Coming Soon? Will Nurses be Taking Over the Lab?

[Nerd eNurse]

It sounds crazy but a vague ruling but the Center for Medicare and Medicaid Services could be interpreted that way.

I have been discussing, with Clinical Laboratory Scientist's, what current communication between nursing and the lab is like and how we can improve this relationship. I have been working on trying to standardize blood collection across the continuum. During my research I found out that the Center for Medicare and Medicaid Services (CMS) recently ruled that a Bachelor of Science in Nursing is the equivalent to a Bachelor of Science in Biological Science.

Here is an excerpt from that ruling:

Quote

"Bachelor Degree in Nursing: 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 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. "

I don't understand why this was done and would like to learn more. Where better to gather information than here on allnurses? Therefore, I am asking for you to help me in identifying what this all means. Can we wear any more hats? Is this going to put more stress on a career that is already overloaded with responsibility? Does this mean a BSN can be a lab director? Does this mean that a BS in Biological Science can be a CNO, or ICU director? Is this another way of dealing with shortages by trying to combine resources? Doing more with less? Both nursing and the laboratory science field are experiencing shortages. This is a very confusing ruling. (view attached pdf)

I can tell you that the Clinical Laboratory Scientist community is not happy and would like our support. The American Society for Clinical Pathology (ASCP) is encouraging everyone that has an interest to sign a petition to get the CMS to reconsider its decision. For starters the ASCP says a biological science degree requires three to four times more academic science than does nursing. This CMS ruling seems to be a very broad ruling and deserves to be scrutinized. This can cause a rift between nursing and the lab if the reasons for the ruling are not spelled out.

The ASCP Board of Certification (BOC) has been talking with staff from the Centers for Medicare and Medicaid Services (CMS) about this decision. The CMS memo does not provide a rationale or justification regarding this decision. The BOC communications are on behalf of the Board of Governors (BOG), whose member institutions include:

• ASCP (American Society for Clinical Pathology)
• American Association for Clinical Chemistry (AACC)
• American Association of Pathologists' Assistants (AAPA)
• Association of Genetic Technologists (AGT)
• American Society for Clinical Laboratory Science (ASCLS)
• American Society of Cytopathology (ASC)
• American Society of Hematology (ASH)
• American Society for Microbiology (ASM)
• AABB
• Clinical Laboratory Management Association (CLMA)
• National Society for Histotechnology (NSH)

They are taking this very serious so it makes me think it deserves a good looking at. I wonder what the impact will be for nurses. With your help we can formulate what this ruling may mean to nursing and what potential impact this will have. In my limited research I can't find where the American Nurses Association, Nursing Boards, Nursing Unions etc. have weighed in on this subject. I don't think this subject matter has been exposed enough and may not be on their radar yet.

Have you heard about this? Has this affected your job? What do you think?

Survey-and-Cert-Letter-16-18.pdf

[nutella, MSN, RN]

Speaking as someone who looks at these issues from an enterprise risk management perspective, I would be concerned about putting a BSN into a lab role. Unless they meet the qualifications for a MT/MLT/CLS, I would not think that a BSN has the training, experience or competence to do many of the lab tests in the lab. POC testing is another matter.

CMS does not establish the standard of care, and if my BSN/lab tech makes an error in a test with adverse results to a patient, they will be held to the standard of care of a lab professional. I would imagine that the plaintiff could find lots of MT/MLT/CLS willing to testify on the lab standard of care and how a BSN, without additional training or experience, is not qualified and therefore breached the lab standard of care. I would also seek clarification from the state BON that working in a lab would be within the scope of practice and licensure for a BSN.

I agree with you 100% here.

There needs to be evidence that the person is actually able to perform the task, works within standards of care.

[Nerd eNurse, ADN]

No - I do not think that the purpose is for nurses to engage in complexity lab tests.

CMS ruling: 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.

I don't understand the reason for it... especially being so broad... there has to be a reason. If not why even bother making the ruling. You are right, many of the lab scientist are upset and from my point of view it may be justified. I hope you are not upset that I am raising the question? Thank you for the comment.

[LadysSolo]

I have BS in Biology and a MSN in nursing. I can say when I graduated with my BS, I took the ASCP test to work in a lab, and it was not a particularly easy test, although I do not remember it being as difficult as nursing boards (This was in 1979 so memory may be faulty.) Lab technology has changed so much I would never feel capable to work in a lab without a refresher. If they mean in an administrative capacity, maybe. But to actually do all the testing? No way.

[RiskManager]

^^^I worked part time in the hospital lab while in undergrad school and as a paramedic in grad school. I graduated with a MS in analytical chemistry in 1982. I thought it ironic back then that despite my work experience and grad degree, I was not qualified under ASCP policies to sit for the MT exam despite doing the tests on the lab bench for all those years. I wonder if that has changed.

[LMLS]

CMS had a meeting with ASCP and ASCLS to Address it saying it for rural doctors offices and labs where there is a severe shortage of lab personnel and yes they are saying nurses running the actual lab equipment doing QC and Calibration. Performing lot to lots and instrument to instrument studies.

[WCSU1987]

As one who holds both a BS in Biology and a BSN I can state, unequivocally, that the two degrees are not equivalent. Not even close. In my Biology program, I had to take 8 credit hours of REAL chemistry, with lab, 8 credit hours of REAL organic chemistry, with lab, 10 credit hours of REAL physics, with lab plus physiology, microbiology, genetics, bio statistics and a whole host of other REAL science courses. The BSN students at that university had watered down versions of a fraction of those classes. Most BSN nurses I currently work with can barely calculate IV infusion rates. Put them in a lab with real chemical calculations and they would be lost. Centrifuges, micropipettes, mass spectrometers??? There would be blood on the walls,.....literally!!!

I am in support of the Medical Technologist! Can see this going the way as cost saving measures.

Will say though for the BSN in our State the prerequisite required are Chem 1, Chem 2, Bio Genetics, Intro to Physics, Anatomy & Physiology 1 and 2, Statistics, Microbiology, and Pre-Calculus.

[LadyFree28, BSN, LPN, RN]

CMS had a meeting with ASCP and ASCLS to Address it saying it for rural doctors offices and labs where there is a severe shortage of lab personnel and yes they are saying nurses running the actual lab equipment doing QC and Calibration. Performing lot to lots and instrument to instrument studies.

^This may be the MAIN issue to the ruling; Not every area has a complex teaching hospital within a 10-20 mile radius; they MAY have an RN available; if one lived in a rural area and needed an important test result-one would like the results sooner rather than later; I know I would.

The MLT community should pump the breaks; nurses are NEVER going to do their work; if anything, we will continue to run bedside testing as needed and necessary.

[michellerenebell]

I'm an RN and my daughter is a Clinical Laboratory Scientist. She told me recently that this was being floated around. We've both agreed we couldn't do each other's jobs. It makes no sense to us!

[Julius Seizure]

Will say though for the BSN in our State the prerequisite required are Chem 1, Chem 2, Bio Genetics, Intro to Physics, Anatomy & Physiology 1 and 2, Statistics, Microbiology, and Pre-Calculus.

Wow thats more than I was required to have. I didn't need physics, biogenetics, or stats, and only one chem class.

I'm kind of jealous now!

[Nerd eNurse, ADN]

^This may be the MAIN issue to the ruling; Not every area has a complex teaching hospital within a 10-20 mile radius; they MAY have an RN available; if one lived in a rural area and needed an important test result-one would like the results sooner rather than later; I know I would.

The MLT community should pump the breaks; nurses are NEVER going to do their work; if anything, we will continue to run bedside testing as needed and necessary.

Thanks for the comment. The ruling is too broad and if there is a specific reason where there is a need to bend the rules then the lab industry should be involved in the solution. And it should be spelled out in the ruling. I don't like the fact that nurses are going to be doing complex lab testing. We don't even get taught how to properly draw blood and now we are to believe that we will be properly trained to do complex lab testing. I remember being taught how to do ACT testing... I was taught technique but not process. I didn't have a clue as to the process the blood went through or what the machine did other than give me a value. If there is a need for bending the rules I wish the would look at other options. Nurses have med techs and nurses aides. Lab Scientist have phlebotomist. Maybe they can utilize staff within their discipline. I would rather have an accurate lab than a fast lab unless I was dying and the benefits outweigh the risk. Nurses don't need any more liability either. As far as nurses not doing MLT work... nurses are bailing out of bedside nurses in droves for less pay... I personally know some that have left the profession to do other careers.

[NRSKarenRN, BSN, RN]

RN's in homecare frequently perform laboratory tests most often PT/INR and blood sugar testing via glucometer and other testing in agencies/facilities (physician office, outpatient clinics, methadone clinic) that have CLIA waved testing certificate. The CMS language quoted supports that BSN prepared nurses (as opposed to LPN's) have expertise to be responsible for laboratory testing. Of course, BON regs require that RN's have the education/expertise/skill level to perform task.

CLIA Waived Tests:

All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system.

Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed.

Tests Granted Waived Status under CLIA iStat included on list.

MMWR R&R Good Laboratory Practices for Waived Testing Sites

In 2005, CDC, Division of Laboratory Science and Standards (DLSS) (previously Division of Laboratory Systems), published the MMWR Recommendations and Reports on "Good Laboratory Practices for Waived Testing Sites." The recommendations in this report are intended to be a resource for physicians, nurses and others who perform waived tests in sites holding a CLIA Certificate of Waiver. The recommendations were published to promote quality testing, reduce testing errors, and enhance patient safety.

[Nerd eNurse, ADN]

RN's in homecare frequently perform laboratory tests most often PT/INR and blood sugar testing via glucometer and other testing in agencies/facilities (physician office, outpatient clinics, methadone clinic) that have CLIA waved testing certificate. The CMS language quoted supports that BSN prepared nurses (as opposed to LPN's) have expertise to be responsible for laboratory testing. Of course, BON regs require that RN's have the education/expertise/skill level to perform task.

Thank you for the good information! The ruling does not limit highly complex testing to Istat machines. And with the lack of training of nurses on the basics of quality blood drawing(order of draw, invert don't agitate, maximum amount for blood culture bottles, best to draw without a tourniquet... etc.) I have a low confidence level that proper training is or will be done for nurses doing highly complex testing. Some train critical care nurses on how to use Istat machines but not the intricate details of the process. Many times the nurses will rarely do an Istat test and need a quick refresher from someone else that has done one recently. I don't like hoe broad the ruling is. There is too much room for interpretation.