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- CMS Makes Technical Reporting Changes to CLIA Proficiency Testing Regulation for 2023
On July 7, the Centers for Medicare & Medicaid Services (CMS) released the final 2023 Clinical Laboratory Improvement Amendments Proficiency Testing Regulations Related to Analytes and Acceptable Performance. This final regulation updates proficiency testing (PT) rules under the CLIA to amend the current list of regulated analytes to address newer technologies. The CMS added 29 analytes and removed five from its regulations. Download this fact sheet about the regulation from the CMS.
This final regulation also clarifies that waived testing is exempt from participating in PT regardless of if non-waived laboratories provide tests. However, if laboratories elect to participate in PT for waived testing, they are subject to PT referral and other requirements. The CAP advocated to ensure regulations balance patient safety without overburdening pathologists and laboratories.
The final regulation also revised the microbiology PT regulations to reflect current microbiology practices. The rule indicates that laboratories must report PT results for microbiology organism identification to the “highest” level on patient specimens to ensure that the “same” level is reported on patient specimens.