Individual Donor Assessment
On December 6, 2023 Bloodworks Northwest implemented the U.S. Food and Drug Administration’s (FDA) new individual donor assessment guidance for all blood donors. What does this mean?
- 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 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.
- 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.
- Maintaining the safety of the blood supply for patients is Bloodworks’ top priority. In addition to the donor history questionnaire, 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.
Bloodworks Northwest’s Dr. Kirsten Alcorn and new blood donor Mark Dyce-Ryan discuss breaking down barriers to blood donation.
What You Need to Know
Old FDA Guidance
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.
New FDA Guidance
All potential donors are screened using a series
of questions that assess individual risk of HIV, regardless of gender or sexual orientation.
What Are The New Donation Criteria?
The criteria will now focus on sexual contact proven to have a higher risk of disease transmission. All potential donors will be asked whether, in the three months prior to their date of donation, they have:
- Had sexual contact with a new partner. If so, they will be asked if they have had anal sex in the last three months.
- Had sexual contact with more than one partner. If so, they will be asked if they have had anal sex in the last three months.
Anyone who has had sexual contact with a new partner or more than one partner and who has had anal sex in the past three months is at an increased risk for transmitting HIV and other infectious diseases and is deferred for three months.
Additionally, the new gender neutral questionnaire asks every donor if they’ve ever been pregnant and if they’ve ever had a transfusion.
Frequently Asked Questions
What is changing with the new donor eligibility questionnaire?
The biggest change is that the new question set will be gender neutral. This means that all donors, whether they identify as male or female, will receive the same questionnaire. Bloodworks does not currently have another gender option, but we hope to at some point.
Every donor will now be asked if they’ve ever been pregnant and if they’ve ever had a transfusion.
The FDA is also moving away from asking gender-specific HIV risk questions. Donors who identify as male will no longer see “In the past 3 months have you had sexual contact with another male?” on their screen. Instead, it will be replaced with two gender neutral questions addressing if a donor has had new or multiple sexual partners in the past three months.
Preventative HIV medication questions with examples of PrEP or PEP are being updated.
Who determines donor health questions?
These initial fifty-some-odd questions are not actually generated by Bloodworks: they come from the Association for the Advancement of Blood & Biotherapies (AABB), the “not-for-profit Association representing individuals and institutions involved in the fields of transfusion medicine and biotherapies.
The AABB takes the Biological Products guidance put out by the Food and Drug Administration (FDA) and creates a question set that complies with the guidelines put forth by the FDA. These questions include some that protect the donor. For example, the FDA doesn’t want someone donating if they’ve had heart problems in the last six months. While other questions protect the potential recipient, for example, some active infections currently being treated with antibiotics may exclude a donor.
Why is Pre/Post-exposure prophylaxis PrEP/PEP a cause for deferral?
Based on current guidance from the FDA, individuals taking preventative HIV medications (such as PrEP or PEP) are still deferred.
AABB addresses these concerns, stating that while PrEP/PEP, “…is a highly effective medication regimen used for HIV prevention… low levels of HIV may be missed by current testing methods.”
Current definitions of an “undetectable” HIV+ viral load only applies to sexual transmission of HIV. AABB states, “Even blood donated by those who have an undetectable viral load could potentially put a patient at risk for HIV following a blood transfusion.”
At this time, the FDA recommends that individuals who take oral PreEP or PEP are deferred from donation for three months from their most recent use. Bloodworks does not recommend stopping taking this medication to donate blood.
For the most up-to-date information on medication deferrals and other eligibility requirements, please visit our eligibility page.
I attempted to donate prior to December 6 and have a three-month deferral from donating under the previous FDA policy. How can I verify if I’m eligible to donate now?
If you have been told you were deferred for three months under the old FDA MSM policy, you may now be eligible if you meet all other eligibility requirements to be a blood donor. Please contact us at [email protected] to confirm status or to have the deferral removed from your donor profile and ask if you are eligible to be re-entered as a donor before donating. Our Donor Care Team can also assist with booking your donation appointment.
I’ve never tried donating before because of the FDA’s previous MSM policy. Am I eligible now?
If you’ve never donated with Bloodworks before, you can book an appointment for December 6, 2023 and beyond. Most people in good health, at least 18 years old, and weighing 110 pounds may donate blood if they meet all other eligibility requirements to be a blood donor. Check out our eligibility page for more information or reach out to our clinical specialists at (425) 656-3077 or [email protected] to review specific eligibility questions.
Why am I being asked about my sexual history with new or multiple partners? And why is there a focus on anal sex?
Although HIV testing has improved, there is still a window period in which the tests may not identify an infection. These risk-based questions are still in the questionnaire using a timeframe of three months to account for this window period.
From AABB’s FAQ on Individual Donor Assessment Screening, “Statistically, anal sex has a significantly higher chance of HIV transmission per sex act… this does not account for individuals’ safe sex practices, but is based on an evidence-based approach to overall risk.”
If the question set is gender neutral, why do I have to confirm my gender in the screening room?
There are different physical value acceptations for things like iron levels and weight for minors that are dependent on the gender self-identified by the donor. Gender can also determine which donors get screened for HLA antibodies (more on this below).
Why am I being asked about pregnancy and transfusions?
Donors, regardless of gender, are still eligible to donate if they are not currently pregnant, have not been pregnant within the last six weeks, and have not had a transfusion within the last three months. Pregnancy includes miscarriages, abortions, and live or still births.
Donors who have been pregnant or been transfused have a higher chance of developing HLA antibodies, protein markers that are part of the body’s immune response. The questions about having ever received a transfusion or been pregnant are both related to the development of HLA antibodies and subsequent risk of transfusion-related acute lung injury (TRALI) reactions in the recipient.
TRALI is currently the single highest risk for a patient during a blood transfusion. There have been studies indicating these HLA antibodies in transfusion-related reactions. Blood centers try to reduce this risk by not making high volume plasma from donors who have screened positive for having HLA antibodies.
Have any additional questions? Please email us at [email protected].
New Era of Blood Donation:
Bloodworks and its LGBTQIA+ community partners believe in creating an equal opportunity for everyone to save lives. Learn more.
Seattle Times: More gay men will at last be allowed to give blood -“We welcome newly eligible donors. This change backed by science is a remarkable opportunity for people to know this is open to them and to help heal wounds.” – Dr. Kirsten Alcorn
Bloodworks Northwest is dedicated to advocating for fair and science-based blood donor eligibility. Take a look back at our years of pushing for change ahead of implementing new, more inclusive guidelines regarding the FDA’s MSM deferral.