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Major Changes | Frequently Asked Questions
Major Changes Are Here!
On July 31, 2023, the NIH implemented the changes outlined in the recently revised FDA Guidance that recommends the adoption of Individual Donor Assessment (IDA) to determine blood donor eligibility. The finalized guidance poses the same donor screening questions to every donor, regardless of gender or sexual orientation.
This change is the result of a multi-year research process informed by data from Canada and the United Kingdom, surveillance information from the Transfusion Transmissible Infections Monitoring System (TTIMS), data assessing performance characteristics of nucleic acid testing for HIV, and results from the FDA-funded ADVANCE study.
The NIH Blood Bank fully supports this important step towards inclusivity, one which will allow more individuals to safely contribute to the vital cause of blood donation. Our top priority is the safety of our volunteer blood donors and the patients in need of lifesaving blood products.
We look forward to welcoming new blood donors!
Frequently Asked Questions
Can I donate if I am a man who has sex with men?
The FDA recently revised blood donor eligibility criteria in recent guidance document. Based on review of the available science, FDA recommends eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, FDA recommends assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender.
Can I donate if I identify as transgender or non-binary?
Effective November 15, 2023, donors may select male (M), female (F) or other (X) designation in our computer system. We welcome blood donations from eligible donors regardless of sexual orientation or gender identity. Donors who were previously registered as M or F may change their designation if desired; please speak with a donor resources specialist to make this change.
Why do we ask blood donors about sex and gender?
In the past, the donor health history questionnaire was gender-specific; blood donors were asked different questions based on their self-reported sex. Effective July 31, 2023, the NIH Blood Bank implemented the changes outlined in the recently revised FDA Guidance that recommends the adoption of Individual Donor Assessment (IDA) to determine blood donor eligibility. The finalized guidance poses the same donor screening questions to every donor, regardless of gender or sexual orientation.
However, certain aspects of the donor safety evaluation are based on criteria derived from historical sex-specific data, namely hemoglobin determination and estimation of blood volume for apheresis procedures. Hemoglobin (Hb) is the substance in red blood cells that carries oxygen to tissues in the body. The minimum Hb threshold per FDA criteria is higher for males (13.0 g/dL) than females (12.5 g/dL). Drawing blood from donors with a low Hb may be unsafe for them. Blood volume estimation calculations are important for a procedure called double red cell apheresis, which removes twice as many red cells as a routine blood donation. Estimated blood volume is larger for males than females. Drawing too much blood from donors with smaller blood volumes may be unsafe for them.
To optimize donor safety, our policy is as follows:
- For donors who self-identify as female, minimum Hb ≥ 12.5 g/dL, smaller estimated blood volume criteria
- For donors who self-identify as male, minimum Hb ≥ 13.0 g/dL and larger estimated blood volume criteria
- For donors who do not identify as male or female, we utilize the criteria with the lowest risk, i.e., minimum Hb ≥ 13.0 g/dL and smaller estimated blood volume criteria.
If you have any questions, please speak with a donor resources specialist, or ask to speak with a physician.