CLIA Proficiency Testing Rule: A Guide to Major Update Preview: 

In its first update since the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) was implemented in 1992, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) amended CLIA proficiency testing (PT) regulations. This major update, announced in July 2022, was developed, in part, because testing has advanced significantly, and tests not required in 1992 are now done routinely.

The final rule, Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F), affects laboratories performing testing for any of the analytes or microbiology subspecialties listed in CLIA regulations (subpart I) and those participating in PT for waived testing. The revisions include 29 new analytes, five removed analytes, grading and reporting changes, and new definitions to clarify terms.

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