News

See also Events for training courses and other events of interest.

Circular of Information - 2016 edition now available

posted 6 Jun 2016, 04:20 by Eoin McGrath   [ updated 6 Jun 2016, 04:22 ]

This Circular is intended to provide general information to those who administer cellular therapy products, and serves as an extension and enhancement of the label found on the cellular therapy product.

It was prepared jointly by the AABB, America’s Blood Centers, the American Association of Tissue Banks, the American Red Cross, the American Society for Apheresis, the American Society for Blood and Marrow Transplantation, the College of American Pathologists, the Cord Blood Association, the Foundation for the Accreditation of Cellular Therapy, ICCBBA, the International Society for Cellular Therapy, the Joint Accreditation Committee of ISCT and EBMT, the National Marrow Donor Program, and Netcord.

Access the document here at the ICCBBA website.

Extended to 1 July - Feedback on HSCT standards requested for preparation of next edition

posted 19 Apr 2016, 07:43 by Eoin McGrath   [ updated 31 May 2016, 05:47 ]

The FACT-JACIE Standards Committee will begin drafting the 7th edition International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration Standards in June 2016. FACT and JACIE invite you to complete a short survey focusing on general concepts of interest.
You are also encouraged to promote this survey in your national or regional professional society. The results of this survey will be reported to the Standards Steering Committee for review and consideration. Input from programs, facilities, and individuals performing cellular therapy helps maintain the clarity, usefulness, and relevance of the Standards.

Due to ongoing interest, responses will continue to be accepted up to July 1, 2017.
 
www.surveymonkey.com/r/FACT-JACIE7thEDSurvey

JACIE Training Course, Barcelona 6-7 October 2016

posted 15 Apr 2016, 01:28 by Eoin McGrath   [ updated 15 Apr 2016, 01:29 ]

JACIE will host a training course in Barcelona in October. More details can be found here.

Note that an additional event is being scheduled for Nijmegen, The Netherlands for 27-28 October 2016. More details will be announced shortly.

Post-EBMT 2016 - JACIE

posted 8 Apr 2016, 01:48 by Eoin McGrath   [ updated 8 Apr 2016, 01:55 ]

Thanks to everyone who attended the quality sessions and especially to all of the speakers. Feedback was great even if the room was sometimes a bit noisy. We have some ideas for 2017 in Marseille.
Anyone who attended can get access at no cost to all of the slides via the eMaterials service e-materials.com/ebmt2016.

A nice video was also made as part of EBMT TV featuring Prof. John Snowden and Dr. Riccardo Saccardi explaining why they think that quality and accreditation are important for transplantation. See it on YouTube below.

EBMT TV video on JACIE


Nature | News: "How quality control could save your science"

posted 1 Apr 2016, 08:58 by Eoin McGrath

Nice piece from Nature (27-01-2016)
"Having data that are traceable — down to who did what experiment on which machine, and where the source data are stored — has knock-on benefits for research integrity"
Access the article here.

English-Spanish glossary of quality management terms

posted 5 Feb 2016, 02:42 by Eoin McGrath   [ updated 5 Feb 2016, 02:43 ]

The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA) and Worldwide Network for Blood & Marrow Transplantation (WBMT) along with the Latin American Group for Bone Marrow Transplantation (LABMT) have facilitated the preparation of a simple glossary of quality management terminology to help create awareness and understanding of basic but important quality management terminology among Spanish-speaking transplant professionals. The glossary can be accessed at www.ahcta.org/documents.html.

JACIE introduces new fees and agreement document for applications.

posted 5 Jan 2016, 02:18 by Eoin McGrath   [ updated 9 Feb 2016, 04:11 ]

From 1 January 2016, centres submitting applications for accreditation will be required to sign an agreement with the EBMT which covers all aspects of the accreditation process. The agreement sets out the rights and obligations of both organisations during the process. This agreement replaced the previous terms and conditions document.
The document entitled 'F-009-01-Standard Agreement for JACIE Accreditation' can be accessed in the Document Centre in the 'Applicants' section.

New applications must also be completed using the updated application form, also available in the Document Centre.

Both documents are also linked below.

New fees will also be applied from 3 April 2016. See here for more information.

Changes in the JACIE Accreditation Process for 2016

posted 30 Nov 2015, 03:41 by Iris Bargallo   [ updated 30 Nov 2015, 03:47 ]

JACIE has reviewed the current Accreditation process with the objective to improve and optimize the process for all parts involved. Our goal is to make the process shorter for centres that are already well prepared for the accreditation and to identify the centres that need more time and support from the JACIE Office to prepare their application sufficiently in advance of any eventual inspection.

Therefore the following changes will be introduced with effect from 1 January 2016: 

  • Applicant centres will be required to formally accept a quotation for the fees. This will make clear the scope of the accreditation and related costs at the earliest possible point in the process in order to avoid misunderstandings and time-consuming corrections at a later date.
  • Applicants must sign an agreement with the EBMT (JACIE’s parent organisation) once the application for Accreditation is approved. This document outlines the responsibilities both of JACIE and of the centre. 
  • Applicant centres will be required to submit the Pre-audit documentation within 30 days from receipt of the service agreement signed by the centre’s representative. Where an applicant delays more than 30 days in submitting the pre-audit documentation, the accreditation process of the centre will be considered expired and the centre must restart the process

You will find the process in detail in the applicant's flowchart and in the JACIE Inspection guide, both documents can be downloaded from the Document Centre in this website.

If you have any queries, please do not hesitate to contact the JACIE Office.

EDQM Survey on Tissues and Cells Guide 2015

posted 25 Nov 2015, 06:44 by Eoin McGrath   [ updated 17 Dec 2015, 02:14 ]

The EDQM Guides are excellent and accessible sources for help on all aspects associated with tissues and cells including HSC. EBMT experts have contributed to the Guides in the past and to the 3rd edition which is currently in preparation.
The review committee have launched a survey to help them understand how it has been accessed and used in the past. You are now invited to participate in this review by completing the survey. The survey is expected to take between 5-10 minutes to complete.

New data indicate that country- and center-specific economic factors impact on survival after HSCT

posted 24 Nov 2015, 08:31 by Eoin McGrath   [ updated 25 Nov 2015, 02:21 ]

Abstract

Hematopoietic stem cell transplantation (HSCT) is a lifesaving expensive medical procedure. Hence, more transplants are performed in more affluent countries. The impact of economic factors on patient outcome is less defined. We analyzed retrospectively a defined cohort of 102,549 patients treated with an allogeneic (N = 37,542; 37%) or autologous (N = 65,007; 63%) HSCT. They were transplanted by one of 404 HSCT centers in 25 European countries between 1999 and 2006. We searched for associations between center-specific microeconomic or country-specific macroeconomic factors and outcome. Center patient-volume and center program-duration were significantly and systematically associated with improved survival after allogeneic HSCT (HR 0·87; 0·84–0·91 per 10 patients; p < 0·0001; HR 0·90;0·85–0·90 per 10 years; p < 0·001) and autologous HSCT (HR 0·91;0·87–0·96 per 10 patients; p < 0·001; HR 0·93;0·87–0·99 per 10 years; p = 0·02). The product of Health Care Expenditures by Gross National Income/capita was significantly associated in multivariate analysis with all endpoints (R2 = 18%; for relapse free survival) after allogeneic HSCT. Data indicate that country- and center-specific economic factors are associated with distinct, significant, systematic, and clinically relevant effects on survival after HSCT. They impact on center expertise in long-term disease and complication management. It is likely that these findings apply to other forms of complex treatments.

Gratwohl, A., Sureda, A., Baldomero, H., Gratwohl, M., Dreger, P., Kröger, N., … Brand, R. (2015).  Economics and Outcome After Hematopoietic Stem Cell Transplantation: A Retrospective Cohort Study. EBioMedicine. doi:10.1016/j.ebiom.2015.11.021

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