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§ 64812.05. Laboratory Facilities and Equipment.

22 CA ADC § 64812.05Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 22. Social Security
Division 4. Environmental Health
Chapter 19. Certification of Environmental Laboratories
Article 5. Laboratory Personnel, Facilities and Equipment
22 CCR § 64812.05
§ 64812.05. Laboratory Facilities and Equipment.
Currentness
(a) A laboratory facility shall:
(1) Comply with 2016 TNI Standard - Revision 2.1, Volume 1, Module 2, Sections 5.3, 5.5, and 5.6, herein incorporated by reference; or
(2) Be arranged and operated so that:
(A) Utilities are maintained to the degree necessary to allow the laboratory equipment to function and produce analyses in each Field(s) of Accreditation for which the laboratory is accredited;
(B) Ventilation and environmental control are maintained in the laboratory so that analytical results are not adversely affected beyond established quality control limits as specified in the approved test methods or in the laboratory's Quality Manual;
(C) The design, arrangement, housekeeping, and operation of the laboratory minimizes the potential for sample contamination;
(D) Each piece of laboratory equipment meets all operational, quality assurance, quality control, and design criteria established in the approved method(s) employed by the laboratory;
(E) Each piece of laboratory equipment is operated and maintained by the laboratory as specified in the Quality Manual and standard operating procedures; and
(F) Records are kept of all operational and maintenance activities associated with the operation of laboratory equipment.
(b) Subdivision (a)(2), above, will become invalid three (3) years from the effective date of these regulations, and laboratories will be required to comply with subdivision (a)(1), above.
(c) A laboratory shall store and handle hazardous materials in accordance with the California Code of Regulations, Title 8, Division 1, Chapter 4, Subchapter 7, General Industry Safety Orders.
(d) A laboratory shall dispose of chemical wastes and maintain records of disposal in accordance with Health and Safety Code section 25200.3.1 and California Code of Regulations, Title 22, Division 4.5, Chapter 12, Standards Applicable to Generators of Hazardous Waste.
(e) When there is a change of Sophisticated Technology the laboratory shall:
(1) Update the Quality Manual necessitated by the change of Sophisticated Technology;
(2) Update or create standard operating procedure(s) necessitated by the change of Sophisticated Technology;
(3) Submit an amendment application package in accordance with 64808.15(g), if the Sophisticated Technology is a new technology to the laboratory; and
(4) Retain all records necessary to determine compliance with this subdivision and provide these records to ELAP upon request.

Credits

Note: Authority cited: Sections 100829 and 100830, Health and Safety Code. Reference: Sections 100825 and 100830, Health and Safety Code.
History
1. New section filed 11-19-2020; operative 1-1-2021 (Register 2020, No. 47). (Filing deadline specified in Government Code section 11349.3(a) extended by 60 calendar days pursuant to Executive Order N-40-20.)
This database is current through 5/10/24 Register 2024, No. 19.
Cal. Admin. Code tit. 22, § 64812.05, 22 CA ADC § 64812.05
End of Document