DOCTORAL EDUCATION IN CLINICAL LABORATORY SCIENCE

Document: DOCTORAL EDUCATION IN CLINICAL LABORATORY SCIENCE
Classification: Position Paper
Date: June 1989
Status: Approved by ASCLS House of Delegates June, 1989

Introduction

In adopting the recommendations on the "Future Directions in Clinical Laboratory Science Education Programs,"1 ASMT has recognized the need for a continuum of education for clinical laboratory scientists culminating with graduate studies at the doctoral level. Specifically, it is recommended that the doctorate degree be the terminal degree by the year 2000, that institutions be urged to encourage and assist faculty in pursuing doctoral level studies, and that appropriate institutions develop programs tailored to the needs of clinical laboratory scientists.

In support of these recommendations, a task force was charged with the responsibility to identify available doctoral programs, to assess the needs for additional doctoral programs, and to provide guidelines for development of new doctoral programs in clinical laboratory science.

Clinical laboratory science (CLS) is the application of basic scientific knowledge and skills to all aspects of the provision of laboratory services for the diagnosis, treatment and prevention of disease. The complexity and level of sophistication of laboratory services in health care continues to expand in terms of both technology and application, and now includes increasingly sensitive and specific test methods and systems that extend clinical knowledge beyond the molecular level; complex analytical systems that permit rapid performance systems that bring clinical monitoring into the physician's office and the patient's home; and methods of data analysis that permit derivation of more useful clinical information from raw laboratory data.

In the future the clinical laboratory will combine its traditional function of producing accurate, precise, and timely laboratory results with expanded roles in the management of clinical testing, utilization of testing services, and interpretation of test results. Stronger linkages will be formed between the laboratory service process, including matching the clinical question with test selection, interpreting test results in light of the patient's clinical characteristics, establishing and monitoring institution-specific or population-specific prevalence rates and reference ranges, and assessing validity of test results in terms of the characteristics of laboratory test methods. Clinical laboratory scientists will examine the practices and policies related to test offerings, quality control, selection of methods and instrument systems, definition of reference ranges, and selection of decision levels in light of the clinical consequences of the patient population and cost implications to the institution.

These expanded roles will require new skills and expertise. The establishment of information-driven laboratory data bases and the management and improvement of clinical laboratory information will be central to these new skills. Improving test selection will require the combination of disease prevalence with test characteristics to produce algorithms or test selection protocols; improving the information content of test results will require the establishment of likelihood ratios and disease-specific probability estimates. All will require the integration of knowledge derived from statistics, epidemiology, clinical decision analysis, and other analytic methods.

Doctorally prepared clinical laboratory scientists will be needed to provide the leadership for clinical laboratory science to move into the future. A major role will be as academic leaders who can establish clinical laboratory science as an academic discipline within college and university settings; serve as faculty for CLS programs at both baccalaureate and graduate levels; conduct both basic and applied research to expand the body of knowledge in the profession; provide service to the patient, community, and profession; develop new technologies and methods of testing to improve the quality of health care and the cost effectiveness of laboratory practice.

Doctoral level clinical laboratory scientists will also serve as directors of laboratory sections, associate directors of laboratory departments, and directors of laboratories. They will be responsible for the development, provision, and appropriate use of clinical testing services. They will design new measurement processes and optimize the performance of existing processes. Through transformation of testing data into clinical information, they will provide unique expertise to the health care team. Through clinical liaisons, they will provide consultation regarding the use of clinical information, will monitor the changing clinical needs and requirements for further optimization and development of laboratory services, and will be stimulated to perform clinical research studies.

Presently there are forty-four master's level programs in medical technology or clinical laboratory science, and only two doctoral programs designed especially for clinical laboratory scientists. Northeastern University in Boston offers a Doctor of Philosophy in Biomedical Science, with a concentration in Medical Laboratory Science. Catholic University of American in Washington, D.C., offers a Doctor of Arts in Medical Technology.

It is apparent, then, that there is an undersupply of advanced programs in clinical laboratory science particularly at the doctoral level. This need is further reinforced by data published in 1986 by the American Society of Allied Health Professions Survey of Institutional Members. In 37 United States academic health science centers, it was found that the highest earned degree for medical technology faculty members were as follows: baccalaureate degree, 18 percent; master's degree, 60 percent; doctoral degree (Ph. D., Ed. D), 21 percent. Therefore, most clinical laboratory science faculty do not hold doctorates when compared with traditional academic disciplines where most if not all faculty are doctorally-prepared. This situation creates difficulties for faculty promotion and tenure, as well as the advancement of the profession.

Undergraduate education in clinical laboratory science provides individuals who have broad generalist skills and knowledge of the many different disciplines within clinical laboratory sciences. Graduate education is available in some of the different disciplines and provides specialists in each of those disciplines. These specialists, once established in their separate disciplines, may no longer choose to identify themselves with clinical laboratory science per se, resulting in a loss of future researchers, educators and leaders.

Graduate education is also needed to develop expertise across disciplines and central to all of clinical laboratory science. Such areas include: monitoring the quality of laboratory results; development of both simple and complex testing systems; transformation of laboratory results into useful clinical information; planning, managing and delivering effective and efficient laboratory services; and education of clinical laboratory personnel at all levels.

Doctoral programs in clinical laboratory science may be developed via two different paths:

xThe word "clinimetrics" was first used in 1083 by Alvan R. Feinstein of Yale University School of Medicine to describe "quantitative methods in the collection and analysis of comparative clinical data, and particularly with improved 'measurement' of the distinctively clinical and personal phenomena of patient care."4 The application of clinimetrics to laboratory science was developed by the faculty of the University of Wisconsin-Madison who have given permission to use their concept for this position paper.5

Essential to the success of doctoral education for clinical laboratory science is program consistency with the character and mission of the academic institution. Ideally, institutions planning to offer doctorate studies should be universities with a strong research mission and established doctoral programs in related science and clinical disciplines. The research mission supports an atmosphere of scientific inquiry and embodies a commitment to the resources necessary to carry out the investigative activities that comprise the foundation of doctoral education.

A setting with established graduate programs in health professions may be preferred, but the absence of such graduate programs should not negatively affect the implementation of a doctorate in clinical laboratory science, so long as the needed resources are available to operate the program. Such resources include, but are not limited to, a faculty that is doctorally prepared and qualified to teach and supervise doctoral-level research, a library with all the services and materials necessary to support research activities of both students and faculty, suitably equipped research space, financial aid for graduate students, and accessible clinical facilities and materials to support clinical research.

In establishing a new doctoral program careful consideration should be given to the university's view of what doctoral education should be. Doctoral programs are expected to be characterized by academic rigor and depth of inquiry into a specific research question, resulting in students having an extensive and exhaustive preparation in a limited area of inquiry. Therefore, the curriculum needs to be structured in a way that study in the discipline is narrowly focused, and avoids redundancy, while still allowing for application in the broad context of the profession.

The required uniqueness of a doctoral program is of concern when proposing a new graduate program. In universities without academic health centers or medical schools, the specialty model for graduate studies in any of the disciplines of clinical laboratory science may provide that uniqueness. In universities with academic health centers or medical schools, often there are established doctoral programs in biochemistry, clinical chemistry, microbiology, immunology, pathology, molecular biology and other disciplines related to clinical laboratory science. The proposed graduate model with a "clinimetrics" core provides a unique focus, yet has application to all the disciplines of clinical laboratory science.

Opposition to proposals for new graduate programs in clinical Laboratory science may be expected, especially from related program areas. Yet, the institution that offers these related graduate programs may also provide the best environment for a doctoral program in clinical laboratory science. The challenge is to structure a CLS doctorate on a unique foundation, such as clinimetrics, and allow for research application in the traditional laboratory disciplines, as well as clinimetrics itself.

Clinimetrics is the application of scientific and epidemiological principles to the design, development, operation, and management of clinical measurement processes. The name is derived from its similarity with "chemometrics", which has emerged in recent years as a new discipline in the field of chemistry.

The central focus of clinimetrics is the clinical measurement process. That process is applicable to all laboratory testing and all specialty disciplines. That process includes the acquisition of clinical measurements, validation of the quality of measurement data, and transformation of measurement data into clinical information. Clinimetrics is therefore concerned with all aspects of the process, including:

• what test measurements distinguish health from disease and are useful for diagnosis, monitoring, and prevention of disease;
• what requirements must be met to provide clinically useful information;
• how these requirements are translated into quality specifications for the process;
• what specimens and conditions are best for sampling;
• how samples are processed to stabilize analytes of interest;
• what measurement procedures provide clinically useful data;
• how reliability of the measurement data is assured via internal quality control and external quality assessment procedures;
• how measurement data are collected and stored;
• how measurement data are transformed into clinical information;
• how clinical information is best utilized, and
• how measurement decisions affect patient, institutional, and cost consequences.

Clinimetrics, through its process focus, provides a new approach for studying clinical laboratory science. It emphasizes the principles and theory needed to design and develop new clinical measurement processes and to optimize the performance of existing processes. It provides the tools, techniques, and skills to manage the operation of clinical measurement processes.

The study of clinimetrics can provide a strong emphasis on the clinical aspects of the testing process, considering both the tests that are useful in a given patient/disease state, as well as how the test data should be interpreted and utilized. The process orientation provides a solid background for the technical management of clinical testing processes, even those occurring outside the boundaries of the central laboratory. Clinical laboratory scientists will have the expertise to manage the technology, not just the expertise to perform laboratory tests. The image of the profession will be that of managers of testing processes, not doers of tests.

Doctoral studies having a clinimetrics core will equip laboratory scientists to deal with the future needs of health care laboratories. Laboratories of the future will need scientists who can bring new technology into proper use, assure the quality of measurement data and provide clinically useful information for patients and clinicians.

• The graduate curriculum should be based on the principles and theory that are related to the steps in the design, development, and operation of a clinical measurement process which include the following:
• understanding medical needs for laboratory tests; selecting tests based on patient needs (state of health, symptoms, etc.); determining analytical requirements and specifications for performance;
• selecting and sequencing diagnostic tests that meet medical needs; developing new diagnostic tests; validating medical utility; evaluating tests for their intended application;
• selecting and evaluating measurement procedures and systems to include instrumentation, electronics, microprocessors, measuring approaches for bioanalysis; evaluating instrument and system performance;
• monitoring and maintaining the performance of a testing process to include reference materials and methods, statistical quality control, external quality assessment and proficiency testing, governmental and regulatory requirements, quality management;
• providing clinical information based on test results to include clinical correlation with disease processes, reference value studies, likelihood ratios, clinical decision making, laboratory data processing, artificial intelligence applications, modeling of biochemical and physiological systems;
• managing the quality of services to provide the improvement necessary to satisfy changing medical needs and requirements to include quality assurance, quality improvement, tools and techniques for problem solving groups, quality planning.

A core group of courses can be provided to teach advanced courses in the principles and theory involved with these steps, for example: principles for selection and evaluation of diagnostic tests for medical use; approaches for development and evaluation of diagnostic tests; electronics and instrumentation for laboratory measurements; measurement techniques for bioanalysis; principles of statistical quality control; laboratory computing and medical informatics; modeling and simulation of biomedical systems; clinical decision making; quality management for health care laboratories. Core curricula at different institutions would be expected to differ, based on the faculty interest and expertise, the strengths and resources of related programs, and research areas being developed.

Advanced training in a specialty area can build on this core by providing advanced clinical courses, complementary course work in related departments, an advanced clinical internship, and a basic research project in a specialty area of clinical laboratory science or in clinimetrics itself. The specialty areas that can be studied will depend on the interests and expertise of the faculty, but potentially could extend to all the specialty areas of the field.

Clinimetrics provides an innovative curriculum for graduate study. The course work will complement existing curricula in specialty departments and should be of interest to other graduate students as a minor subject area. Improved computing skills and expertise will be an essential part of providing the tools and techniques for designing, developing, and operating clinical testing processes. Advanced clinical courses and experiences provide opportunities for applying the principles, theory, tools, and techniques in different specialty areas. Research studies will provide opportunities for developing a deeper knowledge of selected aspects of specialty areas of the clinical testing process itself and will contribute to the knowledge base in clinical laboratory science.

The clinimetrics model fits well in ASMT's support of career laddering. A salient feature of clinimetrics is that it is built upon the generalist background of Clinical Laboratory Scientists at the baccalaureate level. It is that broad background that permits application to the various specialty areas of the laboratory.

In the future and at the undergraduate level, a broad background in science will continue to be needed, including biology, chemistry, physiology, microbiology, and instrumentation. Following these pre-professional courses in the physical, biological, and medical sciences, clinical science courses are required, coupled with appropriate clinical experiences. The "generalist" orientation should continue to dominate undergraduate education.

At the masters level, options will continue to available for knowledge and skills in business and management, clinical aspects of laboratory science, education, and specialist training in areas such as clinical chemistry, clinical microbiology, immunohematology, computer science, etc. Increased demands for business and management training will dominate master's level education, followed by needs for advanced clinical expertise and skills.

At the doctoral level, programs with a specialty emphasis will continue to exist in specialty departments and will continue to provide in-depth study in specialty areas, but they will not formally apply that knowledge to other areas in a health care laboratory. New programs having a clinimetrics core will provide greater transferability of knowledge, skills, and techniques, and will provide a stronger identity for the field of clinical laboratory science.

The success of new doctoral programs will depend on the ability to attract qualified and enthusiastic students in sufficient numbers to assure both visible, high quality graduates and cost effectiveness in program operation. It is anticipated that for the near future there may be only a few CLS doctoral programs available in the nation. Therefore, it will be necessary that these programs be widely supported and publicized within the profession and with undergraduate programs throughout the country, regardless of location of the programs.

To attract students who may be candidates for doctoral studies, faculty in entry-level programs should be alert to students who show promise for graduate studies. Once identified, these students should be mentored carefully to foster their interest in graduate education and should be encouraged to set their sights on the leadership positions that would be possible by completion of a doctoral degree. Their undergraduate course work would be structured to fulfill general entry level requirements of graduate programs, which may require additional courses in mathematics, chemistry, and the like. Undergraduate research projects should be encouraged, as well as supportive course work in research design and statistics. Students should be encouraged to take the Graduate Record Examination upon completion of their undergraduate program, even though they may be intending to spend time working prior to applying for graduate school.

For those institutions offering doctoral programs, it will be necessary to establish liaisons with entry-level programs in other institutions throughout their region and to offer opportunities for promising students to become familiar with their institution and faculty. Cooperation among many institutions will be necessary to identify and nurture that cadre of students who are qualified for and interested in doctoral study in clinical laboratory science.

Given the need for doctoral level clinical laboratory scientists, it is important to support existing graduate programs in clinical laboratory science, both at the masters and doctoral levels.

Because there are only a few available doctoral level graduate programs in clinical laboratory science, it is essential to support the development of new graduate programs in those institutions capable of implementing such programs.

New programs can follow the specialty model or the clinimetrics model. Although program design is highly dependent upon the characteristics of the institution, faculty expertise, resources, and clinical/research opportunities, the clinimetrics model provides a unique program of study to integrate and advance the disciplines within clinical laboratory science. Clinimetrics provides a basis for studying the principles and theory that are important in all specialty areas. It contributes to the development of transferable knowledge, skills, and techniques. It equips the Clinical Laboratory Scientist for dealing with the changing boundaries of the laboratory and new functions of laboratories in the future.

1. Future Directions of Clinical laboratory Science Education Programs. Adopted by the American Society for Medical Technology House of Delegates, June, 1987.
2. Evans Z: Fourth Annual Clinical Laboratory Educators Conference, Dallas, Texas, February 25, 1988. Department of Medical Laboratory Sciences, University of Texas Southwestern Medical Center, Dallas.
3. American Society of Allied Health Professions: Faculty Salary Survey, Academic Health Science Centers, Academic Year 1985-86. Compiled and distributed by the University of Mississippi Medical Center School of Health Related Professions. September 16, 1986.
4. Feinstein AR: An Additional Basic Science for Clinical Medicine: IV. The Development of Clinimetrics. Annals of Internal Medicine. 1983; 99: 843-848.
5. Clinimetrics: A Process Focus for Graduate Education in Clinical Laboratory Science. J.O. Westgard, Sharon S. Ehrmeyer, Arthur A. Eggert, Bret M. Steiner, Medical Technology Program, University of Wisconsin-Madison. February 17, 1988 Draft.
6. Content of Pathology Residency training for the 1990s and Beyond. Sponsored by the Association of Pathology Chairmen, Graduate Medical Education Committee, February 6-8 1987. Park City, UT. Printed in the Newsletter of the Academy of Clinical Laboratory Physicians and Scientists, January, 1988.
7. A Paradigm of Curriculum Design for Educational Programs in Clinical Laboratory Science, Final Draft, October, 1987. Kathy Doig, Chair. American Society for Medical Technology.