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FOODBORNE ILLNESS AND OUTBREAK INVESTIGATION MANUAL March 2008 Kansas Department of Health and Environment Division of Health Office of Surveillance and Epidemiology 1000 SW Jackson, Suite 210 Topeka, KS 66612 24-Hour Technical Assistance: (877) 427-7317 Fax: (877) 427-7318 [email protected] www.kdheks.gov/epi 2 PREFACE The Foodborne Illness and Outbreak Investigation Manual (March 2008) is an inclusive update of the previous foodborne disease outbreak investigation manuals first developed in 1997. This revised version provides more detail about the epidemiologic tools used during outbreaks investigations, offers more guidance with regards to clinical specimen and food sample collection, and includes a section on intentional contamination. Improvements have been made based on user input. Comments, questions, and suggestions regarding this manual may be directed to Epidemiologic Services in the Office of Surveillance and Epidemiology at the Kansas Department of Health and Environment. We may be reached toll free by phone at (877) 427-7317, by fax at (877) 427-7318), or by e-mail at (EPIHotline @kdhe.state.ks.us). An electronic version of this manual may be downloaded from http://www.kdheks.gov/epi/. Contributing editors of this revision: Sheri A. Anderson, MS, MPH, Epidemiologist1 Cheryl Bañez Ocfemia, MPH, Senior Epidemiologist1 Mary Ella Vajnar, MT (ASCP)1 Nicole Hamm, Contract Manager2 Angela Kohls, CSFP, Program Director2 1 Epidemiologic Services Section, Office of Surveillance and Epidemiology, Kansas Department of Health and Environment 2 Food Safety and Consumer Protection Section, Bureau of Consumer Health, Kansas Department of Health and Environment 3 4 TABLE OF CONTENTS REFERENCES 8 INTRODUCTION 9 SECTION 1 ─ Foodborne Illnesses 13 Characteristics of foodborne pathogens 13 Foodborne transmission of pathogens and toxins 14 Classifications of foodborne illnesses 15 Clinical features of foodborne illnesses 15 Public health surveillance and foodborne illnesses 17 Epidemiology and foodborne illnesses 17 Laboratory diagnosis of foodborne illnesses 18 Pulsed-field gel electrophoresis (PFGE) 19 Food handlers, foodborne illnesses, and public health 20 SECTION 2 ─ Foodborne Disease Outbreaks 23 Defining a foodborne disease outbreak 25 Identifying foodborne disease outbreaks 25 Reasons for investigating foodborne disease outbreaks 26 Three components of a foodborne disease outbreak investigation 26 Roles and responsibilities in a foodborne disease outbreak investigation 26 The importance of confidentiality 29 SECTION 3 – The Epidemiologic Investigation 31 Steps of an epidemiologic outbreak investigation 33 Step 1. Determine that an outbreak has occurred 34 Step 2. Contact and coordinate with key personnel 35 Step 3. Obtain clinical specimens and food samples for laboratory testing 37 Step 4. Implement control and prevention measures 38 Step 5. Define cases and conduct case finding 38 Line list 38 Case definition 40 Case finding 41 Step 6. Describe the outbreak by time, place, and person 42 Epidemic curves 42 Maps and pictures 44 Frequency tables 44 Step 7. Develop possible hypotheses 45 Step 8. Plan and conduct the epidemiologic study to test hypotheses 45 Questionnaire 46 Study design 46 Logistics 49 5 TABLE OF CONTENTS (continued) Step 9. Analyze the data collected and interpret results 49 Step 10. Report the findings of the outbreak investigation 50 Intentional contamination of food 51 SECTION 4 – The Laboratory Analysis 53 General guidelines for clinical specimen collection 55 Stool specimens 55 Vomitus specimens 57 Culture isolates 58 Serology for hepatitis A 58 Requesting stool kits, mailers, and submission forms 59 General guidelines for food sample collection during an outbreak investigation 60 Chain of custody procedures for food samples 62 SECTION 5 – The Environmental Assessment 65 Fundamental concepts of food microbiology 67 Potentially hazardous foods 67 High-risk factors in food preparation 68 Food inspections in Kansas 69 Steps of an environmental assessment during an outbreak investigation 69 Step 1. Determine that an outbreak has occurred 70 Step 2. Contact and coordinate with key personnel 71 Step 3. Conduct food establishment inspection 71 Identifying high-risk food preparation and handling practices 71 Enforcing safe food handling practices 72 Supporting the epidemiologic investigation 72 Step 4. Conduct a Hazard Analysis Critical Control Points (HACCP) inspection 73 Step 5. Report findings 74 Step 6. Revisit establishment and conduct after action meeting 74 Intentional contamination of food 75 SECTION 6 – Appendices Appendix A – Glossary 77 Appendix B – Supplemental documents for epidemiologic investigations 85 Foodborne Outbreak Investigation Flowchart 87 Foodborne Disease Outbreak Checklist for Local Health Departments 89 Enteric Outbreak Worksheet 91 Enteric Disease Supplemental Form 93 Kansas Notifiable Disease Form 99 Kansas Notifiable Disease List 100 Creating a line list 101 Creating an epidemic curve 103 CDC’s “Investigation of a Foodborne Outbreak” Form (eFORS) 105 6 TABLE OF CONTENTS (continued) Guidelines for Completing “Investigation of a Foodborne Outbreak” Form 111 Data Analyses 115 Final Epidemiology Report 129 Appendix C – Supplemental documents for laboratory analysis 133 Requisition Form for Ordering Stool Kits, Universal Submission Forms, and Mailers 135 KDHE Universal Laboratory Specimen Submission Form and Instructions 137 Enteric Specimen Kit Packing and Shipping Instructions 139 O & P Specimen Kit Packing and Shipping Instructions 141 Diagnostic Blood Packaging and Shipping Instructions 143 Appendix D – Supplemental documents for the environmental assessment 145 Foodborne Outbreak Investigation Flowchart 147 Foodborne Disease Outbreak Checklist for Food Inspectors 149 Flowchart for Kansas Department of Health and Environment inspectors 151 Flowchart for Kansas Department of Agriculture inspectors 153 KDHE Compliant Investigation Report 155 Gastroenteritis Surveillance Form for Employees 157 Procedures for Distributing and Collecting Employee Surveys 159 Exclusion and Restriction Requirements for Infected Foodhandlers 161 Removal of Exclusion and Restriction Requirements for Foodhandlers 163 Hazard Analysis and Critical Control Point (HACCP) 165 Appendix E – Foodborne Illness and Etiology Tables 169 Etiologic Agents to Consider for Various Manifestations of Foodborne Illness 171 Foodborne Illnesses 173 Guidelines for Laboratory Confirmation of a Foodborne Disease Outbreak 179 7 REFERENCES The Kansas Department of Health and Environment acknowledges the following sources which served as good resources in the development and revision of this manual: • Kansas Department of Health and Environment. Foodborne Illness and Outbreak Investigation Manual. Septemner 2004. • Kansas Department of Health and Environment. 2005 Kansas Food Code. • Kansas Department of Health and Environment. Focus on Food Safety. June 2002. • Kansas Department of Health and Environment. “Packaging and Shipping”. http://www.kdheks.gov/labs/packaging_and_shipping.html. • Massachusetts Department of Health. Foodborne Illness Investigation and Control Reference Manual. September 1997. • Oklahoma State Department of Health. 2002 CDN-San Outbreak Training Conference Manual. May 2002. • Wisconsin Division of Health. Foodborne and Waterborne Outbreak Investigation Manual. September 2005. • International Association for Food Protection. Procedures to Investigate Foodborne Illness. 5th ed. 1999. Reprinted 2007. • Centers for Disease Control and Prevention. “Foodborne Illness”. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodborneinfections_g.htm • Centers for Disease Control and Prevention. “Diagnosis and Management of Foodborne Illnesses: A Primer for Physicians and other Health Care Professionals.” MMWR 2004:53 (No. RR-4). • Centers for Disease Control and Prevention. Principles of Epidemiology in Public Health Practice: An Introduction to Applied Epidemiology and Biostatistics. 3rd ed. • Heymann, DL., ed. Control of Communicable Diseases Manual. American Public Health Association. 18th ed. 2004. • Gordis, L. Epidemiology. Saunders: 1996. 8 INTRODUCTION Foodborne pathogens cause an estimated 76 million cases of foodborne illness, 325,000 hospitalizations, and 5,200 deaths in the U. S. annually. Related medical costs and lost wages are significant, accounting for a yearly loss of up to $17 billion1. In Kansas, the main bacterial causes of food-related illness are Campylobacter, Salmonella, Escherichia coli O157:H7, and Shigella. Viral pathogens, specifically Norovirus (formerly known as Norwalk-like virus) and Hepatitis A virus, are also major causes of foodborne illness in Kansas. Food-related and other diarrheal illnesses remain underreported throughout the U.S., including in Kansas. Most diarrheal illnesses resolve within 24 to 48 hours without any medical attention. As a result, many food-related illnesses are not diagnosed and associated foodborne disease outbreaks are often not recognized. This poses a challenge for public health professionals to maintain the knowledge and resources to identify and respond to these outbreaks. This manual is written primarily for infection control nurses, food inspectors, and outbreak investigators for the purpose of 1. Describing the fundamental concepts related to foodborne illnesses and outbreaks; 2. Discussing the roles and responsibilities of key personnel when responding to foodborne illnesses and outbreaks; and 3. Establishing guidelines for investigating foodborne