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- CLIA Request for Information on Remote Sign-Out and More
The proposed regulation also included a request for information on histopathology, cytology, and clinical cytogenetics regulations under CLIA.
The request for information is soliciting feedback from the public on how to develop final regulations to achieve the following objectives:
- Developing regulations around slide staining and tissue processing as a part of the wider CLIA regulations and certification
- Making the public health emergency enforcement discretion permanent to allow pathologists to review slides remotely
- Making the public health emergency enforcement discretion permanent that allows for cytogeneticists to review images remotely
The CAP has been engaged with Clinical Laboratory Improvement Advisory Committee (CLIAC) and the CMS on ensuring CLIA regulations are appropriate since CLIA was first promulgated. The CAP will review the request for information and further provide input to the CMS.
The CAP will analyze in detail the provisions of the proposed regulation and submit comments during the agency’s 60-day comment period, which is through September 11.