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

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

(a) at least every six months for each analyte/method in ARM 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 testing laboratory shall report all analytes available by the proficiency testing program provider and for which the testing laboratory is required to test as required under this subchapter.

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

(5) The testing 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) Testing laboratory 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 testing 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 testing laboratory to provide the proficiency testing program data and results to the state laboratory within three business days after the testing laboratory receives notification of their test results from the proficiency testing program provider.

(9) The testing 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 the state laboratory upon request.

(10) When performing a proficiency test, a 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 laboratory test 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 testing laboratory to participate in the generation of data or reporting of results;

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

(e) discuss the results of a proficiency testing across sites or locations, if the testing 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 testing laboratory to be tested; or

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

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

(12) For the purposes of this subchapter, the state laboratory 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: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22; TRANS, from ARM 37.107.311, 2023 MAR p. 570, Eff. 7/2/23.