Biologically Derived Product

The globally unique identifier for each blood or biologic product identified using the ISBT 128 international standard.

Submitted By: Karen Moniz / ICCBBA
Data Element Information
Rationale for Separate Consideration	The identifier serves a similar purpose to the UDI for implanted medical devices. The UDI does not apply to blood and biologics but the traceability requirements for these transfused/transplanted products are critical to patient safety.
Use Case Description(s)
Use Case Description	Efficient lookback capability is essential to ensure the timely follow-up of patients that have received transfusions/transplants that have subsequently been found to be linked with disease transmission. Current systems are inefficient and sometimes incomplete. The capability to search patient records using this identifier would significantly improve lookback and follow-up activities. (see https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a1.htm for a CDC report on a lookback case)
Estimated number of stakeholders capturing, accessing using or exchanging	Provides important information for use throughout the blood and biologics professional community. The data element would be used for every blood transfusion and cell therapy (approx. 21 million events in the US per annum – ref: ARC Blood Services). It is anticipated that future use of the data element will increase as adoption of the ISBT 128 in other areas of MPHO, such as tissue, continues to progress.
Healthcare Aims	Improving patient experience of care (quality and/or satisfaction) Improving the health of populations Reducing the cost of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	ISBT 128 https://www.iccbba.org/docs/tech-library/technical/st-001-isbt-128-standard-technical-specification.pdf
Additional Specifications	An implementation guide is currently being developed by ICCBBA.
Current Use	In limited use in test environments only
Supporting Artifacts	The MPHO Unique Identifier is a recently developed data element designed to be incorporated into medical records. It combines existing data elements (donation identification number, product description code, and division number) that are widely used in blood transfusion systems. It provides a consistent data format across all areas of blood and biologics clinical application.
Number of organizations/individuals with which this data element has been electronically exchanged	N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	This data element applies to blood and biologics identified using ISBT 128. The US blood supply is 100% ISBT 128 labeled. Cellular therapy products and eye banking tissues are also standardized on ISBT 128. Adoption within tissue banking is progressing.
Restrictions on Use (e.g. licensing, user fees)	Labelers using ISBT 128 pay a license fee to ICCBBA to maintain the ISBT 128 Standard.
Privacy and Security Concerns	The data element contains identifiers essential to traceability of these products. These identifiers are already stored in healthcare systems. They are anonymized and the link to the donor is securely maintained within the labeler organization.
Estimate of Overall Burden	The data required to format this data element is routinely captured from the barcodes on the product. The coding required to format the element is simple.