• The FDA draft guidance proposes a shift that will create equitable donor eligibility standards for blood donors by using gender inclusive, individual sexual behavior-based questions in pre-donation screening.
• This proposed change is in line with policies in place in countries like the United Kingdom and Canada that have made changes in recent years.
• The FDA evaluated data from ongoing surveillance of the U.S. blood supply and results from studies conducted by other countries. The FDA also sponsored a recent study, Assessing Donor Variability and New Concepts in Eligibility (ADVANCE), to observe data among domestic populations.
• This guidance has been updated two times, starting in 2015 when the lifetime ban of men who have had sex with another man was lifted and then again in 2020 when the 12-month deferral for sexual contact with another man was reduced to three months.

On January 27^th, the U.S. Food and Drug Administration published proposed draft guidance on recommendations for evaluating donor eligibility using individual assessment of health and history to reduce the risk of HIV transmission by blood and blood products.

• The current blanket deferrals for men who have sex with men and for women who have sex with men who have sex with men would be eliminated. 
• The current donor history questionnaire would be revised to ask all donors about new or multiple sexual partners in the past three months. 
• Donors who have had a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months. 
  • If donors have had a new sexual partner or more than one sexual partner and had anal sex in the past three months, they would be deferred from donation for three months. 
  • Donors who have not had new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
  • Donors who have had new or multiple sexual partners without anal sex may be eligible to donate provided all other eligibility criteria are met.   
• Medications taken to prevent or reduce likelihood of HIV infection (PrEP or PEP) will result in deferral for three months (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
  • Donors should not stop taking any medication regimen prescribed by their provider to donate blood.

The U.S. Food and Drug Administration outlines the requirements and recommendations for screening blood donors. The questions were developed by professional societies and recognized by the FDA to be acceptable for determining donor eligibility across the nation.  

No.

• Having a safe and adequate blood supply is in the best interests of all patients requiring blood transfusions, which come from volunteer blood donors of all political parties and affiliations.
• Blood centers across the country have united in support of this change and have advocated for change for years due to the excellent safety record of current infectious disease tests and more recent data on the minimal risks associated with transmission of HIV.
• The current deferral has alienated a subset of the population due to its focus on gender identity and sexual orientation rather than individual sexual behavior.
• The new guidance proposes screening protocols that will be applied to all donors regardless of gender identity and sexual orientation.

• Based on the data available to the U.S. Food and Drug Administration today, the decision was made to proceed with confidence that these new criteria would continue to support a safe and robust blood supply. The new screening protocols would apply a set of screening questions about sexual behavior to all donors vs. a small subset of donors, which supports safety screening methodology.

We don’t know. 

• Currently more than 60% of adults in the U.S. are eligible to voluntarily donate blood, yet in most communities less than 5% roll up their sleeves to help each year.
• The volunteer donor base is aging and lacking in younger more diverse blood donors, so there are concerns about the long-term sustainability of the blood supply.
• A donor screening process that equitably applies to all donors should help support a robust blood supply.
• It is too early to tell how many donors will or will not be deferred with the new criteria.

• Medications taken to prevent or reduce likelihood of HIV infection (PrEP or PEP) will result in deferral for three months (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
• Peter Marks of The U.S. Food and Drug Administration, indicated in a January 27^th press conference, that they would continue to monitor data for possible changes in the future.
• The U.S. Food and Drug Administration and blood centers across the country recommend that donors continue medicine regimes as prescribed by their physicians and do not discontinue or delay taking medications to be eligible to donate blood.
• To see a full list of medications that result in deferral from blood donation, contact your local community blood center.

• Most blood centers will still ask gender identity questions because it helps determine which blood components can be made from a single donation.
• For example, blood centers cannot make plasma products from a donor that has had a history of pregnancy (without additional testing) or positive genetic markers in their plasma that can cause Transfusion Related Acute Lung Injury (TRALI) among patients receiving transfusion.
• With no knowledge of gender, blood centers must use the most stringent criteria based on gender, such as hemoglobin (HGB) and total blood volume (TBV). This would mean that all females must have a minimum HGB of 13.0 rather than 12.5 and lead to unnecessary deferrals. The same is true TBV, which is used to determine eligibility to donate some apheresis products. This would limit the number of females eligible for those apheresis procedures. Both scenarios would have a detrimental impact on the blood supply.
• These gender-questions may not defer a donor from giving.

Gulf Coast Regional Blood Center tests for markers of infectious diseases using the Food and Drug Administration’s (FDA) approved testing kits. These include markers for HIV (human immunodeficiency virus) type 1 and 2, Hepatitis B and C, Syphilis, Human T-Lymphotropic Virus (HTLV) type I and II, West Nile Virus and Chagas disease. All blood units sent for transfusion to patients have been tested and found to be negative for these markers.

Gulf Coast Regional Blood Center offers many ways for people to give back to the community. There can never be enough Digital Advocates. Our Digital Advocates are writers, guest bloggers, social media influencers, and strong advocates in our community.

Support your community by hosting a blood drive. Gulf Coast Regional Blood Center needs 1,000 donations a day to sustain the blood supply. We work with groups of all sizes, from Fortune 500 companies to family-owned and operated small businesses. Become a volunteer at Gulf Coast Regional Blood Center. The opportunities are endless! Volunteers have the chance to help at blood drives and community events during the week. We occasionally have opportunities for public speaking and light office work as well. If you’d like to explore these opportunities, complete the volunteer form, and we will contact you to schedule your training.

Gulf Coast Regional Blood Center would like to thank you for taking the time and exploring these topics! 

Customer Experience team is available: 

8 a.m. to 4 p.m. Monday–Friday

Email: cs@giveblood.org  

Call: (713) 791-6373 or +1 (877) 948-5433 toll-free