Technical Director, ICCBBA ICCBBA San Bernardino, California, United States
Background/Case Studies: Secure transfer of information on product identification and characteristics is essential for the safe use of blood and cellular therapy products. Standardized terminology and internationally agreed reference tables ensure clarity and consistency of meaning and permit the use of automated data transfer systems, thus avoiding the risks associated with manual transcription errors. The ISBT 128 Standard supports this objective and has been widely adopted. ISBT 128 was designed to support the transfer of information using bar codes on product labels. The increasing use of electronic messaging and electronic health records drives the need to allow the same standardized information to be embedded in electronic messages.
Study
Design/Methods: The ISBT 128 Standard was systematically reviewed to identify the individual data elements that are used within the data structures used in bar codes. A new standards document was developed to present these data elements in a format suitable for their use in electronic messages. Each data element was assigned a universal resource identifier in the form of a web address.
Individuals knowledgeable about the ISBT 128 Standard worked with the HL7 Orders and Observations Committee to modify the existing Fast Healthcare Interoperability Resource (FHIR) Standard biologically derived product resource to allow it to accommodate the ISBT 128 information required for blood, cellular therapy, and other medical products of human origin. The updated version of the resource is included in Release 5 of HL7 FHIR.
Results/Findings: The changes introduced to the biologically derived product resource allow ISBT 128 information to be included in the resource in a manner that retains consistency with information carried on the product label. The FHIR Standard itself is highly flexible so an ISBT 128 implementation guide is being developed to specify how ISBT 128 information should be included. This includes requiring the use of the MPHO Unique Identifier as the primary identifier for the product and making data elements essential for traceability mandatory.
The resource can be seen in the HL7 FHIR Standard, Release 5 under the name BiologicallyDerivedProduct. Conclusions: This development allows the use of ISBT 128 standardized information more widely in transfusion and transplantation informatics. In particular, it facilitates the inclusion of standardized information about transfused blood and cellular products in the patient's electronic medical record. This will help to improve end-to-end traceability and support rapid tracking in the event of lookback investigations.
Importance of research: Although a standardized label will always be essential for product instance identification, moving beyond the label via electronic transfer of standardized data elements supports interoperability. This could decrease the time and labor associated with bringing products into inventory, as well as enhance patient safety by consistently including standardized information about the application of blood and cell therapy products in the patient’s electronic medical record.
