2.1 Donor Qualification

2.1 Donor Qualification

Quick Answer: Eligibility is determined on the day of donation and before collection (21 CFR 630.10). A standard allogeneic whole-blood donor must weigh at least 110 lb (50 kg), have an acceptable pulse, blood pressure, and temperature, and meet sex-specific hemoglobin/hematocrit minima (female ≥12.5 g/dL or hematocrit ≥38%; male ≥13.0 g/dL or ≥39%). Autologous minima are lower (hemoglobin ≥11.0 g/dL or hematocrit ≥33%). Whole blood may be collected no more than once in 8 weeks (56 days). HIV-risk screening uses FDA’s individual-risk questions, not the retired orientation-based MSM deferral. ASCP BB donor-eligibility items follow regulations current as of June 2026.

Donor qualification exists to protect two people at once. Low weight, low hemoglobin, recent pregnancy, and unstable vital signs protect the donor. Infectious-risk history, medications that could harm a fetus, and travel or exposure questions protect the recipient. Every BB item in this domain is asking which person is being protected and which regulation or AABB/FDA document sets the number.

Allogeneic, autologous, and directed — start here

Allogeneic donation is volunteer community blood intended for an unknown recipient. The donor must meet the full 21 CFR 630.10/630.15 eligibility set, including the higher hemoglobin minima, infectious-disease history, and donation-interval rules. Unused allogeneic units remain in general inventory.

Autologous donation is collected from a patient for that same patient’s later use, usually preoperative autologous donation (PAD). The responsible physician of the blood establishment still determines that the donor’s health permits the procedure, but several allogeneic bars are relaxed. The published hemoglobin floor is 11.0 g/dL or hematocrit 33%. Autologous units are labeled for autologous use. In most current U.S. practice they are not crossed over into the allogeneic supply if unused; they are discarded. Infectious-disease testing is still performed. A reactive autologous unit is not quietly converted into a community unit.

Directed donation is collected from a donor the patient or family named for a specific recipient. Directed donors must meet the same eligibility and testing standards as allogeneic donors. Directed donation is not inherently safer. Directed units are reserved for the named recipient; they are not a loophole around hemoglobin, interval, or HIV-risk rules. Section 2.3 covers labeling, irradiation of blood-relative units, and the “not safer” exam trap in more depth.

These three categories share the same-day physical assessment. They do not share the same hemoglobin table or the same fate of an unused bag.

When eligibility is decided (21 CFR 630.10)

You must not start the collection until eligibility is determined. The regulation is specific: determine eligibility on the day of donation and before collection. The establishment consults deferred-donor records, confirms the interval since the last donation, takes a medical history, and performs the physical assessment. Two narrow exceptions exist. If the component cannot be stored more than 24 hours, eligibility and the sample for required testing may be obtained no earlier than 2 calendar days before the day of donation, if SOPs address that workflow. Incomplete questionnaire answers may be clarified within 24 hours of collection, again only if SOPs allow it. Neither exception lets you discover a low hemoglobin or a disqualifying history after the needle is already in and then pretend the unit was collected from an eligible donor.

The donor must also provide proof of identity and a postal address where the donor can be contacted for 8 weeks after donation, and must give a documented acknowledgement that is free of exculpatory language. That acknowledgement covers educational material on relevant transfusion-transmitted infections, agreement not to donate when a risk factor is present, infectious-disease testing, deferral notification, procedure risks, and the right to ask questions or withdraw.

Physical assessment numbers you must not mix

21 CFR 630.10(f) sets the published physical-assessment minima. Temperature must not exceed 37.5 °C (99.5 °F) orally, or the equivalent at another site. Systolic blood pressure must be 90–180 mm Hg and diastolic 50–100 mm Hg; values outside those limits require the responsible physician to examine the donor and document that donation will not harm the donor. Pulse must be regular and 50–100 beats per minute; an irregular pulse or a rate outside that range likewise requires a documented physician determination. A July 2024 FDA compliance policy allows telehealth physician review for some out-of-range blood pressures and SOP-based handling of athletic bradycardia, but the regulatory numbers on the exam remain 90–180 / 50–100 and 50–100 regular.

Weight must be at least 50 kg (110 lb) for a standard collection. That floor exists because a 500 mL collection plus samples is a meaningful fraction of blood volume in a smaller donor. AABB Standards also cap collection at 10.5 mL/kg including samples; a donor at the 50 kg floor is already near that limit for a 500 mL bag. Double-red-cell apheresis uses higher center-specific weight and hematocrit gates because two red-cell units are removed.

Hemoglobin or hematocrit must be measured from a fingerstick, venipuncture, or equivalent sample. Earlobe blood is not acceptable — capillary earlobe values run higher and would pass donors who fail a fingerstick. Published minima:

A female allogeneic donor at 12.3 g/dL is not automatically acceptable. She is acceptable only if the center operates an FDA-accepted alternative procedure. A male allogeneic donor at 12.8 g/dL fails. An autologous donor at 11.4 g/dL may proceed if the rest of the assessment allows it. Mixing those three rows is one of the highest-yield traps in this chapter.

Skin at the phlebotomy site must be free of infection, inflammation, and lesions. Arms and forearms must be free of punctures and scars that suggest injected drugs of abuse.

Donation intervals (21 CFR 630.15 and AABB practice)

For a collection that yields a single unit of Whole Blood or a single apheresis red-cell unit, donation frequency must be no more than once in 8 weeks (56 days). For two red-cell units in one apheresis procedure (double RBC / “Power Red”), the donor must not donate more than once in 16 weeks (112 days). Those intervals apply unless the responsible physician examines the donor and the donation is autologous as prescribed, or a dedicated donation for documented exceptional medical need. After whole blood or a single red-cell apheresis unit, plasmapheresis is generally deferred 8 weeks (a 2-calendar-day exception exists if extracorporeal volume is <100 mL). After double RBC, plasma deferral is 16 weeks.

Plateletpheresis intervals are shorter because red-cell mass is returned. Current AABB/community practice, consistent with FDA device labeling and AABB Standards, is no more than twice in 7 days and no more than 24 plateletpheresis procedures in a rolling 12 months. Concurrent plasma or platelet-plasma collections follow the center’s FDA-cleared device instructions and cumulative red-cell-loss rules. Source Plasma donors have additional 21 CFR 630.15(b) requirements: physician history and physical at least annually (and after a 6-month lapse), informed consent, a weight at each visit, and total protein 6.0–9.0 g/dL before each procedure. Freedom from malaria risk is not required for Source Plasma.

Therapeutic phlebotomy may be more frequent than the 8-/16-week clocks when it is prescribed to promote the donor’s health. Labeling of the disease is required unless the donor independently meets all eligibility criteria, the condition is hereditary hemochromatosis (or another FDA-accepted condition), and therapeutic phlebotomies for that condition are performed without charge (21 CFR 630.15(a)(2)). That variance is how some hemochromatosis units become allogeneic inventory; it is not automatic.

Individual risk assessment replaced MSM orientation rules

Through 2015 FDA recommended indefinite deferral of men who had sex with men even once since 1977. That became a 12-month MSM deferral in 2015 and a 3-month MSM deferral in April 2020. None of those orientation-based MSM rules is current. The May 2023 guidance Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions… eliminated MSM-specific and “woman who has sex with MSM” questions. Every donor, regardless of sex or gender, answers the same HIV-risk questions. That guidance remained FDA’s current thinking through June 2026 and is what BB items in this cycle test.

Ask every donor about a new sexual partner or more than one sexual partner in the past 3 months. If the answer is yes, ask about anal sex in the past 3 months. Defer 3 months from the most recent sexual contact only when both are present: (new partner or more than one partner) and anal sex. A monogamous male donor who has sex with men and has neither a new partner nor multiple partners is not deferred on orientation. Quoting “MSM wait 3 months” or “MSM are indefinitely deferred” as current U.S. policy is an exam miss.

Other current 3-month HIV-risk deferrals (from most recent event or last dose) include: exchanging sex for money, drugs, or other payment; non-prescription injection drug use; sex with a person who has ever tested positive for HIV; sex with a person who exchanged sex for payment or injected non-prescription drugs in the past 3 months; allogeneic transfusion; percutaneous blood exposure; syphilis or gonorrhea (3 months after completion of treatment); and a tattoo, ear, or body piercing that was not done in a state-regulated facility with sterile needles and non-reused ink (piercings with single-use equipment are not deferred). Oral HIV PrEP or PEP is a 3-month deferral from the last oral dose. Injectable PrEP/PEP (long-acting cabotegravir and, on the July 2025 AABB Medication Deferral List update, lenacapavir) is a 2-year deferral from the last injection. A history of a positive HIV test, or any medication taken to treat HIV (ART), is a permanent deferral. Donors must not stop prescribed PrEP, PEP, or ART in order to donate.

DHQ, medications, travel, tattoo, jail

U.S. centers use an FDA-accepted Donor History Questionnaire (AABB DHQ/aDHQ v4.0 is the current standardized instrument) plus the Medication Deferral List. Educational material is given before the history so the donor can self-defer. Classic teratogen deferrals you must still know: isotretinoin (Accutane and generics) 1 month; finasteride (Propecia, Proscar) 1 month; dutasteride (Avodart, Jalyn) 6 months; acitretin (Soriatane) 3 years; etretinate (Tegison) ever. Hepatitis B immune globulin is 3 months on the current DHQ Medication Deferral List (older 12-month HBIG figures are stale). Aspirin and other antiplatelet drugs do not usually defer whole-blood donation; they do defer platelet donation — aspirin is commonly 2 days (48 hours) before plateletpheresis. Warfarin, heparin, and direct oral anticoagulants are assessed for donor safety and product quality; they are not platelet-apheresis medications.

Malaria (FDA 2020 guidance, still the operative travel framework): a resident of a non-endemic country who traveled through a malaria-endemic area is deferred 3 months after last departure. A former resident of an endemic country is deferred 3 years after leaving, unless that person has already lived 3 consecutive years in a non-endemic country, in which case a later trip is a 3-month deferral. A history of malaria is 3 years after treatment, remaining symptom-free. Source Plasma is exempt from malaria-risk freedom.

vCJD geographic rules changed. FDA’s 2022 guidance removed the remaining UK (1980–1996) and France/Ireland (1980–2001) geographic deferrals and the deferral for transfusion in those countries. Donors previously deferred only for those geographic or transfusion-in-Europe reasons may be requalified if they meet all other criteria. Teach current policy: most UK/Europe travel is no longer a vCJD bar. Remaining CJD/vCJD-type deferrals are clinical (diagnosis of CJD or vCJD) and certain iatrogenic exposures such as human cadaveric pituitary growth hormone or dura mater graft — not “lived in the UK in 1992.”

Incarceration: 21 CFR 630.10 makes a donor ineligible for institutionalization of 72 hours or more consecutively in the past 12 months in a correctional institution. Pregnancy at donation or within 6 weeks prior is a deferral. A donor who appears intoxicated, unreliable, or who says the purpose of donating is to get an HIV test is ineligible. A xenotransplantation-product recipient is ineligible.

The BB exam will hand you a stem that looks like an older textbook. If the option still says “indefinite MSM deferral” or “female allogeneic hemoglobin 11.0 g/dL,” it is teaching a retired rule or mixing autologous with allogeneic. Use the June 2026 regulation set.