| Submitted By: Barbee Whitaker
/ FDA Center for Biologics Evaluation and Research
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| Data Element Information |
| Use Case Description(s) |
| Use Case Description |
Biologically derived products are an essential yet unique domain within healthcare, with properties and risks that are different from those of synthetic medicines due to their human (or animal) origin. There are numerous types including blood, organs, tissues, and cells – each with their own complexities. Since these products are biologically derived, they are truly unique at the individual product (e.g., blood bag) level. Therefore, it is critical that healthcare organizations, source product collectors, patients, and regulators are able to track treatments and orders in an interoperable manner. Each of these stakeholders must be able to communicate with each other. This includes use cases related to product collection, inventory, orders, and administration.
The existing BiologicallyDerivedProduct FHIR resource is intended for this exact purpose. Robust product code systems, particularly ISBT-128, product codes already exist and are widely in use, yet they are stored in a complex and diverse set of locations within different EHRs.
This data class and data element provides critical traceability (to the individual donor) and granularity regarding product type and product manipulations into biologic products for practitioners (i.e., blood banks) and patients. There is currently no acceptable location for these data in other USCDI data classes such as Medications or Procedures. Currently details about biologically derived products that are administered to patients are not captured in any resource within USCDI, and therefore portability of treatment administration information for patients treated with biologically-derived products are severely limited. This serves as an opportunity to enhance the availability of treatment information for patients treated with biologic products.
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| Estimate the breadth of applicability of the use case(s) for this data element
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5 stakeholder groups will use this resource for capture, access, use, and exchange (donation collection organizations such as the American Red Cross, blood banks within the hospital laboratory, researchers, clinicians, and patients). |
| Use Case Description |
Biologic products require regulatory oversight and surveillance for safety and effectiveness, including but not limited to adverse event reporting by healthcare providers to regulatory agencies (FDA and CDC), and conducting large-scale observational epidemiological studies using EHR data. Given the unique nature of each biologic product, it is essential that product codes, such as ISBT-128 codes, are captured to ensure sufficient product identification granularity for monitoring and tracking any issues that may be associated with the product. The cost of the current lack of interoperability in this area was reinforced during the recent rollout of COVID-19 convalescent plasma therapies. Without ISBT product codes, it is not possible to differentiate between convalescent plasma use, traditional plasma therapy, or any blood component transfusion. This caused significant limitations for FDA CBER and researchers performing safety and effectiveness surveillance in EHR systems. Thus, these data elements are critical to this use case. |
| Estimate the breadth of applicability of the use case(s) for this data element
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5 stakeholders groups will use this resource for capture, access, use, and exchange (regulators, blood banks within the hospital laboratory, researchers, clinicians, and patients). |
| Link to use case project page |
https://confluence.hl7.org/display/BRR/FHIR+Implementation+Guide+for+Transfusion+and+Vaccination+Adverse+Event+Reporting |
| Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Improving provider experience of care
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| Maturity of Use and Technical Specifications for Data Element |
| Applicable Standard(s) |
ISBT-128 for biologically derived products of human origin (blood components, fluid, cells, tissues, or organs), and NDC/RxNorm for productized biologics such as blood derived products (e.g. IVIGs, clotting factors, and others).
Links URLs (added here to enable sharing multiple):
- ISBT: http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2
- RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html
- NDC: https://www.fda.gov/drugs/drug-approvals-and-databases/nati
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| Additional Specifications |
FHIR Implementation Guide for Transfusion and Vaccination Adverse Event Detection and Reporting (https://best-im.com/fhir-ig/index.html), which reference the HL7 FHIR R4 BiologicallyDerivedProduct Resource (http://hl7.org/fhir/biologicallyderivedproduct.html) |
| Current Use |
Extensively used in production environments |
| Supporting Artifacts |
Resource: Endorsed by HL7. BiologicallyDerived Product is a resource within FHIR R4.
Element / Code System: ISBT-128 is administered by ICCBBA. It is “the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). It is used in more than 87 countries across six continents and disparate health care systems.” It is endorsed extensively by numerous organizations including the WHO.
Links URLs (added here to enable sharing multiple):
- HL7 FHIR R4 BiologicallyDerivedProduct Resource: http://hl7.org/fhir/biologicallyderivedproduct.html
- ISBT-128 Endorsements: http://www.iccbba.org/tech-library/endorsements
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| Extent of exchange
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2-3 |
| Supporting Artifacts |
BiologicallyDerivedProduct: This resource is being used with the FDA BEST project and FHIR IG, which consist of biologics-related adverse event case reports being generated by an academic health center and submitted to FDA.
ISBT-128: This element/CodeSystem is used extensively internationally and in the US.
Supporting Link (added here to enable sharing multiple):
- ISBT-128 Endorsements: http://www.iccbba.org/tech-library/endorsements
- FDA BEST FHIR IG (https://best-im.com/fhir-ig/index.html
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| Potential Challenges |
| Restrictions on Standardization (e.g. proprietary code) |
The use and exposure of ISBT-128 codes within clinical and patient records are not proprietary. However, the full dictionary for ISBT-128 codes and their associated descriptions are currently proprietary to contributing members of ICCBBA, which consist of member blood/organ banks. |
| Restrictions on Use (e.g. licensing, user fees) |
There is no restriction on the data elements, but as mentioned above, the acquisition of the ISBT-128 dictionary requires payment of a licensing fee to ICCBBA. |
| Privacy and Security Concerns |
Much like other unique identifiers used within FHIR resources (e.g. a patient or encounter ID), the ISBT Donor Code can potentially uniquely identify the donor and treated patient. |
| Estimate of Overall Burden |
Much of the information associated with biologic treatment is recorded by blood/organ banks in some fashion, but lack standardization. Integration of blood banking data and EHR systems is also limited. While variation exists across the information systems between collection facilities, blood banks, and healthcare providers, some level of standardization exists in the HL7 V2 exchange paradigm between blood banks and healthcare providers. This paradigm can be expanded to conform to the BiologicallyDerivedProduct resource in FHIR, with participation from EHR vendors and provider networks. |
| Other Implementation Challenges |
Each biologically derived product represents a somewhat unique subdomain (e.g. advanced therapies such as CAR-T cell therapies compared to blood components). This proposal recommends focusing initially on implementing data elements associated with biologic products of human origin, such as blood components, fluids, cells, tissues, and organs, which are covered by the ISBT-128 terminologies, and productized biologics like blood derived products that are covered by NDC/RxNorm terminologies. |
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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.
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.