AABB22: The Next Version of the Donor History Questionnaires is Coming. Here’s What to Expect.

AABB’s Donor History Questionnaire (DHQ) is recognized by FDA as an acceptable method of screening donors of blood and blood components. It is a well-known and essential tool for helping ensure the safety of blood donor and recipient safety, but the considerations that inform updates to this important document may be less clear – even to blood collection staff who use the DHQ most frequently.

In the on-demand Annual Meeting session “Keeping up with the Donor History Task Force – Implementation of DHQ Version 3.0,” speakers described which circumstances require updates to the DHQ and shared what changes staff may find in DHQ version 3.0, which is currently undergoing Food and Drug Administration review.

Karen Palmer, MT(ASCP) CQA(ASQ), director of Regulatory Affairs at AABB, began the session by describing when, why and how updates to the DHQ occur. The DHQ is not updated each time FDA issues a new guidance document, and the DHTF works to minimize version changes and the burden of repeated updates to the DHQ. As an example, Palmer cited FDA guidance documents from April 2020 that expanded donor eligibility in response to blood shortages.

“At that time, FDA specifically requested that the Donor History Task Force not submit version 3.0 for review because they wanted to focus their concentration on the recent guidance documents to address the urgent need for blood at that time,” Palmer explained. “Then, following the issue of DHQ 2.1, AABB heard from members asking that the Task Force not immediately issue version 3.0 because back-to-back version changes would be overwhelming.”

So, how can blood centers keep track of regulatory changes without updates to the DHQ? Toolkits, Palmer said, at least when FDA issues guidance recommendations that are less restrictive than current donor eligibility criteria. An example is the May 2022 toolkit, “Compliance Options for Implementation of FDA’s May 2022 CJD/vCJD Guidance,” issued in response to FDA guidance that removed deferral recommendations related to geographic risk of vCJD infection.

However, when FDA issues more restrictive eligibility criteria, the DHTF moves quickly to incorporate those recommendations into a new version of the DHQ. The revised DHQ must then be reviewed internally by AABB and sent to FDA for formal review and acceptance.

What to Expect in DHQ Version 3.0

While DHQ v3.0 is still undergoing FDA review and cannot be considered final, Mary Townsend, MD, senior medical director at Vitalant and chair of the Donor History Task Force (DHTF), shared several of the proposed revisions to the DHQ.

Significant changes include the following:

• Revisions to Question 3, v2.1, related to donor pregnancy. All donors will be asked if they have ever been pregnant and if they are currently pregnant.
• Revisions to Question 39, v2.1, related to bleeding conditions and blood diseases. Donors will be asked whether they have hemophilia or a related clotting factor deficiency.
• Flexible options for establishing the “day of donation” using a 24-hour timeframe rather than calendar day. Blood collectors must define “day of donation” in their SOPs.

v3.0 also includes new questions that address receipt of medications to prevent HIV infection (either pre-exposure prophylaxis or post-exposure prophylaxis) or to treat an established HIV infection (antiretroviral therapy) in the 3 months preceding the donation. Similarly, an additional new question addresses receipt of injectable medications to prevent HIV in the preceding 2 years.

Additional revisions to v3.0 reflect FDA guidance related to risk of HIV transmission (August 2020) and risk of CJD/vCJD transmission (May 2022).

Townsend concluded by emphasizing that these documents are under review and available for planning purposes only. AABB will produce a toolkit to assist blood collectors with implementation and will share that resource with members following FDA approval of the documents.

Individuals with questions may contact regulatory@aabb.org.