ASCP Issues Statement on CLIAC Personnel and Non-Traditional Testing Requirements

The future of laboratory medicine, especially testing in non-traditional sites, is the focus of a virtual meeting today and tomorrow of the Clinical Laboratory Improvement Advisory Committee (CLIAC), hosted by the U.S. Centers for Disease Control and Prevention (CDC). The public comment session will consider anticipated changes in testing practices, personnel issues, and emerging technologies used in non-traditional testing sites. 

In advance of the meeting, ASCP and the ASCP Board of Certification (BOC) urged that personnel / workforce issues and the growth of non-traditional testing sites be addressed. A statement by ASCP urges that the Clinical Laboratory Improvement Amendments (CLIA) personnel rules be updated to be in line with CLIAC’s 2019 recommendations. The recommendations call for changes to the CLIA high complexity testing personnel requirements to ensure all testing personnel are adequately trained to perform high complexity tests and procedures. 

ASCP also addressed growth in non-traditional testing sites, much of which occurred to support COVID-19 testing with rapid, CLIA-waived tests. Given past concerns about the quality of testing at certain CLIA-waived testing sites, ASCP urged CLIAC to recommend CMS increase its oversight over waived testing.

The crux of the issue is the Centers for Medicare and Medicaid’s opinion that a bachelor’s degree in nursing is equivalent to a biology degree, which means these degree holders can perform high complexity testing. 

The ASCP statement raises concern about the continuation of pathologists and laboratory professionals to provide remote review of pathology and other laboratory slides. When CMS authorized this accommodation, it only did so for the duration of the Public Health Emergency. The statement urged CLIAC to recommend making this benefit permanent after the conclusion of the PFE.