The CAP submitted comments on a federal Request for Information that could shape future CLIA regulations. The letter addresses topics ranging from artificial intelligence and specimen retention to cybersecurity, laboratory specialties, and emerging laboratory technologies.
Read the CAP’s comment letter.
Key recommendations on proposed CLIA updates
The CAP is advocating for a balanced approach to any future updates to the Clinical Laboratory Improvement Amendments (CLIA) regulations, emphasizing the need to preserve quality, patient safety, and innovation while avoiding unnecessary regulatory burdens on laboratories.
In a letter to regulators, the CAP called for a practical approach to laboratory oversight that considers the diverse array of clinical laboratory settings, recognizes that pathologists interpret diagnostic tests (not AI-enabled devices), and accommodates continued innovation.
Among the CAP’s recommendations:
- Maintain existing medical specialties and subspecialties and keep regulations technology-neutral: CLIA regulations best accommodate continued innovation through existing specialty regulations, allowing laboratories to adopt new tools (such as artificial intelligence (AI) and next-generation sequencing) while maintaining quality and accuracy.
- Pathologist oversight of laboratory AI is essential: AI can assist and augment pathologists’ diagnostic interpretation. AI systems cannot provide a medical diagnosis or be responsible for decision-making in patient care. Laboratories cannot adequately validate or monitor an AI-enabled system if essential information is withheld as proprietary.
- Avoid unnecessary regulatory burden: Emergency preparedness, biosafety, biosecurity, and cybersecurity should be assessed and addressed as shared responsibilities across the healthcare system, rather than creating CLIA-specific responsibilities and requirements.
- Support practical laboratory operations: The CAP advocated that regulators preserve flexibility in areas such as processing of suboptimal specimens, remote direct observation of competency assessment, technical advancements in clinical cytogenetic testing and immunohematology, and monitoring for blood culture contamination.
- Refrain from expanding CLIA oversight: The CAP urged regulators to avoid adding requirements for breath testing and preanalytic activities (including specimen preparation and the personnel involved). Existing CLIA specialties and subspecialties must enable clinical laboratories to manage novel test methods/technologies and workflows to maintain overall quality and accuracy.
The bottom line: The CAP told regulators that CLIA provides an adequate baseline to ensure the accuracy and reliability of clinical laboratory results. Continuing work to review and revise the CLIA regulations is the best way to keep CLIA focused on quality, patient safety, and innovation while allowing laboratories to adapt to advances in medicine and technology.