International Cellular Therapy Coding and Labeling Advisory Group
Work Program
Three task groups have been working on specific tasks:
Terminology Task Group - Leader Phyllis Warkentin
This group has developed an international terminology for product descriptions, ensuring that all terms are adequately defined. This has involved a review of the current ISBT 128 database to identify any redundant or inaccurate terms. The group is finalizing its Terminology recommendation.
Labeling Task Group - Leader Adrian Gee
The group has developed label designs, based as much as possible on the ISBT 128 four quadrant model, that can be used for the full range of cellular therapy products. The group has taken into account the labeling requirements of other bodies including FACT, JACIE, European Commission, Council of Europe and FDA. The group is finalizing its Labeling recommendation.
Implementation Task Group - Leader Kathy Loper
This group has considered the logistics requirements of implementing ISBT 128 and has prepared best practice guidance. The recommendations are being finalized.
Cellular Therapy Documents for Review
The United States Industry Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128, Version 1, DRAFT G
This US document is the result of the collaborative efforts of AABB, ASBMT, ASFA, FACT, ICCBBA, ISCT, and NMDP. It is available for public comment until August 1, 2008. All comments will be taken into consideration prior to the final publication of the document. Please e-mail your comments to ICCBBA.
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