Today's Clinical Lab - News, Editorial and Products for the Clinical Laboratory
Illustration of multiple circles on a blue background with the words “CMS UPDATE.”
On December 27, CMS posted an update to the Federal Register notifying the public of a number of changes to rules applicable to CLIA
iStock, filo

CMS Update Raises Standards for Clinical Laboratories under CLIA

Effective January 28, the updated rules address recent questions around nursing degree equivalency and the status of DCLS professionals

Photo portrait of Jesse L. Day, MHA, BSc, MLS(ASCP)CM
Jesse L. Day, MHA, BSc, MLS(ASCP)CM

Jesse L. Day, MHA, BSc, MLS(ASCP)CM, serves as the current president for the American Society for Clinical Laboratory Science–Tennessee Chapter (ASCLS-TN), as well as the ASCLS National Ascending Professional Vice Chair and Government Affairs Committee member. He holds a master’s of health administration and bachelor of science in clinical laboratory science.

ViewFull Profile
Learn about ourEditorial Policies.
Published:Jan 11, 2024
|2 min read
Register for free to listen to this article
Listen with Speechify
0:00
5:00

Medical laboratory professionals in the US have once again demonstrated the power of their collective voice and asserted that they are capable of controlling and directing their own affairs.

In 2022, the US Centers for Medicare & Medicaid Services (CMS) announced a rule change stating that a bachelor of science in nursing would be recognized as equivalent to a bachelor of science in clinical laboratory science and the biological sciences, allowing nurses to perform high complexity testing. 

In this same set of proposed rule changes, CMS also questioned whether or not a doctorate of clinical laboratory sciences would be accepted as qualifying for high complexity lab director status.

There was significant pushback from the medical laboratory community, and we’ve been waiting since the comment period for a final answer. 

On December 27, 2023, CMS posted a 203-page update to the Federal Register notifying the public of a number of changes to rules applicable throughout the Clinical Laboratory Improvement Amendments (CLIA) program. There were many updates, including to the fee schedule.

Most notably, effective January 27, 2024:

  • CMS has changed its proposed rule that would have defined a nursing degree as equivalent to a biological sciences degree, which the clinical laboratory community, for many years, has opposed and effectively demonstrated that the two degrees are not equivalent. In response, CMS will create a separate pathway and educational requirements for those with nursing degrees to become moderate complexity testing personnel. However, individuals with nursing degrees will no longer be able to qualify as laboratory directors, as nursing is not listed as a qualifying degree under revised § 493.1405(b).
  • The update also strengthens and clarifies requirements and documentation for training and experience for those working in moderate and high complexity testing.
  • CMS confirmed that the doctorate of clinical laboratory science (DCLS) degree will be accepted as qualifying for high complexity laboratory director.
  • The update also helps advance the profession's efforts to bring standardization to our nomenclature.

These changes wouldn’t have occurred without the voices of more than 8,000 people. Notably, high complexity testing remains in the hands of laboratory professionals and recognition of our professional doctorate, DCLS degree, as qualified experts in the field has been affirmed.

Because of the work of so many within our community to protect patients, 2024 will raise standards for clinical laboratories under CLIA. This would not have occurred without ongoing investment and commitment from groups like ASCLS and ASCP, as well as all members of the medical laboratory community.

Congratulations to the medical lab community!