The following provides a detailed explanation of the changes made to the User Brochure flowcharts for Questions 28 and 39 of version 1.3 of the Donor History Questionnaire (DHQ) and Question 12 of version 1.3 of the Abbreviated Donor History Questionnaire (aDHQ) in response to the 2013 Food and Drug Administration guidance on malaria and the need to add a question to the aDHQ if used. As a reminder, the AABB User Brochure (available on the AABB Web page) describes the use of symbols within the flowcharts, such as diamonds for questions or decision points.
Based on the recommendation of the AABB Transfusion Transmitted Diseases Committee, the AABB Donor History Task Force took advantage of this update to the flowcharts to remove the deferral for time spent in Iraq. This is consistent with action taken when U.S. troops returned home from the first Gulf War in the 1990s.
DHQ Flowchart Corresponding to Question 28: “In the past 3 years have you been outside the United States or Canada?”
Information has been added to the donor eligibility section of this flowchart. As in the prior edition, this section describes the different donor deferral outcomes. A note has been added that alerts the historian to the need to use the definitions provided in the 2013 guidance and provides excerpts from the definitions and a link to the guidance.
The flowchart for Question 28 has been reorganized. The 2013 guidance recommendations include three different deferral periods:
- 12 months from the most recent date of departure from a malaria-endemic area
- three years from the date of departure from the malaria-endemic country of residence
- three years from the most recent date of departure from a malaria-endemic area
Donors who have never established residency in malaria-endemic countries will be deferred for 12 months after travel to a malaria-endemic area.
A prior resident is a donor who has spent more than five years continuously in a malaria-endemic country at any time in his or her life. Depending on their travel history, prior residents may be assigned any one of the three deferral periods or accepted as donors.
A prior resident is deferred for three years after leaving the malaria-endemic country of residence. A prior resident who has spent three consecutive years in non-endemic countries without traveling to any malaria-endemic areas can be accepted as a donor. If that donor traveled to a malaria-endemic area after completing the three consecutive years in non-endemic countries, the donor would be deferred for 12 months. Travel to a malaria-endemic area before completing the three-year period, would result in a three-year deferral after departure from the malaria-endemic area.
The first three decision points following the question determine whether the donor traveled to, or was a resident of, any malaria-endemic countries in the past three years. These are similar to the earlier flowchart. If the donor is not a recent resident of any malaria-endemic countries, the donor is evaluated for travel to and length of stay in any malaria-endemic areas within the countries visited. If the donor was not in malaria-endemic countries for more than five years, or not in any malaria-endemic area for more than 24 hours, the donor will be accepted.
The second page of the flowchart focuses on the various risk exposures that will result in donor deferrals. The length of deferral depends on several factors.
Donors who are recent residents of malaria-endemic countries, processing down the left-hand side of the second page of the flowchart, will be deferred for three years. The beginning of the three-year deferral period is determined by whether the donor has spent more than 24 hours in any malaria-endemic area after leaving the malaria-endemic country of residence. If not, the donor will be deferred for three years from the date of departure from the malaria-endemic country of residence. If the donor has spent more than 24 hours in a malaria-endemic area, the donor must be deferred for three years from the most recent date of departure from the malaria-endemic area.
Donors who have not been residents of malaria-endemic countries within the past three years and who have spent more than 24 hours in a malaria-endemic area are processed down the center of the second page of the flowchart. They must be sorted into either a 12-month deferral or a three-year deferral.
Determination of prior residency by asking “Has the donor EVER lived for more than five years in malaria-endemic countries prior to the recent travel to a malaria-endemic area?” is necessary to determine deferral length. A 12-month deferral will apply to a donor who has never been a prior resident of any malaria-endemic countries.
If the donor has been a prior resident of malaria-endemic countries, the donor will either be deferred for 12 months or three years. A prior resident who has spent three consecutive years in non-endemic countries without traveling to any malaria-endemic areas will be deferred for 12 months. Otherwise, the donor will be deferred for three years from the most recent date of departure from the malaria-endemic area.
DHQ Flowchart Corresponding to Question 39: “Have you ever had malaria?”
Minimal revisions were made to align this flowchart with language in the 2013 guidance. For clarity, the phrase “while residing in a non-endemic country” was added to both the donor eligibility section and the flowchart to emphasize that donors must be both asymptomatic and residing in a non-endemic country to avoid additional deferrals.
aDHQ Question 12 and an Additional Question
aDHQ Flowchart Corresponding to Question 12: “Since your last donation, have you been outside the Unites States or Canada?”
Information has been added to the donor eligibility section for this question. The statement about institutional designation of malaria risk countries is no longer needed. It has been replaced by the definitions of “malaria-endemic area” and “travel to a malaria-endemic area,” along with a link to the 2013 guidance. The language in the flowchart has been aligned with the terms used in the 2013 guidance.
For the first year after implementing the 2013 guidance recommendations, establishments using the aDHQ should suppress or omit the assessment for travel to malaria-endemic countries. The rest of the travel assessments must be maintained to determine risk of exposure to HIV Group O (if facility testing does not include Group O) and variant Creutzfeldt-Jakob Disease.
An additional question (see below) must be added to the aDHQ for one year to ensure all donors meet the recommendations in the 2013 guidance. At the end of the year, the establishment may remove the question from the additional questions list and revert to using the malaria-related travel assessment on the revised flowchart for aDHQ Question 12.
aDHQ Additional Question
Although no new questions were added to the DHQ to meet the recommendations in the 2013 guidance, additional decision points were needed in the flowchart for DHQ Question 28. Frequent donors using the aDHQ must be evaluated against the revised criteria. To do this, establishments using the aDHQ must add a question identical to DHQ Question 28, along with the revised flowchart or an equivalent tool, in the additional questions area.
The aDHQ User Brochure describes the procedure for adding new questions. “On occasion, new donor history questions will be added. The new questions must be added to the full-length and the abbreviated DHQ. The new questions will remain on the aDHQ for one year from the date the question was added. If the question must be asked at each donation, the question will remain indefinitely on both DHQs.” A question identical to DHQ Question 28 must remain on the aDHQ for one year from the date the establishment implements the 2013 guidance recommendations.
The updated flowcharts are available on the AABB website.
AABB’s Regulatory Affairs department is available to support any questions you may have regarding these revised documents.