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CMS issues new CLIA guidance for labs

Sep 30, 2025

The CMS announced it will end enforcement discretion for remote review of digital images of cytology slides, effective March 23, 2026.

The changes will affect labs relying on remote cytology digital slide reviews, requiring them to adjust their operations to comply with CLIA standards. 

  • cTnI test cartridge update: The CMS also announced that enforcement discretion related to the cTnI test cartridge for the i-STAT system will also end.

Go deeper: Read the full guidance update.

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