EXPIRED: Advance Copy Revisions to State Operations Manual (SOM), Appendix C Survey Procedures and Interpretive Guidelines for Laboratories and LaboratoryServices (Clinical Laboratory Improvement Amendments (CLIA))

Memorandum Summary:
EXPIRED AS OF 12/6/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-10-CLIA: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Clinical Laboratory Improvement Amendments (CLIA) - Advanced Copy

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)