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Modernization of CLIA Regulations

The prospect of updating laboratory regulations governed by the Clinical Laboratory Improvement Amendments (CLIA) has long been a subject of debate in the laboratory community. Originally enacted in 1988, discussions regarding if or how CLIA should be modernized have periodically occurred over the years, with proposals seeking to provide a forward-looking framework for evaluating and regulating the emerging landscape of cutting-edge tests.

the Association for Diagnostics & Laboratory Medicine (formerly AACC) has been actively engaged in the discourse regarding potential updates to CLIA regulations. The association holds the position that CLIA should continue to provide room for new advancements in testing while maintaining rigorous standards for accuracy and patient safety, and has called for any changes to CLIA to be made in a manner that prioritizes these goals and maintains high standards for laboratories.

The association has regularly provided input and guidance to regulatory agencies, as well as the Clinical Laboratory Improvement Advisory Committee (CLIAC) in numerous comment letters. The association has also published a series of position statements on the issue


Position Statements

•    Modernization of CLIA: Laboratory Developed Tests (LDTs)
•    Modernization of CLIA: Certificate of Waiver Sites
•    Modernization of CLIA: Moderate and High Complexity Testing

Comment Letters