Initially genetic disorders were all considered as rare
diseases. At present, in the mid of 2009, the OMIM catalogue
contains information on more than 12 000 entries of which about
2500 are available for clinical testing based on the identification
of the responsible gene defect. However, altogether it has been
estimated that about 8 percent of a population in the economically
developed countries will during their lifetime suffer from a
disease mainly as the result of their genetic constitution. Adding
to that, it is estimated that all diseases have a genetic
component, which will determine who will be at a higher than
average risk for a certain disorder. Further it is postulated that
in the near future, this genetic profiling could become useful in
selecting an appropriate therapy adapted to the genetic
constitution of the person. Thus, genetic disorders are not
rare.
Measuring quality of health care related processes became an
issue in the 1990s, mainly in laboratory medicine, but also for
hospitals and other health care systems. In many countries national
authorities started to implement recommendations, guidelines or
legal procedures regulating quality of health care delivery. In
laboratory medicine, in parallel, the use of accreditation as a
method assuring high quality standards in testing came in use. With
the increasing possibilities of performing molecular genetic
testing, genetic laboratories needed to become involved in this
process.
As many genetic disorders are rare, most laboratories worldwide
offered analysis for a specific set of disorders, and, therefore,
very early on a transborder flow of samples occurred. While
international quality criteria (ISO) have been in existence for a
number of years, the regulation of quality issues still may differ
between countries.
Based on their personal experience in the varying fields of
quality research and clinical implementation of quality criteria in
genetic services the authors of this book share their experience
and give examples of the implementation of quality issues in
national quality systems worldwide. This book, which is the result
of the effort of many persons, is destined to aid laboratory
managers and counsellors, health care managers and other
stakeholders in national or international health care service to
improve the services to the benefit of patients with suspected
genetic disorders.
General
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