Alabama Administrative Code › Title 538 - ALABAMA MEDICAL CANNABIS COMMISSION › Chapter 538-X-10 - Regulation of State Testing Laboratories › Section 538-X-10-.06 - Proficiency Testing

Current through Register Vol. 42, No. 9, June 28, 2024
In addition to the standard inspection requirements applicable
				to all licensees pursuant to Rule 538-X-4-.02 of Chapter 4 of these Rules, the
				Commission may require a State Testing Laboratory, at its own cost, to have an
				independent third party validate and monitor, on an ongoing basis, the State
				Testing Laboratory's basic proficiency to correctly execute its analytical
				testing methodologies.
(1) The
			 Commission will establish a proficiency testing program for State Testing
			 Laboratories. A proficiency testing program must include, without limitation,
			 providing rigorously controlled and standardized proficiency testing samples to
			 State Testing Laboratories for analysis, reporting the results of such analysis
			 and performing a statistical evaluation of the collective demographics and
			 results of all State Testing Laboratories.
(2) Each State Testing Laboratory must
			 participate in the proficiency testing program established pursuant to this
			 section.
(3) If required by the
			 Commission as part of being issued or renewing a license, the State Testing
			 Laboratory must have successfully participated in the proficiency testing
			 program within the preceding 12 months.
(4) To maintain continued registration as a
			 State Testing Laboratory, a laboratory must participate in the designated
			 proficiency testing program with continued satisfactory performance as
			 determined by the Commission.
(5) A
			 State 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 State
			 Testing Laboratory and all testing analysts that participated in a proficiency
			 test must sign corresponding attestation statements.
(7) The scientific director of the State
			 Testing Laboratory must review and evaluate all proficiency test
			 results.
(8) Successful
			 participation includes the positive identification of eighty percent (80%) of
			 the target analytes that the State Testing Laboratory reports to include
			 quantitative results when applicable. Any false positive or false negative
			 results reported will be considered an unsatisfactory score for the proficiency
			 test.
(9) Unsuccessful
			 participation in a proficiency test may result in limitation, suspension,
			 revocation, or non-renewal of the State Testing Laboratory's license.
(10) The Commission 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 State Testing Laboratories for
			 analysis.
(11) In addition to
			 achieving the standard required pursuant to paragraph 8. of this Rule, a State
			 Testing Laboratory successfully participates in the proficiency testing program
			 only if the State Testing Laboratory does all of the following:
(a) Obtains single-blind proficiency testing
			 samples from the proficiency testing provider.
(b) Analyzes the proficiency testing sample
			 for all analytes required by the Act and this Chapter.
(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.
(f) Authorizes the proficiency testing
			 provider to submit to the Commission the results of any test performed pursuant
			 to this section.