The laboratory community is being presented a once-in-a-generation opportunity to guide the updating of CLIA regulations to reflect the current and future practices in clinical laboratories that support clinical decision-making in an ever-evolving healthcare system. In advance of a March 12, 2018 deadline, CMS is requesting information, comments, information, evidence, research, and trends related to CLIA personnel regulations that the Agency intends to use to update the existing CLIA personnel regulations in the future. This will be the first time since 1992 that there has been a comprehensive review of the regulations.

ASCLS is preparing detailed comments for CMS on all of the issues raised, with a central focus on strengthening laboratory personnel standards and ensuring the ongoing, invaluable contributions of laboratory professionals in the healthcare system.

Nursing Degrees Are Not Equivalent to Biological Sciences Degrees

In April 2016, CMS released a memo updating its interpretation of the personnel regulations allowing surveyors to consider a bachelor’s degree in nursing as equivalent to a bachelor’s degree in a biological science for high complexity testing personnel. After CMS published the previously “unwritten rule” in April 2016, ASCLS, working through the Board of Certification, raised deep concerns with the agency. The societies presented more than 30,000 signatures from laboratorians, physicians, nurses and other healthcare professionals demanding that CMS reverse its decision, expressing their deep concern about patient health and welfare in those institutions that placed unqualified people in key positions in the laboratory.

The ASCLS position has not changed. Nursing and biological sciences degrees are not equivalent and creating a regulatory framework where they are, puts the lives of patients at risk. CMS claimed that this previous unwritten rule was necessary for areas where there were not enough qualified laboratory personnel to perform the necessary work. Equating a bachelor’s degree in nursing with a degree in biological sciences would allow nurses to:

Perform high complexity testing without any additional training.

Serve as a technical consultant for high complexity laboratories or as lab director or technical consultant for a moderate complexity laboratory with defined laboratory experience.

Nurses seem to have no interest in taking on these roles, understanding their training best prepares them to contribute to patient health in other ways. The fear is that nurses will be forced into roles for which they do not have adequate training by short-sighted administrators.

In both scope and depth, the natural science coursework required for a biological sciences degree vastly outweighs the natural science coursework required as part of a nursing degree. Typical coursework requirements for a bachelor of sciences degree in biological sciences includes a total of at least 63 hours of natural sciences, including at least 39 hours of major requirements in the biological sciences and 32 hours of prerequisites. In contrast, nursing degrees include only a quarter of the course hours in the natural sciences.

Comparisons from some leading universities with both nursing and medical laboratory science programs illustrate the entirely different degree programs.