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TRALI Risk Reduction Requirements in the 29th Edition of BBTS Standards

This page does not contain current information about the Standards for Blood Banks and Transfusion Services, 29th edition as it relates to TRALI. To read AABB's current standard on TRALI risk reduction and to learn more about the edits to the standards and the rationale for the change, please click here. In July, the AABB Board of Directors approved the 29th edition of Standards for Blood Banks and Transfusion Services for publication. The 29th edition of Standards, which will go into effect on April 1, 2014, includes the following new requirements for TRALI risk reduction: 5.4.1.1 Donors implicated in a transfusion-related acute lung injury (TRALI) event or associated with multiple events of TRALI shall be evaluated regarding their continued eligibility to donate.   5.4.1.1.1 High plasma volume components for allogeneic transfusion (i.e. plasma, high plasma volume platelet components, and whole blood) 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.     5.4.1.1.1.1 For high plasma volume platelet components, standard 5.4.1.1.1 shall be implemented by October 1, 2014. The final 29th edition also includes a glossary entry for high plasma volume components, which reads: "For the purposes of these BBTS Standards, these allogeneic components are whole blood, unmanipulated apheresis platelets, and plasma products." Platelets with reduced plasma volume due to the addition of an approved platelet additive solution would not be considered a high plasma volume component and are excluded from this definition.

The Blood Bank/Transfusion Service Standards Program Unit (BB/TS SPU) decided on the wording of standard 5.4.1.1.1 shortly after AABB's public workshop on TRALI risk reduction. In response to the many comments submitted, the BB/TS SPU reasoned that the wording of the standard should be as direct as possible. For example, the language in the proposed Standards called on facilities to prevent preparation of high plasma volume components from individuals "at high risk for leukocyte alloimmunization." The BB/TS SPU preferred to simply identify those individuals in the body of the standard. Accordingly, the language approved by the Board specifically lists males, females who have not been pregnant, and females with known negative HLA antibody results as acceptable donors of high plasma volume components.

The BB/TS SPU also recognized the importance of implementing TRALI risk reduction in a manner that minimizes possible disruptions to the supply of Apheresis Platelets. In light of the fact that some AABB-accredited facilities may require a longer time frame in which to implement appropriate donor deferral or testing strategies, the BB/TS SPU elected to delay the effective date of the requirement for platelet components until October 1, 2014.

In addition, members of the BB/TS SPU, TRALI task force, and AABB's Board of Directors are working closely together to develop an Association Bulletin with specific guidance on how to meet the new standards. The Association Bulletin will outline a number of strategies for TRALI risk reduction, including donor qualification, HLA antibody testing considerations, donor re-testing (when necessary), the use of platelet additive solutions, and inventory management.

Questions about these new standards can be submitted to the Standards Development Department.