The 2026 CLIA RFI: AI, NGS, cyber, and emergency preparedness
CMS and CDC asked the field how CLIA should treat AI, sequencing, cybersecurity, and surge. Here is how a PHL should answer in practice.
The questions are the preview
A Request for Information is not a final rule. It is a list of topics the regulators already believe belong in the quality system: AI in post-analytic work, NGS performance characteristics, cyber and operational resilience, emergency preparedness, biosafety, and specialty testing.
Laboratories that wait for the rule to start documenting those topics will write the same binder twice.
What good looks like now
Name every model or agent, what it may draft, and what it is forbidden to do (release, diagnose, transmit, bill). Version bioinformatics pipelines the way you version an SOP. Write the surge and outage plan as if the next H5 week is next Tuesday.
Salus personas already carry those gates. The workbench outlines attach them to a specific assay so the documentation matches the menu.
See it in your laboratory's context.
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