Our institution was accredited for the first time in 2009 by the former German accreditation body (Deutsche Akkreditierungssystem Prüfwesen, DAP) and successfully reaccredited in 2013 by the German national accreditation body (Deutsche Akkreditierungsstelle, DAkkS) formed in 2010 (‘Pathological-anatomical assessments of human tissues, human cells and body fluids incorporating macroscopic, histological, cytological and immunopathological examinations as well as expert assessments’). As part of the accreditation process, DAkkS defines the workflows for a pathology institute described in the quality management system in line with the requirements of DIN EN ISO/IEC 17020 and, among other functions, monitors compliance with the guidelines published by the German Association of Pathologists and the German Society of Pathology for specialist standards and specialist knowledge of medical and non-medical staff. Accreditation therefore does not simply refer to certification limited to testing compliance with organisational workflows but also formally recognises our specialist expertise in terms of the quality of the organisational structures, processes and results.
The decision to introduce and systematically apply a quality management system in our practice aims to ensure patient-oriented diagnostics that satisfy the highest quality standards. This includes ensuring careful preparation of all tissue samples, some of which cannot be repeated, so that all the diagnostic information contained in this material can be exploited. Efficient, transparent and standardised workflows are also designed to minimise processing time for specimens, enabling rapid turnaround and prompt provision of results.
Along with diagnostic reliability, the internal quality management system also ensures that all equipment including our measurement, testing and processing facilities are based on the latest technology, that strict principles of confidentiality, discretion and data privacy are respected both internally and during the transmission of findings and that all requirements are met regarding the archiving of order forms, written reports as well as histology slides, smears and paraffin material.
To monitor the quality and reproducibility of our lab and diagnostic services based on external standards, every two years or, if it is required by the currently valid S3 guidelines, every year our practice takes part in all relevant interlaboratory comparisons provided by the Pathology Quality Assurance Initiative (QuIP) of the German Society of Pathology and the German Association of Pathologists. Also as part of our external evaluation an external quality assessment slide scheme (EQA) involving our department and the departments of histopathology of the Schleswig-Holstein University Hospitals in Kiel and Lübeck and the Borstel Research Centre has been established. This involves exchanging randomly selected, anonymised cases every six months between all four institutions for critical assessment.
Regular internal audits ensure that the practicability and efficiency of our workflows and processes are continuously checked and any potential for improvement is identified and exploited. Because the high level of qualification of all employees is a basic prerequisite for maintaining quality standards, professional development programmes to increase the level of expertise of both our doctors and our non-medical staff are of key importance. As a result of accreditation in accordance with DIN EN ISO/IEC 17020, our department undergoes recurrent evaluation by an independent external institution ensuring that we maintain high standards and level of professional expertise.