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
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.
In a press release on March 6, the Food and Drug Administration announced its approval of the Babesia microti Arrayed Fluorescent Immunoassay (AFIA) and B. microti nucleic acid test (NAT) (both from Imugen) for the detection of antibodies to Babesia in human plasma and whole blood donor samples, respectively.
AABB’s Donor History Task Force has finalized additional donor questions and donor educational materials based on the FDA's January 2017 Ebola Guidance, which addresses risks associated with Ebola virus during periods both with and without widespread transmission. The new web page, Evaluating Donors for Risk of Ebola Virus Infections, contains the donor questions and materials, describes an appropriate approach and includes deadlines for implementation of the recommendations.
AABB posted an analysis of the FDA’S January 2017 Ebola Guidance which provides recommendations for assessing blood donor eligibility, donor deferral and blood product management during periods both with and without widespread transmission. AABB’s Donor History Task Force is working to develop an approach appropriate for implementation of the recommendations.
AABB posted new web page, May 2015 Final Rule Resources, to provide a consolidated list of AABB resources related to the Food and Drug Administration’s May 2015 Final Rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use.
AABB submitted comments to FDA's proposed rule, "Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories," on May 31, 2016. The
comments prepared by AABB's Information Services Committee expressed agreement with the FDA's proposed classification of blood establishment computer software (BECS) and BECS accessories into class II (special controls) and noted disagreement with the proposed definition for a BECs accessory as insufficiently clear. AABB recommended FDA clarify the scope of the BECs accessory definition to enable industry to apply the requirements as intended by FDA.
AABB, along with the American Red Cross and America’s Blood Centers, submitted
comments to FDA’s draft guidance “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus.”
AABB submitted draft Version 2.0 DHQ materials — as revised by the Donor History Task Force (DHTF) — to the FDA for approval. The DHTF believes that these materials are consistent with FDA’s December 2015 final guidance,
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, and the May 2015 final rule,
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use. AABB has made the
draft Version 2.0 materials available to facilitate planning for implementation of recommendations in the final guidance and new regulations in the final rule.
analysis of the Final Rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” is now available online. An attachment to the analysis — prepared for educational purposes only — depicts amended sections of Title 21 of the Code of Federal Regulations (CFR). High profile revisions to the CFR include FDA’s decision to raise the minimum hemoglobin requirement for male donors to 13.0 g/dL and the new section on control of bacterial contamination of platelets. The final rule, reflected in updated sections of the CFR, becomes effective on May 23, 2016.
responded to a Federal Register Notice – published November 7, 2014 – and notified the Centers for Medicare and Medicaid Services that the Hemoglobin - copper sulfate – non-automated test is still in use and should not be removed from the regulation [§ 493.15(c)(6)]. Under the current regulation the copper sulfate test is listed as a waived test.