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. 2009 May 15:157–182. doi: 10.1016/B978-0-443-06981-9.50016-8

Table 11-3.

AABB Standards Requirements for Donor Qualification*

Item Category Criteria
1 Age ≥17 years or applicable state law
2 Whole Blood Maximum of 10.5 mL/kg of donor weight, including samples; blood collection container shall be cleared for volume collected
Volume Collected
3 Donation Interval
  • 8 weeks after whole blood donation (Standard 5.6.7.1 applies)

  • 16 weeks after 2-unit red cell collection

  • 4 weeks after infrequent plasmapheresis

  • ≥2 days after plasma, platelet, or leukapheresis (see exceptions in Standard 5.5)

4 Blood Pressure
  • ≤180 mm Hg systolic

  • ≤100 mm Hg diastolic

5 Pulse 50–100 beats per minute, without pathologic irregularities; <50 beats per minute accepTable if an otherwise healthy athlete
6 Temperature ≤37.5°C (99.5°F) if measured orally, or equivalent if measured by another method
7 Hemoglobin/Hematocrit ≥12.5 g/dL/≥38%; blood obtained by earlobe puncture shall not be used for this determination
8 Drug Therapy
  • Medication evaluation:
    • Finasteride (Proscar, Propecia), isotretinoin (Accutane)—defer 1 month after last dose
    • Dutasteride (Avodart)—defer for 6 months after last dose
    • Acitretin (Soriatane)—defer for 3 years after last dose
    • Etretinate (Tegison)—defer indefinitely
    • Bovine insulin manufactured in UK—defer indefinitely
    • Medications that irreversibly inhibit platelet function preclude use of the donor as sole source of platelets:
      • Defer for 36 hours after ingestion of aspirin
      • Defer for other medications as defined by the facility's medical director
9 Medical History
 General health
  • The prospective donor shall appear to be in good health and shall be free of major organ disease (e.g., heart, liver, lungs), cancer, or abnormal bleeding tendency, unless determined eligible by the medical director. The venipuncture site shall be evaluated for lesions on the skin.

  • Family history of Creutzfeldt-Jakob disease (CJD)—defer indefinitely

 Pregnancy Defer if pregnant in the last 6 weeks
 Receipt of blood, component, or other human tissue
  • Receipt of dura mater or pituitary growth hormone of human origin—defer indefinitely

  • Receipt of blood, components, human tissue, or plasma-derived clotting factor concentrates—defer for 12 months

 Immunizations and vaccinations Receipt of toxoids or synthetic or killed viral, bacterial, or rickettsial vaccines if donor is symptom-free and afebrile—no deferral [anthrax, cholera, diphtheria, hepatitis A, hepatitis B, influenza, Lyme disease, paratyphoid, pertussis, plague, pneumococcal polysaccharide, polio (Salk/injection), Rocky Mountain spotted fever, tetanus, typhoid (by injection)]
Receipt of live attenuated viral and bacterial vaccines—defer for 2 weeks [measles (rubeola), mumps, polio (Sabin/oral), typhoid (oral), yellow fever]
Receipt of live attenuated viral and bacterial vaccines—defer 4 weeks [German measles (rubella), chickenpox (varicella zoster)]
Smallpox (refer to FDA Guidance)
Receipt of other vaccines, including unlicensed vaccines—defer for 12 months unless otherwise indicated by medical director
 Infectious diseases
  • Defer indefinitely:
    • History of viral hepatitis after 11th birthday
  • Confirmed positive test for HBsAg

  • Repeatedly reactive test for anti-HBc on more than one occasion

  • Present or past clinical or laboratory evidence of infection with HCV, HTLV, or HIV or as excluded by current FDA regulations and recommendations for the prevention of HIV transmission by blood and components

  • Donated the only unit of blood or component that resulted in the apparent transmission of hepatitis, HIV, or HTLV

  • A history of babesiosis or Chagas disease

  • Evidence or obvious stigmata of parenteral drug use

  • Use of a needle to administer nonprescription drugs

  • Donors recommended for indefinite deferral for risk of vCJD, as defined in most recent FDA Guidance

  • 12-month deferral from the time of:
    • Mucous membrane exposure to blood
  • Nonsterile skin penetration with instruments or equipment contaminated with blood or body fluids other than the donor's own. Includes tattoos or permanent makeup unless applied by a state-regulated entity with sterile needles and ink that is not re-used.

  • Sexual contact with an individual with a confirmed positive test for HBsAg

  • Sexual contact with an individual who is symptomatic (clinical evidence or diagnosis) for any viral hepatitis

  • Sexual contact with an HCV-positive individual who has had clinically apparent hepatitis within the past 12 months

  • Sexual contact with an individual with HIV infection or at high risk of HIV infection§,

  • Incarceration in a correctional institution (including juvenile detention, lockup, jail, or prison) for more than 72 consecutive hours

  • Completion of therapy for treatment of syphilis or gonorrhea or a reactive screening test for syphilis in the absence of a negative confirmatory test

  • History of syphilis or gonorrhea

  • Other: West Nile virus—defer in accordance with FDA Guidance#

Malaria
  • Prospective donors who have had a diagnosis of malaria or who have traveled or lived in an area where malaria is endemic and have had unexplained symptoms suggestive of malaria, shall be deferred for 3 years after becoming asymptomatic.

  • Individual(s) who have lived for at least 5 consecutive years in areas where malaria is considered endemic by the Malarial Branch, Centers for Disease Control and Prevention,

  • U.S. Department of Health and Human Services, shall be deferred for 3 years after departure from that area(s).

  • Individuals who have traveled to an area where malaria is endemic shall be deferred for 12 months after departing that area.**

10 Travel The prospective donor's travel history shall be evaluated for potential risks.††
*

Reference Standard 5.4.1A-Requirements for Allogeneic Donor Qualification.

FDA Guidance for Industry, January 9, 2002. Revised Preventative to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by Blood and Blood Products.

AABB Association Bulletin 05–11. Interim Standard for Standards for Blood Banks and Transfusion Services (23rd edition). Sept. 30, 2005.

§

FDA Memorandum, April 23, 1992, Revised Recommendation for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.

FDA Memorandum, December 11, 1996. Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection. #FDA Guidance for Industry, June 2005, Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known of Suspected West Nile Virus.

**

The Department of Defense has recommended a 24-month deferral. Department of Defense Memorandum, October 14, 1999, “Deferral of Service Members Stationed in Possible Malaria Areas in the Republic of Korea,” and February 28, 2001 update.