On December 28, 2023, the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a final rule that includes the first significant revision of the CLIA personnel regulations since the CLIA ’88 rules were adopted in 1992. The long-awaited final rule follows CMS’s 2018 Notice of Inquiry concerning prospective revisions to the CLIA personnel standards, which in turn was followed by a proposed rule issued in July 2022. 果冻传媒was among more than 20,500 organizations and individuals that submitted comments in response to the proposed rule.
Key provisions:
- CMS received over 19,750 comments from laboratory personnel groups (including AMT) and individual laboratorians opposing the agency’s proposal to allow persons with a bachelor’s degree in nursing (BSN) to perform high complexity testing. The July 2022 proposed rule already had acknowledged that a BSN is not equivalent to a degree in a biological or chemical science. But the agency had nevertheless proposed a separate route by which BSNs could perform high complexity testing – without any additional documented training. In response to the overwhelming opposition, CMS determined not to finalize its proposal to qualify BSNs for high complexity testing. Individuals with a nursing degree may still qualify as moderate complexity Testing Personnel, which covers most point-of-care testing, but cannot serve as Lab Directors or Technical Consultants in those settings.
- The final rule revisions add a route by which individuals with an associate degree in laboratory science or medical technology plus four years’ clinical training and/or experience can qualify as Technical Consultant (TC) in a moderate complexity setting. Thus, after the final rule takes effect in December 2024, most MLTs will be qualified to perform competency assessments for both moderate and high complexity testing personnel.
- CMS finalized its proposal to eliminate a degree in a “physical science” as a route to qualifying for various job positions in nonwaived labs. Moving forward, CMS will recognize bachelor’s degrees in biological or chemical science, or medical/clinical laboratory technology or science. Individuals with other degrees can qualify only if they meet an “educational algorithm” requiring minimum semester-hours of specified biology and chemistry courses.
- CMS finalized its proposal to make permanent the route by which military-trained MLTs can qualify to perform high complexity testing. Previously, military-trained technicians qualified only if they had been grandfathered as of April 24, 1995.
- CMS officially recognized the lab community’s effort to adopt a uniform nomenclature and incorporated the change suggested by commentators (including AMT) to include reference to Medical Laboratory Science (in addition to CLS and MT) where applicable in the final rule.
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