HHS Adopts First Major Update to CLIA Personnel Rules Since 1992

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HHS Adopts First Major Update to CLIA Personnel Rules Since 1992

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. AMTwas 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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