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U.S. Food and Drug Administration

U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated . . Questionnaire Data for Risk Assessment . Presented by:

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U.S. Food and Drug Administration

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  1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

  2. Questionnaire Data for Risk Assessment Presented by: Richard Forshee FDA/CBER/OBE

  3. Donor Questionnaire Issues At least 2 purposes of DHQ Protect the health of the donor Identify risk factors to protect the health of recipients Understanding how donors respond to the questionnaire Complexity of questions varies Some questions involve personal and sensitive subjects Use of DHQ in risk assessment

  4. Donor Health Example Healthy and Well

  5. Risk Factor Example 1 Transplant

  6. Risk Factor Example 2 Travel to Malarial Area

  7. Risk Factor Example 3 Sexual contact with a prostitute

  8. Use in Risk Assessment Does the questionnaire accurately identify donors with selected risk factors? Travel to malarial areas Are low-risk donors being deferred because of answers to the questionnaire? Travel to malarial areas

  9. Hypothetical Example • Later in this workshop we will be considering a hypothetical outbreak of a viral hemorrhagic fever caused by an RNA virus in 3 Midwest US states • We have constructed an extremely simplified risk assessment to predict the cases of transfusion transmitted hemorrhagic fever • Imagine two different DHQ methods of assessing the risk that a donor is infected with the hemorrhagic fever

  10. Two Hypothetical DHQ Instruments

  11. Hypothetical Result

  12. Conclusion • Effective DHQ screening is an important component of blood safety • We look forward to the presentations in this section

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