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Quality management

In order to maintain and further improve its high standard in microbiological laboratory diagnostics, the Institute of Medical Microbiology and Virology at the University Medical Center Göttingen has established a comprehensive quality management system (QMS). The QMS relates to all levels of microbiological diagnostics and hygienic-microbiological examinations performed in the department, as well as the services offered in addition.
In terms of content, the QMS complies with the guideline of the German Medical Association for quality assurance of laboratory medical examinations.

The QMS is documented in a quality management manual (QMH). Likewise, all workflows are comprehensively set out and described in procedural instructions (VAN) and all examination procedures performed in standard operating procedures (SOPs). Information relevant to senders is summarized in a service specification.
Internationally recognized guidelines are adhered to or applied, in particular the:

  • Quality standards in microbiological-infectiological diagnostics, published by the specialist group "Diagnostic procedures in microbiology" of the German Society for Hygiene and Microbiology (DGHM),
  • Standards and Guidelines (Cumitech) of the American Society for Microbiology (ASM),
  • Standards and guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST)
  • Specifications of the German Institute for Standardization (DIN EN ISO),
  • Guideline for Hospital Hygiene of the Robert Koch Institute (RKI).

An essential part of quality assurance, in addition to the daily internal quality controls for examination procedures, equipment and reagents, is regular participation in the interlaboratory comparisons (RV) offered in the department (INSTAND, Institute for Standardization and Documentation in Medical Laboratories e.V.) for external quality control:

RV (annual participation)

Bacteriology A (2x);bacterial genome detection (2x); TB/mycobacteriology II, III, IV (2x); mycology (2x); parasitology (2x); bacteriological infection serology (2x); mycological infection serology (2x); parasitological infection serology (2x); virus immunology (2x); virus genome detection (2x).

Another important aspect of the QMS is the provision of comprehensive information for senders and clients on the tests performed and, in particular, on pre- and postanalytics (e.g. sample collection, storage and transport), which is stored in the service catalog on the institute's homepage.

By including all areas and activities of the Diagnostic Department in the QMS, this should ensure a comprehensive QMS (TQM = Totally Quality Management) on an ongoing basis, with the goal of "Good Use of Laboratory Medicine (GULM)".

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