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.

Analysis of transfusion reactions associated with prestorage-pooled platelet components.

BACKGROUND: The goal of this study was to assess transfusion reactions arising from prestorage-pooled platelet (PSPP) infusions compared with apheresis single-donor platelets (SDPs) and poststorage-pooled, whole blood-derived random-donor platelets (RDPs). STUDY DESIGN AND METHODS: Over a span of 18 months, transfusion reaction records of patients receiving platelet (PLT) infusions were retrospectively reviewed at two academic, tertiary care hospitals. Chi-square analysis was used for statistical comparisons; significance was a p value of less than 0.05. RESULTS: For the two sites, 10,251 prestorage-leukoreduced PLT products were infused including 4731 PSPPs, 3999 SDPs, and 1521 RDPs. Of the total infusions, 0.91% (93/10,251) were associated with a transfusion reaction. The aggregate transfusion reaction rate was 0.89% (42/4731) for PSPPs, 0.75% (30/3999) for SDPs, and 1.38% (21/1521) for RDPs. There were no significant differences in total reaction rate between PSPPs and the other PLT products (p > 0.05). Allergic transfusion reactions were the most common adverse event for PLT products evaluated (63/10,251; 0.61%) and febrile reactions were second most common (27/10,251; 0.26%). There were 2 suspected cases of sepsis (1 associated with PSPP and 1 associated with RDP; both culture negative) and 1 case of volume overload associated with RDP infusion. There were no significant differences in aggregate allergic or febrile reaction rates among the 93 PLT products evaluated (p > 0.05). No reports of transfusion-related acute lung injury or hemolysis were noted. CONCLUSIONS: No difference in reactions rates was observed among PSPPs and the other PLT products. The transfusion reactions occurring in this population were not dependent on the type of PLT product infused.

Transfusion-transmitted Babesia microti identified through hemovigilance.

BACKGROUND: Babesia microti, the primary cause of human babesiosis in the United States, is an intraerythrocytic parasite endemic to the Northeast and upper Midwest. Published studies indicate that B. microti increasingly poses a blood safety risk. The American Red Cross Hemovigilance Program herein describes the donor and recipient characteristics of suspected transfusion-transmitted B. microti cases reported between 2005 and 2007. STUDY DESIGN AND METHODS: Suspected transfusion-transmitted Babesia infections were reported by transfusion services or were discovered through recipient-tracing investigations of prior donations from donors with a positive test for B. microti in a serologic study. Follow-up samples from involved donors were tested by Babesia-specific immunofluorescence assay, Western blot, and/or real-time polymerase chain reaction analysis. RESULTS: Eighteen definite or probable B. microti infections, including five fatalities, were identified in transfusion recipients, 16 from hospital-reported cases and two through serologic lookback studies. Thirteen recipients were 61 to 84 years old and two were 2 years old or younger. Two recipients had sickle cell disease and four were known to be asplenic, including one with sickle cell disease. Seventeen antibody-positive donors were implicated; 11 (65%) were residents in Babesia-endemic areas, while four (24%) nonresident donors had a history of travel to endemic areas. CONCLUSIONS: Transfusion-transmitted B. microti can be a significant cause of transfusion-related morbidity and mortality, especially in infant, elderly, and asplenic blood recipients. These data demonstrate the need for interventions, in both endemic and nonendemic areas of the United States, to reduce patient risk.

Bacterial contamination of whole-blood-derived platelets: the introduction of sample diversion and prestorage pooling with culture testing in the American Red Cross.

BACKGROUND: Bacterial sepsis following whole blood-derived platelet (WBP) transfusion has remained a substantial patient risk, primarily due to a lack of practical and effective means to limit or detect bacterial contamination. We describe the risk of reported septic reactions to WBPs and the introduction of prestorage-pooled whole blood-derived platelets (PSPs) collected using initial sample diversion and cultured for bacterial contamination. STUDY DESIGN AND METHODS: Product qualification and quality control (QC) testing with the Acrodose PL system (Pall Medical) were evaluated in four regional blood centers. Bacterial contamination risk was assessed by review of reported septic transfusion reactions to WBPs and by aerobic QC culture of leukoreduced PSPs utilizing automated microbial detection system cultures (BacT/ALERT 3D, bioMérieux). RESULTS: Before implementing PSPs (January 2003-December 2006), we distributed 2,535,043 WBP units and received 20 reports of septic reactions including 2 fatalities (7.9 per million [1:126,752] reactions and 0.79 per million [1:1,267,522] fatalities). In October 2006, PSPs were effectively implemented with a product qualification success rate of 99.6 percent and a mean yield of 4.0 x 10(11) platelets (PLTs) per pool. Whole blood collection sets with sample diversion technology were introduced during the operational trial and decreased the rate of confirmed-positive bacterial culture of PSPs from 2111 (1:474) to 965 (1:1036) per million (odds ratio, 0.46; 95% confidence interval, 0.22-0.95). No septic reactions to PSPs were reported (25,936 PSP units distributed). CONCLUSION: Sample diversion and bacterial culture are effective methods to reduce bacterial risk with WBP transfusion. Bacterial contamination of PSPs was assessed at 5.8-fold our current rate for apheresis PLTs utilizing comparable culture protocols.