REGULATORY UPDATE: New FDA Guidance Accepts Donor History Questionnaire Version 4.0 and Accompanying Materials

The Food and Drug Administration issued a Level 2 guidance this morning formally recognizing the AABB Donor History Questionnaire version 4.0 (DHQ v4.0) and Accompanying Materials, stating the documents are an acceptable mechanism for collecting blood donor history information from donors of blood and blood components.

The DHQ v4.0 system of documents incorporates the revised donor eligibility recommendations related to HIV risk described in a final FDA guidance, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Product,” released earlier this morning.

Formal recognition of the DHQ allows all blood collectors to begin extensive work in a regulated change-control process for implementation of individual donor assessment (IDA) protocols and other FDA recommendations in their facilities. To support this effort, AABB Regulatory Affairs has made the DHQ v4.0 Implementation Toolkit available for use on the Regulatory Toolkits web page. The Toolkit includes documents that highlight all revisions to help members easily identify changes in v4.0 documents. AABB reminds blood collection facilities that, as expected, the draft v4.0 documents posted for planning purposes have been revised during the FDA review process. Refer to the final documents posted by AABB and the Toolkit for those revisions.

Facilities may contact regulatory@aabb.org with any questions regarding the v4.0 DHQ documents.

AABB’s Unprecedented Update of the DHQ

This expedited DHQ v4.0 approval process was possible in part due to the early and proactive work of the AABB Donor History Task Force (DHTF), which includes member experts from the blood community, the Armed Service Blood Program, FDA and the Centers for Disease Control and Prevention. AABB extends its gratitude for their work and dedication.

Resources to Prepare to Welcome New Donors 

AABB launched an Individual Donor Assessment (IDA) Resource Library on Monday to help the blood community prepare to implement IDA protocols outlined in the final guidance. The Resource Library comprises complimentary educational and planning materials developed in consultation with LGBTQ+ organizations and in partnership with Canadian Blood Services (CBS), which implemented IDA in 2022. AABB appreciates CBS’s generous support and partnership with this important work.

In the weeks ahead, AABB will introduce a series of professionally prepared complimentary educational courses designed to help blood center staff members address potential challenges associated with the new IDA protocols, including communicating with and welcoming new and returning donors from the LGBTQ+ community, addressing donors’ questions about new eligibility criteria, and building long-standing relationships with new donors.

The educational offerings will also include a “Train the Trainer” program for blood collectors seeking more in-depth education and tools to lead sex-positive awareness and donor conversation training with their staff. AABB members can sign up to be notified when additional resources are released and when these courses formally launch.