Five-Year Experience of Haemophilia Centre Certification Performed by the German, Austrian and Swiss Society for Thrombosis and Haemostasis Research

Abstract

Introduction: To enhance the treatment quality in haemophilia centres (HC), the German, Austrian and Swiss Society for Thrombosis and Haemostasis Research (GTH) started in 2017 the development of guidelines to define the structural and process quality of HC, essentially related to the EUHANET guidelines. Aim: A certification process for HC located in Germany, Austria and Switzerland started in 2019. Methods: Within the first 5 years, 17 Haemophilia Comprehensive Care Centres (HCCC; ≥ 40 patients with severe HaemA/HaemB or vWD Type 3) and 6 Haemophilia Treatment Centres (HTC; ≥ 10 patients) were certified following a 1-day on- site audit performed by two trained haemophilia doctors. Experienced quality management staff supported the audit preparation in the HC. The entire certification process was coordinated by the accredited certification body ClarCert. Results: In the vast majority of the HCs, the precise specifications of the GTH guidelines in combination with the intensive audit preparation resulted in a mean number of only 2.80 nonconformities per audit (range 0–14). In addition, a mean number of 5.96 (range 2–13) recommendations were documented by the auditors. The feedback of the centres showed a high level of satisfaction with an excellent rating for both the professional auditors and ClarCert as the organizing certification body. Conclusion: After the successful implementation of the certification process, a certificate is now an essential prerequisite for HC in Germany to conclude separate contracts regarding comprehensive care with health insurance bodies.