State Operations Manual (SOM), Chapter 5 - Complaint Procedures

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Title
State Operations Manual (SOM), Chapter 5 - Complaint Procedures
Memo #
QSO-25-22-CLIA
Posting Date
2025-06-27
Fiscal Year
2025
Title
Memorandum Summary

• Updates to the SOM, Chapter 5 Sections 5500-5590: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Chapter 5 Sections 5500-5590 that provides guidance on complaint procedures related to Clinical Laboratory Improvement Amendments of 1988 (CLIA).
• Updates include:
• Procedures for conducting complaint investigations in laboratories for all certificate types and temporary testing sites
• Revisions to complaint investigations and enforcement timelines
• Reporting and investigating of transfusion-related fatalities (TRF)

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