Last April, the Centers for Medicare & Medicaid Services (CMS) Center for Clinical Standards and Quality’s Survey & Certification Group released an internal memo intended to guide Clinical Laboratory Improvement Amendments of 1988 (CLIA) inspectors on personnel qualifications for laboratory staff. Much to the chagrin of the laboratory community, the memo indicated that a bachelor’s degree in nursing would meet the requirements of a bachelor’s degree in biological science, with a similar acceptance in regards to associate degrees. This translated into nurses being able to perform non-waived laboratory testing under CLIA. Prior to the memo, this had not been the case.
The Laboratory Community Responds
In response, in September, the American Society for Clinical Pathology (ASCP), the ASCP Board of Certification (BOC), and the American Society for Clinical Laboratory Science (ASCLS) met with CMS to express concerns about these changes. These groups pointed out the potential negative impacts on patient care and the importance of ensuring the accuracy and reliability of laboratory results. ASCP and ASCLS collected 35,000 signatures on a petition opposing the degree equivalency recommendation.1
Nurses are Well Educated but the Degrees are Not Equivalent
The reasoning behind the memo was attributed to personnel shortage concerns, particularly in rural areas. In the meeting, comparing the details of the two degrees side by side revealed that nursing degrees have significantly less science-related class hours than biological science degrees. This does not downplay a nursing degree’s level of difficulty, but it points out that the science educational background that results in a deep understanding of the principles behind laboratory testing is not included; that is not the intent of a nursing degree.
Two Different Educational Tracks
It is widely recognized that laboratorians and nurses have a different educational “upbringing,” and the precisions and methodologies behind lab specimen collection, preparation, and testing is often misunderstood by those without the educational component that stresses these concepts. At the meeting, people with both degrees were in agreement that there is a stark difference of path between the two degrees. These “dual-degreed” individuals confirmed that a nursing degree does not contain sufficient scientific background to allow someone to step in and perform non-waived lab testing, just as a biological science degree does not prepare one to act as a nurse.
The VA Follows Suit
Along a similar path, in May 2016, the U.S. Department of Veterans Affairs (VA) published a proposed rule expanding the authority of Advanced Practice Registered Nurses (APRNs). The rule gave the Certified Nurse Practitioner (CNP) authority to “order, perform, supervise, and interpret laboratory and imaging studies.”2 This was interpreted as a CNP being able to not only perform, but also to direct high-complexity lab testing.
Again, the Lab Community Steps Up
The Clinical Laboratory Management Association’s (CLMA) Legislative, Compliance and Regulatory Committee (LCRC) banded together with other lab associations and submitted thoughtful comments to which the VA paid heed. In December, the VA announced an amended final rule. The revision removed the wording that allowed CNPs to perform and supervise lab testing. The VA also acknowledged the critical role that laboratorians play and the rigorous educational and training requirements necessary to understand and perform complex lab testing.
CMS Intends to Review the Policy
While no final word has been issued, CMS has expressed its intent to review the policy and propose better regulations that will alleviate concerns about the reliability of lab testing. ASCP, ASCLS, and the BOC intend to continue to work with CMS to come to a consensus. We will continue to keep you informed on the issue as updates occur.
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1. The American Society for Clinical Laboratory Science. (n.d.). BOC, ASCLS, and ASCP meet with CMS on nursing degree equivalency rule. Retrieved from http://www.ascls.org/communication/blog-society-news-now/339-boc-ascls-and-ascp-meet-with-cms-on-nursing-degree-equivalency-rule.
2. Office of the Federal Register (2016, December 14). Advanced Practice Registered Nurses: A rule by the Veterans Affairs Department on 12/14/2016. Retrieved from https://www.federalregister.gov/documents/2016/12/14/2016-29950/advanced-practice-registered-nurses
Kim Futrell, BS, MT(ASCP)
Products Marketing Manager
Orchard Software Corporation