Minimum donor HB requirements are addressed in FDA’s final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use”, effective May 23, 2016.
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 collection “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.”
AABB’s Work Group on Management of Female Hemoglobin Levels (the Working Group) has identified a range of strategies to assist blood collection facilities who elect to develop an alternative standard to assure donor safety when collecting blood from female donors with HB values of 12.0 - ˂12.5 g/dL. The Working Group has reviewed and discussed current literature and relevant experience with this issue and determined what they believe are flexible strategies that incorporate minimal elements of an acceptable approach. These strategies may need to be further refined for the operational needs of individual blood collection establishments. The strategies developed by the Working Group have not been approved by the FDA; a blood establishment that seeks approval for these collections, as provided in the Final Rule, must submit the SOPs based on these strategies or other protocols they develop, to FDA in a prior approval supplement.
A blood collection establishment will need to determine if one or more of the proposed strategies will meet the unique needs of the facility’s resources and preferred approach for management of the risk for iron deficiency:
AABB Encourages Member Collaboration
AABB is inviting members to share their FDA-approved strategies on this web page. Blood collection establishments who receive FDA approval for SOPs based on these proposed strategies, or other protocols they develop, are encouraged to contact AABB at firstname.lastname@example.org. This web page is available to publish processes approved by FDA for collections from female donors with a HB greater than or equal to 12.0 and less than 12.5 g/dL (a hematocrit greater than 36 % and less than 38%).