CMS Suggests Nurses Can Perform High Complexity Testing

AACC is calling on the Centers for Medicare and Medicaid Services (CMS) to suspend a recent decision that would allow nurses to perform high-complexity laboratory testing. CMS should publish a proposed rule on this issue and review public comments before proceeding, AACC wrote in a letter to the agency, as the decision “sets a dangerous precedent for altering personnel requirements without public consultation.”

CMS announced the policy change in an April 1 memo that focused on allowing primary source verification (PSV) as evidence of compliance with CLIA personnel qualifications. AACC supports this part of the memo that permits laboratories to use PSV, but also wants the agency to permit organizations that provide professional certification to fill the role of PSV, provided they have verified the information sought by CMS.

However, the CMS memo goes on to state that a bachelor’s degree in nursing meets the requirement of having earned a bachelor’s degree in biological science for high-complexity testing personnel, and that an associate’s degree in nursing meets the requirement of having earned an associate’s degree in a biological science for moderate-complexity testing personnel.

“AACC agrees that nurses are invaluable members of the healthcare team,” the association wrote. “However, their education and training necessarily covers a breadth of medical disciplines and therefore does not delve into the depths of scientific concepts underlying clinical laboratory testing. CMS’ decision to accept nursing degrees as equivalent to the currently accepted degrees would exempt nurses from having to complete valuable clinical laboratory training prior to performing patient testing.

In the CLIA regulations, testing personnel for high complexity testing—not consultants or supervisors—have been able to meet requirements with “a bachelor’s degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution…or have earned an associate degree in a laboratory science, or medical laboratory technology.” The regulation also allows a combination of education and training equivalents. Nursing degrees have not been mentioned in the regulation or interpretive guidelines from CMS until now.

Workshop Takes on Mass Spectrometry Regulation

The Food and Drug Administration (FDA) has noticed the growth of liquid chromatography-mass spectrometry (LC-MS) testing and is taking measured steps to “develop a regulatory path forward,” noted FDA officials at a May 2 workshop, which focused on analytical validation. While FDA has cleared or approved LC-MS tests for newborn screening, identifying microbes, and therapeutic drug monitoring, the agency has not approved any LC-MS tests that measure proteins and peptides. “We want to engage in a conversation between FDA, manufacturers, [and] clinical labs, to develop a regulatory path forward for these devices,” said FDA scientist Julia Lathrop, PhD, at the workshop.

Yan Victoria Zhang, PhD, DABCC, an associate professor in the department of pathology and laboratory medicine at the University of Rochester Medical Center in New York, offered a statement on behalf of AACC. Zhang emphasized that protein and peptide assays measured by mass spectrometry differ widely in the number of targets they measure, the choice of intact proteins or surrogate peptide markers, the type of quantitation, and in what kind of post-analytical data processing they require. AACC suggests that the agency consider this “diversity” before drafting guidance or attempting to regulate LC-MS assays.

“While recognizing that some LC-MS-specific considerations should be evaluated, we believe that the validation requirements for LC-MS assays for proteins and peptides should be similar to those for current in vitro diagnostic instruments/methods,” Zhang said. “It is also important that regulatory guidelines not place an undue additional burden on this technology relative to other established analytical principles in light of the potential analytical advantages of LC-MS.”

AACC submitted further comments to FDA in a letter, available at

Final Rules Aims to Improve Equality in Healthcare

The Department of Health and Human Services (HHS) issued a final rule that protects individuals from discrimination in healthcare on the basis of race, color, national origin, age, disability, and sex, including discrimination based on pregnancy, gender identity, and sex stereotyping. The rule also enhances language assistance requirements for people with limited English proficiency, and effective communication for individuals with disabilities. The protections in the final rule affect health insurers, hospitals, and health plans receiving federal funds.

This new policy is more specific than prior rules. Previously, civil rights laws enforced by HHS’s Office for Civil Rights (OCR) broadly barred discrimination based only on race, color, national origin, disability, or age. Now, for example, women are specifically protected from discrimination not only in health insurance but also in health services from providers.

The rule does not, however, resolve whether discrimination on the basis of sexual orientation status alone is a form of sex discrimination. The rule makes clear that OCR will evaluate discrimination complaints related to sexual orientation to determine if they involve the sorts of stereotyping laid out in the regulation. According to HHS, the agency “supports prohibiting sexual orientation discrimination as a matter of policy” and will monitor legal developments in this area.

Another provision in the final rule makes an exception for any requirement that would violate federal statutes protecting religious freedom and conscience.