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

Biologically Derived Product information
Description
This set of data elements describes information related to the biologically derived product: a. Product Code (productCode): this is the data element which can store 1 to many codable concepts describing the product. We propose the ability to use the following product codes to identify biologically derived products: a.i. ISBT-128 Product Code: identifies the biologically derived product type, such as blood components, fluids, tissues, organs, or cells. a.ii. ISBT-128 Donation Identification Number: uniquely identifies a biologic product donation, such as blood components, fluids, tissues, organs, or cells. a.iii. NDC or RxNorm codes can be used for biologically derived products that are manufactured and labeled with an NDC, such as blood derived products (e.g. IVIG’s, clotting factors). Vaccines shall use the Immunization Data Class resource. b. Product Type/Category (FHIR R4: productCategory): this element identifies the product type (e.g. organ | tissue | fluid | cells | biologicalAgent). c. Collector (FHIR R4: collector): identifies the collection entity practitioner resource instance, if appropriate. d. Source (FHIR R4: source): linkage to Patient or Organization resource identifying the biologically derived product donation source. e. Collected date/time (FHIR R4: collected): date and time of biologic product collection. f. Quantity (FHIR R4: quantity): quantity of biologic product identified in the resource instance.

Comment

ICCBBA support for Biologically Derived Product Information Data

The use cases identified by FDA/CBER demonstrate the importance of this data element to support safety and effectiveness surveillance, and to facilitate portability of treatment information.  Additional use cases include: assisting hospital transfusion committees in the analysis of MPHO usage leading to improved efficiency; assisting researchers in the analysis of treatment regimens and clinical outcomes (e.g. convalescent plasma or massive transfusion protocols) to determine best practice; providing detailed MPHO usage information to support financial analysis and billing; and, enhancing the ability to perform an efficient lookback for either a single product or multiple products from the same donation.  The inclusion of MPHO information in a standardized manner and location within the EHR will significantly improve traceability by making this important transfusion and transplantation information more readily accessible. ICCBAA strongly supports the creation of the Biologically Derived Product Information Data Element within the USCDI and recommends that the MPHO Unique Identifier, as separately submitted (see https://www.healthit.gov/isa/uscdi-data/unique-identifier-a-medical-product-human-origin) be incorporated within this Biologically Derived Product Information Data Element.  The MPHO Unique Identifier combines existing ISBT 128 data elements (donation identification number, product description code, and division number) that are widely used in transfusion and transplantation practice and provides critical, globally unique, traceability to the donor and processing facility.  The MPHO Unique Identifier contains elements a.i and a.ii as detailed in this submission.  

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. Use case and additional supporting information from the “Unique Identifier for a Medical Product of Human Origin” data element submission are added here. The MPHO Unique 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. 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) The MPHO Unique Identifier is a 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. 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.

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.

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