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37.107.315    TESTING LABORATORY FAILED LABORATORY TEST SAMPLES

(1) If the results of quality assurance testing for any analyte/method exceed the action levels defined in ARM 37.107.316, then the laboratory test sample and related lot or test batch has "failed" quality assurance testing.

(2) When a testing laboratory performs quality assurance testing, the testing laboratory must verify that the following quality control criteria are within acceptable limits based upon the testing laboratory's method specific standard operating procedures, the testing laboratory quality manual, and the manufacturer's instructions for use, if applicable:

(a) standard curves;

(b) coefficient of determination (r²);

(c) quality control samples:

(i)  ICV, CCV, LCS, MB, REP, and MS;

(d) positive and negative controls; and

(e) cycle thresholds.

(3) If the quality control criteria for initial quality assurance testing are within acceptable limits, then the results of all individual laboratory test samples within the analytical batch are considered valid, including "failed" laboratory test samples and must be reported.

(4) A licensee may request that the testing laboratory resample the failed batch or lot for repeat testing within seven calendar days of receiving notice from the testing laboratory of any failed testing and resampled analyses must be completed by the testing laboratory within 10 days of receiving the request from the licensee.

(5) Quality assurance testing on resampled batches or lots must include all of the analytes defined in ARM 37.107.316.

(6) The results of resample quality assurance tests are considered valid and must be reported if the quality control criteria are within the acceptable limits.

(7) The licensee is responsible for the costs of resampling and retesting.

(8) If the quality control criteria for initial quality assurance testing are not within acceptable limits, then the results of all laboratory test samples within an analytical batch are considered invalid (failed run) and the entire run must be repeated with new quality controls and not reported to the licensee.

(9) The testing laboratory should document and investigate failed runs, as part of the testing laboratory's quality manual, to determine the root cause of the failure and whether corrective and preventative action measures are warranted.

(10) A licensee is not permitted to sell or transfer to customers marijuana items that have a failed quality assurance test.

(11) Failed harvest lots, process lots, or test batches may be remediated as long as the remediation method does not impart any substance or effect to the usable marijuana, marijuana concentrates and extracts, or marijuana-infused products that may have a toxic or deleterious effect on the health of the customer.

(12) Remediation methods used on specific lots or batches of marijuana or marijuana-infused products that have failed initial quality assurance testing must be disclosed to the state laboratory prior to remediation.

(13) No remediated harvest lots, process lots, or test batches may be sold or transferred until the completion and successful passage of all quality assurance testing, and the results certified in a certificate of analysis, as required in these rules and Montana statute.

(14) With the exception of moisture analysis or residual solvent screening, a laboratory test sample from a remediated harvest lot, process lot, or test batch that fails quality assurance testing cannot be remediated again and the harvest lot, process lot, or test batch must be destroyed. Harvest lots, process lots, or test batches that fail initial quality assurance testing for moisture analysis or residual solvent screening may be remediated and retested a maximum of two times.

(15) The testing laboratory must document all sampling, resampling, testing, retesting, and results under this subchapter.

 

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.

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