The new ISBT 128 Standard for the Chain of Identity (CoI) Identifier (ST-028), developed based on requirements developed collaboratively with the Standards Coordinating Body (www.standardscoordinatingbody.org) (SCB), has been published. John Kling, President and Jeff Dragoo, CTO of Digi-Trax, both serve on the ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group.

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 given therapy. This new identifier provides a standardized, globally unique identifier that can be used to link these donations together. The CoI Identifier should be allocated either before, or at the time of, collection of the first donation.

The CoI Identifier data structure was also added to ISBT 128 Standard Technical Specification (ST-001), and the label examples in ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturers (ST-018) have been updated. All ISBT 128 standards and implementation guides are available to the public in the technical library on the ICCBBA website (www.isbt128.org).

ICCBBA thanks all who contributed to this effort, either by participating with the SCB, serving on ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group or Standards Committee, or providing comments during the public comment period.

Our HemaTrax®-CT Cellular Therapy labeling software supports the ICCBBA ST-028 CoI standard. When your facility is ready to implement CoI, HemaTrax®-CT is ready to support your CT labeling efforts.

For more information on this standard, visit ICCBBA’s ST-028 web page.

Learn why FACT is enouraging accredited facilities to participate in clinical trials and provide advanced celllar therapies to their patients. Handwritten information create risks of product mix-ups with incorrect information. Read more >>

At right, read how our MFG label format can be used for your CT clinical trial “split labeling” solution.