ISBT 128 “Print-on-Demand” Labeling System Validation
Any software automation process of labeling or re-labeling modified blood products (i.e., making components, aliquoting, pooling) requires validation to ensure that the labels generated accurately reflect the ICCBBA ISBT 128 nomenclature associated with the final blood product produced. Both stand-alone and blood bank software-integrated labeling systems must be validated.
TxMS has developed proprietary ISBT128 label validation scripts to allow you to rapidly verify that your output labels are accurately reflecting the proper ABO/Rh type, component descriptions, donation category, aliquots, volumes, donation warnings, etc. as required by ICCBBA ISBT128 standards. The output labels created by this process can be attached directly to the script document for easy review by staff, management and regulatory agencies.
TxMS label validation scripts contain:
- Instructions for step-by-step label generation and validation
- Instructions for comprehensive testing of all standard functions
- Comprehensive testing (for integrated systems) of labeling output for modifications of blood components (making components, aliquoting and pooling)
- Customization for each of your sites using your actual ISBT128 codes and your suppliers
- Your codes in both barcode format, ready-to-scan for easy data entry into the system, and “human readable” format
- ICCBBA Standard descriptions for each code, for determining acceptability of results
Blood Supplier Label Validation
When your blood supplier converts to ISBT128, you will be faced with demonstrating that their barcoded labels accurately scan into your blood bank information system. TxMS blood supplier label validation scripts test and document that all modules or functions of your blood bank information system that use the barcode scanning capabilities function as expected.
We customize the validation script with client-specific ISBT128 barcoded unit numbers, supplier identification, component type E codes, ABO/Rh types and expiration dates, for scanning to populate specific fields in your system for the following applications:
- Entering blood components into inventory
- Blood component testing
- Results of testing blood components
- Allocation of blood components to patient for transfusion
- Issue of blood component to patient for transfusion
- Blood component unit update
- Blood component unit correction
- Ship-out or transfer of blood components to another facility
- Testing of invalid codes, as recommended by ICCBBA ISBT 128
