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AABB > Resource Center > Regulatory/Government Affairs > Blood Donor Screening and Testing

Blood Donor Screening and Testing 

Overview

In an effort to ensure the blood supply is as safe as possible, all donors must meet specific eligibility criteria outlined by the Food and Drug Administration, accrediting organizations such as AABB, and individual donation centers. To donate, individuals must be at least 16 years old (or the age specified by state law), healthy and feeling well on the donation day. In addition, donors must meet weight and hemoglobin level requirements. Specific criteria exist for donors of human cells, tissue, and cellular- and tissue-based products as well. Although the criteria are very similar to that applied to blood donors, there are differences due to the unique patient needs for these products (see related HCT/P content).

Donors also are screened for disease risk factors using a health history questionnaire. Through this confidential questionnaire, donors are asked specific and direct questions regarding lifestyle, health, medical history and travel to assure their own health will not be compromised by a blood donation and that patients receive safe blood products. Donors can be deferred for a variety of reasons: signs and symptoms of relevant transfusion-transmitted infections, such as HIV, viral hepatitis, HTLV, syphilis or West Nile virus; social behaviors that increase their risk of exposure to infectious diseases, including men who have sex with other men, intravenous drug use and exchanging sex for drugs or money; travel to certain countries where the risk of exposure to a particular infectious disease is of concern; medical procedures that involve receipt of dura mater graft, transfusion of blood or blood components within the previous 12 months, or human-derived clotting factors within the previous 12 months; incarceration under certain circumstances; obtaining a piercing or tattoo using nonsterile materials within the previous 12 months; certain medications; and pregnancy.

Donors also may be deferred because of reactive test results to infectious diseases, such as syphilis, HIV, hepatitis, HTLV and WNV. In some cases, if it is determined that these results were false positives, an individual may be re-entered into the donor pool by following the requalification methods outlined by the FDA.

Because donor eligibility requirements are considered to be an important step in assuring a safe donation process for the donor and reducing the risk of transfusion transmission of a disease to a patient, AABB works with the FDA to ensure appropriate eligibility requirements are in place. AABB also works with the FDA to streamline processes for re-entry of donors deferred for false-positive test results.

Recent Actions

11/1/13
The Blood Products Advisory Committee met on Nov. 1 to advise the FDA on interpretive criteria for the MP Diagnostics HTLV Blot 2.4, manufactured by MP Biomedicals LLC.  AABB, America’s Blood Centers and the American Red Cross presented a joint statement at the meeting

5/22/13
AABB, America's Blood Centers and the American Red Cross submitted comments to the Food and Drug Administration on the draft guidance for industry titled "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis." The comments, which were submitted jointly, primarily address donor testing recommendations.  The comments include revised language related to evidence of the completion of syphilis treatment and inclusion of a re-entry process for donors assessed by their physician and determined not to have syphilis.

2/26/13
FDA publishes “Draft Guidance: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis.” See the AABB Analysis of the Draft Guidance document and comments submitted to the FDA docket.

11/8-9/11
FDA holds workshop on hemoglobin standards and maintaining adequate iron stores in blood donors. See Resources for a summary of the workshop.

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