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An organized advocacy campaign led by the College of American Pathologists (CAP) persuaded the federal government to issue a temporary work waiver allowing pathologists to work remotely.
The Trump administration announced the temporary waiver giving pathologists the regulatory flexibility requested by the CAP on March 26.
CLIA regulations mandate that pathologists must perform diagnostic tests in CLIA-licensed facilities, but the Centers for Medicare & Medicare Services (CMS) stated during this public health emergency, it will exercise enforcement discretion to ensure pathologists may review pathology slides remotely.
In addition, the CLIA regulations for cytology state that cytology slide preparations must be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology.
However, as has been done in previous public health emergencies, the agency is exercising enforcement discretion, and it will not enforce the requirement to have a separate certificate for laboratories that are located at temporary testing sites, provided that the designated primary site or home base has a CLIA certificate, and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate.
CAP is the leading organization of board-certified pathologists. It serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
