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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. 

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