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

Transfusion Medicine Reviews

Volumn 33, Issue 2, 2019, Pages 84-91

  Haass, Kathryn A ^a   Sapiano, Mathew R P ^a   Savinkina, Alexandra ^a,b   Kuehnert, Matthew J ^a   Basavaraju, Sridhar V ^a  

^a NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES   (United States)

^b OAK RIDGE INSTITUTE FOR SCIENCE AND EDUCATION   (United States)

Author keywords

Babesia spp.; Bacterial contamination; Hemovigilance; Transfusion transmitted infections

Indexed keywords

APHERESIS; BABESIA; BACTERIAL LOAD; BACTERIAL TRANSMISSION; BACTERIUM CONTAMINATION; BLOOD SAFETY; BLOOD TRANSFUSION REACTION; CONTROLLED STUDY; GRAFT RECIPIENT; HEALTH CARE FACILITY; HUMAN; INCIDENCE; INFECTION; MAJOR CLINICAL STUDY; MORBIDITY; MORTALITY; NONHUMAN; PATIENT MONITORING; PIROPLASMOSIS; REVIEW; STAPHYLOCOCCUS AUREUS; THROMBOCYTE TRANSFUSION; TRANSFUSION TRANSMITTED INFECTION; ADVERSE EVENT; BLOOD BANK; BLOOD COMPONENT THERAPY; BLOOD TRANSFUSION; STAPHYLOCOCCUS INFECTION; UNITED STATES;

BABESIA; BABESIOSIS; BLOOD BANKS; BLOOD COMPONENT REMOVAL; BLOOD COMPONENT TRANSFUSION; BLOOD SAFETY; BLOOD TRANSFUSION; HUMANS; PLATELET TRANSFUSION; STAPHYLOCOCCAL INFECTIONS; STAPHYLOCOCCUS AUREUS; TRANSFUSION REACTION; UNITED STATES;

EID: 85063506097     PISSN: 08877963     EISSN: 15329496     Source Type: Journal    
DOI: 10.1016/j.tmrv.2019.01.001     Document Type: Review

References (73)

1. Stramer, S.L., Hollinger, F.B., Katz, L.M., Kleinman, S., Metzel, P.S., Gregory, K.R., et al. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion, 49, 2009.
2. Bihl, F., Castelli, D., Marincola, F., Dodd, R.Y., Brander, C., Transfusion-transmitted infections. J Transl Med, 5, 2007, 25.
3. Brecher, M.E., Hay, S.N., Bacterial contamination of blood components. Clin Microbiol Rev 18 (2005), 195–204.
4. Glynn, S.A., Kleinman, S.H., Schreiber, G.B., Busch, M.P., Wright, D.J., Smith, J.W., et al. Trends in incidence and prevalence of major transfusion-transmissible viral infections in US blood donors, 1991 to 1996. Retrovirus Epidemiology Donor Study (REDS). JAMA 284 (2000), 229–235.
5. Stramer, S.L., US NAT yield: where are we after 2 years?. Beitr Infus 12 (2002), 243–253.
6. Dodd, R.Y., Stramer, S.L., Aberle-Grasse, J., Notari, E., Risk of hepatitis and retroviral infections among blood donors and introduction of nucleic acid testing (NAT). Dev Biol 102 (2000), 19–27.
7. Dodd, R.Y., Notari, E.P., Stramer, S.L., Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 42 (2002), 975–979.
8. Zou, S., Dorsey, K.A., Notari, E.P., Foster, G.A., Krysztof, D.E., Musavi, F., et al. Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing. Transfusion 50 (2010), 1495–1504.
9. Sapiano, M.R.P., Savinkina, A.A., Ellingson, K.D., Haass, K.A., Baker, M.L., Henry, R.A., et al. Supplemental findings from the National Blood Collection and Utilization Surveys, 2013 and 2015. Transfusion 57 (2017), 1599–1624.
10. National Blood Authority Haemovigilance Advisory Committee, Australian haemovigilance report, data for 2013-14. 2015.
11. New Zealand Blood Service Haemovigilance Steering Group, New Zealand blood annual report 2016. 2017.
12. Funk MB on behalf of the Paul-Ehrlich-Institut, Haemovigilance report of the Paul-Ehrlich-Institut 2015: assessment of the reports of serious adverse transfusion reactions pursuant to Section 63i AMG (Arzneimittelgesetz, German Medicines Act). 2017.
13. French National Agency for Medicines and Health Products Safety (ANSM), Rapport d'activité hémovigilance 2016. 2018.
14. Foundation T, TRIP report 2016 hemovigilance. 2017.
15. Swissmedic Swiss Agency for Therapeutic Products Safety of Medicines Department Haemovigilance Unit, Haemovigilance Annual report 2016. 2017.
16. DeChristopher, P.J., Risks associated with administration of allogeneic blood components. Anticoagulation and hemostasis in neurosurgery, 2016, Springer, 139–147.
17. Stroup, D.F., Wharton, M., Kafadar, K., Dean, A.G., Evaluation of a method for detecting aberrations in public health surveillance data. Am J Epidemiol 137 (1993), 373–380.
18. Dodd, R.Y., Bacterial contamination and transfusion safety: experience in the United States. Transfus Clin Biol 10 (2003), 6–9.
19. Eder, A., Dy, B., Barton, J., Kennedy, J., Benjamin, R., The American Red Cross Hemovigilance Program: advancing the safety of blood donation and transfusion. Immunohematology 25 (2009), 179–185.
20. Chung, K.W., Harvey, A., Basavaraju, S.V., Kuehnert, M.J., How is national recipient hemovigilance conducted in the United States?. Transfusion 55 (2015), 703–707.
21. Bolton-Maggs, P.H., Transfusion and hemovigilance in pediatrics. Pediatr Clin North Am 60 (2013), 1527–1540.
22. Cumming, M., Osinski, A., O'Hearn, L., Waksmonski, P., Herman, M., Gordon, D., et al. Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network. Transfusion 57 (2017), 478–483.
23. Vallabhaneni, S., Sapiano, M., Weiner, L.M., Lockhart, S.R., Magill, S., Antifungal susceptibility testing practices at acute care hospitals enrolled in the National Healthcare Safety Network, United States, 2011-2015. Open forum infectious diseases, 2017, Oxford University Press US, ofx175.
24. U.S. Centers for Disease Control and Prevention, The National Healthcare Safety Network (NHSN) manual: biovigilance component v2.4. 2017, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA [cited 2017 September 21]; Available from: http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf.
25. Kuehnert, M.J., Roth, V.R., Haley, N.R., Gregory, K.R., Elder, K.V., Schreiber, G.B., et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion 41 (2001), 1493–1499.
26. Traore, A.N., Delage, G., McCombie, N., Robillard, P., Heddle, N.M., Hyson, C., et al. Clinical and laboratory practices in investigation of suspected transfusion-transmitted bacterial infection: a survey of Canadian hospitals. Vox Sang 96 (2009), 157–159.
27. Eder, A.F., Goldman, M., How do I investigate septic transfusion reactions and blood donors with culture-positive platelet donations?. Transfusion 51 (2011), 1662–1668.
28. Edens, C., Haass, K.A, Cumming, M., Osinski, A., O'Hearn L., Passanisi K., Evaluation of the national healthcare safety network hemovigilance module for transfusion-related adverse reactions in the United States. Transfusion, 2018.
29. U.S. Centers for Disease Control and Prevention. Surveillance for babesiosis—United States, 2014 Annual Summary. Altanta, GA. [cited 2018 march 1]; available from: https://www.cdc.gov/parasites/babesiosis/resources/babesiosis_surveillance_summary_2016.pdf, 2016.
30. Prevention USCfDCa, Number and incidence of reported cases of babesiosis, by state and year, 2011-2014. Atlanta, GA. [cited 2018 August 21]; Available from: https://www.cdc.gov/parasites/babesiosis/data-statistics/index.html, 2016.
31. Ramirez-Arcos, S., DiFranco, C., McIntyre, T., Goldman, M., Residual risk of bacterial contamination of platelets: six years of experience with sterility testing. Transfusion 57 (2017), 2174–2181.
32. U.S. Food and Drug Adminstration, Fatalities reported to FDA following blood collection and transfusion: annual summary for fiscal year 2016. 2016.
33. Daurat, A., Roger, C., Gris, J., Daurat, G., Feissel, M., Le Manach, Y., et al. Apheresis platelets are more frequently associated with adverse reactions than pooled platelets both in recipients and in donors: a study from French hemovigilance data. Transfusion 56 (2016), 1295–1303.
34. Bravo, M., Shaz, B.H., Kamel, H., Vanderpool, S., Tomasulo, P., Custer, B., et al. Detection of bacterial contamination in apheresis platelets: is apheresis technology a factor?. Transfusion 55 (2015), 2113–2122.
35. Burgstaler, E.A., Blood component collection by apheresis. J Clin Apher 21 (2006), 142–151.
36. Eder, A.F., Dy, B.A., DeMerse, B., Wagner, S.J., Stramer, S.L., O'neill, E.M., Herron, R.M., Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions. Transfusion 57:12 (2017), 2969–2976.
37. Yockey, C., Murphy, S., Eggers, L., Garratty, G., Dingle, A., Helms, C., et al. Evaluation of the amicus separator in the collection of apheresis platelets. Transfusion 38 (1998), 848–854.
38. Poles, D., on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group, Bolton-Maggs, P.H.B., (eds.) The 2017 annual SHOT report, 2018.
39. Perez, P., Salmi, L.R., Folléa, G., Schmit, J.L., De Barbeyrac, B., Sudre, P., et al. Determinants of transfusion-associated bacterial contamination: results of the French Bacthem case-control study. Transfusion 41 (2001), 862–872.
40. Ness, P., Braine, H., King, K., Barrasso, C., Kickler, T., Fuller, A., et al. Single-donor platelets reduce the risk of septic platelet transfusion reactions. Transfusion 41 (2001), 857–861.
41. Jacobs, M.R., Good, C.E., Lazarus, H.M., Yomtovian, R.A., Relationship between bacterial load, species virulence, and transfusion reaction with transfusion of bacterially contaminated platelets. Clin Infect Dis 46 (2008), 1214–1220.
42. Jenkins, C., Ramírez-Arcos, S., Goldman, M., Devine, D.V., Bacterial contamination in platelets: incremental improvements drive down but do not eliminate risk. Transfusion 51 (2011), 2555–2565.
43. Palavecino, E.L., Yomtovian, R.A., Jacobs, M.R., Bacterial contamination of platelets. Transfus Apher 42 (2010), 71–82.
44. De Korte, D., Marcelis, J.H., Verhoeven, A.J., Soeterboek, A.M., Diversion of first blood volume results in a reduction of bacterial contamination for whole-blood collections. Vox Sang 83 (2002), 13–16.
45. Jacobs, M.R., Smith, D., Heaton, W.A., Zantek, N.D., Good, C.E., Group PGDS, Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test. Transfusion 51 (2011), 2573–2582.
46. Murphy, W.G., Foley, M., Doherty, C., Tierney, G., Kinsella, A., Salami, A., et al. Screening platelet concentrates for bacterial contamination: low numbers of bacteria and slow growth in contaminated units mandate an alternative approach to product safety. Vox Sang 95 (2008), 13–19.
47. Larsen, C.P., Ezligini, F., Hermansen, N.O., Kjeldsen-Kragh, J., Six years’ experience of using the BacT/ALERT system to screen all platelet concentrates, and additional testing of outdated platelet concentrates to estimate the frequency of false-negative results. Vox Sang 88 (2005), 93–97.
48. Benjamin, R., Dy, B., Perez, J., Eder, A., Wagner, S., Bacterial culture of apheresis platelets: a mathematical model of the residual rate of contamination based on unconfirmed positive results. Vox Sang 106 (2014), 23–30.
49. Osselaer, J.C., Messe, N., Hervig, T., Bueno, J., Castro, E., Espinosa, A., et al. A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment. Transfusion 48 (2008), 1061–1071.
50. Goodrich, R.P., Gilmour, D., Hovenga, N., Keil, S.D., A laboratory comparison of pathogen reduction technology treatment and culture of platelet products for addressing bacterial contamination concerns. Transfusion 49 (2009), 1205–1216.
51. McDonald, C., Allen, J., Brailsford, S., Roy, A., Ball, J., Moule, R., et al. Bacterial screening of platelet components by National Health Service Blood and Transplant, an effective risk reduction measure. Transfusion 57 (2017), 1122–1131.
52. Kamel, H., Townsend, M., Bravo, M., Vassallo, R.R., Improved yield of minimal proportional sample volume platelet bacterial culture. Transfusion 57:10 (2017), 2413–2419.
53. Dumont, L.J., Kleinman, S., Murphy, J.R., Lippincott, R., Schuyler, R., Houghton, J., et al. BLOOD COMPONENTS: screening of single-donor apheresis platelets for bacterial contamination: the PASSPORT study results. Transfusion 50 (2010), 589–599.
54. Tomasulo, P.A., Reducing the risk of septic transfusion reactions from platelets. Transfusion 57 (2017), 1099–1103.
55. Erony, S.M., Marshall, C.E., Gehrie, E.A., Boyd, J.S., Ness, P.M., Tobian, A.A.R., et al. The epidemiology of bacterial culture–positive and septic transfusion reactions at a large tertiary academic center: 2009 to 2016. Transfusion 58 (2018), 1933–1939.
56. Su, L.L., Kamel, H., Custer, B., Vanderpool, S., Harpool, D., Busch, M., et al. Bacterial detection in apheresis platelets: blood systems experience with a two-bottle and one-bottle culture system. Transfusion 48 (2008), 1842–1852.
57. De Korte, D., Curvers, J., De Kort, W.L.A.M., Hoekstra, T., Van Der Poel, C.L., Beckers, E.A.M., et al. Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands. Transfusion 46 (2006), 476–485.
58. Brecher, M.E., Hay, S.N., Investigation of an isolate of Staphylococcus lugdunensis implicated in a platelet fatality: a possible advantage of the use of an anaerobic bottle. Transfusion 47 (2007), 1390–1394.
59. Abela, M.A., Fenning, S., Maguire, K.A., Morris, K.G., Bacterial contamination of platelet components not detected by BacT/ALERT((R)). Beitr Infus 28 (2018), 65–70.
60. Cushing, M., Shaz, B., Transfusion-transmitted babesiosis: achieving successful mitigation while balancing cost and donor loss. Transfusion 52 (2012), 1404–1407.
61. Simon, M.S., Leff, J.A., Pandya, A., Cushing, M., Shaz, B.H., Calfee, D.P., et al. Cost-effectiveness of blood donor screening for Babesia microti in endemic regions of the United States. Transfusion 54 (2014), 889–899.
62. Gubernot, D.M., Lucey, C.T., Lee, K.C., Conley, G.B., Holness, L.G., Wise, R.P., Babesia infection through blood transfusions: reports received by the US Food and Drug Administration, 1997–2007. Clin Infect Dis 48 (2009), 25–30.
63. Herwaldt, B.L., Linden, J.V., Bosserman, E., Young, C., Olkowska, D., Wilson, M., Transfusion-associated babesiosis in the United States: a description of cases. Ann Intern Med 155 (2011), 509–519.
64. Moritz, E.D., Winton, C.S., Tonnetti, L., Townsend, R.L., Berardi, V.P., Hewins, M.E., et al. Screening for Babesia microti in the U.S. blood supply. N Engl J Med 375 (2016), 2236–2245.
65. Levin, A.E., Williamson, P.C., Bloch, E.M., Clifford, J., Cyrus, S., Shaz, B.H., et al. Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. Transfusion 56 (2016), 1866–1874.
66. Young, C., Chawla, A., Berardi, V., Padbury, J., Skowron, G., Krause, P.J., Preventing transfusion-transmitted babesiosis: preliminary experience of the first laboratory-based blood donor screening program. Transfusion 52 (2012), 1523–1529.
67. Leiby, D.A., Transfusion-transmitted Babesia spp.: bull's-eye on Babesia microti. Clin Microbiol Rev 24 (2011), 14–28.
68. U.S. Food and Drug Adminstration, Blood Products Advisory Committee minutes: 112th meeting. 2015 [Silver Spring Maryland].
69. U.S. Food and Drug Adminstration, FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply. 2018.
70. Busch, M.P., Glynn, S.A., Stramer, S.L., Strong, D.M., Caglioti, S., Wright, D.J., et al. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 45 (2005), 254–264.
71. CDC, HIV transmission through transfusion—Missouri and Colorado, 2008. MMWR Morb Mortal Wkly Rep 59 (2010), 1335–1339.
72. Dodd, R.Y., Notari, E.P., Nelson, D., Foster, G.A., Krysztof, D.E., Kaidarova, Z., et al. Development of a multisystem surveillance database for transfusion-transmitted infections among blood donors in the United States. Transfusion 56 (2016), 2781–2789.
73. Hong, H., Xiao, W., Lazarus, H.M., Good, C.E., Maitta, R.W., Jacobs, M.R., Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance. Blood 127 (2016), 496–502.