On Apr. 1, 2016, the Centers for Medicare & Medicaid Services (CMS), in a policy memorandum stated the following: A bachelor’s degree in nursing meets the requirement of having earned a bachelor’s degree in a biological science for high complexity testing personnel. The laboratory may show a Primary Source Verification (PSV) report verifying that a bachelor’s degree in nursing was earned, a diploma with the type of degree earned, or transcripts as evidence of meeting the education personnel requirement.


An associate’s degree in nursing meets the requirement of having earned an associate’s degree in a biological science for moderate complexity testing personnel. The laboratory may show a PSV report verifying that an associate’s degree in nursing was earned, a diploma with the type of degree earned, or transcripts as evidence of meeting the education personnel requirement.

This personnel qualification update prompted the following response from the world’s largest professional membership organization for pathologists and laboratory professionals, the American Society for Clinical Pathology (ASCP), as was covered here in late August:

Based on our review of biological science and nursing degree requirements,biological science degrees require three to four times more academic science than does nursing. Another notable contrast is that biological science degrees are heavily reliant on advanced level coursework in the sciences while nursing degrees are not. 

We have great respect for the work and invaluable services nurses provide patients. That said, given the significant lack of biological and other science obtained through a typical degree in nursing, we do not agree that the nursing degree is equivalent to a biological sciences degree or that it would adequately prepare someone to perform non-waived laboratory services

Dozens of comments on the website and on the Facebook page, Infectious Disease News, revealed the disagreement many laboratory professionals feel concerning this issue.

Outbreak News Today reached out to several people in the industry, scientists and educators, to get their thoughts on the CMS memorandum and here’s the responses we received:

Professor, Dept of Medical Laboratory Sciences at the University of Delaware and American Society for Clinical Laboratory Science (ASCLS)-Delaware President, Mary Ann McLane, PhD, MLS(ASCP) said the following:

The CMS position holds that a nursing associate’s or baccalaureate degree is, in content and skill, the same as a degree in a biological science, and therefore fully prepares a person to direct a moderate complexity lab or be in a supervisory role in high complexity testing. I have no idea how CMS got this idea, and I have two sisters who are nurses (so fully appreciate and respect their gifts to patient care), but this is the WORST idea ever. Two reasons:

This shows the basic flaw in the CLIA regulations, which do not specify clinical training of folks with a biological sciences BS degree. Anyone who thinks they can do all of the troubleshooting and interpretation of laboratory test results just by a BS degree in biology OR nursing, is basically a button-pusher who will repeatedly, and predictably, place patient care in danger. Ask any of the students in my University of Delaware MLS program, and they will tell you quite forcefully that the idea of “anyone can do this” without the specific education they are getting, is a lie.

It is quite well known that nurses have a hard time complying with even the simplest quality control requirements for waived testing. Testing such a fingerstick glucoses used to have no mechanism to force calibration checks and quality control to be done. When it became obvious that the very people doing these tests in hospital settings were skipping the steps, the manufacturers re-engineered their glucometers to have a lockout unless the QC was done. You would not need such a lockout if an MLT/MLS were doing the testing since quality assurance of all testing is in our blood!

Bottom line is that patient safety is at stake here. Moderate and high complexity testing should only be done by those who understand the test method inside and out. That is NOT a part of nursing’s Body of Knowledge, is not taught in nursing programs, and the nursing degree, itself, does not qualify an individual to do laboratory testing. It is not prejudice, it is just facts!

My sister, a nurse with over 40 years of experience, was equally dumbfounded by the CMS opinion, and happily signed the petition against CMS implementing this policy.


Kyle B Riding, PhD, MLS(ASCP), Instructor, Medical Laboratory Science at Keiser University – Orlando Campus had this to say:

Like many in the industry I am dismayed by the decision of CMS to allow nursing professionals to run moderate and high complexity testing. CLIA’s standards regarding qualified personnel are already sub-optimal in that they do not require formal training in an accredited medical laboratory program nor do they require certification as a benchmark for competency. Nurses do not receive nearly enough science to understand the complexities involved in laboratory testing.

I am unsure at what point in this country laboratory services will be viewed as more than simply button-pushing by policy makers. However, we as a profession have become united by this dangerous policy that places patients at risk. Hopefully, as we demand change from CMS they will begin to see how valuable we are to medicine.

Stephanie Noblit, MLS (ASCP)cm, Medical Laboratory Scientist  (Medical Toxicology) with the Hospital of the University of Pennsylvania writes:

I am very much in agreement with the stance that ASCP and other laboratory organizations, such as ASCLS, have taken against this CMS memorandum.  It seems like CMS is trying to make an effort to address the workforce shortage in the clinical laboratory profession, but giving nurses the ability to perform complex laboratory test does not solve that problem.  You cannot solve a shortage by pulling people from another profession to do the work.

While nursing degrees are not equivalent to a biological science degree, it is important to remember that the laboratory profession is not trying to put down nurses.  We have a huge respect and admiration for the work that nurses do each day.  They are trained to do their jobs, and I think it is fair to say that any patient would not want anyone other than someone with a nursing degree to be their nurse.  If CMS can realize that, then why would they think it would work the other way around?  If the degrees are truly equivalent, then why don’t we let laboratory professionals work up on the floors as nurses?

David M. Falleur, M.Ed., MT(ASCP), Associate Professor with the Clinical Laboratory Science Program at Texas State University notes:

The recent proposal by staff from the Centers for Medicaid and Medicare Services, CMS, to recognize nursing degrees as equivalent to biological or clinical laboratory science degrees would allow nurses to add complex laboratory testing and management to their scope of practice.

As a laboratory professional with more than 40 years of clinical experience, I believe this decision would negatively affect the quality and reliability of complex clinical laboratory testing in our healthcare facilities.  The CMS regulations do not require specific training requirements or certification for personnel performing and managing moderate and high complexity laboratory testing.  The regulations do require a degree in the biological, chemical, physical, or clinical laboratory sciences to perform and manage complex laboratory testing procedures.

Nursing degrees typically have only a few biology and chemistry courses in their degree requirements, and no clinical experience in performing complex laboratory test procedures.  Nursing practice is different than training as a laboratory scientist.  Although nurses can and should be able to order and interpret clinical laboratory test results for their patients, laboratory testing and management should be under the direction of laboratory scientists.

Chair & Professor, Clinical Laboratory Science (CLS) and Associate Dean for Research at the College of Health Professions at Texas State University, Rodney E. Rohde, PhD, MS, SV, SM(ASCP) CMMBCM released the following statement:

Image/James Gathany
Image/James Gathany

Have you ever wondered who conducts the detailed laboratory testing for your annual exam, such as cholesterol and glucose levels, and analyzes the results? Or who conducts specialized testing for genetic disorders like sickle cell disease? How about those who identify an antibiotic resistant infection like Methicillin Resistant Staphylococcus aureus (MRSA) and determine which antibiotic is required to save someone’s life? Well, if you thought that it was your physician, or perhaps a nurse or someone else you see at your doctor’s office or in the hospital, you would be incorrect.

Medical laboratory professionals provide up to 70 percent of patients’ laboratory testing to physicians so they can provide an accurate diagnosis and treatment plan, according to a 2002 study in Clinical Leadership and Management Review titled “The Value of the Laboratory Professional in the Continuum of Care.” In that study, author Rodney Forsman, Administrative Director Emeritus of the Mayo Clinic Medical Laboratories and President of the Clinical Laboratory Management Association, stated that 94 percent of the objective medical data in the patient record comes from the laboratory professionals.

Doctors (and nurses) rely on laboratory test results to make informed patient diagnoses. Patient history along with physical signs and symptoms are vital, but most diagnoses need confirmation that only laboratory tests can provide. The laboratory professionals also contribute to wellness testing, guiding treatment, and monitoring patient progress.

People often think their lab tests are done by their doctor or nurse, like it’s done on House, or Dr. Kildare or Grey’s Anatomy. In fact, you would probably not want your personal physician or nurse to do your lab tests because the specialized skills required are not an integral part of the medical school or nursing curriculum.

Ask your physician, nurse, pharmacist or biology graduate about Vitamin C acting as interference in glucose and triglyceride testing, or causes of false positives in pregnancy testing, or World Health Organization (WHO) classifications for Hodgkin disease and diagnostic criteria, or ways to test for Zika, swine flu (H1N1) and avian flu (H5N1), or genetic testing modalities for cystic fibrosis, or who is most likely to show antibodies to Kell during a STAT emergency test for life-saving blood in surgery, or any other critical laboratory test and its interpretation. These aspects of lab testing are generally not in the body of knowledge of any of these medical professionals, and yet it is completely in ours.

Formal coursework training in medical laboratory testing comprises a small portion of the curriculum for physicians, nurses, pharmacists, physical therapists, occupational therapists, and biology graduates. However, for Medical Laboratory Science (MLS) and medical laboratory technician (MLT) students, medical laboratory theory for all 1,000+ available lab tests, sources of interference, and connections between test results and diagnoses is the main focus of their studies.

We respect nurses, and every healthcare professional that works to put the patient’s health and safety first. However, in regards to this CMS memorandum we completely disagree and feel that if nurses (or anyone else without our educational and clinical training) are allowed the same rights to do moderate and high complexity testing as certified laboratory professionals,  it would create issues of poor quality laboratory testing. Or worse, it puts the patients’ health in real danger. It’s simply an issue of the right person for the right job. Our professionals would never advocate to do the work of a nurse, physician or any other healthcare professional because that would be dangerous.

As for me, I cannot understand the logic behind the CMS policy–Is this a way to improve patient care? Will this solve shortages in the field effectively and efficiently? I think not.

The problem is they are making this an apples to apples comparison when such a comparison cannot be made. These two careers require different backgrounds, knowledge and skill sets to be performed optimally.

The CMS “diluting” basic science requirements to perform high-complexity laboratory testing is just a bad idea for everyone involved.

If you are a laboratory professional, or a nurse, who also thinks the CMS policy is a bad idea, I encourage you to sign the petition at the link HERE