Solicitating Your Opinion! A New ISBT 128 Standard for Chain of Identity (COI) Identifier has been Proposed and Your Input is Requested – Comments Now Due September 13th
Updated on August 19, 2022
ICCBBA, the organization that develops and maintains ISBT 128 coding and labeling technology for products of human origin (including cellular therapy products), has developed a draft standard for a Chain of Identity (COI) identifier. This draft titled, ISBT 128 Standard Chain of Identity (CoI) Identifier – ST-028, is available for public comment until September 13, 2022. This is an extension from the original due date of August 22nd.
ICCBBA introduced this draft standard as the following: “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.”
ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) and its Standards Committee reviewed the requirements developed by the Standards Coordinating Body and incorporated their comments and suggestions into this draft.
FACT encourages professionals in all areas of cellular therapy product collection, processing, and administration to review the proposed standard and provide comments.
Review the Chain of Identity (COI) Identifier Standard
Submit Comments to STfirstname.lastname@example.org