Application Fees JACIE Board Related Publications The Joint Accreditation Committee-ISCT & EBMT is a non-profit body established in 1998 for the purposes of assessment and accreditation in the field of haematopoietic stem cell (HSC) transplantation. JACIE's primary aim is to promote high quality patient care and laboratory performance in haematopoietic stem cell collection, processing and transplantation centres through an internationally recognised system of accreditation. The Committee was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organisations involved with HSC transplantation in Europe. JACIE in collaboration with FACT has established standards for the provision of quality medical and laboratory practice in HSC transplantation; conducts inspections, and accredits programmes that will encourage health institutions and facilities performing HSC transplantation to voluntarily meet these standards; and recognises compliance with standards by issuance of Certificates of Accreditation. Accreditation is the means by which a centre can demonstrate that it is performing to a required level of practice in accordance with agreed standards of excellence. Essentially it allows a centre to certify that it operates an effective quality management system. A quality management system is a mechanism to ensure that procedures are being carried out in line with agreed standards with full participation by all staff members. In a cell transplant programme, this ensures that the clinical, collection and laboratory units are all working together to achieve excellent communication, effective common work practices and increased guarantees for patients. It is a means of rapidly identifying errors or accidents and resolving them so that the possibility of repetition is minimised. It assists in training and clearly identifies the roles and responsibilities of all staff. Once the required level of quality has been achieved, the remaining challenge is to maintain this standard of practice. With a working quality management system in place and adequate resources, the fundamental elements necessary to sustain the programme are continued staff commitment and vigilance. The JACIE Accreditation Programme was supported in 2004 by the European Commission under the Public Health Programme 2003-2008. Fees The fees are as follows: First Inspection Fee: Initial Registration Fee (Paid only at the time of first application and is non-refundable): €1,500 Inspection Fee: This includes one (1) adult OR one (1) paediatric clinical site/unit one (1) collection site for marrow one (1) collection site for peripheral blood progenitor cells one (1) cell-processing laboratory Any additional sites to be inspected will be charged a supplementary fee* €6,000 Supplementary Fee: A supplementary fee is applied where an application includes: • both adult AND paediatric units AND/OR A supplementary fee per site is applied where an application includes: • more than one (1) adult inpatient clinical site • more than one (1) paediatric inpatient clinical site • more than one (1) peripheral blood collection site • more than one (1) bone marrow collection site • more than one (1) cell processing laboratory. €1,000 Independent Facility Accreditation This fee includes one (1) clinical site, OR one (1) collection site, OR one (1) cell processing laboratory Any additional areas to be inspected will be subject to a supplementary fee. €2,000 Reaccreditation Inspection Fee: Registration Fee (Paid only at the time of first application and is non-Refundable): n/a Reaccreditation Inspection Fee: These are calculated on the same basis as for First Inspection Fee (see above) including supplementary fees where applicable. Facilities may choose between two payment options: • Full Payment: Facilities may elect to pay the entire sum, due the final year of their accreditation prior to the renewal inspection. • Annual Payments: Facilities may elect to pay one-third of the renewal fee each year following accreditation. - Examples 1: HPC transplant programme requiring accreditation for one adult clinical unit, one bone marrow collection unit, an apheresis until and a cell processing laboratory will pay: €1500 registration fee + €6000 inspection fee = €7500 2: Combined HPC transplant programme requiring accreditation for their adult and paediatric clinical units, one bone marrow collection unit, an apheresis until and a cell processing laboratory will pay: €1500 registration fee + €6000 inspection fee + €1000 supplement for the additional paediatric unit = €8500 3: Combined HPC transplant programme requiring accreditation for their adult and paediatric clinical units on one site, an additional adult unit in a satellite centre, an apheresis until and a cell processing laboratory will pay: €1500 + €2000 per part + €1000 supplement for the paediatric unit + €1000 for additional clinical site = €9500 4: Cell processing laboratory requiring accreditation will pay: €1500 + €2000 = €3500 The centre will be invoiced for the full amount on receipt of the application. The centre should expect to be ready for inspection within a maximum of 12 months from the date of their application being accepted. If the inspection takes place more than 12 months later, then a centre may have to submit a new application and registration fee. Effective date: The new fees apply from September 8th 2008. An invoice will be sent to the centre upon application. Payment of the accreditation fee must be made in Euros and transferred directly to the JACIE bank account in Maastricht. Please be aware that you must have the IBAN and BIC codes in order to incur lower costs and faciliate faster transfers. The inspection will not be arranged until payment has been confirmed. Payment cannot be made by cheque. You can download this information in PDF from the Document Centre on the left-hand side of this page. The document is called 'Accreditation Fee 5 June 2008...'. If you would like to register for information or apply for accreditation please consult the home page of this web site or contact the JACIE Office at jacie@ebmt.org. JACIE Board Executive Committee President: Ineke Slaper-Cortenbach (ISCT) Vice-President: Jane Apperley (EBMT) Medical Director: Diana Samson Accreditation Committee chair: Derwood Pamphilon National & Sectoral Representatives Related publications Standards for the Terminology and Labeling of Cellular Therapy Products. Paul Ashford et al. Transfusion Volume 47 Issue 7 Page 1319-1327. Current status of JACIE accreditation in Europe: a special report from the Joint Accreditation Committee of the ISCT and the EBMT (JACIE). D. Samson et al. Bone Marrow Transplant (2007) 39, 133–141. ASBMT White Paper on Measurement of Quality Outcomes. Committee on Hematopoietic Cell Therapy Quality Outcomes. Biology of Blood and Marrow Transplantation 12:594-597 (2006). American Society for Blood and Marrow Transplantation. What Is Quality in a Transplant Program? C. Fred LeMaistre, Fausto R. Loberiza, Jr. Biology of Blood and Marrow Transplantation 11:241-246 (2005) Who will regulate the regulators? J M Goldman. Bone Marrow Transplantation (2004) 34, 1013-1014 Implementation of the JACIE standards for a haematopoietic progenitor cell transplantation programme: a cost analysis. Zahnd D, Leibundgut K, Zenhausern R, Pabst T, Fontana S, Schneider R, Tobler A, Zwicky C. Bone Marrow Transplant. 2004 Nov;34(10):847-53. Just Another Cost Increasing Exercise (JACIE)? Apperley J. Bone Marrow Transplant. 2004 Nov;34(10):835-8. Real-time process/quality control for HPC processing. Arpagaus M, Leibundgut EO, Zbaren K, Brunold C, Ischi E, Tobler A, Zwicky C. Cytotherapy. 2004;6(5):505-13. Stem-cell harvesting and manipulation. D. Pamphilon. Vox Sanguinis Volume 87 Issue s1 Page 20 - June 2004 Impact of regulations on translational research in cell and gene therapy: the US experience. Raphaël F. Rousseau, Adrian P. Gee. (French). Bulletin du Cancer. Number 91, volume 3, 239-47, MARS 2004 Outbreaks of infectious diseases in stem cell transplant units: a silent cause of death for patients and transplant programmes. McCann S, Byrne JL, Rovira M, Shaw P, Ribaud P, Sica S, Volin L, Olavarria E, Mackinnon S, Trabasso P, VanLint MT, Ljungman P, Ward K, Browne P, Gratwohl A, Widmer AF, Cordonnier C; Infectious Diseases Working Party of the EBMT. Bone Marrow Transplant. 2004 Mar;33(5):519-29. Quality issues in stem cell and immunotherapy laboratories. L. Smith and M. W. Lowdell. Transfusion Medicine Volume 13 Issue 6 Page 417 - December 2003 JACIE accreditation in Europe moves ahead. Kvalheim G, Gratwohl A, Urbano-Ispizua A; JACIE national representatives.Cytotherapy. 2003;5(4):306-8. The role and activities of the ISCT Regulatory Affairs Committee. Kelley L Cytotherapy. 2003;5(4):279-83 Development and operation of a quality assurance system for devaitions from standard operating procedures in a clinical cell therapy laboratory.McKenna D, Kadidlo D, Dumstad D, McCullough J. Cytotherapy 2003, 5: 314-322. Voluntary accreditation of cellular therapies: Foundation for the Accreditation of Cellular Therapy (FACT). Warkentin PI; Foundation for the Accreditation of Cellular Therapy. Cytotherapy. 2003;5(4):299-305. Current regulatory issues in cell and tissue therapy. Burger, SR. Cytotherapy. 2003;5(4):289-98. Donor-derived hematopoietic stem cells in organ transplantation: technical aspects and hurdles yet to be cleared. Herve, Patrick. Transplantation. 75(9) Supplement:55S-57S, May 15, 2003. Validation of Haematopoietic Progenitor Cell Processing. Arpagaus M, Oppliger Leibundgut E, Zbären K, et al. Schweiz Med Forum 2003; (suppl.12): 67S (abstr. P423). Implementation of the JACIE-standards for hematopoietic stem cell transplantation at the university hospital of Bern, Switzerland Zahnd D., Schneider R., Tobler A., Zwicky C. ISQua Conference, Paris 8 November, 2002. Oral Presentation 231 Regulation of hematopoietic stem cell processing and transplantation. Rowley SD. Int J Hematol. 2002 Apr;75(3):237-45. A European reference protocol for quality assessment and clinical validation of autologous haematopoietic blood progenitor and stem cell grafts. Serke S, Johnsen HE. Bone Marrow Transplant. 2001 Mar;27(5):463-70. Regulatory aspects and accreditation of the clinical use of hematopoietic progenitor cells in Europe. Kvalheim G, Urbano-Ispizua A, Gratwohl A. J Biol Regul Homeost Agents. 2001 Jan-Mar;15(1):79-80. Standards of stem cell transplantation: Part I: the accreditation of paediatric stem cell transplantation centres within the EBMT; Part II: intensive care units in paediatric stem cell transplantation; Part III: informed consent and sibling donor issues. Cornish J, Peters C. Bone Marrow Transplant 2001; 28 (suppl. 1):S4-S5. FAHCT accreditation: common deficiencies during on-site inspections. Warkentin PI, Nick L, Shpall EJ. Cytotherapy. 2000;2(3):213-20. FAHCT-JACIE workshop on accreditation for blood and marrow progenitor cell processing, collection and transplantation, Barcelona, Spain. Kvalheim G, Urbano-Ispizua, Gratwohl A. Cytotherapy 2000; 2: 223-224. Can improving quality decrease hospital costs? Jarlier A, Charvet-Protat S. Int J Qual Health Care. 2000 Apr;12(2):125-31 EBMT and ISHAGE-Europe create a foundation for inspection and accreditation in Europe. Editorial. Kvalheim G. Cytotherapy 1999; 1: 363-364. Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) response to FDA (Docket no. 97N-0068). FAHCT Board of Directors. Shpall EJ. J Hematother. 1997 Aug;6(4):287-9. as follows: