CMS seeks input on specimen retention, staff qualifications, AI and remote competency under CLIA review
CMS asked stakeholders to comment on whether pathology specimen retention periods should be extended, how specimen-prep personnel should be qualified, performance specifications for non-FDA-cleared tests, AI-assisted interpretation, and the effectiveness of remote competency assessments.
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Bradford Belts outlined the laboratory processes and procedures section as the largest part of the RFI, covering eight subsections ranging from pathology specimen retention to AI use and remote competency assessments. He noted current CLIA rules require a minimum two-year retention period for pathology specimens and asked whether that period should be extended and what operational impacts would follow.
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