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New Era of Donor Eligibility Begins

On August 21, 2023 OneBlood implemented the U.S. Food and Drug Administration’s (FDA) new individual donor assessment guidance for all blood donors.

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Returning Blood Donor

  • All potential donors, regardless of gender or sexual orientation will be asked the same questions to determine if they are eligible to donate blood.
  • The new FDA policy further ensures safety of the blood supply, treats all potential donors equally and enables more people the opportunity to donate blood.
  • The FDA’s previous donor eligibility criteria based on sexual orientation, which made it challenging for gay and bisexual men to donate blood, has been eliminated.
  • Safety of the blood supply is OneBlood’s top priority. All blood donations undergo more than a dozen tests to ensure donations are safe for patients, including HIV, Hepatitis B and C, West Nile and other infectious diseases. Testing takes place at our state-of-the-art testing facility, Creative Testing Solutions.

New Blood Donor

  • If you never donated with OneBlood before you DO NOT need to fill out the form. Click the button below to find a Big Red Bus or donor center location near you.

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Individual Donor Assessment
Frequently Asked 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.

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.

Data shows 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.

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. 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.

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.

The new Donor History Questionnaire is gender-neutral and will pose all questions to all donors regardless of their gender or sexual orientation. Transgender individuals are welcome to donate blood.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

Have any additional questions? Please email us at: Questions@oneblood.org

History of FDA’s MSM Policy

1980s

The FDA’s MSM policy was first put in place in the 1980’s during the height of the AIDS epidemic. Back then, men who had sex with men were banned from donating blood. The lifetime ban remained in place for more than two decades.

2015

In 2015 the FDA updated the policy and moved to a one-year deferral period. This meant any man who had sex with another man would have to wait one year following their last sexual contact with another man before they could donate blood.

2020

In 2020, the FDA implemented the three-month deferral period, requiring men who have sex with men to wait three months following their last sexual contact with another man before they can donate blood.

2023

In 2023, the FDA eliminated the MSM policy and implemented gender-inclusive, individual assessment of all donors.