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.
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
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.
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!
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.
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
"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."
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.
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.