The Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control & Prevention (CDC) have released a proposed rule that would update several CLIA requirements.
Key proposals include:
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Virtual access: Allow qualified pathologists and laboratory personnel to remotely review digital laboratory data, results, live imaging, and digital images under the primary testing laboratory’s CLIA certificate, excluding cytology.
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Digital gynecologic cytology proficiency testing (PT): Allow digital images of glass slides to be used for gynecologic cytology PT.
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Personnel qualifications: Revise qualification requirements, including provisions affecting laboratory science education and histopathology gross tissue examination personnel.
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Other updates: Remove SARS-CoV-2 reporting requirements and revise certain certificate, test reporting, enforcement, and public consultation requirements.
Our view: The CAP supports efforts to reduce unnecessary burden, provide greater flexibility in testing personnel educational requirements, and better align CLIA requirements with current laboratory practice. We are also reviewing areas of concern, including proposed changes affecting certain laboratory director qualifications and public consultation requirements.
What’s next: The CAP will submit comments to CMS and the CDC during the 60-day comment period.