Both traceability and chain of identity are essential components for patient safety for medical products of human origin (MPHO).
The ISBT 128 Donation Identification Number (DIN) provides a globally unique identifier that can be used to identify all products derived from a single donation. The DIN is also suitable for identifying pools of donations where the pooling process is performed at an ICCBBA licensed facility.
However, 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. To ensure that the individual DINs of the collected donations can be linked, a new identifier, the CoI Identifier is required. The CoI Identifier may be allocated either before, or at the time of, collection of the first donation.
A new ISBT 128 draft standard for a globally unique Chain of Identity (CoI) Identifier is now available for public comment. Both a data structure that can be used in labeling and a data element to be used in the electronic transfer of information 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.
How does the Chain of Identity (CoI) Identifier fit into the ISBT 128 ecosystem?
The CoI Identifier does not replace the DIN on the collection products but will be an additional identifier that is the same on all donations associated with a single patient therapy event.
The CoI Identifier can be utilized on both ISBT 128 Standard labels and non-ISBT 128 labels.
The responsibility for allocating the CoI Identifier may lie with the collecting facility, the clinical trials sponsor, or manufacturers of cellular therapy products. The draft standard supports these approaches.
The public comment period is now open and is scheduled to conclude on August 22. Please direct comments to ST-028comments@isbt128.org.