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

Comment

ISBT 128 Critically Needed as Biologics Unique Identifier

eHealth Exchange, the nation’s largest health information exchange network, wholeheartedly agrees the ISBT 128 international standard should be used in USCDI v2 as the globally-unique identifier for blood and other biologic products. The addition of Biologically Derived Products to USCDI v2 using the ISBT standard is critical to improving patient safety, coordination of care, and patient data portability for patients treated with biologic products of human origin. The addition of the Biologically Derived Products data class to USCDI v2 enables the exchange of granular details related to biologic products for the coordination of care between exchange participants, in addition to linkage of exposure records to adverse events that can be traced to specific biologic products of human origin

FDA CBER Response to eHealth Exchange

Thank you for your comment. eHealth Exchange has identified important Use Cases that reinforce the need to include the Biologically Derived Product unique identifiers the USCDI.

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.

FDA CBER Biologically Derived Product Submission Clarifications

FDA’s Center for Biologics Evaluation and Research appreciates the comments shared by numerous stakeholders related to the Biologically Derived Product submission. As of April 2021, there are three aspects worth noting:
  1. Resubmission: A revised version of the Biologically Derived Product submission was resubmitted in January 2021 following an update to the ONDEC guidance. This version has not yet been updated on the ONC USCDI website as of April 2021. See attachment for details.
  2. Product Information Elements: Based on other stakeholder comments, the submission could be further modified to incorporate division number and derived or concatenated identifiers (i.e., Medical Products of Human Origin).
  3. Policy: Based on other stakeholder comments, the submission could be further modified to clarify that inclusion of Biologically Derived Product in USCDI would not require the use of a particular identification standard if it is not currently being exchanged by an organization. The current submission references code systems/identifiers (i.e., ISBT-128, RxNorm, and NDC) that are widely used and support a majority of use cases.
As demonstrated above, the ONDEC process has enabled a valuable platform for stakeholders to discuss specifics related to the Biologically Derived Product domain. Continued discussion will be critical to ensure this submission is sufficiently robust to meet criteria for inclusion in USCDI.

FDA CBER ONDEC BioDerProd Resubmission 2021-01.docx

ABC Supports a Biologically Derived Product Unique Identifier

America’s Blood Centers (ABC) represents 46 independent blood centers throughout the United States and a portion of Canada, who collect and distribute 60% of the U.S. blood supply.  ABC member centers support efforts to improve transfusion safety, including measures to increase traceability for blood, blood products and cellular therapies. Blood centers already label blood products with a plethora of identifying information about the contents of the product, the method of collection and production, and a unique product code to allow for tracing a product from the donor to the recipient.  However, no standard mechanism currently exists for entering transfusion/infusion related information into a patient’s electronic health record (EHR). ABC supports the addition of a Medical Product of Human Origin (MPHO) Unique Identifier that utilizes the existing information and codes already generated by blood centers as a part of the blood label.  Adding an MPHO to the U.S. Core Data for Interoperability (USCDI) data set will allow for easier data collection and tracing, without creating any additional work for blood collectors. Capturing existing ISBT-128 data elements (donation number, product code, and division number), into the MPHO Unique Identifier will provide critical traceability to the donor and collection/processing facility, providing a more efficient and accurate process for disease transmission look-back activities and transfusion reaction investigations. Interoperability will provide patients and health care providers access to previous transfusion records, which is critical in managing individuals with unexpected antibodies (e.g. sickle cell disease patients) or a history of adverse transfusion events. ABC supports the creation of a new standardized data element utilizing existing ISBT-128 blood labeling information to increase transfusion safety, improve patient outcomes and enhance data collection valuable to monitoring blood utilization. 

Terumo Supports a Biologically Derived Product Unique Identifier

Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our associates around the world believe in the potential of blood and cells to do even more for patients than they do today.  Terumo Blood and Cell Technologies supports the addition of a Biologically Derived Product data element to the United States Core Data for Interoperability (USCDI). Addition of the Medical Product of Human Origin (MPHO) Unique Identifier to USCDI will enhance the industries’ ability to track blood utilization and will enable more efficient hemovigilance activities such as disease transmission tracing, transfusion reaction investigations and preventing the transfusion of an incompatible unit of blood. Including the existing ISBT-128 label information into the MPHO Unique Identifier will provide seamless traceability of a transfusion from the donor to the patient. This simple act can help improve the health outcomes for all transfused patients and especially sickle cell and other chronically transfused individuals.

Support for Biologically Derived Product

Inclusion of the Biologically Derived Product element in USCDI, including the use of ISBT-128 standard codes, is vital for public health, regulatory, and research activities related to biological product effectiveness and safety, including hemovigilance surveillance supported by CDC’s National Healthcare Safety Network (NHSN). Current tracking of adverse events related to biologically derived products (e.g., blood transfusion-associated adverse events) is hindered by lack of accurate identifiers for transfusions amenable to fully electronic extraction from the electronic health record. The capability of identifying biologically derived products using this identifier would facilitate automated reporting for transfusions/transplants, reduce burden of reporting on providers, and significantly improve accuracy of hemovigilance and other patient safety activities. Ongoing surveillance for blood safety in the United States is conducted through the CDC’s National Healthcare Safety Network (NHSN) Hemovigilance (HV) module, which is part of the Biovigilance component of NHSN. The NHSN HV module captures several types of transfusion-associated adverse events as well as monthly totals of blood use, by component type, at participating facilities. This surveillance is used to track the incidence and prevalence of transfusion-associated adverse events with the goal of informing strategies to reduce such events and improve overall patient safety.  In addition, CDC performs investigations and other studies as needed that do not currently make use of automated capture of electronic health records but are potential candidates for such automation in the future. Lantana supports NHSN in hemovigilance surveillance and strongly recommends inclusion of a Biologically Derived Product in USCDI, including the use of ISBT-128 standard codes. A Biologically Derived Product data element would enable capture of individual blood components as well as adverse events for hemovigilance. Current tracking of adverse events in the NHSN HV module requires manual input of adverse events (including ISBT-128 codes for all implicated products), which can be burdensome and may not always yield complete information. Inclusion of a Biologically Derived Product element is vital for hemovigilance surveillance for multiple reasons, including reducing burden on providers by facilitating more automated reporting, improving overall participation in hemovigilance activities, and strengthening robustness and accuracy of reporting. Inclusion of the Biologically Derived Product data element now is important for future consideration regarding how the standard will need to be expanded to meet the needs of hemovigilance and overall surveillance of biologically derived products in the future. It is vital that the USCDI engages with stakeholders in hemovigilance and other areas of surveillance of biologically derived products to ensure the standards are harmonized with the community-consensus definitions of adverse events, and to facilitate automated capture of essential safety information. The Biologically Derived Product data element is relevant to all U.S. healthcare settings where blood transfusions, transplants, and other biological products are administered. Use Case: https://www.cdc.gov/nhsn/biovigilance/blood-safety/index.html In addition to the NHSN HV module, Lantana is leading work that relies on accurate information from electronic health records regarding identity of biologically derived products, https://www.lantanagroup.com/resources/blood-bank-ig/. This initiative is seeking to establish FHIR standards for blood product phenotyping. A biologically derived product element in USCDI is vital to support interoperability of data exchange to improve blood product inventory, facilitate safer transfusions, and contribute to more efficient adverse event reporting. Additionally, Lantana is engaged on work led by IBM and FDA on adverse event reporting related to transfusions, which could benefit from inclusion of the Biologically Derived Product data element in USCDI: https://build.fhir.org/ig/HL7/fhir-icsr-ae-reporting/branches/main/index.html.

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