Updated FDA Guidelines

New Individual Donor Assessment Screening Questionnaire

On December 4, 2023, Hoxworth Blood Center implemented the U.S. Food and Drug Administration’s (FDA) new individual donor assessment guidance for all blood donors.

In May 2023, the U.S. Food and Drug Administration (FDA) finalized its guidance that changes the blood donation screening process to be more equitable while continuing to reduce the risk of transfusion-transmitted infection. Instead of using questions focused on gender and sexual orientation, a new questionnaire will be based on gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted infection.

Most notable changes under the new guidance:

  • All donors will be asked the same questions.
  • All donors will be asked about new or multiple sexual partners in the past three months.
  • If a donor reports a new sexual partner or more than one sexual partner in the past three months, the donor would then be asked if they engaged in anal sex within the last three months.
  • If a donor answers yes to the anal sex question, a donation waiting period of three months will be required from the time they recently had anal sex. A no answer means they will be able to donate blood or platelets, provided they meet all other eligibility criteria.
  • The new individual donor assessment questionnaire will also have an additional gender category labeled “other”.

Why the change?
The approved FDA guidance aligns the United States with other countries that have implemented similar donation eligibility changes, including Canada and the United Kingdom. The FDA, along with blood centers across the country, have always placed the safety of the blood supply at the forefront of its mission by adhering to a donor health questionnaire and extensive testing of blood donations.

Maintaining the safety of the blood supply.
As the only steward of the Tri-State blood supply, Hoxworth Blood Center places the highest priority in the safety of our volunteer blood donors and the patients in need of lifesaving blood products. High safety standards mean Hoxworth tests every unit of donated blood and platelets for a variety of infectious diseases, including (but not limited to) HIV, hepatitis, and syphilis. While testing has greatly improved in recent years, it is not 100 percent effective at detecting infectious diseases in donors with early infection.