Latest Developments

FAQs

• What is Individual Donor Assessment?

  ImpactLife implemented Individual Donor Assessment in pre-donation screening on Sept. 25, 2023. Individual Donor Assessment creates more equitable donor eligibility standards for prospective blood donors by using gender-inclusive, individual sexual behavior-based questions in pre-donation screening.

  AABB: FAQs on Individual Donor Assessment (.pdf)

• What are the changes to the regulations?

  On May 11, 2023 the U.S. Food and Drug Administration published final guidance on recommendations for evaluating donor eligibility using individual assessment of health and history to reduce the risk of HIV transmission by blood and blood products. Under the new guidance from FDA:

  • The (previous) blanket deferrals for men who have sex with men and for women who have sex with men who have sex with men were eliminated. 
  • The Donor History Questionnaire has been revised to ask all donors about new or multiple sexual partners in the past three months. 
  • Donors who have had a new sexual partner, or more than one sexual partner in the past three months, will then be asked about a history of anal sex in the past three months. 
    • Donors who have had a new sexual partner or more than one sexual partner and had anal sex in the past three months are now deferred from donation for three months. 
    • Donors who have not had new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
  • Medications taken to prevent or reduce likelihood of HIV infection (PrEP or PEP) will result in deferral for three months (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
    • Donors should not stop taking any medication regimen prescribed by their provider to donate blood.
• Why are these changes happening?
  • The FDA guidance creates more equitable donor eligibility standards for blood donors by using gender inclusive, individual sexual behavior-based questions in pre-donation screening.
  • This change is in line with policies in place in countries like the United Kingdom and Canada that have made changes in recent years.
  • The FDA evaluated data from ongoing surveillance of the U.S. blood supply and results from studies conducted by other countries. The FDA also sponsored a recent study, Assessing Donor Variability and New Concepts in Eligibility (ADVANCE), to observe data among domestic populations.
  • This guidance has been updated two times, starting in 2015 when the lifetime ban of men who have had sex with another man was lifted and then again in 2020 when the 12-month deferral for sexual contact with another man was reduced to three months.
• Is this change politically motivated?

  No.

  • Having a safe and adequate blood supply is in the best interests of all patients requiring blood transfusions, which come from volunteer blood donors of all political parties and affiliations.
  • Blood centers across the country have united in support of this change and have advocated for change for years due to the excellent safety record of current infectious disease tests and more recent data on the risks associated with transmission of HIV.
  • The previous time-based deferral has alienated a subset of the population due to its focus on gender identity and sexual orientation rather than individual sexual behavior. 
  • The new guidance provides for screening protocols that are applied to all donors regardless of gender identity and sexual orientation.
• Will this impact the safety of blood products for patients?
  • Based on the data available to the U.S. Food and Drug Administration today, the decision was made to proceed with confidence that it would continue to support a safe and robust blood supply.
  • The new screening protocols apply a set of screening questions about sexual behavior to all donors vs. a small subset of donors, which supports safety screening methodology.
• Will this help overcome blood shortages?

  We don’t know. 

  • Currently more than 60% of adults in the U.S. are eligible to voluntarily donate blood, yet in most communities less than 5% roll up their sleeves to help each year. 
  • The volunteer donor base is aging and lacking in younger more diverse blood donors, so there are concerns about the long-term sustainability of the blood supply. 
  • A donor screening process that equitably applies to all donors should help support a robust blood supply.
  • It is too early to tell how many donors will or will not be deferred with the new criteria.
• Why can’t people on PrEP or PEP donate while taking this preventative medication?
  • Medications taken to prevent or reduce likelihood of HIV infection (PrEP or PEP) will result in deferral for three months (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
  • The U.S. Food and Drug Administration (FDA) will continue to monitor data for possible changes in the future.
  • FDA 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.
  • Click here to see a full list of medications that result in deferral from blood donation, and for more information, see www.bloodcenter.org/eligibility.
• Why is this sexual behavior-based screening protocol necessary?

  Despite excellent dual testing protocols for sexually transmitted viruses, there is a short window of time that a new infection may not be detectable by antibody or Nucleic Acid Testing protocols.

• Will blood centers still ask donors about gender identity?

  Most blood centers will still ask gender identity questions because it helps determine which blood components can be made from a single donation. 

  • For example, blood centers cannot make plasma products from a donor who has previously been pregnant (without additional testing) or positive genetic markers in their plasma that can cause Transfusion Related Acute Lung Injury (TRALI) among patients receiving transfusion.
  • With no knowledge of gender, blood centers must use the most stringent criteria based on gender, such as hemoglobin (HGB) and total blood volume (TBV). This would mean that all females must have a minimum HGB of 13.0 rather than 12.5 and lead to unnecessary deferrals. The same is true TBV, which is used to determine eligibility to donate some apheresis products. This would limit the number of females eligible for those apheresis procedures. Both scenarios would have a detrimental impact on the blood supply.

  These gender questions may not defer a donor from giving.