Milano, 10 Novembre 2010

Accreditamento JACIE: è utile per i pazienti?

• A worldwide comparable organisation for HSCT

• JACIE and regulators

• JACIE accreditation: facts not words (or paper)

• Impact on clinical outcome

Points of presentation

FACT-JACIE relationship

FACT developed standards in mid-1990’s

Developing interest in standards among European transplanters in

late 1990’s

JACIE provided input to 2nd edition of Standards e.g. paediatric

requirements

Closer cooperation on 3rd and 4th editions. Introduced more global

terminology

5th edition will see equal European and North American

representation

JACIE accreditation in Europe

Total centres registered: 216

Inspections in preparation (includes reaccreditations): 71

Total completed inspections: 191

Facilities accredited: 102

Reaccrediations in progress: 31

Countries: 17  

Cumulative initial applications & all inspections

2

95

129

160

205220

1 1 3 429

52 62

96

145168

191

3 419

4766

0

30

60

90

120

150

180

210

240

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Initial applications Inspections

Activity indicators

JACIE Initial & Reaccreditation applications per year

1528

1929 35 31

45

15

1

1312

2 1 1

14

16

0

10

20

30

40

50

60

70

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Initial Reaccreditation

Activity indicators

% distribution of total initial applications by country

United Kingdom20,8%

Germany15,4%

Italy14,0%

France13,1%

Netherlands10,0%

Spain7,7%

Belgium5,4%

Switzerland5,0%

Norway0,5%

Israel0,5%

Poland0,5%

Saudi Arabia0,5%

Turkey0,9%

Czech Republic1,4%

Finland1,4%

Austria1,4%

Sweden1,8%

Geographical distribution of applications

Valid as of today: 101 | Awarded once: Initial 134; Reaccreditation 24

JACIE awarded accreditations by year

0 1 1 1 2 19 17 9 39 27 18

15

4

5

0

10

20

30

40

50

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Initial Reaccreditation

Activity indicators

JACIE & Regulators

Regulations

France

Engagement with JACIE a requirement for allogeneic transplant centres

Arrêté du 3 avril 2009 relatif au contenu du document d'évaluation des activités de greffes d'organes et de greffes de cellules hématopoïétiques.21 abril 2009 - Edition numéro 0093, Journal Officiel de la Republique Francaise

Switzerland

Accreditation required to receive reimbursement from Social Insurance for treatments

The Netherlands

Accreditation required to receive authorisation to transplant from Ministry of Health

25 October 2006 Regeling stamceltransplantatie

Guidelines 

United Kingdom

JACIE cited in National Institute for Health and Clinical Excellence (NICE) guidelines October 2003 Improving Outcomes in Haematological Cancers: The Manual

 

Collaboration Italy

Centro Nazionale de Trapianti (CNT) has coordinated inspections of Italian centres with JACIE through GITMO.  

Spain

Collaboration project with the National Transplant Organisation (ONT) and the Transfusion Accreditation Committee (CAT) under the name Comité Conjunto de Acreditación (CCA).

Guidelines 

United Kingdom

JACIE cited in National Institute for Health and Clinical Excellence (NICE) guidelines October 2003 Improving Outcomes in Haematological Cancers: The Manual

 

Collaboration Italy

Centro Nazionale de Trapianti (CNT) has coordinated inspections of Italian centres with JACIE through GITMO.  

Spain

Collaboration project with the National Transplant Organisation (ONT) and the Transfusion Accreditation Committee (CAT) under the name Comité Conjunto de Acreditación (CCA).

JACIE accreditation: facts not words (or paper)

0.0

00

.25

0.5

00

.75

1.0

0

0 20 40 60 80 100 120 140analysis time

.

0.0

00

.25

0.5

00

.75

1.0

0

0 20 40 60 80 100 120 140analysis time

N=72, 0.38

Any CRN=40, 0.62

Active diseaseN=32, 0.1

P<0.0001

SOPRAVVIVENZA GLOBALE DI 72 PAZIENTI CON LAM SOTTOPOSTI A

TRAPIANTO ALLOGENICO DI CSE

Farmasafe@: gestione interamente informatizzata dei farmaci

dalla prescrizione alla somministrazione attraverso la

valutazione/scelta, approvvigionamento, stoccaggio,

distribuzione e personalizzazione

Farmasafe@: obiettivi del progetto

Gestione completa del farmaco: dalla prescrizione alla somministrazione

Miglioramento dei processi organizzativi, nella collaborazione, comunicazione, e condivisione fra medici, farmacisti e infermieri

Miglioramento della sicurezza per il paziente (abbattimento dell’errore di terapia)

Tracciabilità del processo farmacologico, documentazione di terapia completa

Eliminazione della documentazione cartacea per l’operatività

Applicazione disponibile ovunque, attività in tempo reale

ambito prescrittivo: atto medicoambito prescrittivo: atto medico

ambito farmaceutico:

nutrizione Artificiale antitumoralidosaggi orfani

ambito farmaceutico:

nutrizione Artificiale antitumoralidosaggi orfani

ambito farmaceutico

dalla farmacia centrale

agli armadi di reparto

ambito infermieristico:Carrello terapia/Somministrazione

Farmasafe@: il paziente, il suo farmaco

Impact of quality management onthe clinical outcomes of HSCT

Global Distribution of Hematopoietic Stem Cell Transplantations (HSCTs) in 2006

Copyright restrictions may apply. Gratwohl, A. et al. JAMA 2010;303:1617-1624.

Copyright restrictions may apply. Gratwohl, A. et al. JAMA 2010;303:1617-1624.

Macroeconomic Factors and Transplant Rates

Impact of a Quality Management Systemon the clinical outcome after HSCT

Data from 107,000 HSCT 1999-2007 in 421 European Teams

Analysis of overall survival, relapse incidence, non-relapse mortality and relapse free survival

Outcome correlated with era of transplant: 3 years prior to application, during application and after JACIE accreditation

Analysis clustered by team, stratified for type of HSCT, disease, year of HSCT, conditioning, Gross National Income/capita and adjusted by EBMT score as a key risk factor

Gratwohl et al, JCO 2010; Chabannon et al, 2010 in preparation

Gratwohl et al, JCO 2010; Chabannon et al, 2010 in preparation

Impact of a Quality Management Systemon the clinical outcome after HSCT

Improvement in outcome of allogeneic HSCT from pre-accreditation compared to post-accreditation

Improvement of overall survival peaked at 14% for patients with chronic leukemias who received an allogenic HSCT

Improvement in overall and disease-free survival was also apparent for recipients of high-dose chemotherapy supported with autologous HSCT

Improvement in survival is =/>than the consequences of what are now thought of as major innovations in the field of HSCT

Conclusioni

L’accreditamento JACIE si sta diffondendo in Europa e viene sempre più riconosciuto come uno strumento di garanzia per i pazienti e per garantire i Sistemi Sanitari Nazionali e le Assicurazioni a riguardo della qualità delle prestazioni erogate

L’organizzazione e la pratica clinica quotidiana traggono giovamento dai comportamenti virtuosi implementati grazie ad una gestione in qualità di una organizzazione complessa quale quella di un Programma di Trapianto

Si stanno accumulando dati scientifici che suggeriscono come i programmi di trapianto accreditati hanno risultati clinici superiori