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(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.
s 1075. Local Health Departments.
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.
s 1076. Certificates of Approval Required.
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.
s 1076.1. Public Health Laboratory.
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.
s 1077. Reports Required.
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.
(c) Such additional reports shall be made as required by the Department.
Note: Authority cited: Sections 208 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code.
s 1078. Minimum Requirements Specified.
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.
(c) Establish and maintain for a minimum of two years adequate record systems and files of laboratory work done.
(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.
s 1079. Professional Personnel to Be Certified.
(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.
s 1080. Professional Training.
(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.
s 1081. Certain Cultures and Specimens to Be Sent to the State Laboratory.
(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.
s 1082. Certain Specimens to Be Sent to Approved Laboratories.
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.
s 1083. Inspections to Be Made.
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.
s 1084. Health Departments May Contract with Private Laboratories.
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.
s 1125. Application Required.
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: ss 1125 to 1134, inclusive, originally issued under authority contained in Section 79.04, Civil Code, and Deering's General Laws, Act 6265. Source ofss 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.
s 1126. Approved Tests.
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.
s 1127. Method of Conducting Tests.
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.
s 1128. Evaluation Sera.
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."
s 1129. Marriage Health Certificates.
"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.
s 1130. Persons Permitted to Perform Tests.
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.
s 1131. Change of Personnel.
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.
s 1132. Change of Director or Location.
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.
s 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.
s 1134. Withdrawal of Approval.
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.
s 1150. Definitions.
(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.
(c) For purposes of these regulations, "department" means: the State Department of Public Health.
(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.
s 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.
s 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.
s 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.
(c) Similarly, such licensees shall submit such data and records as may be designated by the department.
s 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;
(c) Use and disposition of the animals.
Such records may be open to inspection by authorized agents of the department during the normal working hours of operation.
s 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.
s 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.
s 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.
s 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.
s 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.
s 1160. Application of Subchapter.
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.
s 1161. Methadone Drug Analysis.
"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.
s 1162. Methadone Drug Analysis Laboratory.
"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.
s 1163. Methadone Drug Analysis Supervisor.
"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.
s 1164. Method.
"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.
s 1165. Instrument or Device.
"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.
s 1166. Sample or Specimen.
"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.
s 1167. Department.
"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.
s 1168. May, Shall.
"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.
s 1169. Methadone.
"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.
s 1170. Primary Metabolite of Methadone.
"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.
s 1171. Licensing Requirement.
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.
s 1172. Qualifications for Licensing.
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.
(c) Maintains an internal quality control program.
(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.
s 1173. Qualifications of Methadone Drug Analysis Supervisor.
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.
s 1174. Use or Access of Patients.
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.
s 1175. Qualifying for License.
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.
s 1176. Renewal of Licenses.
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.
s 1177. Application Forms.
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.
s 1178. Report of Change or Discontinuance.
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.
s 1179. 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 license.
Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11887, Health and Safety Code.
s 1180. Display of Licenses.
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.
s 1181. Fees.
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.
s 1182. Urine.
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.
s 1183. General.
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 col lection 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.
s 1184. Sample Preservation.
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.
s 1185. General.
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.
s 1186. Standards of Performance.
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.
s 1187. Specificity.
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.
s 1188. Evaluation of Standards of Performance.
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.
s 1189. Expression of Analytical Results.
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.
s 1190. Inspections and Proficiency Testing.
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.
s 1191. Access to Premises.
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.
s 1192. Quality Control Program and Proficiency Testing.
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.
s 1193. Standard of Performance in Proficiency Testing Program.
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.
s 1194. List of Certified Methadone Laboratories.
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.
s 1195. General.
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.
s 1196. Methadone Drug Analysis Laboratory Records.
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.
Note: Authority cited: Sections 208 and 4025, Health and Safety Code. Reference Section 4025, Health and Safety Code.
s 1200. Definitions.
(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
s 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.
s 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.
(c) The person shall be prepared to begin operations at the time application for approval is submitted.
(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.
s 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. (continued)