REGULATORY UPDATE: FDA Releases Final Guidance on Individual Donor Assessment for Blood Donors

The Food and Drug Administration released a new, highly anticipated final guidance that recommends the adoption of individual donor assessment (IDA) to determine blood donor eligibility.

The agency also plans to follow with a Level 2 guidance that formally recognizes the Donor History Questionnaire version 4.0 (DHQ v4.0) and Accompanying Materials, which incorporates the revised donor eligibility recommendations and allows blood collectors to move forward with preparations for implementation of FDA’s landmark policy changes. AABB worked closely with FDA to complete advance preparations for close alignment of the v4.0 DHQ with FDA’s recommendations with the goal of delivering the next version of the DHQ as soon as possible after the release of the final guidance.

The final guidance, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products,” eliminates the use of time-based blood donation criteria for men who have sex with men (MSM) and women who have sex with MSM. FDA now recommends a new donor screening process that uses gender-inclusive, individual donor-based questions for all individuals to establish donor eligibility.

The final guidance is the culmination of a years-long research process informed by numerous data sources: data from the United Kingdom and Canada, surveillance information from the Transfusion Transmissible Infections Monitoring System (TTIMS), data assessing performance characteristics of nucleic acid testing for HIV and results from the FDA-funded Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study. AABB commends FDA for its careful consideration of this data supporting evidence-based changes to update donor eligibility criteria that will welcome new blood donors while protecting the safety of the blood supply.

The sections below outline the recommendations in the guidance and describe AABB’s complimentary educational and planning resources to assist blood collectors with implementation. Members with questions about the recommendations should contact AABB Regulatory Affairs.

A Closer Look at the Recommended Updates

 The final guidance recommends the removal of the following donor eligibility requirements:

• Defer for three months from the most recent sexual contact, a man who has had sex with another man during the past three months.
• Defer for three months from the most recent sexual contact, a woman who has had sex during the past three months with a man who has had sex with another man in the past three months.

In addition, FDA recommends the following changes to donor eligibility:

• Defer permanently an individual who has ever taken any medication to treat HIV infection (i.e., ART).
• Defer for three months from the most recent dose, an individual who has taken any medication by mouth (oral) to prevent HIV infection (i.e., short-acting antiviral PrEP or PEP).
• Defer for two years from the most recent injection, an individual who has received any medication by injection to prevent HIV infection (i.e., long-acting antiviral PrEP).
• Defer for three months from the most recent sexual contact, an individual who has had a new sexual partner in the past three months and who has had anal sex in the past three months.
• Defer for three months from the most recent sexual contact, an individual who has had more than one sexual partner in the past three months and who has had anal sex in the past three months.

The revised recommendations closely align with Canadian Blood Services’ donor eligibility criteria, which took effect in September 2022. Additionally, FDA’s recommended deferral for any individuals using medications to treat or prevent HIV infection, including pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) and antiretroviral therapy (ART), is consistent with AABB’s Association Bulletin #22-03, issued in September 2022.

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. The library consists of complimentary educational and planning resources developed in consultation with LGBTQ+ organizations and in partnership with Canadian Blood Services, which introduced IDA in 2022.

In the weeks ahead, AABB will introduce a series of 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.