On December 4, 2023, Hoxworth Blood Center will implement the U.S. Food and Drug Administration’s (FDA) new individual donor assessment guidance for all blood donors.
New Inclusive Individual Donor Assessment Screening Questionnaire
The change to Individual Donor Assessment
The approved 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.
New Donor Health Questionnaire (DHQ 4.0): Individual Donor Assessment
By asking all donors the same questions about their sexual behavior, this change reflects the fact that diseases caused by infectious agents such as HIV could be contracted by anyone, regardless of their sexual orientation. Additionally, these questions are only the first layer of safety and follows extensive and sensitive tests for a variety of infections.
Under the new guidance, all donors will be asked about new or multiple sexual partners in the past three months. If they report a new sexual partner or more than one sexual partner in the past three months, they would then be asked if they engaged in anal sex over the prior three months.
Those donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be temporarily deferred from donation. A donor who does not report having new or multiple sexual partners or anal sex in the past three months may be eligible to donate, provided all other eligibility criteria are met.
Product Testing and safety of the blood supply
As the only steward of the Tri-State blood supply, the highest priority of Hoxworth Blood Center has always been the safety of our volunteer blood donors and the patients in need of lifesaving blood products. Because of our highest safety standard, Hoxworth tests every unit of blood donated 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 very early infection.
Transgender & Nonbinary Donors
Being transgender is not a cause for donor deferral. Donor eligibility will be based upon the criteria associated with your self-identified, self-reported gender.
Being non-binary is not a cause for donor deferral. The new individual donor assessment questionnaire will allow donors to self-identify as "Male", "Female", or "Other". All donors will be asked the same questions regardless of self-identified gender category.
Donor Record Updates and Eligibilty Questions:
For questions regarding donor eligibility or to change your reported gender in your donor record, please contact Hoxworth at 513-558-1304.
- This change prioritizes the safety of the nation’s blood supply and is supported by extensive data collected through the Department of Health and Human Services’ Transfusion Transmitted Infections Monitoring System (TTIMS) and the recent Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study.
- The FDA has long engaged in collecting data on the safety of the blood supply and will continue this collection of data. Additionally, studies and real-world evidence from countries that have already implemented a similar change further support the safety of this change.
- FDA determined, based on its review of currently available scientific data, that this change will not compromise the safety or adequacy of the nation's blood supply.
- The new approach to donor screening will continue to defer those with a higher chance of acquiring a new HIV infection. Other criteria already in place identify additional risk factors for acquiring HIV, and these will continue to be applied.
- To decrease the transmission risk of HIV/AIDS, blood donors have been asked since 1983 to read very explicit information about sexual contact including anal sex before answering questions about HIV risk factors.
- With the new questionnaire, donors with a new partner or multiple partners in the past three months will be explicitly asked about recent anal sex history as there is a higher chance of HIV transmission through anal sex than vaginal or oral sex.
- Statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex.
- This does not account for an individual’s safe sex practices, but is based on an evidence-based approach to overall risk.
- Prospective donors taking oral medications to prevent HIV transmission like PrEP will be subject to a three-month deferral.
- Those taking injectable PrEP will be deferred for two years from the date of the most recent dose
- This is due to the effectiveness of these medications in suppressing the presence of HIV in the blood, especially during the so-called “window period” of infection (the time between infection and its ability to be recognized by testing).
- This deferral is for anyone taking the medication and is not based on any characteristic of the individual taking the medication. It is just one of many medications that can result in an individual being unable to donate blood while taking the medication and for some time after.
The U.S. Food and Drug Administration and blood centers across the country recommend that donors continue medicine regimes as prescribed by their physicians and do not discontinue or delay taking medications to be eligible to donate blood.
Listen to episode 47 of In the Know with Dr. Oh where Cheif Medical Officer, Dr. David Oh sits down with Quality Assurance Director, Jan Habel, to discuss the FDA updates to the Individual Risk Assesment.