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WSLH Proficiency Testing

Wisconsin State Laboratory of Hygiene

Final rule from CMS & CDC on PT programs

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On July 11, 2022, CMS and CDC issued a final rule [CMS-3355-F] to update proficiency testing (PT) regulations related to analytes, acceptable performance for laboratories, and administrative processes for proficiency testing programs established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The final PT rule considers improvements in accuracy and precision of testing since 1992 and new and emerging technologies.

The effective date of the revisions to PT requirements (§§ 493.2 and 493.801 through 493.959) will be July 11, 2024, two years after the publication date of this final rule in the Federal Register.  The delayed effective date reflects the timeframe PT programs will need to produce or acquire PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements.  In addition, laboratories will need time to prepare and enroll in proficiency testing to meet the new requirements once the samples are available from the PT programs.  However, the regulations related to laboratories performing tests of moderate complexity and high complexity testing that also perform waived testing and proficiency testing enrollment (§§ 493.20 and 493.25) will be effective 30 days (August 10, 2022) after the publication date of this final rule.

WSLH Proficiency Testing will keep you up-to-date in our communications on how we are aligning our PT programs with the final PT rule. If you are not already receiving our monthly newsletter, please sign up here to receive relevant updates and more. You may also follow WSLH Proficiency Testing on LinkedIn to receive information directly to your newsfeed. If you have any questions, please review the fact sheet on the CLIA website, or download the fact sheet directly here. 

You can download the final rule from the Federal Register at: https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to.   You may also go to https://www.federalregister.gov/ and search for “CMS-3355-F.”