See also Events for training courses and other events of interest.
Please welcome Eva Controle to the EBMT. Eva joined the Barcelona EBMT Executive Office as a JACIE Accreditations Coordinator in February 2017.
Eva is from France and received her Bachelor degree in Biotechnology in Paris. Her professional experience has been in Clinical Research. She worked in this field in Paris, London and most recently, Barcelona.
She speaks French, English and Spanish.
New interim standards to cover administration of immune effector cell products in bone marrow transplantation programmes
FACT and JACIE have published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration.
The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others.
The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.
The new standards were initially developed by the FACT Immune Effector Cell Task Force and then JACIE experts were invited to contribute to the final version that is now incorporated into the FACT-JACIE Standards, edition 6.01.
The new editions of the Standards and Manual are attached here. They can also be downloaded from the JACIE website at www.jacie.org/document-centre in the Standards section.
If you are not utilizing any immune effector cell products, these standards do not apply to the transplant program, and you can complete the checklist as “NA” (not applicable) for the new standards.
If your haematopoietic cellular therapy (HCT) transplant program begins using immune effector cells, you must be in compliance with these standards as part of starting the new activity. These aspects will be assessed at the next on-site inspection.
Current accreditation awards do not include the administration of these products.
For any questions, please contact firstname.lastname@example.org or telephone +34 93 453 8570 ext. 8101.
Changes to the JACIE fees structure were approved by the EBMT Executive Committee on 09 January 2017 and presented to the EBMT Board on 14 January 2017. Effective from Monday 17 April 2017.
For applications received before 17 April 2017, please click here to see applicable fees.
This is the third JACIE fee increase since 1 January 2009. Since then inspections have increased from 23 in 2009 to 64 in 2016 with the associated increase in inspectors’ travel and other costs including the per diem payment introduced in 2014.
Apart from covering established costs, the increased fee income will be invested as follows:
For more information please go here.
The full programme for the Quality Management Day has been published on the meeting website at www.ebmt2017.org/quality-management.We hope to see you by the Mediterranean in Marseilles in March!
Registration and other details will be published shortly. If you are interested in receiving more information, please write to email@example.com.
JACIE plans to run several events in 2017. These events will primarily be aimed at training new inspectors. If places remain, these will be open to other participants.
If you are interested in hosting an event on JACIE in your country, please contact firstname.lastname@example.org.
See also the Spanish Society of Hematology and Hemotherapy (SEHH) bulletin (in Spanish).
12 Diciembre 2016Spanish | English
La Organización Nacional de Trasplantes (ONT), la Sociedad Europea para el Trasplante de Médula Ósea (EBMT, en sus siglas en inglés) y la Fundación Calidad en Transfusión Sanguínea, Terapia Celular y Tisular (FCAT) han firmado un convenio de colaboración, encaminado a asegurar la mejora continua y la máxima calidad en todos los procedimientos clínicos necesarios para efectuar trasplantes de células madre sanguíneas.
The Spanish National Transplant Organisation (Spanish acronym: ONT), the European Society for Blood and Marrow Transplantation (EBMT) and the Foundation for Quality in Blood Transfusion, Cellular Therapy and Tissue Therapy (FCAT) signed a partnership agreement on Monday morning aimed at ensuring ongoing improvement and the utmost quality in all the clinical procedures necessary for conducting haematopoietic stem cell transplants.
See the JACIE section of the latest EBMT Newsletter.Includes:
Access previous editions here.
The long-awaited Single European Coding (SEC) system for tissues and cells is closer to being fully implemented. EU Member States are required to transpose the provisions of Directive (EU) 2015/565 into their national legislation by 29 October 2016 and then should apply the requirements on the SEC from 29 April 2017.
The ICCBBA, the organisation behind ISBT128, has prepared a guide "Simultaneous Implementation of the Single European Code and ISBT 128".
To support the SEC, the EU Commission has launched the EU Coding platform. The platform will allow public, free of charge access to the EU Tissue Establishments Compendium and the EU Tissue and Cell Product Compendium.
The link to the EU Coding Platform is available here: https://webgate.ec.europa.eu/eucoding/.
JACIE introduces a new version of the Checklist which reflects QM inspector inclusion in the inspection teams
From September 1st, 2016, centres submitting applications for accreditation or re-accreditation will be required to submit version 9 of the checklist (CH-001-09-Inspection Checklist). The contents of the checklist have not been modified since the publication of the 6th edition of the Standards. In this new version, QM Standards have been separated into individual sections of the Checklist to better manage the inclusion of the QM inspector into the inspection teams.
This version replaces all previous versions and older versions of the checklist will not be accepted after August 31st, 2016. Given that the contents of the checklist remain without change and have only been reorganized, if needed it should not be difficult to transfer the information from an older version of the checklist into the current one. Centers that might have started working on an older version are kindly requested to transfer the information to the current version.
Please note that the checklist includes an Instructions section. A brief tutorial for the current version of the Checklist will be available in the Fall. In the meantime, if you have any questions regarding the checklist please do not please do not hesitate to contact the JACIE Office.
The checklist entitled 'CH-001-09-Inspection Checklist' can be accessed in the 'Document Centre' in the 'Checklist' section.
Also by clicking HERE.
Mapping of More Stringent Tissues and Cells Donor Testing Requirements - Mapping Exercise 2015More
Directive 2004/23/EC defines the mandatory tests that must be performed on tissues and cells donors each time they donate. The legal basis of this legislation allows Member States to adopt more stringent measures on a national basis. Implementation surveys have indicated that many Member States have done this, in some cases in response to local epidemiological risks and in some other cases because they consider that a higher level of safety can be ensured with these more stringent provisions. The more stringent measures are either adopted in national legislation and/or they are defined by national standards organisations to be taken into consideration by authorities in their regular inspections.