CMS Wants Nurses to do High Complexity Testing…Again

Publication Date: Jul 25, 2022

On July 22, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would allow individuals with a nursing degree to perform high (and moderate) complexity testing. The proposed rule to the Clinical Laboratory Improvement Amendments (CLIA) regulations would place nursing on the same level as clinical laboratory science, biology, and chemistry degrees. This would mean that individuals with a nursing degree would not be required to meet any coursework or clinical training requirements under CLIA. During a previous advocacy campaign against this policy, ASCP, ASCP Board of Certification (BOC), and our members pointed out that nursing degrees typically require a fraction of the scientific coursework (about one-quarter) and laboratory training required by CLIA of laboratory testing professionals.

The proposed rule would not allow nursing degree holders to supervise or direct laboratory staff in a formal CLIA role, such as a laboratory director, technical consultants, technical supervisors, or general supervisors. Regardless, ASCP and ASCP BOC will be opposing the proposed rule and will be launching an action alert to encourage its members and the broader laboratory community to urge CMS to withdraw this proposal.

In justifying the proposed new policy, CMS said: “We recognize that in many health care systems, nurses perform the majority of the point of care testing in many different scenarios (for example, bedside, surgery centers, 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.”

ASCP and ASCP BOC recognize that nurses often need to perform point-of-care testing for patients. Most of these tests, however, are classified as waived under CLIA, and authorizing individuals who have been trained to perform waived testing to perform all manner of high complexity tests without the requisite academic science and clinical training recklessly disregards patient health.

When CMS first publicly announced plans to allow individuals with a nursing degree to perform (and supervise) moderate and high complexity testing in a 2018 Request for Information (RFI), ASCP and ASCP BOC organized the laboratory community against the proposal. (See here.) More than 8,700 comments were submitted and only a handful supported the Agency’s proposal to recognize the nursing degrees toward performing non-waived testing. Also, when ASCP learned in 2016 that the Agency had sent state and local CLIA officials a memo stating that nursing degrees are equivalent to biology degrees and therefor nursing degree holders may perform high and moderate complexity testing, ASCP and ASCP BOC responded by submitting to the Agency a petition signed by more than 35,000 laboratory professionals urging the Agency to abandon its flawed policy.

ASCP will again work with laboratory and pathology organizations concerned about patient safety to stop this policy. Keep an eye out for ASCP’s Action Alert asking you and your colleagues to stop this risky policy.

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

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