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Changes to the federal CLIA rules and CMS guidance that affect laboratory documents, in plain language and in date order. We write each summary ourselves and link the source so you can read it in full.
CMS revised the CLIA application form and set November 9, 2026 as the date from which the new version must be used. Laboratories applying for a certificate, or reporting a change that needs a new application, should download the current form before filling it in.
Kits affected: Waived Testing, Inspection Readiness. Source: CMS: Clinical Laboratory Improvement Amendments
The proposal would loosen several laboratory director qualification and site-visit requirements, allow remote review of digital data under the testing laboratory's certificate, remove the six-month wait for reinstatement after certain proficiency testing failures, and require the CLIA number on test reports. It is not final. Comments are due December 7, 2026. Read our explainer.
Kits affected: Competency Assessment, Proficiency Testing. Source: AABB summary ยท ADLM summary
The agencies asked for public input on a wide list of topics, including remote observation for competency assessment, calibration verification for factory-calibrated instruments, software and AI used in interpretation, specimen preparation staff, cybersecurity and whether data-only sites need a certificate. The comment period closed September 14, 2026. A request for information changes no requirements, but it shows where future rules may go.
Kits affected: None yet. Source: Federal Register, 91 FR 43586
This page covers federal requirements only. State law and accreditation checklists change on their own schedules. Summaries are for general information and are not regulatory or legal advice.