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(1) For a laboratory to become approved to conduct quality assurance testing, the laboratory must, at its own expense, meet the proficiency testing requirements of this subchapter.

(2) A laboratory shall successfully participate in a proficiency testing program(s):

(a) at least every six months for each analyte/method in 37.107.316 that the laboratory performs on marijuana or marijuana-infused products;

(b) that are matrix specific or controlled when available; and

(c) that are provided by an organization operating in conformance with the requirements of ISO/IEC 17043:2010.

(3) The laboratory shall report all analytes available by the proficiency testing program provider and for which the laboratory licensee is required to test as required under this subchapter.

(4) The laboratory shall participate in the proficiency testing program by following the laboratory's existing standard operating procedures for testing marijuana or marijuana-infused products.

(5) The laboratory shall rotate the proficiency testing among all of the laboratory testing personnel who perform a specific test method(s) or have multiple analysts perform the same proficiency test, when sample quantity/volume permits.

(6) Laboratory testing personnel who participate in a proficiency testing program shall sign the corresponding analytical reports and proficiency providers attestation forms, if provided, to certify that the proficiency testing program was conducted in the same manner as the laboratory tests marijuana or marijuana-infused products.

(7) The scientific director shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed.

(8) The laboratory shall request the proficiency testing program provider to send all proficiency data and results concurrently to the state laboratory, when the data and results become available. If the proficiency provider does not provide this service then it is the responsibility of the laboratory to provide the proficiency testing program data and results to the state laboratory within three business days after the laboratory receives notification of their test results from the proficiency testing program provider.

(9) The laboratory must maintain a paper and/or electronic copy of all proficiency testing records, including analytical data, quality control, standard curves, spreadsheets, calculations, and worksheets and a copy of the proficiency testing provider report forms for a period of three years. The records must be easily and readily available to state laboratory staff or state auditors upon request.

(10) When performing a proficiency test, a marijuana testing laboratory may not:

(a) perform multiple analyses (such as replicates or duplicates) that are not normally performed in the course of analysis of a routine sample;

(b) average the results of multiple analyses for reporting when not specifically required to do so by the analytic method in question;

(c) permit anyone other than bona fide testing personnel who perform the analyses on a day-to-day basis for the laboratory to participate in the generation of data or reporting of results;

(d) discuss the results of proficiency testing with any other laboratory until after the deadline set for receipt of results by the proficiency testing provider;

(e) discuss the results of a proficiency testing audit across sites or locations, if the laboratory has multiple testing sites, until after the deadline set for receipt of results by the proficiency testing provider;

(f) send proficiency testing samples or portions of samples to another laboratory to be tested; or

(g) knowingly receive a proficiency testing sample from another laboratory for analysis and fail to notify the state laboratory of the receipt of the other laboratory's sample within five business days of discovery.

(11) The state laboratory may also provide inter-laboratory proficiency testing samples to laboratory licensees in order to ensure that Montana marijuana testing laboratories are providing consistent and uniform results.

(12) For the purposes of this subchapter, the department adopts and incorporates by reference ISO/IEC 17043:2010, which specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. A copy of the publication may be obtained from the American National Standards Institute (ANSI), 1899 L St. NW, 11th Floor, Washington, DC 20036; https://webstore.ansi.org/SDO/ISO.


History: 50-46-344, MCA; IMP, 50-46-304, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.

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