Although bacteremia and sepsis are infrequently reported complications of red blood cell (RBC) transfusion, receipt of transfused blood contaminated with bacterial pathogens may result in sepsis, disseminated intravascular coagulation, and death. Such pathogens have included Yersinia enterocolitica and Pseudomonas fluorescens. From November 1985 through February 1991, a total of 11 cases of sepsis associated with receipt of transfused Y. enterocolitica-contaminated RBCs were reported in the United States (1-3). This report describes an additional 10 cases of Y. enterocolitica sepsis reported to CDC during March 1991-November 1996 in patients who received transfusions with contaminated RBCs and describes the development of a study to detect bacteria-associated reactions to transfusion of RBCs and other blood components.

Y. enterocolitica sepsis in a patient who had received a transfusion was defined as a reported transfusion reaction (e.g., fever, chills, or respiratory distress) and confirmation of Y. enterocolitica in the donor by titrating serum agglutinins against the recipient's Y. enterocolitica isolate and isolating Y. enterocolitica from the blood bag. Titers greater than or equal to 1:128 were considered indicative of recent Y. enterocolitica infection. Medical records of the 10 case-patients were reviewed to determine the specific outcomes of these transfusions, and donors of the implicated units of blood were interviewed to determine risk factors for Y. enterocolitica bacteremia. When available, Y. enterocolitica strains were obtained to confirm species and serotype. Quantitative bacterial cultures and endotoxin concentrations were measured in samples of remaining blood contained in the implicated RBC bags, and Y. enterocolitica antibody titers were measured in the RBC bags, donors, and recipients (4,5).

Of the 10 case-patients, two received autologous RBCs (6). During the transfusion or within 12 hours following the transfusion, eight of the 10 patients developed fever (two recipients were receiving anesthesia for surgery at time of transfusion); seven, respiratory distress; four, hypotension; and three, disseminated intravascular coagulation. Five died less than or equal to 6 days (range: 2.5 hours-6 days) after transfusion, and death was attributed to Y. enterocolitica sepsis. Y. enterocolitica was isolated from blood samples from seven of eight patients; the recipient whose blood culture was negative was receiving antimicrobials when the specimen was obtained. Serum specimens obtained from five patients were analyzed for endotoxins; levels were elevated in all five serum specimens tested (median: 11,645 ng/mL; range: 3510-17,400 ng/mL).

The 10 donors were interviewed less than or equal to 3 months following donation; of these, three denied having had any symptoms, five denied fever at the time of donation but reported having had diarrhea less than 1 month before or less than 2 weeks after donation, and one reported having had fever with abdominal pain. One autologous donor had been hospitalized for Y. enterocolitica sepsis 1 day after blood donation; blood bank personnel were not notified about this hospitalization, and the autologous unit was subsequently transfused. The other autologous donor also developed symptoms after donation but was fully recovered when the transfusion was administered. Of the nine donors for whom antibody titers had been determined (titers were not measured for the one autologous donor), Y. enterocolitica antibody titers were elevated in seven patients 24-109 days after donation (median: 41 days). Of the two donors with antibody titers less than 1:128, Y. enterocolitica was isolated from the implicated unit in both instances.

Reported by: TJ Halpin, MD, State Epidemiologist, Ohio Dept of Health. W Moore, MD, State Epidemiologist, Tennessee Dept of Health. SH Waterman, MD, State Epidemiologist, California Dept of Health Svcs. JL Hadler, MD, State Epidemiologist, Connecticut Dept of Public Health. KR Wilcox, Jr, MD, State Epidemiologist, Michigan Dept of Community Health/Community Public Health Agency. B Ensign, MD, Lackland Air Force Base, Lackland; DM Simpson, MD, State Epidemiologist, Texas Dept of Health. KE Toomey, MD, State Epidemiologist, Div of Public Health, Georgia Dept of Human Resources. FJ Rentas, MS, The Blood Bank Center, US Army Medical Dept Activity, Fort Hood, Texas. DM Dwyer, MD, State Epidemiologist, Maryland Dept of Health and Mental Hygiene. R Haley, MD, American Red Cross Biomedical Svcs, Arlington, Virginia. Office of Compliance, Center for Biologics Evaluation and Research, Food and Drug Administration. Investigation and Prevention Br, Hospital Infections Program, National Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: From 1986 through 1991, of 182 transfusion-associated fatalities reported to the Food and Drug Administration (FDA), 29 (16%) were caused by bacterial contamination of blood products (7). However, because FDA requires reporting of only fatal transfusion-related complications, the overall incidence of both fatal and nonfatal infectious complications associated with the receipt of blood and blood products in the United States probably is underestimated. The U.S. General Accounting Office estimated the rate of bacteria-associated adverse reactions from random donor platelet pools was 0.6 per 1000 pooled units and from Yersinia-associated RBC transfusion reactions was one per 500,000 units of RBCs (8). The incidence also may be underestimated because of failure to suspect bacterial contamination as a possible mechanism for adverse reactions to transfusion. If blood products are not cultured promptly following an adverse transfusion reaction, the role of bacterial contamination cannot be definitely established. In one referral hospital, a cluster of cases of reaction to bacterial contamination of platelets prompted education of clinicians about adverse transfusion reactions and initiation of active surveillance for bacterial contamination of platelets; the number of monthly reported platelet transfusion reactions and the rate of bacterial contamination of platelets subsequently increased 31- and 23-fold, respectively (9).

Potential mechanisms for the bacterial contamination of RBCs and of other blood components include donation by persons with asymptomatic Y. enterocolitica bacteremia on the day of donation, contamination with skin flora at the time of donation, or contamination during the processing of the unit. The findings in this report indicate that Y. enterocolitica antibodies or bacteria were identified in donors or isolated from the implicated blood bags, indicating that blood from each donor was infected.

Because rates of bacteria-associated transfusion reactions in the United States are unknown, during late summer 1997, CDC, in collaboration with national blood-collection organizations, will initiate a prospective study to determine the rates of bacteria-associated transfusion reactions from whole blood, RBCs, and platelets (10). The study will be used to establish standardized definitions of adverse transfusion reactions in recipients of contaminated blood or blood components, develop an educational program to increase awareness among clinicians about bacterial contamination as a mechanism for these reactions, determine microbiologic safety of the U.S. blood supply, and attempt to identify methods to improve donor screening to reduce or eliminate bacterially contaminated blood products. Additional information about bacterial contamination of blood products and the collaborative study can be obtained from CDC's Hospital Infections Program, National Center for Infectious Diseases, telephone (404) 639-6413, fax (404) 639-6459.

At the time of donation, blood donors are asked whether they feel well that day or have a cold, the flu, a sore throat, or trouble breathing. Although donors may be asymptomatic or may not become ill until after donating, their blood can transmit bacteria. When transfusion-associated bacteremia or endotoxemia is suspected, the residual blood product unit should be saved and the recipient's blood and serum specimens collected. In addition, the associated transfusion service should be immediately informed of the reaction. Fatalities must be reported to the Office of Compliance, Center for Biologics Evaluation and Research, FDA, telephone (301) 594-1191.

References

1. Collins PS, Youkey JR, Collins GJ Jr, et al. Fatal sepsis from blood contaminated with Yersinia enterocolitica: a case report. Mil Med 1985;150:689-92.

2. CDC. Yersinia enterocolitica bacteremia and endotoxin shock associated with red blood cell transfusion -- United States, 1987-1988. MMWR 1988;37:577-8.

3. CDC. Yersinia enterocolitica bacteremia and endotoxin shock associated with red blood cell transfusion -- United States, 1991. MMWR 1991;40: 176-8.

4. Hawkins TH, Brenner DJ. Isolation and identification of Yersinia enterocolitica. Atlanta, Georgia: US Department of Health, Education, and Welfare, Public Health Service, CDC, 1978.

5. Novitsky TJ, Roslansky PF, Siber GR, Warren HS. Turbidimetric method for quantifying serum inhibition of Limulus amoebocyte lysate. J Clin Microbiol 1985;21:211-6.

6. Richards C, Kolins J, Trindade CD. Autologous transfusion-transmitted Yersinia enterocolitica {Letter}. JAMA 1992;268:1541-2.

7. Hoppe PA. Interim measures for detection of bacterially contaminated red cell components {Editorial}. Transfusion 1992;32:199-201.

8. US General Accounting Office. Blood supply: transfusion-associated risks -- report to the ranking minority member, Committee on Commerce, House of Representatives. Washington, DC: US General Accounting Office, 1997; document no. GAO/PEMD-97-2.

9. Zaza S, Tokars JI, Yomtovian R, et al. Bacterial contamination of platelets at a university hospital: increased identification due to intensified surveillance. Infect Control Hosp Epidemiol 1994;15:82-7.

10. CDC. Year-long estimation of the frequency of bacterial contamination of blood products in the United States. Federal Register 1997;62: 22952-5.

    
    

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