Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Data Element

Information from the submission form

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.

Comment

FDA Support for (Consolidated) Biologically Derived Product Subm

This comment is to document the FDA’s support for the addition of the Biologically Derived Product to USCDI. After reviewing ICCBBA’s submission, we can confirm that the specifications, use cases, and challenges of the “Unique Identifier for a Medical Product of Human Origin” data element are consistent with the FDA submitted “Biologically Derived Product Information” data element. Additionally, the FDA submission’s terminology is consistent with the HL7 FHIR BiologicallyDerivedProduct resource (http://hl7.org/fhir/biologicallyderivedproduct.html). Therefore, we recommend consolidating these two submissions using the FDA submission currently in Level 1. ICCBBA will then add its submission material and use case as a supporting comment.

ICCBBA support for consolidation of submissions

This comment is to document ICCBBA’s support for consolidating 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.  

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.

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