The statute and the regulations for CLIA are very dry, and often vague ("Lab director shall ensure appropriate controls and validations...").
However, CMS also issues a richly textured 379-page manual for actually running CLIA labs and CLIA inspections. This is called, "Pub. 100-07 State Operations Provider Certification.' It just got a 379-page update with numerous small changes, issued September 12, 2025.
CMS writes,
- Revisions have been made to reflect comments and recommendations from regional office and State Agency surveyors, professional and accrediting organizations, other Health and Human Services components, and a GAO audit.
- Changes have also been made to include partial deletions of certain subsections affected and to reflect the recent publication of regulations and updates in technologies within the field of laboratory medicine.
For example, there are lots of little redline edits around failure of proficiency testing (PT).
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| page 80, PT rules, 493.803 edits |
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| page 84, 493.821 microbiology |
