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Sažeci 2. Hrvatskog kongresa medicinske biokemije SEKCIJSKA PREDAVANJA Sl/2 QUALITY MANAGEMENT IN MEDICAL LABORATORIES: FACTS AND FABLES J. G. Loeber Diagnostic Laboratory for Infectious Diseases and Perinatal Screening, National Institute of Public Health and the Environment, Bilthoven, The Netherlands The head of a medical laboratorv that considers the question vvhether to take on the implementation of a quality system shoulcl try to ansvver the next questions: 1 Is the functioning of my laboratory adequate, also to the satisfaction of my "customers" (patients, physicians)? 2 If they were given a free choice of laboratories, would they still choose mine? 3 Have I got sufficient ways to measure the total quality of my laboratory? 4 Whenever there is discussion about the correctness of a certain laboratory result, is it possible to reconstruct the whole administrative and analytical procedure? If a definite "yes" can be answered to these and similar questions, the laboratory probably has a running quality system already; if not, it is time to start such a system. This is not an easy task, but it can be achieved provided one should not try to have it finished too fast. The laboratory should be viewed as being a factory with various production processes. Each process should be described and criteria formulated for the necessary personnel, means and infrastructure. At the same time it should be considered how these criteria may be checked. Several guidance documents to set up and maintain a quality system have been published in the last 5 years, ali based on the European Standard EN 45001, ISO Guide 25, ISO Guide 9000, the OECD GLP principles. In the Netherlands the CCKL Code of Practice has found a wide-spread use in this respect. For each subject (e.g. personnel, technical infrastructure, sampling, analysis, reporting, etc.) a standard has been formulated by following an explanatory paragraph and minimal requirements. The Code of Practice is applicable to any kind of medical laboratory After initial development of a quality system it should be updated regularly This updating is more easily achieved by choosing a modu- 30 BIOCHEMIA MEDICA god. 6, br. 1, 1996.
SEKCIJSKA PREDAVANJA Sažeci 2. Hrvatskog kongresa medicinske biokemije lar approach: a small and simple quality manual with a variety of annexes concerning method descriptions, calibration and maintenance data, laboratory report forms, etc, rather than compiling one large document. It is advisable to appoint a staff member or a chief technician as quality manager. There should be close collaboration between the quality manager and the head of the laboratory to convince ali personnel of the need of implementation. Not only does the paperwork take time, but also this important mental turn around process unfortunately cannot be circumvented. The quality manager is in charge of regular internal checks. After it has been demonstrated that the system functions satisfactorily, application for some form of accreditation may be considered. BIOCHEMIA MEDICA god. 6, br. 1, 1996 31
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