Bulletin 26-2

Ebola Donor Screening Criteria

In light of an ongoing outbreak of Ebola disease in Africa, AATB has developed donor screening and eligibility criteria to help establishments make informed donor eligibility determinations. These criteria are based on recommendations from the Emerging Infectious Diseases Working Group, which is composed of individuals from AATB’s Physicians Council and Scientific and Technical Affairs Council, with participation by representatives from the Eye Banking Association of America and the Organ Procurement and Transplantation Network’s Disease Transmission Advisory Committee. This working group reviewed information that included a CDC analysis of the outbreak, a June 29 FDA guidance document for blood establishments, and a July 16 FDA communication related to donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). See these resources for background on the outbreak and considerations related to risk for transmission.  
 
The criteria specified in this bulletin apply to all donor and tissue types. Establishments are encouraged to implement these criteria within 30 days of the publication of this bulletin. All actions specified below as new requirements must be implemented by November 23, 2026
 
Donor Risk Assessment Interview (DRAI) 
To identify donors at risk of transmitting a virus associated with Ebola disease, it is important to evaluate the donor’s infection status and potential for exposure through travel and contact with a person who was confirmed to have or is suspected of having Ebola disease. As such, it is required to collect information, as part of a DRAI, on whether the donor: 

  • Was diagnosed with or was suspected of having Ebola disease 
  • Traveled to a country with widespread transmission of Ebola disease 
  • Had close contact or sexual contact with a person who was confirmed to have or suspected of having Ebola disease 
  • Was notified by a public health authority that they may have been exposed to a person with Ebola disease 

Current Uniform DRAI forms include questions about travel history and diagnosis with Ebola infection. A new DRAI addendum includes related resources, including three new questions to elicit information regarding suspicion of Ebola disease, exposure through close contact or sexual contact, and notification of potential exposure by a public health agency. AATB expects that medical directors will consider this information as part of donor eligibility determination. 
 
Donor Eligibility Criteria 
As specified in section H19.500 of Standards for Tissue Banking, 15th edition, a donor with evidence of a significant active infection at the time of donation shall not be determined to be eligible. As such, a donor with evidence of Ebola infection is required to be excluded. While not required by this bulletin, establishments are strongly encouraged to consider a donor to be ineligible if they ever had or were suspected of having Ebola disease, were potentially exposed in the prior 8 weeks through travel or close/sexual contact with a person who was confirmed to have or is suspected of having Ebola disease, or if they were told by a public health authority that they may have been exposed in the prior 8 weeks.  
 
The DRAI addendum, which was developed by the DRAI Working Group of AATB’s Standards Committee, includes flowcharts and rationale designed to help support training and implementation of these considerations. AATB will continue to monitor the outbreak and provide additional information as necessary. The need for the addendum will be evaluated one year after its posting to ensure that it is discontinued when no longer necessary.  
 
If you have questions, please contact standards@aatb.org.