Guidelines (1988) for training in clinical laboratory management

Trainees in laboratory medicine must develop skills in laboratory management. Guidelines are detailed for laboratory staff in training, directors responsible for staff development and professional bodies wishing to generate material appropriate to their needs. The syllabus delineates the knowledge base required and includes laboratory planning and organization, control of operations, methodology and instrumentation, data management and statistics, financial management, clinical use of tests, communication, personnel management and training and research and development. Methods for achievement of the skills required are suggested. A bibliography of IFCC publications and other material is provided to assist in training in laboratory management.


Introduction
The scope of the disciplines that comprise laboratory medicine has expanded significantly in the last three decades. The range of quantities assayed and the variety and complexity of analytical techniques used have substantially increased. The turnaround time from the submission of a specimen to the receipt of a result has decreased and the performance characteristics of analytical procedures have continuously improved.
Simultaneously with these changes, the clinical use of results has also altered. Most results from patients in hospitals are used for management rather than as aids to diagnosis. Frequently, laboratory tests are performed prior to the actual clinical examination. In certain countries, the monitoring of apparently healthy individuals makes use of laboratory test results in preventative medicine. Hospital practices also have changed with significant ramifications for laboratory services; for example, more severely ill patients are being treated in specialist units such as intensive care, neonatal, coronary care and oncology units. The changing spectrum of disease, for example the growing number of patients with acquired immunodeficiency syndrome, also imposes new demands on laboratory services. Hence laboratory medicine is not a static discipline and undoubtedly changes will continue to occur, probably ever more rapidly as time progresses. For this reason and because, with the current worldwide concern about the costs of health care, modifications and improvements in laboratory services will probably need to be introduced without significant new expenditure on staff or equipment, it is beholden upon trainees in laboratory medicine to develop adequate skills in laboratory management. This document is intended to serve as guidelines for training in this important area. It is suggested that the guidelines will be of value to laboratory staff learning management skills, directors of laboratories responsible for training staff in management and professional bodies wishing to generate guidelines appropriate to their national needs.

Scope
Although a considerable amount of knowledge about laboratory management is gained by experience, it is vital, particularly for those likely to become directors of laboratories, to learn both theory and application in an ordered and systematic manner. The qualifications regarded as necessary prerequisites for appointment as a laboratory director differ from country to country but, irrespective of this, the syllabus detailed here is designed to fulfil the needs of both medical and science graduates.
Before commencing in-depth training in laboratory management, an adequate basic training must have been gained; ideally, for clinical chemists, the material detailed in the previous recommendations of the Committee/ Commission on a scheme for a 2-year postgraduate course in clinical chemistry should have been assimilated.
It is particularly important that the science graduate is familiar with the clinical and interpretative aspects and that medical graduates have sufficient understanding of laboratory techniques before undergoing the training detailed in these guidelines. 3.1.4. Strategies for organization of the laboratory; benefits and disadvantages of discretionary and profiling approaches, problems associated with biochemical screening, analytical equipment operated by non-laboratory personnel outside the laboratory (including local regulations, medical requirements, equipment and range of analyses available, training of analysts and quality assurance).
3.1.5. Organization ofworkflow, including the collection and transportation of specimens; identification of specimens and samples using colour codes, unique numbers, bar codes and other methods, distribution of specimens throughout the laboratory, work simplification techniques, referral of specimens to other laboratories.

Syllabus
The subject material to be included in the training programme is organized under the following headings:

Control of operations
All aspects of laboratory work should be monitored with the aim of always achieving the highest possible quality of performance. This implies that a quality assurance programme must be established, including internal quality control, participation in external quality assessment and a series of monitoring schemes specifically designed for other aspects of laboratory work, including the materials used, specimens submitted, staff morale and skills, reporting systems and turnaround times.
Training in laboratory management should therefore include the following: 3.2.1. Establishment of comprehensive internal quality control programmes, participation in quality assessment schemes, the availability of such schemes, analysis of the data generated in the assessment of imprecision, inaccuracy, linearity and other performance characteristics, the use of such data in method and instrument selection.

Methodology and instrumentation
Correct selection and use of methodology and instrumentation are of vital importance if the laboratory is to play a full role in the provision of optimal health care; adequate training therefore must be provided in the following:

Financial management
In addition to gaining a basic understanding of budgetting systems, especially those adopted locally, an awareness of the following must be gained:

Clinical use of tests
It is of vital importance that senior laboratory staff are able to advise the clinician not only on the selection of the most appropriate tests and the interpretation of results, but also on the nosological characteristics of the tests.
Moreover, the ability to discuss the introduction of new tests and the phasing out of obsolete tests with clinicians must be gained, as must the knowledge to be able to develop efficient and effective strategies for the use of the laboratory. Training should therefore cover the following topics: 3 3.9. Research and development Although most individuals who are in the final stages of training for a career in laboratory management will have 102 performed some research and development work, it is essential that adequate skills be gained in the following: 3.9.1. The ability to develop improvements in methods and techniques, to evaluate proposals for both laboratory-based and clinical research projects and to evaluate published work critically. 3.9.2. Analysis and documentation of results obtained through research and development, presentation of results in lectures, seminars and workshops, oral and poster presentations at conferences, congresses and meetings and the preparation of scientific papers.
3.9.3. Preparation of requests for grant funding, development ofproposals forjoint research projects, role of committees on ethnics of research.
3.9.4. Supervision of junior staff and students in the day-to-day performance of research and development projects.

Achievement of skills
As stated earlier, a considerable amount of knowledge on laboratory management will be accumulated through experience; however, it is advisable, if possible, for trainees to attend local or national courses that deal with the more general issues of management, for example, personnel and finance.
These courses often have participants from a number of disciplines which enhances their value.
Visits to other laboratories should be undertaken and a spectrum of types and sizes should be studied during the training period in order to assess both the common and different management problems and view the different approaches to solving problems. Indeed, attainment of the skills required may necessitate the trainee being formally employed in different laboratories or being seconded for appropriate lengths of time to laboratories of different types.
Ideally, much of the training in laboratory management should be performed in a large tertiary care teaching hospital laboratory where a large repertoire of tests are performed on a wide variety of specimens from patients with a broad range of clinical conditions. This will facilitate review and tutorial sessions with a number of senior members of staff with different qualifications, backgrounds, interests and experience. Moreover, in such laboratories, there is likely to be a cohort of individuals in training which facilitates learning by, for example, the setting up of discussion groups, interactive solution of problem-solving exercises and simple peer pressure. In addition, it is easier in these situations gradually to give the trainee increasing responsibilities and management functions.
It is considered unlikely that a full-time didactic course in laboratory management will be a satisfactory educational vehicle. A part-time course of, for example, one evening or day per week over year would have advantages; the number of participants should be limited to ensure educational effectiveness.
An important component of the advocated training in laboratory management is the performance of relevant project work. Circumscribed projects, for example, on the selection of a new instrument, preparation of a budget for a section of the laboratory, assessment of a new clinical test in collaboration with a clinician, would provide useful exercises during training. A summary project, of potential benefit to the laboratory of the trainee, could be a study reviewing the management of the laboratory in which the trainee is employed.
It is most important for the head of the laboratory to ensure the availability of adequate resources for training in laboratory management, to encourage the development of managerial skills and to involve the trainee (even as an observer) in the real decision-making processes of the laboratory.
Laboratory medicine is continuously and rapidly evolving, and therefore the syllabus detailed in these guidelines should not be regarded as inflexible, but should be modified as changes in practice occur. Moreover, in different countries, there are diverse approaches to laboratory management of laboratories and these guidelines should be modified locally as deemed necessary; professional bodies are considered to be ideal groups to perform such changes.

Bibliography
There are no texts which satisfactorily cover all of the material outlined in the syllabus. should be familiar to those embarking upon in-depth training in laboratory management and are therefore not included in the bibliography.