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Eligibility update

Individual Donor Assessment

The U.S. Food and Drug Administration (FDA) announced its individual donor assessment final guidance, which for the first time in 40 years, evaluates blood donor eligibility regardless of gender or sexual orientation while maintaining the safety of the blood supply.

Vitalant implemented the Individual Donor Assessment on Aug. 21, 2023, and looks forward to welcoming more blood donors to help save lives.

What Changed

FDA’s Men Who Have Sex with Men (MSM) guidance requires gay and bisexual men to wait three months following their last sexual contact with another man.
All potential donors are now screened using a series of questions that assess individual risk of HIV, regardless of gender or sexual orientation.

View current eligibility guidelines

Maintaining the Safety of the Blood Supply

Vitalant’s top priority is maintaining the safety of the blood supply for patients. The donor history questionnaire is just one part of a multi-step process.

Following donation, all blood undergoes roughly a dozen tests for the presence of transfusion-transmitted infectious diseases, including HIV, Hepatitis B, Hepatitis C, and Syphilis. These multiple layers of safety ensure donated blood remains safe for the millions of individuals who rely on blood transfusions each year.

The data from countries that have already implemented this change – including Canada and the United Kingdom – have shown using the individual donor assessment approach does not put the safety of the blood supply at risk.

As part of Vitalant’s commitment to safety, we are one of four blood centers to participate in the Transfusion Transmissible Infections Monitoring Systems (TTIMS), which continually evaluates U.S. blood safety. Vitalant also served as the lead research organization and coordinator of the ADVANCE Study, which evaluated the effectiveness of an individual risk assessment as an alternative to the MSM guidance while maintaining the safety of the blood supply. The FDA cited results from both TTIMS and the ADVANCE Study in its final guidance.

What to Expect – Individual Donor Assessment FAQs

What changed?

The donor history questionnaire is revised 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.

Is the blood supply still safe?

Yes, the blood supply is still 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.

Since every unit of blood is tested for infectious diseases, why are donors asked about their risk behaviors?

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 transfused patients due to technological limitations in identifying individuals in the earliest stages of infection with very low virus levels. 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. 

I currently take PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis) to prevent HIV. Why are there deferrals after taking my last dose of these medications before I can donate blood?

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.

How does a donor who had a blood donation deferral verify or update their eligibility status to donate blood with Vitalant?

If you were previously deferred but believe you may now be eligible, please review eligibility requirements on before scheduling an appointment. If you are unable to make an appointment or have additional questions about your eligibility status, please call 877-25-VITAL (84825). 

How many new donors does Vitalant expect to gain?

It is difficult to accurately estimate the number of people who will come to donate blood as a result of the FDA guidance moving to an individual donor assessment but allowing for more people to be eligible while ensuring the safety of the blood supply is always a good thing. 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. 

What should transgender or non-binary individuals expect when donating blood with Vitalant?

Vitalant encourages and welcomes blood donations from eligible donors regardless of sexual orientation or gender identity. To ensure the safest possible donation, the process for transgender and non-binary donors can be a bit more involved as important donor safety measures are based on physiology associated with sex at birth.  

All blood, platelet and plasma donors are asked to self-identify if their gender identity is not the same as their sex at birth to ensure donors who identify as transgender, transitioning or non-binary – regardless of hormone therapy status – are safely collected. The “male” sex status is then entered into the computer system which ensures the safest hemoglobin (protein that carries oxygen in blood) level is met before donating. Giving blood while being anemic can cause or worsen associated symptoms including fatigue, dizziness and shortness of breath. 

For those giving a platelet, plasma or Power Red donation, the total volume limit is set to the lower female threshold to ensure donors aren’t over-collected, which can lead to anemia or reactions including losing consciousness – something we all want to avoid!

We recognize this is not an ideal experience for our donors who identify as transgender, transitioning or non-binary. We are working with software providers to develop a revised computer application to allow for additional categories for donor registration beyond the current male and female options – including transgender and X – so we can also register donors according to how they identify. When developed, the FDA will have to approve it. 

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. 

History of Blood Donor Eligibility

1983 The FDA outlined a lifetime ban on donations by men who have sex with men (MSM) even one time since 1977 in response to the HIV/AIDS crisis.
1985 The FDA approves the first blood-screening test to detect HIV antibodies.
2006 Blood centers across the nation release a joint statement that the lifetime MSM blood donation ban was “medically and scientifically unwarranted” and called for guidelines to be comparable to other groups at “increased risk of sexual transmission of transfusion transmitted infections.”
2015 The FDA revised guidance, moving to a one-year deferral, requiring any man who had sex with another man to wait one year until they could give blood.
2020 Along with announcing shorter deferral periods for other eligibility factors, the FDA updates its MSM guidance to a three-month blood donation deferral.
2023 The FDA issues final guidance recommending an individual assessment of HIV risk for all donors, regardless of gender or sexual orientation.