FDA Finalizes Recommendations for Evaluating Blood Donor Eligibility

New Guidance Accepts AABB’s Updated Donor History Questionnaires

On May 11, 2023, the U.S. Food and Drug Administration announced final recommendations for evaluating blood donor eligibility through the implementation of individual risk-based questions to reduce the possibility of transfusion-transmitted HIV (Human Immunodeficiency Virus). The final guidance issued to the blood industry is entitled: “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products”.

The Association for the Advancement of Blood & Biotherapies (AABB) has updated its donor history questionnaire (DHQ) documents to reflect the new recommendations. The FDA has issued a new Level 2 guidance that accepts this latest version (DHQ v4.0). To help blood collection facilities with changes to the DHQ process, the AABB has provided a DHQ v4.0 Implementation Toolkit as a regulatory resource that can be accessed through its website.

Blood establishments that collect blood and blood components (including Source Plasma) will need to revise their donor history questionnaires and procedures to be in compliance with the new recommendations, which supersede the April 2020 guidance. The risk-based questions included in the questionnaires must be the same for every donor, without the need for screening questions related to sexual identity.