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Revisions to ISBT 128 nomenclature for cellular therapy

      ISBT 128 terminology has been widely adopted by cellular therapy facilities globally and its use has been an accreditation requirement by AABB, FACT and JACIE for several years. Accredited facilities are now required to put in place an implementation plan for the full use of ISBT 128 coding and labeling in addition to terminology, and many facilities are moving forward with this implementation. Responding to regulator concern about the use of TC (“therapeutic cell”) terminology, the Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) re-evaluated existing terminology. As a result of this review, a revision of the terminology was drafted to eliminate the “TC” class designation and to create a more consistent format for cellular therapy class terms. The revised terminology also takes into consideration consistency with nomenclature used for tissue products. Changes will not affect HPC terminology which represents about 65% of ISBT 128 product description codes. For class names that will change, not all nomenclature changes will result in a change to the ISBT 128 product description code (“S” code). While accepting that changing terminology will create rework for facilities that have implemented ISBT 128 and delay for those in the process of implementation, it is felt the revised terminology provides a strong foundation for consistent nomenclature as new products are developed and addresses regulatory concerns. An appropriate timescale for implementation of the revised terminology will be developed.
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