The Centers for Medicare & Medicaid Services (CMS) has announced updates to the State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA).
Key revisions:
· Chapter 6 surgery procedures have been omitted.
· Guidelines 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)” are included.
· Details are included from past QSO and memos.
· The addition of “approved HHS training program for neuromuscular pathology.”
· Comments from stakeholders were considered and included.
· Omitting certain guidelines from the Appendix C advance copy.
· “Correcting clerical errors” from the Appendix C advance copy.
EXPIRED: Memos: S&C: 17-11-CLIA, S&C: 16-02-CLIA, and S&C: 15-17-CLIA.
