On May 11, 2023, the FDA’s Center for Biologics Evaluation and Research (CBER) issued guidance updating the blood donor history questionnaire (DHQ). Also known as the DHQ v4.0. The hope was that creating a gender-neutral questionnaire would increase the number of people eligible to donate, improving the nation’s blood supply.
After 3 months, has it made a difference?
The DHQ v4.0 is a series of questions asking potential donors about their lifestyle activities and travel to assess whether they are eligible to donate blood. The questionnaire is a risk-based model and is a critical step in ensuring the safety and potency of the nation’s blood supply.
As knowledge and understanding about disease increases along with the ongoing need to maintain an adequate blood supply, the FDA, in conjunction with the Association for the Advancement of Blood and Biotherapies (AABB), reviewed the restrictions or limitations on groups or individuals who may be allowed to donate with the goal of increasing the pool of eligible donors.
The DHQ v3.0 contains gender-specific questions impacting the eligibility of LGBTQ members. The new DHQ v4.0 was developed to be gender-neutral. There was concern that the new questions (especially the follow-up if any were answered yes) would be uncomfortable, but they were necessary to assess every potential donor the same.
“Some of the follow-up questions can seem to be a bit personal,” states Marvin Opulencia, Donor Operation Trainer at Inova Blood Donor Services (IBDS).
But Marvin thinks the change was a good thing because the questionnaire is no longer gender-specific and makes the process easier. “Some of my friends are members of the LGBTQ community, and now they are able to donate. I’m happy about that.”
Recognizing the difficulty and sensitivity inherent in the impacted topics, the FDA did not issue a deadline for implementation but has allowed blood donation centers to integrate the new guidance at their own pace. However, there were some blood donor centers that were ready to move forward with the recommendations. Their experience tells us that it is still too early to evaluate the effect of the change.
Nicholas Lilly, Interim Director of IBDS in Northern Virginia, believes we still don’t know the overall impact of the DHQ v4.0. “Inova Health System welcomes and supports initiatives improving the diversity, inclusiveness, and equity of our services. That’s why we were one of the first to implement the DHQ v4.0 in June. We serve the DMV area (D.C., Maryland, and Virginia), which is a highly diverse community, and so we saw the new guidance as a continuation of our vision and goals.”
With three months of data to evaluate, Director Lilly still doesn’t know what impact the change has on the blood supply. “Though we have received no negative feedback from our clients, we still haven’t seen a net increase in the number of donors. We have seen more non-binary people donate, but overall, there has not been a noticeable increase in donations. But it’s still early.”
It was expected that changing the Individual Donor Assessment to a more gender-neutral questionnaire would generate a bit of consternation and questions regarding whether it was in the nation’s best interest. However, so far, it was just one more step toward allowing everyone to make a difference.
Stated simply, Blood Saves Lives and is desperately needed. Now everyone has the opportunity to donate. Limitations or restrictions should be determined by science-backed non-judgmental research. That’s what the DHQ v4.0 is… that’s the difference it makes.
–Darryl Elzie is a Quality Consultant for Inova Blood Donor Services. He has been an ASCP Medical Technologist for over 25 years, performing CAP inspections for 15+ years. He has held the roles of laboratory generalist and chemistry senior technologist. He has a Master’s in Healthcare Administration from Ashford University, a Doctorate of Psychology from The University of the Rockies, and is a Certified Quality Auditor (ASQ). Inova Blood Donor Services is the largest hospital-based blood center in the nation. Dr. Elzie is also a Counselor and Life Coach at issueslifecoaching.com.
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