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Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel

by | May 17, 2023 | News

While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.

On July 22, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (CMS-3326-P) purporting to “update the CLIA personnel requirements to better reflect current knowledge, changes in the academic context, and advancements in laboratory testing.” To accomplish that objective, CMS is essentially proposing to water down the credentials required for the laboratory director (LD), technical supervisor (TS), technical consultant (TC), and testing personnel (TP) roles at CLIA moderate and high complexity testing labs.

The most controversial part of the proposal is the addition of nursing degrees to the list of degrees that qualify a person to perform moderate and high complexity testing. If the rule becomes final, a bachelor’s degree in nursing would be considered equivalent to a bachelor’s degree in biological science, which is currently accepted as meeting the educational requirements for moderate complexity TC, moderate complexity TP, and high complexity TP. CMS also says that it’s considering whether to make a nursing degree a separate qualifying degree, as opposed to the equivalent of a biological science degree, for purposes of meeting educational requirements for moderate and high complexity TP and TC.

According to CMS, nurses perform most point-of-care testing in many different settings and scenarios, such as bedside, surgery centers, and end-stage renal disease facilities.

“We do not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing with appropriate training and demonstration of competency,” CMS says. Besides, allowing nursing degree holders to perform high and moderate complexity testing “would decrease the burden on laboratories by allowing one individual to fulfill multiple responsibilities while still maintaining the laboratory’s ability to perform accurate and reliable testing,” CMS reasons in a Fact Sheet on the rule.

Key clinical and professional organizations have voiced strong objections to the idea of treating a nursing degree as the equivalent of a degree in clinical lab science, noting that most of the point-of-care tests currently performed by nurses are CLIA-waived tests. Allowing nurses to do high complexity testing is a quantum leap that “recklessly disregards patient health,” according to the American Society for Clinical Pathology (ASCP).

The American Hospital Association (AHA) has also called on CMS to withdraw the rule, and the American Association for Clinical Chemistry (AACC), though raising concerns about nurses doing such testing, suggested that nurses may still be able to “demonstrate testing competency” by passing a lab-specific curriculum of continuing education courses or a competency exam.

AACC has also come out against the CMS’s proposed expansion of the qualifying education credentials for LD at high complexity testing labs. Under current CLIA rules, individuals must possess an MD or board-certified PhD to serve as LDs at high complexity labs. CMS is proposing to allow those with a “professional doctorate” or “master’s equivalency” to qualify for those positions.

See the full analysis in our June 2023 National Lab Reporter Staffing Special Report.”