Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004-2006)
Anne F. Eder
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorJean M. Kennedy
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorBeth A. Dy
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorEdward P. Notari
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorJohn W. Weiss
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorChyang T. Fang
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorStephen Wagner
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorRoger Y. Dodd
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorRichard J. Benjamin
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorAmerican Red Cross Regional Blood Centers
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorAnne F. Eder
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorJean M. Kennedy
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorBeth A. Dy
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorEdward P. Notari
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorJohn W. Weiss
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorChyang T. Fang
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorStephen Wagner
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorRoger Y. Dodd
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorRichard J. Benjamin
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorAmerican Red Cross Regional Blood Centers
From Biomedical Services, Medical Office, National Headquarters, American Red Cross, Washington, DC; the Jerome H. Holland Laboratory, Rockville, Maryland; and the Badger Hawkeye Region, American Red Cross, Madison, Wisconsin.
Search for more papers by this authorAbstract
BACKGROUND: The American Red Cross initiated systemwide bacterial testing of all apheresis platelet (PLT) collections in March 2004, yet continues to receive reports of septic reactions after transfusion of screened components.
STUDY DESIGN AND METHODS: The rates of confirmed bacterial contamination of apheresis PLT collections detected by prospective quality control (QC) testing, and by surveillance of reported septic reactions to screened-negative apheresis PLTs, were analyzed according to the technology utilized for collection.
RESULTS: Between March 1, 2004, and May 31, 2006, bacterial culture testing was performed on 1,004,206 donations; of these, 186 (1:5,399) had confirmed-positive culture results. Transfusion of all but 1 of the associated 293 components was prevented. A significantly higher rate of confirmed-positive bacterial cultures was seen with products collected utilizing two-arm collection procedures compared to one-arm procedures (22.7 vs. 11.9 per 105 donations; odds ratio [OR], 1.9; 95% confidence interval [CI], 1.4-2.7). During this period, 20 septic transfusion reactions were reported, including 3 fatalities (1:498,711 fatalities per distributed component), which implicated screened-negative apheresis PLT products. The frequency of septic reactions was 4.7-fold higher for collections utilizing two-arm procedures (1:41,173; 95% CI, 1:25,000-1:66,667) compared to collections from one-arm procedures (1:193,305; 95% CI, 1:52,632-1:500,000; OR, 4.7; 95% CI, 1.2-18.4); most septic reactions (16 of 20) were due to Staphylococcus spp. and occurred on Day 5 (13 of 20) after collection.
CONCLUSION: PLT contamination with bacteria that evade detection by QC culture remains a significant residual transfusion risk, in particular for older PLTs and skin-commensal bacteria in components collected by two-arm apheresis procedures during the study period.
REFERENCES
- 1 Wagner SJ. Transfusion-transmitted bacterial infection: risks, sources and interventions. Vox Sang 2004; 86: 157-63.
- 2
Blajchman MA,
Beckers EA,
Dickmeiss E, et al.
Bacterial detection of platelets: current problems and possible resolutions.
Transfus Med Rev
2005; 19: 1-14.
10.1016/j.tmrv.2004.09.008 Google Scholar
- 3 Hillyer CD, Josephson CD, Blajchman MA, et al. Bacterial contamination of blood components: risks, strategies, and regulation: joint ASH and AABB educational session in transfusion medicine. Hematology Am Soc Hematol Educ Program 2003: 575-89.
- 4 Hogman CF, Fritz H, Sandberg L. Posttransfusion Serratia marcescens septicemia. Transfusion 1993; 33: 189-91.
- 5 Braine HG, Kickler TS, Charache P, et al. Bacterial sepsis secondary to platelet transfusion: an adverse effect of extended storage at room temperature. Transfusion 1986; 26: 391-3.
- 6 Blajchman MA, Goldman M, Baeza F. Improving the bacteriological safety of platelet transfusions. Transfus Med Rev 2004; 18: 11-24.
- 7 Ness P, Braine H, King K, et al. Single-donor platelets reduce the risk of septic platelet transfusion reactions. Transfusion 2001; 41: 857-61.
- 8 Kuehnert MJ, Roth VR, Haley NR, et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion 2001; 41: 1493-9.
- 9 Perez P, Salmi LR, Follea G, et al. Determinants of transfusion-associated bacterial contamination: results of the French BACTHEM Case-Control Study. Transfusion 2001; 41: 862-72.
- 10 Yomtovian RA, Palavecino EL, Dysktra AH, et al. Evolution of surveillance methods for detection of bacterial contamination of platelets in a university hospital, 1991 through 2004. Transfusion 2006; 46: 719-30.
- 11 Standards for blood banks and transfusion services. 24th ed., AABB Standard 5.4.21. Bethesda: American Association of Blood Banks; 2006.
- 12 Fang CT, Chambers LA, Kennedy J, et al. Detection of bacterial contamination in apheresis products: American Red Cross experience, 2004. Transfusion 2005; 45: 1845-52.
- 13 Benjamin RJ, Mintz PD. Bacterial detection and extended platelet storage: the next step forward. Transfusion 2005; 45: 1832-5.
- 14 Options for arm preparation [monograph on the Internet]. Rockville (MD): U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration; 2004 accessed 2006 Dec 1. Available from: http://www.fda.gov/cber/blood/armpreprev.htm
- 15 McDonald CP, Lowe P, Roy A, et al. Evaluation of donor arm disinfection techniques. Vox Sang 2001; 80: 135-41.
- 16 Kleinman SH, Kamel HT, Harpool DR, et al. Two-year experience with aerobic culturing of apheresis and whole blood-derived platelets. Transfusion 2006; 46: 1787-94.
- 17 Silva MA, Gregory KR, Carr-Greer MA, et al. Summary of the AABB Interorganizational Task Force on Bacterial Contamination of Platelets: Fall 2004 impact survey. Transfusion 2006; 46: 636-41.
- 18 Preacher KJ. Calculation for the Chi-squared test: an interactive calculation tool for chi-squared tests of goodness of fit and independence [computer software]. Lawrence (KS): The University of Kansas Department of Psychology;c2005 accessed 2006 Dec 1. Available from: http://www.quantpsy.org
- 19 Pezzullo JC. 2-way contingency table analysis [computer software]. c2006 accessed 2006 Dec 1. Available from: http://www.statpages.org/ctab2x2.html
- 20 Bekeris LG, Tworek JA, Walsh MK, Valenstein PN. Trends in blood culture contamination. a College of American Pathologists Q-Tracks study of 356 institutions. Arch Pathol Lab Med 2005; 129: 1222-5.
- 21 Haimowitz MD, Hernandez LA, Herron RM Jr. A blood donor with bacteraemia. Lancet 2005; 365: 1596.
- 22 Whitaker BI, Sullivan M. The 2005 Nationwide Blood Collection and Utilization Survey Report [monograph on the Internet]. Rockville (MD): US Department of Health and Human Services; 2006 accessed 2006 Dec 1. Available from: http://www.aabb.org/apps/docs/05nbcusrpt.pdf
- 23 Centers for Disease Control and Prevention (CDC). Fatal bacterial infections associated with platelet transfusions—United States, 2004. MMWR Morb Mortal Wkly Rep 2005; 54: 168-70.
- 24 McDonald CP, Roy A, Mahajan P, et al. Relative values of the interventions of diversion and improved donor-arm disinfection to reduce the bacterial risk from blood transfusion. Vox Sang 2004; 86: 178-82.
- 25 Wagner SJ, Robinette D, Friedman LI, Miripol J. Diversion of initial blood flow to prevent whole-blood contamination by skin surface bacteria: an in vitro model. Transfusion 2000; 40: 335-8.
- 26 De Korte D, Marcelis JH, Verhoeven AJ, Soeterboek AM. Diversion of first blood volume results in a reduction of bacterial contamination for whole-blood collections. Vox Sang 2002; 83: 13-6.
- 27 De Korte D, Curvers J, De Kort WL, et al. Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands. Transfusion 2006; 46: 476-85.
- 28 Bruneau C, Perez P, Chassaigne M, et al. Efficacy of a new collection procedure for preventing bacterial contamination of whole-blood donations. Transfusion 2001; 41: 74-81.
- 29 Robillard P, Nawej KI, Delage G. Platelet bacterial contamination and effectiveness of diverting the first 40ml at whole blood donation [abstract]. Transfusion 2005; 45: 25A.
- 30 Wagner SJ, Eder AF. A model to predict improvement of automated blood culture bacterial detection by doubling platelet sample volume. Transfusion 2007; 47: 430-3.
- 31 Goldman M, Roy G, Frechette N, et al. Evaluation of donor skin disinfection methods. Transfusion 1997; 37: 309-12.
- 32 McCullough J, Vesole DH, Benjamin RJ, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood 2004; 104: 1534-41.
- 33 Brecher ME, Hay SN, Rothenberg SJ. Evaluation of a new generation of plastic culture bottles with an automated microbial detection system for nine common contaminating organisms found in PLT components. Transfusion 2004; 44: 359-63.
- 34 Brecher ME, Heath DG, Hay SN, et al. Evaluation of a new generation of culture bottle using an automated bacterial culture system for detecting nine common contaminating organisms found in platelet components. Transfusion 2002; 42: 774-9.
- 35 McDonald CP, Hartley S, Orchard K, et al. Fatal Clostridium perfringens sepsis from a pooled platelet transfusion. Transfus Med 1998; 8: 19-22.
- 36 Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev 2005; 18: 195-204.
- 37 Jacobson JL, O'Brien T, McQuail E, Strauss D. A blood center's twenty nine month experience with bacterial detection using the bioMerieux BacT/ALERT system [abstract]. Transfusion 2006; 46(Suppl): 3A.
- 38 Aubuchon JP. The reliability of bacterial detection in platelets. ISBT Sci Series 2006; 1: 59-63.
- 39 Blajchman MA, Sarwal S, Loeb M. A second example of a transfusion-associated septic reaction associated with Clostridium perfringens. Transfusion 2001; 41: 427-8.
- 40 Vostal J. Update on FDA review of bacterial detection devices for a platelet release test indication and extension of platelet dating [monograph on the Internet]. Washington (DC): U.S. Department of Health & Human Services; 2005 accessed 2006 Dec 1. Available from: http://www.hhs.gov/bloodsafety/presentations/Vostal.pdf
- 41 Brecher ME, Hay SN, Rose AD, Rothenberg SJ. Evaluation of BacT/ALERT plastic culture bottles for use in testing pooled whole blood–derived leukoreduced platelet-rich plasma platelets with a single contaminated unit. Transfusion 2005; 45: 1512-7.
- 42 Te Boekhorst PA, Beckers EA, Vos MC, et al. Clinical significance of bacteriologic screening in platelet concentrates. Transfusion 2005; 45: 514-9.
- 43 Munksgaard L, Albjerg L, Lillevang ST, et al. Detection of bacterial contamination of platelet components: six years' experience with the BacT/ALERT system. Transfusion 2004; 44: 1166-73.
- 44 Lee CK, Ho PL, Lee KY, et al. Estimation of bacterial risk in extending the shelf life of PLT concentrates from 5 to 7 days. Transfusion 2003; 43: 1047-52.
- 45 Schmidt MS, Karakassopoulos A, Burkhart J, et al. Comparison of three bacterial detection methods under routine conditions. Vox Sang 2007; 92: 15-21.
- 46 Stevens WT, Bolan CD, Oblitas JM, et al. Streptococcus agalactiae sepsis after transfusion of a plateletpheresis concentrate: benefit of donor evaluation. Transfusion 2006; 46: 649-51.
- 47 Rhame FS, Root RK, MacLowry JD, et al. Salmonella septicemia from platelet transfusions: study of an outbreak traced to a hematogenous carrier of Salmonella cholerae-suis. Ann Intern Med 1973; 78: 633-41.
Citing Literature
