Revisions to State Operations Manual, Appendix C

Dec. 9, 2024
Survey procedures and interpretive guidelines for laboratories and laboratory services – advance copy.

The Centers for Medicare & Medicaid Services (CMS) is updating Appendix C of the SOM for laboratories and laboratory services, according to a December 6 memorandum. 

Key updates include:

  • Survey protocols from SOM Chapter 6 will be removed.
  • The update will “provide guidance and new and revised D-tags for the regulations finalized in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing – Analytes and Acceptable Performance Final Rule (CMS-3355-F) and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories Final Rule (CMS-3326-F).”
  • Guidance and details from past QSO (previously S&C) and Admin Info memos will be included.
  • A U.S. Department of Health and Human Services (HHS) training program for neuromuscular pathology.
  • Stakeholder feedback.
  • Expiration dates of expired memos.

CMS has the memo