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Abstract |
The Preanalyical Phase - Can the Requirements of the DIN-EN-ISO 15189 be Met Practically for All Laboratories? A View of the "German Situation" |
This article describes practical problems in carrying out witness audits in terms of the international normal ISO 15189, with special regard to the situation in medical diagnostic laboratories in Germany. The presence of central laboratories – for example in hospitals – and decentralised laboratories – usually in the private sector – present different problems, especially in terms of the preanalytical phase and its control during witness audits for laboratories accredited according to ISO 15189.
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