HHS Interim Report Represents First Step in Building a National Red Blood Cell Antibody Exchange

A national red blood cell (RBC) antibody patient data exchange is one step closer to reality with the release of an interim report from the U.S. Department of Health and Human Services in September 2023. Through a series of case studies of existing/attempted red blood cell antibody exchanges (RBCAX) and registries, as well as other health information exchanges (HIEs), the report examines the need for such a registry and considerations required for the development, implementation and sustainment of a successful national exchange.

“The successful implementation of a national RBCAX would be a critical instrument in the equitable treatment of all patients. Such a system holds the potential to enhance health outcomes in all transfused patients, including those in underserved populations, while also serving as an avenue for patient education,” according to the report. “Additionally, a national RBCAX would provide researchers with a valuable data set to better understand disease complexities, including sickle cell disease (SCD) and thalassemia, and clinical phenomena, such as evanescent antibodies.”

Based on the knowledge generated from the case studies, three pilot option examples were developed for consideration. The pilot projects are all intended to determine the feasibility of the implementation of a national RBCAX. The proposed projects include a District of Columbia/Maryland/Virginia (DMV) metro area pilot, a Mid-Atlantic pilot and a multi-agency pilot. The report notes that subsequent efforts should focus on solidifying a pilot implementation strategy, one that anticipates and addresses the key considerations as part of the planning process.

Addressing Patients’ Needs

The blood community in the U.S. has made great strides in reducing the risks associated with transfusion over the last several decades, the report says. Despite this progress, individuals who are repeatedly transfused and who have relatively high prevalence rates of RBC alloimmunization — such as those with sickle cell disease or thalassemia — still face an elevated risk of transfusion reaction. The risk is most likely to be elevated when there is incompatibility between the recipient of a blood transfusion and the unit of blood transfused. If a recipient has developed RBC antibodies following a blood transfusion or pregnancy, a delayed hemolytic transfusion reaction can occur if a hospital is unaware of existing antibodies.

Currently, there are several systems in place to try to address these issues. However, success depends on getting information about antibodies (including evanescent antibodies that can fall below detection level) to the right people in time to obtain specially matched units. The fragmented nature of the U.S. blood supply — and U.S. healthcare in general — can make this challenging. For example, patients are not always treated at the same facility or by the same health care providers, and information about their antibodies might not be shared. In addition, if a patient relocates to a different geographic area and establishes new health care providers, their health data currently does not necessarily transfer.

Advocating for a Registry

AABB has been advocating for such a national red blood cell registry for several years. In fact, the interim report concludes by acknowledging the work of AABB, along with the American Society for Clinical Pathology, the American Society for Hematology, America’s Blood Centers, the American Red Cross, and others to identify opportunities to drive progress.

In June 2020, AABB submitted comments to the Department of Health and Human Services that advocated for the establishment of a national RBC antigen typing patient database and noted that such a resource would improve patient outcomes by expediting access to compatible units of blood for individuals with special transfusion requirements. In particular, they cited a recent survey about registry development submitted by members of the AABB Transfusion Medicine Subsection Coordinating Committee, in which 97% of respondents said they were in favor of a nationwide RBCAX.

Next Steps

The report also outlines next steps, with the completion of this interim report considered as an initial step in Phase I. In the next stage of Phase I work will include addressing unanswered questions — such as those raised in this report — and building on the current findings to develop a pilot exchange. A RBCAX Working Group and other subject matter experts will be consulted as needed to help resolve issues such as data systems requirements, clinical data inclusion, standardization, validation and development of a pilot framework.

Phase II will address pilot readiness and implementation and will include refinement of the selected pilot model, pilot launch and continued management of the national exchange with the aim of sustainability and improvement. Phase III will address data exchange readiness and implementation.