JACIE in Belgium. Ivan Van Riet. National Jacie representative

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1 JACIE in Belgium Ivan Van Riet National Jacie representative National JACIE meeting day 24 January 2013

2 Stem cell transplantation programme Collection Processing Transplantation Autologous and/or allogeneic Adult and/or pediatric patients Stand alone facility or integrated programme National JACIE meeting day 24 January 2013

3 JACIE and Belgian SCT centers GENERAL ACCREDITED CENTERS 20 EBMT centers (eligible for JACIE accreditation?) 11 centers applied for JACIE accreditation (+2 for re-accreditation) 9 centers accredited 1 center post-inspection (for re-accreditation) 2 centers pre-inspection (1 for re-accreditation) UCL hospital Brussels (complete programme; allo + auto in A+P) Bordet Institute (+Reine Fabiola hospital) Brussels (complete programme; allo + auto in A+P) UZ Leuven (complete programme; allo + auto in A+P) UZ Gent (complete programme; allo + auto in A+P) ZN Antwerpen (complete programme; allo + auto in A) UZ Antwerpen (complete programme; allo + auto in A) National JACIE meeting day 24 January 2013 UZ Brussel (complete programme; allo + auto in A) Jessa ziekenhuis Hasselt (complete programme; auto in A) HH ziekenhuis Roeselare (clinic+collection; allo + auto in A) A: adult patiens P: pediatric patients

4 % 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 National JACIE meeting day 24 January 2013

5 Belgian JACIE inspectors in international inspection teams 14 inspectors: 11 (BHS) + 3 (independent) >Clinic adults: 7 >Clinic children: 1 >Collection: 6 >Processing: 4 75 participations to JACIE inspections: > France (39) > The Netherlands (9) > Belgium (12) > UK > Switserland > Israel > Saudi Arabia

6 Belgian JACIE inspectors in international inspection teams Times that Belgium Inspectors participated in Inspections France Netherlands Belgium Other Countries

7 Exchange inspectors with The Netherlands So far 9 Belgian inspectors participated to inspections in The Netherlands while 13 Dutch inspectors participated to inspections in Belgium JACIE inspections in The Netherlands are coordinated by CCKL JACIE accreditation in The Netherlands obligatory So far: Belgian inspectors in case of conflict of interest or as back-up Future (proposal): one pool of Dutch speaking inspectors and one integrated inspection planning

8 Exchange inspectors with France So far 39 times a Belgian inspector participated to inspections in France while 4 French inspectors participated to inspections in Belgium French internal inspector pool too limited Inspector training (in French) in Paris (January 2013)

9 Strenghts and problems Strenghts: Less change for conflict of interest International JACIE spirit >more callibration among inspections More opportunities for international networking Problem: Availability of international inspectors > long delay in inspection planning (up to 1 year!)

10 JACIE and national regulations in Europe 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 meeting day 24 January 2013

11 JACIE and national regulations in Belgium JACIE accreditation required for reimburesement by RIZIV/INAMI: Royal decree of 21/12/2012: > At 1/1/2013: start preparation of JACIE accreditation process > At 31/12/2017: JACIE accreditation obtained JACIE standards as official advisory document for national stem cell bank inspections (Superior Health Council) National JACIE meeting day 24 January 2013

12 BHS Subcommittee: the past Subcommittee meetings Organisation centre preparation courses Organisation internal auditor trainings Two national review manuscripts JACIE in Belgium Critical evaluation and discussion about new version of the international JACIE standards + writing of BHS recommendation report (sent to JACIE/FACT) First national JACIE meeting day (La Hulpe) in 2011

13 BHS subcommittee: the future Members: national JACIE inspectors and/or other SCT center delegates (max 2/center) JACIE forum (inspections, trainings, standards, annual meeting, National regulations Discussion topics: > education and competency testing > outcome analysis > validation >

14 National JACIE meeting day 2013 JACIE in Europe: current situation and future E. Mc.Grath (JACIE office Barcelona) The experiences of the medical director T. Kerre (Gent) The experiences of the quality manager O. Giet (Liége) A. Verbeek (Hasselt) Coffee break Discussion Moderators E. Baudoux (Liège) K. Theunissen (Hasselt) M. Cleeren (Leuven) P. Huynh (Brussels) Closing remarks National JACIE meeting day 24 January 2013

BHS COMMITTEES MEETING 30 January 2014

BHS COMMITTEES MEETING 30 January 2014 BHS COMMITTEES MEETING 30 January 2014 Regulatory affairs JACIE Ivan Van Riet Ivan.vanriet@uzbrussel.be Scopes Supporting implementation of JACIE standards in national SCT centres with the aim to obtain

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