CMS Says Nurses Can Perform High Complexity Tests

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The Centers for Medicare and Medicaid Services (CMS) recently published a memo that it sent to CLIA inspectors on how to interpret educational requirements. CLIA had always specified the minimum educational requirements for individuals performing laboratory tests.

In recent years there has been quite a  strong lobby from nursing to recognize a nursing degree as a biological science degree, having the requisite credit hours of biology, chemistry etc. Those of us with oversight for point of care testing (POCT) had also been unsure as to whether nurses could perform non-waived tests and maybe even fully manage a POCT program where non-waived tests were utilized.

Now CMS has weighed in definitively by saying that, yes, a nursing degree is a science degree making nurses qualified to perform non-waived tests. A careful reading of the CLIA regulations would suggest that if that is true, then nurses may in fact be allowed to even direct laboratory testing.

In my view, this is an encroachment on our scope of practice that also potentially endangers the patient health.  POCT and some other laboratory tests are seen as merely “recipes” by some inside and outside the profession. But we know that laboratory testing requires critical thinking skills way beyond the memory and motor skills required to add 1 drop of this, 2 drops of that and time for 5 minutes to see if a blue line appears or not.

The CMS guidance to its CLIA inspectors directs them to accept a bachelor’s degree in nursing as a biological science degree qualifying the  holder to perform even high complexity testing, and that an associates in nursing qualifies the holder to perform moderate complexity testing. Yes!

Lest you think this is something that no serious employer will follow, bear in mind that this came after lobbying from nurses who wanted to perform and supervise laboratory testing. They had a definite goal in mind and will certainly take advantage of this new development.

Not wasting much time the Veterans Administration  (VA) has already jumped on the band wagon.

In a recent letter to its members ASCLS said the following regarding the VA decision:

“The Department of Veterans Affairs (VA) has published Proposed Rule that would expand the authority of Advanced Practice Registered Nurses (APRNs) beyond ordering and interpreting lab tests, as they can now, to supervising and performing laboratory testing. If adopted, an APRN could supervise and direct a clinical laboratory.

“In proposed § 17.415(d)(1)(i), a CNP would have full practice authority to provide the following services: Comprehensive histories, physical examinations and other health assessment and screening activities; diagnose, treat, and manage patients with acute and chronic illnesses and diseases; order, perform, supervise, and interpret laboratory and imaging studies; prescribe medication and durable medical equipment and; make appropriate referrals for patients and families; and aid in health promotion, disease prevention, health education, and counseling as well as the diagnosis and management of acute and chronic diseases.”

This is setting a dangerous precedent. Nurses are valuable members of the healthcare team but they have a body of knowledge and a scope of practice different from those of medical laboratory practitioners.

This is not about competition and “staying in ones lane.” It is about a real risk to the public health. I can no more practice nursing from reading a package insert and following schematic workflows than a nurse can (safely and effectively) practice medical lab science.

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About Author

Glen McDaniel
Glen McDaniel

Glen McDaniel is a veteran laboratorian with quite a diverse background. He has been a clinical lab scientist for over 25 years, and is active in local and national professional organizations. He believes vehemently in a strong, proud profession, with independent practice under the control of clinical lab scientists. Mr. McDaniel has studied both in Canada and the U.S., and has a bachelor’s degree in medical technology, a masters in clinical chemistry, bachelors in healthcare administration and an MBA as well. Most recently, he served as a hospital COO. He writes the popular “Scope of Practice” column for ADVANCE and freelances for other magazines. He is also a speaker and provides healthcare consulting for hospitals, corporations and investment bankers. Other areas of interests include conflict resolution, leadership, change and ethics. Glen can be reached at glenmcdan@aol.com and his Web site is www.glenmcdaniel.com.

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