State Operations Manual (SOM), Chapter 6 – Special Procedures for Laboratories

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Title
State Operations Manual (SOM), Chapter 6 – Special Procedures for Laboratories
Memo #
QSO-25-13-CLIA
Posting Date
2025-01-17
Fiscal Year
2025
Title
Memorandum Summary

• Updates to the SOM, Chapter 6: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Chapter 6. Chapter 6 provides guidance on special procedures for laboratories.
• Updates include:
• Revisions to survey and enforcement timelines;
• Revisions with respect to budget responsibilities;
• Incorporation of current procedures and practices for federal monitoring surveys, State Agency Performance Reviews, and revisit surveys.
• Removal of the use of Form CMS-1557 in the survey process; and
• Incorporation of several previous memos and regulatory updates.
• Several previously released memos are now expired. Memos: QSO 19-20-CLIA, S&C 16-18-CLIA, S&C 10-07-CLIA, and Admin Info 23-05-CLIA are now expired. CMS will note the expiration date on these memos that are currently on the CMS website. This memo and the associated updates to Chapter 6 supersede the expired memos upon the Effective Date of this memo.

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