Donor Risk Assessment Interview (DRAI)

A Donor Risk Assessment Interview (DRAI) is a documented conversation used to gather a donor’s medical history and relevant social-behavior information for donor screening. In the HCT/P context—human cells, tissues, and cellular and tissue-based products—the naming distinction matters: DRAI is not the term defined in 21 CFR 1271.3(n). The defined regulatory term is donor medical history interview. That definition describes a documented dialogue about medical history and relevant social behavior, including activities, behaviors, and descriptions considered to increase the donor’s relevant communicable-disease risk.

PRACTICE — Thinking of the interview as a dialogue, rather than simply a completed form, helps explain its evidentiary role. A useful record makes the information understandable to someone who was not present: what was reported, what the source could explain, and where uncertainty remained. A filled field and a well-understood answer are different things. This is a way of reading and organizing evidence, not a prescribed questionnaire format.

Under § 1271.3(s), a current donor medical history interview is one component of relevant medical records. The collection also includes a current report of the physical assessment of a cadaveric donor or the physical examination of a living donor. Additional listed information is included if available: other laboratory results, excluding the required relevant-communicable-disease testing under that subpart; medical records; coroner and autopsy reports; and records or other information from any source concerning relevant communicable-disease risk factors. The availability qualification applies to those additional items, not generally to the interview and physical report.

Section 1271.75(a) describes screening as reviewing the donor’s relevant medical records for the specified communicable-disease risks and evidence, subject to the exception it expressly references. The interview therefore sits inside the records collection being reviewed. It is neither the whole screening review nor a substitute for donor testing.

The comparison below separates the regulatory concepts. Its final column is PRACTICE: an optional record-reading focus, not a list of mandatory fields.

PRACTICE — This distinction prevents a common conceptual shortcut: treating a document titled DRAI as if its title established that every other relevant source had been considered. Read the interview for the dialogue it records, then read the wider record for how that information fits with the other evidence.

Section 1271.3(n) starts with a living donor who is able to participate: the dialogue is with that donor. If that condition is not met—including a living donor unable to participate or a deceased donor—the dialogue is with an individual or individuals able to provide the information sought. The definition is not restricted to legal next of kin.

The regulation’s examples include the donor’s next of kin, nearest available relative, a household member, an individual with an affinity relationship, and the primary treating physician. These are examples of possible information sources, not a hierarchy declaring that one relationship always supplies the best information. The wording also allows multiple individuals rather than assuming one person can supply the entire history.

PRACTICE — A relationship label and the scope of someone’s knowledge are separate matters. A household member might know everyday events but not earlier care; a treating physician might know documented treatment but not every aspect of social history. These are illustrations of possible knowledge limits, not rules about which source to select. An informative record can distinguish personal knowledge, information obtained from another source, and matters the person cannot address.

PRACTICE — Do not silently turn a source’s lack of knowledge into a negative answer. Preserve the limitation so that a later reviewer can understand the evidence actually available. Where sources differ, distinguish their accounts rather than presenting an unexplained combined answer as though everyone supplied the same information.

Under § 1271.50(a), the establishment responsible for the donor-eligibility determination must base that determination on donor screening and donor testing. A responsible person must determine and document eligibility. Section 1271.3(t) defines a responsible person as someone authorized to perform designated functions for which that person is trained and qualified. The interview is an input to this process, not a stand-alone determination.

Section 1271.55(d)(1)(iii) requires documentation of the determination, including the responsible person’s name and the date of the determination. That is distinct from recording who performed the interview and when interview entries were made.

PRACTICE — Keep completion of a conversation conceptually separate from completion of the review and from the final determination. An interview record can be understandable while still identifying an unresolved factual issue. Conversely, a notation that the interview was completed does not explain how screening and testing supported the determination.

Section 1271.75(e) permits an abbreviated donor-screening procedure for repeat donations if the establishment has performed a complete donor-screening procedure on a living donor within the previous six months. This is an establishment-specific condition: the provision does not merely say that the donor reports having been screened somewhere during that period.

The abbreviated procedure must determine and document any changes in the donor’s medical history since the previous donation that would make the donor ineligible, including relevant social behavior. Two reference points therefore matter: the complete screening within the previous six months, and the previous donation from which changes are assessed.

PRACTICE — When reading a repeat-donor record, distinguish the qualifying complete-screening date from the previous-donation date. Keeping those references understandable helps prevent an abbreviated review from becoming an unexplained carry-forward of an older record. This is a documentation-reading aid, not a new calendar rule or a substitute for the conditions in the regulation.

Section 1271.270(a) requires records to be maintained concurrently with performance of each required step. Records must be accurate, indelible, and legible; identify the person performing the work and the dates of the entries; and contain enough detail to provide a complete history of the work and relate the records to the particular HCT/P. These requirements concern the record of the work, not merely a completed-form label.

PRACTICE — A later clarification can be presented as a separately dated entry that identifies the earlier information it clarifies. That approach helps distinguish what was known during the original dialogue from what was established afterward. The useful distinction is between an original entry and a transparent follow-up, rather than between paper margins and electronic text.

Section 1271.270(c) permits electronic records, original paper records, and true copies. Equipment needed to make the records available and legible must be readily available, and electronic records must be backed up. Under § 1271.55(d)(3), required records must be retained and made available for authorized FDA inspection or on request; records readily retrievable electronically from another location count as retained.

The underlying interview record is also conceptually different from the records accompanying an HCT/P. Once a donor-eligibility determination has been made, § 1271.55(a) requires a distinct identification code affixed to the container, an eligible-or-ineligible statement based on screening and testing, and a summary of the records used for the determination to accompany the HCT/P at all times. A summary of records is not simply another name for the interview.

Retention is not simply ten years from the interview date. Section 1271.270(d) establishes a general ten-year period after record creation unless otherwise stated. For records pertaining to a particular HCT/P, both § 1271.270(d) and § 1271.55(d)(4) require retention for at least ten years after administration. If the administration date is unknown, the period is at least ten years after distribution, disposition, or expiration, whichever is latest.

For determination and retention context, see donor eligibility. For lookback clocks rather than record-retention timing, see lookback. Keeping those topics separate avoids using one kind of time period to answer a different question.

An interview can supply information relevant to an ineligible determination. Section 1271.75(d) requires an ineligible determination when a donor is identified as having a risk factor or clinical evidence within the screening categories referenced there, or a communicable-disease risk associated with xenotransplantation. The responsible-person determination remains the distinct documented action described in § 1271.50(a).

PRACTICE — Separate a source’s report, an unresolved question about that report, and a reviewed finding. They describe different stages of understanding the evidence. This definition does not assign a clinical meaning to an ambiguous answer or treat every missing detail as an established risk finding. It also does not authorize a product-use decision from the interview alone.

For the distinction between a pending determination and an ineligible donor, and for the associated use restrictions, consult the donor eligibility definition. Keeping that discussion with the eligibility definition avoids reducing product-use rules to a single exception or implying that an interview label resolves them.

PRACTICE — Consider record FICTIONAL-DRAI-EXERCISE-01. The exercise concerns ambiguity about a document’s date, not a donor’s clinical risk. Its purpose is to show how one uncertainty can be clarified without making a different evidence gap disappear.

• 2026-09-14 — Fictional interviewer EXAMPLE-A records that the living donor cannot participate. Information source EXAMPLE-B is a household member. The source describes a document as recent, but the entry does not establish whether that refers to its creation or receipt. The document itself is unavailable. The uncertainty is recorded rather than resolved by assumption.
• 2026-09-15 — EXAMPLE-A makes a separate dated clarification entry. EXAMPLE-B explains that the reference concerned receiving a copy on September 13, not the document’s creation date. The creation date remains unknown, and the document has still not been supplied.
• 2026-09-16 — The fictional handoff for review identifies both entries, the clarified meaning of the date reference, and the unresolved absence of the document. It does not convert the clarification into a negative medical-history answer or an eligibility conclusion.

The exercise illustrates a limited but useful distinction: clarification can improve the meaning of an entry without completing the evidence. It does not decide whether that document is required or whether the interview is complete. The optional practice is to preserve the information source, the original ambiguity, the subsequent clarification, and the remaining limitation as distinguishable parts of the record.

For broader operational cases rather than this definition-level exercise, use the donor eligibility, lookback, and deviation-readiness guide.

Blood has a separate interview provision. The introductory text of 21 CFR 630.10(e) requires a medical history interview before collection to determine whether the donor is in good health; identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection; and determine whether other conditions may adversely affect donor health or the safety, purity, or potency of blood, blood components, or products manufactured from them.

PRACTICE — The useful comparison is the stated purpose of gathering history before a decision, not an assumption that blood and HCT/P workflows are identical. This blood provision should not be used to infer identical respondents, forms, timing rules, or determination pathways for HCT/Ps. The comparison here stops at the introductory interview requirement; it does not provide blood-screening factors or a questionnaire.