Published by Kirby Winn on Tuesday, October 3, 2023 in News Releases
ImpactLife has implemented Individual Donor Assessment, a donor screening practice that is consistent with new guidance on donor eligibility issued by the U.S. Food and Drug Administration earlier this year. The change to Individual Donor Assessment creates more equitable donor eligibility standards by using gender-inclusive, individual sexual behavior-based questions in pre-donation screening.
Under Individual Donor Assessment:
- The previous blanket deferrals for men who have sex with men and for women who have sex with men who have sex with men have been eliminated.
- The donor history questionnaire has been revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who have had a new sexual partner, or more than one sexual partner in the past three months, are then asked about a history of anal sex in the past three months.
- Prospective donors who have had a new sexual partner or more than one sexual partner and had anal sex in the past three months, are deferred from donation.
- Prospective donors who have not had anal sex with a new partner or with multiple partners in the last three months 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 90 days (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
“We are pleased to announce our participation in the nationwide adoption of the Individual Donor Assessment," stated Dr. Daniela Hermelin, Chief Medical Officer (left). "We have implemented uniform pre-donation screening questions related to HIV risk, irrespective of the donor's gender or gender identity. This signifies a significant advancement in our field, enabling us to expand the pool of potential donors while safeguarding the safety and accessibility of our region’s crucial blood supply.”
U.S. FDA finalized changes to its guidance on donor eligibility in May 2023. ImpactLife was then able to update policies and conduct staff training to implement Individual Donor Assessment its pre-donation screening practices on Sept. 25, 2023. For more information, see www.bloodcenter.org/update.
AABB: FAQs on Individual Donor Assessment
History of FDA Recommended Deferrals
FDA News Release (May 2023)
Joint Statement from AABB, America's Blood Centers, and American Red Cross (May 2023)
ImpactLife is a not-for-profit community organization providing blood services and emergency services providers to 124 hospitals in Illinois, Iowa, Missouri, and Wisconsin, as well as resource sharing partners across the country. Services extend from southcentral Wisconsin to St. Louis, Missouri and from Danville, Illinois to Chariton, Iowa. (See a map of the ImpactLife service region.) ImpactLife operates 22 Donor Centers and holds approximately 5000 mobile blood drives annually to provide blood components needed for patient transfusions at hospitals throughout our region.
For more information, see www.bloodcenter.org and find us @impactlifeblood on Facebook, Instagram, LinkedIn, TikTok, Twitter, Snapchat, and YouTube.