There are circumstances in the collection and processing of cellular therapy products for further manufacture where more than one donation may need to be collected to deliver a specific therapy event. A Chain of Identity (CoI) identifier is needed to link disparate collections that will be used for the same therapy event. At the current time, the CoI identifier is manufacturer-dependent, varies in format between manufacturers, and may not be unique across different manufacturers. To standardize the CoI Identifier, a new ISBT 128 data structure (Data Structure 040) and data element (ChainOfIdentityIdentifier) have been developed utilizing the requirements collaboratively defined by the Standards Coordinating Body for Regenerative Medicine. The specifications for the data structure and data element are defined in the draft ISBT 128 Standard Chain of Identity (CoI) Identifier – ST-028.
The draft standard has incorporated comments/suggestions from ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) and Standards Committee.
The document is available for public comment from July 25 through September 13, 2022.
Comments should be directed to ST-028comments@isbt128.org.
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