This toolbox contains helpful items to provide guidance in the process of implementing the ISBT 128 standard.
What is ISBT 128?
This provides a brief overview of the information environment and the ISBT 128 Standard. New users who are unfamiliar with ISBT 128 or the elements that contribute to standardization may find this useful.
I’ve completed my registration with ICCBBA and received my Facility Identification Number (FIN). Now what?
This document provides a number of recommended actions to take after registering with ICCBBA. Users who aren't sure what to do next can refer to this document for the next steps in their implementation process.
Example Implementation Plan (TB-012 ISBT 128 Implementation Plan)
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.
A technical explanation (with citations/references) on common ISBT 128 Data Structures:
Facility Identification Number Database
The Facility Identification Number (FIN) Database contains all FINs and information from registered facilities. The database allows users to see where a product was collected or processed.
🔒Product Description Code Database*
The ISBT 128 Product Description Code Database contains the product description codes for all types of medical products of human origin (e.g., blood components, cellular therapy, tissues, etc.). These codes are used in the ISBT 128 Product Code. Click here for more information about the product code. (Note: you must be a registered user to view this page).
ISBT 128 Product Lookup Program
This program contains all current product description codes and allows users to search across all product types for the codes they need. The program may also be used to look up a code's product description. Instead of looking through the thousands of codes in the ISBT 128 Product Description Code Database, the program makes it easier to search for codes you need.
Here are some label examples that were provided by ISBT 128 registered and licensed facilities from various places around the world.
Audit Tool for Cellular Therapy
This audit tool may be used for ensuring compliance with the ISBT 128 Standard. It contains interactive and printable checklists that can be used to verify that a facility has successfully implemented ISBT 128.
ST-001 ISBT 128 Standard Technical Specification
This document is a comprehensive description of the rules surrounding the ISBT 128 standard, as well as guidance in the interpretation of these rules. Users can reference this document for help with regards to the coding and labeling of medical products of human origin (e.g., blood components, cellular therapy products, tissues, etc.).
ST-002 ISBT 128 Standard Terminology for Medical Products of Human Origin
The Standard Terminology document provides definitions to all ISBT 128 terminology. This terminology is used to create the unique product description codes in the ISBT 128 Product Description Code Database. The document should be used in conjunction with the ISBT 128 Product Description Code Database.
ST-010 ISBT 128 Standard Product Description Code Database
This document provides specifications and guidance for the use of the ISBT 128 Product Description Code Database. Reference this document for help with understanding the structure of the ISBT 128 Product Description Code Database.
🔒IG-043 Implementation Guide: A Validation Tool for ISBT 128 Data Structures
This document contains a number of valid and invalid barcodes that may be used to validate software that reads and interprets ISBT 128 barcodes. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.
🔒IG-033 Implementation Guide: Use of the Donation Identification Number [Data Structure 001]
This document provides guidance for the use of the Donation Identification Number (DIN) [Data Structure 001]. It goes into detail regarding each element that makes up the DIN.
🔒IG-034 Implementation Guide: ISBT 128 Facility Identification Number
This document provides guidance for the use of Facility Identification Numbers (FINs) found in a number of ISBT 128 data structures. If you are also unsure if you need multiple FINs or a single FIN, this document provides some scenarios regarding the usefulness of multiple and single FINs in an organization.