By Jennifer Boyer, AABB Communications Staff
The AABB Donor History Questionnaire (DHQ) underwent significant changes this year when the U.S. Food and Drug Administration (FDA) released several new donor deferral guidances to support the blood supply in the face of COVID-19, according to information presented during an on-demand session at the AABB 2020 Virtual Annual Meeting and posted on the association's blog.
The session, “Keeping Up with the Donor History Task Force: Major Changes in Blood Donor Screening,” focused on discussing these guidances from the FDA, along with summarizing expected changes to the upcoming DHQ version 3.0, describing the latest developments in screening of non-binary and transgender blood donors and explaining eligibility requirements for individuals taking medication for the prevention or treatment of HIV.
The Donor History Task Force (DHTF) consists of volunteer representatives from across AABB membership, American Red Cross, America’s Blood Centers, Armed Services Blood Program, Canadian Blood Services, Centers for Disease Control and Prevention (CDC), Plasma Protein Therapeutics Association and the FDA, as well as a public ethicist. The task force prepares and maintains the full-length and abbreviated DHQs and all accompanying materials for compliance with FDA’s regulation and recommendations.
The 2020 FDA guidances included revised recommendations for reducing the risk of transfusion-transmitted malaria, HIV, Creutzfeldt-Jakob disease (CJD) and variant CJD. The malaria and HIV guidance helps to address the U.S. blood supply shortage during the COVID pandemic and is meant to remain in effect through the duration of the emergency; however, the FDA expects the recommendations to last beyond that point. This guidance will be revised and replaced within 60 days following the end of the emergency.
DHQ v3.0 has not been approved and is not final. Along with new updates, it will incorporate the changes already covered by v2.1.
Yvette M. Miller, MD, of the American Red Cross, located in Charlotte, NC, discussed the development of a gender-neutral DHQ, explaining that the DHTF has a Gender-Neutral DHQ Subgroup that oversaw the development of a gender-neutral questionnaire (GNQ). A conversation about creating a GNQ began in 2015 with the release of an FDA guidance related to donor eligibility. Prior to this, potential donors were assessed based on gender assigned at birth. The guidance opened up the pathway to donors self-identifying their gender.
A GNQ has been a top priority for the DHTF to support a more inclusive, effective path for the screening of non-binary donors. Members have requested it as well, and there is recognition that it will remove barriers to blood donation. Miller noted that the GNQ will be optional and will not replace the DHQ v2.1; rather, it will be used by centers to accommodate donors who do not wish to provide a gender or who identify as non-binary.
The subgroup’s goal was assessing men having sex with men (MSM) risk in all donor test cases, including inappropriate acceptance of a donor who should be deferred and deferral of a donor who is actually eligible to donate. They carefully assessed questions 18 and 19 of the DHQ and assessed test cases. The subgroup’s findings have been combined into a package that will be submitted to FDA for review. Revisions have been made based on the feedback and recommendations of an ethicist to ensure that the document’s language identifies an individual as non-binary, not gender-neutral, and that the approach to donor screening is gender-neutral.
