CLIA: CMS Revises State Operations Manual for Labs

In late September, the Centers for Medicare and Medicaid Services (CMS) released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, which went to all State Survey Agency Directors, includes a “comprehensive revision to establish quality laboratory policies and procedures to ensure accurate and reliable test results to protect patients and improve the quality of healthcare,” CMS’ website states.

The Update Initiative

The revision, CMS states, aligns with its efforts to ensure consistency in practice and eliminate duplication. The problem was that information contained in the existing guidance covering Special Procedures for Laboratories hadn’t been revised in several years. As a result, it didn’t include new and updated policies and procedures issued by CMS via policy memoranda during that time.

To fix the problem, the agency had workgroups composed of subject matter experts review the SOM Chapter 6 to identify outdated information and update each section to match current policies and procedures. Additionally, these workgroups were charged with ensuring that all sections of the SOM Chapter 6 aligned with the information within the SOM Chapter 6 Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.

What CMS Changed

CMS made numerous revisions to the SOM (which can be viewed here), including those affecting:

  • 6008 – CLIA identification numbers;
  • 6010 – Regulatory Exceptions for a Multiple Site Certificate;
  • 6014 – CLIA Certificate Status Changes;
  • 6036 – Referrals to the Office of Inspector General (OIG) for CLIA Violations (e.g., Testing without a CLIA Certificate);
  • 6106 – Announced and/or Unannounced Surveys;
  • 6254 – Enforcement Options for All Laboratories;
  • 6256 – Sanction(s) – General;
  • 6260 – Certificate Changes When Enforcement Action is Pending;
  • 6266 – CLIA Conditions Not Met – Additional Sanctions Related to Medicare Payments – Principal and Alternative Sanctions for Laboratories that Participate in Medicare;
  • 6276 – Suspension, Limitation, or Revocation of Any Type of CLIA Certificate;
  • 6280 – Alternative Sanctions.

All changes took effect on the date CMS published them, i.e., Sept. 26, 2019.


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