Biologically Derived Product
Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.
Data Element
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Unique Identifier for a Medical Product of Human Origin
Description
The globally unique identifier for each blood or biologic product identified using the ISBT 128 international standard.
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| Submitted By: Karen Moniz
/ ICCBBA
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| 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
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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.
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| Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Reducing the cost of care
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| 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
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| 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.
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| Extent of exchange
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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. |
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Official Website of The Office of the National Coordinator for Health Information Technology (ONC)
Submitted by Leah Stone on
Support for “Biologically Derived Product” Data Element
AABB is an international, not-for-profit association representing institutions and individuals involved in transfusion medicine and cellular therapies. The association is committed to “improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide.” AABB works toward this vision by developing and delivering standards, accreditation, and educational programs that focus on optimizing patient and donor care and safety. AABB individual membership includes physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers.
AABB supports the addition of a Biologically Derived Product data element to the United States Core Data for Interoperability (USCDI) and believes that using the ISBT-128 standard will enhance the nation’s understanding of blood availability and utilization, advance hemovigilance capabilities and improve health outcomes. We support the recommendation to consolidate the “Unique Identifier for a Medical Product of Human Origin” data element, currently at Comment level, with the “Biologically Derived Product Information” data element, currently at Level 1.
A Biologically Derived Product data element would enable providers to uniformly capture the utilization of individual blood components as well as adverse events for hemovigilance. As noted in the FDA’s use case description, the absence of interoperability in this area was particularly problematic during the rollout of COVID-19 convalescent plasma (CCP) and limited the ability of regulators and researchers to perform safety and effectiveness surveillance. The data could be used to assess whether the current supply of specific blood components is adequate to satisfy patient needs and to monitor safety and effectiveness.
Additionally, a Biologically Derived Product data element has the potential to inform policies and guide clinical practices early in the course of treatment (e.g., capturing blood group genotyping in chronically transfused patients or patients initiating novel monoclonal therapies known to cause complication in transfusion workups). It would also serve as a tool to help identify non-infectious complications, such as transfusion-associated circulatory overload (TACO), the transfusion-related acute lung injury (TRALI), and transfusion of an incompatible unit of blood. Importantly, interoperability in this area would facilitate the ability of providers to have access to a patient’s transfusion history, regardless of where a previous transfusion occurred. This can help prevent incompatible transfusions, support red blood cell antigen matching, and ultimately improve health outcomes for chronically transfused individuals, such as patients with sickle cell disease.
AABB believes that adding a Biologically Derived Product data element to the USCDI is key to strengthening the nation’s blood system, advancing patient safety, and improving health outcomes.