[Quality management and outcome--pathology sets an example].

Abstract

The implementation and further development of a quality-management system with regard to structure, process and outcome (the established dimensions of quality) are complex tasks. Thus, it is necessary to guide structures and processes according to the quality of their outcome. In this context, outcome indicators defined as measurable parameters to predict adverse events are the critical factors of success. The definition of quality indicators with regard to medical performance is extremely complex, representing the greatest barrier for the establishment of quality control; a human factor, the "natural" resistance against being measured, poses an additional problem. Pathology has always acknowledged the importance of documentation, measurement, and evaluation of defined criteria. Autopsy protocols are the equivalents of outcome reports of medical performance based on specific medical indicators. This principle is also valid for the currently pre-eminent part of pathology activities, i.e., the diagnostic examination of cell and tissue samples from hospitals and out-patient centers. The Institute of Pathology, University Hospital Dresden, has taken these requirements into consideration in its decision for certification according to DIN EN ISO 9001:2000. A critical principle was the adherence to external and internal quality-assurance measures, i.e., the definition of quality indicators including systematic documentation, statistical analysis, and critical evaluation of the content. The first results are encouraging and confirm not only the feasibility of the ambitious project, but also (and principally) the benefit for the institute and its personnel and more so for the patients.