In a letter to Health and Human Services Secretary Xavier Becerra, the American Society for Clinical Laboratory Science (ASCLS) has raised serious objections to a proposed federal rule that would allow individuals with bachelor’s degrees in nursing to serve as high complexity testing personnel under CLIA without any additional training or experience.

Noting the proposal “opens a new vector for diagnostic error,” the Society called the Centers for Medicare and Medicaid (CMS) “reckless” for advancing this harmful proposal over many years based on a foundation of “unwritten rules” allowing nurses to perform this kind of testing in the early years of CLIA implementation.

CMS justified the proposal by pointing to widespread waived testing in point of care settings performed by nurses.

“ASCLS is stunned that the agency has equated the experience with waived testing in point of care settings as somehow similar to high complexity testing,” ASCLS President Kimberly Von Ahsen wrote,  “It suggests the authors have not stepped into a clinical laboratory, nor reviewed any of the agency’s own reports, nor consulted any of the agency’s own experts on the subject.”

The Society does not believe nurses are seeking these responsibilities and fears that “this rule would be an open license for healthcare administrators to abusively push more complex and risky testing into point of care settings staffed by an already dangerously under-resourced nursing workforce.”

Read the full letter to Health and Human Services Secretary Xavier Becerra.

Laboratory professionals are strongly encouraged to add their voices by commenting on the rule and sharing their experiences and expertise on the subject.