Attn: CLIA Laboratories
CMS announces revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA))
As part of the Division’s commitment to Teach, Learn, and Collaborate, the Division of Quality Assurance (DQA) is providing you with the following important message from CMS.
On June 23, 2025, Centers for Medicare & Medicaid Services (CMS) issued QSO-25-10-CLIA-REVISED. The following summary was provided by CMS.
Updates to the State Operations Manual (SOM) Appendix C
On December 6, 2024, CMS published an advance copy of SOM Appendix C- Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. Stakeholders had concerns regarding the guidance contained in the advance copy of SOM Appendix C specific to:
- Evaluating courses on transcripts for personnel qualifications. Specifically, stakeholders noted that the narrow interpretation of what constitutes a biological or chemical course creates a burden on individuals to provide documentation for courses labeled differently by a university or college.
- Guidance for performing competency in person for direct observation in light of technology that allows virtual observation.
CMS will be removing guidance from the final publication to address stakeholder concerns.
Additionally, stakeholders had concerns regarding nurses performing high complexity glucometer testing:
- Nursing degrees would no longer meet the educational requirements under the high complexity testing personnel regulations under §493.1489(b). As a result, nurses would no longer be able to perform the patient bedside glucometer tests that fall under the CLIA high complexity test categorization.
CMS will be adding guidance to the final publication to address stakeholder concerns.
Questions
For questions or concerns relating to QSO-25-10-CLIA-REVISED, please contact LabExcellence@cms.hhs.gov.
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For more information, visit the CMS CLIA Program website.
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