Updated FDA Guidance on Blood Donation Screening: Where Are We Now?

In July 2022, Velasco et al. brought attention to ongoing and systemic discriminatory policies regarding blood donation in the United States. The Food and Drug Administration (FDA) guidelines specifically targeted individuals who identify as men who have sex with men (MSM). The screening questions specifically asked men if they had sex with other men. A “yes” answer disqualified potential donors from donating blood even if they were in monogamous relationships where both partners were HIV-negative.

In December 2022, the FDA’s commissioned study (ADVANCE) wrapped, and news emerged that the study’s results prompted potential changes in the FDA-required screening policies. In a post on this blog titled Potential Changes to Blood Donation Policies for MSM in the United States, I reported the possible changes.

At the time, although we knew there would be potential change, we did not have full transparency or a final answer. Then in May 2023, the FDA updated the guidance for screening blood donors based on the results of the ADVANCE study. You can review those changes here. However, until August 7, some major blood donation centers, such as the American Red Cross, had not fully implemented the new screening guidance.

What are the current guidelines?

• All potential donors will see new non-gendered screening questions when presenting for donation.
• All potential donors, regardless of sexual orientation, will be asked the same questions and be screened for blood donation eligibility based on individual risk factors.
• The previous FDA blood donation eligibility criteria based on sexual orientation, which restricted sexually active MSM from giving blood, has been officially eliminated.

Moving forward and what to expect.

As a potential donor who was previously rejected for donation because of the screening procedures, I look forward to donating in the future. However, given the gap between the updated guidelines and the screening that actually occurs in some blood centers across the nation, potential donors should inquire about the donation center’s screening policies before attempting to donate.

This exciting change in FDA policy can profoundly affect the nation’s currently stressed blood supply. Potential donors and health care professionals must inform themselves about the current screening processes and watch the uptake of these changes to keep the blood supply safe and plentiful.

Justin Fontenot, DNP, RN, NEA-BC, FAADN, is an assistant professor of nursing at the University of Louisiana at Lafayette and the editor-in-chief of Teaching and Learning in Nursing.