Hemoglobin Screening/Iron Management

Evaluation of donor hemoglobin (HB) or hematocrit performed during the donor eligibility process helps ensure the donor can safely experience the loss of blood that results through blood donation. The loss of red blood cells and the resulting potential for postdonation iron deficiency is addressed by AABB’s recommendations in Association Bulletin #17-02 “Updated Strategies to Limit or Prevent Iron Deficiency in Blood Donors.” In response to member requests for a tool to support education on blood donation and iron health, AABB’s Donor Health and Safety Committee has updated this resource, “Information on Blood Donation and Iron Health”. This education resource is intended to assist centers considering additional donor education on this topic.

The minimum donor HB requirements are addressed in FDA’s May 2015 final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use.” FDA evaluated the normal range of HB levels to help prevent iron depletion in male allogeneic donors and revised the eligibility requirements accordingly. The Final Rule established a new minimum HB requirement of 13.0 g/dL, or a hematocrit value that is ≥39%, that aligns more closely with the low range of normal levels for men. 

Likewise, in the May 2015 final rule, FDA also evaluated the normal range of HB levels in female allogeneic donors. Although the Final Rule maintained current requirements for HB and hematocrit levels for female donors at a minimum of 12.5 g/dL and 36%, respectively, the FDA recognizes that HB levels lower than 12.5 g/dL are also within the normal range for women. 21 CFR 630.10(f)(3)(i)(A) authorizes blood collections “from female allogeneic donors who have a hemoglobin level between 12.0 and 12.5 grams per deciliter of blood, or a hematocrit value between 36 and 38 percent, provided that you [the establishment] have taken additional steps to assure that this alternative standard is adequate to ensure that the health of the donor will not be adversely affected due to the donation, in accordance with a procedure that has been found acceptable for this purpose by FDA.” At the invitation of FDA, AABB presented to BPAC proposed strategies for managing iron health in this subset of female donors, with and without ferritin testing, in support of this provision in the final rule.