ࡱ>  [bjbj΀  RDD4hKGK7 (333K6666666$-9;J6}@63K27 3K6 6 1[T33 ː@22670K72<<(3<3 66 K7<D M: Foodborne Illness Outbreak Investigation Case Study: Escherichia coli O157:H7 Teacher Version Seven physicians from bordering counties in the states of Washington and Oregon report to their respective State Departments of Health a total of 20 individuals with severe gastroenteritis and stool samples positive for E. coli O157:H7. The Departments of Health from both states notify the United States Centers for Disease Control and Prevention (CDC). The CDC launches an investigation into the cluster of illnesses. As an epidemiologist with the CDC, it is your job to determine how widespread the outbreak has become, the source of infection, and means to halt the outbreak. This involves interviewing food borne illness victims, determining common exposures, determining what potential vehicles (food, individuals, environmental samples, other) should be tested, interpreting laboratory results, helping to determine necessary actions to stop the outbreak, and helping to determine actions necessary to prevent future outbreaks. You interview the patients to determine a possible common source of infection. From these interviews, you are able to identify one commonality: all patients had visited Rainy County Farm during elementary school field trips within 1 to 5 days prior to the onset of symptoms. Were their illnesses the result of consumption of one type of contaminated food or beverage, several different contaminated foods or beverages, environmental exposure, and/or exposure to an infected individual? Or is the farm a purely coincidental commonality and not the point of infection? Eleven patients are showing signs of recovery; however, 8 individuals are in reportedly in poor medical condition and another has since died due to kidney failure. Additional cases of severe gastroenteritis have been reported in the region. More people may become sick if you cannot identify the source quickly and recommend actions necessary to stop the outbreak. The public is counting on you to solve this case. Aside from talking with farm patrons who contracted E. coli O157:H7 infection, who else should you interview to help determine what could have been the source of the illness versus what did not cause illness? Answer: Farm employees and patrons from the same time period who did not contract E. coli O157:H7 infection to serve as negative case controls. You have been provided with names of interviewees. Based on the information you already have (Table 1), prepare a list of interview questions to gather more of the same type of information from the new interviewees. Answer: Describe health condition and symptoms, if any. When did symptoms begin? Have you recently been exposed to someone diagnosed with or exhibiting symptoms of gastroenteritis? Food/beverage intake history in past 5 days? With whom did you share meals in the past 5 days? Anyone report illness to your knowledge? Prior health conditions? Did you visit Rainy County Farms? Have you traveled in the past 5 days? Using the sets of questions you developed, conduct interviews with the latest cases. Compile interview responses in Table 1. Answer: Interview actors selected by teacher. Scripted answers are provided in Appendix A and compiled in Table 1. Graphs are helpful to quickly visualize patterns in large data sets. Using data from Table 1, prepare the following: A bar graph of the number of patients who developed symptoms for the dates of symptom onset. On the same graph as plotted for part a, plot the number of patients who developed symptoms for the dates they visited the farm. Table 2 completed with data on the foods consumed by all individuals and whether the foods were positively or negatively associated with illness. Answer: See bar graph presented in Figure 2 and Table 2 completed. A review of farm employee health and absentee records and interviews with select individuals were conducted. Could the ill farm employee listed in Table 1 have been the original source of contamination in this outbreak? Why or why not? Answer: No, at least not this employee, because the onset of illness for affected employees was after the onset date of the first case considering the full presumed incubation period and potential for overlap. One of the individuals whose stool sample tested positive for E. coli O157:H7 is a food handler in a restaurant. What additional measures should be taken to protect the public? Answer: All individuals with symptoms of E. coli O157:H7 infection should be advised of measures they should take to prevent spreading the disease. These individuals should wash hands after using the restroom and should not prepare foods for others. News of the outbreak and the association to the farm has hit news sources including newspapers, radio, television, and the internet. As a result, numerous individuals other than those sought during the interviews have contacted their doctors, public health professionals, and/or attorneys with concerns they may also be victims in this foodborne illness outbreak. Review the symptoms and circumstances of the cases presented in Table 3, and determine which individuals may be additional victims of foodborne illness due to this particular outbreak versus which individuals are not likely to be cases associated with this outbreak. Provide an explanation for your assessment on each individual. Answer: Individual 1: Time period not consistent with this particular outbreak. Symptoms and incubation period not typical. Individual 2: Possibly victim of this outbreak. Should be tested and interviewed. Individual 3: Could be extremely mild case. Individual could be interviewed. Individual 4: Symptoms, time period, and exposure consistent with possible secondary case of outbreak (possibly contracted from close contact with sick family member). Individual 5: Symptoms consistent with E. coli O157:H7 infection and timing consistent with other cases. Route of exposure not clear. Individual should be tested and interviewed further. Other illnesses with similar symptoms should not be overlooked. From the data compiled in Table 2, calculate the odds ratio to determine what foods/events are positively associated with illness? Answer: Data in table 2 What do you want to have tested for E. coli O157:H7 contamination? Answer: Foods positively associated with illness (unpasteurized apple juice), if still available and preferably from unopened containers. Give a reason why would you not necessarily want to have all foods tested. Answer: Testing is time consuming and costly. Time spent testing foods not reasonably associated with illness could slow the determination of the true source of illness and subsequently delay actions needed to remove contaminated source and prevent additional cases. In any outbreak, when there are multiple foods associated with illness, what could be the reasons for several foods being implicated? Answer: Common ingredient in each of the menu items, common production settings for different companies products, cross contamination between foods, infected food handler contaminating multiple foods, secondary case of illness from close contact with infected individual rather than ingestion of contaminated food at original source. Laboratory data for various foods consumed at Rainy County Farm and stool samples from affected individuals are presented in Figure 1. Do the laboratory results support your hypothesis on which food(s) were associated with illness? Explain your response. Answer: Depends on previous answers. The unpasteurized apple cider (lane 3) gives the same banding pattern as the patient stool specimen (lane 2). The United States Department of Agriculture (USDA) Economic Research Service (ERS) has an interactive website to calculate the cost of foodborne illness outbreaks attributed to shiga-toxin producing E. coli O157:H7. Enter the calculator at  HYPERLINK "http://www.ers.usda.gov/Data/FoodborneIllness/" http://www.ers.usda.gov/Data/FoodborneIllness/. In the cost component feature (left column of the table), click on . Enter the number of known cases from this case according to how they meet the descriptions of severity of illness. What is the estimated total cost associated with this outbreak using the ERS assumptions? Answer: $7,412,100 If it is concluded that a product grown and processed (elsewhere, by two different organizations) but distributed at the farm is the vehicle for E. coli O157:H7 in this outbreak, provide an opinion statement on who is responsible for contamination. Provide an opinion statement on who should be held financially accountable (grower, processor, retail (Rainy County Farm), other) for expenses associated with the outbreak including: Individuals medical expenses, lost wages Costs associated with determining source of outbreak (epidemiologist wages, lab tests, etc.) Expenses associated with recall and destruction of food Answer: Opinion After this outbreak, various groups with stake in this issue met to discuss appropriate actions for consumer protection with this type of product. Two alternatives were discussed. Which of these do you favor? State the reason(s) for your opinion. Label product with a warning that it might contain microorganisms that can cause illness. Require treatment to kill pathogenic bacteria prior to distribution to the consumer. Answer: Opinion If a vaccine could be developed to minimize or even prevent the shed of E. coli O157:H7 by cattle, do you think administration should be required? Do you think such a strategy would be sufficient to decrease the risk of E. coli O157:H7 in human foods and beverages? Please state the reason(s) for your opinion. Answer: Opinion Prepare a 60-second television news piece that informs the public of the critical information related to the case. Answer: Suggested for inclusion: source of contamination, relevant time exposures, number individuals affected, region individuals affected, basic facts about E. coli O157:H7, symptoms, treatment, how to prevent spread, what to do if concerned about exposure or if develop some symptoms, and reliable resources for more information. No sensationalism. Prepare a 15-minute presentation for the class giving an overview of case study. Table 1. Data from Interviews with IndividualsIndividualGenderAge (yrs)SymptomsDate Symptom OnsetDate visited FarmEmployee, Patron, Close ContactConsumedParticipatedSpecial Health Concerns Current Health Status1Female7BD, HUS, A, KFOct 2Oct 1PatronH, J, IONKDeceased2Female8BD, HUSOct 2Oct 1PatronH, J, IONKPoor, Hospitalized3Male7BD, HUSOct 2Oct 1PatronH, J, IO, PZNKPoor, Hospitalized4Female8BDOct 3Oct 1PatronH, J, IO, PZNKRecovering5Male7BDOct 3Oct 1PatronH, J, IPZNKRecovering6Male7BDOct 2Oct 1PatronJ, IPZNKRecovering7Male7BDOct 2Oct 1PatronJ, L, IPZNKRecovering, Hospitalized8Male35BDOct 4Oct 1PatronH, J, W, LO, PZNKRecovering9Female6BDOct 3Oct 2PatronS, J, IPZNKRecovering10Female7BD, HUSOct 3Oct 2PatronJ, INANKPoor, Hospitalized11Male7BDOct 4Oct 2PatronH, J, IO, PZNKRecovering12Female29BDOct 4Oct 2PatronS, JNANKRecovering13Male7BDOct 5Oct 4PatronH, J, INANKPoor14Male7BDOct 5Oct 4PatronH, JO, PZNKPoor15Male8BD, FOct 5Oct 4PatronH, J, LPZNKRecovering16Female8BD, HUSOct 7Oct 6PatronJ, L, INANKPoor, hospitalized17Female8BDOct 8Oct 6PatronH, J, WONKPoor18Female8BD, VOct 8Oct 6PatronH,JO, PZNKRecovering19Female25BDOct 10Oct 6EmployeeS, JNANKRecovering20Male23BDOct 11Oct 6EmployeeH, L, IPZNKPoor21*Male33NoneNAOct 3PatronS, H, L, IO, PZNKGood22*Female32NoneNAOct 6PatronS, H, LO, PZNKGood23*Female29NoneNAOct 6PatronS, H, WO, PZNKGood24*Male19NoneNAOct 5EmployeeH, IPZNKGood25*Female17NoneNAOct 4EmployeeH, J, W, LNANKGood26*Female30NoneNAOct 4PatronS, H, WONKGood27*Male35NoneNAOct 3PatronS, L, IO, PZNKGood* Data gathered by students through mock interviews Symptoms Key: BD, bloody diarrhea; V, vomiting; F, fever; HUS, hemolytic uremic syndrome; KF, kidney failure; A, anemia All sick individuals visited their physicians. Food Key: S, salad; H, hamburger; J, fresh-pressed apple juice; L, fresh lemonade; W, water; I, ice cream, Event Key: PZ, petting zoo; O, orchard picking Other: NA, Not applicable; NK, None known Table 2. Activity/Consumption at Farm and Association with Illness Food or Activity# Consumed or participated and Sick# Consumed or participated Not Sick# Not Consumed or participated and Sick# Not Consumed or participated and Not Sick Odds RatioUnpasteurized Apple Juice19116114Bottled Water231840.15Lemonade541530.25Hamburger136710.31Salad351720.07Ice Cream133742.48Petting Zoo125820.60Orchard Picking951120.33 Odds Ratio = [(# Consumed and Sick) ( (#Not Consumed and Sick)] [(# Consumed Not Sick) ( (#Not Consumed and Not Sick)] Table 3. New Cases - Related to Outbreak? IndividualSymptomsSymptom OnsetSymptom DurationDate Visited FarmCurrent Health Status1Nausea, headacheJuly 301 dayJuly 30Good2Severe diarrhea, abdominal painOctober 6Nearly goneOctober 4Recovering3Mild diarrheaOctober 52 hoursOctober 5Good4Abdominal pain, diarrheaOctober 7OngoingNA, mother of child who visited farm on Oct 2Poor5Bloody diarrhea, abdominal painOctober 8OngoingNA, no known contact with sick patron, employeePoor Figure 1. Laboratory Data from Food Products, Environmental Swabs, and Patient Stool Specimen from Rainy County Farm-Associated Illness Outbreak Pulsed field gel electrophoresis results. Bacterial isolates from growth media are treated with enzymes to cut the genetic material at specific sequences. Pieces of DNA of different sizes react with a dye and are visualized on a gel. Isolates from different sources are compared to determine relatedness based on banding patterns.   Image Source: Delaware Public Health Laboratory Figure 2. Bar Graph for Questions 4a and 4b  Appendix A Actor Responses for Interviewees # 21- 27 to Complete Table 1. Note: Only provide answers if questions asked. Do not offer unsolicited information. Actor 1: Male, age 33 years. Not sick, health currently good. No known health problems. Patron of farm on October 3. Consumed salad, hamburger, lemonade, and ice cream. Participated in orchard picking and petting zoo. Actor 2: Female, age 32 years. Not sick, health currently good. No known health problems. Patron of farm on October 6. Consumed salad, hamburger, and lemonade. Participated in orchard picking and petting zoo. Actor 3: Female, age 19. Not sick, health currently good. No known health problems. Patron of farm on October 6. Consumed salad, hamburger, and water. Participated in orchard picking and petting zoo. Actor 4: Male, age 19 years. Not sick, health currently good. No known health problems. Employee of farm. Worked on October 5. Consumed hamburger and ice cream. Participated in petting zoo. Actor 5: Female, age 17 years. Not sick, health currently good. No known health problems. Employee of farm. Worked October 4. Consumed hamburger, juice, water, and lemonade. Did not partipate in orchard picking or petting zoo. Actor 6: Female, age 30 years. Not sick, health currently good. No known health problems. Patron of farm on October 4. Consumed salad, hamburger, and water. Particpated in orchard picking. Actor 7: Male, age 35 years. Not sick, health currently good. No known health problems. Patron of farm on October 3. Consumed salad, lemonade, and ice cream. Participated in orchard picking and petting zoo. Background Information: Escherichia coli O157:H7 is an enterohemorrhagic human pathogen that is estimated to cause tens of thousands of cases of gastroenteritis in the U.S. per year and is the leading cause of hemolytic uremic syndrome (HUS). It can colonize the gastrointestinal tracts of ruminant animals including cattle, sheep, deer, and goats without adverse health response in the animals. Outbreaks of E. coli O157:H7 in humans have been associated with consumption of contaminated undercooked beef, raw milk, and produce including leafy greens and unpasteurized apple cider, despite its acidity. Infections have been acquired by direct contact, as in petting zoos, with animals shedding the bacteria in feces. Person-to-person transmission occurs through the fecal-oral route. E. coli O157:H7 produces shiga-like toxin(s) and is not to be confused with nonpathogenic E. coli which is part of the natural gastrointestinal microbiota of healthy individuals. The scenario created for this educational case study was designed to incorporate foods and behaviors previously associated with E. coli O157:H7 infection as well as those not associated with infection. Additionally, the scenario was designed to highlight the importance of human and environmental factors in transfer of contaminants in foods. While the scenario was created, the implication of contaminated unpasteurized apple cider as the illness exposure source is based on three outbreaks of E. coli O157:H7 with unpasteurized apple juice. In all three outbreaks, the product was made locally and on a small scale. In fall of 1996, a landmark outbreak of E. coli O157:H7 was associated with unpasteurized juice distributed in the Northwest region of the United States and British Columbia, Canada. Illnesses of 70 people were linked to consumption of the juice, of which 25 people were hospitalized, 14 developed HUS, and 1 died. Cases were confirmed by culturing bacteria from stool, serum antibody to O157 lipopolysaccharide, and pulsed field gel electrophoresis match. The company recalled juices associated with the outbreak and products containing the implicated juice. E. coli O157:H7 was recovered from one of 184 unopened recalled bottles. Investigators presumed that fermentation of the juice complicated recovery of bacteria as the product was past its recommended shelf life when tested. Polymerase chain reaction (PCR) detection could not be used most likely due to interference of product constituents with the assay. Investigation of practices throughout the production chain yielded the following observations: (1) the production facility was state-of-the-art and appeared to be clean, (2) there were no reports of illnesses among employees that could account for the outbreak, (3) the company had policies to wash apples and exclude dropped apples for pressing, but enforcement of these policies were either not fully realized or could not be documented. This outbreak led to changes in regulations for unpasteurized juices. In late 1998, unpasteurized acidic fruit and vegetable juices were required to be labeled with the statement, Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems. In 2002 (or later, depending on size of operation), the application of Hazard Analysis and Critical Control Point (HACCP) principles were mandated for acidic fruit and vegetable juice processing, which effectively required processors to implement a control factor, such as pasteurization, to inactivate the pertinent organism, the pathogen of greatest risk for the product, by a level deemed sufficient for the potential risk (5-log reduction). Possible means to shorten exercise if desired: Question 3 provide data from Appendix A to eliminate need for interviews. Skip questions 17, 18 or opinion questions. References Cody, S. H., Glynn, M. K., Farrar, J. A., Cairns, K. L., Griffin, P. M., Kobayashi, J., Fyfe, M., Hoffman, R., King, A. S., Lewis, J. H., Swaminathan, B., Bryant, R. G., and D. J. Vugia. 1999. An outbreak of Escherichia coli O157:H7 infection from unpasteurized commercial apple juice. Annals of Internal Medicine 130(3): 202-209. United States Food and Drug Administration (Division of Plant Product Safety in the Center for Food Safety and Applied Nutrition). 2004. Guidance for Industry: Juice HACCP Hazards and Controls Guidance First Edition; Final Guidance. Available at:  HYPERLINK "http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm#ftn1" http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm#ftn1. Accessed 28 April 2010. This case study was prepared by the 91ԭ. This material is based upon work supported by the Cooperative State Research, Education, and Extension Service, U. S. Department of Agriculture, under Award No. 2009-38414-19698. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture.     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