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37.107.313    TESTING LABORATORY SATISFACTORY AND UNSATISFACTORY PROFICIENCY TEST PERFORMANCE

(1) The testing laboratory shall be deemed to have "successfully" participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate a "satisfactory," "passed," or otherwise proficient performance determination by the proficiency testing program provider.

(2) The testing laboratory shall be deemed to have "unsuccessfully" participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate an "unsatisfactory," "unacceptable," "questionable," or "failed or otherwise deficient" performance determination by the proficiency testing program provider.

(3) If a testing laboratory is notified by a proficiency provider of an "unsuccessful" result for an analyte tested in a specific method, the testing laboratory may continue to report test results for the analyte(s) if all of the following conditions are met:

(a) the testing laboratory notifies the state laboratory of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;

(b) the testing laboratory has "successfully" participated in a proficiency program for the failed analyte(s) in the specific method in the previous six months;

(c) the testing laboratory submits to the state laboratory, for approval, a corrective and preventative action plan detailing how the testing laboratory will proceed to determine the cause of the failure within 10 business days of receiving the "unsuccessful" performance determination by the proficiency testing provider; and

(d) within 30 days of plan approval by the state laboratory, submit a corrective and preventative action final report describing the cause of the failure, the corrective action, and processes that will ensure the effectiveness of the corrective action.

(4) The state laboratory will approve or reject a corrective action plan and/or final corrective action reports as soon as reasonably practicable.

(5) If a testing laboratory is notified by a proficiency provider of an "unsuccessful" result for an analyte tested in a specific method and the testing laboratory has not "successfully" participated in a proficiency program for the failed analyte(s) in the previous six months, the testing laboratory may not continue to report test results for the analyte(s) until all of the following conditions are met:

(a) the testing laboratory notifies the state laboratory of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;

(b) the testing laboratory submits to the state laboratory, for its approval, a corrective and preventative action plan detailing how the testing laboratory will proceed to determine the cause of the failure within 10 business days of receiving the "unsuccessful" performance determination by the proficiency testing provider;

(c) within 30 days of plan approval by the state laboratory, submit a corrective and preventative action final report demonstrating the cause of the failure, the corrective action, and processes that will ensure the effectiveness of the corrective action; and

(d) "successfully" participate in a proficiency test for the failed analyte(s) by a proficiency testing provider that meets the requirements of 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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