ASCP Action Alert: Don’t Let CMS Undermine CLIA’s Personnel Requirements

CMS Proposal Would Let Nursing Degree Holders Perform High Complexity Testing

The Centers for Medicare & Medicaid Services (CMS) just released a proposed rule to revise the Clinical Laboratory Improvement Amendments (CLIA) personnel standards. In it, CMS is proposing to add nursing degrees to the CLIA high and moderate complexity testing personnel requirements. The proposal would place nursing degrees on the same footing as more appropriate degrees in medical laboratory science, biology, and chemistry.  

Bachelor’s degrees in medical laboratory science, biology and chemistry typically require, at a minimum, between 35 to 45 semester hours (or more) of academic science, which can provide these degree holders with a solid foundation in the academic sciences and techniques employed in high complexity laboratory testing. In contrast, bachelor’s degrees in nursing provides a fraction of the academic science obtained by laboratory professionals—often less than 14 semester hours and usually only introductory level coursework.  

While CMS expects that nursing degree holders will be properly trained, it is not requiring any uniform coursework or training requirements to ensure this will happen. In justifying the leap from waived testing, CMS states that “nurses perform the majority of the point-of-care testing in many different scenarios including, for example, bedside, surgery centers, end-stage renal disease facilities.” We recognize that nurses often need to perform point-of-care testing for patients. However, many, if not most, of these tests are classified as waived and authorizing individuals who have only been trained to do these simple tests to perform all manner of high complexity tests without the requisite academic science and clinical training recklessly disregards patient health and safety.

If we are going to stop this proposal, ASCP needs YOUR help to protect patient care and quality laboratory medicine. Please click here to Take Action to send a quick message (we’ve already drafted one you can use), urging CMS to not adopt this proposal in its current form!

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