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Background
The role of nurses in health care is increasing nowadays. They help in prevention, primary and secondary special care, and provide education. Having different positions based on qualifications shapes the nurses duties and their potential. Registered nurses (RNs) perform fewer procedures than nurses with a bachelors degree (BSN). Masters degree nurses (MSNs) are capable of self-management and many close to therapeutic functions. The functionality of nurses with different qualifications relates to laboratory tests. Centers for Medicare and Medicaid Services (CMS) believe that BSNs can perform tests of high complexity (American Society for Clinical Pathology [ASCP], 2022b). ASCP has challenged this decision due to the lack of complete consistency between Clinical Laboratory Improvement Amendments (CLIA) and the program for BSNs.
Discussion
The laboratory technician program has years of training in laboratory test standards related to human bodily fluids. The tests developed for laboratories are governed by a list of certifications and federal quality standards. It is based on the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which aims to provide patients with reliable and accurate diagnostic results. CLIA is responsible for evaluating tests and test systems for risk and complexity. It forms the rules for evaluating clinical laboratories, specifying how many procedures and testing they can perform (Clinical laboratory improvement amendments [CLIA], 2022). Differences in laboratories translate into hiring staff that are qualified in one way or another to perform testing.
Competencies such as analytical, quality control, and cognitive ability memory are needed in clinical diagnostics. All of these together make it possible to work as a laboratory medical technician (MLT) after completing higher education. MLTs receive a national credential and qualification from working in a clinical laboratory and then qualify for a higher degree and position. During their training, students focus on many practical jobs, including working as laboratory technicians in colleges or laboratories. Consequently, MLTs focus entirely on gaining education in applying clinical biomedical knowledge to practice with tests.
MLTs are the employees of clinical laboratories, performing assays of varying levels of complexity. It depends on the skill level, position, abilities, and desires. CLIA standards imply highly specialized training for technicians, requiring them to comply with legislation and its requirements (American Hospitals Association, 2022). These include storage times for laboratory equipment (coverslips and test tubes are stored for different periods), sterilization conditions for equipment, and ways to handle different automatic analyzers. The standards are in the public domain, which allows anyone to get an idea of the duties of the MLT, but in practice, it is not enough to work in the laboratory and perform complex analyses.
A recent CMS decision establishes that BSNs can work as laboratory technicians. Specifically, CMS believes that BSNs can perform simple and complex lab tests at the same level as MLTs (A proposal rule, 2022). This decision seems unreasonable, but CMS probably has reasons for making this assumption. An important factor is the severe MLT shortage that began during the pandemic. The number of PCR tests for coronavirus and specific microbiological assays has increased several-fold over the past two years. Clinical laboratories were required to increase the workload for each staff member (Gohar & Nowrouzi-Kia, 2022). Senior positions and directors were brought in to handle the total workload of the laboratories. The current workload has decreased, but the pandemic has led to burnout in the workplace, and many MLTs have chosen to leave extensive studies. The pandemic has increased the focus on diagnostic problems and improved laboratory testing (Gohar & Nowrouzi-Kia, 2022). The number of laboratories increased, and requirements may have decreased as staff shortages were felt.
Another justification for this CMS decision is the development of BSN career opportunities within clinical diagnostics. Nurses diagnose critical patient problems, risk factors, and imaging abnormalities (A proposal rule, 2022). They have a role in identifying external and internal abnormalities that can be modified through care and nursing. Based on this, CMS decision to expand capacity seems logical. However, without the programs and advanced training provided, it does not make sense because it will not fix the problem of the increased burden on clinical laboratories.
American society for clinical pathology is challenging CMS proposal decision. Comments on the BSN expansion proposal should have ended by August 25, but ASCPs request to extend the discussion period was lengthened by a month. ASCP believes this is the wrong tactic because it will hurt clinical laboratory diagnosis by making it simplistic and stilted (ASCP, 2022a). More than 16,000 urgent messages have been sent to CMS asking them not to accept the BSN proposal in labs. ASCP said this proposal raises many questions because CMS rationale does not seem strong enough. CMS does not fully address BSN qualification issues, even though the amount of laboratory diagnostic work and knowledge for nurses is significantly less than for MLTs. BSNs also do not get enough semester hours and courses for the entire academic and practical base they need to perform on complex tests. Conversely, CMS indicates that nurses perform testing and diagnosis on the job in specialized clinical settings (A proposal rule, 2022). The proposed rules would allow the inclusion of BSNs in complex diagnostic processes, including testing for complex diseases.
ASCP state that including BSN in laboratory diagnostics will not lead to improved staffing shortages and quality control. On the contrary, it may lead to additional consequences due to BSNs limited academic training and inability to act independently and effectively as they do in daily nursing practice. ASCPs believe that with the introduction of such a rule, they would have to revise the CLIA standards, potentially leading to a violation of patient safety (ASCP, 2022a). CLIA currently identifies tests performed by nurses as deviated tests: meaning that they have no diagnostic relevance and no specific clinical purpose (American Hospitals Association [AHA], 2022). ASCP indicates that the quality control problem will only intensify. Comments are still being accepted on the opposition to the CMS policy.
Argument
Nurses with a bachelors degree complete four years of training, depending on whether they are qualified at the time of admission. BSNs have opportunities to work in an expanded field of medicine, including practice and narrow job responsibilities. The narrow specialties constitute a significant advantage over registered nurses (RNs), which is why many people continue their studies. As part of a BSN degree, students learn how to work independently and specialize in relevant areas of health care, including computer science, administration, management, and severe clinical diseases (Bay Atlantic University, 2020). After earning their degree, nurses can manage care, create new ethical practices, and monitor patient health. They have access to creating specific educational standards and implementing evidence-based practice elements of nursing. BSNs have many more advantages over RNs, including financial opportunities and career and personal growth (Bay Atlantic University, 2020). However, their qualifications are insufficient to perform complex tests, and BSNs must engage in their own activities outside clinical laboratories.
First, as mentioned earlier, the number of hours given to MLS and BSN are different. The BSNs have a general laboratory diagnostic course that meets the requirements of clinical laboratories. They do not have courses in laboratory quality assurance and equipment, as well as familiarity with various analyzers (ASCP, 2022a). They have jurisdiction to take biological material directly for analysis: for example, general and biochemical blood tests, swabbing for microbiology, or virology. Moreover, nurses often learn how to manage care based on the data they have already received. If a patient has edema (both visually and according to tests), nurses recommend dietary habits; if a patient has a high concentration of viruses in the body, nurses provide an increased level of safety. Consequently, the lack of laboratory diagnostic skills within the BSN program is a barrier to implementing BSN in the laboratory.
Second, as health care workers, nurses have a different role: to provide care and comfort to patients. Healing comes when physical, spiritual, moral, and ethical needs are met, and nurses can provide that. It is not their responsibility to prescribe medications and administer specific treatments. As a result, replacing their role with laboratory technicians will result in a shortage of nurses who are specialists in nursing. Changing staff positions will not solve the problem of nursing shortages, and the quality of services will drop significantly (AHA, 2022). Nurses in labs generally make no sense because they cannot perform complex tests and analyze them when MLTs devote all their work time to doing so.
Summary
BSNs have a wide range of capabilities to provide care. At the same time, their qualifications do not allow them to perform complex laboratory testing, so CMSs proposal to include them as laboratory technicians is not justified. The ASCP opposes this decision, pointing first to the lack of qualifications due to the small number of diagnostic courses and, secondly, to the displacement of the nurses role from nursing. ASCP expects that such a decision would undermine CLIA standards, reduce the quality of care, and decrease patient safety. They recommend rejecting the CMS proposal to expand the BSN role in laboratory diagnostics.
References
American Hospitals Association. (2022). AHA to CMS: Proposed rule risks weakening CLIAs high regulatory standards. American Hospitals Association. Web.
American Society for Clinical Pathology (2022a). ASCP members score extension on CLIA rule. American Society for Clinical Pathology. Web.
American Society for Clinical Pathology (2022b). CMS wants nurses to do high complexity testing&again. American Society for Clinical Pathology. Web.
Bay Atlantic University. (2020). Associate degree vs. bachelor degree: Which is a better fit for you? Bay Atlantic University. Web.
A proposal rule: Clinical laboratory improvement amendments of 1988 (CLIA) fees; histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories (2022). Centers for Medicare & Medicaid Services. Web.
Gohar, B., & Nowrouzi-Kia, B. (2022). The forgotten (invisible) healthcare heroes: Experiences of Canadian medical laboratory employees working during the pandemic. Frontiers in Psychiatry, 13. Web.
Clinical laboratory improvement amendments (CLIA). (2022). Centers for Medicare & Medicaid Services. Web.
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