Proposed CLIA Rule to Revise Proficiency Testing Regulations

Public comment period has closed.

Public Comments Requested

On Monday, February 4, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued a proposed rule in the Federal Register (CMS-3355-P) to revise the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) related to required analytes and microbiology subspecialties and their associated criteria for acceptable performance. The proposed rule would update 42 CFR Part 493, Subparts H and I, to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. It would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.

Public comments are invited on the provisions proposed in CMS-3355-P. Comments must be received no later than 5p.m. on Tuesday, June 4, 2019. Read the rule here and see this page to submit a public comment. After reviewing and considering all comments received, CMS and CDC will publish a final rule in the Federal Register.