ISBT128 Labelling

Cellular therapy products are frequently collected in other countries and shipped worldwide. To ensure the safety of these irreplaceable products it is imperative that they are uniquely identified and labelling is readable across multiple languages.

ISBT128 is a barcode system that uses a globally unique identification number generated from an allocated facility identification number (FIN) and donation identification number (DIN). The unique identification is barcoded on product labels along with key donor/patient and collection/processing information designed to meet international and national standards. ISBT128 allows encoded information to be transferred from one computer system to another in a way that is unambiguous and accurate.

The use of ISBT128 labels is mandated for unrelated donor products that cross state and national borders. This accounts for a quarter of the products collected or infused in NSW. ISBT128 is also mandatory for paediatric centres to comply with the Foundation for the Accreditation of Cellular Therapies (FACT) standards. Effector Cell Translational sites involved in administration of commercial chimeric antigen receptor T-Cells are also required to use ISBT128 labelling to meet pharmaceutical requirements.

ISBT128 is not available through the current hospital IT solutions. To avoid duplication across the health system an ISBT128 software system STAFA-CT has been procured.

STAFA-CT is specifically designed software that can be accessed by all sites securely with data separated for each clinical program. The software is browser based and hosted by eHealth NSW on a central server. Staff can access at each critical time point (collection, laboratory and infusion) to generate and authenticate labelling data.

This project aims to implement a centralised system for ISBT128 that can be accessed by twelve blood and marrow programs across ten local health districts that collect and infuse blood and marrow products in 2020-21.