AABB contributions to plasma safety

A guiding principle of the AABB is to improve donor and recipient safety. In the area of plasma transfusion safety there have been a number of measures taken by the AABB, particularly addressing the risk of transfusion-related acute lung injury (TRALI). Over the past 10 years, AABB has issued major recommendations to address TRALI (Table 1) that have resulted in a significant reduction of TRALI risk. In 2001, the AABB published an association bulletin (#01-04)1 describing the emergence of noninfectious hazards of transfusion as the more common cause of patient harm compared to transfusion-transmitted infectious diseases. The bulletin specifically described TRALI and called for federally funded research in TRALI. Ultimately the National Institutes of Health funded two important areas of TRALI research: a SCCOR (Specialized Centers of Clinically Oriented Research) grant at University of California San Francisco with Pearl Toy, MD, as primary investigator and Retrovirus Donor Epidemiology Study-II (REDS-II) HLA and HNA donor prevalence and lookback studies (Leukocyte Antibody Prevalence Studies [LAPSI, LAPSII]). The 23rd edition (2004) of Standards for Blood Banks and Transfusion Services required that blood banks or transfusion services have a “process for indicating under what circumstances (e.g., TRALI) additional testing will be performed and what that testing will be” (7.4.3.2).2 It further required that the interpretation and evaluation of a suspected reaction be recorded in the patient's medical record and “if suggestive of . . . TRALI . . . it shall be reported to the patient's physician immediately” (7.4.3.3).2 In April 2004 a Canadian Consensus Conference provided a framework for a TRALI case definition and a summary of the state of knowledge at that time. Proceedings from this meeting were published in December 2004.3 In a statement before the Blood Products Advisory Committee of the Food and Drug Administration (FDA) on July 22, 2004, the AABB endorsed the definition of TRALI set forth during the consensus conference, recommended that additional research be conducted, and asserted that more data were needed before donor deferral criteria could be established.4 In June 2005, the AABB published Bulletin 05-06 describing an interim standard for the 23rd edition of the Standards for Blood Banks and Transfusion Services, which addressed the management of donors implicated in or associated with a case of TRALI.5 The new Standard 5.4.2.1 read “Donors implicated in TRALI or associated with multiple events of TRALI shall be evaluated regarding their continued eligibility to donate.”5 The bulletin defined an associated donor if a component from that donor was transfused in the 6 hours before the clinical manifestations of TRALI. An implicated donor is an associated donor who additionally is found to have HLA or HNA antibodies with a specificity for a cognate antigen in the patient or there is a positive reaction between donor serum and patient white blood cells (WBCs). To provide background information on TRALI and guidance to AABB members on complying with Standard 5.4.2.1, Association Bulletin 05-09 was published in August 2005.6 The bulletin provided the consensus conference3 definition of TRALI and compared it to the similar National Heart, Lung, and Blood Institute working group7 definition. It was pointed out that the criteria were virtually identical in patients without other risk factors for acute lung injury. The Canadian consensus definition, however, created the term “possible TRALI” for patients who had existing risk factors for TRALI. Furthermore, the criteria for TRALI were based on clinical and radiographic diagnosis and not on the basis of donor WBC antibody or cognate antigen testing. This bulletin also provided the first description of guidelines for donor management and laboratory case investigation for TRALI, balancing the goal of preventing future cases of TRALI and avoiding unnecessary donor deferrals. To this point the strategy to reduce the risk of TRALI in the United States was largely reactive based on managing donors in TRALI cases. There was no proactive approach to TRALI risk reduction. The AABB board created and charged the AABB TRALI Working Group with exploring potential intervention strategies. The need for action was based on several important emerging pieces of data. First, the FDA provided new data showing that TRALI was the most frequent cause of transfusion-related deaths between October 2003 and September 2005 with a mean of 24 deaths annually.8 Second, growing evidence indicated that donor WBC antibodies were implicated in many if not most cases of TRALI. Furthermore, it was recognized that multiparous women had the highest frequency of WBC antibodies. Third, the UK Serious Hazards of Transfusion (SHOT) system indicated that the risk of TRALI was five to seven times higher for high-plasma-volume components compared to red blood cells (RBCs) and that that majority of TRALI cases involving these components were from WBC antibody–positive female donors.9 Based on these observations, in 2003 the United Kingdom adopted a policy to minimize transfusion of plasma from female donors and buffy coat–derived platelets (PLTs) that were resuspended in plasma from female donors. By 2006 the SHOT data showed a substantial decline in the reported number of TRALI cases and deaths.10 Finally, the American Red Cross provided an analysis of reported TRALI deaths over a 3-year period of 2003 to 2005.11 The report indicated that the number of deaths increased each year, that the majority were associated with plasma (24 of 38), and that 75% of the plasma cases (18 of 24) and 60% of apheresis PLT cases (three of five) involved a WBC antibody–positive multiparous female donor. Based on the knowledge at the time, the AABB board approved the recommendations of the TRALI Working Group, which were communicated to members in the November 3, 2006, Association Bulletin (06-07).12 Led by the AABB, this bulletin marked a change in US policy regarding TRALI risk reduction recommending the following intervention strategies: Blood collecting facilities should implement interventions to minimize the preparation of high-plasma-volume components from donors known to be WBC alloimmunized or at increased risk of WBC alloimmunization. Blood transfusion facilities should work toward implementing appropriate evidence-based hemotherapy practice to minimize unnecessary transfusion. Blood collection and transfusion facilities should monitor the incidence of reported TRALI and TRALI-related mortality. High-plasma-volume components were defined as whole blood, fresh-frozen plasma, plasma frozen within 24 hours after phlebotomy, cryopoor plasma, apheresis PLTs, and buffy coat PLTs resuspended in plasma. Importantly the AABB board felt that the data supporting these interventions were sufficiently strong to recommend timelines for implementation. While implementation was to begin as soon as possible, the full implementation of measures for plasma components was to be completed by November 2007. Because the AABB board recognized that additional time was needed to mitigate the effects of TRALI interventions on apheresis PLT availability, the full implementation date for PLT components was set for November 2008. This controversial bulletin was received with mixed reaction particularly for apheresis PLTs, prompting a follow-up Association Bulletin 07-03 in November 200713 clarifying that the bulletin contains recommendations only and they do not constitute a standard or requirement for AABB accreditation. It further clarified that facilities “should have weighed the benefits of potential interventions against the potentially adverse effects . . . on apheresis platelet availability.” Further, “. . . this may mean that a facility may be able to implement only part of a particular strategy by November 2008 or may need to adjust an intervention to protect apheresis platelet availability.” This bulletin also provided results of a September 2007 AABB electronic survey of progress toward implementation. Among the respondents (54 of 89 of blood centers and 57 of 125 transfusion services), 86% reported partial or full implementation of risk reduction strategies for plasma and 70% had not yet begun implementation of strategies for PLTs. A second survey was performed by the AABB TRALI Working Group in August to September 2009 to assess TRALI risk reduction practices.14 The electronic survey focused on the 47% of responding blood centers representing 1.57 million apheresis PLTs and 3.15 million plasma units annually. Of the 47 blood centers, 41 (87%) indicated that they had implemented some measures to reduce TRALI risk from apheresis PLTs. The most common measures were increasing the collections from male donors (70%), performing HLA antibody testing (43%), and increasing the number of whole blood–derived PLTs (22%). Plasma TRALI risk reduction strategies were implemented in 46 of 47 (91%) responding blood centers. There was substantial variability in plasma policies based on both sex and blood group (O/A vs. AB). Some centers used male-only plasma, some used predominantly male plasma, and some used never-pregnant female donors in addition to male donors. Policies regarding sources of AB plasma were more likely to involve never-pregnant female donors or multiparous donors compared to A/O plasma. By 2010 it was apparent that the plasma risk reduction strategies recommended by the AABB in November 2006 were effective. The American Red Cross hemovigilance reports from 2006 to 2008 indicated that as the proportion of male plasma increased from 55% in 2006 to 95% in 2008, the number of TRALI fatalities from plasma declined from six in 2006 to five in 2007 to zero in 2008.15 The rate of fatal and nonfatal TRALI observed from plasma was not different than that of RBCs (4.0 vs. 2.3 per 106 distributed components; odds ratio, 1.78; 95% confidence interval, 0.67-4.36).15 Additionally the 2010 FDA annual report “Fatalities Reported to the FDA Following Blood Collection and Transfusion” reported that TRALI fatalities attributed to plasma declined from a peak of 23 cases in 2006 to four in 2010, an 83% decline.16 Similar data were reported from the UK SHOT program in 2009.17 The data are less clear regarding the effectiveness of strategies to mitigate the TRALI risk from apheresis PLTs since full implementation was not recommended until November 2008. The FDA 2010 annual report, however, does show a decline in TRALI deaths from apheresis PLTs from five in 2008 to one in 2010.16 The role of AABB in improving plasma safety can be seen in a number of other areas. In March 2008 the AABB published a “Resource Guide on Labeling, Storage and Comparability of Plasma Components.”18 The publication was intended to provide guidance for transfusion services on labeling and storage of thawed plasma components. It also described the differences in content of plasma prepared by different methods. The AABB recently funded a systematic review of the literature using GRADE methodology to establish appropriate plasma transfusion guidelines.19 Importantly the AABB has partnered with the Centers for Disease Control to launch a nationwide biovigilance program. This program is designed to allow for early recognition of new threats to plasma safety and assess effectiveness of interventions to improve safety. The AABB has maintained a leadership role in patient and donor safety and is expected to continue to do so as emerging risks such as transfusion-associated circulatory overload are addressed. The author serves as a member of the AABB board of directors and its current president.

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