Abstract
Cellular therapy products frequently need to cross multiple borders, continents, and jurisdictions from collection to administration to the recipient. International standardization is required to transfer information critical to patient safety in an accurate and secure manner regardless of the source and destination of the products and to ensure effective traceability. ISBT 128 fulfills this requirement through international standardization of the identification, terminology, coding, and labeling of medical products of human origin. Its successful implementation worldwide required involvement of many professional organizations. This chapter presents the historical perspective and addresses key elements of traceability and ISBT 128. Uniqueness of both donor and donation identification, structured standardized terminology, and Product Description Codes and product database are introduced and illustrated with examples. Finally, the role of ICCBBA, supported by stakeholder involvement through technical advisory groups, in ensuring the continuous development of ISBT 128, is presented.
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Szczepiorkowski, Z.M., Ashford, P. (2022). ISBT 128 in Labeling of Cellular Therapy Products. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_30
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DOI: https://doi.org/10.1007/978-3-030-75537-9_30
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