The U.S. Food and Drug Administration in May updated its guidance on who is allowed to donate blood. The new rules eliminate restrictions specifically prohibiting gay and bisexual men from donating. The Tri-State's two blood centers are in the process of updating their procedures to comply with the new guidance.
"I think it's a positive change for the industry. It will hopefully increase donor eligibility and people who have been not able to donate will be able to donate as a result of these changes," says David Oh, MD, chief medical officer with Hoxworth Blood Center.
Oh notes the changes are being made "with blood safety for transfusion recipients as a priority."
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"We welcome this change and are optimistic it will mean more donors joining our mission and safely providing the blood so essential to saving the lives of hospital patients across our region," agrees Community Blood Center Vice President of Donor Services Tracy Morgan.
What changed?
The FDA is issuing a new series of "individual risk-based questions" that will be the same for everyone who donates blood. Anyone who has had more than one sexual partner, or anyone who has had anal sex with a new partner within the last three months will be asked to wait to donate blood. Previously, only men who have sex with men (or women who have sex with men who have sex with men) had to wait three months before donating blood.
The updated guidelines mean most gay and bisexual men in monogamous relationships will not have to refrain from sex in order to give blood.
"This new questionnaire is a change in terms of approach towards determining donor eligibility, where instead of grouping people together — and especially one group that was identified was men who have sex with men — so identifying people just based on sexual preference and sexual orientation as well as gender identity, they decided to go from that methodology to what they call an 'individual donor risk assessment,' where people are asked questions about sexual contacts, but not based on sexual preference," Oh explains.
When will the new rules be in place?
Hoxworth and Community Blood Center (CBC) both anticipate it will take several months to fully implement the new guidance. CBC is aiming for September and Hoxworth would like to start rolling out the new procedures in three to six months, but is setting a goal of the end of 2023 to have them fully in place.
"Community Blood Center and blood centers around the nation have been working toward the implementation of these recommendations by revising our donor history questionnaires and procedures. It doesn't happen overnight, and we're in the process now," says Mark Pompilio, public relations and marketing manager for CBC.
Once the questionnaires are updated, staff will also have to be trained on the new questions and how to answer any follow-up questions donors may ask. Hoxworth says computer systems also need to be updated.
"We need to make changes in our computer system so that donors are asked the right questions, as well as company algorithms in the computer system to ask follow-up questions if necessary," says Oh. "(It) may take a little bit, as well, as training of our individuals and then making sure that our people who are asking the questions understand why we're asking the questions and what to do with whatever answers we get."
Oh spoke about the recent changes in episode 47 of his podcast, In the Know with Dr. Oh. You can listen to it on Hoxworth's website.
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Pompilio adds, "It's, frankly, unfortunate that we aren't able to get this implemented faster because we do hope that it'll mean more availability of donors, and not just donors who have been specifically limited, restricted or totally excluded during the time of the old guidelines ... but also people who may be more inclined to donate now because they feel better about what these regulations say to the community at large."
Why were these restrictions in place?
Restrictions on gay and bisexual men giving blood date back 40 years. They were put in place during the early days of the AIDS epidemic as a way to protect the blood supply from HIV. Gay and bisexual men were totally prohibited from donating blood for a long time. The FDA has been slowly easing the prohibition.
As NPR reported in May, "The newly updated guidelines are aimed at addressing years-long criticisms that the previous policy was discriminatory and outdated, and posed yet another barrier to bolstering the nation's blood supply.
"Blood banks already routinely screen donated blood for HIV.
"And for decades, organizations including the American Medical Association, the American Red Cross and numerous LGBTQ+ advocacy groups have called for a rule change."
Some advocates, like GLAAD, welcomed the changes, but say there are still barriers. CEO Sarah Kate Ellis points to a restriction on potential donors who use pre-exposure prophylaxis (PrEP), an FDA-approved drugproven to prevent the transmission of HIV.
"Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives," she wrote in a May statement. "GLAAD urges the FDA to continue to prioritize science over stigma and treat all donors and all blood equally."
