milano, 10 novembre 2010 accreditamento jacie: è utile per i pazienti?
TRANSCRIPT
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