CMS Announces Clinical Laboratory Improvement Amendment (CLIA) Enforcement Discretion and Clarification on Personnel Regulations

Published: 06/24/2025

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Clinical Lab

The U.S. Centers for Medicare and Medicaid Services (CMS) has published an update with clarification on the enforcement discretion for CLIA personnel qualification requirements. The new personnel qualification regulations found in CMS-3326-F went into effect on December 28, 2024; these updates are effective immediately.

According to CMS, since the effective date, the agency has received stakeholder feedback that some of the new personnel qualification regulations are burdensome and unclear. B

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