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Standards, 7th edition – Key Dates in 2018

posted 29 Nov 2017, 01:10 by Eoin McGrath

The preparation of the 7th edition is approaching its final phase with approval by FACT and JACIE expected for early December. In anticipation of the release on 1 March 2018, the following dates are important for applicants planning to apply in late 2017 or early 2018:

28/02/2018 - This is the final date for sending completed applications based on the 6th edition of the FACT-JACIE Standards. All applications after this date must be made under the 7th edition.

01/03/2018 - The 7th edition of the FACT-JACIE Cellular Therapy Standards, Accreditation Manual, Checklist and associated documents will be published.

29/05/2018 - Final date to submit the complete pre-audit documentation under the 6th edition. Any centre that fails to submit all pre-audit documentation by this date will have to restart the application process under the 7th edition of the Standards and submit a new application

30/05/2018 - The new edition of the Standards becomes effective. Centres already accredited under the 6th edition will not have their accreditation affected. However, all centres are expected to being adapting their processes and systems to the requirements of the 7th edition.

For interim audits, centres will be assessed on the same standards as used for the main inspection. However, all centres are expected to being working on implementing the requirements of the 7th edition as soon as they are published.

Quality @ EBMT2017 video

posted 31 Mar 2017, 05:46 by Eoin McGrath

Quality @ EBMT2017


BMT Special Report on JACIE published

posted 27 Mar 2017, 14:50 by Eoin McGrath   [ updated 31 Mar 2017, 02:16 ]

Advanced online publication in BMT today. "JACIE accreditation for blood and marrow transplantation: past, present and future directions of an international model for healthcare quality improvement". OPEN ACCESS.

New interim standards to cover administration of immune effector cell products in bone marrow transplantation programmes

posted 2 Feb 2017, 01:41 by Eoin McGrath

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 eoin.mcgrath@ebmt.org or telephone +34 93 453 8570 ext. 8101.

Single European Coding system for tissues & cells

posted 10 Oct 2016, 01:45 by Eoin McGrath   [ updated 10 Oct 2016, 01:46 ]

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/.




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