Accreditation model of European Haemophilia Centers in the era of novel treatments and gene therapy

Authors: Boban, A; Baghaei, F; Karin, F; Klamroth, R; Miesbach, W; Stephensen, D; Kavanagh, M; Noone, D; Crato, M; Peyvandi, F

Affiliations: Haemophilia Centre, Department of Haematology, University Hospital Centre Zagreb, Zagreb, Croatia. School of Medicine, University of Zagreb, Zagreb, Croatia. Coagulation Centre, Department of Medicine, Section of Haematology and Coagulation, Sahlgrenska University Hospital, Gothenburg, Sweden. Amsterdam UMC, Emma Children’s Hospital, Pediatric Hematology, University of Amsterdam, Amsterdam, Netherlands. Department of Internal Medicine – Vascular Medicine and Haemostaseology, Haemophilia Treatment Centre, Vivantes Clinic im Friedrichshain, Berlin, Germany. Institute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Bonn, Germany. Department of Haemostaseology and Haemophilia Centre, Medical Clinic 2, Institute of Transfusion Medicine, University Hospital Frankfurt, Frankfurt, Germany. Kent Haemophilia and Thrombosis Centre, East Kent Hospitals University NHS Trust, Canterbury, UK. Paediatric Coagulation Centre, Children’s Health Ireland at Crumlin, Dublin, Ireland. European Haemophilia Consortium, Bruxelles, Belgium. Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi, Hemophilia and Thrombosis Center, Milan, Italy. Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.

Publication: Haemophilia. 2023

ABSTRACT: INTRODUCTION: The international certification of haemophilia centers in Europe is run by the European Association of Haemophilia and Allied Disorders (EAHAD) and European Haemophilia Consortium (EHC) since 2013. The centers are designated as European Haemophilia Comprehensive Care Centers (EHCCC) or European Haemophilia Treatment Centers (EHTC), based on the specific requirements which evaluate centers’ ability to provide care for patients with haemophilia and allied disorders. AIM: To establish the new protocol for accreditation of European Haemophilia Centers. METHODS: EAHAD, in collaboration with EHC, established Accreditation Working Group with the aim to define necessary measures to safeguard quality and improvement of bleeding disorders care throughout Europe and to build a novel model for accreditation of European Haemophilia Centers. RESULTS: The European guidelines for certification of haemophilia centers have been updated to guidelines for the accreditation and include all the requirements regarding facilities, laboratory and personnel needed for optimal management of novel treatment options, including the introduction of the hub-and-spoke model for delivery of gene therapy. A pilot project for the accreditation of haemophilia centers including on-site audit has been designed. CONCLUSION: Implementation of the novel accreditation protocol of the haemophilia treatment and haemophilia gene therapy centers has been made to further improve the quality of care for patients with haemophilia and other inherited bleeding disorders.