In order to conform to this standard, a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components. An alternative strategy (targeted HLA typing) requires that a facility obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies. The risk of HLA antibody production is exceedingly low in women who have been pregnant but have not carried to term (abortions and miscarriages); thus, they need not be screened for HLA antibodies. HLA typing need not be repeated unless the donor has a subsequent pregnancy. Each blood collection facility must develop procedures and policies regarding documenting donor pregnancy histories at the time of each donation to ensure that plasma components are not released before appropriate testing is completed and interpreted as negative for HLA antibodies. HLA antibody testing should be performed using FDA-approved tests that detect both HLA Class I and Class II antibodies. The facility should use the cutoff stated in the manufacturer’s circular or perform validation studies to determine the cutoff for the assay used.
Mitigation efforts such as this, which divert an otherwise healthy donor population away from a specific donation (in this case, FFP production), place a strain on the already scarce plasma resource. However, until other mitigation strategies are identified, it has been determined that the risk of TRALI outweighs issues of plasma supply. With regard to AB plasma, it is considered inappropriate to use AB plasma for all recipients without regard to their blood type (universal plasma donor). Every attempt should be made to use other ABO group plasma for transfusion to recipients who are not group AB.
It is important to report suspected cases of TRALI to the blood center so that implicated donor units can be screened for HLA antibodies. Once HLA antibodies have been identified, implicated donors should not be used for plasma production and, if applicable, other plasma products from these donors should be located and removed from the inventory.
