JACIE in Europe and Belgium Ivan Van Riet National Jacie representative Ivan.vanriet@uzbrussel.be
What is JACIE? Joint Accreditation Committee of the International Society of Cellular Therapy (ISCT) and European Group for Blood and Marrow transplantation (EBMT) Non-profit organisation, founded in 1998 to promote high quality in patient care and laboratory activities in the domain of hematopoietic stem cell transplantation (HSCT) through an international accreditation system. Accreditation after inspection and screening based on standards of excellence to European stem cell transplantation centers.
Stamceltransplantatieprogramma Collection Processing Transplantation Autologous and/or allogeneic Adult and/or pediatric patients Stand alone facility or integrated programme
JACIE standards Initially established by FACT (Foundation for the accreditation of cellular therapy), review in collaboration with JACIE Three domains: collection, processing and transplantation of hematopoietic stem cells 4 versions (5 e version release in 2012) Compliant with EU directives 2004/23/EC en 2006/17/EC
JACIE standards Facilities Personell Quality mamagement Policy and procedures (SOP s) Reports Donor management Collection Processing Labels Storage Release and distribution Transport Therapy adminstration Data management and clinical research Communication
JACIE inspection process Accreditation application Pre-inspection documentation Inspection team + on-site visit Inspection report Evaluation by accreditation committee Corrections Accreditation (4 year; interim audit after 2 years)
JACIE inspectors Experts; actively involved in domain; sufficient experience JACIE training and evalution International exchange JACIE inspections on-site visit interviews documents / software
JACIE in Belgium Support for implementation en accreditation process by the Belgian Hematological Society (BHS) Training JACIE inspectors Accreditation subcommittee Organisation centre preparation courses and internal auditor trainings National JACIE day
Belgian JACIE inspectors in international inspection teams 15 Inspectors participation to 51 JACIE inspections: > France > The Netherlands > Belgium > UK > Switserland > Israel > Saudi Arabia
Cumulative initial applications & all inspections 270 240 210 180 150 120 90 60 30 0 226 236 226 205 199 160 168 145 129 95 96 47 66 52 62 19 29 21 13 43 4 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Initial applications Inspections
% distribution of total initial applications by country Spain 7,1% Belgium 5,9% Switzerland 4,6% Sweden 2,1% Austria 1,3% Turkey 1,3% Finland 1,3% Netherlands 9,7% Czech Republic 1,3% France 12,6% Germany 15,1% Italy 15,5% United Kingdom 20,6% Israel 0,4% Norway 0,4% Poland 0,4% Saudi Arabia 0,4%
2009 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Belgium Total 2009 Comparison of percentage of Belgian and total centres reporting data to the 2009 EBMT Activity Survey that are also registered with JACIE
JACIE and European SCT centers Registered centers : 244 (88% auto+allo SCT centers) Inspections in preparation (inclusive re-accreditations ):51 Completed Inspections:234 Accredited centers and stand-alone facilities:103 Countries:17
JACIE and Belgian SCT centers 17 centers eligible for JACIE accreditation 11 centers applied for JACIE accreditation (+1 for re-accreditation) 6 centers accredited 1 center post-inspection 4 centers pre-inspection (+1 for re-accreditation) Accredited centers: UZ Leuven (complete programma) UCL hospital Brussels (complete programma) Bordet institute (+Reine Fabiola hospital) Brussels (complete programme) Jessa ziekenhuis Hasselt (autologous SCT/adults) UZ Brussel (processing laboratory)* Red Cross BTC Gent (processing laboratory) Red Cross DC Jette (apheresis unit)* * joined application
JACIE and national regulations INTERNATIONAL. JACIE accreditation criterium for national licence as SCT center in the Netherlands JACIE accreditation required for reimburesement by social security in Switserland JACIE accreditation (or active implementation) required for Allo SCT centers in France JACIE accreditation required for licence by national registry in Germany NATIONAL JACIE accreditation on voluntary basis Solid basis for obtaining national tissue bank licence (FAGG/AFMPS) Reference to JACIE standards in specific standards of the Superior Health Council RIZIV/INAMI reimbursement linked to EBMT accreditation
JACIE : why (not)? Just another cost increasing exercise (JACIE)? Apperley J. Bone Marrow Transplant. 2004 Nov;34(10):835-8. A LOT OF TIME A LOT OF MONEY CHANGING MENTALITY BETTER ORGANISATION BETTER COMMUNICATION BETTER RESULTS
Implementation of JACIE standards in SCT centers has positive impact on survival 421 EBMT teams 41.623 allo SCT 66.281 auto SCT Gratwohl, A. et al. Introduction of a Quality Management System and Outcome After Hematopoietic Stem-Cell Transplantation. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1-7(2011).doi:10.1200/JCO.2010.30.4121 17