|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)|
|Estimate the breadth of applicability of the use case(s) for this data element||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.
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||ISBT 128
|Additional Specifications||An implementation guide is currently being developed by ICCBBA.|
|Current Use||In limited use in test environments only|
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.
|Extent of exchange||N/A|
|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.|
Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.
Unique Identifier for a Medical Product of Human Origin
The globally unique identifier for each blood or biologic product identified using the ISBT 128 international standard.