BHS COMMITTEES MEETING 30 January 2014

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1 BHS COMMITTEES MEETING 30 January 2014 Regulatory affairs JACIE Ivan Van Riet

2 Scopes Supporting implementation of JACIE standards in national SCT centres with the aim to obtain (re-) accreditation Organisation of national JACIE inspections and contribution to international JACIE inspections (training and exchange of inspectors) Discussion about specific topics related to QM (national and international regulations)

3 JACIE and European SCT centres Registered centres : 308 Inspections in preparation (inclusive re-accreditations ):50 Completed Inspections (first time/reaccreditations):257/96 Accredited centres and stand-alone facilities:154 Countries: Focus Conference

4 Applications in Europe Applications Reaccreditation Initial Year applied

5 Applications in Europe Total Germany 16% France 12% Netherlands 7% Spain 6% Belgium Switzerland 6% 3% Sweden 2% Finland Austria 1% 1% Other 3% Turkey 1% Greece 1% Czech Republic 1% Israel 1% Ireland 0% South Africa 0% Singapore 0% Saudi Arabia 0% Poland 0% Italy 21% Portugal 0% Norway 0% Hungary 1% United Kingdom 18% Focus Conference

6 Applications in Belgium Applications 3 1 Reaccreditation Initial Year applied

7 Accreditations in Europe Accreditation awards per year Accreditations Reaccreditation Initial Year accredited

8 Accredited centres

9 Take-up (applied, been inspected or been accredited ) Applications by centres reporting transplant to survey Total Belgium % total qualified* 36% 68% % qualified auto only 17% 25% % qualified allo 52% 100% Based on 2012 EBMT Activity Survey * Qualified auto 5 tx; allo 10 tx

10 Take-up of centres reporting allogeneic transplants to 2011 EBMT Activity Survey % 80-89% 70-79% 60-69% 50-59% 40-49% 30-39% 20-29% 10-29% 0-9% Also: Saudi Arabia South Africa Countries colour-coded according to percentage of reporting centres that have applied for accreditation * Survey data provided courtesy of Helen Baldomero, EBMT Activity Survey

11 JACIE and Belgian SCT centres 20 EBMT centres 13 centres applied for JACIE accreditation (4 for reaccreditation) 10 centres accredited (3 reaccreditation) 3 centres pre-inspection Accredited centres: UCL hospital Brussels (complete programme) Bordet institute (+Reine Fabiola hospital) Brussels (complete programme) UZ Leuven (complete programme) UZ Gent (complete programme) ZN Antwerpen (complete programme-adults) UZ Brussel (complete programme-adults) Sart Tilman ULiège (complete programme-adults) UZ Antwerpen (complete programme-adults) HH ziekenhuis Roeselare (collection and clinic-adults) Jessa ziekenhuis Hasselt (autologous SCT-adults) Focus Conference

12 Belgian JACIE inspectors Name Hospital Inspector area(s) Paediatrics Status Maria Victoria Bordon Cueto UZ Gent Clinical yes Active Pascale Frère CHU Liège Clinical Active Alain Gadisseur UZ Antwerpen Clinical Active Marleen Renard UZ Leuven Clinical Yes Active Christiane Vermylen Cliniques Universitaires St.Luc - UCL Clinical Yes Active Dries Deeren AZ St Jan Brugge Clinical/Collection Active Lucien Noens UZ Gent Clinical/Collection Active Timothy Devos UZ Leuven Processing Active Koen Theunissen Jessa ziekenhuis Hasselt Clinical/Collection Active Pierre Zachée UZ Leuven Clinical/Collection Active Phuong Huynh Institut Jules Bordet - ULB Collection Active Etienne Baudoux University Hospital (CHU) ULiège Collection/Processing Active Pieter De Schouwer ZNA Antwerpen Processing Active Dominique Latinne Cliniques Universitaires St.Luc - UCL Processing Active Ivan Van Riet UZ Brussel Processing Active Robrecht de Bock ZNA Antwerpen Clinic No longer active

13 Belgian JACIE inspectors 15 Inspectors Participation to > 75 JACIE inspections: > France > Netherlands > Belgium > UK > Switserland > Israel > Saudi Arabia > South Africa Focus Conference

14 Participation Belgian inspectors in national and international inspections

15 Belgian delegates in JACIE Dominique Latinne : member accreditation committee (processing) Christiane Vermylen : member accreditation committee (paediatric) Phuong Huynh (Brussels) : member quality members committee Koen Theunissen (Hasselt): member standards committee (clinical) Tiene Bauters (pharmacist-ugent): member standards committee (clinical) Ivan Van Riet (Brussels): member JACIE board (NR)

16 Previous and current meeting topics/activities National JACIE centre preparation courses National JACIE internal auditor training National JACIE meeting days Comments on new version of the standards E-learning project Two Publications in national journals (2009 and 2011) Presentation EBMT meeting 2013 (London) Survey on quality indicators and outcome analysis (on request of the BHS SCT-peer review committee)

17 6th Edition Standards 2013 June - Kick-off Aug-Dec - Sub-committee telecons 2014 Feb - Meeting of Committees Apr-Jun - Public consultation Oct - Approve final version 2015 Mar publish

18 Previous and current meeting topics/activities National JACIE centre preparation courses National JACIE internal auditor training National JACIE meeting days Two Publications in national journals (2009 and 2011) Presentation EBMT meeting 2013 (London) Comments on new version of the standards Survey on quality indicators and outcome analyses (on request of the BHS SCT-peer review committee) E-learning project

19 Morning session (10:00-12:30) Welcome Ivan Van Riet National JACIE representative JACIE in Europe: Current Situation & Future Iris Bargallo (JACIE-Barcelona) JACIE Accreditations coordinator The keys to successful quality management Luc Noens (UZ Gent UGent) JACIE inspector E-learning for SCT staff Geneviève Mertens (Hôpital St.Luc - UCL) THIRD NATIONAL JACIE MEETING DAY FEBRUARY 21 TH 2014, LA HULPE Afternoon session (14:00-16:30) Group discussions Moderators: Luc Noens (UZ Gent UGent) JACIE inspector Alain Gadisseur (UZ Antwerpen UA) JACIE inspector Etienne Baudoux (Hôpital Sart Tilman - ULiége) JACIE inspector Timothy De Vos (UZ Leuven KU Leuven) JACIE inspector Cryostorage and discard of therapeutical cell products: scientific, ethical and legal aspects Etienne Baudoux (Hôpital Sart Tilman - ULiége) JACIE inspector Introduction to national survey about quality indicators and outcome analysis Timothy Devos (UZ Leuven KU Leuven) JACIE inspector Free registration on BHS website

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