With the significant increase in the number of nontraditional testing sites since the COVID pandemic, the CAP has urged the Centers for Medicare & Medicaid Services (CMS) to consider the optimal oversight for nontraditional testing sites and point of care testing (POCT). Regardless of where any of the test components are performed, laboratories should observe good laboratory practices throughout the total testing process. In addition, a new category of testing personnel should be considered for individuals that use POCT devices as a support function to their primary roles and have no formal laboratory training.

The CAP provided its testimony and recommendations on nontraditional testing sites during an April 14 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), which provides recommendations to the CMS on CLIA regulations. Other nontraditional sites that are increasing include distributive testing sites. The CAP asserted that all aspects of clinical laboratory testing performed in a distributive testing model should be regulated under CLIA, including bioinformatics and cloud-based software computing. The CAP further urged CLIAC to recognize bioinformatics facilities (including stand-alone facilities) as subject to CLIA, add personnel requirements for bioinformaticists, and revamp proficiency testing (PT) requirements to test the total testing process.

Finally, there was significant interest in the so-called remote testing waiver that was borne from the pandemic. Although a change in this would require a change in regulations, CLIAC discussed the many considerations needed in any future regulations. While the CAP sees the benefits in continuing to allow remote work for clinical laboratory personnel, the CAP encouraged CLIAC to explore the risks and impacts on clinical laboratory operations and patient care if the remote work waiver is made a permanent practice for clinical laboratories.

Joe Saad, MD, FCAP, Vice-Chair of the CAP’s Council of Government and Professional Affairs, provided the testimony supporting the CLIAC’s efforts to examine the CLIA regulations to determine modifications to ensure the regulations accommodate advancements in clinical laboratory practice. Dr. Saad stated, “since the inception of CLIA, non-traditional testing sites have exploded across the range of CLIA specialties and subspecialties. Therefore, the CLIA regulations should be updated by adding personnel requirements for point-of-care-testing, recognizing bioinformatics (including stand-alone facilities) as subject to CLIA, adding personnel requirements for bioinformaticists, revamping proficiency testing requirements to test the total testing process, and considerations for remote work.”

While the CAP encouraged CLIAC to consider recommendations to ensure the regulations accommodate advancements in clinical practice, the CAP also indicated that “any modifications should assure patient access to quality testing by affording the least burdensome approach to oversight.”