Revised complaint procedures for labs

July 7, 2025

Chapter 5 of the State Operations Manual (SOM), Complaint Procedures, has been revised, according to The Centers for Medicare & Medicaid Services (CMS).

Key updates:

  • Subsections are now included for “laboratories with Certificates of Compliance, Certificates of Registration, and temporary testing sites.”
  • State Agencies and CMS now have 10 business days to send labs Form CMS-2567 and three business days to look into IJ complaints. Three business days are allowed for State Agencies and CMS to “send Form CMS-2567 to laboratories with immediate jeopardy findings” and perform “an on-site revisit survey before imposing principal sanctions.”
  • Instructions for looking into transfusion-related fatalities (TRF) are now included.

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