On July 22, the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention issued a proposed rule updating the Clinical Laboratory Improvement Amendments (CLIA) Fees; Histocompatibility alternative Waived Testing Sanctions regulation.


According to the College of American Pathologists (CAP), the proposed regulation includes changes to laboratory director qualifications, specifically with regard to doctorate-level scientists and consideration of the doctor of clinical laboratory scientist. The proposed regulation also includes a qualification algorithm, making it possible for people without scientific degrees to qualify for technical supervision, testing personnel, and laboratory director roles within CLIA.


Other changes in the proposed regulation include the creation of a new fee structure that would consider travel and inspection costs; creation of a new category for blood gas labs that includes nurses and respiratory therapists as testing personnel and testing staff, respectively; language to update the histocompatibility requirements to take into account modern crossmatching practices; and alternative sanctions for Certificate of Waiver laboratories (such as civil monetary fines, a directed plan of correction, and on-site monitoring).


According to CAP, these proposed changes are a combination of proposals from a 2019 Clinical Laboratory Improvement Advisory Committee report and 2018 CDC request for information. While many of the changes align with CAP efforts in histocompatibility, separate testing categories for nursing, and alternative sanctions for waived testing, CAP said it will advocate against changes to laboratory director requirements. CAP plans to respond to the proposed rule within the 60-day deadline.


More information on the proposed rule is available in a CMS fact sheet.