Dynamic List Information
Dynamic List Data
Title
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
Posting Date
2024-12-06
Fiscal Year
2025
Title
Memorandum Summary
• 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.
• 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.
• 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.