Donor Qualification, Collection, and Reactions

Donor qualification

US blood establishments must determine eligibility before collection. The determination follows four linked controls:

1. Confirm the donor's identity and contact address, then check applicable deferral records.
2. Review the interval and losses from previous whole-blood and apheresis donations.
3. Assess current health, medication use, pregnancy, travel, procedures, and exposures associated with transfusion-transmitted infection.
4. Perform the required physical assessment and obtain the donor's documented acknowledgement of the procedure, testing, risks, and opportunity to withdraw.^{11 Electronic Code of Federal Regulations. Title 21, §§630.5, 630.10, 630.15, and 630.20.}

The FDA-accepted AABB Donor History Questionnaire (DHQ) v4.0 supplies one standardized route through the history. Its accompanying materials include donor education, response flowcharts, and the Medication Deferral List. A collecting facility uses the current materials or another FDA-acceptable method for evaluating donor responses.^{2,32 US Food and Drug Administration. Implementation of Acceptable Full-Length and Abbreviated Donor… 2023.3 Association for the Advancement of Blood &… Blood Donor History Questionnaires.}

Platelet count and platelet function are separate eligibility checks. Under 21 CFR §640.21(b), a plateletpheresis donor who recently took a drug that impairs platelet function cannot supply platelets for transfusion, even with an adequate count. The drug-label exception in §640.21(c) covers only platelets derived from Whole Blood. The medication history and the current drug-specific deferral procedure therefore remain necessary alongside the count.^{44 Electronic Code of Federal Regulations. Title 21, §640.21(b)-(d).}

Physical assessment

The federal minimum assessment for a routine allogeneic donation includes these limits. A responsible physician may approve and document certain exceptions specified by the regulation.

An autologous donor may qualify under a physician-prescribed exception with hemoglobin at least 11.0 g/dL or hematocrit at least 33% when the responsible physician determines and documents that the collection is safe.^{11 Electronic Code of Federal Regulations. Title 21, §§630.5, 630.10, 630.15, and 630.20.}

Current history decisions

The May 2023 FDA guidance recommends the same individual HIV risk questions for every donor. A 3-month deferral follows several recent exposures, including an allogeneic transfusion, a needlestick, use of nonprescription injected drugs, and a tattoo or piercing performed without the sterile-process exception described in the guidance. Sexual-history questions evaluate recent partners and practices associated with HIV exposure. One individual risk framework applies across sex and sexual orientation.^{55 US Food and Drug Administration. Recommendations for Evaluating Donor Eligibility Using… 2023.}

Travel and residence require agent-specific evaluation. For malaria, a resident of a nonendemic country who travels to a malaria-endemic area is generally deferred for 3 months after leaving that area. Prior residence in an endemic country and a history of malaria carry longer intervals. The final disposition follows the current DHQ flowchart, FDA guidance, and facility procedure.^{66 US Food and Drug Administration. Recommendations to Reduce the Risk of Transfusion-Transmitted… 2022.}

Agent-specific requirements change as FDA guidance is revised. FDA removed the former time-based geographic deferrals for exposure in the United Kingdom, France, and Ireland while retaining evaluation for other CJD and variant CJD risks. Babesia screening uses licensed nucleic acid testing in FDA-designated jurisdictions; how history and requalification are handled depends on local testing and pathogen-reduction strategies.^{7,87 US Food and Drug Administration. Recommendations to Reduce the Possible Risk of Transmission of… 2022.8 US Food and Drug Administration. Recommendations for Reducing the Risk of Transfusion-Transmitted… 2019.}

Federal regulations establish the eligibility floor. FDA guidance describes accepted approaches, including the DHQ and individual risk assessment. AABB Standards are requirements for AABB-accredited facilities, and the facility procedure translates all applicable requirements into the local workflow.^{99 Association for the Advancement of Blood &… Standards for Blood Banks and Transfusion Services. 2026.}

Applicable law and adopted standards set age eligibility. Current AABB criteria begin at age 16, and local law takes precedence where it differs; federal evaluation of older donors rests on current health and ability to donate safely.^{1,91 Electronic Code of Federal Regulations. Title 21, §§630.5, 630.10, 630.15, and 630.20.9 Association for the Advancement of Blood &… Standards for Blood Banks and Transfusion Services. 2026.}

Whole-blood collection controls

Every bag, tube, and segment from one donation has to trace back to one donor. Under 21 CFR 606.160(c), a donor number is assigned to each accepted donor. The number relates the collected unit to that donor, the donor's medical record, any component or blood product from the unit, and the records describing the products' history and ultimate disposition.^{1010 Electronic Code of Federal Regulations. Title 21, §§606.160, 606.170, 640.4, and 640.24.} In ISBT 128 labeling, the Donation Identification Number (DIN) uniquely identifies a donation or product pool. The DIN is applied before collection and appears on collection containers and final component labels. Facility records link the DIN with the donor number to preserve traceability.^{10,1110 Electronic Code of Federal Regulations. Title 21, §§606.160, 606.170, 640.4, and 640.24.11 ICCBBA. United States Industry Consensus Standard for the Uniform… 2024.} The collection record, primary bag, sample tubes, tubing segments, and each prepared component must remain traceable through these linked identifiers. Each component receives its own final label and disposition record. Apply labels before drawing samples, and reconcile identity at every transfer. Aseptic skin preparation and a sterile closed collection set reduce contamination risk. A validated scale and mixer control the amount collected and preserve the blood-to-anticoagulant ratio. The collection set instructions and facility procedure define the accepted volume, mixing pattern, draw-time limits, and response to an interrupted draw. Product records are retained for at least 10 years after processing or 6 months after the latest expiration date, whichever is later; records for products without an expiration date are retained indefinitely. Whole blood intended for platelet preparation is held at 20 to 24 °C until separation; other whole blood is stored at 1 to 6 °C under its processing and transport procedure.^{1010 Electronic Code of Federal Regulations. Title 21, §§606.160, 606.170, 640.4, and 640.24.}

Reduced collection volume

Routine allogeneic whole-blood donation requires a donor weight of at least 50 kg. A physician may approve an otherwise ineligible autologous donor under the federal exception. When the approved collection system and facility procedure authorize a reduced volume, the calculation preserves the intended blood-to-anticoagulant ratio.

For a collection set designed for 450 mL of blood with 63 mL of anticoagulant:

collection volume (mL) = donor weight (kg) ÷ 50 × 450

anticoagulant volume (mL) = collection volume ÷ 450 × 63

The math shows the ratio. Authority to modify a commercial collection set comes only from its instructions and the facility's validated procedure. If a standard set receives less than its target blood volume while retaining the full anticoagulant volume, the AABB Circular defines the applicable RBC Low Volume range and limits component preparation to red cells. Collection authorization also requires an acceptable donor health assessment and the responsible physician's documented determination.^{1,10,121 Electronic Code of Federal Regulations. Title 21, §§630.5, 630.10, 630.15, and 630.20.10 Electronic Code of Federal Regulations. Title 21, §§606.160, 606.170, 640.4, and 640.24.12 Association for the Advancement of Blood &… Circular of Information for the Use of Human Blood and Blood… 2024.}

Apheresis donation

An apheresis instrument withdraws anticoagulated blood, separates the target component, and returns the remaining elements to the donor. Citrate keeps the extracorporeal circuit from clotting by lowering ionized calcium. Perioral tingling, acral tingling, chills, muscle cramping, and carpopedal spasm signal increasing citrate effect. The device instructions and facility procedure set the collection target, extracorporeal-volume limit, anticoagulant delivery, and response to symptoms.

Donation intervals depend on the components removed and cumulative red-cell loss:

Platelet and plasma collection may require longer intervals after whole-blood or red-cell loss. After a whole-blood or single-red-cell loss, an 8-week interval generally applies; platelet or plasma collection may resume after at least 2 calendar days only when the apheresis device's total extracorporeal volume is less than 100 mL. For plateletpheresis, a missing previous platelet count permits a narrow exception only when a precollection or immediate post-start count cannot be obtained, and the total collection target must remain below 9 × 10¹¹ platelets.

Plateletpheresis generally limits retained plasma, excluding anticoagulant, to 500 mL per procedure or 600 mL for a donor weighing at least 175 lb unless the FDA-cleared device labeling specifies another volume.^{2020 US Food and Drug Administration. Guidance for Industry and FDA Review Staff. 2007.} After an incomplete automated red-cell collection, a donor who lost less than 200 mL of red cells may return within 8 weeks. A loss of 200 mL to less than 300 mL requires an 8-week deferral. A total loss of 300 mL or more within 8 weeks requires a 16-week deferral from the last loss.^{2121 US Food and Drug Administration. Guidance for Industry. 2001.}

Granulocyte and other multicomponent procedures also require review of cumulative red-cell, platelet, plasma, medication, and sedimenting-agent exposure. One collection can affect several intervals, so the complete donation record must be checked before the next procedure.^{1313 Electronic Code of Federal Regulations. Title 21, §630.3(e), infrequent plasma donor definition…}

Collection apheresis obtains a component for transfusion or further manufacturing. Therapeutic apheresis removes a pathologic substance from a patient and follows a separate clinical workflow.

Donor reactions

A donor who turns pale and sweaty in the chair needs the collection stopped first. Current hemovigilance classifies each reaction by the event and its consequences. Recognition, immediate care, follow-up, and severity are recorded together.

The collection facility maintains a rapid emergency-service procedure and keeps at least one responsible physician, physician substitute, or trained person with current cardiopulmonary resuscitation certification on site while collection is in progress.^{11 Electronic Code of Federal Regulations. Title 21, §§630.5, 630.10, 630.15, and 630.20.}

Directed and autologous collections

Directed donation

A directed donation is reserved for a named recipient. The donor completes the allogeneic eligibility process, and the donation receives the required testing and labeling. FDA reports that directed donations use the same regulatory screening and may carry higher infectious-marker rates. Requests based on personal traits may also delay an appropriate transfusion.^{1616 US Food and Drug Administration. Important Information About Directed Blood Donations that are… 2023.}

Cellular components donated by a blood relative require irradiation because shared human leukocyte antigen (HLA) haplotypes can allow viable donor T lymphocytes to engraft and cause transfusion-associated graft-versus-host disease. The label and inventory record must preserve the directed status and the irradiation requirement through issue.^{99 Association for the Advancement of Blood &… Standards for Blood Banks and Transfusion Services. 2026.}

Autologous donation

Autologous blood is collected for the same person who will receive it. It avoids exposure to allogeneic donors and red-cell antigens while retaining risks from bacterial contamination, volume overload, hemolysis, and identification error.

FDA permits collection from an otherwise ineligible autologous donor when the donation is prescribed for autologous use, hemoglobin is at least 11.0 g/dL or hematocrit is at least 33%, and the responsible physician or an FDA-accepted physician-approved procedure determines that the collection is safe. FDA's compliance policy permits a reduced infectious-risk assessment for blood kept solely for autologous use. Shipment to another establishment or release into allogeneic inventory triggers the applicable donor testing and allogeneic eligibility requirements.^{1717 US Food and Drug Administration. Determining Donor Eligibility for Autologous Donors of Blood and… 2016.}

An autologous unit collected, stored, and transfused at one facility with crossover prohibited may be labeled "Donor Untested." Shipment to another establishment that does not allow autologous units to cross over requires testing of at least the first donation in each 30-day period under 21 CFR 610.40(d).^{1818 Electronic Code of Federal Regulations. Title 21, §610.40(d), Test requirements.} Crossover into allogeneic inventory requires full allogeneic donor eligibility, donation suitability, and testing. Reactive units kept for the donor's own use carry the applicable "Biohazard" and "For Autologous Use Only" labels and require physician authorization.^{1717 US Food and Drug Administration. Determining Donor Eligibility for Autologous Donors of Blood and… 2016.}

A perioperative program defines patient inclusion and exclusion criteria, collection and wash settings, anticoagulant, filtration, labeling, storage, final inspection, adverse-event response, equipment control, staff training, and competency. Components separated from the patient carry two patient identifiers, the component name, collection and expiration times, and collector identification. Before any directed or autologous unit is issued, check that its label still carries the status and requirements its record shows.^{1919 Association for the Advancement of Blood &… Standards for Perioperative Autologous Blood Collection and… 2024.}

Practice