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Advance Copy –Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA))
Memo #
15-17- CLIA
Posting Date
Fiscal Year
Revisions to Appendix C of the SOM: The entire document has been revised and updated to include comments and recommendations from: • Regional Office (RO)and State Agency(SA) surveyors, professional and accrediting organizations (AO); • Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC); • CMS Office of General Counsel (OGC); and • General Accounting Office (GAO) on reporting complaints. Deletion • Removal of Clinical Laboratory Standards Institute (CLSI) and CLSI standards and guidance documents. It also includes: • Patient Access regulatory changes and guidance on Patient Access to Test Reports; • Proficiency testing regulatory changes and definitions; • New D-tags for surveyors; and • New name for the American Board of Medical Genetics (ABMG)