ARTICLE
18 February 2019

HHS Proposes Updates To CLIA Proficiency Testing Rules

The CMS and the CDC have proposed updates to the CLIA PT regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992.
United States Food, Drugs, Healthcare, Life Sciences

The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have proposed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing (PT) regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992. The proposed rule would, among other things, revise the list of analytes requiring PT and update the scoring criteria for acceptable laboratory performance. Comments on the proposed rule will be accepted until April 5, 2019.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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