Post-doctoral training of the non-physician doctoral scientist

ELSEVIER

Clinica

Post-doctoral

Chimica

Acta 232 (1994) 33-37

training of the non-physician doctoral scientist M.K. Schwartz

Department

of Clinical

Chemistry,

Memorial

Sloan Kettering

Cancer Center,

New

York. NY 10021.

USA

Accepted 30 September 1993

Abstract Postgraduate training of the non-MD clinical chemist (clinical biochemist) is for the most part ‘on the job training’. There are few formally structured programs to achieve the necessary skills and understanding needed by individuals before he or she can assume the directorship of a modern clinical laboratory. The experience and training must include management, laboratory performance, medical interface, research and education. Keywords: Training;

Post-doctoral;

Clinical chemistry

1. Introduction

A definition of clinical chemistry (clinical biochemistry) is as follows: “Clinical chemistry comprises the study of metabolic processes in relation to their physiological and pathological changes in man and in animals. For this study, the clinical chemist applies the techniques of analytical chemistry and biochemistry to obtain diagnostic and prognostic information about patients and to investigate the evolution of disease and response to therapy. Clinical chemistry is thus a discipline which is inseparable from modern medicine and is implicated in fundamental clinical and pathophysiological research” [l]. If this definition is accepted, the doctoral graduate with a degree in the biological or physical sciences is usually well trained * Corresponding author 0009-8981/94/$07.00 0 1994 Elsevier Science B.V. All rights reserved SSDI 0009-8981(93)05678-8

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in the analytical aspects of clinical chemistry, but is poorly prepared to provide the medical consultation, management and needs of a modern clinical chemistry laboratory. Post-doctoral training of clinical chemists in the United States as well as in most parts of the world occurs primarily in hospital laboratories as ‘on the job training’. There are few formally designated post-doctoral training programs which follow approved training schedules [2]. The American Association for Clinical Chemistry has established the Commission on Accreditation in Clinical Chemistry (Corn ACC) to review and accredit training programs. Corn ACC is cosponsored by the Academy of Clinical Laboratory Physicians and Scientists, the American Chemical Society, the Association of Clinical Scientists and the National Academy of Clinical Biochemistry. In 1992 there were, in the United States and Canada, 23 Corn ACC accredited programs, 20 of which are accredited for post-doctoral training. The emphasis of each program is somewhat different and is related to the interests and qualifications of the teaching staff. Accreditation is granted after review of facilities and qualification of the Director of the program and the staff. The certification of clinical chemists is under the auspices of certifying agencies such as the American Board of Clinical Chemistry (ABCC) and the National Registry in Clinical Chemistry in the United States, the Australian Association of Clinical Biochemists, the Association of Clinical Biochemists in the United Kingdom, The Canadian Society of Clinical Chemistry and other professional societies throughout the world [2]. In the United States continuing education is primarily provided by professional societies such as the American Association for Clinical Chemistry through local, regional and national meetings, the Clinical Ligand Society, the National Academy of Clinical Biochemistry, the Association of Clinical Scientists, the Academy of Clinical Laboratory Physicians and Scientists and the College of American Pathologists. Licensure of Clinical Chemists is required by many states and requirements for a Laboratory Director have been clearly defined in the recently implemented Clinical Laboratory Improvement Act (CLIA 88). Under these regulations the non-MD director of a laboratory performing moderately complex tests or those of high complexity must “hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified by an approved board in one of the laboratory specialities” [3]. Until 1 September 1992 board certification may be replaced by 2 years of laboratory training or experience and 2 years of experience directing or supervising high complexity testing. In the United States hospitals are also regulated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In their regulations “Clinical laboratory services are under the direction of a physician or a doctoral scientist who is qualified by virtue of documented training, expertise and experience to assume professional, scientific, consultative, organizational, administrative and educational responsibilities for the facilities and for the services rendered. In a hospital where the director of clinical laboratory services provides clinical consultation and or medical opinions, the director is a physician and preferably a pathologist” [4]. In an interpretation of the last sentence the Joint Commission has defined “clinical consultation as the interpretation, evaluation and application of test results in diagnosing and treating a particular patient. By this in-

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terpretation clinical consultation would not include provision to a practitioner of: (a) laboratory test results, (b) normal ranges for test results, (c) interpretive comment describing the probable significance to patients in general of an abnormal result, (d) information about additional laboratory tests that are usually indicated, based on the initial test results and (e) information that a specific diagnosis is for all practical purposes, defined by the laboratory test result (e.g. hemolytic anemia, hypercholesterolemia)” [5]. Training of the doctoral scientist with a degree in chemistry, biochemistry or some related field must clearly include an understanding of the quality assurance process required in the modern clincial chemistry laboratory and an understanding of the necessary interfaces with the physician user of the laboratory and other health professionals. This understanding is required to allow smooth operation of the clinical chemistry laboratory. It is the areas of management, quality assurance and interpretation of clinical chemistry results that must be emphasized in post-doctoral training of non-MD doctoral scientists. In addition training in performance of research oriented to clinical chemistry is essential. This must include research in clinical chemistry (analytical), clinical biochemistry (medical aspects) as well as method and instrument development and evaluation. Many national societies have prepared detailed syllabi for post-doctoral training. Porter and Curnow have proposed for the IFCC a scheme for a 2 year postgraduate course in clinical chemistry [61. 2. Management The doctoral scientist will in most instances serve as the laboratory director and be responsible for the organization of the laboratory, the choice of tests and instruments, the assignment and training of other staff, the preparation of budgets, generation of management statistics and interface and communication with nonlaboratory managers. Management training requires close contact with individuals responsible for these aspects of laboratory operation. It involves attendance at staff meetings, observation and experience in budget preparation and assignments in planning, staffing, review of data and involvement of assessment of turn-around time. The IFCC and the IUPAC have published guidelines for training in clinical laboratory management [7]. It is emphasized in this document that the training must include review of the structure of government regulations in the country or locality where the laboratory is located. The trainee must be well versed in the policies and regulations in the locality where he will work. Regulations if they exist vary widely. The trainee must become aware of the differences in management needs for central routine laboratories, special test laboratories, emergency laboratories and satellite off-site laboratories. A new area for training is in patient point of contact laboratory testing. It is important that the trainee understands workflow organization, laboratory design, space requirements, safety aspects of handling reagents and instruments, but more importantly an understanding of universal safety precautions in handling specimens and in disposal of both infectious and radioactive waste products. This

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Chim. Acra 232 (1994) 33-37

training must be part of hands-on supervised involvement in the day-to-day operation of the laboratory. The trainee should participate and even organize lectures and seminars required for training of technologists. The trainee must be involved in selection of equipment, its evaluations and the methods to be used. A segment of the training must include preparation of procedure manuals, specimen accession logs and in the total quality assurance program of the laboratory. Finally the trainee must be involved in the presentation of data; this is particularly true for computer transmitted data. The IFCC and IUPAC committee on Education have published an excellent guideline for Training in Clinical Laboratory Management. The titles of the syllabus section include: (1) Laboratory planning and organization; (2) Control of operations; (3) Methodology and instrumentation; (4) Data management and statistics; (5) Financial management; (6) Clinical use of tests; (7) Communication; (8) Personnel management and training; (9) Research and development. Proficiency in all of these areas is essential for a Chnical Chemistry Laboratory Director and in essence is a continuing education process. In a field changing as rapidly as clincal chemistry, post-doctoral education is a continual and life-long process. 3. Laboratory performance and clinical interface The post-doctoral training program must include an understanding of fundamental principles of clinical chemistry and clinical biochemistry. This can be accomplished by formal courses or self-education. The trainee must achieve a high degree of practical competence (supervised handson experience) with all tests in all areas of the clinical chemistry laboratory. These should include automated chemistry, ligand assays, chromatography, electrophoresis, atomic absorption spectroscopy, immunoglobulins and specific proteins including electrophoresis, and emergency laboratory techniques including blood gas analysis and ion selective electrodes. In addition training when available should be given in molecular diagnostics (e.g. the use of DNA probes, polymerase chain reactions, receptor and cytokine assays). Much of the clinical chemist’s day is spent in interpretation of results. For this he must have an understanding and knowledge of clinical biochemistry and disease mechanisms. He must be familiar with both analytical and physiological effects on clinical chemistry values and the significance of groupings of tests. This will involve a knowledge of statistics and the ability to compare data and use biostatistical methods including ROC curves and multivariate analysis. The non-MD doctoral clinical chemist must develop an ability to interface without discomfort with his medical colleagues and with other members of the health community. He must learn that he is an integral and important link in providing health care. This can be accomplished by attendance at medical rounds and conferences. 4. Research Research is divided into the development and evaluation of new methods and

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Schwartz / Clin. Chim. Acta 232 (1994) 33-37

37

clinical research related to the understanding of the mechanism of disease as well as the affects of treatment on biochemical pathways. During his training the doctoral scientist must have hands-on experience in both of these areas. The effort must include planning the research as well as carrying it out. The successful clinical chemistry laboratory takes part in these activities and the doctoral scientist must be the keystone in implementing and carrying out research. 5. Education The doctoral scientist must learn to be a good teacher and a good communicator. He must be able to present his thoughts in written material and learn to present his thoughts, ideas and research findings in oral presentations. He must teach technologists and his peers. He should take part and be responsible for formal courses and lectures as well as departmental seminars. He should attend and present material at local and national meetings and read journals devoted to clinical chemistry and laboratory medicine. An excellent approach for review of current material is through a ‘Journal Club’ where articles are reviewed as the journals appear. 6. Conclusion It is essential for the doctoral level clinical chemist (clinical biochemist) to be involved in health assessment, diagnoses and treatment. His or her training must permit participation in medical education, laboratory service, research and presenting new thoughts and ideas for the laboratory’s use of innovative techniques and procedures. Much of this training must be self-taught and motivated. In the United States, and more and more throughout the world, the indicator of success is the ability of the trainee to pass certifying board examinations. However, as more structured programs are introduced it will be essential to review and accredit them. The trainee must know in advance that the training is acceptable to the profession. References

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ISI 161 171

International Federation of Clinical Chemistry Handbook, 1991-1993;5. Schwartz MK, de Cediel N, Curnow DH, Fraser CG, Porter CJ, Worth HG. Definition of the terms certification, licensure and accreditation in clinical chemistry. J Clin Chem Clin Biochem 1985;23:899-901. Federal Register, United States Government Printing Office, Item 493.1443. 1992;57:7175. Accreditation Manual for Hospital. Pathology and Clinical Laboratory Service PA I. I. 1992; I. American Association for Clinical Chemistry, Periodic Report on Government Affairs Issues of Interest to AACC. October 30, 1991, p. 44. Porter CJ, Curnow DH. A scheme for a two year post graduate course in clinical chemistry. Clin Chim Acta 1983;131:351F-359F. De Cediel N, Fraser CG, Deom A, Josefsson L, Worth HGJ, Zinder 0. Guidelines (1988) for training in clinical

laboratory

management.

J Clin Chem Clin Biochem

1989;27:393-401.