Donor Eligibility Update

In 2023, the Food and Drug Administration issued final guidance evaluating blood donor eligibility independent of gender or sexual orientation while maintaining the safety of the blood supply. At Vitalant, we revised the donor history questionnaire to remove questions that were specific to sex among and with gay and bisexual men. Instead, the questionnaire asks all prospective donors gender-inclusive, individual risk-based questions to assess blood donor eligibility. 

The donor history questionnaire asks prospective donors about new or multiple sexual partners in the past three months. Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, are asked a secondary question about a history of anal sex in the past three months. A prospective donor who answers “yes” to both questions is deferred for three months since the last occurrence due to a demonstrated higher incidence of HIV transmission in these settings. 

Prospective donors who answer “no” are eligible to donate, provided they meet all other eligibility requirements.

Yes, the blood supply remains as safe as possible. The FDA's safety regulations are based on scientific evidence and supported by the experience of other countries that have implemented similar eligibility changes. In its final guidance, the FDA cited data from the Transfusion Transmissible Infections Monitoring System (TTIMS) and the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) Study. Vitalant is one of four blood centers that participate in TTIMS, which is continually evaluating blood safety in the U.S. Vitalant also served as the lead research organization and coordinator of the ADVANCE Study. Initial comparative analyses of TTIMS and other data since Individual Donor Assessment was implemented in the U.S. show continued stability in infectious disease rates and overall blood supply safety. 

The FDA still requires blood centers to ask questions about behaviors or exposures. Blood testing alone cannot detect all donors who could transmit infections to blood recipients through transfusion because it cannot identify individuals in the earliest stages of infection, when virus levels are very low. The best available approach for complementing infectious disease screening tests is the donor health history questionnaire because it identifies individuals with significant infectious disease risk factors. 

We appreciate the critical importance of HIV PrEP (or PEP) in reducing the risk of sexual transmission of HIV. The FDA currently recommends deferring people on oral PrEP/PEP for three months and injectable PrEP for two years, regardless of sexual orientation, out of an abundance of caution. PrEP (or PEP) does not uniformly prevent HIV infection. It can decrease HIV viral load and delay antibody formation after breakthrough infection, potentially allowing a recently HIV-infected person to give blood or platelets within the window period where testing does not detect HIV.

If you were previously deferred but believe you may now be eligible, please review eligibility requirements on vitalant.org and call 877-25-VITAL (84825) to confirm your eligibility status.

The safety of our donors, volunteers, staff and ultimately, patients is Vitalant’s top priority. The FDA requires male or female sex (reflecting physiology in most people) to be registered when donating. Identifying a donor’s sex assigned at birth prioritizes donor safety, allowing Vitalant to determine safe hemoglobin levels and blood donation volume limits associated with each donor’s unique physiology.  

We updated our computer system to help provide a more respectful and inclusive experience for all donors and the different ways individuals identify. (As of Sept. 27) In addition to sex assigned at birth, we now ask all first-time donors and can record whether a donor’s gender identity differs. Sex assigned at birth information no longer displays on the Fast Track Ticket and post-donation materials.  

It is difficult to accurately estimate the number of people newly able to donate blood as a direct result of individual donor assessment since donors do not identify by sexual orientation, but data from the Transfusion Transmissible Infections Monitoring System (TTIMS) shows an increase in first-time and male donors since U.S. blood centers adopted the individual donor assessment policies. In the first two years since the new policy went into effect, male first-time donors increased 14% compared to the two years prior.  

Vitalant welcomes and encourages everyone who is eligible to donate and contribute to a safe and ready blood supply. While most of the population is estimated to be eligible, currently only about 3% donate in any given year.

Vitalant welcomes eligible blood donors regardless of sexual orientation or gender identity. To ensure the safest possible donation experience, donor safety measures are based on physiology associated with sex assigned at birth.   

As of Sept. 27, 2026, all first-time donors are asked their sex assigned at birth and whether their gender identity differs to ensure donations from those who identify as transgender, transitioning or non-binary – regardless of hormone therapy status – are safely collected. When a donor’s gender identity is different than their sex assigned at birth, the computer system ensures the donor meets the safest hemoglobin eligibility threshold. This helps protect donors from giving if their hemoglobin level is too low, which could increase the risk of anemia-related symptoms including fatigue, shortness of breath and chest discomfort.  

For those giving a platelet, plasma or Power Red donation, collection limits are also set to the safest threshold. This approach helps prevent over-collection, which can lead to anemia or reactions including losing consciousness – something we all want to avoid! 

If you have questions, please contact us at 877-25-VITAL (877-258-4825) before your donation visit and our staff can help answer your questions. 

While HIV care has advanced to the point where viral loads can become undetectable, undetectable does not mean untransmissible when it comes to transfusion-transmission, as the concentration of the virus in blood could still pose a risk to the recipient.