The purpose of this document is to provide guidance for the use of Facility Identification Numbers found in a number of ISBT 128 data structures.

The purpose of this document is to provide a mechanism to validate software reading bar-coded labels. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.

The purpose of this document is to provide a toolbox of commonly used items essential for implementing ISBT 128. It also provides guidance and recommended steps for consideration when planning out one’s ISBT 128 implementation.

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.