Attn: Clinical Laboratory Improvement Amendments (CLIA) Providers
Revisions to State Operations Manual (SOM), Appendix C-Survey Procedures and Interpretive Guidelines for Laboratories (Clinical Laboratory Improvement Amendments (CLIA))- Advance Copy
As part of the Division’s commitment to Teach, Learn and Collaborate, the Division of Quality Assurance (DQA), is informing you that on December 6, 2024, the Centers for Medicare & Medicaid Services (CMS) issued – QSO-25-10-CLIA.
CMS has revised Appendix C of the SOM to provide guidance to CMS staff, State Agencies (SA), and the laboratory community.
Memorandum Summary
- Removed survey protocols. The information in this section is included in SOM Chapter 6 – Special Procedures for Laboratories Medicare State Operations Manual.
- Added guidance for new and revised regulations finalized in Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F) | CMS and Final Rule- Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F) | CMS.
- Created new and revised D-tags for regulatory changes finalized in CMS-3355-F and CMS-3326-F and for clarity.
- Incorporated guidance and information from several previously released QSO (previously S&C) and Admin Info memos, including S&C-16-18-CLIA (SC16-18.Personnel Qualifications for CLIA_REVISED 05.03.16), QSO18-19-CLIA, QSO18-20-CLIA, and Admin Info: 23-11-CLIA.
- Added an approved HHS training program for neuromuscular pathology, United Council for Neurologic Subspecialties (UCNS).
- Incorporated feedback and addressed frequently asked questions from stakeholders and surveyors.
- Revised guidance for clarity with respect to quality assessment, temperature and humidity monitoring, calibration verification, alternative control materials for provider-performed microscopy procedures, cytology annual statistical laboratory evaluation, test reports, and other areas.
- Added guidance and probes to applicable regulations for cybersecurity and advancements in laboratory medicine, including a probe on the use of the race-free equation for the estimated glomerular filtration rate (eGFR).
Questions
For questions or concerns relating to QSO-25-10-CLIA please contact LabExcellence@cms.hhs.gov.
For more information, visit the CMS CLIA Program website.
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