CMS Updates CLIA Complaint Investigation Procedures, Effective Immediately

Published: 07/09/2025

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

The U.S. Centers for Medicare and Medicaid Services (CMS) has released updates to State Operations Manual Chapter 5 Sections 5500-5590 that provide guidance on complaint procedures related to Clinical Laboratory Improvement Amendments of 1988 (CLIA).

In Chapter 5, Sections 5500-5590, a complaint is defined as an allegation that could result in citing noncompliance with CLIA requirements. A complaint may be substantiated or unsubstantiated as a result of an investigation or survey.

With the

Sign Up for Free Trial