The 5th edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration are now available from the Document Centre in the Standards section. The related Inspection Checklist is also available in the Checklist section.

A document summarising the main changes introduced in the 5th edition of the FACT-JACIE Standards is now available from the Document Centre.
The Standards, Manual and checklists will be published on 1 March.

Se va a realizar un curso de auditores JACIE el día anterior al comienzo de la reunión GETH  (miércoles 14 y mañana del jueves 15). Es necesario aumentar el número de inspectores (sobre todo en las áreas de obtención y procesamiento y pediatría) y les rogamos le déis difusión entre los componentes de vuestro servicio. Para recibir más información sobre el curso enviar un email a Antoni Aules de JACIE (antoni.aules@ebmt.org) quien les ampliará la información.

Dónde: Hotel Montemálaga Pº Mª Antonio Machado nº 10, Malaga

Ver los requistos para ser auditor JACIE (en inglés).

Web del congreso GETH.

The 5th edition FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration is nearing completion. The following are important dates for cellular therapy programs to remember:

• 5th Edition Publication Date: 01/03/2012
  The final version of the 5th edition Cellular Therapy Standards will be officially published on 01/03/2012.This includes the Accreditation Manual and associated documents.
• 5th Edition Effective Date: 31/05/2012
  The 5th edition Cellular Therapy Standards will be effective from and including 31/05/2012. All applications after this date will be assessed according to the 5th edition.
  

Taking into account the following aspects,

• the publication and implementation dates
• that JACIE requires the Inspection Checklist to be submitted along with the Application Form
• that the 5th edition checklist will not be available until March 1st 2012
• that JACIE Accreditation Office wishes to draw a clear line between the 4th and 5th editions in order to minimise confusion and overlap of different versions of Inspections for inspectors and centres,

the following dates should be noted by centres that expect to apply within the next 2-3 months.

• 31/12/2011 - Final date for acceptance of applications based on the 4th edition of the JACIE Standards
• Between 01/01/2012 - 28/02/2012 inclusive - No new applications accepted.
• 01/03/2012 - Earliest date for accepting applications and checklists based on the 5th editions
  

All centres that have already applied with the 4th edition of the JACIE Standards and are in the process of preparing for the JACIE Inspection must submit the pre-audit documentation before 01/04/2012. All centres that do submit the pre-audit documentation on or after 01/04/2012 will have to restart the application process against the 5th edition of the Standards and submit a new application. Given the effort required to prepare for the inspection, please consider carefully your timing for submission of documentation and completion of the Inspection Checklist.

Use of Data Structure [003] for Cellular Therapy - is now Available for Comment

The draft version 1.0.0. of this document is available for public comment. This is an international document that provides detailed infomation about data structure [003], specifically, it explains:

• the Product Code Data Structure [003] in detail,
• the structure of the data base that supports the product description code,
• how to select an appropriate product description code, and
• how to request new product description codes.

View the document here

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Standard Labeling - Cellular Therapy now Available for Public Comment

This document provides an international labeling guideline for ISBT 128 Cellular Therapy products. Greater detail is given for labeling than that provided in the Technical Specification.
This will in part replace the Product Code Structure and Labeling Document.

View the document here.

Two new flowcharts have been developed for applicants and inspectors to map all of the steps in the accreditation process. 

The two documents can be downloaded from the Document Centre.

The JACIE Welcome Guide gives a general overview of the JACIE Accreditation process - taking you from the initial stage of thinking about applying for JACIE, through the Inspection process, to achieving JACIE Accreditation. The guide answers many frequently asked questions and it also provides a useful timeline and top tips.
We believe that this guide will be of great benefit to centres that are in the process of applying for JACIE Accreditation, as well as to new members of staff that have joined an accredited programme

Go to the Document Centre to download the Guide.

The Journal of Clinical Oncology has published the Gratwohl et al paper on quality management and patient outcome in the BMT setting.

JCO Apr 11, 2011:JCO.2010.30.4121;
published online on April 11, 2011;

In early 2010, the American Society of Histocompatibility and Immunogenetics (ASHI) formed the Harmonization of Histocompatibility Typing Terms Working Group with members representing clinical, registry, and histocompatibility organizations to harmonize histocompatibility typing terms. The goal was to define a consensual language for laboratories,physicians, and registries to communicate histocompatibility typing information.
The Working Group defined terms for HLA typing resolution, HLA matching, and a format for reporting HLA assignments. In addition, definitions of verification typing and extended typing were addressed.
The 2011 article Definitions of histocompatibility typing terms was published in Blood (doi: 10.1182/blood-2011-05-
353 90] and Human Immunology (doi: 10.1016/j.humimm.2011.06.002]).

FACT and JACIE announce the publication of an interim standard to the fourth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration.

Standard B3.1.1 now requires that Program Directors have at least achieved specialist certification, and does not require that board certification be renewed or kept current. The use of the term "achieve" is believed to be compatible with international requirements, and programs are reminded that they must still comply with any applicable laws and regulations requiring recertification.

The interim standard will be effective on May 1, 2011. The following documents have been updated on the JACIE Document Centre:

• 4th Ed. Standards v. 4.1
• 4th Ed. Accreditation Manual v. 4.3
• JACIE Inspection Checklist 4th ed ver.6