Advocacy - Lab Advocate
The Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention issued a Request for Information (RFI) seeking feedback on potential updates to the Clinical Laboratory Improvement Amendments regulations. The RFI does not propose specific regulatory changes but could inform future efforts to modernize the federal standards governing clinical laboratory testing. Comments are due September 14.
The RFI covers a wide range of issues relevant to laboratory professionals, including laboratory-developed and modified tests, next-generation sequencing, artificial intelligence, data-only facilities, laboratory personnel requirements, remote competency assessment, cybersecurity, emergency preparedness, biosafety and biosecurity, and potential changes to CLIA specialties and subspecialties. It also asks about laboratory processes such as test validation, specimen quality, result interpretation, quality systems, and the use of emerging technologies in laboratory operations.
ADLM is developing comments with input from expert members. The response will consider how CLIA can be updated to reflect current laboratory practices and technological developments while maintaining appropriate standards for quality, patient safety, and access to testing.
Members can access the RFI through the Federal Register and are encouraged to submit their own comments by the September 14 deadline.