Final Guidance Released on New Blood Donor Criteria

Individual Risk Based Assessment

On May 11, 2023, the Food and Drug Administration (FDA) released a final guidance that moves blood donor screening criteria to individual, risk-based assessments for the transmission of human immunodeficiency virus (HIV). The guidance establishes blood–donor–screening criteria based on individual behaviors, not sexual orientation or gender identity.

On August 22, LifeSouth implemented these changes by updating our pre-donation screening questions. For more information about these sweeping changes, please read our FAQs: link here.

If you were previously deferred under the FDA’s prior policy related to sexual contact with men, you can return to donate at any time. However, if you were previously deferred for use of pre-exposure or post-exposure HIV drugs, your prior deferral remains in place.

LifeSouth supports the new guidance and its use of evidence-based deferral periods that are applied fairly and consistently among blood donors. We look forward to welcoming new donors to help in our mission to provide a safe and consistent blood supply for patients in need. 

If you have questions regarding the new screening criteria or your eligibility, please contact medicaloffice@lifesouth.org.

FDA Guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human

Cruetzfeldt- Jakob Disease (Mad Cow Disease)

As of May 2022, a guidance by the FDA lifts the deferral for donating blood for those who were previously deferred due to spending time or living in the United Kingdom, France or Ireland. The FDA determined there is no longer a risk of transmitting Cruetzfeldt-Jakob Disease (or mad cow disease) to patients receiving blood transfusions.

In April 2020, the FDA eliminated the deferral of U.S. military personnel, Department of Defense civilians, and their families who spent time at U.S. military installations in Europe during the period of 1980-1996.

Blood donors who were previously deferred for living in or traveling to the UK, France or Ireland are asked to come in and donate blood. Please visit lifesouth.org or call 888-795-2707 to schedule an appointment to donate or to find out more information.

Cancer

Donors with a history of cancer are eligible to donate as long as they have completed treatment and recovered with no sign of active cancer remaining. Donors receiving prophylactic treatment, such as hormone therapy after breast cancer, are eligible to donate. Donors with low-grade prostate cancer (i.e. Gleason score 3+3) with no treatment planned are eligible to donate.