Transfusion medicine

Blood donation

Donor eligibility


Editorial Board Member: Kyle Annen, D.O.
Deputy Editor-in-Chief: Patricia Tsang, M.D., M.B.A.
Melissa R. George, D.O.
Evelyn M. Potochny, D.O.

Topic Completed: 30 September 2021

Minor changes: 30 September 2021

Copyright: 2021, PathologyOutlines.com, Inc.

PubMed Search: eligibility[title] blood donor

Melissa R. George, D.O.
Evelyn M. Potochny, D.O.
Page views in 2020: 2
Page views in 2021 to date: 95
Cite this page: George MR, Potochny EM. Donor eligibility. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/transfusionmeddonoreligibility.html. Accessed December 3rd, 2021.
Definition / general
  • Donor eligibility is established by donor history questionnaire, evaluation of vital signs and hemoglobin, brief physical examination and laboratory testing for transfusion transmissible infectious disease
Essential features
  • Donor eligibility is determined by a combination of:
    • Donor health / history questionnaire
    • Brief physical examination
    • Laboratory screening testing
  • Overarching principles are to protect safety of the donor and recipient
  • Screening is sensitive but not as specific
  • Confirmatory testing (preferably FDA approved) needed to diagnose infectious disease
Terminology
  • DHQ: donor history questionnaire
  • ADHQ: abbreviated donor history questionnaire
  • TTI: transfusion transmitted infection
Pathophysiology
  • Donor screening is performed through donor history questionnaire, limited physical examination and laboratory testing of donor blood for transfusion transmissible infectious disease
  • 2 basic principles:
    • Protect the donor
      • Blood donors must be:
        • Feeling well on the day of donation to avoid a donor reaction
        • Healthy enough to tolerate blood donation
          • Adequate venous access
          • Tolerance of volume loss
          • Tolerance of red blood cell (RBC) oxygen carrying capacity loss
    • Protect the recipient
      • Blood donors must be (AABB: DHQ/aDHQ Medication Deferral List v2.1 [Accessed 20 July 2021]):
        • Feeling well on day of donation (decreases risk of transmitting virus or subclinical bacterial sepsis)
        • Free of transfusion transmitted infectious disease
        • Not taking teratogenic medications
        • Not taking medications that alter platelet function (if donating platelets) or clotting factors (if donating plasma containing products)
        • Not currently on human immunodeficiency virus (HIV) preventive medication or HIV antiretroviral therapy
Donor requirements
Transmission
Blood donor screening
  • Sample
    • Generally, about 5 test tubes drawn
      • Nucleic acid testing (NAT) for infectious disease
      • ABO / Rh testing and testing for syphilis antibodies
      • Viral antibody markers
      • Antibodies against T. cruzi (Chagas)
      • Tube retained in case repeat testing is necessary
  • Screening has high sensitivity but lower specificity
  • False positives are possible
  • Confirmatory testing may be necessary for final disposition of donor eligibility
  • See separate entry on Blood donor testing for more detail
Donor deferral (not all inclusive)
  • General:
    • Deferrals for safety of recipient:
      • Definitive TTIs = indefinite deferral
      • Self limited, high risk for TTI (e.g. one time events) used to be 1 year deferral, now usually 3 months
      • Medications based on risk of teratogenicity if donated blood were to be transfused to a pregnant woman, depends on drug clearance
      • Vaccine deferrals are quite variable
    • Deferrals for safety of donor:
      • Time needed to replenish red blood cells, plasma and platelets
    • Blood collectors still have some discretion in creating policies potentially stricter than FDA
  • Indefinite:
    • Confirmed TTI (HBV, HCV, HIV, etc.)
    • Etretinate (also known as Tegison) use: psoriasis drug with teratogenic effects
  • 3 years:
    • Acitretin (Soriatane) use: psoriasis drug with teratogenic effects, high adipose distribution
    • Immigration from malaria endemic area
    • History of malaria (after becoming symptom free)
  • 1 year:
    • Incarceration for > 72 hours
    • Residing with or sexual contact with person with hepatitis
  • 6 months:
    • Dutasteride (Avodart) use: drug for treating benign prostatic hyperplasia with teratogenic effects
  • 3 months (most used to be a 1 year deferral) (U.S. Food and Drug Administration: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products [Accessed 20 July 2021]):
    • Exchanging sex for money or drugs
    • Nonprescription injection drug use
    • Sex with any of the following individuals:
      • Person with any history of a positive test for HIV
      • Person with a history in the past 3 months of exchanging sex for money or drugs
      • Person with a history in the past 3 months of nonprescription injection drug use
    • Receipt of blood product transfusion
    • Mucous membrane exposure to blood / needlestick
    • Tattoo (in states without health department oversight of tattoo parlors)
    • History in the past 3 months of syphilis or gonorrhea or treatment for syphilis or gonorrhea
    • For male donors: sex with another man
    • For female donors: a history in the past 3 months of sex with a man who has had sex with another man in the past 3 months
  • 4 months / 16 weeks:
    • Double unit red cell collection by apheresis
  • 2 months / 8 weeks:
    • Whole blood donation
  • 1 month / 4 weeks:
    • Isotretinoin (Accutane): acne drug
    • Finasteride (Proscar, Propecia)
    • Live attenuated viral and bacterial vaccines
      • German measles
      • Varicella (chicken pox)
  • 2 weeks:
    • Live attenuated viral and bacterial vaccines
      • Measles
      • Polio (Sabin oral)
      • Mumps
      • Typhoid (oral)
      • Yellow fever
  • Variable:
    • Smallpox vaccine: if no complications 21 days or until scab falls off; if complications, 14 days after resolution
  • 72 hours:
    • Autologous whole blood donation
  • > 48 hours:
    • Between apheresis plasma, platelet or granulocyte donations
  • 36 hours:
    • Aspirin use, if platelets from donation are to be used
  • No deferral:
    • Toxoids
    • COVID-19 vaccine
    • Synthetic or killed (inactivated) vaccines, including:
      • Anthrax
      • Cholera
      • Diphtheria
      • Hepatitis A
      • Hepatitis B
      • Lyme
      • Paratyphoid
      • Pertussis
      • Plague
      • Pneumococcal polysaccharide
      • Polio (Salk injection)
      • Rabies
      • Rocky Mountain Spotted Fever
      • Tetanus
      • Typhoid (injection)
  • Medical director discretion
    • Some donor eligibility issues fall outside usual categories
    • Judged on case by case basis
    • Assess potential risk to donor and recipient
  • Reference: AABB: Standards for Blood Banks and Transfusion Services, 32nd Edition, 2021
Laboratory
  • Typical findings
    • Donors must be negative for screening tests
    • Confirmatory testing may clarify nonspecific or false positive results
    • Even false positives are deferred until negative screening testing is achieved
Sample blood donor deferral letter
Dear ### (Blood Donor Name),

In order to safeguard the blood supply, we perform a number of laboratory tests to make sure that potential donors do not have transfusion transmissible illnesses (TTI). This includes screening for various viruses and bacteria. Such testing is very sensitive but false positives may also occur. One of your tests warrants further investigation.

Please call the Blood Donor Center at (###) ###-#### between the hours of 8 a.m. to 4:30 p.m., Monday through Friday for more information.

Sincerely,

Medical Director of Transfusion Medicine

Reference: U.S. Food and Drug Administration: Guidance for Industry Donors of Blood and Blood Components: Notification of Donor Deferral Small Entity Compliance Guide [Accessed 20 July 2021]
Board review style question #1
A 20 year old man schedules an appointment to donate blood at a blood drive held on his university campus. He previously donated blood while he was a high school student. On his donor questionnaire, he notes that he recently started taking isotretinoin (Accutane) for acne. What is the blood donation deferral period for taking this medication?

  1. 1 month after the last dose
  2. 1 year after the last dose
  3. 6 months after the last dose
  4. Indefinite
  5. No deferral
Board review style answer #1
A. Isotretinoin (Accutane) use is a 1 month deferral after the last dose due to the potentially teratogenic effects, should the donated blood be transfused to a pregnant woman.

Comment here

Reference: Donor eligibility
Board review style question #2
A 35 year old woman presents to donate blood. Upon screening, she reveals that she was treated for Plasmodium vivax malaria after spending 3 months on a medical missions trip to Africa. Her treatment ended 6 months ago. How long should she be deferred from donating blood?

  1. 3 months after treatment; she has been eligible to donate for 3 months
  2. 3 years after treatment has ended and donor is symptom free
  3. 6 months after treatment; she is eligible to donate now
  4. 6 more months for a total of 1 year deferral after treatment
  5. Indefinite deferral
Board review style answer #2
B. Donors who have been diagnosed with malaria are deferred for a 3 year period after treatment and with the qualification that they are symptom free. Some forms of malaria may remain dormant in the liver and reactivate at a later time. Proper treatment is critical for preventing reactivation. A 3 year deferral takes the potential of reactivation into account. Individuals who have been successfully treated for the potential latent, liver phase of malaria are deferred for 3 years after completion of treatment. After this deferral period, provided there is no additional travel history or evidence of reinfection / reactivation of infection, these individuals are eligible for donation.

Comment here

Reference: Donor eligibility
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