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Under New CLIA Regs, Nursing Degree No Longer Sufficient for High-Complexity Testing


NEW YORK – Updated CLIA regulations make clear that a nursing degree is no longer considered sufficient training to perform high-complexity testing, resolving what had become a point of controversy within the lab industry.

The new regulations, which went into effect in January, reverse a previous US Centers for Medicare and Medicaid Services (CMS) policy under which the agency recognized a bachelor's degree in nursing as meeting the educational requirement for performing testing deemed high-complexity under CLIA.

Under the updated regulations, a nursing degree will not qualify individuals to perform high-complexity testing, but it will qualify them to perform moderate-complexity and CLIA-waived testing provided they meet certain additional continuing education requirements.

Joe Saad, governor of the board of the College of American Pathologists, which had opposed the previous CMS policy, said the organization viewed the revision favorably, noting that while CAP did not believe a nursing degree provides individuals with sufficient training to perform high-complexity testing, it recognizes the need for nurses to perform moderate-complexity and CLIA-waived testing for purposes such as point-of-care testing of patients at the bedside or in the operating room.

The origins of the previous CMS policy are somewhat unclear. The question of nurses and high-complexity testing first became an issue in 2016 when the agency published a policy memorandum that included the notice that a bachelor's degree in nursing met "the requirements for earning a degree in a biological science for … high-complexity testing personnel."

CMS said at the time that this did not represent new CLIA policy but was simply a clarification of existing CLIA policy. Many in the lab industry were caught by surprise, however. As Matthew Schulze, director of government relations at the American Society for Clinical Pathology (ASCP), told 360Dx in a 2022 interview, his organization was caught off guard by the announcement and could not find any previous documentation of the policy.

In 2018, CMS put out a request for information asking for comments on a proposal to formalize its policy on nursing degrees as qualification for high-complexity testing. The agency noted in its 2018 RFI that while it considered a bachelor's degree in nursing to be on equal footing as a bachelor's degree in a biological science for the purposes of performing a high-complexity test under CLIA, it was considering amending the CLIA regulations to codify it into policy.

The agency received close to 9,000 comments in response to the RFI, and nearly all of them opposed codifying a nursing degree as qualifying for high-complexity testing, with organizations including CAP, ASCP, the American Association for Clinical Chemistry, the American Society for Clinical Laboratory Science, and the American Society for Microbiology coming out against the measure.

Of the major US nursing organizations, the American Association of Nurse Practitioners (AANP) and the American Nurses Association (ANA) publicly commented on the RFI, both issuing statements supporting codification of a bachelor's in nursing as a qualifying degree for high-complexity testing.

In its response to the public comments that it published along with the updated CLIA regulations, CMS noted the overwhelming opposition to the proposal and said that it agreed with the commenters that the knowledge and experience required for high-complexity testing "may not be obtained in the nursing curriculum despite its science course requirements."

Given the uncertain origins of the original CMS policy, stakeholders have been unclear as to the motivations that originally drove it.

One possibility, raised by CMS in meetings with lab organizations, is that allowing nurses to perform high-complexity testing might ease the staffing shortages facing the lab industry. This was also suggested in the American Hospital Association's (AHA) public comment on the RFI, in which the organization noted that "clinical laboratories are facing a critical and growing shortage of qualified laboratory personnel" and that this shortage "may pose problems for patient access to appropriate care."

The AHA also said, however, that it did not believe that a "bachelor’s of nursing degree should qualify for non-waived testing in a hospital central laboratory." Instead, the organization suggested that CMS create a separate point-of-care testing category for which a bachelor's degree in nursing would qualify an individual. This, it said, "would allow nurses to carry out their essential role in healthcare delivery while ensuring the reliability and accuracy of laboratory testing."

By allowing nurses to perform moderate-complexity and CLIA-waived testing — the categories into which most point-of-care testing falls — the updated CLIA regulations essentially incorporated a version of the AHA proposal.

The AHA noted in particular the difficulty that rural hospital systems are having hiring and retaining laboratory personnel. Speaking to 360Dx in 2022, Brock Slabach, chief operating officer at the National Rural Health Association, said that given CMS's claim that its policy of considering nursing a biological degree is a longstanding one, a change to the policy would likely cause disruptions for some rural hospitals.

In an email this month, however, he said that he has not received any feedback from providers about negative impacts from the updated regulation.

Unaddressed by the new regulations, however, are situations where nurses perform point-of-care testing in a manner not fully consistent with the labeled requirements, in which case a waived or moderate-complexity test becomes a high-complexity test under CLIA guidelines.

ASCP's Schulze provided the example of a test that might, according to its label, need to be performed within 30 minutes of being opened but which a nurse, due to some event during their rounds, might not get to until 35 minutes after opening it, at which point it has become a high-complexity test.

"I believe that [the updated regulation] does not resolve this issue," Schulze said, noting that ASCP believed such situations might have been one of the reasons CMS proposed allowing nurses to perform high-complexity testing in the first place.

He suggested, however, that the best solution is not to allow nurses to do high-complexity testing but rather to ensure that waived and moderate-complexity tests are consistently conducted according to their labeling.

Saad likewise said that he thought this issue formed part of CMS's rationale for its original policy on nurses and high-complexity testing.

He indicated, however, that CAP is not particularly troubled by such scenarios. For instance, he said, a nurse might conduct a point-of-care test in whole blood even though it has only been cleared by the US Food and Drug Administration for use in serum or plasma, in which case the test would become high-complexity.

"We believe it's OK for [hospitals] to allow [nurses] to do that testing," Saad said.