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  Project funded in 2003 - Strand 2: Health Threatsslide
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JACIE

Description      -      Financing      -      Outcomes      -      More info

Description

Action
Enhancing the capability of responding rapidly and in a co-ordinated fashion to health threats

Area of activity
Health Threats (HT 2003) - 2.3.4: Safety of blood, tissues and organs.

Summary
The aims of the project are to provide vital impetus to the JACIE programme and ensure its integral role in standard setting, inspection and accreditation for health institutions and facilities involved in haematopoietic stem cell collection, processing and transplantation in Europe.

The specific objectives are:
1. To harmonise the JACIE standards and programme of accreditation with the Community Directive arising from COM (2002) 319 final and contribute to the ongoing development of technical standards and systems for quality and safety of human tissues and cells.
2. To implement the JACIE standards in health institutions and facilities involved in haematopoietic stem cell collection, processing and transplantation in Member States.
3. To promote the JACIE programme among the scientific community, medical professionals, national authorities, Community officials and the general public, with a view to encouraging harmonisation of standards and systems of accreditation across the Community.
4. To strengthen the central resources for managing and administering the JACIE programme and to extend and enhance the effectiveness of the existing JACIE network.
5. To establish equivalent JACIE training courses for medical professionals and inspectors across the Community and to facilitate the exchange of experience and best practice between them.
6. To contribute to the comparability of data across Member States by supporting the existing network of EBMT and national registries in the collection of compatible and comparative transplant data.

More info...

Description      -      Financing      -      Outcomes      -      More info

Financing

Leader organisation
European Group for Blood and Marrow Transplantation
P. Debyelaan 25
Haematologie
NL-6229HX Maastricht
THE NETHERLANDS
Tel: +34.93.454.9543
Fax: +34.93.453.1263
Web site: www.ebmt.org
E-mail: info@ebmt.org
Contact Persons
Fiona Mc DONALD
Department of Haematology, Hospital Clinico de Barcelona
VILLAROEL 170
E-08036 Barcelona
Tel: +34.93.451.95.43
Fax: +34.93.453.12.63
E-mail: fiona.mcdonald@ebmt.org

Jane Apperley
Tel: +44.20.838.33237 / +34.93.451.95.43
Fax: +44.20.874.29335 / +34.93.453.12.63
E-mail: j.apperley@imperial.ac.uk
Associated beneficiaries
Belgian Haematological Society established in Belgium
Société française de greffe de moelle et de thérapie cellulaire established in France
Dutch National Registry established in The Netherlands
Spanish Group for Hematopoietic Transplantation established in Spain
Swedish Society of Hematology established in Sweden
British Society of Blood and Marrow Transplantation established in United Kingdom
Starting date and duration of project
- 01/01/2004
- 14 months
Total cost
351,695.41 €
Subsidy from the Commission
167,526.13 €

Description      -      Financing      -      Outcomes      -      More info

Outcomes

- Harmonisation and promotion of standards:
Production of a second edition of the JACIE Manual in line with the Community Directive. Distribution of 1000 copies to healthcare professionals, health authorities and the Commission (January 20004).
Production of 300 JACIE information packs for dissemination to health authorities and healthcare professionals in countries being brought into the JACIE network (January 2004).
Delivery of JACIE education sessions as part of EBMT 2004 (March 2004) and the ESH-EBMT Postgraduate Training Course in Eastern European (May 2004). To be attended by at least 20 healthcare professionals from applicant countries.
Model materials (SOPs. and QMPs, etc.) for sharing of best practice made available for download from the JACIE Website (as of March 2004).
- Implementation of the JACIE accreditation programme:
Establishment of a European JACIE Office in Barcelona. Recruitment and training of a full-time administrative assistant and part-time medical consultant (by December 2003). Implementation of an online IT system with transnational access, supporting administration, management and dissemination of JACIE information throughout Europe (by February 2004).
Development of modular training materials (February 2004) for use in central and national training courses throughout the Community. Delivery of 3 central training courses for 50 medical professionals in centres in the process of accreditation (Jan/Feb 2004) and for 30 inspectors (March 2004).
Implementation of the JACIE accreditation programme (registration, submission of documents, inspection visit, inspection report, review and issue of certificates of accreditation where appropriate) in 25 centres throughout Europe by the project end date.
- Networks:
Extension of the JACIE network to include 8 new applicant countries and four more Member States. JACIE National Representatives for these countries to be appointed by June 2004. Increased collaboration with health authorities, demonstrated by official acceptance of the JACIE standards and accreditation programme (to be evaluated at the end of the project compared with the situation at the outset of the project).
- Information and learning:
Completion of an analysis of the difficulties and deficiencies in the implementation of standards (Dec 2004) and an assessment of the impact of implementation (June 2005).
Production of a final report documenting implementation of JACIE at the national and Community level for use in widespread communication of the project results to the scientific community, healthcare professionals, national and Community officials and the general public (Dec 2004)
An assessment report on how data collected by the EBMT and JACIE can feed into long-term monitoring and evaluation process will be produced (Dec 2004).

Reports:

Description      -      Financing      -      Outcomes      -      More info

More info

Statement of project aim(s) and objectives

The aims of the project are to provide vital impetus to the JACIE programme and ensure its integral role in standard setting, inspection and accreditation for health institutions and facilities involved in haematopoietic stem cell collection, processing and transplantation in Europe.

The specific objectives are:
1. To harmonise the JACIE standards and programme of accreditation with the Community Directive arising from COM (2002) 319 final and contribute to the ongoing development of technical standards and systems for quality and safety of human tissues and cells.
2. To implement the JACIE standards in health institutions and facilities involved in haematopoietic stem cell collection, processing and transplantation in Member States.
3. To promote the JACIE programme among the scientific community, medical professionals, national authorities, Community officials and the general public, with a view to encouraging harmonisation of standards and systems of accreditation across the Community.
4. To strengthen the central resources for managing and administering the JACIE programme and to extend and enhance the effectiveness of the existing JACIE network.
5. To establish equivalent JACIE training courses for medical professionals and inspectors across the Community and to facilitate the exchange of experience and best practice between them.
6. To contribute to the comparability of data across Member States by supporting the existing network of EBMT and national registries in the collection of compatible and comparative transplant data.

Methods

The JACIE programme currently provides a comprehensive set of standards, developed with reference to International standards, which cover all stages of haematopoietic collection, processing and transplant. It has a full accreditation programme and encourages healthcare institutions and facilities (centres) to voluntarily meet the standards by disseminating information, conducting inspections and issuing certificates of accreditation.

A key objective of this project is to implement the JACIE standards in a core number of centres in Member States. This process will be facilitated through effective centralised administration, training and by covering costs to reduce the economic burden of inspection visits.

Accreditation of a core number of centres within the project timeframe has a strategic role to play in the promotion of the JACIE programme. By demonstrating that the accreditation programme is viable and has the full support of the medical profession, it will serve to promote the standards and accreditation programme among health authorities. The National JACIE Representatives have a key role to play in advocating on behalf of JACIE with the national health authorities. Information on JACIE will be made available for this purpose and meetings will be arranged as required with representatives of the national authorities.

As part of the harmonisation process a contact person will be appointed to the Commission to keep JACIE abreast of Community legislation and open a communication channel. This will also facilitate input by the scientific community into the development of standards and systems for quality and safety management. The JACIE programme will be in line with the requirements of the Community Directive and will continue to be developed in line with Community legislation.

Strengthening central resources is fundamental to the effective management and administration of the JACIE programme and will facilitate extension and enhancement of the existing JACIE network. Taking advantage of the infrastructure and resources currently available at the EBMT Secretariat, a European JACIE Office will be established alongside the Secretariat in Barcelona. Staff will be recruited and bureaucracy and paperwork will be kept to a minimum by developing an Online IT system for the administration and management of the JACIE accreditation programme and dissemination of information.

Training for centres and inspectors will be carried out both centrally and at the national level. Modular training programmes, with core materials and common examination systems will be developed for use in all JACIE training courses. The central office will maintain an overview of training provided and keep an up to date list of trained inspectors. Centrally co-ordinated training will encourage exchange of experience and best practice across the Community. An online forum will also be set-up for this purpose. Best practice will be documented and model materials made available online.

Production of informative materials will be a key tool for building knowledge and awareness of the JACIE programme and for reporting progress of the project. Full use of available media will be made to target key stakeholders, encouraging harmonisation and creating public confidence.

The existing network of EBMT and national registries will be supported in the collection of compatible and comparative transplant data. A programme of training courses on how to submit data using the EBMT database (ProMISe) will be delivered by the EBMT throughout 2004 and an assessment will be made of how the data collected in the registries can contribute to monitoring impact of standards and accreditation in the long-term.

 
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