reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1176 - Renewal of Licenses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11887,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1177 - Application Forms

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11887,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1178 - Report of Change or Discontinuance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1179 - License Implications

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Licenses issued under these regulations shall not imply
						  approval of anything carried out by a laboratory other than what is specified on the
						  license.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11885,
							 11886
							 and
							 11887,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1180 - Display of Licenses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Licenses issued under these regulations shall be displayed
						  on request to representatives of the Department.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11885
							 and
							 11887,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 4 - LICENSING PROCEDURES › Section 1181 - Fees

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11887,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 5 - SUBSTANCES APPROVED FOR ANALYSIS, REQUIREMENTS FOR COLLECTION AND HANDLING OF SAMPLES › Section 1182 - Urine

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The only presently approved body fluid which may be tested
						  for a methadone program is urine.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11885
							 and
							 11886,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 5 - SUBSTANCES APPROVED FOR ANALYSIS, REQUIREMENTS FOR COLLECTION AND HANDLING OF SAMPLES › Section 1183 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 5 - SUBSTANCES APPROVED FOR ANALYSIS, REQUIREMENTS FOR COLLECTION AND HANDLING OF SAMPLES › Section 1184 - Sample Preservation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
While not in transit to a laboratory, or being analyzed, any
						  urine sample not containing a preservative shall be refrigerated.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 6 - METHODS OF ANALYSIS AND STANDARDS OF PERFORMANCE › Section 1185 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 6 - METHODS OF ANALYSIS AND STANDARDS OF PERFORMANCE › Section 1186 - Standards of Performance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 6 - METHODS OF ANALYSIS AND STANDARDS OF PERFORMANCE › Section 1187 - Specificity

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 6 - METHODS OF ANALYSIS AND STANDARDS OF PERFORMANCE › Section 1188 - Evaluation of Standards of Performance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 6 - METHODS OF ANALYSIS AND STANDARDS OF PERFORMANCE › Section 1189 - Expression of Analytical Results

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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."
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 7 - INSPECTIONS, QUALITY CONTROL, PROFICIENCY TESTING › Section 1190 - Inspections and Proficiency Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11888
							 and
							 11890,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 7 - INSPECTIONS, QUALITY CONTROL, PROFICIENCY TESTING › Section 1191 - Access to Premises

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11888
							 and
							 11890,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 7 - INSPECTIONS, QUALITY CONTROL, PROFICIENCY TESTING › Section 1192 - Quality Control Program and Proficiency Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 7 - INSPECTIONS, QUALITY CONTROL, PROFICIENCY TESTING › Section 1193 - Standard of Performance in Proficiency Testing Program

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11885,
							 11889
							 and
							 11893,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 7 - INSPECTIONS, QUALITY CONTROL, PROFICIENCY TESTING › Section 1194 - List of Certified Methadone Laboratories

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11889,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 8 - RECORDS › Section 1195 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Sections
							 11885
							 and
							 11890,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 5.5 - METHADONE DRUG ANALYSIS LABORATORIES › Article 8 - RECORDS › Section 1196 - Methadone Drug Analysis Laboratory Records

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Editorial
						  correction of NOTE filed 11-6-84 (Register 84, No.
						  45).
Note: Authority cited: Sections
							 208,
							 11881
							 and
							 11885,
							 Health and Safety Code. Reference: Section
							 11885,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 6 - WATER LABORATORIES

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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).
Note: Authority cited: Sections
						208 and
						4025,
						Health and Safety Code. Reference Section
						4025,
						Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1200 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
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).
Note: Authority cited for Group 7: Sections
							 102 and
							 208,
							 Health and Safety Code
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1201 - Approval Required for Tissue Preservation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1202 - Provisions for Approval

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1203 - Exemptions from Approval

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1204 - Records

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
(c) Records shall contain the
						following data:
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 7 - HUMAN TISSUE PRESERVATION › Article 1 - APPROVAL › Section 1205 - Labels

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 1 - General › Section 1215.1 - Definitions. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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).
3. Renumbering of former
						  section 1215.1 to new section
						  1215 filed 1-26-2017; operative
						  4-1-2017 (Register 2017, No. 4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 2 - Requirements for Forensic Alcohol Laboratories › Section 1216 - Notification Requirement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every
						laboratory performing forensic alcohol analysis shall provide the Department with
						the following within 90 days of any change to the information listed in 1-4 below:
(1) A statement of intent to perform or stop
						performing alcohol analysis, to include fluid analysis, breath analysis, or
						both;
(2) The laboratory's current
						address, as well as the name, address, and phone number of the laboratory's point of
						contact;
(3) A list of current
						laboratory personnel qualified to do forensic alcohol analysis; and
(4) A list of current instruments used by
						laboratory personnel for alcohol analysis.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 2 - Requirements for Forensic Alcohol Laboratories › Section 1216.1 - Qualifications to Perform Forensic Alcohol Analysis

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A laboratory meets the qualifications to
						perform forensic alcohol analysis by:
(1)
						Maintaining a quality control program in forensic alcohol analysis procedures as
						specified in Section
						1220.3;
(2) Meeting the proficiency testing requirements
						specified in Health and Safety Code Section
						100702.
						Laboratories shall direct approved providers to submit all external proficiency test
						results as required by Health and Safety Code Section
						100702
						to the Department. The laboratories shall submit, at a minimum, one test per analyst
						per year. In addition, laboratory staff shall provide the Department any
						documentation pertaining to corrective actions with respect to proficiency
						tests.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217 - Training Program Review

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any
						organization, laboratory, institution, school, or college conducting a course of
						instruction for persons to qualify under section
						1221.2(a)(3) shall
						provide the following to the Department to demonstrate compliance with Title 17,
						Division 1, Chapter 2, subchapter 1, Group 8, sections
						1215 through
						1222.1:
(1) A complete outline of the training which meets
						the requirements of Section
						1221.2;
(2) A copy of the written examination together
						with the correct answers;
(3) A written
						description of the practical examination;
(4) A list of qualified instructors; and
(5) A description of the qualifications of
						instructors for the training, which at a minimum, shall mean persons that meet the
						requirements described under Section
						1221.2(a)(4)(A).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.1 - Renewal of Licenses. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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).
3. Repealer filed 1-26-2017; operative 4-1-2017
						  (Register 2017, No. 4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.2 - Application Forms. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.3 - Report of Change or Discontinuance. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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).
4. Repealer filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.4 - License Implications. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.5 - Licensing Records. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.6 - Inspection and Additional Requirements. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.7 - Surveys and Proficiency Tests. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Amendment
						  filed 11-24-75; effective thirtieth day thereafter (Register 75, No.
						  48).
2. Repealer filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1217.8 - Fees and Other Procedures. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1218 - Training Program Approval. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
						  Renumbering of former article 4 to article 3 and renumbering of former section
						  1218 to new section
						  1217 filed 1-26-2017; operative
						  4-1-2017 (Register 2017, No. 4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1218.1 - Additional Requirements. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 3 - Training of Personnel › Section 1218.2 - Contracts. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 4 - Collection and Handling of Blood and Urine Samples › Section 1219 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Samples taken for forensic alcohol analysis shall be
						  collected and handled in a manner in which the identity and integrity of the samples
						  shall be maintained through collection to analysis and reporting.
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).
3. Renumbering and
						  amendment of former article 5 to article 4 and amendment of section and NOTE filed
						  1-26-2017; operative 4-1-2017 (Register 2017, No. 4).
Note: Authority cited: Section
							 100703,
							 Health and Safety Code. Reference: Section
							 100700,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 4 - Collection and Handling of Blood and Urine Samples › Section 1219.1 - Blood Collection and Retention

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Blood
						samples shall be collected by venipuncture from living individuals as soon as
						feasible after an alleged offense and processed in compliance with Vehicle Code
						Section
						23158.
(b) Alcohol or other volatile organic disinfectant
						shall not be used to clean the skin where a specimen is to be collected. Examples of
						suitable aqueous disinfectants include: aqueous povidine-iodine (Betadine) or
						aqueous benzalkonium chloride (zephiran chloride).
(c) Blood samples from living individuals 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 with or kept in alcohol or other volatile organic solvents.
(d) 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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 4 - Collection and Handling of Blood and Urine Samples › Section 1219.2 - Urine Collection and Retention

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A urine
						sample from a living individual 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 sufficient sample remains, the forensic
						laboratory, law enforcement agency, or coroner/medical examiner's office 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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 4 - Collection and Handling of Blood and Urine Samples › Section 1219.3 - Breath Collection. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Amendment
						  filed 4-7-71; effective thirtieth day thereafter (Register 71, No.
						  15).
2. Repealer filed 1-26-2017; operative 4-1-2017 (Register 2017, No.
						  4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 5 - Methods of Forensic Alcohol Analysis › Section 1220 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All laboratory
						methods used for forensic alcohol analysis shall be subject to standards set forth
						in this Article.
(b) Each forensic
						alcohol laboratory shall have 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.
(2) Each such description
						shall include the instrument calibration procedures and the quality control program
						for the method.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 5 - Methods of Forensic Alcohol Analysis › Section 1220.1 - Standards of Performance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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 0.100% or higher. If the value is lower
						than 0.100%, the result must be within plus or minus 0.005;
(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 shall 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 specifically identified as ethyl
						alcohol; and
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 8 - Forensic Alcohol Analysis and Breath Alcohol Analysis › Article 5 - Methods of Forensic Alcohol Analysis › Section 1220.2 - Standards of Procedure

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Methods
						for forensic alcohol analysis shall meet the following standards of procedure:
(1) The method shall employ calibration
						standard(s) which is/are water solution(s) of ethyl alcohol.
(A) Such alcohol solutions are secondary
						standards, which, for the purposes of these regulations, applies to prepared or
						purchased solutions.
(B) Each forensic
						alcohol laboratory shall purchase NIST traceable CRMs, or prepare a secondary
						alcohol standard, establishing the concentration of the prepared standard by using a
						direct oxidimetric method which employs a primary standard, such as NIST potassium
						dichromate.
(C) The forensic alcohol
						laboratory personnel shall verify the concentration of any new secondary standard
						used in the method by analyzing the new secondary standard concurrently with a NIST
						SRM.
(D) If a purchased secondary
						standard (CRM) has been certified as analytically verified against a NIST SRM, the
						verification pursuant to 1220.2 (a)(1)(C) is not required.