DRAIDonor Risk Assessment Interview

The Donor Risk Assessment Interview is the documented, structured conversation that captures a prospective HCT/P donor's medical, social, and behavioural-risk history as part of the donor-eligibility determination required by 21 CFR 1271.75. For living donors the interview is conducted with the donor; for cadaveric donors it is conducted with a knowledgeable historian — typically the legal next of kin, a treating physician, or another person who can speak to the donor's recent health and behaviour.

The DRAI is one of three legs of an HCT/P eligibility determination. The other two are the medical-record review (21 CFR 1271.75(b)(1)) and the infectious-disease testing panel (21 CFR 1271.85). All three must be complete, documented, and reviewed by the Responsible Person before the eligibility determination can be signed.

21 CFR 1271.75 enumerates the relevant communicable disease agents and diseases (RCDADs) the screening must address, plus the categories of risk factors and clinical evidence that must be assessed. In practice that means the DRAI must ask about:

• General health and cause-of-death history (for cadaveric donors).
• Risk factors and clinical evidence of HIV-1/2, hepatitis B, hepatitis C, transmissible spongiform encephalopathies (CJD/vCJD), syphilis, sepsis, and — for viable leukocyte-rich tissue — HTLV-I/II, CMV, and WNV.
• Recent sexual contact behaviour and exposure history within the relevant lookback window.
• IV drug use, incarceration, tattoos and piercings, body modification, and other percutaneous exposures.
• Travel and residence history relevant to malaria, vCJD, and other geographically-restricted agents.
• Vaccination history within the relevant deferral windows (live attenuated vaccines).
• Prior tissue or organ transplant and prior xenotransplantation.
• Reproductive-donor-specific elements (gonorrhoea, chlamydia, CMV exposure history) where applicable.

Per 21 CFR 1271.3(t), the Responsible Person is the qualified individual designated by the establishment to make the eligibility determination. The DRAI itself can be administered by a trained interviewer, but the eligibility determination — which integrates DRAI, medical-record review, physical assessment, plasma-dilution assessment, and IDM results — must be signed by the Responsible Person. Initials are not sufficient. The signature must be bound to the specific donor and donation, attributable, and contemporaneous.

21 CFR 1271.270 requires HCT/P records — including the DRAI — to be retained at least 10 years after the date of administration of the HCT/P or, if administration date is unknown, at least 10 years after distribution, disposition, or expiration, whichever is latest. Deferral records on ineligible donors should be retained indefinitely because deferred donors may re-present at the same or another facility and the prior deferral must be retrievable.

Records must be legible, attributable to the person who recorded them, contemporaneous with the activity, and available for FDA inspection. Free-text margin notes on a paper questionnaire are not contemporaneous if they were added later.

If the DRAI reveals risk factors or clinical evidence that the donor is ineligible, the HCT/P from that donor must not be released for clinical use under the standard pathway. Two narrow exceptions exist:

• Urgent medical need — under 21 CFR 1271.65(b) an ineligible HCT/P may be distributed if the consignee documents urgent need and the HCT/P is labelled with the required warning statement and accompanied by a summary of records. Rarely invoked.
• Specific exceptions in 1271.90 — for example reproductive cells from a sexually intimate partner where Subpart C is not required.

Otherwise the HCT/P must be destroyed or used in research or training only, and that disposition must be documented.

The DRAI is one of the highest-volume, highest-risk transactions a tissue bank runs. The operational mistakes are predictable: paper questionnaires with missing pages, electronic forms that allow blank answers, questionnaires completed by recovery staff without identifying the historian, eligibility determinations signed before IDM results are in. The technical and regulatory fix is the same — make the DRAI a structured, software-enforced workflow with no skippable questions, an explicit historian identity, and a hard gate on the Responsible Person signature.