Nev. Admin. Code § 453A.660

Current through December 12, 2024
Section 453A.660 - Proficiency testing program: Establishment by Division; participation
1. The Department will establish a proficiency testing program for independent testing laboratories. A proficiency testing program must include, without limitation, providing rigorously controlled and standardized proficiency testing samples to independent testing laboratories for analysis, reporting the results of such analysis and performing a statistical evaluation of the collective demographics and results of all independent testing laboratories.
2. Each independent testing laboratory must participate in the proficiency testing program established pursuant to this section.
3. If required by the Department as part of being issued or renewing a medical marijuana establishment registration certificate, the independent testing laboratory must have successfully participated in the proficiency testing program within the preceding 12 months.
4. To maintain continued registration as an independent testing laboratory, a laboratory must participate in the designated proficiency testing program with continued satisfactory performance as determined by the Department.
5. An independent testing laboratory must analyze proficiency test samples using the same procedures with the same number of replicate analyses, standards, testing analysts and equipment as used for product testing.
6. The scientific director of the independent testing laboratory and all testing analysts that participated in a proficiency test must sign corresponding attestation statements.
7. The scientific director of the independent testing laboratory must review and evaluate all proficiency test results.
8. Successful participation includes the positive identification of 80 percent of the target analytes that the independent testing laboratory reports to include quantitative results when applicable. Any false positive results reported will be considered an unsatisfactory score for the proficiency test.
9. Unsuccessful participation in a proficiency test may result in limitation, suspension or revocation of the medical marijuana establishment registration certificate of the independent testing laboratory.
10. The Department will select a proficiency testing provider to conduct the proficiency testing program and determine the schedule that the proficiency testing provider will follow when sending proficiency testing samples to independent testing laboratories for analysis.
11. In addition to achieving the standard required pursuant to subsection 8, an independent testing laboratory successfully participates in the proficiency testing program only if the independent testing laboratory:
(a) Obtains single-blind proficiency testing samples from the proficiency testing provider;
(b) Analyzes the proficiency testing sample for all analytes listed in NAC 453A.654 and sections 9, 10 and 11 of this regulation;
(c) Reports the results of its analysis to the proficiency testing provider;
(d) Analyzes a proficiency testing sample pursuant to the proficiency testing program not less frequently than once each 12 months;
(e) Pays the costs of subscribing to the proficiency testing program; and
(f) Authorizes the proficiency testing provider to submit to the Department the results of any test performed pursuant to this section.
12. The performance of an independent testing laboratory is satisfactory pursuant to subsection 4 if the results of the testing performed pursuant to this section are within the limits of the acceptance range established by the proficiency testing provider. An independent testing laboratory that fails to meet this standard may request that the Department allow the independent testing laboratory to retest a proficiency testing sample once to establish satisfactory performance. If the Department denies the request or if the independent testing laboratory fails to meet the standard on retesting, the Department may limit, suspend or revoke the medical marijuana establishment registration certificate of the independent testing laboratory.

Nev. Admin. Code § 453A.660

Added to NAC by Div. of Pub. & Behavioral Health by R004-14, 3-28-2014, eff. 4-1-2014; A by R092-17AP, eff. 2/27/2018
NRS 453A.370, as amended by section 47 of Assembly Bill No. 422, chapter 540, Statutes of Nevada 2017, at page 3706 and section 48 of Senate Bill No. 487, chapter 541, Statutes of Nevada 2017, at page 3759