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CMS clarifies remote cytology practices for laboratories

What’s happening: CMS has responded to the CAP’s request for clarification on remote cytology practices following recent federal policy updates, including requirements related to CLIA certification for laboratories.

What CMS said:

  • CMS officials stated that remote Rapid Adequacy Assessments, also known as rapid on-site evaluation (ROSE), require a separate CLIA certificate for the off-site location where the pathologist performs the review, including virtual slide review.
  • They noted that adequacy assessment does not count as a separate examination for workload limit purposes.
  • For surgical pathology cell blocks, CMS indicated that remote review by a pathologist may be performed without a separate CLIA certificate if directed by the laboratory director.

The impact: Many laboratories rely on remote workflows to support patient access and timely diagnosis. CMS’s interpretation may affect how labs structure remote adequacy assessments and manage CLIA certification compliance.

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