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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.

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.

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.

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, bioMerieux). 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 × 1011 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.

Fibrin glue is a biological tissue adhesive that has also been found to be an effective sealant and topical hemostatic agent. ‘J It is a two-component system in which a solution of concentrated fibrinogen and factor XIII are combined with a solution of thrombin and calcium to form a coagulum. The system essentially simulates the final stage of the clotting cascade, producing a fibrin clot within seconds after the administration of the thrombin-activating solution. In some clinical situations antifibrinolytic agents are also included to prevent lysis of the clot. Fibrin glue prepared commercially from pooled human plasma has been used extensively in Europe. Its use has been reported in a variety of procedures encompassing many surgical subspecialties including; microsurgery, neurosurgery, cardiothoracic surgery, plastic surgery, trauma surgery, oral surgery, orthopedic surgery, general surgery, urology and otolaryngology.1~2 More recently, it has been used in ophthalmology, as well as in obstetrics/gynecology, i.e. in vitro fertilization.3’4 The use of fibrin glue in the United States has developed more slowly than in the European countries, since the commercial kits for its preparation are not approved for use in humans, primarily due to the risk of transmitting viral diseases from a pooled source of fibrinogen. Over the past 10 years, there have been several alternative methods reported for obtaining fibrinogen from either autologous or single-donor homologous sources. These developments have sparked a resurgence of interest in the investigation and use of fibrin glue in the surgical community.’ As the potential applications for the use of fibrin glue expand (i.e. fibrin glue combined with antibiotics for antibacterial effect8) it is likely that the requests to blood banks and transfusion services to provide a consistent and highly concentrated source of fibrinogen and factor XIII will also increase.

RAFT-VERSUS-HOST DISEASE (GVHD) is comG monly observed after allogeneic bone marrow transplantation (BMT), but transfusion-associated (TA) GVHD is only rarely reported. Although early reports of TAGVHD were recognized in immunocompromised hosts, more recent cases have been documented in immunocompetent transfusion recipients. The increasing awareness of this serious complication of transfusion prompted a national survey of transfusion medicine practices to identify patients at risk for TA-GVHD and assess methods for its prevention. HISTORICAL PERSPECTIVE The reported cases of TA-GVHD have recently been summarized.' To date, it has been documented after transfusion of unirradiated blood components to at least 87 patients: in patients with severe combined immunodeficiency, thymic hypoplasia, and Wiskott Aldrich syndrome2.'*; premature newborns and those with erythroblastosis fetali~'~-*~; patients with hematologic malignancies including Hodgkin's and non-Hodgkin's lymphomas, acute myelocytic and lymphoblastic leukemias, chronic lymphocytic leukemia, and aplastic patients with solid tumors including neuroblastomas, glioblastoma, rhabdomyosarcoma, cervical carcinoma, small cell lung cancer, and germ cell tum08'-'~; patients after cardiac surgery and cholecystectomp-60; and in an apparently healthy 22-year-old woman.6' This syndrome has developed after neonatal exchange and intrauterine transfusions; and after transfusion of whole blood, fresh (nonfrozen) plasma, red blood cells, and platelets. Leukocytes harvested from normal donors and from donors with chronic myelocytic leukemia transfused to patients with hematologic malignancies have also been implicated in TA-GVHD. TA-GVHD results in an overall mortality of 84% at a median of 21 (8 to 1,050) days after transfusion.'

BACKGROUND: The potential use of solvent/detergent-treated plasma (S/D plasma) in transfusion practice raises concerns about the cytolytic effects that any residual solvent and detergent in the virally inactivated blood component might have on units of red cells in vitro, if the two components are mixed during preparation. STUDY DESIGN AND METHODS: S/D plasma was mixed with variously processed units of stored red cells, in vitro, to evaluate the effect the residual solvent and detergent would have on cell membrane integrity. A paired protocol design was used in which half-units of red cells were exposed to S/D plasma (test), and the matched half-units were exposed to either the supernatant additive solution from the original red cell unit or standard fresh-frozen plasma (FFP) (control). After incubation for up to 5 days, the units were evaluated for evidence of hemolysis or changes in other red cell storage assays. RESULTS: This study showed that, for fresh additive solution red cells (AS-1), the 5-day storage plasma hemoglobin levels were comparable in the red cells exposed to S/D plasma (21 mg/dL) and in the paired half-units stored in the original AS-1 supernatant (31 mg/dL) (p > 0.05). Similar findings were recorded for stored AS-1 red cells (S/D plasma; 111 mg/dL vs. AS-1 supernatant, 147 mg/dL; p > 0.05); stored CPDA-1 red cells (S/D plasma, 133 mg/dL vs. FFP, 103 mg/dL; p > 0.05); frozen red cells (S/D plasma, 28 mg/dL vs. FFP, 18 mg/dL; p > 0.017); and stored irradiated AS-1 red cells (S/D plasma, 608 mg/dL vs. AS-1 supernatant, 726 mg/dL; p > 0.05). Comparable results were found for other assays, including levels of plasma potassium, osmotic fragility, and red cell antigen titer. CONCLUSION: These data show that S/D plasma does not induce red cell lysis even after 5 days of in vitro storage. These results are consistent with previous findings by this laboratory that platelets are not harmed by storage in S/D plasma. Red cells resuspended in S/D plasma and stored for up to 5 days maintain in vitro storage characteristics that are acceptable for the use of the cells in clinical transfusion practice.

To define the groups of patients at risk for transfusion-transmitted cytomegalovirus infection and to define the methods to reduce this risk.English-language publications on transfusion medicine.Studies were selected that described cytomegalovirus infection in transfusion-dependent patients. Special attention was paid to reports that included observations about the prevalence and clinical manifestations of cytomegalovirus infection and recommendations for the prevention of infection.Some patients with impaired immune responses who have never been exposed to cytomegalovirus are at risk for transfusion-transmitted cytomegalovirus infection. This infection, which is associated with substantial morbidity and mortality, can be avoided by additional screening of blood donors or by special processing of components for transfusion.Transfusion products that are unlikely to transmit cytomegalovirus infection can be prepared by filtration to remove leukocytes or can be obtained by selecting donors who are seronegative for antibodies to cytomegalovirus. These products are indicated for certain groups of immunosuppressed patients, including pregnant women who are cytomegalovirus seronegative, premature infants of low birth weight who are born to cytomegalovirus-seronegative mothers, cytomegalovirus-seronegative recipients of allogeneic bone marrow transplants from cytomegalovirus-seronegative donors, and cytomegalovirus-seronegative patients with the acquired immunodeficiency syndrome (AIDS).

Assessment of venous hemoglobin (Hb), serum ferritin, and zinc protoporphyrin (ZPP) levels was carried out in women identified by CuSO4 screening as ineligible to donate blood. The correlation of log ferritin with ZPP was relatively poor (r = -0.580) but significant (p greater than 0.01). However, a ZPP level of 2.0 micrograms per g Hb or greater (upper limit of normal for first-time female donors) showed a predictive value of 0.85 for a ferritin level of 12 ng per ml or less in these donors. The correlation of hemoglobin concentration with ZPP level was significant (r = -0.667; p less than 0.001) in blood donors with ferritin levels at or below 12 ng per ml. ZPP level appears to be increased in iron-depleted (hypoferritinemic) blood donor in whom animals had developed or was developing (Hb less than 12.5 g/dl). Although direct measurements of venous hemoglobin and ferritin levels most accurately evaluate such blood donors, these tests are time-consuming and expensive and are currently not adaptable to bloodmobile operations. Copper sulfate screening has proved feasible in the bloodmobile setting, and the measurement of ZPP level has been used for mobile screening for lead poisoning. ZPP may be an inexpensive and useful screening test to determine a subset of donors who should receive supplemental iron or reduce their frequency of blood donation.