The Need for Laboratory Medicine in the Undergraduate Medical Education Curriculum: A White Paper from the Association of Pathology Chairs

Abstract

Considering laboratory results are used to make medical decisions, a fundamental understanding of laboratory medicine is paramount to enhance patient care, optimize health care cost containment, and prevent legal repercussions. With increasing laboratory testing complexity, this education is needed now more than ever. This article is a call to action to have medical schools adequately incorporate practical laboratory medicine content into their undergraduate medical education (UME) curricula. The authors discuss the definition of laboratory medicine, what it encompasses, who uses it and why it matters, and propose that a core laboratory medicine curriculum is a necessary part of UME.

The COVID-19 pandemic thrust laboratory medicine into the worldwide spotlight. New test development for the novel virus required collaboration between clinical laboratories and industry partners. These efforts brought attention to the critical role of laboratory testing in appropriate testing strategies for population health and reopening society.

The academic literature highlights many of the clinical laboratories’ efforts in response to COVID. Recently, Academic Pathology [1], the Journal of Applied Laboratory Medicine [2], and the journal of Clinical Chemistry and Laboratory Medicine [3] published Special Collections on the COVID response, emphasizing the pivotal role laboratories play in prevention, diagnosis, risk assessment, treatment, management, and monitoring of disease during viral outbreaks [3, 4].

However, it is not just during pandemics in which laboratory medicine plays an essential role. In non-pandemic times, clinical laboratories yield objective, actionable data on a daily basis, playing pivotal roles in preventative medicine, risk management, and integrated care, while simultaneously providing benefits for patients, payers, clinicians, and health care systems [4].

Despite laboratory medicine’s critical role in health care, there remains a disconnect between what physicians learn about laboratory medicine in medical school and what they need to know for clinical practice. Unfortunately, errors involving laboratory medicine are not infrequent and are often multifactorial. Perhaps surprisingly, most laboratory medicine errors occur outside of the clinical laboratory. Failure to order the appropriate test and misinterpretation of results are frequent sources of error leading to the inappropriate use of the clinical laboratory [5]. Inappropriate use has far-reaching implications, ranging from increased waste and health care costs, to delayed diagnosis, and sometimes to litigation. As a profession, many of these negative effects are avoidable if physicians are trained to understand laboratory medicine and to consult laboratory medicine professionals when questions arise regarding proper test ordering and interpretation.

Laboratory Medicine in Practice

What Is Laboratory Medicine? Who Makes Up the Laboratory Medicine Team?

Medical professionals have a basic understanding that the clinical laboratory is where tests are performed, but they may not be able to clearly articulate what laboratory medicine is and what distinguishes it from other pathology-related specialties. Laboratory medicine, also referred to as clinical pathology, is “a clinical science and discipline, devoted to the quantitative measurement, or qualitative assessment, of any substance which can be assayed in any type of biological fluid of any animal species, thus including humans, for either medical or research purposes. The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population” [6].

Laboratory testing includes three phases: pre-analytical, analytical, and post-analytical. Table 1 describes the various activities in each phase. The pre-analytical phase consists of all the steps up until the specimen undergoes testing within the laboratory. The analytical phase includes all aspects of performing the test on the sample. The post-analytical phase is everything that happens after the laboratory results are released.

Table 1.

Phases of laboratory testing, activities performed within each phase, and examples of laboratory diagnostic error occurring within each phase

Phase of testing	Activities	Diagnostic errors
Pre-analytical	• Centrifugation (if needed) • Collecting the specimen in the right container • Identifying the correct patient • Labelling the specimen correctly • Ordering the right test • Proper identification of the specimen in the laboratory • Transportation to the laboratory within stability and temperature limits for the tests ordered	• Collection from wrong patient • Collection of specimens (wrong tube, wrong amount) • Contamination of specimens • Delay in testing • Hemolyzed specimens • Inappropriate patient preparation • Knowledge of diagnostic tests (wrong tests ordered) • Loss of specimens • Mislabeling of specimens • Specimen delivery • Storage of specimens (non-refrigeration when required) • Test ordering (inaccurate/incomplete requisition)
Analytical	• Calibrations • Ensuring training and competency of laboratory personnel • Maintenance of equipment • Parallel testing • Proficiency testing • Quality control • Selecting the instrumentation or methodology • Validation of the instrumentation or methodology	• Delay in testing • Failure to comply with standard operating procedures • Lack of quality control • Lack of training of personnel • Mixing up samples • Performance of wrong test • Reference range calculation • Reporting wrong result
Post-analytical	• Calculations • Calling back critical values • Interpretations of results • Provider’s action after receiving results • Storing specimens and laboratory reports for the appropriate time	• Failure to notify physician of results • Failure to order necessary follow-up tests • Improper interpretation of results • Not reporting critical “panic” values • Reporting results from wrong patient • Turnaround time

Laboratory medicine professionals — physicians trained in laboratory medicine and PhD scientists — are supported by a staff of highly trained medical laboratory scientists and phlebotomists to perform the scientific bench work.

The Laboratory’s Customers: Patients and Health Care Providers

Physicians, advanced practice providers, and other health care workers all utilize laboratory services daily. According to the Centers for Disease Control and Prevention, 70% of today’s patient care medical decisions depend on laboratory test results [7]. This reliance on the clinical laboratory was highlighted during the COVID pandemic. Patients and providers, historically, have assumed that laboratory results will be delivered in an accurate, efficient, and reliable manner. With the advent of COVID, everyone across the globe concurrently experienced what it feels like when a new laboratory test needs to be developed, when testing supplies are in short supply, and when test results are not available as rapidly as one would desire.

Perhaps even more critical, many providers experienced the challenge of not fully understanding the characteristics of the various types of laboratory tests available to test for SARS-CoV-2, and how those characteristics relate to patient care. Furthermore, given their reliance on laboratory testing, if a provider does not fully understand the essential pre-analytical, analytical, and post-analytical phases in test performance, they may not appropriately order tests, obtain samples for tests, use tests, or interpret test results.

The pandemic underscored physicians’ gaps in knowledge when it came to laboratory medicine. It is just as imperative for all practicing health care workers to have a fundamental understanding of laboratory medicine as it is for them to have a fundamental understanding of how to perform a history and physical examination. Physicians may not all perform these tasks in their jobs, but the appreciation for these core clinical skills and knowing their own limitations and when to consult laboratory professionals is essential.

Fortunately, laboratory professionals are in the best position to be clinical consultants throughout all phases of laboratory testing [8]. Not only do they routinely consider the pre-analytic variables of a given test, but they generate diagnostic laboratory tests taking these variables into account, such that the analytical phase of testing provides clinical value to the result. Post-analytically, laboratory professionals possess the competency to interpret test results, including when the result deviated from what was expected. They also possess the knowledge to help determine the next step in patient care. Their role is to ensure accurate test performance while simultaneously being able to provide expertise and advice to health care workers on all matters related to laboratory testing.

The Economics of a Delayed or Incorrect Diagnosis

The appreciation of laboratory medicine by health care workers is important for a variety of reasons in addition to patient care. When laboratory tests are inappropriately ordered, used, or interpreted, they have far-reaching implications from an economic standpoint.

In the fee-for-service environment which has dominated for the past decades, health care systems and physicians have been far more focused on revenue generation than on cost savings [9]. As we move into value-based care arrangements, we are challenged to not only live by the new payment rules, but to avoid unnecessary costs to patients and to the health care system broadly. The challenge is quantitating the impact.

Revenue is easy to quantitate. For example, hospitals that brought up SARS-CoV-2 PCR tests had a large positive impact on hospital income statements. Additionally, due to the quick turnaround time, there was a shorter length of stay in the hospital and in the intensive care unit, and reduced use of personal protective equipment. These effects allowed for more elective surgeries and more quantifiable revenue. The savings from a PCR test with less than a one-day turnaround time was quantified by Kaul et al. [10] in their institution, and the savings were greater than $50 million over a period of 10 months. COVID provided an example of the exact type of work that laboratories do daily for a multitude of tests.

Savings on the other hand often go unrecognized or are unable to be quantified accurately. This is because it is difficult if not impossible to determine how much has been needlessly spent when a diagnostic error has been made. Inaccurate diagnoses can lead to unnecessary, expensive treatments or longer hospital stays. For every missed diagnosis scenario, there are multiple commonly encountered outcomes, and, for an individual patient, it is not possible to predict which outcome will occur, nor its associated cost. Similarly, false positive diagnoses inherent to any laboratory test, also dependent on factors outside of the test itself, lead to similar situations. Accurate diagnoses, however, ameliorate these expenditures, even if they are not acknowledged.

Legal Implications of a Delayed or Incorrect Diagnosis

An accurate and timely diagnosis not only has economic implications, but legal ones as well. Many, if not most, patient diagnoses are based on accurate laboratory tests. Diagnostic errors may lead to the wrong diagnosis, no diagnosis, or a delay in diagnosis, and as such have the potential to lead to litigation. In fact, malpractice claims indicate that 34% of payments were due to diagnostic error, including laboratory error [11].

As mentioned previously, laboratory testing is divided into three stages: pre-analytical, analytical, and post-analytical. Error can occur in each phase (Table 1). The least amount of error occurs in the analytical phase (7–13%), while the most error occurs in the pre-analytical phase (46–68%), with mislabeled specimens being a frequent cause [12, 13]. Post-analytical error is reported to occur between 18.5 and 47% of cases [13]. Examples of litigation occur in all three phases [14–17].

As evidenced above, laboratory medicine errors most commonly arise outside of the physical laboratory (i.e., the pre-analytical and post-analytical phases). Lack of formal education in laboratory medicine and the rapid proliferation of diagnostic tests are cited as reasons for pre-analytical error, especially with complex tests, and practice demands leave physicians limited time to obtain relevant laboratory medicine knowledge [18]. Therefore, communication between health care workers and the laboratory is critical in minimizing pre-analytical and post-analytical error. Communication failure leads to error, patient safety issues, and ineffective use of resources [18].

In summary, understanding the principles of laboratory medicine by students and where error occurs has the potential to both generate revenue and save on health care spending, decrease patient morbidity and mortality, and ameliorate litigation.

Laboratory Medicine and the Medical School Curriculum

Current State of Laboratory Medicine in the Medical School Curriculum

Despite the importance of laboratory medicine, its emphasis is lacking in the UME curriculum. A 2015 committee report from the Institute of Medicine [19] recommended that given “the diagnostic process is a dynamic team-based activity, health care organizations should ensure that health care professionals have the appropriate knowledge, skills, resources, and support to engage in teamwork in the diagnostic process.” They further recommended health care professionals collaborate with pathologists (laboratory medicine professionals), radiologists, other diagnosticians, and treating health care professionals to improve diagnostic testing processes. This type of collaboration, however, is often deficient. One reason for this deficient partnership is the mismatch between the presentation of laboratory medicine in UME and its use in everyday practice within health care systems [20].

A 2014 status report [21] on the state of laboratory medicine teaching in US medical schools showed that 84% of medical schools surveyed required coursework in laboratory medicine. Only 18% of those schools required training during the clinical years, with only 11% doing so in a clinical setting versus lectures. Lecture time for anatomic pathology ranged from 61 to 302 h in the UME curriculum, while the median amount of time devoted to laboratory medicine was only 8 h [22]. As such, the majority of laboratory medicine education used in clinical practice is relegated to a more informal curriculum.

Additionally, the latest trends in medical student education include decreased lecture time, increased collaborative instructional methods, and decreased laboratory instruction [23]. The majority (84%) of US medical schools are undergoing curricular changes [24], with schools trending from traditionally discipline-focused courses to those topics being a component of an integrated course. This new paradigm shifts emphasis from the empirical study of basic biochemical modules, such as pathology, towards a clinical relevance and patient-centered focus.

The combination of new topics being covered and a more integrated educational approach risks dilution of disciplines such as pathology, including laboratory medicine, with the net result contributing to misconceptions about the field of pathology and laboratory medicine [25].

Graduating medical students are expected to correctly order the appropriate test or assay from an ever-growing and increasingly complex test menu. Medical students are at an ideal point in their medical education path to benefit from learning a more robust and thoughtful approach to laboratory medicine. They can learn the science of errors in all three phases of laboratory testing, how to optimize the likelihood of receiving a biologically relevant test result, and to frequently consult experts on test selection and result interpretation.

Formal laboratory medicine education will help to establish laboratory stewardship principles while reinforcing the critical thinking processes needed to establish an accurate diagnosis [20], with the added benefit of stimulating interest in the field of pathology and laboratory medicine. Furthermore, this is in line with the “Choosing Wisely” initiative. The aim of this initiative, started in 2012, is to change physician behavior leading to higher quality care, lower costs, more efficient use of the clinical laboratories, and empowering patients in their health care decisions [26]. “Choosing Wisely” underscores the need for medical students to understand basic principles of laboratory medicine in order to ask questions before ordering lab tests and to respond to patient questions. In fact, the American Medical Association (AMA) House of Delegates recently approved a policy put forth by the Council on Medical Education supporting the “Choosing Wisely” program in an effort “to promote educational resources regarding appropriate test ordering and interpretation” [27]. So how do we address these issues? Fortunately, laboratory medicine can be incorporated into several already existing curricular frameworks.

Entrustable Professional Activities

One such curricular framework is the Core Entrustable Professional Activities (EPAs) for entering residency, which were designed by the American Association of Medical Colleges (AAMC) in an effort to standardize knowledge, behaviors, and skills for the undifferentiated medical student [28]. The EPAs are a road map, recognizing that teaching, learning, and assessment can happen over a longitudinal time period.

The EPAs are divided into 13 core activities, including skills and topics such as gathering a patient history, developing a differential diagnosis, clinical reasoning, documentation of patient encounters, patient presentations, and working in inter-professional teams. Importantly, EPA 3 focuses on laboratory testing. Although laboratory testing is only explicitly stated in EPA 3, laboratory testing underlies, and is part of, many more of the EPAs.

Although the AAMC has developed the core EPAs and provides guidance for evaluating and assessing behaviors at different levels of a student’s progression throughout medical school, each medical school has the opportunity to develop their own implementation assessment methods. Laboratory medicine educators should be included in discussions for implementing EPA 3, as they would be invaluable and able to underscore the need for integration of core clinical laboratory educational activities in the curriculum.

Health System Science

Another UME framework in which to consider laboratory medicine is the Health System Science (HSS) curriculum. This curriculum was designed by the AMA to increase knowledge in medical students practicing in a modern health care environment [29, 30]. Many medical schools are integrating HSS as the third pillar in the UME curriculum. HSS incorporates a system approach of essential medical practice that is necessary for medical students to understand in the context of the challenges in modern system-based practice.

The HSS curriculum focuses on patient-centered care, with all components of medical care supporting the patient. The core domains include health care structures and processes, health care policy, clinical informatics and technology, population health, value-based care, and health system improvement. HSS promotes systems-based thinking to build an integrated systems approach to patient care.

In looking at the core domains of the HSS curriculum, laboratory medicine can, and arguably should, be incorporated into many of these domains. Understanding laboratory medicine is certainly part of the clinical data, particularly considering laboratory data is presented to providers in electronic health records. Timely and accurate access to laboratory data is essential for diagnosis. This was highlighted time and again during the COVID-19 pandemic, where correct and timely access to testing proved essential for population health management.

Value based care also underscores the need for physicians to understand laboratory testing. Ducatman et al. [31] have eloquently described the value of laboratory testing in which they present data showing the small fraction of health care costs due to laboratory testing (2.3% or around $82.7 billion of total health care dollars). This is compared to the nearly two-thirds of total health care spending (63.8% or $1.18 trillion) influenced by the results of laboratory testing. In summary, laboratory testing can easily be included in at least three of the six domains of the HSS curriculum.

Designing a Curriculum for the Undifferentiated Medical Student

Several resources are available to help educators incorporate laboratory medicine into the UME curriculum. One such resource, the Pathology Competences in Medical Education (PCME), developed by over 60 pathology course directors and pathology department chairs as a set of national standards in pathology education based on LCME accreditation standards, was created to highlight foundational knowledge, skills, and attitudes essential for the undifferentiated medical student [32–34]. The PCMEs divide learning goals and objectives into three major competencies: (1) disease mechanisms and processes, (2) organ system pathology, and (3) diagnostic medicine and therapeutic pathology. The PCME learning objectives are broad to allow flexibility for any learning institution to easily adopt and incorporate into their curricula. The level of knowledge incorporated into the learning objectives by the PCME collaborators was felt necessary for the practice of medicine.

The diagnostic medicine and therapeutic pathology competency focuses on laboratory medicine. The very first learning goal under the general principles subdivision is focused on laboratory tests, and states “Apply knowledge of clinical medicine, pathology, and statistics to determine the utility of a laboratory test in making a diagnosis and in monitoring chronic disease management. Explain the interpretation and limitations of clinical laboratory assays.” Specific learning objectives follow on analytical errors, sensitivity and specificity, pretest probability, and others. These competencies do not focus on overly detailed minutiae, rather they are basic things every physician in clinical practice does daily. The PCMEs focus on elements that are or should be common knowledge for the practicing physician, and therefore are essential in the UME curriculum.

Along with the PCMEs, accompanying Educational Cases have been developed and published in Academic Pathology. The cases highlight the level of knowledge expected for the PCME’s learning objectives. Key elements of educational cases include a clinical presentation, diagnostic findings, discussion or questions, teaching points, and references. They provide a straightforward way to present how clinical reasoning is used in evaluating laboratory data to medical students. All educational cases are peer reviewed and are published with open access so that educators can easily find and use them. A table of the published educational cases and the learning objectives which they cover are on the Association of Pathology Chairs (APC) website [34].

There are also other resources and strategies available both in print and online that provide laboratory medicine teaching content (Table 2). One recently published resource is a concise table of the pathophysiology and clinical pearls of common laboratory tests [35]. This publication also references the PCME objective for each laboratory test, which nicely links the above resources.

Table 2.

Strategies to incorporate laboratory medicine into the undergraduate medical education curriculum

Advocate for laboratory medicine in the curriculum to meet accreditation standards and school’s objectives

Advocate for Curriculum Committee membership for laboratory medicine (pathology) faculty

Incorporate a laboratory medicine concept in each clinical case throughout the curriculum

Incorporate the Essential Laboratory Tests for Medical Education list into the curriculum [35]

Develop a laboratory medicine (pathology) bootcamp (intensive elective course) for M3 and M4 students interested in or preparing for pathology residency

Tour of the clinical laboratory, elaborating on turnaround time, reference range, cost of test, potential laboratory error

Develop a 1–2-week elective offered during pre-clerkship or M4 year

Develop a pathophysiology course M4 year, integrating basic and clinical science, laboratory medicine and pharmacology

Utilize virtual courses (e.g., pathelective.com) to integrate laboratory medicine concepts into clerkships

Pathology-related Adaptive Spaced Education, consisting of clinical scenarios and questions distributed weekly via e-mail to improve students’ retention of laboratory medicine concepts [41]

Integrate laboratory medicine cases during clerkship rotations taught by pathology faculty on-line or via spaced education [42]

Advocate for laboratory medicine faculty to participate in medical student clinical rotations, or have laboratory medicine faculty on the diagnostic medicine team

Develop a Mock Trial scenario during pre-clerkship to illustrate laboratory medicine litigation cases [39]

Develop scenarios on how to disclose error (e.g., wrong diagnosis, mislabeled specimen) led by laboratory medicine faculty

Grants for educational scholarship (AMA Changing Medical Education)

Incorporate formative and summative feedback on ability to utilize laboratory tests into clinical rotations and acting internship

Market laboratory medicine professionals as clinical consultants [8]

Utilize Academic Pathology Educational Cases during M3 and M4 clerkships [32]

AMA American Medical Association, M3 third-year medical student, M4 fourth-year medical student

These types of strategies have recently begun to be implemented into undergraduate medical education in practical ways. One example from Emory University [36] was the implementation of a 1.5-day medical student clinical laboratory experience for fourth year medical students in the last month of training. Course effectiveness was evaluated through a short quiz. Though this method could only measure a small amount of recently acquired knowledge, the authors state “it was encouraging that improvement could be observed by fourth year medical students devoting a short period to learning laboratory medicine principles.”

Another example comes from the University of Michigan [37], where a newly designed mandatory 1-week pathology rotation was embedded within surgery clerkship. Most of the students agreed the rotation improved understanding of pathology workflow and its integration into the larger picture of health care delivery.

At the University of Chicago, the topic of laboratory testing and, more specifically, laboratory regulation was introduced into medical student-run free clinics [38]. Medical students became more aware of the role played by local laboratory directors and the value that position brings to patient care. Early exposure of medical students to laboratory medicine increased both formal and informal conversations regarding pathology and laboratory medicine as a career, and educated “both medical students and clinical faculty medical directors about the administrative process and regulatory frameworks governing clinical laboratory testing, as well as reinforcing routinely necessary steps to ensure accurate test results.”

A more novel approach of exposing medical students to laboratory medicine is using mock malpractice trials [39]. This type of courtroom experience can be tailored to the specialty by having lawyers playing the roles of judge, plaintiff attorney and defendant attorney, and clinical pathologists the role of plaintiff. These unique scenarios can give insight into the various ways in which laboratory medicine impacts patient care.

The issue of decreasing curricular time devoted to clinical pathology and the need to implement it in unique ways during undergraduate medical education is not exclusive to the USA. As such, other countries are implementing similar and unique strategies to address this. For example, the Shiraz University of Medical Sciences in Shiraz, Iran, implemented a 1.5-day medical student course [40], similar to that provided by Emory University. This course, however, was given to both pre-clinical and clinical medical students, with similar outcomes of increases in laboratory medicine knowledge on post-course evaluations compared to pre-course evaluations.

The Royal College of Pathologists (RCPath) of the UK has developed innovative programs to increase awareness of pathology. One such program [25] was developed to take advantage of National Pathology Week, an annual celebration of the invaluable contribution pathologists make to health care. A comprehensive curriculum using a public engagement model, which empowers students to learn pathology by teaching the public, was created using primarily RCPath online resources. Medical students and other health-related courses from the University of Exeter were recruited to learn pathology by teaching the public at Exeter National Pathology Week 2016. Post-event surveys showed the students gained knowledge and skills regarding the principles of antibiotic resistance and cancer screening programs, and competent use of microscopes and gram staining.

Since every learner and every medical school curriculum is unique, the currently available resources do not fill the needs of every educator. As faculty, we need to continue to develop user-friendly educational tools that give options to educators and students as they teach and learn about laboratory medicine.

Conclusion

The field of laboratory medicine is much more complicated than it may appear on the surface. The clinical laboratory does not serve as a black box to obtain a test result or receive a diagnosis. Rather, the laboratory is a function of a dynamic medical specialty, one which has a direct impact on the vast majority of patient outcomes.

With the ever increasing and complicated subject matter that must be taught to medical students, as educators, we need to be selective in what we teach students. This debate is not a matter of gaining curricular time. The debate is about appropriately integrating laboratory medicine into the time we already have devoted to teaching students about disease and treatment. If we neglect the integration, then yes, additional time should be added to laboratory medicine training.

Because laboratory medicine applies to, and is intricately involved in, virtually every aspect of medical practice, and given the fact that laboratory medicine is becoming increasingly complicated with the advent of molecular and personalized medicine, learning these basic principles during medical school will help ongoing learning both in graduate and continuing medical education, helping physicians to make more efficient, more meaningful use of the clinical laboratory. In short, we must ensure that every graduating medical student has a basic, functional, and applicable knowledge base of laboratory medicine.

Author Contribution

All authors contributed to the manuscript conception and design. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Declarations

Ethical Approval

Not applicable.

Conflict of Interest

The authors declare no competing interests.

Disclaimer

The contents of this publication are the sole responsibility of the author(s) and do not necessarily reflect the views, opinions, or policies of Uniformed Services University of the Health Sciences (USUHS), the Department of Defense (DoD), the Departments of the Army, Navy, or Air Force.