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AABB Recommendations Regarding Plasma Donors

Because of the data associating HLA antibodies with TRALI and the incidence of HLA antibodies in multiparous women, the AABB (Association Bulletin #06-07) encouraged a voluntary mitigation strategy, which recommended a reduction or elimination of the production of FFP from all females or alternatively from females with a history of pregnancy. An alternative strategy, especially for products in short supply, like group AB plasma, was to test females with a pregnancy history for HLA antibodies and limit production to those who tested negative. A number of published studies have reported that these mitigation strategies have been successful in significantly reducing the number of cases of TRALI and the number of TRALI fatalities. In 2010 the FDA reported that TRALI fatalities had been reduced 83% from the peak (prior to mitigation efforts) of 23 cases in 2006 to 4 cases in 2010. The trend has continued with only 4 reported cases in both 2011 and 2012.
Most recently the AABB Blood Bank and Transfusion Service Program Unit has developed a standard for the Standards for Blood Banks and Transfusion Services, 29th ed that addresses TRALI mitigation. The standard (5.4.1.2) reads:
Plasma and whole blood for allogeneic transfusion shall be from males, females who have not been pregnant, or females who have been tested since their most recent pregnancy and results interpreted as negative for HLA antibodies.
Components addressed by this standard include:
  • Fresh Frozen Plasma (FFP) prepared from whole blood
  • FFP collected by apheresis (collected alone or concurrent with a cellular component such as platelets)
  • Plasma, Cryoprecipitate-Reduced
  • Plasma, Frozen Within 24 Hours of Phlebotomy (PF24)
  • Thawed plasma from any of the products listed above
  • Liquid Plasma
  • Whole Blood (if designated for transfusion as Whole Blood)