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Donor Safety, Screening and Testing

Donor screening is conducted in accordance with federal and state regulations, as well as AABB Standards, to protect the safety of the donor, and to ensure the safety, purity and potency of the blood collection. Blood collectors are fully committed to ensuring the health and safety of the blood donor before, during and after collection, including the use of minimum hemoglobin requirements and safety considerations for nonbinary donors, information on blood donation and iron health and limiting donation frequency. The donor screening process also protects the safety of the transfusion recipient by identifying eligible donors who meet specific criteria to help ensure blood safety.

Key elements of the blood donor screening process include: 1) Blood Donor Educational Material, 2) Donor History Questionnaires (DHQ) and Related Materials designed to assess both the safety of the donor and the blood collection, 3) a focused health exam including hemoglobin screening, 4) donor testing for transfusion-transmitted infectious diseases, and 5) management of all donation information including adverse donation events and post donation information.

The AABB DHQ and related materials are recognized by FDA as an acceptable mechanism for blood donor screening as follows:

  • The DHQ must be administered on the date of donation.
  • All donors must read the Blood Donor Educational Material and use the Medication Deferral List to complete the DHQ as part of this FDA recognized system.
  • The goal of this screening system is to facilitate donor understanding of questions and accurate recall of relevant activities.
  • AABB accredited blood collection facilities must comply with AABB standards for donor selection.
  • When donor testing is not available for certain diseases, such as Malaria and Ebola, the risk assessment relies on the DHQ process, as required by the FDA.

Donor testing requirements are found in FDA regulations (including Title 21 of the Code of Federal Regulations), FDA recommendations and AABB Standards. All donations must be tested for the following infectious diseases and found to be:
Negative for antibodies to

  • human immunodeficiency virus (anti-HIV-1/2),
  • hepatitis C virus (anti-HCV),
  • human T-lymphotropic virus (anti-HTLV-I/II),
  • and hepatitis B core antigen (anti-HBc), and
  • Trypanosoma cruzi either on the current donation or at least one previous donation.

Nonreactive for hepatitis B surface antigen (HBsAg).
Nonreactive when tested using licensed nucleic acid tests (NAT) for:

  • hepatitis B virus (HBV) deoxyribonucleic acid (DNA),
  • HCV ribonucleic acid (RNA),
  • HIV-1 (RNA),
  • West Nile virus (WNV) RNA, and
  • Zika virus (RNA),

Nonreactive when tested using a licensed NAT for Babesia spp. (RNA and DNA) for blood collected in states where Babesia testing is required by FDA.
Nonreactive when tested using a licensed serologic test for syphilis.

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