@JACIE_EBMT

Up-date - JACIE project international

1

@JACIE_EBMT

Take-up of JACIE

among allo-

transplanting

centres –

Centres that have

applied as

percentage of

total centres

reporting

transplants to

2014 EBMT

Activity Survey2

S. Africa

@JACIE_EBMT

Take-up among transplant centres*

• Percentage of transplanting centres reporting to the 2014

EBMT Activity Survey* that have at least applied for

accreditation since 2000

*data May 2016

Transplants Global Belgium UK Italy Germany France

All types 42% 75% 88% 65% 47% 43%

Auto 21% 38% 88% 24% 9% 14%

Allo 59% 100% 100% 85% 74% 71%

Total

respondents

657 20 51 95 109 76

* Passweg JR, Baldomero H, Bader P, Bonini C, Cesaro S, Dreger P, et

al. Hematopoietic stem cell transplantation in Europe 2014: more than 40

000 transplants annually. Bone Marrow Transplant [Internet]. 2016 Feb

22;(January):1–7. Available from:

http://www.nature.com/doifinder/10.1038/bmt.2016.20

@JACIE_EBMT

City FacilityName InstitutionNameProgrammeDirector

(s)AccreditFinishDate Type

1.Bruges Afdeling hematologie AZ Sint-Jan Brugge-

Oostende AV

Dominik Selleslag 11/06/2019 Initial accreditation

2. Brussels Hematopoietic Stem

Cell Transplantation

Programme - Clinical

Hematology

UZ Brussel R. Schots 22/01/2017 Initial accreditation

3. Brussels Programme de

transplantation de

cellules souches

hématopoiétiques

adulte et pédiatrique

Cliniques

universitaires Saint

Luc, Université

Catholique de

Louvain

Christiane Vermylen 14/07/2017 Reaccreditation 1

4. Brussels Departement

d'Hémato-

transplantation,

Institut Jules Bordet

(IJB); Hôpital

Universitaire des

Enfants Reine

Fabiola (HUDERF);

Hospital Saint-Pierre

Centre des tumeurs

de l’Université Libre

de Bruxelles (ULB)

D. Bron 09/07/2019 Reaccreditation 1

5. Brussels Stem Cell Laboratory

Clinical Hematology

& Donor Centre Jette

UZ Brussels Rick Schots 22/09/2020 Reaccreditation 1

6. Charleroi Site Notre Dame Grand Hôpital de

Charlerroi

Delphine Pranger 28/02/2020 Initial accreditation

4

Accreditations

@JACIE_EBMT

City FacilityName InstitutionNameProgrammeDirector

(s)AccreditFinishDate Type

7. Edegem Antwerp University

Hospital

Wilfried Schroyens 06/11/2016 Initial accreditation

8. Gent Stem Cell

Transplantation

center - SCT UZG

UZ Gent Lucien Noens 17/12/2016 Initial accreditation

9. Haine-Saint-Paul Service Clinique

d'Hématologie

Hôpital de Jolimont Nicole Straetmans 27/09/2019 Initial accreditation

10. Hasselt Dienst Hematologie Jessa Ziekenhuis Koen Theunissen 24/01/2017 Reaccreditation 1

11. Leuven Hematopoëtisch

Progenitor cel

Transplantatie

Programma, HPTP

Collectiecentrum,

HPTP -

Verwerkingslaborator

ium

UZ Leuven Gregor Verhoef 20/09/2019 Reaccreditation 1

12. Liege Programme ULICE –

Centre de Thérapie

Cellulaire, Service

Hématologie Clinique

B35 - Sart Tilman

Centre Hospitalier

Universitaire de

Liège

Y. Begun 13/10/2017 Initial accreditation

13. Roeselare Hematopoietisch

stamceltransplantatie

programma

H.-Hartziekenhuis

Roeselare-Menen

vzw

Dries Deeren 17/12/2016 Initial accreditation

14. Yvoir Hematology

Department

CHU UCL Namur Marc Andre 28/06/2020 Initial accreditation

5

Accreditations

@JACIE_EBMT

Applications

6

@JACIE_EBMT

Inspections - Belgium

7

@JACIE_EBMT

Expiring Accreditations

Year 2016 2017 2019 2020 Total

Belgium 4 4 4 3 15

@JACIE_EBMT

Programmes still to apply

9

City Team Hospital Total

1st

HSCT*

Total all

HSCT

1st.

Allo

1st.

Auto

Liège L. Lammertijn,

C.Jacquy

CHR-Citadelle 9 9 0 9

Brussels B. Bailly, A.

Kentos, M.

Lambermont

U.L.B. Hôpital Erasme 15 15 0 15

Mons V. Robin Hopital Ambroise Pare 6 7 0 6

Charleroi A. Triffet CHU Charleroi 5 5 0 5

Turnhout G. Bries, I.

Vrelust

AZ Turnhout 15 16 0 15

*Transplants reported for 2014 Activity Survey

@JACIE_EBMT

Activity

10

*

* 2016 – 11 inspections scheduled up to Dec.

2011 2012 2013 2014 2015 2016

Inspections-complete 44 52 57 49 62 51

Accreditations 37 47 42 47 50 58

Applications 61 51 55 49 74 47

0

10

20

30

40

50

60

70

80

Activity

@JACIE_EBMT

11

47

64

31

47

29

43

0

10

20

30

40

50

60

70

201620152014201320122011

Applications to OCTOBER

@JACIE_EBMT

12

Turkey

SerbiaSan Marino

MonacoAndorra

Iceland

NorwayRussia

Russia

Belarus

Ukraine

Lebanon

SyriaIraq

Iran

Armen.

Azerbaijan

Georgia

Kazakhstan

Croatia

Denmark

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Malta

Cyprus

Bulgaria

Greece

Slovakia

Romania

Hungary

Luxemburg

The Netherlands

Spain

Portugal

UnitedKingdom

Ireland

Czech Rep.

AustriaSwitzerland

Germany

JACIE & Regulations

France

Italy

Austria

Belgium

@JACIE_EBMT

Other EBMT/JACIE interactions with

European Union

• EU Commission

– DG SANTÉ

• Invitation to contribute to upcoming stakeholders consultation

on Tissue & Cell Directives revision assessment

– Projects / Joint Actions

• EuroGTP II

• ARTHIQS

• VISISTART

@JACIE_EBMT

INSPECTORS

15

@JACIE_EBMT

Inspectors

• 260+ cellular therapy professionals on the

JACIE register

• Volunteers

• Receive only expenses and per diem

• Fundamental to the process

16

@JACIE_EBMT

Criteria for inspectors

• 5 years professional experience in their BMT

field

• Membership of professional society

• Attend JACIE Training Course

• Pass online exam on standards and process

• Level B1 in English (at least writing)

• Coming soon – interviews of new candidates

before acceptance by JACIE

17

@JACIE_EBMT

Languages & inspectors

18

EN; 175

DE; 58

IT; 51

FR; 48

ES; 35 NL; 31

TR; 23

HE; 13

GR; 8SE; 6AR; 7PL; 7PT; 5FI; 4NO; 4

CZ; 3

MC; 2

HR; 2

DK; 1

VT; 1

SB; 1

HU; 1

RM; 1

Others; 12

Languages & speakers

@JACIE_EBMT

Experience among inspector pool

19

GLOBAL BELGIUM

@JACIE_EBMT

Inspectors BelgiumName Surname Hospital City Inspector area(s) Paediatrics?

Maria

Victoria

Bordon

Cueto

Ghent University Hospital Gent Clinical yes

Pascale Frere Liege Liege Clinical

Alain Gadisseur Edegem Edegem Clinical

Tom Lodewyck AZ Sint-Jan, Brugge Brugge Clinical

Marleen Renard Univerity Hospital Leuven Leuven Clinical Yes

Christiane Vermylen Cliniques Universitaires St. Luc Brussels Clinical Yes

Dries Deeren Roeslaere Clinical/Collection

Lucien Noens Gent Clinical/Collection

Timothy Devos University Hospital Gasthuisberg Leuven Clinical/Collection/Proce

ssing

Pierre Zachée U.Z. Gasthuisberg Hospital Antwerpen Clinical/Collection/Proce

ssing/Quality

Management

Phuong Huynh Institut Jules Bordet Brussels Collection/Quality

Management

Jessy Lardon ZNA Stuivenberg Antwerp Processing

Dominique Latinne Service of Bioclinical hematology Brussels Processing

Ivan Van Riet Academic Hospital Free University Brussels

(AZ-VUB)

Brussels Processing

Geneviève Mertens Cliniques universitaires saint-luc Brussels Quality Management 20

Anticipated inspector needs for 2017*

• Paediatrician

• Collection

• Quality Management

* Taking into account expected activity in The

Netherlands in 2017

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@JACIE_EBMT

JACIE OFFICE

22

@JACIE_EBMT

JACIE Team

• And then there were 4!

23

@JACIE_EBMT

• New HR Coordinator

– Focus on Volunteers > Inspectors

Main Tasks

1.Retain existing inspectors via motivation and

stimulation

2.Recruit new inspectors in line with anticipated

needs

24

@JACIE_EBMT

• Change from….

25

@JACIE_EBMT

• Change to…

• More targetted recruitment based on needs

26

Southampton, UK2-3 Jun

Training Course

Barcelona, Spain 6-7 October

Training Course

Antalya, Turkey02 Mar

Turkish HematoCongress

Warsaw, Poland23 Sep

DKMS event

Brussels, Belgium 28 Oct

BHS National Meeting

Training, Events, Representation & Participation

Riyadh, S. Arabia9 Jun

SSBMT Workshop

Barcelona, Spain 17 Jun

Standards meeting

Brussels, Belgium 21 Jun

EU Commission

Stockholm, Sweden

24-25 NovTraining course

Nijmegen, Netherlands27-28 Oct

Training course

I FACT-JACIEWebinar

(in Spanish) Online

21 October

Santiago, Spain

21 OctoberSpanish Hemato

Congress

Sinagpore29 October

APBMT

@JACIE_EBMT

Training 2017

• Planning

– 2 events in Barcelona – May & October

– May be others…

• Planning

– Online material to maintain inspectors’ knowledge

• Standards

• Process

• Etc.

28

@JACIE_EBMT

Fees – new for 2017

• Increase in fees

• Typical programme

Clinical/Collection/Processiing

– €15,000 (39%+)

• Discounts

– 10% 1 active inspector

– 20% 2 or more active inspectors

@JACIE_EBMT

Inspection Checklist

• Evaluation of electronic alternatives to Excel

Checklist

– Mobile Apps

30

@JACIE_EBMT

Also…..

• Open consultation

on proposed

immune receptor

cell adminstration

standards –

please participate

@JACIE_EBMT

• 7th edition review process ongoing – public

consultation Apr 2017

• Call for cases to present on CAPAs and

benchmarking @EBMT17 in Marseille

• All details at www.jacie.org

32

@JACIE_EBMT

Social media

https://www.linkedin.com/

groups/5027189

33

@JACIE_EBMT

@JACIE_EBMT

Acknowledgements

34

JACIE Patrons

EBMT

ISCT

JACIE Founders

Alois Gratwohl

Günnar Kvalheim

JACIE Board Chairs

Alvaro-Urbano-Ispizua

Ineke Slaper-Cortenbach

Jane Apperley

Christian Chabannon

Alessandro Rambaldi

John Snowden

• JACIE Committee

• JACIE Accreditation

Committee

• JACIE QM Committee

• JACIE National

Representatives

• JACIE Inspectors

• 27 countries