Welcoming More Donors with Our Updated Donor History Questionnaire

At San Diego Blood Bank, we are always striving to evolve and adapt to the latest scientific recommendations and guidelines. We are thrilled to announce that, starting today, our new Donor History Questionnaire (DHQ) is live at all San Diego Blood Bank donor center locations and mobile drives. This update aligns with the FDA's recent move towards an individual assessment approach for blood donations.

A Step Towards Inclusivity

Earlier this year, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using questions based on individual activity instead of identity. This approach aims to reduce the likelihood of transfusion-transmitted HIV and ensures that questions are consistent for every donor, irrespective of their sexual orientation, sex, or gender.

What Does This Mean for Donors?

The new DHQ eliminates time-based deferrals and specific screening questions related to men who have sex with men (MSM) and women who have sex with MSM. Instead, all prospective blood donors will answer a series of individual, activity-based questions to determine their eligibility. This approach is designed to identify and defer donations from individuals with new or recent HIV infections that might be in the window period for detection.

It's important to note that individuals taking medications to treat or prevent HIV infection, such as antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP), will also be deferred. While these medications are crucial public health tools, their use may delay the detection of HIV by currently licensed screening tests for blood donations.

Safety First

In light of the results from the FDA’s ADVANCE study, we have full confidence in the thorough scientific work undertaken by the FDA to implement this change. The FDA sets requirements for blood banks throughout the U.S. and follows a data-driven approach to inform blood establishments that collect blood or blood components of revised recommendations for evaluating donor eligibility. This approach ensures the protection of the recipients of blood products. Our primary focus remains on ensuring the safety of the blood supply for our region. The FDA's move towards an individual risk assessment is based on extensive scientific evidence and mirrors policies in countries like the United Kingdom and Canada. By adopting these recommendations, we aim to expand the number of people eligible to donate blood while upholding the highest standards of safety.

Join Us in Making a Difference

We are grateful for the continued support of our community and donors. With these changes, we hope to make the blood donation process more inclusive and straightforward. If you've ever considered donating blood or if you're a returning donor, now is a great time to join us in our mission to connect lives through the gift of blood.

Schedule an Appointment to Donate

If you have any questions regarding this change, please see our FAQs below. To discuss specific eligibility questions, please contact Donor Services at donorservices@sdbb.org or call (619) 400-8251.

Frequently Asked Questions (FAQs)

What are the most notable changes for individual donor assessment questions?

All donors will be asked if they’ve had new and/or multiple sexual partners in the past three months. If they answer yes to either, they will then be asked if they’ve had anal sex with any of these partners. If they have, they will be required to wait three months from when they most recently had anal sex to donate. If they have not and meet all other eligibility criteria, they will be able to donate.

Why the focus on anal sex?

Statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex. This does not account for individuals’ safe sex practices, but is based on an evidence-based approach to overall risk.

Why are there questions about anal sex with multiple partners?

Data show that the risk of a new/recent infection of HIV that cannot be detected by current testing methods (particularly “window period” infections) increases with new sexual partners and multiple sexual partners. Statistically, anal sex has a significantly higher risk of HIV transmission per sex act compared with vaginal or oral sex. Multiple sexual partners can increase the chance of HIV transmission.

Why are people who have used PrEP/PEP in the past three months deferred?

Pre-exposure prophylaxis (PrEP) is a highly effective medication regimen used for HIV prevention. In people taking PrEP or post-exposure prophylaxis (PEP), low levels of HIV may be missed by current testing methods. The blood community relies on accurate HIV testing as part of its multilayered approach to safety. There needs to be more research on how PrEP and PEP affect HIV testing. At this time, FDA recommends that individuals who take oral PrEP or PEP are deferred from donation for three months from their most recent use. For individuals who have received PrEP by injection, FDA recommends deferral from blood donation for two years from their most recent injection. This is an issue impacting blood operators worldwide. Tests used to detect HIV and other viruses are manufactured by independent companies, not blood collectors or regulatory bodies. Work to understand the true impact of PrEP and PEP medication regimens on HIV tests can only be completed in collaboration with or directly by the manufacturers of the test, who hold the licensing for these products.

How was it determined that it was safe to change to an individual donor assessment approach?

FDA determined, based on its review of currently available scientific data, that this change will not compromise the safety or adequacy of the United States blood supply. The new approach to donor screening will continue to defer those with a higher chance of acquiring a new HIV infection. Other criteria already in place identify additional risk factors for acquiring HIV, and these will continue to be applied. Evidence from the ADVANCE Study, the TTIMS monitoring system, and other data assessed by the FDA support making this change. Currently the risk of HIV being introduced to the blood system is extremely low. All available evidence confirms that an individual donor assessment approach to screening will continue to ensure the highest safety and quality for the blood supply.

Why are there not questions about condom use?

Condom use, while an excellent sexual health practice, isn’t an evidence-based method of screening donors because condoms are not always effective and can break or slip. It is important to note that our individual donor assessment screening questions are not comprehensive in asking about safe sexual practices, such as condom use, that can effectively mitigate the risk of acquiring HIV. The updated donor history questionnaire is designed to be applied as broadly as possible to screen a large number of potential donors and identify the possibility of new exposures to certain viruses within the window period of testing platforms.

Isn’t all blood tested anyway? Why are screening questions necessary?

Yes, every donation is tested for an array of infections that could potentially be transmitted by blood transfusion. But no test is perfect, and there are some infections for which there is no reliable test available. One reason we have such a safe blood supply is the layering of a donor screening questionnaire with donation testing. Tests that are used to test every blood donation have a limitation called the “window period.” The window period is the time between when a donor has acquired a new infection and is able to transmit it, to the time a lab test can reliably detect the infection. If a donor has recently acquired an HIV or hepatitis infection, current testing methods may not pick it up. The Donor History Questionnaire is critical in helping identify people who may have had a recent new exposure to an infection of concern, such as HIV or hepatitis C.

Is this eligibility change being made because of political correctness?

No. The blood community’s goal is to be as inclusive as possible while maintaining the highest level of safety for the blood supply. Donor eligibility undergoes frequent revisions resulting in changes based on current scientific evidence.

I’ve heard that undetectable means untransmissible (U=U). Why can’t HIV+ people donate if their viral load is undetectable?

It’s amazing that HIV care has reached a point where people’s viral loads can be undetectable. Undetectable equals untransmissible only applies to sexual transmission of HIV. Unfortunately, this does not apply to the risk for transfusion-transmission. Even blood donated by those who have an undetectable viral load could potentially put a patient at risk for HIV following a blood transfusion. The risk of transmission is much higher with a unit of blood due to the large volume of a blood transfusion and the much higher total amount of virus present.

Why do the questions not address receptive vs. insertive anal sex when they have such different risk profiles?

It is true that receptive anal sex is associated with a higher risk of HIV transmission per sex act than insertive anal sex. However, in research studies involving asking donors about receptive anal sex, the term was not well understood and the question was inconsistently answered. For the safety of the blood supply, it is important that donor screening criteria is easily understood by all donors.

What about people who are in exclusive relations with multiple people/ practice polyamory/polyfidelity? Why aren’t they able to donate?

The blood community recognizes that some people may be in sexual relationships with multiple people where their partners are not new partners. At this point, there is insufficient evidence to inform criteria about people in exclusive relationships with more than one partner.

Why can’t I have anal sex and donate blood? Is this just another version of the previous policy using “anal sex” instead of asking men if they’ve had sex with men?

The new individual donor assessment questions will only ask donors about anal sex if they have had a new sexual partner or have had multiple sexual partners in the past three months. Donors who have one sexual partner they’ve been with three months or longer won’t be asked about anal sex. Donors who have anal sex with one partner who they’ve been with for three months or longer will be eligible, as long as they meet all other eligibility criteria.

Does it count as anal sex if I use sex toys/hands/fingers?

No, using sex toys/hands/fingers is not considered anal sex in the context of our donor screening criteria.

Are donors eligible if they have multiple partners if it’s vaginal/oral sex?

The individual donor assessment screening criteria focus on anal sex in the context of new or multiple partners, rather than vaginal or oral sex. This is because, statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex. Multiple sexual partners can increase the chance of HIV transmission. This does not account for individuals’ safe sex practices but is based on an evidence-based approach to overall risk.

I’m monogamous. Can I donate and still have anal sex with my partner?

Yes. If you are having anal sex with one person you’ve been with for at least three months, you will be able to donate as long as you meet all other eligibility criteria. All donors are asked if they’ve had a new partner in the past three months, or multiple partners in the past three months. Donors who have one sexual partner they’ve been with three months or longer won’t be asked about anal sex.

Why do I need to choose male or female on the donor card?

The FDA requires each donor to self-identify their gender by choosing male or female on the DHQ every time they attempt to donate blood. Blood donors must answer each question on the health history questionnaire during the screening process. Failure to answer all questions on the questionnaire forfeits the individual’s ability to donate blood on that date and time (or until a gender is selected, in this specific instance). SDBB understands that gender is not binary; however, donors are currently required to answer the gender question, per FDA requirements.

For additional information regarding these eligibility changes, visit aabb.org/ida.