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 It was current when produced, but is no longer maintained and may be outdated.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: Richard Forshee FDA/CBER/OBE

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

Donor Health Example Healthy and Well

Risk Factor Example 1 Transplant

Risk Factor Example 2 Travel to Malarial Area

Risk Factor Example 3 Sexual contact with a prostitute

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

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

Two Hypothetical DHQ Instruments

Hypothetical Result

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