Dynamic List Information
Dynamic List Data
Title
REVISED: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)) – Advance Copy
Memo #
QSO-25-10-CLIA REVISED
Posting Date
2025-06-23
Fiscal Year
2025
Title
REVISION TO QSO-25-10 CLIA ORIGINALLY RELEASED ON December 06, 2024
• Updates to the SOM: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Appendix C of the SOM for laboratories and laboratory services. Appendix C provides interpretative guidance on the laboratory requirements at 42 CFR Part 493.
• Updates to Appendix C: The updates to Appendix C:
• Remove survey protocols found in SOM Chapter 6;
• 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);
• Incorporate guidance and information from several previously released QSO (previously S&C) and Admin Info memos;
• Added an approved HHS training program for neuromuscular pathology; and
• Incorporate feedback previously received from stakeholders.
• Updates to the advance copy of Appendix C: The updates include:
• Removing and adding guidance as outlined below in the discussion section; and
• Correcting clerical errors.
• Several previously released QSO (previously S&C) memos are now expired. Memos: S&C: 17-11-CLIA (incorporated into the SOM), S&C: 16-02-CLIA (incorporated into the SOM), and S&C: 15-17-CLIA (incorporated into the SOM) are now expired. CMS will note the expiration date on these memos, which are currently on the CMS website. This memo and the associated SOM updates supersede the expired memos upon the Effective Date.
• Updates to the SOM: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Appendix C of the SOM for laboratories and laboratory services. Appendix C provides interpretative guidance on the laboratory requirements at 42 CFR Part 493.
• Updates to Appendix C: The updates to Appendix C:
• Remove survey protocols found in SOM Chapter 6;
• 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);
• Incorporate guidance and information from several previously released QSO (previously S&C) and Admin Info memos;
• Added an approved HHS training program for neuromuscular pathology; and
• Incorporate feedback previously received from stakeholders.
• Updates to the advance copy of Appendix C: The updates include:
• Removing and adding guidance as outlined below in the discussion section; and
• Correcting clerical errors.
• Several previously released QSO (previously S&C) memos are now expired. Memos: S&C: 17-11-CLIA (incorporated into the SOM), S&C: 16-02-CLIA (incorporated into the SOM), and S&C: 15-17-CLIA (incorporated into the SOM) are now expired. CMS will note the expiration date on these memos, which are currently on the CMS website. This memo and the associated SOM updates supersede the expired memos upon the Effective Date.