I’ve completed my registration with ICCBBA and received my Facility Identification Number (FIN). Now what?

This is a comprehensive implementation plan and the applicable steps may vary due to different needs in facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

ISBT 128 defines Plasma Derivatives as, "A product that contains concentrated fractions of plasma proteins that have been separated using physico-chemical or other fractionation processes. It is made from pooling plasma from large numbers of donors and is traced based on the lot or batch number of the pooled product.”

It is recommended that those products for which ABO blood groups is not relevant (e.g., Rh Immune Globulin or Gamma Globulin) be labeled with GS1 bar codes. Conversely, plasma derivatives for which the ABO blood group is relevant should be labeled with ISBT 128.

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

This document is intended to provide guidance to blood bag manufacturers, their customers, and software developers on the bar coding of blood bags and their shipping containers. It deals with the relationship between information held in the GS1 carton codes and the ISBT 128 blood container label codes, and recommends ways to simplify the mapping between this information.

This document visits two mechanisms for assigning patient identification numbers – a globally unique option using the GS1 Global Service Relation Number (GSRN) and a locally assigned number using the ISBT 128 data structure.