Sažeci 2. Hrvatskog kongresa medicinske biokemije - Klinički zavod ...

Sažeci 2. Hrvatskog kongresa medicinske biokemije
SEKCIJSKA PREDAVANJA
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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.