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Evaluating Donors for Risk of Ebola Virus Infection

This page provides assistance with donor eligibility assessment using additional questions with flowcharts and donor educational materials to evaluate donor risk for Ebola virus infection. AABB Regulatory Affairs has posted an Analysis of FDA Guidance for Industry - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus to assist blood collection establishments with review of the January 2017 FDA guidance, "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry” (the Ebola virus guidance). You can review this analysis to supplement your understanding of the recommendations in the guidance.

The AABB’s Donor History Task Force (DHTF) believes this information provides an acceptable approach to assist blood collection establishments with plans to implement the recommendations in the Ebola virus guidance. The DHTF includes FDA Liaisons but this information is not submitted through a formal process for FDA review and acceptance because it will not be permanently added to the v2.0 DHQs. Rather, blood collection establishments can follow this approach, consistent with the User Brochure for the Donor History Questionnaire and Accompanying Materials, in developing:

  • donor educational materials, and
  • questions to be added to the area for additional questions, found at the end of the v2.0 DHQs (both full-length and abbreviated DHQs).

The Ebola virus guidance recommendations address risks associated with Ebola virus during periods with and without  widespread transmission of the virus. The Ebola virus guidance provides additional safety measures for implementation based on CDC’s classification of one or more countries with “widespread transmission of Ebola virus disease (EVD) or with cases in urban areas with uncertain control measures. (See https://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-map.html).”

What can I do to prepare for implementation of the recommendations?

As previously mentioned, AABB Regulatory Affairs has posted an Analysis to assist blood collection establishments with review of the January 2017 Ebola virus guidance. The analysis will supplement your understanding of the recommendations. You should also become familiar with the information on the CDC website.

What should I do when CDC does not show widespread transmission on their website?

This recommendation must be implemented within 12 weeks of the issuance of the Ebola virus guidance:
FDA states: “We expect very few individuals with a history of Ebola virus infection or disease to present as blood donors. When there are no countries classified by CDC as having widespread transmission of Ebola virus, self-deferral of donors with a history of Ebola virus infection or disease should provide sufficient protection. We recommend that you update your donor educational materials to instruct donors with a history of Ebola virus infection or disease to not donate blood or blood components.”

  • AABB has posted an example of language that you can use to develop donor educational materials (PDF, Word) for use during periods without widespread transmission.
  • The language for the educational material can be added to the end of the FDA accepted AABB v2.0 Blood Donor Educational Material, as described in the User Brochure OR added to other information developed by your facility. Refer to the section on implementation for other options.
What should I do when CDC classifies one or more countries with “widespread transmission of Ebola virus disease (EVD) or with cases in urban areas with uncertain control measures?”
  • You should implement the recommendations for additional safety measures within 4 weeks of the CDC’s classification of one or more countries with “widespread transmission of Ebola virus disease (EVD) or with cases in urban areas with uncertain control measures” on the CDC webpage, Ebola Outbreak in West Africa - Outbreak Distribution Map (https://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-map.html).
  • You should implement revised donor educational material:
    • AABB has posted an example of language that you can use as you develop donor educational materials (PDF, Word) for use during widespread transmission.
    • The language for the educational material can be added to the end of the FDA accepted AABB v2.0 Blood Donor Educational Material, as described in the User Brochure OR added to other information developed by your facility.
    • This remains in place for the period with widespread transmission.
  • You should add the Ebola additional questions during a period of widespread transmission:
    • AABB posted Ebola additional questions (PDF, Word) to be added to the area for additional questions, found at the end of the v2.0 DHQs (both full-length and abbreviated DHQs) during widespread transmission.
    • AABB posted flowcharts for each Ebola additional question (PDF, Word) to provide donor screening process flow, donor eligibility statements to assist donor historians in the screening process, and relevant links to the Ebola virus guidance.
    • This remains in place for the period with widespread transmission.
Can I discontinue any of these recommendations if there is no longer widespread transmission?

Yes - the Ebola virus guidance provides for a return to donor educational material for use during a period without widespread transmission and discontinuing the Ebola additional questions. The guidance refers to dates for classification of former widespread transmission  (found in the footnotes on CDC’s webpage) and states:

“After this period, when there are no countries classified by CDC as having widespread transmission of Ebola virus, it is appropriate to discontinue asking donors questions related to risk of Ebola virus infection or disease. (See http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-map.html for CDC’s classification of countries with reported Ebola cases and for the specific dates when a country is classified as a country with former widespread transmission of Ebola virus).”

Where can I find information on post donation information and other relevant information?

The Ebola virus guidance includes a unique approach to PDI. The FDA provides instructions for contacting FDA as soon as possible after a blood collection facility learns of a prior collection from a donor later determined to have Ebola virus infection or EVD. Refer to the Ebola virus guidance for detailed recommendations for donor education materials, donor screening, donor deferral, postdonation information, product retrieval, quarantine, and notification, product deviation reporting, convalescent plasma and implementation.

Individuals may contact regulatory@aabb.org with questions or for additional information.