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Current status of JACIE accreditation in Europe: a special report from the Joint Accreditation Committee of the ISCT and the EBMT (JACIE)

Abstract

JACIE (Joint Accreditation Committee of the ISCT and the EBMT) launched its first official inspection programme in January 2004. Since then, 35 centres in Europe have been inspected. Almost all were found to be functioning at a high level of excellence, with the majority having only minor deficiencies in compliance with the standards. In one-third of centres there were more significant deficiencies. The most common deficiencies were in quality management, and a survey of the applicant centres confirmed this was the area where centres experienced most difficulty in preparation for accreditation. Following correction of deficiencies, 28 centres have at the time of writing achieved full accreditation. Implementation of JACIE required a significant investment of time and resources by applicant centres. The majority required at least 18 months to prepare for accreditation and 85% needed to employ a quality manager and/or data manager on an ongoing basis. However, all centres felt their programme had benefited from the implementation of JACIE. In addition to the inspection and accreditation of individual centres, JACIE maintains an educational programme including training courses for inspectors and for centre preparation. JACIE is also working closely with other international organisations working in cellular therapy to develop international standards for all aspects of stem cell transplant. The recent implementation of Directive 2004/23/EC has provided an impetus for the implementation of JACIE in EU member states and in particular the requirements for safety of imported tissues and cells have emphasised the need for global harmonisation.

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References

  1. Directive 2004/23/EC. http://europa.eu.int/scadplus/leg/en/cha/c11573.htm.

  2. Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:038:0040:01:EN:HTML.

  3. Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006L0086.

  4. JACIE Standards. 2nd edn, 2003, modified Jan 2005: www.jacie.org.

  5. NETCORD: Details of Cord Blood Bank accreditation process. http://www.unmc.edu/Community/fahct/NETCORD_Accreditation_Procedure.htm.

  6. JACIE: Requirements for inspectors. www.jacie.org/portal/jacie/inspectors.

  7. Warkentin PI, Nick L, Shpall EJ . FAHCT accreditation: common deficiencies during on-site inspections. Cytotherapy 2000; 2: 213–220.

    Article  CAS  Google Scholar 

  8. International Cell Therapy Coding and Label Advisory Group. http://www.iccbba.com/.

  9. Zahnd D, Leibundgut K, Zenhausern R, Pabst T, Fontana S, Schneider R et al. Implementation of the JACIE standards for a haematopoietic progenitor cell transplantation program: a cost-analysis. Bone Marrow Transplant 2004; 34: 847–855.

    Article  CAS  Google Scholar 

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Acknowledgements

In 2004, the European Commission part-funded the JACIE Project under the Programme of Community action in the field of public health (2003–2008). The total project budget of €351, 695 was also supported by the EBMT and ISCT, and a number of national haematology and HSCT societies, We would like to acknowledge the assistance of Sarah Craig, JACIE administrative officer, and Sara Notley, EBMT administrative officer in the work of JACIE and the preparation of this paper.

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Samson, D., Slaper-Cortenbach, I., Pamphilon, D. et al. Current status of JACIE accreditation in Europe: a special report from the Joint Accreditation Committee of the ISCT and the EBMT (JACIE). Bone Marrow Transplant 39, 133–141 (2007). https://doi.org/10.1038/sj.bmt.1705564

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