Donor EligibilityDonor Eligibility Determination (21 CFR 630 + 21 CFR 1271 Subpart C)

Donor Eligibility is the determination whether a donor meets the requirements applicable to a particular donation context. For blood and blood components, Part 630 addresses the donor’s health and factors affecting the donation. For human cells, tissues, and cellular and tissue-based products (HCT/Ps), Part 1271, Subpart C establishes a determination based on communicable-disease screening and testing. These are distinct regulatory determinations, not interchangeable approvals.

Blood and blood components

Under §630.10(a), the collecting establishment must determine eligibility—or determine that an exception applies—before collection. Eligibility requires good health and freedom from transfusion-transmitted infections as determined through the regulatory processes. Factors that could adversely affect the donor’s health or the blood component’s safety, purity, or potency make the donor ineligible.

HCT/Ps

Section 1271.45(b) requires a determination for donors of cells or tissue used in HCT/Ps, except as provided in §1271.90. For embryos or embryo-derived cells, both the oocyte and semen donors require determinations. Each establishment must comply with requirements applicable to the functions it performs.

At the establishment responsible for the determination, a responsible person must determine and document eligibility under §1271.50. This means someone authorized, trained, and qualified for the designated functions. Eligibility requires screening that establishes freedom from the specified communicable-disease risks and clinical evidence, including xenotransplantation-associated risks, and negative or nonreactive required testing, subject to §1271.80(d)(1).

Section 630.10(c) requires determination on the day of donation and before collection. It provides exactly two qualified exceptions:

1. For blood components that cannot be stored for more than 24 hours, eligibility may be determined and the sample for §610.40 testing collected no earlier than 2 calendar days before the day of donation, provided standard operating procedures address these activities.
2. If review identifies incomplete responses to donor questions asked before collection, a response may be clarified or information required under §630.10(e) obtained within 24 hours of collection, provided standard operating procedures address these activities. This is not blanket permission to determine eligibility after collection.

Under §630.10(d), the establishment must consult both the local and cumulative deferral records required by §606.160(e)(1) and (2). Only the cumulative-record check may move to before release, and only when precollection review is not feasible because that record cannot be consulted at the collection site. This exception does not move the local-record check or the whole eligibility determination to release.

Other inputs are an appropriate interval since the last donation, medical-history assessment, and physical assessment. The precollection medical-history interview addresses good health, relevant transfusion-transmitted infection risks or clinical evidence, and conditions that could adversely affect the donor or the blood, components, or products manufactured from them.

Section 630.10(g) also requires proof of identity and a postal address where the donor can be contacted for 8 weeks after donation, obtained on the donation day. Before each donation, the establishment must provide the required information and obtain a signature or other documented acknowledgement of its review.

A blood donation is suitable under §630.30(a) only when the donor is not currently deferred; the prescribed results indicate good health and donor-protection procedures were followed; medical-history results establish freedom from the specified infection risks and other disqualifying factors; §610.40 testing is negative or nonreactive unless its stated exception applies; and other subchapter requirements are met.

An unsuitable donation must not be released for transfusion or further manufacturing unless it is an autologous donation or a chapter exception applies. Unsuitability under §630.30(a)(1)–(4) requires donor deferral; deferred donors must be notified under §630.40. This release provision is not a blanket autologous exemption from other requirements.

For HCT/Ps, §1271.45(c) prohibits implantation, transplantation, infusion, or transfer until the donor is determined eligible, except under §§1271.60(d), 1271.65(b), and 1271.90. Shipment in quarantine is a different event from clinical use.

A donor medical history interview is a documented dialogue about medical history and relevant social behavior. Under §1271.3(n), it is conducted with a living donor able to participate; otherwise, it is conducted with people able to provide the information. It is not simply an undocumented conversation.

Relevant medical records include a current interview and current physical-assessment report for a deceased donor or physical-examination report for a living donor. They also include, when available, other laboratory results, medical records, coroner and autopsy reports, and information from other sources about relevant communicable-disease risks.

Screening under §1271.75(a), subject to §1271.90, means reviewing those records for risk factors and clinical evidence involving HIV, hepatitis B, hepatitis C, human transmissible spongiform encephalopathy including Creutzfeldt-Jakob disease, and Treponema pallidum, as well as xenotransplantation-associated communicable-disease risks. Findings covered by §1271.75(d) require an ineligible determination.

An abbreviated repeat-donor screening procedure may be used on repeat donations only if the establishment has performed a complete donor screening procedure on that living donor within the previous 6 months. It must determine and document changes since the previous donation that would make the donor ineligible, including relevant social behavior. It is not permission to omit the change assessment.

Testing is a separate input

Section 1271.80 requires testing for the agents specified in §1271.85, subject to §1271.90. For a donor 1 month old or younger, the specimen is from the birth mother. The all-donor agents in §1271.85(a) are HIV-1, HIV-2, hepatitis B virus, hepatitis C virus, and Treponema pallidum. That paragraph is not the complete panel for every donor type.

Generally, the specimen must be collected at recovery or within 7 days before or after recovery. Collection up to 30 days before recovery is permitted for peripheral blood stem/progenitor-cell donors, bone-marrow donors if not excepted under §1271.3(d)(4), and oocyte donors. For repeat semen donors with a specimen already collected and tested and retesting required under §1271.85(d), a specimen is not required at every donation.

Testing uses appropriate FDA-licensed, approved, or cleared donor-screening tests according to manufacturer instructions. Section 1271.80(c) specifies interim detection-test provisions for Chlamydia trachomatis and Neisseria gonorrhea, using tests labeled for an asymptomatic, low-prevalence population until appropriate donor-screening tests are available. Cadaveric-specimen-labeled tests must be used when applicable and available. Required testing must occur in a CLIA-certified laboratory or one meeting CMS-determined equivalent requirements.

Reactive required screening tests ordinarily require ineligibility. Section 1271.80(d)(1) provides the specific exception for a reactive non-treponemal syphilis screening test followed by a negative specific treponemal confirmatory test.

Section 610.41(a) requires deferral from future blood donations after reactive screening for a relevant transfusion-transmitted infection under §610.40(a), with these specified exceptions:

• One occasion of anti-HBc or anti-HTLV, types I and II, reactivity does not require deferral by itself. Deferral is required if further §610.40(e) testing establishes HBV or HTLV positivity, a second licensed, cleared, or approved HBV or HTLV screening test on the same donation is reactive, or the specified antibody reactivity occurs on more than one occasion.
• A deferred reactive donor may provide blood or components shipped or used under §610.40(h)(2)(ii).
• A donor previously deferred for HBsAg evidence under §610.40(a), (b), and (e) may subsequently donate Source Plasma for Hepatitis B Immune Globulin (Human) if the current donation is HBsAg-nonreactive and the donor is otherwise eligible.
• An otherwise eligible deferred donor reactive for anti-HBc or evidence of HTLV types I and II may donate Source Plasma.
• A deferred donor reactive under §610.40(a) may serve as an autologous donor under §610.40(d).

Under §610.41(b), a deferred donor may become eligible through an FDA-acceptable requalification method or process and is then no longer deferred. Section 610.41(c) separately invokes §§610.46 and 610.47 for specified HIV or HCV findings. See Lookback for those clocks rather than treating deferral as the entire lookback process.

Under §1271.60, HCT/Ps must remain in quarantine until the required determination is complete, with identification that distinguishes them from products available for release and distribution. If shipped before completion, they remain quarantined during shipment. Accompanying records must identify the donor, state that the determination is incomplete, and prohibit clinical use until completion except under §1271.60(d).

Pending determination: §1271.60(d)

Documented urgent medical need can permit use before completion. The definition requires that no comparable HCT/P be available and that the recipient be likely to suffer death or serious morbidity without it.

The product must prominently bear “NOT EVALUATED FOR INFECTIOUS SUBSTANCES” and “WARNING: Advise patient of communicable disease risks.” Completed screening and testing results and a list of outstanding required screening or testing must accompany it. The manufacturing establishment must document notifying the using physician that screening and testing were incomplete. The determination must be completed during or after use, and the physician informed of its results.

Already ineligible donor: §1271.65

HCT/Ps from donors determined ineligible require separate, clearly identified storage or other procedures adequate to prevent improper release until destruction or other permitted disposition. Section 1271.65(b) permits limited clinical uses within Subpart C: allogeneic use in a first- or second-degree blood relative, reproductive cells or tissue from a directed reproductive donor, or documented urgent medical need.

These products require the Biohazard legend and “WARNING: Advise patient of communicable disease risks”; reactive results also require “WARNING: Reactive test results for (name of disease agent or disease).” Section 1271.55 records must accompany them, and the manufacturer must document notifying the using physician of screening and testing results. This is not the pending-determination labeling pathway.

Section 1271.55(d) requires documentation of screening results and interpretations; testing results and interpretations, including testing-laboratory names and addresses; and the determination, including the responsible person’s name and determination date.

Under §1271.270(a), records must be maintained concurrently with each required step, be accurate, indelible, and legible, identify the person doing the work and entry dates, and provide a complete work history linked to the particular HCT/P.

Once a determination is made, §1271.55(a) requires an accompanying distinct identification code on the container, an eligible-or-ineligible statement, and a summary of the supporting records. The code links the HCT/P, donor, and records. Except for autologous donations, directed reproductive donations, and donations by first- or second-degree blood relatives, it cannot include an individual’s name, Social Security number, or medical-record number. Accompanying records must not contain the donor’s name or other identifying personal information.

The summary includes the testing laboratory’s qualification statement, all communicable-disease test results and interpretations, and the determining establishment’s name and address. For a screening-ineligible donor released under §1271.65(b), it also states the reasons for ineligibility.

Donor-identity information and relevant medical records must be in English or retained in their original language with an English translation and the translator’s document-specific authenticity statement. Required records must be available for authorized FDA inspection or request; records readily retrievable electronically from another location count as retained.

Section 1271.270(c) permits electronic records, original paper, or true copies. Necessary reading equipment must be readily available, and electronic records must be backed up.

Section 606.160(e)(1) requires each blood-establishment location to maintain a record of all donors found ineligible or deferred there, preventing collection or release while that status applies.

The cumulative record under §606.160(e)(2) covers locations under the same license or common management. Its scope is donors deferred under §610.41 because §610.40(a)(1) testing was reactive for HIV, HBV, or HCV; establishments other than Source Plasma establishments must also include deferrals for reactive §610.40(a)(2) testing for HTLV or Chagas disease. It must be updated at least monthly for newly covered deferrals and revised to remove donors requalified under §610.41(b).

Section 606.160(d) also requires retention beyond expiration as necessary to facilitate reporting unfavorable clinical reactions. Its indefinite-retention provision is not a rule that deferred-donor records are retained indefinitely. Nor do blood and HCT/P records share one interchangeable 10-year clock.

Fictional example: On April 12, 2030, donor FICTION-BLOOD-001 is determined eligible before collection. The unit is still awaiting applicable test results; the donor decision alone therefore does not establish donation suitability. On the same day, tissue is recovered from donor FICTION-TISSUE-002, whose HCT/P eligibility determination remains incomplete. That HCT/P remains in quarantine. Neither product is described as released, and no urgent-use exception is assumed.