Donor eligibilityDonor eligibility determination (21 CFR 630 + 21 CFR 1271 Subpart C)
Donor eligibility is the determination — required before any unit of blood or any HCT/P is released — that the donor meets the medical, behavioural, and infectious-disease screening criteria the regulator demands. What 21 CFR 630 (blood) and 21 CFR 1271 Subpart C (tissue) actually require, how the determination is documented, and where most blood centers and tissue banks get caught.
01What 'donor eligibility' means
Donor eligibility is the formal, documented determination that a donor — a person giving blood, a living tissue donor, or the source of cadaveric tissue — meets the regulator's screening criteria such that their donation may be released for clinical use. The determination has two components: a donor risk assessment (medical history, social/behavioural history, physical assessment) and an infectious-disease testing panel. Both must be complete, in-spec, and documented before a unit leaves quarantine.
FDA codifies the requirements separately for blood (21 CFR 630) and for HCT/Ps (21 CFR 1271 Subpart C). The two share most of the underlying logic but differ on test panel, eligibility windows, and the specific carve-outs for autologous, directed, urgent-need, and reproductive donations.
02Blood donor eligibility — 21 CFR 630
Part 630, finalised in 2015 and continuously updated since, sets the framework for whole blood, apheresis, and source plasma donors. Key elements:
- Medical history interview using a standardised questionnaire (most US centres use the AABB DHQ — Donor History Questionnaire) covering general health, medications, exposure history, and risk factors.
- Physical assessment — vital signs (temperature, blood pressure, pulse), hemoglobin or hematocrit, weight, age, donation interval since last donation.
- Behavioural-risk screening — recent travel, exposure to malaria-endemic areas, sexual contact risk factors, IV drug use, incarceration, body modification.
- Infectious-disease testing — minimum panel per 21 CFR 610.40: HIV-1/2, HBV (HBsAg + anti-HBc), HCV, HTLV-I/II (first-time donors), syphilis, plus current FDA guidance additions (WNV in qualifying months, Zika, Trypanosoma cruzi for first-time donors, bacterial detection on platelets).
- Deferral — temporary or indefinite deferral for any criterion not met. Deferral records are retained indefinitely.
FDA has revised behavioural-risk criteria multiple times since 2015 — most recently in 2023 moving from time-based deferrals for men who have sex with men to individual donor risk assessment based on recent sexual contact behaviour. The DHQ is updated to match; AABB publishes harmonised versions.
03HCT/P donor eligibility — 21 CFR 1271 Subpart C
Subpart C sets the framework for tissue and cellular donors. Key elements:
- Donor risk assessment — medical record review, donor or next-of-kin interview, physical assessment (for cadaveric donors, examination of the body for signs of high-risk behaviour or disease).
- Infectious-disease testing — minimum panel: HIV-1/2 (antibody + NAT for some donor categories), HBV (HBsAg + anti-HBc + NAT for some), HCV (antibody + NAT), syphilis. Viable leukocyte-rich tissue adds HTLV-I/II, CMV, WNV (in qualifying months). Reproductive donors add chlamydia and gonorrhoea.
- Specimen timing — living donor specimens within 7 days before or after recovery; cadaveric donor specimens within 24 hours of death (up to 7 days antemortem under specific criteria).
- Plasma dilution assessment — if the donor received fluids or transfusions in the 48 hours before specimen collection, plasma dilution must be assessed using FDA's algorithm.
- Responsible Person determination — a designated, qualified individual makes and signs the eligibility determination. The signature is on the record, not just initials.
04Exceptions and carve-outs
| Category | Eligibility handling |
|---|---|
| Autologous (own use) | Eligibility not required for blood or HCT/P; labelled 'For Autologous Use Only'. |
| Directed (named recipient) | Eligibility required, but specific deferral criteria may differ. Labelled with the intended recipient. |
| Reproductive — sexually intimate partner | Eligibility determination not required; standard infectious-disease testing usually not required. |
| Reproductive — anonymous | Full Subpart C eligibility plus additional gonorrhoea, chlamydia, and CMV testing. |
| Urgent medical need (HCT/P) | Ineligible HCT/P may be distributed with the labelling 'NOT EVALUATED FOR INFECTIOUS SUBSTANCES' (or similar) and a summary of records if the consignee documents urgent need. Rarely used in practice. |
| Bone marrow / PBSC (HRSA programs) | Specific exclusions from Part 1271 under 1271.3(d)(4); separate framework applies. |
05What good eligibility looks like in operation
Eligibility is the single most-cited area in blood-establishment FDA Form 483s and tissue-bank inspections. Common findings: incomplete medical-history interviews, missed deferral criteria, test results not received before release, eligibility determinations signed by unqualified personnel, eligibility determinations made without all required test results in hand. The technical fix is the same as the regulatory fix — make eligibility a hard, software-enforced gate that cannot be bypassed.
Frequently asked questions
Q.What is the AABB DHQ?+
The Donor History Questionnaire — a standardised set of medical-history questions developed by the AABB DHQ Task Force, accepted by FDA as meeting the medical-history elements of 21 CFR 630. The full-length DHQ is supplemented by abbreviated and computer-assisted versions, each separately accepted by FDA.
Q.How long are eligibility records retained?+
Records of eligible donations must be retained at least 10 years (21 CFR 606.160 for blood, 21 CFR 1271.270 for HCT/Ps). Records of deferred donors must be retained indefinitely, because deferred donors may attempt to re-present at the same or another facility and the deferral must be retrievable.
Q.Who can be the Responsible Person?+
Per 21 CFR 1271.3(t), the Responsible Person is a qualified person designated by the establishment as responsible for the donor-eligibility determination. The role is typically held by a physician, RN, or other clinical professional with documented training. The determination must be signed by the Responsible Person — initials are not sufficient.
Q.Does eligibility have to be re-determined for repeat donors?+
Yes for every donation — the medical-history interview is repeated, behavioural-risk questions are re-asked, vital signs are re-taken, and the IDM panel is re-run. Eligibility is donation-specific, not donor-specific.
Q.What about EU and UK?+
EU eligibility is governed by Directive 2004/33/EC (blood) and 2006/17/EC (tissues / cells), implemented in member-state law. The UK post-Brexit operates under the Blood Safety and Quality Regulations 2005 (blood) and the Human Tissue Quality and Safety for Human Application Regulations 2007 (tissue). The substance is similar — risk assessment plus IDM panel — but the specific deferral criteria and test panels are independently maintained.
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