Laboratory testing has evolved considerably over the centuries, particularly in the last few decades, with advancements of substantially complex laboratory methodologies and sophisticated instrumentation interfaced with computers and laboratory information systems. As laboratory services have expanded, so too has the need to improve patient care. Evidence-based and patient-centered care requires more direct patient contact by laboratory professionals with front line roles in healthcare teams consisting of physicians, nurses, pharmacists and other healthcare professionals.

Laboratory Medicine in the 21^st Century

In ancient times, laboratory testing was performed directly by the patient’s physician, most often by examining the most available body fluid: urine. Uroscopy was the examination of the patient’s urine sample in a bladder shaped flask compared to a urine chart.  This also involved tasting for sweetness to determine glucose content. Today, more than 13 billion tests on various specimen types (blood, urine, other body fluids, tissue samples) are performed in the U.S. each year, with approximately two-thirds of all medical decisions directly or indirectly affected by laboratory testing. Medical laboratory professionals perform complex techniques and manage highly sophisticated laboratory automation and state of the art instrumentation.

Medical laboratory technicians (MLT) hold a 2-year associate degree in medical laboratory science or a related field. Medical laboratory scientists (MLS), also referred to as clinical laboratory scientists (CLS) and previously referred to as medical technologists (MT), hold a Bachelor of Science (BS) in medical laboratory science or related science. Most medical laboratory science curriculum programs seek National Accrediting Agency for Clinical Laboratory Science (NAACLS) accreditation. Both degrees include a clinical component/internship.

Upon graduation, these laboratory professionals pursue national professional certification, such as BOC (Board of Certification) from American Society for Clinical Pathology (ASCP) and, in those states with government right to practice, apply for licensure. These professionals are the core of the medical laboratory workforce. Many go on to obtain a master’s degree, as well as several specialization certifications in various laboratory areas, such as molecular biology, microbiology, hematology, clinical chemistry and blood bank/transfusion.

Quality of Patient Care and Sources of Diagnostic Errors

Various studies have been conducted over the years related to laboratory testing and quality of patient care. Laboratory medicine reportedly contributes from 60-80% of medical decisions related to diagnosis and treatment in a patient medical record. The National Academy of Medicine in 2015 estimated that every patient has been, unfortunately, involved in at least one diagnostic error. The total laboratory testing process comprises the pre-analytical (collection and storage of specimens, where 46-68% of errors occur), analytical (laboratory testing, where 7-13% of errors occur) and post-analytical (where 19-47% of errors occur) phases. The accuracy and precision of specimen data at the analytical phase (laboratory testing) is directly and indirectly impacted by variables in both the pre-analytical and post-analytical phase.

However, the value of quality control (QC) and quality assurance (QA) of laboratory testing in expedited turnaround time (TAT) is rendered meaningless if the incorrect test is ordered/re-ordered and the results reported are not read or correctly interpreted. Michael Laposata, M.D., Ph.D., coined the phrase "pre"-pre-analytical phase to describe selecting and ordering the appropriate laboratory tests (before the sample is even collected). "Post"-post-analytical phase refers to establishing the correct interpretation (after laboratory results have been reported).

One survey of 1768 primary care physicians (PCPs) from the Centers of Disease Control and Prevention (CDC) in 2011 showed that PCPs were uncertain in test ordering in 14.7% of cases and uncertain in interpreting test results in 8.3% of cases. Computerized interfacing (CPOE) assists providers with placing orders directly into the hospital information system (HIS). However, more recently, acute attention has focused on physicians and medical staff inadvertently selecting the wrong test from an extensive selection of complex, varied test menus. In addition, researchers noted the follow-up misinterpretation of test results with specialized correlation to disease states. One survey conducted by Laposata of physician staff demonstrated that approximately 75% of cases included some level of test result misinterpretation in the absence of a patient-specific (patient history and relevant clinical studies) and expert-driven interpretation (feedback from an expert familiar with laboratory tests and the clinical conditions associated with the laboratory findings reported).

Reasons for lack of familiarity with laboratory medicine include lack of curriculum in medical schools, as well as the unnecessary defensive ordering of laboratory testing to counteract potential medical errors and lawsuits. Taking into consideration there are over 860 million primary care visits by patients (affecting 84.9% adults and 95.6% children) per year alone, along with over 36.2 million hospital admissions (pre-pandemic), the necessity to find sound solutions that support quality patient care is quite evident.

Development of Diagnostic Management Teams (DMTs)

Reducing/eliminating errors before specimens are collected, as well as after results are reported, leads to positive clinical outcomes with shortened lengths of treatments, along with shortened hospital stays, improved discharges and a notable reduction in financial expenditures. To capitalize on these improvements in patient care, the medical community created the Diagnostic Management Team (DMT), which is composed of diagnostic experts providing much-needed support to clinical colleagues in direct patient contact. Much credit is appropriately designated to Laposata, who pioneered the DMT concept and effectively organized DMTs at major academic centers. DMTs are organized specifically around the disease state, and the experts who contribute are predominantly pathologists and clinical physicians with other interprofessional contributions by nurses, pharmacists and laboratory scientists. The goal is to achieve a faster turnaround time in determining the correct diagnosis and that objective is specifically met through expert team assistance for ordering lab tests and interpreting the results. In its 2015 report, the NAM endorsed the use of expert diagnostic teams by healthcare providers for improvement of patient care.

Today, with the creation of expert-driven algorithms inclusive of reflex testing and updated regularly, DMTs review and manage the use of laboratory testing to prevent both overuse and underuse of tests. Furthermore, the laboratory data released by the laboratory is then compared with the medical record of patients for clinical context of interpretations. Both the time to diagnosis and the accuracy of that diagnosis is significantly improved for patient care. The DMT concept has been successfully implemented in areas such as coagulation, leukemia and lymphoma, transfusion medicine and microbiology and infectious diseases.

Development of the Doctorate in Clinical Laboratory Science (DCLS)

Over the decades, clinical laboratory services and advanced testing have continued to expand tremendously within the healthcare system. With DMTs, focus began to go beyond the acknowledgement of how essential laboratory testing and results are to a responsibility to also contribute more directly to achieving the right diagnosis of patients.

By 2004, NAACLS developed a new advanced practice degree with feedback and input for competencies and curriculum from task forces including representatives from the American Society for Clinical Laboratory Science (ASCLS) and the American Society for Clinical Pathology (ASCP). The NAACLS Board of Directors approved the Standards for Accredited Educational Programs for the Doctorate in Clinical Laboratory Science (DCLS) in the U.S. in 2006. ASCLS has since created the DCLS Took Kit as a resource for educators developing a DCLS curriculum at their institutions.

Rutgers University in New Jersey pioneered the first DCLS, with the first graduate in 2018. University of Texas Medical Branch (UTMB) was approved to offer the DCLS in 2016, with the first graduating class in Aug.2019. The University of Kansas Medical Center enrolled its first cohort in fall 2019.

Based on the prior education and knowledge of a certified medical laboratory scientist, the DCLS curriculum differs from a Ph.D. with broader focus on clinical training. The extensive curriculum includes complex concepts, such as epidemiology, pharmacology and pathophysiology, along with instructional areas in development and application of clinical decision making/critical paths/test algorithms, patient and provider safety, quality systems and medical error prevention. The DCLS curriculum generally is a 3-year, fulltime program (part-time options are available). It combines didactic lectures and practicum/residency at an affiliated clinical site requiring a practice-based research project, as well as teaching and consulting opportunities.

The next phase for the DCLS is the creation of a certification examination. The ASCP Board of Certification (BOC) follows a rigorous process in developing the examination that will be used to certify DCLS graduates. In 2019, the Clinical Laboratory Improvement Advisory Committee (CLIAC) formed a workgroup asking that the Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) revise interpretive guidelines that accreditors follow to include the DCLS as one of the approved doctorates for high-complexity clinical laboratory director (HCLD) positions under CLIA ’88 regulations.

Perspective From a DCLS Professional

One recently distinguished graduate of the UTMB DCLS curriculum is Jennifer Hayes, DCLS, MLS(ASCP)^CM, who (fortunately) managed to complete the clinical internships required prior to the pandemic. She found her calling in laboratory medicine as an entry level phlebotomist and followed a career ladder from MLT to MLS to Laboratory Administrative Director to Laboratory Director of a moderately complex testing facility. As a DCLS, she is now a national laboratory director with extensive regulatory and clinical oversights.

With a compelling passion for the laboratory profession, she is also a strong advocate for the DCLS degree. Hayes firmly believes that "knowledge should not stop at the laboratory door" and conveys how important it is for laboratory professionals to "step out from behind the walls" and "collaborate with peers in healthcare as a team effort." The DCLS is a laboratory liaison is a "critical Lego piece" in total management of patients and quality healthcare.

Although one might expect some pushback and resistance to a new profession, Hayes confirms an overall welcoming reception by medical providers, who embrace and appreciate the feedback and assistance from the laboratory. She sits on a strategic COVID Task Force aiding in the utilization and interpretation of laboratory testing. In particular, with microbiology and molecular diagnostics, she directly contributed to the "speed of healthcare" with savings in time, effort and costs. Under her guidance, review of antigen, antibody and PCR platforms, as well as reflex testing and use of algorithms, has led to streamlining pertinent orders, as well as tailoring reports to assist in digesting the sophisticated data released from the laboratories. All this laboratory feedback aids in the final diagnosis with overall cost savings.

Collaboration of medical professionals, as in DMTs, brings medical experts to the table. The education and knowledge of the DCLS laboratorian contributes immensely to detection, diagnosis and treatment of disease, improving delivery of quality care to patients. The benefits of this team approach are substantial. Brandy Gunsolus, DCLS, MLS(ASCP)^cm, who became the very first DCLS (having graduated from Rutgers) and is now with the Augusta University Medical Center, Department of Pathology states that the DCLS is "currently housed in Pathology-Laboratory Medicine, but like clinical pharmacists, the goal is that every service line would be able to have a DCLS assigned that would ensure the right tests are ordered at the right time and being interpreted correctly within the clinical context of the individual patient."

Healthcare Today and Tomorrow

Today's healthcare continues to be challenged with severe shortages of qualified laboratory professionals. Media attention and public awareness, along with industry support and government legislative lobbying, are all necessary to attract and recruit high school and college students into the field. In addition, this dynamic career is facing the crisis of providing resourceful, supportive environments to retain the highly qualified laboratory professionals needed to perform, manage and maintain highly regulated quality standards of laboratory testing.

While the ongoing COVID-19 pandemic has provided some visibility to laboratory medicine, the profession also struggles with ongoing problem of retention due to burnout from the high volume of laboratory workloads, particularly during the pandemic. The issues of burnout and retention of medical laboratory professionals create a severe shortage of clinical sites where educational programs can place clinical laboratory students for their required clinical rotations.

One outcome bringing increased visibility to the profession is DCLS graduates assuming more direct roles as consultants, educators, administrators and researchers in healthcare. Being directly integrated into the delivery of patient care to assist physicians and the medical community with the appropriate use of laboratory orders and correct interpretation of laboratory results eliminates medical errors, reduces medical costs while improving patient outcomes and brings yet further confirmation of the value of laboratory medicine and the medical laboratory professionals to healthcare. As an advocate for the patient who works alongside other healthcare team professionals, the DCLS is acutely and directly involved in that aiding in the diagnosis, detection and treatment of disease. The DCLS brings the behind-the-scenes laboratory professionals from beyond the laboratory walls and directly to the forefront—to the front lines of healthcare.
 

The authors would like to acknowledge the following individuals for their expert review of this article: Linda A. Smith, Ph.D., MLS(ASCP)BB UT Health - San Antonio, retired Professor Emeritus; Nadine A. Fydryszewski, Ph.D., M.S., MLS(ASCP)^CM, Interim Chair and Professor, Dept. of Clinical Laboratory and Medical Imaging Sciences, Director, Doctorate in Clinical Laboratory Science, Rutgers University, School of Health Professions; Eddie Salazar, Ph.D., MLS(ASCP) ^CM Chair and Associate Professor, Program Director, Doctorate in CLS, University of Texas Medical Branch, School of Health Professions, Depts. of Clinical Lab Sciences and Pathology; and Jim Flanigan, CAE, Executive Vice President, American Society for Clinical Laboratory Science (ASCLS).