Donor Hemovigilance with Blood Donation

Background

Reports on unexpected events (UEs) during blood donation (BD) inadequately consider the role of technical UEs.

Methods

Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations, and UEs from January 1, 2008 to June 30, 2011.

Results

6,605 UEs were observed during 166,650 BDs from 57,622 donors for a corrected incidence of 4.30% (0.66% local, 1.59% systemic, 2.04% technical UEs). 2.96% of BDs were accompanied by one UE and 0.45% by >1 UE (2-4). 6.3% of donors donating blood for their first time, 3.5% of those giving blood for their second time, and 1.9% of donors giving their third or more BD experienced UEs. Most common UEs were: discontinued collections due to venous access problems, repeated venipuncture, and small hematomas. Severe circulatory UEs occurred at a rate of 16 per 100,000 BDs.

Conclusions

Technical UEs were common during BD. UEs accompanied first and second donations significantly more often than subsequent donations.Key Words: Donor hemovigilance, Blood donation, Unexpected events     

Transfusion-Transmitted Infections Reported to the National Healthcare Safety Network Hemovigilance Module

Transfusion-transmitted infections (TTIs) can be severe and result in death. Transfusion-transmitted viral pathogen transmission has been substantially reduced, whereas sepsis due to bacterial contamination of platelets and transfusion-transmitted babesiosis may occur more frequently. Quantifying the burden of TTI is important to develop targeted interventions. From January 1, 2010, to December 31, 2016, health care facilities participating in the National Healthcare Safety Network Hemovigilance Module monitored transfusion recipients for evidence of TTI and recorded the total number of units transfused. Facilities use standard criteria to report TTIs. Incidence rates of TTIs, including for bacterial contamination of platelets and transfusion-transmitted babesiosis, are presented. One hundred ninety-five facilities reported 111 TTIs and 7.9 million transfused components to the National Healthcare Safety Network Hemovigilance Module. Of these 111 reports, 54 met inclusion criteria. The most frequently reported pathogens were Babesia spp in RBCs (16/23, 70%) and Staphylococcus aureus in platelets (12/30, 40%). There were 1.95 (26 apheresis, 4 whole blood derived) TTIs per 100 000 transfused platelet units and 0.53 TTI per 100 000 transfused RBC components, compared to 0.68 TTI per 100 000 all transfused components. Bacterial contamination of platelets and transfusion-transmitted babesiosis were the most frequently reported TTIs. Interventions that reduce the burden of bacterial contamination of platelets, particularly collected by apheresis, and Babesia transmission through RBC transfusion would reduce transfusion recipient morbidity and mortality. These analyses demonstrate the value and importance of facility participation in national recipient hemovigilance using standard reporting criteria.     

Transfusion-related acute lung injury: reports to the French Hemovigilance Network 2007 through 2008

BACKGROUND: Transfusion‐related acute lung injury (TRALI) is a major cause of transfusion‐related mortality and morbidity. Epidemiologic studies using data from national transfusion schemes can help achieve a better understanding of TRALI incidence. STUDY DESIGN AND METHODS: A multidisciplinary working group analyzed TRALI cases extracted from the French Hemovigilance Network Database (2007‐2008). All notified cases were reviewed for diagnosis. Those meeting the Canadian Consensus Conference criteria for TRALI were classified according to imputability to transfusion and clinical severity. Patient data (clinical characteristics, number and types of products transfused, and serology results) were obtained. RESULTS: There were 62 TRALI cases and 23 possible TRALI cases during the 2‐year period. An immune‐mediated mechanism was identified in 30 of 50 TRALI cases with complete serology. TRALI was considered to be the cause of death in 7.1% of patients and might have contributed to death in an additional 9.4% of TRALI or possible TRALI patients. Occurrence ranked high in obstetrics (15%), after surgery (34%), and in hematologic malignancies (21%). Single‐donor high‐plasma‐volume components were involved in half of the cases where the implicated blood product could be determined and carried the highest risk per component (1:31,000 for single‐donor fresh‐frozen plasma units and apheresis platelet [PLT] concentrates, and 1:173,000 for red blood cells). No incident could be definitively related to the transfusion of solvent/detergent‐treated pooled plasma (>200,000 units transfused), nor to pooled PLT concentrates. CONCLUSION: The proportion of TRALI cases related to plasma‐rich components was lower than previously described.     

Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network

A collaboration that grew over time between local hemovigilance stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper‐based method of reporting adverse reactions and monthly transfusion activity for regulatory compliance purposes to statewide adoption of electronic reporting via the National Healthcare Safety Network (NHSN). The NHSN is a web‐based surveillance system that offers the capacity to capture transfusion‐related adverse events, incidents, and monthly transfusion statistics from participating facilities. Massachusetts' hospital blood banks share the data they enter into NHSN with the MDPH to satisfy reporting requirements. Users of the NHSN Hemovigilance Module adhere to specified data entry guidelines, resulting in data that are comparable and standardized. Keys to successful statewide adoption of this reporting method include the fostering of strong partnerships with local hemovigilance champions and experts, engagement of regulatory and epidemiology divisions at the state health department, the leveraging of existing relationships with hospital NHSN administrators, and the existence of a regulatory deadline for implementation. Although limitations exist, successful implementation of statewide use of the NHSN Hemovigilance Module for hospital blood bank reporting is possible. The result is standardized, actionable data at both the hospital and state level that can facilitate interfacility comparisons, benchmarking, and opportunities for practice improvement.     

Hemovigilance network in France: organization and analysis of immediate transfusion incident reports from 1994 to 1998

BACKGROUND: Hemovigilance networks have been introduced in several countries to improve knowledge of blood transfusion-related morbidity and mortality. The general organization of the French network and its results from 1994 through March 1999 are presented here. STUDY DESIGN AND METHODS: The hemovigilance network relies on blood transfusion centers and hospital correspondents, who analyze unexpected and untoward blood transfusion-related effects and transmit a Transfusion Incident Report (TIR) to a national database (Transfusion Incident Reports Electronic Data Management [GIFIT]). RESULTS: As of March 1, 1999, the GIFIT database contained 24,234 TIRs related to incidents that occurred from the start of the hemovigilance network until December 31, 1998. The network was not fully implemented until 1996; but the reporting rate seems to have since stabilized at approximately 7000 per year (2.5 reports per 1000 blood components). The highest reporting rate is observed with platelet concentrates (4.02/1000), followed by RBCs (1.71/1000) and FFP (0.34/1000). Bacterial contamination quickly appeared as a major cause of morbidity and mortality (185 cases and 18 fatalities). However, a general trend of reduction in this type of incident was observed over time, which can be attributed to adoption of several preventive measures. In contrast, major ABO mismatchings during RBC transfusion remained at a constant rate throughout this period and accounted for six fatalities. After the implementation of universal WBC reduction, some incidents known to be related to WBCs, such as nonhemolytic febrile transfusion reactions (NHFTR) and HLA immunization, were dramatically reduced. CONCLUSION: Hemovigilance is an important tool not only to analyze blood transfusion incidents, but also to measure the effects of new processes or corrective actions at a national level.     

Analysis of Transfusion-Related Acute Lung Injury and Possible Transfusion-Related Acute Lung Injury Reported to the French Hemovigilance Network From 2007 to 2013

Using the French Hemovigilance Network database from 2007 to 2013, we provide information on demographics, incidence, and risk factors of reported transfusion-related acute lung injury (TRALI) and possible TRALI, analyze TRALI mitigation efforts for fresh frozen plasma and platelet concentrates, and consider the impact of platelet additive solutions on TRALI incidence. We applied the Toronto consensus conference definitions for TRALI and possible TRALI. Two TRALI subgroups were considered: “antibody positive” when a donor has human leukocyte antigen (class I or II) and/or human neutrophil antigen antibodies and the recipient has cognate antigen, and “antibody negative” when immunological investigation is negative or not done. The analysis targeted 378 cases, divided into antibody-positive TRALI (n = 75), antibody-negative TRALI (n = 100), and possible TRALI (n = 203). TRALI patients were younger and received more blood components than the general population of transfused patients. Moreover, we identified the following clinical conditions where patients seemed to be at higher risk to develop TRALI: postpartum hemorrhage, acute myeloid leukemia, liver transplantation, allogeneic and autologous hematopoietic stem cells transplantation, polytrauma, and thrombotic microangiopathy. Policy measures intended to reduce antibody-positive TRALI were found effective for apheresis platelet concentrates and fresh frozen plasma but not for whole blood–derived platelet concentrates. The use of platelet additive solutions was associated with a significant reduction in the incidence of TRALI following transfusion of buffy coat–derived platelet concentrates but not following transfusion of apheresis platelets. Our data reinforce the concept that possible TRALI and TRALI, as defined in the Canadian consensus conference, share many characteristics. No specific policy measures are currently directed at mitigation of possible TRALI despite its impact on transfusion safety. Despite TRALI mitigation measures, the overall incidence of TRALI cases reported to the French Hemovigilance system was not significantly reduced. Therefore, additional research is needed to reduce, if not eradicate, all TRALI categories.     

A Comparison of Transfusion-Related Adverse Reactions Among Apheresis Platelets,Whole Blood-Derived Platelets,and Platelets Subjected to Pathogen Reduction Technology as Reported to the National Healthcare Safety Network Hemovigilance Module

Despite advances in transfusion safety, concerns with safety of platelet transfusions remain including platelet-related sepsis and higher reaction rates observed among patients receiving apheresis platelets (APLTs). National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) data were analyzed to quantify the burden and severity of adverse reactions occurring from APLTs and whole blood-derived platelets (WBD-PLTs). Facilities participating in NHSN HM during 2010-2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for APLTs and WBD-PLTs stratified by severity, use of platelet additive solution (PAS), and pathogen reduction technology (PRT). Chi-square tests were used to compare rates. During the study interval, 2,000,589 platelets were transfused: 1,435,154 APLTs; 525,902 WBD-PLTs; and among APLTs, 39,533 PRT-APLTs. APLT adverse reaction rates were higher (478 vs 70/ 100,000, P< .01) and more often serious (34 vs 6/100,000; P< .01) compared with WBD-PLTs. Adverse reactions were higher among PRT-APLTs (572/100,000) and were less often serious (18/100,000) compared with non-PRT-APLTs (35/100,000) although this association was not statistically significant. Among components implicated in adverse reactions, 92% of APLTs were suspended in plasma. Compared with PRT-APLTs stored in PAS, rates were higher among units stored in plasma (760 vs 525/100,000). Most serious reactions (75%) were allergic. No transfusion-transmitted infections were reported among PRT-APLTs. APLTs were associated with a 6-fold and 2-fold higher serious adverse reaction risks compared with WBD-PLTs and PRT-APLTs, respectively. These findings demonstrate the importance of monitoring transfusion-related adverse reactions to track the safety of platelet transfusions and quantify the impact of mitigation strategies through national hemovigilance systems.