli- executive officer will

is required cation complete act on the application

Type of Permit

Emergency variance for lead in gasoline 1 5 5 10

Emergency variance for sulfur in gasoline or diesel 2 5 5 10

Waiver for lead in gasoline 3 15 15 45

Approval of independent testers 4 15 15 905

Certification of vapor recovery systems6 60 30 120

1Title 13, California Code of Regulations, Section 2253.2

2Title 13, California Code of Regulations, Section 2252

3Title 13, California Code of Regulations, Section 2253.2

4Title 17, California Code of Regulations, Section 91207

5This period applies to each test, as specified in Section 91201 of Title 17, California Code of Regulations, for which approval is requested.

6Title 17, California Code of Regulations, Section 94011

(c) The executive officer may, in the course of processing the application, request the applicant to clarify, amplify, correct, or otherwise supplement the information required for the application.

(d) The time periods in subsections (a) or (b) may be extended by the executive officer for good cause as provided by Government Code Section 15376.

(e) Based on the state board's experience in processing permits, from the receipt of the initial application to the final permit decision, during the two years immediately preceding the proposal of these regulations:

(1) the minimum time for processing a permit was 5 days;

(2) the maximum time for processing a permit was 567 days; and

(3) the estimated median time for processing a permit was 30 days.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 15375 and 15376, Government Code.

HISTORY

1. New Article 3 (Section 60030) filed 3-2-84; effective thirtieth day thereafter (Register 84, No. 9).

2. Amendment of table and footnotes in subsection (b) filed 3-20-2001; operative 4-1-2001 pursuant to Government Code section 11343.4 (Register 2001, No. 12).

Subchapter 1.25. Administrative Procedures--Hearings

Article 1. Adjudicatory Hearings

§60040. Applicability.

Note • History

(a) The provisions of this article shall apply to all adjudicatory hearings conducted for the purpose of reviewing any of the following decisions of the executive officer: (1) vehicle or engine recalls pursuant to Health and Safety Code Section 43105; (2) intention to revoke or suspend a license as a vehicle emission test laboratory pursuant to Section 2048 of Title 13, California Code of Regulations; and (3) to other decisions of the executive officer where the person directly affected by the executive officer's action requests a hearing and where an adjudicatory hearing is required by law but neither the administrative adjudication procedures contained in Government Code Sections 11500 et seq. nor other hearing procedures are specified. The provisions of this article do not apply to review of decisions of the executive officer related to the programs or actions of air pollution control or air quality management districts.

(b) The provisions of this article shall apply to the review of all decisions of the executive officer covered by subparagraph (a) issued prior to the effective date of article 2, sections 60055.1, et seq. All subsequently issued executive officer decisions shall be subject to the procedures set forth in article 2, sections 60055.1, et seq.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

2. New subchapter 1.25 (articles 1-4), redesignation of former article 4 to article 1 (sections 60040-60053) and amendment adding subsection (b) filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60041. Definitions.

Note • History

(a) “Days” means calendar days.

(b) “Manufacturer working days” means the days when the headquarters of the manufacturer-petitioner is open for business.

NOTE

Authority cited: Section 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60042. Petition for Hearing.

Note • History

(a) Within 20 days after receipt of a decision by the executive officer described in Section 60040, the person directly affected by the decision may file a petition requesting a hearing to review the decision. Notwithstanding the above, a petition for a hearing pursuant to Health and Safety Code Section 43105 may be filed within 30 manufacturer working days of receipt of the executive officer's decision.

(b) Petitions shall be filed with the board secretary at the offices of the state board in Sacramento and shall include the following information:

(1) the name and address of the petitioner;

(2) a copy of the executive officer decision for which review is requested;

(3) the date the decision was received by the petitioner;

(4) the action the state board is requested to take;

(5) a complete, verified statement of the facts and relevant evidence; and

(6) the grounds on which review is requested, including legal argument and authorities. The verification may be on information and belief. The chairperson of the state board shall review the petition and if he/she determines that a hearing is not required by law, the petitioner shall be notified of the decision and there shall be no hearing under this article. The board secretary shall send a copy of the petition to any person who was given written notice of the executive officer's decision.

NOTE

Authority cited: Section 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60043. Effect of Filing a Petition.

Note • History

A decision of the executive officer ordering a recall of vehicles or engines or intending to suspend or revoke the license of a vehicle emission test laboratory shall be stayed on timely receipt of a petition requesting a hearing until the state board has filed a decision with the board secretary. Other decisions of the executive officer shall also be stayed until the state board has filed the decision with the board secretary unless the executive officer finds that the adverse effects of a stay on the public health, safety and welfare outweigh the harm to those persons directly affected by the lack of a stay.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60044. Executive Officer Response to Petition.

Note • History

Within 20 days after receipt of a petition by the board secretary, the executive officer shall file with the board secretary and serve upon the petitioner a response to the petition, except that the executive officer shall file a response within 15 manufacturer working days to a petition regarding executive officer decisions pursuant to Health and Safety Code Section 43105. The response shall contain the reasons for and the facts in support of the decision of the executive officer under review.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60045. Time for and Notice of Hearings.

Note • History

(a) A hearing shall be initiated no later than 75 days after receipt of a petition for review except that the hearing shall be initiated no later than 45 manufacturer working days after receipt of a petition regarding executive officer decisions pursuant to Health and Safety Code Section 43105. The state board may delay the hearing upon a showing of good cause therefore by any party, provided that the petitioner's consent to the delay must be obtained if the executive officer's decision is not stayed.

(b) The state board shall mail written notice to the petitioner and to any persons who have requested notice at least 30 days before the scheduled date of hearing, indicating the time and location of the hearing, except that the notice shall be mailed 25 manufacturer working days prior to a hearing regarding an executive officer decision pursuant to Health and Safety Code Section 43105. The notice shall state that the parties may, but need not be, represented by counsel at the hearing. The notice of the hearing shall also be posted in the state board offices in Sacramento and El Monte.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60046. Appointment of Hearing Officers and Presiding Officer.

Note • History

(a) Hearings under this article may be held by the state board, by a committee of no fewer than two members of the state board, or by an administrative law judge from the Office of Administrative Hearings. In cases where the hearing is conducted by a committee of the state board or an administrative law judge, the committee or administrative law judge shall prepare a recommended decision for consideration by the state board.

(b) When the state board, or a committee of the state board, hears the case, the board or the committee may request that an administrative law judge be present at the hearing to assist in conducting the hearing, and to advise on the admission and exclusion of evidence, and on matters of law.

(c) Notwithstanding Section 60045, if the state board requests that an administrative law judge conduct the hearing or assist in the hearing, the hearing may be delayed if necessary to obtain the services of an administrative law judge. However, when the executive officer's decision is not stayed, no hearing may be delayed beyond 180 days from receipt of the petition without the consent of the petitioner.

(d) The chairperson of the state board may serve as the presiding officer or may designate another member of the state board or the administrative law judge to serve as the presiding officer for the hearing.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60047. Interested Persons.

Note • History

Any person shall have the right to submit written evidence and shall also have the opportunity to present oral evidence, including witnesses and argument, subject to reasonable limitations imposed by the presiding officer. A person shall notify the state board secretary of his/her intent to participate in the hearing at least 20 days prior to the hearing or 15 manufacturer working days prior to the hearing on an executive officer decision pursuant to Health and Safety Code Section 43105.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60048. Subpoenas.

Note • History

The chairperson of the state board, the presiding officer of the hearing, or the administrative law judge may on his or her own motion or at the request of any party in accordance with the provisions of Government Code Section 11510, issue subpoenas for witnesses and for the production of documents at or prior to the hearing. Subpoenas are not required for the production of state board documents which are directly related to the executive officer's decision or which are required to be disclosed under the California Public Records Act (Government Code Section 6250 et seq.). Subpoenas are also not required for attendance at the hearing of members of the state board staff.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 39514, 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60049. Witness List, Prehearing Statement, and Prehearing Conference.

Note • History

(a) No later than 10 days before the scheduled date of the hearing, or 10 manufacturer working days before the scheduled date of a Health and Safety Code Section 43105 hearing, the petitioner, the executive officer, and any person who has indicated that he/she intends to participate in the hearing shall each submit to the board secretary and serve upon one another a witness list including the name and qualifications of each proposed witness and a brief summary of the testimony to be presented by each witness. All parties shall also send to the board secretary and serve upon one another a prehearing statement which sets forth their respective positions regarding all contested issues.

(b) On the presiding officer's own initiative or on the motion of the petitioner or executive officer, the presiding officer may conduct a prehearing conference. The presiding officer shall set the time and place for the prehearing conference and give reasonable written notice to all parties.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60050. Oaths.

Note • History

In hearings under this article, members of the state board, the presiding officer and any administrative law judge assigned to the hearing shall be authorized to administer oaths and affirmations.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60051. Conduct of the Hearing.

Note • History

The presiding officer shall govern the conduct of the hearing and shall make decisions on the admissibility of evidence. The following rules shall apply to any hearing held pursuant to the provisions of this article.

(a) The hearing need not be conducted according to the technical rules relating to civil procedure, evidence and witnesses which would apply in a court of law. Any relevant noncumulative evidence shall be admitted if it is the sort of evidence on which responsible persons are accustomed to rely in the conduct of serious affairs. Relevant noncumulative evidence and legal argument which does not raise significant new issues shall not be denied admission based solely upon the failure of the petitioner to state the evidence or legal argument in the petition for hearing.

(b) Oral testimony offered by any witness shall be under oath.

(c) The petitioner, the executive officer and interested persons shall each, subject to reasonable limitations imposed by presiding officer, have the right to call and examine witnesses, and to introduce exhibits. Parties may cross-examine opposing witnesses and offer rebuttal evidence if the presiding officer determines that cross-examination and rebuttal evidence is necessary to resolve disputed issues of material fact. The rules of privilege shall be effective to the extent that they are otherwise required by California statute to be recognized.

(d) Hearsay evidence may be used for the purpose of supplementing or explaining other evidence but shall not be sufficient in itself to support a finding unless it would be admissible over objections in civil actions.

(e) Official notice may be taken of any generally accepted technical or scientific matter within the state board's field of competence or any matter which may be judicially noticed by the courts of this state. Parties present at the hearing shall be informed of and given an opportunity to rebut the matters proposed to be noticed.

(f) Evidence in the form of affidavits shall be admissible if offered in accordance with Government Code Section 11514.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60052. Decision of the State Board.

Note • History

After the hearing, or in the event the hearing is conducted by a committee of the state board or by an administrative law judge, following consideration of the recommendation of the committee or the administrative law judge and the hearing record by the state board, the state board shall issue a written decision setting forth findings and conclusions regarding all issues necessary to the decision. The state board shall file the decision with the board secretary as a public record and shall serve the written decision by certified mail on the petitioner and all other parties. The state board shall specify in the decision a date on which the decision is effective.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

§60053. Request for Reconsideration.

Note • History

(a) Within 20 days after service of the state board's decision, or within 15 manufacturer working days after service of the state board's decision in a hearing pursuant to Health and Safety Code Section 43105, the petitioner or the executive officer may submit a request for reconsideration, which shall include (1) a detailed statement of the legal and factual grounds on which reconsideration is requested; (2) the specific findings and conclusions for which reconsideration is requested; and (3) if additional evidence is sought to be presented, a description of the additional evidence and an explanation of why in the exercise of reasonable diligence it could not have been presented at the hearing. The party requesting reconsideration shall serve the request by certified mail on parties who participated in the original hearing within one day after submitting the request to the state board.

(b) The request for reconsideration may include a request that the decision of the state board be stayed, pending further administrative proceedings pursuant to this article. If such a request is made, the chairperson of the state board shall decide whether or not to stay the decision pending the state board's review of the request for reconsideration. The Chairperson of the state board shall make his/her decision based on his/her evaluation of the merits of the petition, consideration of possible hardship to the party and possible adverse public health impacts.

(c) Within 45 days after the receipt of a request for reconsideration, or for Health and Safety Code Section 43105 hearings within 30 manufacturer working days after receipt of a request for reconsideration, the state board shall decide whether to grant or deny the request. The state board may decide to reconsider its entire decision or any portion thereof. The state board shall serve written notice of its decision to grant or to deny reconsideration on the party requesting reconsideration and all participants in the prior hearing. If reconsideration is granted, the written notice shall describe any further proceedings.

(d) If reconsideration is granted, and if the party requesting reconsideration also requested a stay of the decision of the state board, the state board shall decide whether the stay shall be granted. If the request for reconsideration is denied, any stay of the decision pending state board review of the reconsideration request shall be dissolved.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Sections 43105 and 44207, Health and Safety Code.

HISTORY

1. New section filed 9-18-89; operative 10-18-89 (Register 89, No. 39).

Article 2. Administrative Hearing Procedures for Petitions for Review of Executive Officer Decisions

Subarticle 1. General Provisions

§60055.1. Applicability.

Note • History

(a) The provisions of this article shall apply to all adjudicatory hearings conducted for the purpose of reviewing any of the following decisions of the executive officer to:

(1) Recall motor vehicles or motor vehicle engine families pursuant to Health and Safety Code Section 43105 and sections 2122, et seq., of title 13, California Code of Regulations;

(2) Revoke or suspend a license as a vehicle emission test laboratory pursuant to section 2048 of title 13, California Code of Regulations;

(3) Revoke or suspend a previously granted executive order certifying a motor vehicle engine family under Chapter 2, Part 5, Division 26 of the Health and Safety Code;

(4) Deny certification of a motor vehicle engine family under Chapter 2, Part 5, Division 26 of the Health and Safety Code; or

(5) Any other decision where the person directly affected by the executive officer's action requests a hearing and where an adjudicatory hearing is required by law but neither the administrative adjudication procedures contained in Government Code sections 11500, et seq., nor other hearing procedures are specified.

(b) The provisions of this article do not apply to review of decisions of the executive officer related to the programs or actions of air pollution control or air quality management districts, and final orders or decisions under this regulation and section 60075.45.

(c) The provisions of this article apply only to executive officer decisions issued on or after the effective date of this article.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 60075, et seq., title 17 and 2048, title 13, California Code of Regulations; and Sections 11500, et seq., Government Code.

HISTORY

1. New article 2 (subarticles 1-10, sections 60055.1-60055.43), subarticle 1 (sections 60055.1-60055.10) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.2. Definitions.

Note • History

(b) The following definitions also apply:

(1) “Administrative record” means all documents and records timely filed with the hearing office, pursuant to section 60055.4 and the time deadlines of these rules, including pleadings, petitions, motions, and legal arguments in support thereof; all documents or records admitted into evidence or administratively noticed by the hearing officer; all official recordings or written transcripts of hearings conducted; and all orders or decisions issued by the hearing officer or the state board regarding the petition for review of an executive officer decision; administrative record does not include any prohibited communications as defined in section 60055.13, and any settlement discussions or offers of settlement pursuant to section 60055.24.

(2) “Days” means calendar days.

(3) “Default” means the failure of any party to take the steps necessary and required by these regulations to further the hearing towards resolution, resulting in a finding by the hearing officer of forfeiture of the cause of action against that party.

(4) “Discovery” refers to the process set forth in section 60055.25 allowing one party to request and obtain information relevant to the proceedings. The scope of discovery is limited by the express terms of that section.

(5) “Ex Parte Communication” means an oral or written communication not on the public record for which reasonable prior notice to all parties should have been given.

(6) “Hearing Office” refers to the administrative hearings office established by the state board to conduct administrative hearings to implement the provisions of these rules or to the Office Administrative Hearings established pursuant to Government Code section 11370.2. The administrative hearing office of the state board shall include at least one administrative law judge who shall act as a hearing officer.

(7) “Hearing Officer” refers to an administrative law judge appointed by the state board to conduct hearings under these procedures or an administrative law judge appointed by the Office of Administrative Hearings.

(8) “Intervenor” means a person who is allowed to voluntarily enter into the proceedings with leave of the hearing officer.

(9) “Party” includes the petitioner, the executive officer and employees of the state board, and an intervenor to the extent permitted by the hearing officer pursuant to section 60055.21. Notice to the executive officer shall constitute notice to all employees of the state board involved in the case.

(10) “Petition” means petition to review an executive officer decision.

(11) “Petitioner” means a person directly affected by a decision of the executive officer who requests a hearing pursuant to Subarticle 5 to review that decision.

(12) “Proceeding” means any hearing, determination or other activity before the hearing officer involving the parties to a petition for review.

(13) “Response” means a document filed by the executive officer responding to the petition for review.

(14) “Settlement Agreement” means a written agreement executed by the petitioner, the executive officer, and, to the extent permitted by the hearing officer pursuant to section 60055.21(b)(4), an intervenor that respectively settles the allegations at issue in the petition for review.

NOTE

Authority cited: Sections 39600, 39601 and 39010, et seq., Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 39514 and 43105, Part 5, (commencing with 39010) Health and Safety Code; Sections 2250, et seq., 2300, et seq., title 13; and Sections 60075.1, et seq., Article 5, title 17, California Code of Regulations.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.3. Right to Representation.

Note • History

(a) A party may appear in person or through a representative, who is not required to be an attorney at law. The right to representation is at the party's own expense. Following notification that a party is represented by a person other than him or herself, all further communications regarding the proceedings shall be directed to that representative.

(b) A representative of a party shall be deemed to control all matters respecting the interest of such party in the proceeding. Persons who appear as representatives shall not engage in unethical conduct or intentionally fail to observe the procedures set forth in these rules and the proper instructions or orders of the hearing officer.

(c) A representative may withdraw an appearance by filing a written notice of withdrawal with the hearing office and by serving a copy on all parties.

NOTE

Authority cited: Sections 39600, 39601 and 43028, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Sections 2180, et seq., title 13, California Code of Regulations.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.4. Time Limits; Computation of Time.

Note • History

(a) All actions required pursuant to these rules shall be completed within the times specified in this article, unless extended by the hearing officer upon a showing of good cause, after consideration of prejudice to other parties. Requests for extensions of time for the filing of any pleading, letter, document, or other writing or completing any other required action must be received in advance of the date on which the filing or action is due and should contain sufficient facts to establish a reasonable basis for the relief requested.

(b) In computing the time within which a right may be exercised or an act is to be performed, the day of the event from which the designated period runs shall not be included and the last day shall be included. If the last day falls on a Saturday, Sunday, or a state holiday, time shall be extended to the next working day.

(d) Unless otherwise indicated by proof of service, the mailing date shall be presumed to be the postmark date appearing on the envelope if first-class postage was prepaid and the envelope was properly addressed.

(e) Where service of any pleading, petition, letter, document, or other writing is by mail, overnight delivery, or facsimile transmission (fax), pursuant to section 60055.5(c), and if within a given number of days after such service, a right may be exercised, or an act is to be performed, the time within which such right may be exercised or act performed shall be extended as provided in section 60055.5(c).

(f) Papers delivered to or received by the hearing office during regular business hours (8 a.m. to 5 p.m.) will be filed on that date. Papers delivered or received at times other than regular business hours will be filed on the next regular business day.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.5. Service, Notice and Posting.

Note • History

(a) Except as otherwise provided in this article, the original of every pleading, petition, letter, document, or other writing served in a proceeding under these rules shall be filed with the designated hearing officer.

(b) Unless otherwise required, service of any documents in the proceedings may be made by personal delivery; by United States first-class or interoffice mail, by overnight delivery, or by fax.

(1) Service is complete at the time of personal delivery.

(2) In the case of first-class mail, the documents to be served must be deposited in a post office, mailbox or mail chute, or other like facility regularly maintained by the United States Postal Service, in a sealed envelope, properly addressed to the person on whom it is to be served at the address as last given by that person on any document filed in the present cause of action and served on the party making service or otherwise at the place of residence of the person to be served. The service is complete at the time of the deposit, but any period of notice and any right or duty to do any act or to make any response within any period or date prescribed after service of the document shall be extended five days if the place of address is within the State of California, ten days if the place of address is outside the State of California but within the United States, and 15 days if the place of address is outside the United States.

(3) If served by overnight delivery, or interoffice mail, the document must be deposited in a box or other facility regularly maintained for interoffice mail or by the express service carrier, or delivered to an authorized courier or driver authorized by the express service carrier to receive documents, in an envelope or package designated by the express service carrier with delivery fees paid or provided for, addressed to the person on whom it is to be served, at the address as last given by the person on any document filed in the present cause of action and served on the party making service or otherwise at that place of residence of the person to be served. The service is complete at the time of the deposit, but any period of notice and any right or duty to do any act or to make any response within any period or date prescribed after service of the document shall be extended two days.

(4) If served by fax, the document must be transmitted to a fax machine maintained by the person on whom it is served at the fax machine telephone number as last given by that person on any document which he or she has filed in the present cause of action and served on the party making the service. The service is complete at the time of the transmission, but any period of notice and any right or duty to do any act or to make any response within any period or date prescribed after service of the document shall be extended two days.

(c) Each document filed shall be accompanied by a proof of service on each party or its representative of record on the date of service. The proof of service shall state whether such service was made personally, first-class mail, overnight delivery, or facsimile.

(1) Where service is made by personal delivery, the declaration shall show the date and place of delivery and the name of the person to whom the documents were handed. Where the person making the service is unable to obtain the name of his or her person to whom the documents were handed, the person making the service may substitute a physical description for the name.

(2) Where service is made by first-class mail or overnight delivery, the declaration shall show the date and place of deposit in the mail, the name and address of the person served as shown on the mailing envelope and that the envelope was sealed and deposited in the mail with the postage fully prepaid.

(3) Where service is made by fax, the declaration shall show the method of service on each party, the date sent, and the fax number to which the document was sent.

(d) The proof of service declaration shall be signed by the person making it and contain the following statement above the signature: “I declare under penalty of perjury under the laws of the State of California that the foregoing is true and correct, and this declaration was executed at (City, State) on (Date).” The name of the declarant shall be typed and signed below this.

(e) Proof of service made in accordance with Code Civil Procedure section 1013a complies with this regulation.

(f) Service and notice to a party who has appeared through a representative shall be made upon such representative.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 11182 and 11184, Government Code; and Sections 1013 and 1013a Code of Civil Procedure.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.6. Motions.

Note • History

(a) Any motion or request for action by the hearing officer relating to any proceeding pending before him or her filed by any party, except those made orally on the record at the hearing, shall be in writing and shall be directed to the hearing officer, with written notice and proof of service to all parties. The caption of each motion shall contain the title and docket number of the proceeding and a clear and plain statement of the relief sought, together with the grounds therefore.

(b) Except as otherwise provided by statute or these regulations, or as ordered by the hearing officer, a motion shall be made and filed at least 15 days before the date set for the motion to be heard or the commencement of the hearing on the merits. Any response to the motion shall be filed and served no later than five days before the motion is scheduled to be heard or as ordered by the hearing officer.

(c) The hearing office shall set the time and place for the hearing of the motion. The hearing shall occur as soon as practicable.

(d) Except as otherwise provided by statute or these regulations, the hearing officer may decide a motion filed pursuant to this section without oral argument. Any party may request oral argument at the time of the filing of the motion or the response. If the hearing officer orders oral argument, the party requesting oral argument, or any party directed to do so by the hearing officer, shall serve written notice on all parties of the date, time and place of the oral argument. The hearing officer may direct that oral argument be made by telephone conference call. The hearing officer may order that the proceedings be recorded.

(e) The hearing officer shall issue a written order deciding any motion, unless the motion is made during the course of the hearing on the merits while on the record. The hearing officer may request that the prevailing party prepare a proposed order.

(f) A request for a prehearing conference or a settlement conference under sections 60055.23 and 60055.27 does not constitute a motion within the meaning of this section.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.7. Form of Pleadings.

Note • History

(a) Except as otherwise expressly provided in this article or by the hearing officer, there are no specific requirements as to the form of documents filed in a proceeding under these rules.

(b) The original of any pleading, letter, document, or other writing (other than an exhibit) shall be signed by the filing party or its representative. The signature constitutes a representation by the signer that it has read the document, that to the best of its knowledge, information and belief, the statements made therein are true, and that it has not filed the document for the purpose of delay.

(c) The initial document filed by any person shall indicate his or her status (as a party or representative of the party) and shall contain his or her name, address and telephone number. Any changes in this information shall be communicated promptly to the hearing office and all parties to the proceeding. A party who fails to furnish such information and any changes to it shall be deemed to have waived his or her right to notice and service under these rules.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.8. Limitations on Written Legal Arguments or Statements.

Note • History

(a) Any written legal argument or statement submitted to the hearing officer by a participant in an action under this part shall be double spaced and typed in a font size 12 point or larger. Except as otherwise provided by this part, further limited by the hearing officer, or otherwise authorized by the hearing officer for good cause shown, no written legal argument, exclusive of any supporting documentation, may exceed:

(1) Fifteen pages, for arguments in support of or opposition to motions; and

(2) Five pages, for reply arguments.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.9. Records of the State Board.

Note • History

Except where public disclosure of information or exhibits is restricted by law, records of the state board are public records and are available to the public pursuant to section 91000, et seq., Title 17, California Code of Regulations.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 6250, et seq., Government Code; and Sections 91000, et seq., title 17, California Code of Regulations.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.10. Interpreters and Other Forms of Accommodation.

Note • History

(a) In proceedings where a party, a party's representative, or a party's expected witness requires an interpreter for any language, including sign language, that party shall be responsible for notifying the hearing office as soon as the requirement is known, but no later than ten days prior to the first day of hearing. The hearing officer may allow later notification for good cause. The hearing office shall be responsible for securing the interpreter, and for providing reasonable accommodation.

(b) The cost of interpreter services shall be paid by the state board if the hearing officer so directs. In determining who should pay the cost of the interpreter, the hearing officer shall base the decision on equitable considerations, including the ability of the party in need of the interpreter to pay the cost.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 11435.25, 11435.30 and 11435.55, Government Code; and Section 751, Evidence Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 2. Hearing Officers

§60055.11. Authority of Hearing Officers.

Note • History

In any matter subject to hearing pursuant to these rules, the hearing officer shall have the authority to do any act and take all measures necessary for the maintenance of order and for the efficient, fair and impartial adjudication of issues arising in proceedings governed by these rules, including, but not limited to, authority to hold prehearing conferences; conduct hearings to determine all issues of fact and law presented; to rule upon motions, requests and offers of proof, dispose of procedural requests, and issue all necessary orders; administer oaths and affirmations and take affidavits or declarations; to issue subpoenas and subpoenas duces tecum for the attendance of a person and production of testimony, books, documents, or other things; to compel the attendance of a person residing anywhere in the state; to rule on objections, privileges, defenses, and the receipt of relevant and material evidence; to call and examine a party or witness and introduce into the hearing record documentary or other evidence; to request a party at any time to state the respective position or supporting theory concerning any fact or issues in the proceeding; to certify official acts; to extend the submittal date of any proceeding; to hear and determine all issues of fact and law presented and to issue such interlocutory and final orders, findings, and decisions as may be necessary for the full adjudication of the matter.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Sections 11181-11182 and 11425.30, Government Code.

HISTORY

1. New subarticle 2 (sections 60055.11-60055.12) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.12. Disqualification.

Note • History

(a) The hearing officer or a member of the state board shall disqualify himself or herself and withdraw from any case in which he or she cannot accord a fair and impartial hearing.

(b) A hearing officer may not hear any case in which he or she has previously served as an investigator, prosecutor, or advocate.

(c) Any party may request the disqualification of a hearing officer or member of the state board by filing an affidavit or declaration under penalty of perjury. A request for the disqualification of a hearing officer must be made no later than five days prior to the commencement of a prehearing conference or first day of hearing on the merits, whichever is earlier. A request for the disqualification of a member of the state board must be made no later than five days prior to the state board's consideration of the recommended decision. The affidavit or declaration must state with particularity the grounds upon which it is claimed that a fair and impartial hearing cannot be accorded. Where the request for disqualification concerns a member of the state board, the issue shall be determined by the other members of the board. Where the request concerns the hearing officer, the issue shall be determined by the hearing officer.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 3. Ex Parte Communications

§60055.13. Prohibited Communications.

Note • History

(a) Except as otherwise provided in this section, while the proceeding is pending, the hearing officer shall not participate in any communications with any party, representative of a party, or any person who has a direct or indirect interest in the outcome of the proceeding about the subject matter or merits of the case at issue, without notice and opportunity of all parties, to participate in communication except a party that has been determined to be in default pursuant to section 60055.37.

(b) No pleading, letter, document, or other writing shall be filed in a proceeding under these rules by a party unless service of a copy thereof together with any exhibit or attachment is made on all other parties to a proceeding. Service shall be in a manner as prescribed in section 60055.5.

(c) For the purpose of this section, a proceeding is pending from the time that the petition for review of an executive officer decision is filed.

(d) Communications prohibited under paragraph (a) do not include communications concerning matters of procedure or practice, including requests for continuances that are not in controversy. It also does not prohibit communications between a party and the hearing officer when the opposing party has had a default entered pursuant to section 60055.37.

(e) A communication between a hearing officer and an employee of the state board that would otherwise be prohibited by this section is permissible if:

(1) The employee is another hearing officer or other employee of the hearing office whose job duties include aiding the hearing officer in carrying out the hearing officer's adjudicative responsibilities. Upon request, the hearing office will provide a list of employees of the hearing office to the parties.

(2) The employee of the state board has not served as an investigator, prosecutor, or advocate in the proceeding or its preadjudicative stage, or in any factually related proceedings, and the purpose of the communication is to assist and advise the hearing officer in determining whether a document is a confidential business record (i.e., trade secrets). In obtaining such assistance and advice, the hearing officer shall give notice to the parties of the person consulted and shall provide the parties with as detailed a summary as possible of the substance of the advice received, while protecting the confidentiality of the business records at issue, and a reasonable opportunity to respond.

(3) The prohibitions of paragraph (a) that apply to the hearing officer shall also apply to all employees covered by subparagraphs (1) and (2) above.

(4) Communications permitted under subparagraphs (1) and (2) above shall not furnish, augment, diminish, or modify the evidence in the record.

NOTE

HISTORY

1. New subarticle 3 (sections 60055.13-60055.15) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.14. Disclosure of Communication.

Note • History

(a) If, while the proceeding is pending, but before serving as hearing officer, the hearing officer receives a communication of a type that would be in violation of this subarticle if received while serving as hearing officer, he or she shall, promptly after starting to serve, disclose the content of the communication on the record and give all parties an opportunity to address it as provided below.

(b) If a hearing officer receives a communication in violation of this article, the hearing officer shall make all of the following a part of the record in the proceeding:

(1) If the communication is written, the writing and any written response of the hearing officer to the communication; and

(2) If the communication is oral, a memorandum stating the substance of the communication, any response made by the hearing officer, and the identity of each person from whom the hearing officer received the communication.

(c) The hearing officer shall notify all parties that a communication described in this section has been made a part of the record.

(d) If a party requests an opportunity to address the communication within ten days after receipt of notice of the communication:

(1) The party shall be allowed to comment on the communication.

(2) The hearing officer has discretion to allow the party to present evidence concerning the subject of the communication, including discretion to reopen a hearing that hearing having been concluded.

(e) Receipt of ex parte communications may be cause for disqualification of the hearing officer.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.15. Applicability to the State Board.

Note • History

The provision of Subarticle 3 governing ex parte communications to the hearing officer also governs ex parte communications with members of the state board on matters that may come before them pursuant to Subarticles 4 and 9. Nothing in this provision shall be construed to prohibit ex parte communications, after a proposed decision has been forwarded to the state board, between members of the state board and the hearing officer who prepared the decision, a hearing officer from the State Office of Administrative Hearings (OAH) not previously involved in the case, or outside legal counsel to the state board. Nor shall anything in this provision be construed to prohibit communications between members of the state board and staff of the state board (including staff counsel), provided reasonable notice and opportunity to participate in such communications either in person or by telephone has been provided to all parties. For purposes of this section, reasonable notice shall be deemed as 24-hours or greater advance notice.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 4. Filing and Initial Review of Petitions for Review and Executive Officer's Response

§60055.16. Filing of Petitions for Review Hearing.

Note • History

(a) Within 30 days after receipt of a decision by the executive officer described in section 60055.1, a person directly affected by the decision may file a petition requesting a hearing to review the decision. The hearing officer may extend the time for filing for good cause.

(b) A petition shall be filed with the clerk of the board, at the offices of the state board in Sacramento and a copy served on the executive officer. The petition shall include the following information:

(1) The name and address of the petitioner;

(2) A copy of the executive officer decision for which review is requested;

(3) The date the decision was received by the petitioner;

(4) A statement of the objections to the decision upon which review is requested; a verified statement of the facts, data and other relevant evidence in support of the objections; a demand for the specific relief the petitioner seeks; a short, concise statement of legal argument, with citation to authorities, in support of the objections and the relief requested. The verification may be made on information and belief.

(c) The petitioner may request permission from the hearing officer to amend the petition. Such request must include an amended statement of objections and, as applicable, verified statement of facts, data, and other relevant evidence in support of the amended objections; demand for the specific relief the petitioner seeks; and amended statement of legal argument. The hearing officer shall grant the request upon determining that good cause exists; in granting the request the hearing officer shall take whatever steps necessary (e.g., continuing the hearing) to prevent any party from being unduly prejudiced by the decision.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New subarticle 4 (sections 60055.16-60055.19) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.17. Appointment of a Hearing Officer; Initial Review of Petition.

Note • History

(a) Initial Assignment:

(1) Upon receipt of a petition, the state board shall refer the matter to the administrative hearing office of the state board for assignment of a hearing officer. The hearing office shall assign an administrative law judge from the hearing office to hear the matter, unless staffing and other resources of the hearing office would prevent timely consideration of the matter. If the resources of the administrative hearing office prevent assignment, the administrative hearing office shall refer the matter to the State Office of Administrative Hearings (OAH) for assignment. For the two years immediately following the effective date of these hearing procedures, it shall be presumed that petitions requesting review of executive officer decisions ordering the recall of motor vehicles or motor vehicle engines or the suspension, revocation, or denial of executive orders certifying motor vehicles or motor vehicle engines are too resource intensive, given the present staffing of the administrative hearing office of the state board. For the two-year period identified above, such matters shall be immediately referred to the OAH for assignment.

(2) In addition to the above, a party may petition the state board to request that hearings be referred to OAH. The state board shall grant the request upon the petitioner providing substantial evidence that it could not receive a full and fair hearing from any hearing officer employed by the administrative hearing office of the state board.

(3) In all cases referred to OAH, under paragraph (2) above, the petitioner shall bear one-half of the fees charged by OAH for the services of the OAH hearing officer.

(b) Within 20 days of assignment of a hearing officer, the hearing officer shall review the petition and determine whether a hearing is required by law. Pursuant to section 60055.1(b), all petitions seeking review of executive officer decision to recall motor vehicles or engines under Health and Safety Code section 43105, to revoke or suspend a license as a vehicle emission test laboratory under Title 13, CCR, section 2048, or to revoke or suspend an Executive Order granting certification to a motor vehicle engine family under Chapter 2, Part 5, Division 26 of the Health and Safety Code shall have the right to a hearing. Petitions for review of executive officer decisions to deny applications for motor vehicle certifications shall be entitled to a hearing on the merits, unless the hearing officer finds that the petition and supporting data and information do not raise a substantial issue of fact or law. If the hearing officer determines that a hearing is not required, the petitioner shall be notified of the decision and there shall be no hearing under this article.

(c) A petitioner adversely affected by a hearing officer determination that a hearing is not required may request reconsideration by the state board under Subarticle 10.

(d) The clerk of the state board shall make arrangements to send a copy of the petition and any decision of the hearing officer or the state board to any person who was given written notice of the executive officer's decision.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.18. Stays Pending Hearing.

Note • History

(a) On timely receipt of a petition requesting a hearing to review a decision of the executive officer to recall motor vehicles or motor vehicle engines, the hearing officer shall issue a stay of the executive officer action until a decision of the state board has been issued pursuant to section 60055.44.

(b) The hearing officer shall not issue a stay pending review of an executive officer decision denying certification of an motor vehicle engine family pursuant to Chapter 2, Part 5, Division 26 of the Health and Safety Code.

(c) For other decisions of the executive officer for which petitions for review have been filed and hearings granted, the hearing officer shall issue a stay pending issuance of the state board's decision under section 60055.38, unless the hearing officer finds that the adverse effects of a stay on the public health, safety and welfare outweigh the harm to those persons directly affected by the lack of a stay. The hearing officer may conduct a hearing or request such submissions by the parties as necessary to obtain information to make a determination on this issue.

(d) If a stay is granted under subparagraphs (a) and (c) above, and the petition is subsequently denied by the Board, the Board may order the petitioner to take whatever remedial action is necessary, including implementing a recall of those vehicles and engines that would not otherwise have been sold in or delivered to California but for the stay, to achieve emissions reductions equal to the amount of emissions that occurred because of implementation of the stay.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.19. Executive Officer Response to Petition.

Note • History

Within ten days after issuance of the hearing officer determination that a hearing is required or ten days after a petition has been amended, the executive officer shall file with the hearing officer and serve upon the petitioner a response to the petition. The response shall contain the reasons for and the facts in support of the decision of the executive officer under review. If a petition for review raises claims or issues in a manner that is so vague or ambiguous that the executive officer cannot reasonably be expected to respond, the executive officer may, within the time allotted for responding, move that the hearing officer require a more definite statement of matters covered in the petition for review. If such motion is granted, the petitioner shall comply within ten days of issuance of the order of the hearing officer.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 5. Prehearing Procedures

§60055.20. Scheduling of Hearings.

Note • History

(a) Within 30 days after receipt of the executive officer's response, the hearing office shall schedule the hearing on the merits of the petition. Except as provided in paragraph (f), below, a hearing on the merits of a petition for review shall, in general, be scheduled to be heard no later than 180 days from the date of the hearing officer's determination under section 60055.17 that a hearing on the petition for review is appropriate. The hearing officer may determine, for good cause and in the interest of justice, that a later hearing date is necessary.

(b) The hearing office shall deliver or mail a notice of hearing to all parties at least 30 days prior to the hearing. The notice shall be in the form specified in section 11509 of the Government Code, and shall also provide notice of the availability of interpreters pursuant to section 60055.10 of these rules.

(c) The hearing officer shall grant such delays or continuances as may be necessary or desirable in the interest of fairly resolving the case.

(1) The hearing officer may, on his or her own motion or upon request of any party accompanied by a showing of good cause, continue a hearing to another time or place.

(2) A party shall apply to the hearing officer for a continuance not less than five days prior to the scheduled hearing.

(3) When a continuance is ordered during a hearing, the hearing officer shall give written notice of the time and place of the continued hearing.

(d) The hearing office shall set the place of hearing at a location as near as practicable to the place where the petitioner resides or maintains a place of business in California. If the owner does not reside or maintain a place of business in California, the hearing shall be in Sacramento. The hearing office may establish hearing locations anywhere in the state; at a minimum one hearing location shall be established in Sacramento and one in the Los Angeles area.

(e) Upon the motion of any party and a showing of good cause, or upon the motion of the hearing officer, and in the absence of an objection from any party, the hearing officer may exercise discretion to conduct all or part of a hearing by telephone.

(1) In granting such a motion, the hearing officer must be assured that each participant in the hearing has an opportunity to participate in and to hear the entire proceeding while it is taking place and to observe all exhibits fully.

(2) The hearing officer may direct the party who has requested the alternative method to make the necessary arrangements and be responsible for any associated costs.

(f)(1) If a hearing has been granted under section 60055.17 in a proceeding requesting review of an executive officer decision denying certification to motor vehicle engine families pursuant to Chapter 2, Part 5, Division 26 of the Health and Safety Code, a motor vehicle manufacturer may file a petition requesting that the hearing schedule be expedited. Such petitions shall be filed concurrently with the petition for review of the action and shall be accompanied by affidavits and other evidence setting forth the reasons why expedited scheduling is warranted. A hearing officer shall be assigned to consider the petition for expedited scheduling and shall issue a determination on the petition within five business days of receipt of the petition. The hearing officer shall grant the petition for expedited scheduling upon the manufacturer presenting evidence showing a reasonable likelihood that it may suffer serious competitive harm if the petition is not granted.

(2) If the petition for expedited scheduling is granted:

(a) The hearing office shall give priority to the scheduling of the hearing on the merits and shall make every effort to schedule the first day of hearing no later than ten days after the granting of the petition.

(b) The hearing officer shall issue a recommended decision that the Board may accept, reject, or modify as necessary.

(3) Notwithstanding section 60055.25, and subject to the discretion of the hearing officer, the parties shall have limited rights to discovery in a matter scheduled for expedited hearing. The parties shall exchange lists of witnesses that are expected to testify and copies of exhibits that are expected to be introduced at hearing no later than 48 hours prior to the commencement of the hearing. The hearing officer may disallow the testimony of witness or the introduction of any evidence that is not timely provided to the opposing party.

(4) Unless expressly provided by the hearing officer, the parties shall not have the opportunity to present closing written arguments.

(5) The hearing officer shall attempt to issue his or her decision as expeditiously as possible, but not later than ten days after the close of hearing.

(6) Upon issuance of the proposed decision of the hearing officer, the decision shall be delivered to the board for review, with copies served on the parties. Consistent with the requirements of Government Code section 11125, the state board shall consider the recommended decision at its next scheduled meeting. The state board may accept, reject, or modify the hearing officer's proposed decision. If the state board rejects or makes substantive modifications to the proposed decision, it shall issue a written decision, with findings of fact and conclusions of law in support of its decision.

(7) The decision of the state board is not subject to reconsideration under section 60055.41.

NOTE

HISTORY

1. New subarticle 5 (sections 60055.20-60055.28) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.21. Motion to Intervene.

Note • History

(a) A person may file a motion to intervene, and the hearing officer may grant such a motion if all of the following conditions are satisfied:

(1) The motion is in writing, with copies served on all parties named in the petition for review.

(2) The motion is made as early as practicable prior to the prehearing conference, if one is held, or the first day of the hearing on the merits of the petition for review.

(3) The motion states facts demonstrating that the requesting intervenor's legal rights, duties, privileges, or immunities will be substantially affected by the proceeding or that it qualifies as an intervenor under a statute or regulation.

(4) The hearing officer determines that the interests of justice and the orderly and prompt conduct of the proceeding will not be impaired by allowing the intervention.

(b) If the motion is granted, the hearing officer may impose conditions on the intervenor's participation in the proceeding, either at the time that intervention is granted or at a later time. Conditions may include:

(1) Limiting the intervenor's participation to designated issues in which the intervenor has a particular interest demonstrated by the motion.

(2) Limiting or excluding the use of discovery, cross-examination, and other procedures involving the intervenor so as to promote the orderly and prompt conduct of the proceeding.

(3) Requiring two or more intervenors to combine their presentations of evidence and argument, cross-examination, discovery, and other participation in the proceeding.

(4) Limiting or excluding the intervenors's participation in settlement negotiations.

(c) The hearing officer shall issue an order granting or denying the motion for intervention as soon as practicable in advance of the hearing, briefly stating the reasons for the order and specifying any conditions that he or she has determined as appropriate. The hearing officer may modify the order at any time, stating the reasons for the modification. The hearing officer shall promptly give notice of any order granting, denying, or modifying intervention to the applicant and to all parties.

(d) Whether the interests of justice and the orderly and prompt conduct of the proceedings will be impaired by allowing intervention is a determination to be made at the sole discretion of the hearing officer, based on his or her knowledge and judgment. The determination is not subject to administrative or judicial review.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Section 11440.50, Government Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.22. Consolidation, Separation of Proceedings.

Note • History

(a) Upon the motion of a party or upon the hearing officer's own motion, the hearing officer may consolidate for hearing and decision:

(1) Any number of proceedings involving the same respondent or petitioner;

(2) Any number of proceedings involving common issues of law or fact where consolidation would expedite and simplify consideration of the issues and would not adversely affect the rights of the parties.

(b) Upon the motion of a party or upon the hearing officer's own motion, the hearing officer may, in furtherance of convenience or to avoid prejudice or when separate hearings will be conducive to expedition and economy, order a separate hearing of any issue, including an issue raised in the notice of defense, or of any number of issues.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.23. Prehearing Conference.

Note • History

(a) Upon the scheduling of a petition for review for hearing, the hearing officer may order the scheduling of a prehearing conference upon his or her own motion or the request of any party. A request for a prehearing conference shall be in writing, addressed to the hearing officer and served on all parties.

(b) A prehearing conference shall be held no later than 30 days after an order of the hearing officer or a request by a party, but no later than 60 days from the date of the executive officer's filing of its response to the petition.

(d) At least ten business days before a scheduled conference, each party shall file with the hearing office and serve on all other parties a prehearing conference statement which shall contain the following information:

(1) Identification of all operative pleadings by title and date signed;

(2) The party's current estimate of time necessary to try the case;

(3) The name of each witness the party may call at hearing along with a brief statement of the content of the witness's expected testimony;

(4) The identity of any witness whose testimony will be presented by affidavit pursuant to section 60055.29, if known;

(5) The name and address of each expert witness the party intends to call at hearing along with a brief statement of the opinion the expert is expected to give. The party shall also attach a copy of a current resumé for each expert witness;

(6) Whether there is need for an interpreter or special accommodation at the hearing;

(7) A list of the documentary exhibits the party intends to present at hearing and a description of any physical or demonstrative evidence; and

(8) A concise statement of any legal issues which may affect the presentation of evidence or the disposition of the case.

(e) At the prehearing conference, the hearing officer may:

(1) Establish a time and place for further proceedings in the action, but no hearing on the merits of the action shall take place sooner than 30 days following the date of the prehearing conference;

(2) Attempt to simplify issues and help the parties to stipulate to facts not in dispute;

(3) Explore the necessity or desirability of amendments to the pleadings; and

(4) Discuss any other appropriate subject.

(f) After the prehearing conference, the hearing officer shall issue a prehearing order which incorporates the matters determined at the conference. This order may be issued orally if an accurate record can be made. Agreement on the simplification of issues, amendments, stipulations, or other matters may be entered on the record or may be made the subject of a written order by the hearing officer. If no matters were determined or dates set at the prehearing conference, a prehearing order is not required. The hearing officer may, to aid the efficient administration of justice, modify the prehearing order as necessary.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.24. Settlement Agreements and Consent Orders.

Note • History

(a) At any time before a final decision is issued, parties, (the complainant and the respondent) may settle the matters at issue, in whole or in part.

(b) The parties may request the assistance of the hearing office in their attempts to settle the matters at issue. Upon receiving such a request, the hearing office may assign a settlement hearing officer, who is not the same hearing officer that has been assigned, to hear the merits of the case, unless the parties specifically request in writing the assignment of the latter hearing officer.

(d) In a petition for review proceeding, if the parties resolve all issues raised by the petition, the petitioner shall agree to withdraw the petition and the case shall be dismissed.

(e) If the settlement does not wholly conclude the action, the hearing officer assigned to hear the merits of the case shall promptly inform the parties of the schedule of the remaining proceedings.

(f) Unless the parties have otherwise consented to use the hearing officer assigned to hear the merits of the case in settlement discussions, settlement discussions or offers of compromise regarding unresolved issues shall not be discussed with that hearing officer. Settlement discussions or offers of compromise shall also not be made part of the record of the proceedings.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Section 11415.60, Government Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.25. Discovery.

Note • History

(a) The provisions of this section provide the exclusive right to, and method of, discovery as to any proceeding governed by these hearing procedures. However, nothing in this section prohibits the parties from voluntarily stipulating to provide discovery deemed appropriate. This section does not authorize the inspection or copying of, any writing, or thing which is privileged from disclosure by law or protected as part of an attorney's work product.

(b) The names and addresses of witnesses; inspection and copying of documents and things.

(1) Unless otherwise stipulated to by the parties, within 30 days of the hearing officer's determination that a hearing is required under section 60055.17, a party may request:

(A) The names and addresses of witnesses to the extent known to the other party, including, but not limited to, those intended to be called to testify at the hearing; and

(B) The opportunity to inspect and make a copy of any thing, document, statement or other writings relevant to the issues for hearing that are in the possession, custody or control of the other party and would be admissible in evidence. This includes the following information from inspection or investigative reports prepared by, or on behalf of, any party that pertain to the subject matter of the proceeding: (i) the names and addresses of witnesses or of persons (other than confidential informants) having personal knowledge of the issues involved in the proceeding, (ii) matters perceived by the investigator in the course of his or her investigation (as opposed to his or her analysis or conclusions), and (iii) statements related to the issues of the proceedings which are otherwise admissible. For purposes of this section, “any thing, document, statement or other writings relevant to the issues for hearing that are in the possession, custody, or control of the other party” would include those items within the possession, custody, or control of a third-party who obtained or used such items while acting as a representative, contractor, or agent of the “other party”.

(2) Parties shall arrange a mutually convenient time for the exchanging of the names and addresses of witnesses and the inspecting and copying of relevant things, documents, statements, and other writings identified in subparagraph (B) above, but such date shall not be later than 30 days from the date of receipt of the request made pursuant to subparagraph (b)(1). Unless other arrangements are made, the party requesting the writings shall pay for the copying.

(3) All requests under subparagraph (b) are continuing, and the party receiving the request shall be under a continuing duty to provide the requesting party with the information requested.

(4) Absent a stipulation between the parties, a party claiming that certain writings or things are privileged against disclosure shall, within 15 days of receipt of the request for inspection and copying, serve on the requesting party a written statement setting forth what matters it claims are privileged and the reasons supporting its claims.

(1) A party may file a motion requesting that the hearing officer order further discovery. The motion shall specify the proposed method of discovery to be used and shall include affidavits describing in detail the nature of the information and/or documents sought, the proposed time and place of the discovery (if applicable), and the information addressing the findings listed in subparagraphs (A)-(D) below. The hearing officer shall grant the motion upon finding that:

(A) The additional discovery will not unreasonably delay the proceedings;

(B) The information to be obtained from the discovery is most reasonably obtained from the non-moving party, who has refused to provide it voluntarily; or that

(C) The information to be obtained is relevant and has significant probative value on a disputed issue of material fact regarding a matter at issue.

(2) The hearing officer may order the taking of oral depositions only under the following circumstances:

(A) After affirmatively making the findings in subparagraphs (c)(2)(A)-(C), and further finding that the information sought cannot be obtained by alternative methods; or

(B) There is substantial reason to believe that relevant and probative evidence may otherwise not be preserved for presentation by a witness at the hearing.

(3) If the hearing officer grants the motion for the taking of a deposition, the moving party shall serve notice of the deposition on the person to be deposed with copies served on the other parties at least ten days before the date set for the deposition.

(4) Where the witness resides outside of the state and where the hearing officer has ordered the taking of the testimony by deposition, the hearing officer shall obtain an order of the court to that effect by filing a petition in the superior court in Sacramento County. The proceedings for such a hearing shall be in accordance with the provisions of Government Code section 11189.

(d) Third-Party Notice of Request for Disclosure of Information Identified as Confidential and Opportunity to Participate.

(1) A third-party shall be notified whenever a party receives a request for disclosure of information that is in the possession, control, or custody of the party subject to a claim of confidentiality asserted by the third-party, including, but not limited to, claims of confidentiality asserted pursuant to the California Public Records Act (CPRA). This section creates rights and obligations in addition to, and does not affect, existing rights and obligations under the CPRA and applicable federal regulations.

(2) A third-party shall have the opportunity to be heard on all issues involving requests for disclosure of information that is in the possession, control, or custody of the party subject to a claim of confidentiality asserted by the third-party. Within five days of receipt of notice pursuant to subparagraph (d)(1), a third-party may object to disclosure of the subject information and may seek a protective order pursuant to subparagraph (e). Objections to disclosure may be based on all legal grounds, including, but not limited to, lack of relevance to the issues for hearing.

(e) Protective Orders:

(1) Upon motion by a party from whom discovery is sought, a third-party who has made a claim of confidentiality regarding the information to be discovered, or by the hearing officer on his or her own motion, the hearing officer may enter a protective order with respect to this material.

(2) Prior to granting a protective order, it must be established by the moving party that the information sought to be protected is entitled to be treated as a trade secret or is otherwise confidential. A party or person seeking a protective order shall have the opportunity to be heard on all issues relevant to preserving the record's confidentiality, including, but not limited to, the following:

(A) The appropriate scope and terms of any governing protective order;

(B) The terms under which the record may be placed in evidence or otherwise used at a hearing; and

(C) The disposition of the record and any copies thereof after all relevant administrative and judicial proceedings have concluded.

(3) A party or person seeking a protective order may be permitted to make all, or part of, the required showing in a closed meeting. The hearing officer shall have discretion to limit attendance at any closed meeting proceeding to the hearing officer and the person or party seeking the protective order.

(4) A protective order, if granted, shall contain terms governing the treatment of the information which are appropriate under the circumstances to prevent disclosure outside the hearing. The protective order may order that the trade secret information not be disclosed or that it be disclosed only to specified persons, or in a specified way. Disclosure may be limited to counsel for the parties who shall not disclose such information to the parties themselves. Disclosure to specified persons shall be conditioned on execution of sworn statements that no disclosure of the information will be made to persons not entitled to receive it under the terms of the protective order.

(5) The protective order shall contain terms governing the treatment of the information which are appropriate under the circumstances to prevent disclosure outside the hearing; the order may require that the material be kept under seal and filed separately from other evidence and exhibits in the hearing.

(6) Any party subject to the terms and conditions of any protective order, desiring to make use of any documents or testimony obtained in a closed meeting, shall file a motion to the hearing officer and set forth justification for the request. The motion shall be granted upon a demonstration of good cause that the information is relevant and has significant probative value on a disputed issue of material fact in issue. In granting the motion, the hearing officer shall enter an order protecting the rights of the affected persons and parties, who have claimed that the information is confidential, by preventing any unnecessary disclosure of the information. The hearing officer may require that the information be presented in a closed meeting, with attendance limited, as necessary and practicable, to specified representatives of the parties and that the material be sealed and filed separately from other evidence and exhibits in the hearing.

(7) The hearing office shall make a record of all closed meetings that are held under this section. The record shall be sealed and made available, upon appropriate order, to the state board or to the court review of the record.

(8) If the hearing officer denies a motion for protective order or grants a protective order only, in part, the order shall not become effective until ten days after the date the order is served. In the interim, a party to the proceeding or third-party holder of the asserted confidential information adversely affected by the order may seek appropriate interlocutory relief in a court of competent jurisdiction.

(f) Proceeding to Compel Discovery.

(1) Any party claiming that its request for discovery pursuant to this section has not been complied with or that the opposing party has failed to comply with a stipulated agreement to provide discovery may serve and file with the hearing officer a motion to compel the party who has refused or failed to produce the requested or stipulated discovery to comply. The motion shall include the following:

(A) Facts showing the party has failed or refused to comply with a discovery request or stipulation;

(B) A description of the information sought to be discovered;

(D) Evidence that a reasonable and good faith attempt to contact the noncomplying party for an informal resolution of the issue has been made; and

(E) To the extent known by the moving party, the measures for the noncomplying party's refusal to provide the requested information.

(2) The motion shall be filed within 15 days after the date the requested information was to be made available for inspection and copying or the date a deposition was scheduled to take place and served upon the party who has failed or refused to provide discovery.

(3) The hearing on the motion to compel discovery shall be held within 15 days after the motion is filed, or a later time that the hearing officer may on his or her own motion for good cause determine. The party who has refused or failed to provide discovery shall have the right to serve and file a written answer or other response which shall be due at the hearing office and personally served on all parties at least three days prior to the date set for hearing.

(4) Where the matter sought to be discovered is under the custody or control of the party who has refused or failed to provide discovery and that party asserts that the matter is not a discoverable matter under this section, or is privileged against disclosure, the hearing officer may order that the party in custody lodge with the hearing office the matters identified in subdivision (b) of section 915 of the Evidence Code and the hearing officer shall examine the matters in accordance with those provisions.

(5) The hearing officer shall decide the case on the matters examined in a closed meeting, the papers filed by the parties, and such oral argument and additional evidence as the hearing officer may allow.

(6) Unless otherwise stipulated by the parties, the hearing officer shall no later than 15 days after the hearing make its order denying or granting the motion. The order shall be in writing setting forth the matters the moving party is entitled to discover. The hearing office shall serve a copy of the order by mail upon the parties. Where the order grants the motion in whole, or in part, the order shall not become effective until ten days after the date the order is served. Where the order denies relief to the moving party, the order shall be effective on the date it is served.

(7) If after receipt of an order directing compliance with the provisions of these rules regarding discovery, a party fails, without good cause, to comply with the order, the hearing officer may draw adverse inferences against that party and may prevent that party from introducing any evidence that had been requested and not produced during discovery into the administrative record.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 11189 and 11507.6, Government Code; and Section 915(b), Evidence Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.26. Subpoena and Subpoena Duces Tecum.

Note • History

(a) Subpoenas and subpoenas duces tecum may be issued for attendance at a hearing and for production of documents at any reasonable time and place or at a hearing.

(b) At the request of a party, subpoenas and subpoenas duces tecum shall be issued by the hearing officer assigned to a proceeding, or the general counsel or executive officer of the state board, or, if represented by an attorney, the attorney of record for the party in accordance with sections 1985-1985.4 of the California Code of Civil Procedure.

(c) The custodian of documents that are the subject of a subpoena duces tecum may satisfy the subpoena by delivery of the documents or a copy of the documents, or by making the documents available for inspection or copying, together with an affidavit in compliance with section 1561 of the Evidence Code.

(d) The process extends to all parts of the state and shall be served in accordance with sections 1987 and 1988 of the California Code of Civil Procedure. A subpoena or subpoena duces tecum may also be delivered by certified mail, return receipt requested, or by messenger. Service by messenger shall be effected when the witness acknowledges receipt of the subpoena to the sender, by telephone, by mail, or in person, and identifies himself or herself either by reference to date of birth and driver's license number or Department of Motor Vehicles identification number, or the sender may verify receipt of the subpoena by obtaining other identifying information from the recipient. The sender shall make a written notation of the acknowledgment. A subpoena issued and acknowledged pursuant to this section has the same force and effect as a subpoena personally served. Failure to comply with a subpoena issued and acknowledged pursuant to this section may be punished as a contempt and the subpoena may so state. A party requesting a continuance based upon the failure of a witness to appear at the time and place required for the appearance or testimony pursuant to a subpoena, shall prove that the party has complied with this section. The continuance shall only be granted for a period of time that would allow personal service of the subpoena and in no event longer than that allowed by law.

(e) No witness is obliged to attend unless the witness is a resident of the state at the time of service.

(f) Upon timely motion of a party or witness, or upon his or her own motion, after notice to the parties and an opportunity to be heard and upon a showing of good cause, the hearing officer may order the quashing of a subpoena or subpoena duces tecum entirely, may modify it, or may direct compliance with it upon other terms or conditions. In addition, the hearing officer may make any other order as may be appropriate to protect a party or witness from unreasonable or oppressive demands.

(g) The state board may quash a subpoena or a subpoena duces tecum that it has issued on its own motion.

(h)(1) In the case of the production of a party to the record of a proceeding or of a person for whose benefit a proceeding is prosecuted or defended, the service of a subpoena on the witness is not required if written notice requesting the witness to attend, with the time and place of the hearing, is served on the representative of the party or person.

(2) Service of written notice to attend under this section shall be made in the manner and is subject to the conditions provided in section 1987 of the California Code of Civil Procedure for service of written notice to attend in a civil action or proceeding.

(i) A witness other than an employee of the state or a political subdivision thereof appearing pursuant to a subpoena or a subpoena duces tecum, other than a party, shall receive the same mileage, and appearance fees allowed by law; such fees are to be paid by the party at whose request the witness is subpoenaed.

NOTE

Authority cited: Sections 39600, 39601 and 43028, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; Sections 11186-11188, 11450.05-11450.30, Government Code; Section 1561, Evidence Code; and Sections 1985-1985.4, 1987 and 1988, California Code of Civil Procedure.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.27. Witness Lists and Exhibits.

Note • History

(a) No later than ten days before the scheduled hearing date, the parties shall submit to the hearing office and serve upon the other parties:

(1) A list of the names, addresses and qualifications of proposed witnesses to be called in making the party's case-in-chief and a brief summary of the testimony to be presented by each witness; and

(2) Each document or other exhibit, the party expects to offer or may offer, if the need arises, into evidence in making the party's case-in-chief.

(b) The hearing officer may prohibit any party from presenting any witness or exhibit that has not been included on that party's witness list or in the exhibits that have been submitted as required under paragraph (a) of this section.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.28. Motions for Summary Determination of Issues.

Note • History

(a) Any party may file a motion for summary judgment or summary adjudication of the issues. Such motions shall include supporting legal argument, and where necessary, affidavits showing that there is no genuine issue of material fact for determination regarding the identified issues. A party opposing such a motion shall show by affidavit or other documentation that a genuine issue of material fact as to the issues raised exists. After reviewing the motion and response of the parties, the administrative record, and any arguments of the parties, the hearing officer shall determine whether a genuine issue of material fact as to the issues exists and whether a party is entitled to judgment on the issue(s) as a matter of law.

(c) Should it appear from the affidavits of a party opposing the motion that the party cannot, for reasons stated, present by affidavit facts essential to justify the party's opposition, the hearing officer may deny the motion or may grant a continuance to permit affidavits to be obtained or to permit such additional discovery as provided under these procedures.

(d) The hearing officer shall deny a request for summary determination of the issue(s) if he or she finds the administrative record, including any evidence presented by the parties as part of this motion, present a genuine issue of material fact. If the hearing officer denies a request for summary determination, or denies such a request in part, the hearing officer shall promptly issue to each party a written ruling as to the existence of a genuine issue of material fact on the issue(s) and the reasons for the ruling. The matter shall continue to be set for hearing on all issues for which a genuine issue of material fact exists.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 6. Contempt and Sanctions

§60055.29. Contempt.

Note • History

If any person in proceedings before the hearing officer disobeys or resists any lawful order or refuses to respond to a subpoena, subpoena duces tecum, or refuses to take the oath or affirmation as a witness or thereafter refuses to be examined, or is guilty of misconduct during a hearing or in its immediate vicinity as to obstruct the proceedings, the hearing officer may certify the facts to the Superior Court in and for the county where the proceedings are held for contempt proceedings pursuant to Government Code section 11455.20.

NOTE

HISTORY

1. New subarticle 6 (sections 60055.29-60055.30) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.30. Sanctions.

Note • History

(a) Notwithstanding the above, the hearing officer may order a party, a party's representative or both, to pay reasonable expenses, including attorney's fees, incurred by another party as a result of bad faith actions or tactics that are frivolous or solely intended to cause unnecessary delay.

(1) “Actions or tactics” include, but are not limited to, the making or opposing of motions; the failure to comply with a discovery request or subpoena; or the failure to comply with a lawful order of the hearing officer.

(2) “Frivolous” means:

(A) Totally and completely without merit; or

(B) For the sole purpose of harassing an opposing party.

(b) An order for sanctions may be oral on the record or in writing and shall set forth the factual findings which are the basis for the imposition of sanctions.

(1) In determining reasonable expenses, the party or parties to whom payment is to be made shall, at the hearing officer's discretion, either make a statement on the record under oath or submit a written declaration under penalty of perjury setting forth with specificity the expenses incurred as a result of the other party's conduct.

(2) Within five days of the receipt of the hearing officer's order for the payment of expenses, a party or representative may, on the ground of hardship, request reconsideration from the hearing officer issuing the order. The request for reconsideration shall be filed in writing, and include a declaration under penalty of perjury.

(c) The order or denial of an order to pay expenses under paragraph (b) is subject of procedural review in the same manner as a final decision pursuant to Subarticle 11.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 7. Hearings

§60055.31. Failure to Appear.

Note • History

If after service of a Notice of Hearing, including Notice of Consolidated Hearing or Continuance, a party fails to appear at a hearing either in person or by representative, the hearing officer may take the proceeding off calendar, or may, at the request of a party, or on his or her own motion, adversely rule against the absent party.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New subarticle 7 (sections 60055.31-60055.36) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.32. Conduct of Hearing.

Note • History

(a) The hearing shall be presided over by a hearing officer who shall conduct a fair and impartial hearing in which each party has a reasonable opportunity to be heard and to present evidence.

(b) The hearing shall be conducted in the English language.

(c) Subject to reasonable limitations that may be imposed by the hearing officer, each party to the proceeding shall have the right to:

(1) Call and examine witnesses;

(2) Introduce exhibits;

(3) Question opposing witnesses on any matter relevant to the issues even though that matter was not covered in the direct examinations;

(4) Impeach any witness regardless of which party first called the witness to testify; and

(5) Call and examine an opposing party as if under cross-examination, even if that party does not testify on his or her own behalf.

(d) Burden of Going Forth.

(1) The executive officer has the initial burden of presenting evidence that those parts of the executive officer decision specifically challenged in the petition for review are supported by the facts and applicable law.

(2) After the executive officer presents its evidence, the petitioner shall present documentation, testimony, or other evidence to support all claims made, including any affirmative defenses raised, that are pertinent to the issues presented to the hearing officer for determination.

(3) Subject to the hearing officer's authority under subparagraph (e)(1) below, at the close of the petitioner's presentation of evidence, the parties may present rebuttal evidence that is necessary to resolve disputed issues of material fact.

(e) The hearing officer may:

(1) Limit the number of witnesses and the scope and extent of any direct examination, cross-examination, or rebuttal testimony, as necessary, to protect the interests of justice and conduct a reasonably expeditious hearing;

(2) Require the authentication of any written exhibit or statement;

(3) Call and examine a party or witness and may, on his or her own motion, admit any relevant and material evidence;

(4) Exclude persons whose conduct impedes the orderly conduct of the hearing;

(5) Restrict attendance because of the physical limitations of the hearing facility; or

(6) Take other action to promote due process or the orderly conduct of the hearing.

(f) The taking of evidence in a hearing shall be controlled by the hearing officer in the manner best suited to ascertain the facts and safeguard the rights of the parties. Prior to taking evidence, the hearing officer shall define the issues and the order in which evidence will be received. The hearing officer shall have discretion to decide whether conferences and informal discussions necessary to facilitate the orderly and expeditious conduct of the case will be conducted in closed session and/or be recorded.

(g) Each matter in controversy shall be decided by the hearing officer upon a preponderance of the evidence test, unless otherwise provided under California law.

(h) Hearings shall be recorded electronically. The recording made by the Administrative Hearing Office shall be the official recording of the hearing.

(1) A verbatim transcript of the official recording will not normally be prepared, but may be ordered by the hearing officer if deemed necessary to permit a full and fair review and resolution of the case. If not so ordered by the hearing officer, a party may, at its own expense, request that a verbatim transcript be made. The party making the request shall provide one copy to the hearing officer and one copy to every other party.

(2) The official recording of the hearing and transcript of the recording, together with all written submissions made by the parties, shall become part of the administrative record for the proceeding.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.33. Evidence.

Note • History

(a) Testimony shall be taken only under oath or affirmation.

(b) The hearing need not be conducted according to technical rules relating to evidence and witnesses. The hearing officer shall admit evidence which is the sort of evidence on which responsible persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule which might make improper the admission of such evidence over objection in civil actions, and which is not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of little probative value. Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but upon timely objection shall not be sufficient in and of itself to support a finding unless it would be admissible over objection in civil actions. The application of these rules shall not affect the substantial rights of the parties as provided in the Evidence Code.

(c) The rules of privilege shall be effective to the extent that they are otherwise required by statute to be recognized at the hearing.

(d) Consistent with the provisions of section 60055.25(d), trade secret and other confidential information may be introduced into evidence. The hearing officer shall take all precautions to preserve the confidentiality of such information, and may make such orders as may be necessary to consider such evidence in a closed meeting, including the use of a supplemental order or decision to address matters which arise out of that portion of the evidence which is confidential.

(e) In reaching a decision, official notice may be taken, either before or after submission of the proceeding for decision, of any generally accepted technical or scientific matter within the state board's area of expertise, and determinations, rulings, orders, findings and decisions, required by law to be made by the state board or the hearing officer.

(1) The hearing officer shall take official notice of those matters set forth in section 451 of the Evidence Code.

(2) The hearing officer may take official notice of those matters set forth in section 452 of the Evidence Code.

(3) Each party shall give notice of a request to take official notice and be given reasonable opportunity on request to present information relevant to:

(A) The propriety of taking official notice; and

(B) The effect of the matter to be noticed.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Sections 451 and 452, Evidence Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.34. Evidence by Affidavit or Declaration.

Note • History

(a) At any time 20 or more days prior to a hearing or a continued hearing, a party may mail or deliver to the opposing party or parties a copy of any affidavit or declaration which the proponent proposes to introduce in evidence, together with a notice as provided in subdivision (b). Unless an opposing party, within seven days after such mailing or delivery, mails or delivers to the proponent a request to cross-examine the affiant or declarant the opposing party's right to cross-examine such affiant or declarant is waived and the affidavit or declaration, if introduced in evidence, shall be given the same effect as if the affiant or declarant had testified orally. If an opportunity to cross-examine an affiant or declarant is not afforded after request therefore is made as herein provided, the hearing officer may allow the affidavit or declaration to be introduced, but if it is allowed to be introduced, it shall only be given the same effect as other hearsay evidence.

(b) The notice referred to in subdivision (a) shall be a separate document concurrently served with the affidavit or declaration, entitled “Notice of Intent to Use Declaration or Affidavit in Lieu of Oral Testimony.” The title shall be in bold print. The content of the notice shall be substantially in the following form:

“The accompanying affidavit or declaration of [insert name of affiant or declarant] will be introduced as evidence at the hearing in [insert title and docket number or petition number of proceeding]. [Insert name] will not be called to testify orally and you will not be entitled to question the affiant or declarant unless you notify [insert name of the proponent, representative, agent or attorney] at [insert address] that you wish to cross-examine the affiant or declarant. To be effective, your request must be mailed or delivered to [insert name of proponent, representative, agent or attorney] on or before [insert a date 7 days after the date of mailing or delivery of the affidavit to the opposing party].”

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.35. Exclusion of Witnesses.

Note • History

Upon motion of a party, the hearing officer may exclude from the hearing room any witnesses not at the time under examination; but the parties or their representatives to the proceeding shall not be excluded.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.36. Oral Argument and Briefs.

Note • History

(a) Prior to the close of the hearing, the hearing officer may, on his or her own motion, or upon motion of a party, grant and determine the length of oral argument.

(b) Motions to submit written closing argument shall be made prior to the close of the hearing and shall be granted at the discretion of the hearing officer upon a determination that written argument will be productive and will not unreasonably delay the disposition of the proceeding. The hearing officer shall determine the appropriate page lengths of all post hearing briefs at the time he or she determines that the filing of closing arguments is appropriate. A party shall file written closing brief within 15 working days from the date of the hearing. Opposing parties may file a reply brief within 10 working days from service of the argument. The hearing officer may extend or reduce the above filing dates for submission of written argument for good cause.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 8. Decisions of the Hearing Officer

§60055.37. Default Order.

Note • History

(a) Upon motion, the hearing officer may find a party to be in default upon failure, without good cause to appear at a scheduled conference or hearing; or to comply with an order of the hearing officer.

(b) A default by the petitioner shall result in dismissal of the petition, with prejudice.

(c) A default by the executive officer shall result in reversal of the decision of the executive officer that is under review.

(d) Any proceeding may be reinstated by the hearing officer upon a showing of good cause that contains sufficient facts to show or establish a reasonable basis for the failure to appear at the hearing. The request for reinstatement shall be made by the defaulting party within 30 days of service of the default order.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New subarticle 8 (sections 60055.37-60055.38) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.38. Proposed Order or Decision of the Hearing Officer after Petition for Review Hearing; Order or Decision of the Board.

Note • History

(a) Unless otherwise ordered, all hearings on petitions for review shall be submitted at the close of the hearing unless otherwise extended by the hearing officer or provided in these rules. Within a reasonable period of time after the proceeding is submitted, the hearing officer shall make findings upon all facts relevant to the issues for hearing, and file a proposed order or decision with the reasons or grounds upon which the order or decision was made.

(b) The proposed order or decision shall be in writing, signed and dated by the hearing officer deciding the proceeding.

(c) The hearing officer shall immediately certify the administrative record and forward it, together with a copy of the proposed order or decision, to the clerk of the board. Within 30 days after receipt of the proposed order or decision, the clerk of the board shall serve a copy of the proposed order or decision on each party to the proceeding or its representative and shall issue a public notice that the state board will conduct a public hearing to consider adoption of the proposed order or decision of the hearing officer. At the public hearing, the state board may take any of the following actions:

(1) Adopt the proposed order or decision in its entirety.

(2) Make technical or other minor changes to the proposed order or decision and adopt it as its own. Actions under this subparagraph are limited to clarifying or other changes that do not affect the factual or legal basis of the proposed decision.

(3) Refer the matter back to the hearing officer for the taking of additional evidence, or order that additional evidence be taken at a hearing before the state board itself. If the matter is remanded to the hearing officer, the hearing officer shall issue and serve upon the parties a new proposed order or decision based upon the new evidence that has been received. In such an event, the state board shall consider the newly proposed order or decision under the procedures set forth in this section.

(4) Issue its own written order or decision, based on the administrative record and any additional evidence presented during the public hearing, setting forth findings of fact and conclusions of law regarding all issues necessary to support the order or decision.

(d) The clerk of the state board shall serve a copy of the order or decision of the state board on the petitioner, other parties to the proceedings, and any member of the public who has requested a copy. The state board shall specify in the order or decision the date that order or decision becomes effective.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 9. Reconsideration

§60055.39. Reconsideration by the State Board.

Note • History

A party aggrieved by an order or decision of the state board relating to a petition for review of an executive officer decision pursuant to section 60055.38 of these rules, or an initial determination by the hearing officer that a hearing to consider a petition is not required by law, pursuant to section 60055.17 of these rules, may within 20 days of service of such order or decision, request that the state board reconsider its order or decision with respect to any matters covered therein. The request for reconsideration shall be filed with the clerk of the state board and shall be served on all parties and the hearing office. The request shall be deemed filed the date it is delivered or mailed to the clerk of the state board.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New subarticle 9 (sections 60055.39-60055.41) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.40. Requirements in Filing Request for Reconsideration; Comments Opposing Request.

Note • History

(a) A request for reconsideration of a state board's order or decision regarding a petition for review of an executive officer decision shall be signed by the party or its representative and verified under oath. The request shall be based upon one or more of the following grounds:

(1) The hearing officer or the state board acted without or in excess of its powers;

(2) The order or decision was procured by fraud;

(3) The order or decision is not supported by the evidence or the findings of fact;

(4) The requesting party has discovered new material evidence that could not, with reasonable diligence, have been discovered and produced at the hearing; or

(5) The hearing officer and/or the state board have misapplied applicable law.

(b) Any request for reconsideration shall specifically detail the grounds upon which the requesting party considers the order or decision to be unjust or unlawful and every issue to be considered on reconsideration. The requesting party shall be deemed to have fully waived all objections, irregularities, and illegalities concerning the proceeding upon which reconsideration is sought other than those specifically set forth in the request for reconsideration. The request for reconsideration will be denied if it contains no more than allegations of the statutory or constitutional grounds for reconsideration, unsupported by specific references to the record and principles of law involved.

(c) When a request for reconsideration or answer thereto has been timely filed, the filing of supplemental papers or answers may be granted at the discretion of the state board. Parties requesting a copy of the hearing record shall bear the cost of reproduction.

(d) The request for reconsideration may include a request that the order or decision of the state board be stayed pending resolution of the request for reconsideration. As provided in section 60055.41, the order or decision shall be automatically stayed for 20 days from the date of filing of the request for reconsideration.

(e) Within ten days of being served with notice of a request for reconsideration, a party opposed to the request may file an opposition to the request with the clerk of the state board. The opposition shall be signed and verified under oath by the party or its representative and shall not exceed six pages.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.41. Decision on Reconsideration; Stays.

Note • History

(a) The state board may upon the request of a party or its own motion, stay, suspend, or postpone the order or decision that it has issued while the request for reconsideration is pending.

(b) The state board shall consider the request for reconsideration at the next scheduled board meeting at which the matter may be timely considered and may:

(1) Review some, but not all issues raised by the request;

(2) Affirm, rescind, or amend the findings and conclusions of law, of the order or decision; or

(3) Direct the taking of additional evidence either by submission or further hearing.

(A) If the state board orders the parties to submit additional evidence, notice and an opportunity to respond shall be given to all parties.

(B) If the state board orders that additional evidence be taken at a further hearing conducted by the state board or the hearing officer assigned to the case and that additional findings of fact be made, notice of the time and place of the hearing shall be given to all parties and to such other persons that may be affected by the order.

(D) The time limits in section 60055.38 of these rules for filing an order or decision shall not apply to further hearings during reconsideration.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Section 1140.10, Government Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Subarticle 10. Final Order or Decision; Judicial Review

§60055.42. Final Order or Decision; Effective Date.

Note • History

(a) If no request for reconsideration of state board's order or decision is filed within 30 days of the service of an order or decision, the initial order or decision of the state board shall become final. The effective date of the final order or decision shall be the date set forth in the state board's initial decision.

(b) If reconsideration has been requested, the order or decision of the state board that addresses and fully disposes of the request for reconsideration is the final order or decision. The effective date of the order or decision shall be the date that the order or decision was served on the parties.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Section 43105, Health and Safety Code.

HISTORY

1. New subarticle 10 (sections 60055.42-60055.43) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

§60055.43. Judicial Review.

Note • History

(a) A party adversely affected by a final decision of the state board, may seek judicial review by filing a petition for a writ of mandate in accordance with section 1094.5 of the California Code of Civil Procedure. The right to petition shall not be affected by the failure to seek reconsideration before the agency. Such petition shall be filed within 30 days after the order or decision becomes final.

(b) The state board may seek to enforce a final order or decision in superior court in accordance with applicable law.

NOTE

Authority cited: Sections 39600 and 39601, Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Section 43105, Health and Safety Code; and Section 1094.5, California Code of Civil Procedure.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

Article 2.5. Administrative Procedures for Review of Executive Officer Determinations Regarding Service Information for 1994 and Subsequent Model Year Passenger Cars, Light-Duty Trucks, and Medium-Duty Engines and Vehicles and 2007 and Subsequent Model Year Heavy-Duty Engines

Subarticle 1. General Provisions

§60060.1. Applicability.

Note • History

(a) This article governs review of Executive Officer determinations regarding compliance with the provisions of Health and Safety Code section 43105.5, and its implementing regulations, title 13, California Code of Regulations, section 1969.

(b) The provisions of this article apply only to determinations issued on or after the effective date of this article.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: 43105.5(e) and (f), Health and Safety Code; Sections 11500, et seq., Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New article 2.5 (subarticles 1-9, sections 60060.1-60060.34), subarticle 1 (sections 60060.1-60060.10) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of article heading filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.2. Definitions.

Note • History

(a) The definitions applicable to these rules include those set out in the Health and Safety Code (commencing with section 39010) and in Title 13, California Code of Regulations, section 1969(c). The definitions set forth in Title 17, California Code of Regulations, section 60065.2 shall also be applicable to the extent that such definitions do not conflict with any terms as defined below. To the extent that any definition in section 60065.2 is applicable to these hearing procedures, any reference to a section within Article 3 that is set forth in that definition shall be read as the parallel section within this Article.

(b) The following definitions also apply:

(1) “Executive Officer” is the Executive Officer of the state board and employees of the state board authorized to represent the Executive Officer in the determination made pursuant to title 13, CCR, section 1969(j).

(2) “Interested Party” shall mean the covered person who filed the underlying request for audit that led to the issuance of a notice to comply.

(3) “Party” refers to the Executive Officer, motor vehicle manufacturer or engine manufacturer appearing before a hearing officer in a hearing to review an Executive Officer determination against the motor vehicle manufacturer or engine manufacturer for noncompliance with Health and Safety Code section 43105.5 and title 13, California Code of Regulations section 1969 and also to any person whose motion to intervene has been granted pursuant to section 60060.8.

(4) “Request for Review” refers to the document requesting an administrative hearing that may be filed by a motor vehicle manufacturer, an engine manufacturer, or the Executive Officer.

(5) “Response” means a document that is responsive to the request for review filed by a party opposed to the review or the relief requested.

NOTE

Authority cited: Sections 39010, 39600 and 39601, Health and Safety Code. Reference: Part 5 (commencing with 39010), and Sections 43105.5(e) and (f), Health and Safety Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsections (b)(3)-(4) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.3. Right to Representation.

Note • History

(c) A representative may withdraw an appearance by filing a written notice of withdrawal with the hearing office and by serving a copy on all parties.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.4. Time Limits; Computation of Time.

Note • History

(a) All actions required under these rules shall be completed within the times specified in this article, unless extended by the hearing officer after a showing of good cause and consideration of prejudice to other parties. Requests for extensions of time for the filing of any pleading, letter, document, or other writing or completing any other required action must be received in advance of the date on which the filing or action is due and should contain sufficient facts to establish a reasonable basis for the relief requested.

(b) In computing the time that a person has to perform an act or exercise a right, the day of the event initiating the running of the time period shall not be included and the last day of the time period shall be included. If the last day falls on a Saturday, Sunday, or a state holiday, time shall be extended to the next working day.

(e) Where service of any pleading, petition, letter, document, or other writing is by mail, overnight delivery, or facsimile transmission (fax), pursuant to section 60060.5(c), and if within a given number of days after such service, a right may be exercised, or an act is to be performed, the time that such right may be exercised or act performed shall be extended as provided in section 60060.5(c).

(f) Papers delivered to or received by the hearing office during regular business hours (8 a.m. to 5 p.m.) will be filed on that date. Papers delivered or received at times after regular business hours will be filed on the next regular business day.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.5. Service, Notice and Posting.

Note • History

(b) A copy of the request for review shall be concurrently served on all other parties.

(c) Unless otherwise required, service of any documents in the proceedings may be made by personal delivery, by United States first-class or interoffice mail, by overnight delivery, or by fax.

(1) Service is complete at the time of personal delivery.

(2) In the case of first-class mail, the documents to be served must be deposited in a post office, mailbox or mail chute, or other like facility regularly maintained by the United States Postal Service, in a sealed envelope, properly addressed to the person on whom it is to be served at the address as last given by that person on any document filed in the present cause of action and served on the party making service or otherwise at the place of residence of the person to be served. The service is complete at the time of the deposit, but any period of notice and any right or duty to do any act or to make any response within any period or date prescribed after service of the document shall be extended five days if the place of address is within the State of California, ten days if the place of address is outside the State of California but within the United States, and fifteen days if the place of address is outside the United States.

(d) Each document filed shall be accompanied by a proof of service on each party or its representative of record on the date of service. The proof of service shall state whether such service was made personally, first-class mail, overnight delivery, or fax.

(1) Where service is made by personal delivery, the declaration shall show the date and place of delivery and the name of the person to whom the documents were handed. Where the person making the service is unable to obtain the name of the person to whom the documents were handed, the person making the service may substitute a physical description for the name.

(3) Where service is made by fax, the declaration shall show the method of service on each party, the date sent, and the fax number to which the document was sent.

(e) The proof of service declaration shall be signed by the person making it and contain the following statement above the signature: “I declare under penalty of perjury under the laws of the State of California that the foregoing is true and correct, and this declaration was executed at (City, State) on (Date).” The name of the declarant shall be typed and signed below this.

(f) Proof of service made in accordance with the California Code of Civil Procedure section 1013a complies with this regulation.

(g) Service and notice to a party who has appeared through a representative shall be made upon such representative.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11182 and 11184, Government Code; Sections 1013 and 1013a, Code of Civil Procedure; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.6. Motions.

Note • History

(a) Any motion or request for action by the hearing officer filed by any party, except those made orally on the record at a hearing, shall be in writing and filed with the hearing officer, with written notice and proof of service to all parties. The caption of each motion shall contain the title and docket number of the proceeding and a clear and plain statement of the relief sought and supporting rationale.

(c) The hearing office shall set the time and place for the hearing of the motion. The hearing shall occur as soon as practicable.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.7. Form of Pleadings.

Note • History

(a) Except as otherwise expressly provided in this article or by the hearing officer, there are no specific requirements as to the form of documents filed in a proceeding under these rules.

(b) The filing party or its representative shall sign the original of any pleading, letter, document, or other writing (other than an exhibit). The signature constitutes a representation by the signer that it has read the document, that to the best of its knowledge, information and belief, the statements made therein are true, and that it has not filed the document for the purpose of delay.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.8. Motion to Intervene.

Note • History

(a) Any person may file a motion to intervene.

(b) The hearing officer shall grant, as a matter of right, a timely written motion to intervene filed by an interested party to the determination for which review has been requested.

(c) As to other persons, the hearing officer may grant such a motion to intervene if all of the following conditions are satisfied:

(1) The motion is in writing, with copies served on all parties named in the request for review.

(2) The motion is made as early as practicable.

(3) The motion states facts demonstrating that the proceeding will substantially affect the requesting person's legal rights, duties, privileges, or immunities.

(4) The hearing officer determines that the interests of justice and the orderly and prompt conduct of the proceeding will not be impaired by allowing the intervention.

(d) Upon a motion filed under paragraph (b) or (c) being granted, the hearing officer may impose conditions on the intervenor's participation in the proceeding, either at the time that intervention is granted or at a later time. Conditions may include:

(1) Limiting the intervenor's participation to designated issues in which the intervenor has a particular interest demonstrated by the motion.

(2) Limiting or excluding the use of discovery, cross-examination, and other procedures involving the intervenor so as to promote the orderly and prompt conduct of the proceeding.

(3) Requiring two or more intervenors to combine their presentations of evidence and argument, cross-examination, discovery, and other participation in the proceeding.

(4) Limiting or excluding the intervenor's participation in settlement negotiations.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.9. Limitations on Written Legal Arguments or Statements

Note • History

(a) Any written legal argument or statement submitted to the hearing officer by a participant in an action under this part shall be double spaced and typed in a font size 12 point or larger. Except as otherwise provided by this part, or otherwise authorized by the hearing officer for good cause shown, no written legal argument, exclusive of any supporting documentation, may exceed:

(1) Fifteen pages, for arguments in support of or opposition to motions; and

(2) Five pages, for reply arguments.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.10. Interpreters and Other Forms of Accommodation.

Note • History

(b) The state board shall pay the cost of interpreter services if the hearing officer so directs. In determining who should pay the cost of the interpreter, the hearing officer shall base the decision on equitable considerations, including the ability of the party in need of the interpreter to pay the cost.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11425.10, 11435.25, 11435.30 and 11435.55, Government Code; Section 751, Evidence Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 2. Hearing Officers

§60060.11. Authority of Hearing Officers.

Note • History

(a) The hearing officer shall have authority to review matters arising under Health and Safety Code section 43105.5 and title 13, CCR, section 1969(k). Such authority shall include those matters in which:

(1) A motor vehicle manufacturer or engine manufacturer has contested a notice to comply that has been issued by the Executive Officer because the motor vehicle manufacturer or engine manufacturer has allegedly failed to comply with the provisions of section 43105.5 or the implementing regulations, title 13, CCR, section 1969;

(2) The Executive Officer has requested review and issuance of a compliance order against a motor vehicle manufacturer or engine manufacturer who has failed to request review of a notice to comply and has not filed a compliance plan as required by the notice to comply; and

(3) The Executive Officer has rejected a compliance plan submitted by a motor vehicle manufacturer or engine manufacturer pursuant to section 43105.5(e); and

(4) The Executive Officer has requested review and issuance of a compliance order against a motor vehicle manufacturer or engine manufacturer that has failed to comply with the terms of an approved compliance plan.

(b) Except as may be specifically limited in title 13, CCR, section 1969, in any matter subject to review pursuant to these rules, the hearing officer shall have the authority to do any act and take all measures necessary for the maintenance of order and for the efficient, fair and impartial adjudication of issues arising in proceedings governed by these rules, including, but not limited to, authority to hold prehearing conferences; conduct hearings to determine all issues of fact and law presented; to rule upon motions, requests and offers of proof, dispose of procedural requests, and issue all necessary orders; administer oaths and affirmations and take affidavits or declarations; to issue subpoenas and subpoenas duces tecum for the attendance of a person and production of testimony, books, documents, or other things; to compel the attendance of a person residing anywhere in the state; to rule on objections, privileges, defenses, and the receipt of relevant and material evidence; to call and examine a party or witness and introduce into the hearing record documentary or other evidence; to request a party at any time to state the respective position or supporting theory concerning any fact or issues in the proceeding; to certify official acts; to extend the submittal date of any proceeding; to hear and determine all issues of fact and law presented and to issue such interlocutory and final orders, findings, decisions, and appropriate remedies, including penalties, as may be necessary for the full adjudication of the matter.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11181-11182 and 11425.30, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 2 (sections 60060.11-60060.12) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsections (a)(1)-(4) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.12. Disqualification.

Note • History

(a) The hearing officer shall disqualify himself or herself and withdraw from any case in which he or she cannot accord a fair and impartial hearing.

(b) A hearing officer may not hear any case in which he or she has previously served as an investigator, prosecutor, or advocate.

(c) Any party may request the disqualification of a hearing officer by filing an affidavit or declaration under penalty of perjury. A request against the hearing officer must be made no later than five days prior to the commencement of a prehearing conference or first day of hearing on the merits, whichever is earlier. The affidavit or declaration must state with particularity the grounds upon which it is claimed that a fair and impartial hearing cannot be accorded. The issue shall be determined, in the first instance, by the hearing officer against whom the request for disqualification has been filed.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11425.10, 11425.30, 11425.40 and 11512, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 3. Ex Parte Communications

§60060.13. Prohibited Communications.

Note • History

(c) For the purpose of this section, a proceeding is pending from the time that a request for review is first filed with the hearing office.

(d) Communications prohibited under paragraph (a) do not include communications concerning matters of procedure or practice, including requests for continuances that are not in controversy.

(e) A communication between a hearing officer and an employee of the state board that would otherwise be prohibited by this section is permissible if the employee is another employee of the hearing office whose job duties include aiding the hearing officer in carrying out the hearing officer's adjudicative responsibilities. Upon request, the hearing office will provide a list of employees of the hearing office to the parties. The prohibitions of paragraph (a) that apply to the hearing officer shall also apply to such other employees employed in the hearing office. Communications permitted under this paragraph shall not furnish, augment, diminish, or modify the evidence in the record.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11425.10 and 11430.70-11430.80, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 3 (sections 60060.13-60060.14) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.14. Disclosure of Communication.

Note • History

(b) If a hearing officer receives a communication in violation of this article, the hearing officer shall make all of the following a part of the record in the proceeding:

(1) If the communication is written, the writing and any written response of the hearing officer to the communication; and

(c) The hearing officer shall notify all parties that a communication described in this section has been made a part of the record.

(d) If a party requests an opportunity to address the communication within ten days after receipt of notice of the communication:

(1) The party shall be allowed to comment on the communication.

(2) The hearing officer has discretion to allow the party to present evidence concerning the subject of the communication, including discretion to reopen a hearing that has been concluded.

(e) Receipt of ex parte communications may be cause for disqualification of the hearing officer.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11425.10 and 11430.10 et. seq., Government Code; Section 1969, title 13, California Code of Regulations; Sections 11425.10 and 11430.10 et. seq., Government Code; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 4. Filing Requests for Administrative Hearing Review

§60060.15. Requests for Review by a Motor Vehicle Manufacturer or Engine Manufacturer.

Note • History

(a) A motor vehicle manufacturer or engine manufacturer may file a request that a hearing officer review an Executive Officer determination to issue a notice to comply against the motor vehicle manufacturer or engine manufacturer, pursuant to Health and Safety Code section 43105.5(e) and title 13, CCR, section 1969(j).

(b) The motor vehicle manufacturer or engine manufacturer shall file the request for hearing within 30 days from the date that the Executive Officer issues a determination to issue a notice to comply. The hearing officer may, for good cause, extend the time for such filing.

(c) A failure to file a timely request for hearing of the Executive Officer's determination to issue a notice to comply, without alternatively serving on the Executive Officer a compliance plan as required by title 13, CCR, section 1969(j)(8), will result in the Executive Officer determination becoming final. The manufacturer's failure to pursue administrative review could subject the manufacturer to penalties pursuant to Health and Safety Code section 43105.5(f) and title 13, CCR, section 1969(n).

NOTE

HISTORY

1. New subarticle 4 (sections 60060.15-60060.22) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of section heading and section filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.16. Requests for Review by the Executive Officer.

Note • History

(a) The Executive Officer shall file a request for hearing officer review and issuance of a compliance order when:

(1) The Executive Officer has issued a notice to comply against a manufacturer and the manufacturer has failed to either request administrative review of the determination, or, in the alternative, to submit a compliance plan as required under Title 13, CCR, section 1969(l)(9). The Executive Officer shall file the request for review within 30 days from the last day that the manufacturer had to file either a request for review of the determination with the hearing office or submit a compliance plan to the Executive Officer.

(2) A motor vehicle manufacturer or engine manufacturer has submitted a compliance plan pursuant to Title 13, CCR, section 1969(l)(9), and the Executive Officer has determined pursuant to the procedures set forth in section 1969(l)(10) that the compliance plan is unacceptable. The Executive Officer shall file the request for review within 30 days from the date that he or she issues the determination.

(3) A motor vehicle manufacturer or engine manufacturer has had a compliance plan approved pursuant to Title 13, CCR, section 1969(l)(11) but has failed to comply with the terms of the plan.

(b) The hearing officer may, for good cause, extend the time for such filing.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsections (a)(1)-(3) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.17. Content of a Request for Review.

Note • History

A request for review is not required to follow any particular form or format. But the request for review shall include all of the following.

(a) The signature of the requesting party or its designated representative.

(b) Copies of and specific reference to the respective determination of the Executive Officer that is the subject of the request for review (i.e., the notice to comply issued against the motor vehicle manufacturer or engine manufacturer, or the determination rejecting the motor vehicle manufacturer's or engine manufacturer's compliance plan).

(c) The correct business address of the requesting party and, if applicable, the name and address of the party's designated representative.

(d) The name and address of any interested party identified in the challenged determination.

(e) A statement of the circumstances or arguments that are the basis of the request for hearing, with specific reference to the evidence that was before the Executive Officer that supports such arguments.

(f) A statement of the proposed relief sought by the requesting party.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsection (b) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.18. Notice of Receipt of Request for Review.

Note • History

(a) Upon receipt of a timely request for review, the hearing office shall review the request for completeness.

(b) If the request does not include the information required under section 60060.17, the hearing office shall immediately acknowledge receipt of the request and notify the requesting party of the deficiencies that must be corrected before the request for hearing may be deemed filed and docketed. The requesting party shall have 10 days from the date of mailing the notice of deficiencies to submit a complete request for hearing. If the deficiencies are not corrected within the 10 days or the time provided for initially filing the request in sections 60060.15 through 60060.16, whichever is later, the underlying Executive Officer determination will become final.

(c) If the hearing office finds the request for hearing to be complete, it shall deem the request filed on the date that the request was received and notify the requesting party, the Executive Officer, and any identified interested party that a request for hearing has been filed.

(d) Except as provided in paragraph (f) below, the notice shall inform the parties that:

(1) Copies of these hearing procedures are available from the hearing office and that the procedures set forth at Government Code section 11500 et seq. are not applicable.

(2) Interested parties may file a motion to intervene pursuant to these rules if they wish to participate in the hearing.

(3) The parties shall submit to the hearing office responsive and reply arguments by the dates specified in these procedures.

(4) The parties have the right to be represented by counsel or other representative of their choosing and the right to an interpreter or other necessary accommodation.

(e) Upon being informed that the request for review is complete, the Executive Officer shall forward to the hearing officer, within 15 days from the date of service, a certified copy of the Executive Officer determination that is the subject of the request for review and the investigative record that was compiled during the Executive Officer's investigation.

(f) In those matters in which the Executive Officer has requested review of his or her determination to issue a notice to comply because the manufacturer has failed to contest the notice or, in the alternative, submit a compliance plan, the notice shall inform the parties that no hearing on the merits of the underlying Executive Officer determination will be held. Instead the notice shall inform the parties that the hearing officer will issue a compliance order against the motor vehicle manufacturer or engine manufacturer within 30 days of receipt from the Executive Officer of a certified copy of the Executive Officer determination and investigative record.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Part 5, Health and Safety Code; Section 11425.10, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsection (f) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.19. Response to Request for Review.

Note • History

Any party opposed to a filed request for review shall file a response within 30 days after service of the notice of filing by the hearing office. The response shall be in writing and address the issues raised in the request for hearing. The response should include any rebuttal to the issues and arguments raised by the party requesting review, with specific reference to the investigative record that was before the Executive Officer when he or she made a determination that is the subject of the review before the hearing officer. The response shall be in the form of a declaration signed under penalty of perjury.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.20. Reply.

Note • History

Within 15 days of receipt of the last submitted response, the party requesting review may file a reply responding to the contentions raised in any response. The reply shall be in the form of a declaration signed under penalty of perjury.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.21. Extensions of Time for Submitting a Response or Reply.

Note • History

The time period for submitting a response required under section 60060.19 or a reply under section 60060.20 may be extended:

(1) By stipulation of the parties for 30 additional days to allow the parties to conduct informal settlement negotiations; or

(2) Upon motion to the hearing officer, who may extend the time period for up to 30 days, if the moving party can show good cause and if the other parties are not prejudiced by a delay.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.22. Stays Pending Issuance of Hearing Officer's Decision.

Note • History

Pending the hearing officer issuing its decision, a motor vehicle manufacturer or engine manufacturer contesting an Executive Officer determination to issue a notice to comply or to reject a compliance plan submitted in response to a notice to comply shall not be required to take any action in response to the challenged Executive Officer determination.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

Subarticle 5. Pre-Hearing Procedures

§60060.23. Schedule of Review Proceedings.

Note • History

(a) Upon receipt of a request for review, the administrative hearing office of the state board shall assign an administrative law judge to be the hearing officer, unless staffing and other resources of the hearing office would prevent timely consideration of the matter. If the resources of the administrative hearing office prevent assignment, the administrative hearing office shall refer the matter to the State Office of Administrative Hearings for assignment.

(b) With the consent of the parties, hearings shall be conducted based on the written record certified by the Executive Officer and the written submissions of the parties, whenever possible.

(c) For matters that are to be decided based upon the submitted written record, the hearing officer shall serve upon the parties a schedule setting forth the date that the record will be closed and submitted for decision.

(d) For hearings requiring personal appearances, the hearing officer shall serve upon the parties the dates scheduled for hearing for the purpose of taking evidence. Such hearing shall not be set earlier than 30 days from the date that the notice is served on all parties.

(e) Upon either a motion of the hearing officer or any party, the hearing officer may grant such delays or adjustments to the schedule for the review proceedings as may be necessary or desirable in the interest of fairness. In filing a motion, the moving party shall file the request not less than five days prior to the date set for the action covered by the request and shall submit such evidence to establish good cause for the requested delay or adjustment to the schedule. If the hearing officer orders a delay or adjustment to schedule, he or she shall provide written notice to all parties.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11509 and 11440.30, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 5 (sections 60060.23-60060.25) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.24. Consolidation, Separation of Proceedings.

Note • History

(a) Upon the motion of a party or upon the hearing officer's own motion, the hearing officer may consolidate for review and decision:

(1) Any number of proceedings involving the same parties; and

(b) Upon the motion of a party or upon the hearing officer's own motion, the hearing officer may, in furtherance of convenience or to avoid prejudice, or when separate review proceedings will be conducive to expedition and economy, order a separate review proceeding of any issue or any number of issues, including issues raised in a party's response to a request for hearing.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.25. Discovery.

Note • History

(a) The provisions of this section provide the exclusive right to, and method of, discovery as to any proceeding governed by these review procedures. Nothing in this section prohibits the parties from voluntarily stipulating to exchange any information that they deem appropriate. This section does not authorize the inspection or copying of, any writing or thing that is privileged from disclosure by law or protected as part of an attorney's work product.

(b) No discovery is available to the parties in matters forwarded to the hearing officer for issuance of compliance orders pursuant to section 60060.16(a)(1).

(c) For other hearings, within 30 days from the date of service of the notice of filing, a party may serve on any other party to the proceeding a written request, for the following:

(1) The names and addresses of witnesses to the extent known to the other party, including, but not limited to, those intended to be called to testify at the hearing; and

(2) The opportunity to inspect and make a copy of any thing, document, statement or other writings relevant to the issues for hearing that are in the possession, custody or control of another party to the proceeding and would be admissible in evidence. This includes the following information from the investigative file compiled by the Executive Officer: (i) the names and addresses of witnesses or of persons (other than confidential informants) having personal knowledge of the issues involved in the proceeding, (ii) matters perceived by the investigator in the course of his or her investigation (as opposed to his or her analysis or conclusions), and (iii) statements related to the issues of the proceedings which are otherwise admissible.

(d) The parties subject to the requirements of paragraph (c) shall arrange a mutually convenient time for the exchanging of the names and addresses of witnesses and the inspecting and copying of relevant things, documents, statements, and other writings identified in subparagraph (B) above, but such date shall not be later than 30 days from the date of receipt of the request made pursuant to subparagraph (b)(1). Unless other arrangements are made, the party requesting the writings shall pay for the copying.

(e) Absent a stipulation between the parties, a party claiming that certain writings or things are privileged against disclosure shall, within 15 days of receipt of the request for inspection and copying, serve on the requesting party a written statement setting forth what matters it claims are privileged and the reasons supporting its claims.

(f) A party may file a motion requesting that the hearing officer allow further discovery. The motion shall specify the proposed method of discovery that it would like to use and shall include affidavits describing in detail the nature of the information that the requesting party seeks through discovery, the relevance and probative value of the information, proposed time and place of the discovery (if applicable), and why the need for the information was not previously raised with the Executive Officer during his or her consideration of the determination under review. After fully considering the arguments of the parties, the hearing officer may order such discovery that will promote a full and fair hearing. The hearing officer's order shall set forth the form and method of permissible discovery and the time and place for its occurrence.

(g) Proceeding to Compel Discovery.

(A) Facts showing the party has failed or refused to comply with a discovery request or stipulation;

(B) A description of the information sought to be discovered;

(D) Evidence that a reasonable and good faith attempt to contact the noncomplying party for an informal resolution of the issue has been made; and

(E) To the extent known by the moving party, the measures for the noncomplying party's refusal to provide the requested information.

(4) Where the matter sought to be discovered is under the custody or control of the party who has refused or failed to provide discovery and that party asserts that the matter is not a discoverable matter under this section, or is privileged against disclosure, the hearing officer may order that the party in custody lodge with the hearing office the matters identified in subdivision (b) of section 915 of the Evidence Code, and the hearing officer shall examine the matters in accordance with those provisions.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference:; Sections 43105.5(e) and (f), Health and Safety Code; Sections 11189 and 11507.6, Government Code; Section 915(b), Evidence Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 6. Contempt and Sanctions

§60060.26. Contempt.

Note • History

If any person in proceedings before the hearing officer disobeys or resists any lawful order or, if applicable, refuses to take the oath or affirmation as a witness or thereafter refuses to be examined, or is guilty of misconduct during a hearing, the hearing officer may certify the facts to the superior court in and for the county where contempt proceedings are held pursuant to Government Code section 11455.20.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11455 and 11525, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 6 (sections 60060.26-60060.27) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.27. Sanctions.

Note • History

(1) “Actions or tactics” include, but are not limited to, the making or opposing of motions and the failure to comply with a lawful order of the hearing officer.

(2) “Frivolous” means:

(A) Totally and completely without merit, or

(B) For the sole purpose of harassing an opposing party.

(b) An order for sanctions shall be in writing and shall set forth the factual findings that are the basis for the imposition of sanctions.

(c) The order or denial of an order to pay expenses under paragraph (b) is subject of procedural review in the same manner as a final decision pursuant to Subarticle 11.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 11455.30 and 11525, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 7. Review Proceedings

§60060.28. Failure to Appear.

Note • History

If after service of a notice of hearing, including notice of consolidated hearing or continuance, a party fails to appear at a hearing either in person or by representative, the hearing officer may take the proceeding off the calendar or such other appropriate action to insure the rights and interests of all parties under Health and Safety Code section 43105.5 and title 13, CCR, section 1969 et seq.

NOTE

HISTORY

1. New subarticle 7 (sections 60060.28-60060.31) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.29. Conduct of Hearings.

Note • History

(a) All hearings shall be presided over by a hearing officer who shall conduct a full and fair hearing in which all parties have a reasonable opportunity to be heard and to present evidence.

(b) All hearings shall be conducted in the English language, although any party may request the assistance of an interpreter.

(c) In matters brought before the hearing officer pursuant to a request for review filed by the Executive Officer under section 60060.16(a)(1), no hearing on the merits of the underlying Executive Officer determination issuing a notice to comply shall be held. At the hearing officer's discretion, the hearing officer may issue an order to comply without convening a formal hearing.

(d) For all other hearings, subject to reasonable limitations that may be imposed by the hearing officer, each party to the proceeding shall have the right to:

(1) Call and examine witnesses.

(2) Introduce exhibits.

(3) Question opposing witnesses on any matter relevant to the issues even though that matter was not covered in the direct examinations.

(4) Impeach any witness regardless of which party first called the witness to testify.

(5) Call and examine an opposing party as if under cross-examination, even if that party has not testified on its own behalf.

(e) The burden of proof and of going forth with evidence in hearings covered by paragraph (c) shall be as follows.

(1) In all hearings for the review of Executive Officer determinations to issue a notice to comply against a motor vehicle manufacturer or engine manufacturer, to reject a motor vehicle manufacturer's or engine manufacturer's compliance plan, or to seek enforcement of a motor vehicle manufacturer's or engine manufacturer's failure to comply with the terms of an approved compliance plan, the burden of proof and of going forward shall be on the Executive Officer.

(2) At the conclusion of Executive Officer's case-in-chief, the motor vehicle manufacturer or engine manufacturer has the burden of producing evidence to show that no basis exists to support the Executive Officer determination that is under review.

(3) At the close of the motor vehicle manufacturer's or engine manufacturer's presentation of evidence, the parties respectively have the right to introduce rebuttal evidence that is necessary to resolve disputed issues of material fact, subject to any limits imposed by the hearing officer pursuant to subparagraph (f)(1) below.

(f) The hearing officer may:

(2) Require the authentication of any written exhibit or statement;

(3) Call and examine a party or witness and may, on his or her own motion, admit any relevant and material evidence;

(4) Exclude persons whose conduct impedes the orderly conduct of the hearing;

(5) Restrict attendance because of the physical limitations of the hearing facility; or

(6) Take other action to promote due process or the orderly conduct of the hearing.

(g) The taking of evidence in a hearing shall be controlled by the hearing officer in the manner best suited to ascertain the facts and safeguard the rights of the parties. Prior to taking evidence, the hearing officer shall define the issues and the order in which evidence will be received.

(h) The hearing officer shall base its decision as to whether a motor vehicle manufacturer or engine manufacturer is not in compliance or whether the Executive Officer properly rejected a manufacturer submitted compliance plan upon a preponderance of the evidence.

(i) Hearings shall be recorded electronically or by a court reporter. The record made by the Administrative Hearing Office shall be the official record of the hearing.

(2) The official record of the hearing and transcript of the recording, together with all written submissions made by the parties, shall become part of the administrative record for the proceeding.

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsections (e)(1)-(3) and (h) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.30. Evidence.

Note • History

(a) Oral testimony shall be taken only under oath or affirmation.

(b) The hearing need not be conducted in accordance with technical rules of evidence. Rather, the hearing officer shall admit evidence that is the type of evidence that responsible persons are accustomed to relying upon in the conduct of serious affairs. Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but upon timely objection shall not be sufficient by itself to support a finding unless it would be admissible over objection in a civil court action.

(c) The rules of privilege shall be effective to the extent that they are otherwise required by statute to be recognized.

(d) Regarding evidence claimed to be trade secrets or other confidential information, the hearing officer will defer to the findings and conclusions of law made by the superior court pursuant to Health and Safety Code section 43105.5(b) and title 13, CCR, section 1969(i). The hearing officer shall preserve the confidentiality of information determined to be a trade secret and may make such orders as may be necessary, including considering such information in a closed meeting.

(1) The hearing officer shall take official notice of those matters set forth in section 451 of the Evidence Code.

(2) The hearing officer may take official notice of those matters set forth in section 452 of the Evidence Code.

(3) Each party shall give notice of a request to take official notice and be given reasonable opportunity on request to present information relevant to:

(A) The propriety of taking official notice; and

(B) The effect of the matter to be noticed.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Sections 451 and 452, Evidence Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

§60060.31. Evidence by Declaration.

Note • History

(a) At any time 20 or more days prior to a hearing or a continued hearing, a party may mail or deliver to the opposing party or parties a copy of any declaration which the proponent proposes to introduce in evidence, together with a notice as provided in paragraph (b). Unless an opposing party, within seven days after such mailing or delivery, mails or delivers to the proponent a request to cross-examine the declarant the opposing party's right to cross-examine such declarant is waived and the declaration, if introduced in evidence, shall be given the same effect as if the declarant had testified orally. If an opportunity to cross-examine a declarant is not afforded after a request is made as herein provided, the hearing officer may allow the declaration to be introduced, but it shall only be given the same effect as other hearsay evidence.

(b) The notice referred to in paragraph (a) shall be a separate document concurrently served with the declaration, entitled “Notice of Intent to Use Declaration in Lieu of Oral Testimony.” The title shall be in bold print. The content of the notice shall be substantially in the following form:

The accompanying declaration of [insert name of declarant] will be introduced as evidence at the hearing in [insert title and docket number or petition number of proceeding]. [Insert name] will not be called to testify orally and you will not be entitled to question the declarant unless you notify [insert name of the proponent or representative] at [insert address] that you wish to cross-examine the declarant. To be effective, your request must be mailed or delivered to [insert name of proponent or representative] on or before [insert a date 7 days after the date of mailing or delivery of the declaration to the opposing party].”

NOTE

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

Subarticle 8. Decisions of the Hearing Officer

§60060.32. Decisions and Orders of the Hearing Officer.

Note • History

(a) Except for compliance orders issued pursuant to or after a request for hearing filed under section 60060.16(a)(1) or otherwise ordered, all proceedings shall be submitted at the time identified by the hearing officer in the schedule for review that has been served upon the parties. Within 30 days of the matter being submitted, the hearing officer shall make findings upon all facts relevant to the issues under review, and file a written decision and order setting forth the reasons or grounds therefore.

(b) If the decision finds that the motor vehicle manufacturer or engine manufacturer has failed to comply with any of the requirements of Health and Safety Code section 43105.5 or title 13, CCR, section 1969, including the obligation to submit an acceptable compliance plan, the decision shall order the motor vehicle manufacturer or engine manufacturer to come into compliance within 30 days of the effective date of the decision.

(1) The order shall further provide that if the motor vehicle manufacturer or engine manufacturer fails to comply within the 30-day time period set forth above, the hearing officer may order that the motor vehicle manufacturer or engine manufacturer be assessed penalties in an amount not to exceed $25,000 per day per violation, commencing of the 31st day of noncompliance and continuing until the violation is corrected.

(2) For purposes of this section, a finding by the hearing officer that a motor vehicle manufacturer or engine manufacturer has failed to comply with the requirements of Health and Safety Code section 43105.5 and title 13 CCR, section 1969 et seq., including the failure to submit a timely compliance plan, shall be considered a single violation.

(c) A compliance order issued pursuant to a request for review filed under section 60060.16(a)(1) shall be in writing and issued within 30 days from the date the hearing officer notified the parties that it is in receipt of the documents forwarded by the Executive Officer. The order shall require that the motor vehicle manufacturer or engine manufacturer, within 30 days from the date of the order, correct the noncompliance identified by the Executive Officer in its notice to comply. The hearing officer may order the assessment of penalties for continuing noncompliance after the 30-day grace period consistent with the provisions of paragraphs (b)(1) and (2) above.

(d) The decision or order of the hearing officer is the final decision of the ARB and is effective on the date of issuance.

(e) A copy of the decision or order shall be served on each party or representative.

(f) Within five days of the filing of any decision or order, a party may file a written request that the hearing officer correct a mistake or clerical error.

(1) Pursuant to the party's request or on the hearing officer's own motion, the hearing officer may issue a revised decision or order correcting a mistake or clerical error with respect to any matter respectively covered therein. If the hearing officer makes such a determination, he shall provide written notice to the parties.

(2) A motion filed by a party under this subparagraph shall be deemed denied if the hearing officer has taken no action to address the request within 15 days of filing of the request. In such a case, the decision shall become effective 15 days after the motion was filed.

(3) Within 15 days notifying the parties of his or her intent to modify the decision or order, the hearing officer shall serve a copy of any modified decision or order on each party that had previously been served with the original. The modified decision or order shall supersede the previously served document. The date of service of the modified decision or order shall become the effective date of the document.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Section 11425.50, Government Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 8 (sections 60060.32-60060.33) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsections (b)-(c) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

§60060.33. Penalty Assessment.

Note • History

In determining the appropriate conditional daily penalties that a motor vehicle manufacturer or engine manufacturer may be subject to under Health and Safety Code section 43105.5(f) and these regulations, the hearing officer shall consider the following factors.

(a) The extent of noncompliance by the motor vehicle manufacturer or engine manufacturer.

(b) The harm caused by the noncompliance to the covered person and other persons, as well as any violations to public health and safety and to the environment.

(d) The compliance history of the motor vehicle manufacturer or engine manufacturer, including the history of past noncompliance.

(e) The efforts made to comply, and any special circumstances preventing or delaying compliance.

(f) The cooperation of the motor vehicle manufacturer or engine manufacturer during the course of the Executive Officer's investigation.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Section 43105.5, Health and Safety Code; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of first paragraph and subsections (a), (d) and (f) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

Subarticle 9. Judicial Review

§60060.34. Judicial Review.

Note • History

(a) Except as provided in paragraph (b) below, a party adversely affected by the final decision of the hearing officer may seek judicial review by filing a petition for a writ of mandate in accordance with section 1094.5 of the California Code of Civil Procedure. Such petition shall be filed within 30 days after the order or decision becomes final.

(b) A motor vehicle manufacturer or engine manufacturer adversely affected by a compliance order issued pursuant to section 60060.33(a) may only request judicial review of a penalty assessment and not the merits of the underlying notice to comply, which the manufacturer never itself contested.

NOTE

Authority cited: Sections 39600, 39601 and 43105.5(e) and (f), Health and Safety Code. Reference: Sections 43105.5(e) and (f), Health and Safety Code; Section 1094.5, California Code of Civil Procedure; Section 1969, title 13, California Code of Regulations; and Mathews v. Eldridge (1976) 424 U.S. 319.

HISTORY

1. New subarticle 9 (section 60060.34) and section filed 9-12-2002; operative 10-1-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 37).

2. Amendment of subsection (b) filed 6-15-2007; operative 7-15-2007 (Register 2007, No. 24).

Article 3. Administrative Hearing Procedures for Review of Complaints

Subarticle 1. General Provisions

§60065.1. Applicability.

Note • History

(a) This article governs hearings to review complaints issued by the state board pursuant to Health and Safety Code sections 42410, 43023, and 43028. The procedures outlined here do not apply to citations that are subject to review under Article 5, section 60075.1, et seq.

(b) The provisions of this article apply only to complaints filed on or after the effective date of this article.

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; Sections 60075, et seq., title 17 and 2048, title 13, California Code of Regulations; and Sections 11500, et seq., Government Code.

HISTORY

1. New article 3 (subarticles 1-10, sections 60065.1-60065.45), subarticle 1 (sections 60065.1-60065.10) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsection (a) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.2. Definitions.

Note • History

(a) The definitions applicable to these rules include those set out in the Health and Safety Code (commencing with section 39010).

(b) The following definitions also apply:

(1) “Administrative record” means all documents and records timely filed with the hearing office, pursuant to section 60065.4 and the time deadlines of these rules, including pleadings, petitions, motions, and legal arguments in support thereof; all documents or records admitted into evidence or administratively noticed by the hearing officer; all official recordings or written transcripts of hearings conducted; and all orders or decisions issued by the hearing officer or executive officer regarding the complaint at issue; administrative record does not include any prohibited communications as defined in section 60065.13, and any settlement discussions or offers of settlement pursuant to section 60065.25.

(2) “Complainant” means the state board, acting through any of its employees that have been authorized to investigate, issue, and prosecute a complaint under this article.

(3) “Complaint” means a document, other than a citation issued for a Class I violation pursuant to title 17, California Code of Regulations, section 60075.1 et. seq., issued by the complainant that seeks administrative civil penalties as an alternative to judicial civil penalties.

(4) “Consent Order” means an order entered by the hearing officer in accordance with the settlement agreement of the parties.

(5) “Days” means calendar days.

(6) “Default” means the failure of any party to take the steps necessary and required by these regulations to further the hearing towards resolution, resulting in a finding by the hearing officer of forfeiture of the cause of action against that party.

(7) “Discovery” refers to the process set forth in section 60065.26 allowing one party to request and obtain information relevant to the complaint proceedings. The scope of discovery is limited by the express terms of that section.

(8) “Ex Parte Communication” means an oral or written communication not on the public record for which reasonable prior notice to all parties should have been given.

(9) “Hearing Office” refers to the administrative hearings office established by the state board to conduct administrative hearings to implement the provisions of these rules or to the Office of Administrative Hearings established pursuant to Government Code section 11370.2. The administrative hearing office of the state board shall include at least one administrative law judge who shall act as a hearing officer.

(10) “Hearing Officer” is either an administrative law judge appointed by the state board to conduct hearings under these procedures pursuant to Health and Safety Code section 43028, or an administrative law judge within the Department of General Services, State Office of Administrative Hearings (OAH) who shall be appointed to conduct hearings pursuant to Health and Safety Code sections 42410 and 43023. Only appointed administrative law judges shall act as hearing officers.

(11) “Intervenor” means a person who is allowed to voluntarily enter into the proceedings with leave of the hearing officer.

(12) “Party” includes the complainant, respondent, and an intervenor to the extent permitted by the hearing officer pursuant to section 60065.22.

(13) “Proceeding” means any hearing, determination or other activity before the hearing officer involving the parties to a complaint.

(14) “Respondent” means any person against whom a complaint has been filed under this article.

(15) “Response/Request for Hearing” means a document, responsive to the complaint and signed by the respondent, in which respondent requests a hearing before an administrative law judge and admits or denies the allegations of the complaint or asserts affirmative defenses to the action.

(16) “Settlement Agreement” means a written agreement executed by the complainant, respondent, and, to the extent permitted by the hearing officer pursuant to section 60065.22(b)(4), an intervenor, that respectively settles the allegations of violation set forth in the complaint. Settlement agreements of a complaint should include:

(A) Stipulations by the parties establishing subject matter jurisdiction;

(B) An admission by respondent that it has committed the violations as alleged in the complaint or a statement by respondent that it neither admits nor denies such violation(s); and

NOTE

Authority cited: Sections 39010, 39600, 39601, 42410, 43023, 43028 and 43031(a), et seq., Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 39010, 39514, 42410, 43023, 43028 and 43031(a), Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsections (a), (b)(3), (b)(10) and (b)(15) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.3. Right to Representation.

Note • History

(c) A representative may withdraw an appearance by filing a written notice of withdrawal with the hearing office and by serving a copy on all parties.

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; and Sections 2180, et seq., title 13, California Code of Regulations.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.4. Time Limits; Computation of Time.

Note • History

(e) Where service of any pleading, petition, letter, document, or other writing is by mail, overnight delivery, or facsimile transmission (fax), pursuant to section 60065.5(c), and if within a given number of days after such service, a right may be exercised, or an act is to be performed, the time within which such right may be exercised or act performed shall be extended as provided in section 60065.5(c).

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); and Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.5. Service, Notice and Posting.

Note • History

(b) The complaint and all accompanying information shall be served on the respondent personally or by registered mail.

(c) Except as provided in (b) above and unless otherwise required, service of any documents in the proceedings may be made by personal delivery; by United States first-class or interoffice mail, by overnight delivery, or by fax.

(1) Service is complete at the time of personal delivery.

(2) In the case of first-class mail, the documents to be served must be deposited in a post office, mailbox or mail chute, or other like facility regularly maintained by the United States Postal Service, in a sealed envelope, properly addressed to the person on whom it is to be served at the address as last given by that person on any document filed in the present cause of action and served on the party making service or otherwise at the place of residence of the person to be served. The service is complete at the time of the deposit, but any period of notice and any right or duty to do any act or to make any response within any period or date prescribed after service of the document shall be extended five days if the place of address is within the State of California, ten days if the place of address is outside the State of California but within the United States, and fifteen days if the place of address is outside the United States.

(1) Where service is made by personal delivery, the declaration shall show the date and place of delivery and the name of the person to whom the documents were handed. Where the person making the service is unable to obtain the name of the person to whom the documents were handed, the person making the service may substitute a physical description for the name.

(3) Where service is made by fax, the declaration shall show the method of service on each party, the date sent, and the fax number to which the document was sent.

(f) Proof of service made in accordance with Code of Civil Procedure section 1013a complies with this regulation.

(g) Service and notice to a party who has appeared through a representative shall be made upon such representative.

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; Sections 11182 and 11184, Government Code; and Sections 1013 and 1013a.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsection (d)(1) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.6. Motions.

Note • History

(c) The hearing office shall set the time and place for the hearing of the motion. The hearing shall occur as soon as practicable.

(f) A request for a prehearing conference or a settlement conference under sections 60065.27 and 60065.28 does not constitute a motion within the meaning of this section.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.7. Form of Pleadings.

Note • History

(a) Except as otherwise expressly provided in this article or by the hearing officer, there are no specific requirements as to the form of documents filed in a proceeding under these rules.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.8. Limitations on Written Legal Arguments or Statements

Note • History

(1) Fifteen pages, for arguments in support of or opposition to motions; and

(2) Five pages, for reply arguments.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.9. Records of the State Board.

Note • History

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; Sections 6250, et seq., Government Code; and Sections 91000, et seq., title 17, California Code of Regulations.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.10. Interpreters and Other Forms of Accommodation.

Note • History

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; Sections 11435.25, 11435.30 and 11435.55, Government Code; and Section 751, Evidence Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

Subarticle 2. Hearing Officers

§60065.11. Authority of Hearing Officers.

Note • History

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; and Sections 11181-11182 and 11425.30, Government Code.

HISTORY

1. New subarticle 2 (sections 60065.11-60065.12) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.12. Disqualification.

Note • History

(a) The hearing officer shall disqualify himself or herself and withdraw from any case in which he or she cannot accord a fair and impartial hearing.

(b) A hearing officer may not hear any case in which he or she has previously served as an investigator, prosecutor, or advocate.

(c) Any party may request the disqualification of a hearing officer or the executive officer, on a request for reconsideration, by filing an affidavit or declaration under penalty of perjury. A request against the hearing officer must be made no later than five days prior to the commencement of a prehearing conference or first day of hearing on the merits, whichever is earlier. A request for disqualification of the executive officer must be included in the request for reconsideration. The affidavit or declaration must state with particularity the grounds upon which it is claimed that a fair and impartial hearing cannot be accorded. The issue shall be respectively determined by either the hearing officer or the executive officer against whom the request for disqualification has been filed.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsection (b) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

Subarticle 3. Ex Parte Communications

§60065.13. Prohibited Communications.

Note • History

(e) A communication between a hearing officer and an employee of the state board that would otherwise be prohibited by this section is permissible if:

(3) The prohibitions of paragraph (a) that apply to the hearing officer shall also apply to all employees covered by subparagraphs (1) and (2) above.

(4) Communications permitted under subparagraphs (1) and (2) above shall not furnish, augment, diminish, or modify the evidence in the record.

NOTE

HISTORY

1. New subarticle 3 (sections 60065.13-60065.15) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsection (c) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.14. Disclosure of Communication.

Note • History

(b) If a hearing officer receives a communication in violation of this article, the hearing officer shall make all of the following a part of the record in the proceeding:

(1) If the communication is written, the writing and any written response of the hearing officer to the communication; and

(c) The hearing officer shall notify all parties that a communication described in this section has been made a part of the record.

(d) If a party requests an opportunity to address the communication within ten days after receipt of notice of the communication:

(1) The party shall be allowed to comment on the communication.

(2) The hearing officer has discretion to allow the party to present evidence concerning the subject of the communication, including discretion to reopen a hearing that hearing having been concluded.

(e) Receipt of ex parte communications may be cause for disqualification of the hearing officer.

NOTE

Authority cited: Sections 39600 and 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 42410, 43023, 43028 and 43031(a), Health and Safety Code; and Sections 11340.1-11340.5, Government Code.

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.15. Applicability to Executive Officer.

Note • History

(a) The provision of Subarticle 3 governing ex parte communications to the hearing officer also governs ex parte communications with the executive officer on matters that may come before him or her pursuant to Subarticle 9. Irrespective of the prohibitions of section 60065.13(a), the executive officer may consult with state board personnel who are not involved as an investigator, prosecutor, or advocate in the proceedings or preadjudicative proceedings of the matter before the executive officer, or in a factually related case, and whose job duties include assisting the executive officer in his or her adjudicative responsibilities.

(b) Except as otherwise provided in these procedures, while a proceeding is pending, the hearing officer shall have no communication, direct or indirect, with the members of the state board regarding the merits of any issue in the proceeding.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

Subarticle 4. Issuance of and Response to Complaints

§60065.16. Violations Subject to a Complaint; Issuance.

Note • History

(a) A complaint may be issued for violations:

(1) Arising under part 5, chapters 1 though 4 and chapter 6 of division 26 of the Health and Safety Code, or violations of any rule, regulation, permit, variance, or orders of the state board adopted or issued pursuant to authority granted under those Health and Safety Code provisions;

(2) Of regulations adopted and orders issued by the state board pursuant to authority granted under parts 1 through 4 of division 26 of the Health and Safety Code.

(b) Complaints issued pursuant to Health and Safety Code 43028 shall not seek penalties that exceed $25,000 per violation for each day of violation or total penalties in excess of $300,000.

(c) Complaints issued pursuant to Health and Safety Code sections 42410 and 43023 shall not seek penalties in excess of the lesser of the maximum amount allowed by statute for a violation or $10,000 per violation for any day in which the violation occurs, with a total penalty assessment not to exceed $100,000. In determining the amount allowed by statute, the ARB shall use the method of calculation set forth in the underlying statute (e.g., HSC §43016 states that penalties shall be assessed on a per vehicle basis and shall not exceed $500 per vehicle.)

(d) The state board shall not issue a complaint for any violation if:

(1) The state board shares concurrent enforcement jurisdiction with a district and the district has commenced an enforcement action for that violation;

(2) The state board has determined the violation to be a Class I violation as defined in title 17, California Code of Regulations, sections 60075.2(b)(5) and 60075.11.

(e) A complaint shall include:

(1) The names of each respondent alleged to have committed a violation(s) covered under this article;

(2) A statement of the facts, in ordinary and concise language, that specifically identifies the statutes and/or rules alleged to have been violated and the acts or omissions of the respondents that constitute the alleged violation(s). The statement shall be specific enough to afford the named respondents notice and information in which to prepare a defense;

(3) A proposed penalty that complainant seeks for the alleged violations committed;

(4) Reference to these procedures, notice that a copy of the procedures is available from the ARB hearing office (the address and phone number of which shall be set forth), and notice that Chapter 5 (commencing with section 11500) of the Government Code is not applicable to these proceedings;

(5) Written notice to the respondent that, within 30 days from the date of service, it may respond to the allegations of the complaint by filing a response/request for hearing that the matter be heard by an administrative law judge. The notice shall also inform the respondent of the consequences of failing to respond by the applicable deadline;

(6) Written notice to the respondent that it has under the hearing procedures the right to counsel; and, if necessary, the right to an interpreter; or

(7) The address of the office issuing the complaint; the address to which payment of the proposed penalty may be sent; and the address of the hearing office to whom a response/request for hearing may be submitted.

(f) A complaint shall be filed with the appropriate hearing office and served on the named respondent(s) by either personal or other form of service consistent with Code of Civil Procedure sections 415 through 417 or by certified mail, restricted delivery.

NOTE

Authority cited: Sections 39600, 39601, 42410, 43023, 43028 and 43031(a), Health and Safety Code. Reference: Mathews v. Eldridge, 424 U.S. 319 (1976); Sections 39674, 42401, 42402, 42402.1, 42402.2, 42402.3, 42403, 42410, 43008.6, 43012, 43016, 43021, 43023, 43026, 43027, 43028, 43029, 43030, 43031(a), 43154, 43201, 43211 and 43212, Health and Safety Code; and Sections 60075.1, et seq., title 13, California Code of Regulations.

HISTORY

1. New subarticle 4 (sections 60065.16-60065.20) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of section and Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.17. Withdrawal of or Amendment to the Complaint.

Note • History

(a) The complainant may without prejudice withdrawal or amend the complaint once as a matter of right at any time before respondent has filed its response.

(b) After the response has been filed, the complainant may move to withdraw or amend the complaint. A motion to amend the complaint must include the proposed amendment. The hearing officer may grant the motion upon finding that good cause exists and that the amendment is in the interest of justice.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.18. Response/Request for Hearing.

Note • History

(a) Within 30 days after service of the complaint, the respondent or its representative may file a response/request for hearing to the complaint with the hearing office designated in the complaint. In addition to requesting a hearing before an administrative law judge, the respondent may:

(1) Object to the complaint on the ground that it does not state acts or omissions upon which the agency may proceed;

(2) Object to the form of the complaint on the ground that it is so indefinite or uncertain that the respondent cannot identify the transaction or prepare a defense;

(3) Admit or deny the complaint, in whole or in part, specifying each allegation of fact or conclusion of law as to liability which is in dispute;

(4) Present new matters by way of affirmative defenses; or

(5) Oppose or agree to pay the penalty amount proposed in the complaint.

(b) The time period for response may be extended:

(1) By stipulation of the parties for 30 additional days to allow the parties to conduct informal settlement negotiations; or

(2) At the discretion of the hearing officer, for a period of up to 60 days, if the respondent can show good cause and if the complainant is not prejudiced by such a delay.

(d) If the respondent fails to respond to the complaint in the time periods provided in this section, the matter shall be considered a default, pursuant to section 60065.41 and the respondent shall be considered to have waived his or her right to appear in the matter covered by the complaint.

(e) If a complaint is amended prior to the time respondent's response was due under subparagraph (a), respondent shall have 15 additional days from the date of service of the amended complaint to file the response.

(f) The respondent may move to amend its response to the complaint. Such motion must include language of the proposed amendment. The hearing officer may grant the motion upon finding that good cause exists and that the amendment is in the interest of justice.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of section heading, subsection (a) and Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.19. Issues for Hearing.

Note • History

The issues for hearing shall be limited to those raised in the complaint or amended complaint and the response or amended response. If the complaint alleges a repeat violation and the validity of the earlier violation(s) was not contested because of the respondent's failure to file a response/request for hearing, the validity of the earlier violations(s) shall not be at issue.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of section and Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.20. Cease and Desist Orders; Stays Pending Hearing.

Note • History

If the ARB enforcement staff has issued a cease and desist order against the respondent for alleged violations set forth in the complaint, the respondent may request a stay pending hearing from the hearing officer. The hearing officer may grant a stay pending issuance of a hearing officer decision under section 60065.39, unless the hearing officer finds that the adverse effects of a stay on the public health, safety and welfare outweigh the harm to those persons directly affected by the lack of a stay. The hearing officer may conduct a hearing or request such submissions by the parties as necessary to obtain information to make a determination on this issue.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

Subarticle 5. Prehearing Procedures

§60065.21. Scheduling of Hearings.

Note • History

(a) Upon filing of a complaint issued pursuant to authority granted under Health and Safety Code sections 42410 and 43023, with OAH, the matter shall be assigned to a hearing officer.

(b) Upon filing of a complaint issued pursuant to Health and Safety Code section 43028, the hearing office of the state board shall assign a hearing officer of the state board to hear the matter, unless staffing and other resources of the hearing office would prevent timely consideration of the matter. If the resources of the state board's administrative hearing office prevent assignment, the administrative hearing office shall refer the matter to the OAH for assignment.

(c) The hearing office in which a complaint is filed shall as expeditiously as possible, but no later than 30 days after a response/request for hearing to the complaint has been filed or 45 days from the date that the complaint was issued if no response/request for hearing has been filed, schedule the matter for hearing. Except as provided in paragraph (f), below, a hearing shall be scheduled for no later than 180 days from the date of issuance of the complaint, unless the hearing officer determines, for good cause, that a later hearing date is necessary and in the interest of justice.

(d) The hearing office shall deliver or mail a notice of hearing to all parties at least 30 days prior to the hearing. The notice shall be in the form specified in section 11509 of the Government Code, and shall also provide notice of the availability of interpreters pursuant to section 60065.10 of these rules.

(e) The hearing officer shall grant such delays or continuances as may be necessary or desirable in the interest of fairly resolving the case.

(1) The hearing officer may, on his or her own motion or upon request of any party accompanied by a showing of good cause, continue a hearing to another time or place.

(2) A party shall apply to the hearing officer for a continuance not less than five days prior to the scheduled hearing.

(3) When a continuance is ordered during a hearing, the hearing officer shall give written notice of the time and place of the continued hearing.

(f) The hearing office shall set the place of hearing at a location as near as practicable to the place where the respondent resides or maintains a place of business in California. If the respondent does not reside or maintain a place of business in California, the hearing shall be in Sacramento. The hearing office may establish hearing locations anywhere in the state; at a minimum one hearing location shall be established in Sacramento and one in the Los Angeles area.

(g) Upon the motion of any party and a showing of good cause, or upon the motion of the hearing officer, and in the absence of an objection from any party, the hearing officer may exercise discretion to conduct all or part of a hearing by telephone.

(2) The hearing officer may direct the party who has requested the alternative method to make the necessary arrangements and be responsible for any associated costs.

NOTE

HISTORY

1. New subarticle 5 (sections 60065.21-60065.29) and section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. New subsection (a), subsection relettering, amendment of newly designated subsections (b)-(c) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.22. Motion to Intervene.

Note • History

(a) A person may file a motion to intervene, and the hearing officer may grant such a motion if all of the following conditions are satisfied:

(1) The motion is in writing, with copies served on all parties named in the complaint.

(2) The motion is made as early as practicable prior to the prehearing conference, if one is held, or the first day of the hearing on the merits of the complaint.

(4) The hearing officer determines that the interests of justice and the orderly and prompt conduct of the proceeding will not be impaired by allowing the intervention.

(b) If motion is granted, the hearing officer may impose conditions on the intervenor's participation in the proceeding, either at the time that intervention is granted or at a later time. Conditions may include:

(1) Limiting the intervenor's participation to designated issues in which the intervenor has a particular interest demonstrated by the motion.

(2) Limiting or excluding the use of discovery, cross-examination, and other procedures involving the intervenor so as to promote the orderly and prompt conduct of the proceeding.

(3) Requiring two or more intervenors to combine their presentations of evidence and argument, cross-examination, discovery, and other participation in the proceeding.

(4) Limiting or excluding the intervenors's participation in settlement negotiations.

(d) Whether the interests of justice and the orderly and prompt conduct of the proceedings will be impaired by allowing intervention is a determination to be made at the sole discretion of the hearing officer, based upon his or her knowledge and judgment. The determination is not subject to administrative or judicial review.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsections (a)(1)-(2) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.23. Consolidation, Separation of Proceedings.

Note • History

(a) Upon the motion of a party or upon the hearing officer's own motion, the hearing officer may consolidate for hearing and decision:

(1) Any number of proceedings involving the same respondent or petitioner; and

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.24. Prehearing Conference.

Note • History

(a) In any action in which the respondent timely responds pursuant to section 60065.18, the hearing officer may require a prehearing conference upon his or her own order or the request of any party. A request for a prehearing conference shall be in writing, addressed to the hearing officer and served on all parties.

(b) A prehearing conference shall be held no later than 30 days after an order of the hearing officer or a request by a party, but no later than 90 days from the date of respondent's filing of the response to a complaint.

(1) Identification of all operative pleadings by title and date signed;

(2) The party's current estimate of time necessary to try the case;

(3) The name of each witness the party may call at hearing along with a brief statement of the content of the witness's expected testimony;

(4) The identity of any witness whose testimony will be presented by affidavit pursuant to section 60065.29, if known;

(6) Whether there is need for an interpreter or special accommodation at the hearing;

(7) A list of the documentary exhibits the party intends to present at hearing and a description of any physical or demonstrative evidence; and

(8) A concise statement of any legal issues which may affect the presentation of evidence or the disposition of the case.

(9) If the matter is a complaint proceeding, the complainant shall specify the proposed penalty and state the basis for that penalty. The respondent shall provide all factual information it considers relevant to the assessment of a penalty.

(e) At the prehearing conference the hearing officer may:

(1) Establish a time and place for further proceedings in the action, but no hearing on the merits of the action shall take place sooner than 30 days following the date of the prehearing conference;

(2) Attempt to simplify issues and help the parties to stipulate to facts not in dispute;

(3) Explore the necessity or desirability of amendments to the pleadings; and

(4) Discuss any other appropriate subject.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of subsections (a)-(b) and amendment of Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.25. Settlement Agreements and Consent Orders.

Note • History

(a) At any time before a final decision of the hearing officer, the complainant and the respondent may settle an action, in whole or in part.

(d) In a complaint proceeding, the hearing officer assigned to hear the merits of the case, shall thereafter enter a consent order in accordance with the terms of the settlement agreement. Such consent order is not subject to further review by the agency or a court.

(e) If the filing of the consent order pursuant to paragraph (d) of this section does not wholly conclude the action, the hearing officer assigned to hear the merits of the case shall promptly inform the parties of the schedule of the remaining proceedings.

NOTE

HISTORY

1. New section filed 9-1-99; operative 10-1-99 (Register 99, No. 36).

2. Amendment of section and Note filed 9-4-2003; operative 10-4-2003 (Register 2003, No. 36).

§60065.26. Discovery.

Note • History

(b) The names and addresses of witnesses; inspection and copying of documents and things.

(1) Unless otherwise stipulated to by the parties, within 45 days of issuance of a complaint or amended complaint, a party may request: