CMS Issues Revisions to CLIA Interpretive Guidance, Effective Immediately

Published: 06/27/2025

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

The U.S. Centers for Medicare and Medicaid Services (CMS) has published revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)), effectively immediately.

The revisions provide an update to the advance copy of Appendix C of the SOM published in December 2024. The updates include:

  • Removing and adding guidance as outlined below in the discussion sectio

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