Minn. R. agency 144, ch. 4740, pt. 4740.2070
Current through Register Vol. 49, No. 20, November 12, 2024
Part 4740.2070 - PROFICIENCY TESTING REQUIREMENTSSubpart 1.Use of approved providers.A laboratory must obtain proficiency testing samples from an approved provider meeting the requirements under part 4740.2075.
Subp. 2. [Repealed, 44 SR 371]Subp. 4.Laboratory testing of PT study samples.A. A laboratory's management and all analysts must ensure that all PT samples are managed, analyzed, reported, and otherwise handled in the same manner as routine samples, including utilizing the same staff, procedures, equipment, facilities, and frequency of analysis as used for routine analysis for that field of testing.B. When analyzing a PT sample, a laboratory must employ the same calibration, quality control, acceptance criteria, sequence of analytical steps, number of replicates, and other standard operating procedures as used when analyzing routine samples. The laboratory must follow sample preparation steps for the PT sample as instructed by the approved PT provider for which the PT sample was obtained.Subp. 7.Evaluation of results. A laboratory may not request from the PT provider a revised report when the revisions to the report are due to any error on the part of the laboratory.
Subp. 9.Corrective actions for unacceptable results.When an approved provider notifies a laboratory that a PT sample result for any reported field of testing is unacceptable, the laboratory must:
A. within 30 days after receiving the notification of unacceptable results from the approved provider, submit written documentation to the commissioner indicating corrective actions planned and taken;B. within 30 days after receiving the notification of unacceptable results from the approved provider, submit written documentation to the commissioner indicating the laboratory's request to purchase a PT sample from an approved provider; andC. within 30 days after receiving the results of the PT sample under item B, supply a copy of the results to the commissioner.Subp. 11.Additional samples for compliance.The commissioner may require certified laboratories to test additional PT samples at any time to determine compliance with parts 4740.2010 to 4740.2120.
Minn. R. agency 144, ch. 4740, pt. 4740.2070
Statutory Authority: MS s 144.97; 144.98