Michigan Department of Agriculture

Training Program for the Professional Food
Service Sanitarian

Module 7: Foodborne Illness Investigations

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Module 7 Table of Contents

Introduction

    Brief History of Epidemiology
    Course Objectives and Goal
    Collecting Surveillance Data

Planning for the Investigation

    Objectives
    Equipment
    Outbreak Investigation Teams

Beginning the Investigation

    Objectives
    Gathering Complaint Information

    Verify the Complaint
    Surveillance

    Questions to Be Answered 

    Taking Action

Expanding the Investigation

    Objectives
    Interview Techniques
    Standard Case Definitions

    Case Finding

    Control Measures
    News Media Communication

Environmental Investigation and Food Hazard Review

    Objectives
    Food Prep Review
    HACCP
    Factors Affecting Growth
    Planning the Food Prep Review
    Data Review

Clinical and Food Samples

    Objectives
    Personal Precautions
    Avoid Contamination

    Consult With the Lab
    Equipment
    Samples

    Viruses
    Reference Material on Clinical Samples and Pathogen Characteristics

EPI Statistics Part I

    Objectives
    Measures of Association
    Study Designs

    Summary

EPI Statistics Part-2

    Objectives
    Compute a Chi Square Statistic

Final Report

    Objective
    Example of Final Report Outline

Glossary 

Go To FP Advisor

A database of agents causing food borne illnesses intended to assist regulators during investigations.

Introduction

We're going to be taking an in-depth look at the steps involved in an investigation from surveillance, to implementing prevention and systems control measures, right on through to the final report.

Reference points in a food borne illness investigation from surveillance through the final report.

  • Passive & Active Surveillance

  • Planning for an Investigation

  • Equipment and the Team

  • Beginning the Investigation

  • Time, Place & Person Associations

  • Verify the Diagnosis & Collecting Surveillance Data

  • Initial Working Case Definitions & Hypothesis

  • Expanding the Investigation

  • Case Findings and Outbreak Specific Questionnaire

  • Interviewing Techniques

  • Line Listing

  • Refined Case Definitions

  • Reformulating the Hypothesis

  • Source & Transmission Control

  • Food Hazard Review

  • On-Site Investigation

  • Person, Process or Product

  • Food Flow & Contributing Factors

  • Food & Clinical Samples

  • EPI Statistics

  • Attack Rate Tables

  • Epidemic Curves

  • Measures of Association

  • Measures of Association & Statistical Significance

  • Final Report

In the Food Microbiology module, we took a look at some of the bacteria, viruses, and parasites that can make us sick, as well as many of the controls for these pathogens. Now, in this Food borne Illness Investigations course, we're going to draw on your previous knowledge and learn about investigative techniques that you'll use to help resolve food borne illness outbreaks. We'll teach you how to track down pathogens and unsafe practices that may lead to widespread food borne illness. You're going to learn to uncover underlying causes that will lead to practical solutions to food borne illness outbreaks.

Food safety concerns have changed in the last several years. The global distribution of food has expanded our food choices. We hear about new pathogens like Cyclospora and new environments for existing pathogens such as E. coli O157:H7, Cryptosporidium, and Salmonella on fruits and vegetables. Food safety risks vary with the type of food and how the food was manufactured, distributed, stored, and prepared.

For example, until a few years ago, it was thought that you didn't have to worry about Salmonella in an acidic product like orange juice. We now know that Salmonella can survive in some acidic environments. The nature of food borne illness has been changing in the last several years as well. In the past, outbreaks were typically local, on a relatively small scale, and focused in a certain area. There seemed to be some end-point contamination due to poor food-preparation practices. We still have these types of outbreaks, but in addition, today, we have illness-illness outbreaks that tend to be on a larger scale. They can be multistate or multinational, and sporadic and difficult to detect.

When a food borne illness occurs, epidemiology is used to help us understand the who, what, where, when, how, and why the illness happened. Epidemiology is defined as the study of the incidence, distribution, and control of health-related events in a specific population. The primary objectives of a food borne illness investigation are to stop the outbreak and prevent additional cases by implementing public health control measures. The epidemiological process can be applied in many different situations, but we are going to focus on food borne illness investigations.

When an illness occurs, we want to find out the following:

  • Etiologic/Causative agent

  • Contributing factors

  • Who is at risk

  • Implicated food

  • Mode of transmission

  • When and where did the exposure occur

When an illness occurs, we want to find out what's the pathogen, agent, or toxin causing the illness; what factors contributed to the food contamination; and the survival or the growth of the causative agent; so illness can be prevented in the future. The Epi-process also helps us identify the exposure group or the population at risk; which food or foods are associated with the illness; the mode of transmission; the food or vehicle; and how the pathogen moves through the population. And finally, the process helps us identify the when and where, or the time and place of the outbreak. Using the Epi-process to answer these questions, food regulatory and health agencies are better positioned to control or prevent further exposure to the microorganisms and toxins (the etiologic agents) that cause food borne illness. Lastly, information from epidemiological investigations is used to develop preventive control measures and to plan food safety programs.

Brief History of Epidemiology

Epidemiological thinking can be traced back as far as 400 BC to Hippocrates, the father of medicine. He was the first to approach disease in a logical rather than a supernatural manner, suggesting that environmental and behavioral patterns may influence the development of disease. In the 1600s, John Graunt, and later in the early 1800s William Farr, began to quantify information gathered on patterns of birth, death, and disease occurrence. In fact, William Farr is regarded as the father of modern vital statistics, with many of his basic practices still being used today. But it wasn't until around 1854 that the epidemiological investigative process was first noted. It centered on a cholera outbreak in London, England.

The title of "father of field epidemiology" was given to Dr. John Snow, an anesthesiologist who systematically investigated this outbreak in London. The area was called Golden Square, and Dr. Snow believed that water from one of the community wells was responsible for the cholera infection. That, in and of itself, is not notable, but the way he went about proving his theory is. Snow began by finding out where in the area the cholera victims lived and worked.

Using this information, he made a spot map showing the distribution of case households. Snow quickly found that more victims lived around the Broad Street pump than around the others, and he theorized that the Broad Street pump was the culprit. But again he had to prove it. So he went about questioning the residents who lived around the other pumps and discovered that they avoided pump B due to gross contamination, and pump C was too inconvenient. So from this, Snow conjectured that the Broad Street pump was the primary source of water for the Golden Square residents. But it still wasn't conclusive. He noted that there was a two-block area just down the street from pump A where no one got sick. How could this be, he asked? Probing some more, he found out that there was a brewery there with a deep well, and workers who lived in that block took their water from it. They also got a ration of malt liquor every day. That explained the one glitch in Snow's spot map. To confirm his theory, Dr. Snow questioned the cholera victims to find out where they got their water. He could now firmly state that water from the Broad Street pump was the one common factor among the victims. As the story goes, John Snow removed the pump handle and thus stopped the outbreak.

Course Objectives and Goal

What we're going to do in this course is teach you how to "remove the pump handle" of a illness-illness outbreak. Just as Dr. Snow illustrated, we're going to step you through the sequence of an epidemiological process from descriptive EPI to hypothesis generation to hypothesis testing to application of controls and preventive steps.

After completing this course, participants will be able to:

  • Identify the rationale for developing and maintaining a surveillance system.

  • Apply epidemiological principles involved in a illness-illness investigation.

  • Discuss the steps associated with investigating food borne illness.

  • Apply environmental investigation techniques for performing a food preparation review and identifying contributing factors.

  • Identify and implement appropriate control measures to prevent additional illness.

  • Discuss the role of the investigation team and the three main components: environmental, epidemiology, and laboratory.

  • Discuss appropriate food and clinical samples to verify the agent.

  • Be familiar with the terminology associated with food borne illness investigations.

  • Interpret descriptive and analytical data, measures of association and significance.

  • Discuss the final report, ways to communicate findings, and implementation of preventive control measures.

The goal of the course is to improve illness-illness investigations to identify rapidly the implicated food and implement control measures to prevent additional illnesses; then utilize investigational findings for the present and future to prevent similar outbreaks.

Collecting Surveillance Data

Objectives

On completion of this module, participants will be able to:

  • Describe a food borne (and waterborne) surveillance system that includes the origins of surveillance data.

  • Describe the reportable disease process in the United States.

  • Compile and organize log data for a reporting period and observe deviations in frequency and distribution for specific illnesses.

Overview

In this module we're going to look at compiling data from several different surveillance methods; talk about the reportable disease process that we use in the United States; and discuss compiling and organizing a data log for a specific reporting period that will help you identify deviations in frequency and distribution of specific illnesses.

Surveillance Systems

  • Ongoing collection, analysis and dissemination of information

  • Monitor changes in disease frequency

  • Establish background levels of specific diseases in a community

  • Determine if changes in disease occurrence are related to time [seasonal]

  • Linked to a place or host

  • Analyze changes in endemic level of disease.

Surveillance systems help to answer questions like: How do you know when an outbreak of food borne disease is occurring? Or how do you know whether a salmonella isolate is the first warning of an outbreak? Surveillance involves the ongoing collection, analysis, and dissemination of information. Using data collected from surveillance, you can monitor changes in disease frequency, establish background levels of specific diseases in a community, or help determine whether changes in disease occurrence are related to time, such as the season of the year. Surveillance data can also be linked to a place (a specific geographic location) or even to a person or "host." Also, analyzing surveillance data over an extended period of time can help detect sudden changes in the usual background level of a disease, or "endemic" level of disease.

Various state and local departments and federal agencies are involved in disease surveillance to detect outbreaks. Surveillance attempts to link sporadic reports, such as a case of botulism, to a series of reports or a cluster of illness and outbreaks. Most of you should recall the "Schwann's ice cream" outbreak and the E. coli 0157:H7 case in the Pacific Northwest. Both are examples of outbreaks that began as little, sporadic reports and then rapidly expanded to multi-state investigations.

There are two kinds of surveillance methods: passive and active. First let's talk about passive surveillance. Most agencies use passive surveillance to find out about food borne illness outbreaks. "Passive" is just like the name suggests: information comes to you; you don't seek it out. A department receives reports, alerts, or complaints of illness from a variety of sources, such as physicians, laboratories, other agencies, and, of course, the public. Many of these people complain of gastrointestinal (GI) distress or have flu-like symptoms and subsequently don't attribute their illness to food. It would not be unusual if they didn't go to their doctor. They may be simply saying, "Oh, it's just a bug that's going around." So only a small percentage of food borne illnesses are ever reported to a physician. And we need to remember that physicians aren't required to report some food borne diseases to the health department.

Even though requirements for reporting diseases are "mandated" by state laws, the list of reportable diseases varies from state to state. For example, prior to 1993, only a few states required the reporting of E. coli 0157:H7. Of course, today, most states require the reporting of this disease. (Editor's comment: Being reportable does not ensure that an illness will be reported to the health department, and being nonreportable does not preclude notification.) In 1997, 52 infectious diseases were designated as notifiable at the national level, and they're listed in this manual. The Centers for Disease Control (CDC) Web page address for the Morbidity and Mortality Weekly Report is:

http://www.cdc.gov/epo/mmwr/mmwr_snd.html

and the Web address for the list of infectious diseases designated as notifiable at the national level, United States, 1997, is:

http://www.cdc.gov/epo/dphsi/casedef/about97.htm.

Infectious Diseases Designated as Notifiable
United States, 1997

Acquired immunodeficiency syndrome (AIDS) Lyme Disease
Anthrax Malaria
Botulism Measles
Brucellosis Meningococcal disease
Chancroid Mumps
Chlamydia trachomatis Pertussis
Genital infections Plague
Cholera Poliomyelitis, paralytic
Coccidioidomycosis Psittacosis
Cryptosporidiosis Rabies, animal
Diphtheria Rabies, human
Encephalitis, California serogroup Rocky Mountain Spotted fever
Encephalitis, eastern equine Rubella, congenital syndrome
Encephalitis, St. Louise Salmonellosis
Encephalitis, western equine Shigellosis
Escherichia coli 0157:h7 Streptococcal disease, invasive, Group A
Gonorrhea Streptococcus pneumoniae, drug resistant invasive disease
Haemophilus influenza, invasive disease Streptococcal toxic shock syndrome
Hansen disease (leprosy) Syphilis
Hantavirus pulmonary syndrome Syphilis, congenital
Hemolytic uremic syndrome, post diarrheal Tetanus
Hepatitis A Toxic shock syndrome
Hepatitis B Trichinosis
Hepatitis, C/non A, non B Tuberculosis
HIV infection, pediatric Typhoid fever
Legionellosis Yellow fever

A physician will decide if a specimen is to be taken, and if necessary which lab tests to order. Obviously, if a specimen is not taken there is no lab test and nothing to report.

To include foodborne illness in the passive surveillance system, the following steps have to occur: A person becomes ill, and the patient must go to a doctor. The doctor must request specimens for analysis. The laboratory must analyze the specimen, the positive results must be reported to the health department, and the reports must be forwarded to the CDC. (Editor's comment: Some reporting systems do not require lab confirmation. Also, some states require that clinically diagnosed ailments be reported, even when laboratory confirmation is not available.) Some labs can test for a variety of microorganisms and use biomolecular typing to determine whether isolates are related to the same outbreak. Usually, tests for toxins, viruses, and parasites are run only if specifically ordered. Other labs have a more limited capacity and can run only routine tests.

Another example of passive surveillance is when someone becomes ill after eating at a restaurant and then complains to the health department. People who are concerned enough to take the time to file a report to a surveillance program want assurance that the appropriate person will be notified and that immediate action will be taken. Surveillance programs should be organized to receive and respond to complaints. The process for reporting should be quick and traceable to ensure that the appropriate person is informed regardless of the point of the first contact. The surveillance system should be "triage-oriented" (respond differently depending upon the circumstances) and should be able to proceed smoothly from one level of action to the next.

The surveillance system should have a referral process that ensures a timely and competent public health response. And finally, the system must be able to terminate effectively when resolution is reached and have a mechanism for feedback notification. If you try to analyze calls and complaints on an individual basis, it's difficult to determine the source of an exposure. That's where the surveillance log comes in. A surveillance log is simply a record of illness complaints.

Basic information in surveillance log:

  • Date and time

  • ID of affected person

  • Event exposure info

  • Geographic area

A log should include at least the date and time of the report, identification of the caller or the person affected, the event exposure information, and the geographic area. In the surveillance log example, the log shows a mix of reports including dog bites, measles, post-op Staph infections, and Hepatitis-A. On closer inspection, we see this log has three entries of Hepatitis-A within about two weeks of each other. All three are identified with the same day-care center. In general, the longer the incubation period, the further back the log must be reviewed for things like time, place, and person associations. If it is determined that follow-up contact is required, a note about the purpose and result of the contact should be cross-referenced in the log so all personnel using the record will have access to the same information. We'll discuss the analysis and interpretation of the surveillance log in more detail later.

Example of a Surveillance Log, Week 2

Case

#

Reported by Time of report Signs & symptoms, and lab results Time of onset Case's name, address, occupation & telephone # Age Sex Possible sources of exposure, per reporting individual Other similar cases
11 W. Hogan, MD

297-6834

1-17

3 p.m.

Hepatitis A

Dark urine, clay colored stool, tired, jaundice

1-12 Billy Michaels

4211 Maple Drive

4 M Unknown - attends Hillside Day Care Center X
12 G.M. Miller, MD

458-2211

1-18

10:30 am

Meningacaccal

Meningitis - headache, pain in legs, chills, fever, vomiting

1-14

5 p.m.

Anna Wilson

Bay City

17 F Unknown  
13 Anna Lewis

543-7918

1-18

10:45 am

Dog bite - puncture wound on left leg 1-18

am

Bobby Lewis

950 Rancho

543-7918

8 M Dog's owner - Fred Allgood

695 E Rancho

543-8842

 
14 W. Hogan, MD

297-6834

1-18

11:45 am

Hepatitis A

Vomiting, fever, dark urine, jaundice

12-31

7 p.m.

Idda May Jones

127 Hill Circle

Cook at Hillside Day Care Center

42 F Unknown - visited relative early in December X
15 F. Diaz, MD

223-8846

1-18

2 p.m.

Measles, fever, rash 1-14

8 am

Joey Hernandez

72 Rancho Road

224-7713

3 M Unknown - attends Hillside Day Care Center  
16 S. Menousek, MD

764-0241

1-18

2:45 p.m.

Hepatitis A 1-13 Susie Smith

238 Taft Street

448-7283

4 F Unknown - attends Hillside Day Care Center X
17 James, Mitchell, MD

Brassfield Hospital

247-8900

1-18

3 p.m.

Post op., staphylococcal infection 5 cases since

1-1

5 cases - hospital has records   F All are post op in general surgery wing  

Passive surveillance

Passive surveillance has its advantages...

  • Inexpensive

  • Can detect rare events

  • Can suggest hypotheses about causative factors

  • Likely to represent illnesses with a short latency/incubation

...and disadvantages...

  • Bias due to self-selection

  • Don't know total exposed and lack comparison groups

  • Others have incomplete reporting of events

A big advantage of passive surveillance is the relatively low cost. Passive surveillance can detect rare events, and it's a good resource for suggesting causative factors, especially for illnesses that have a short incubation or "latency" period. There are also a few limitations. For instance, the data is biased due to self-reporting: here tends to be incomplete reporting, and you will not know the total number of people exposed.

Active Surveillance

With active surveillance you seek out illness information. You actively examine such things as hospital discharge records, laboratory records, and medical examiner reports. (Editor's comment: You can also contact pharmacists to learn about increased sales of over-the-counter medications for specific illnesses such as diarrhea.) Sometimes you may even establish sentinel sites. A sentinel site is a type surveillance system used to track diseases caused by specific pathogens, and to determine the rates of illness in a clearly defined geographic area.

Active surveillance also has advantages...

  • More accurate

  • Measures exposure and illness estimated time relationships

  • Determine circumstances

...and disadvantages...

  • Additional resources needed

  • Expensive

The data in an active surveillance system is more accurate compared to a passive system. It allows you to measure illness. You can also estimate time or temporal relationships. And you can determine circumstances associated with illness. The downside of actively searching for information is the additional resources required. Active surveillance is expensive. Another important aspect of maintaining surveillance is that someone must be responsible for the continuous operation of the surveillance system.

Operating a Surveillance System

  • Responsibility for monitoring surveillance system

  • Organize and interpret data

  • Communicate to public health personnel

  • Trained in EPI methods

  • Monitor and evaluate data

  • Establish base-lines

  • Identify coordinating agencies and individuals

  • Cross train back-up staff

Data must be organized, interpreted, and communicated to public health personnel on a regular basis. The person assigned to surveillance should be trained in EPI methods. They should monitor and evaluate data, establish baselines for communicable diseases, identify agencies and individuals to coordinate with, and cross-train backup staff to operate the surveillance system. Here are some things you need to do to develop sources of information.

Network with medical care facilities such as hospitals, emergency rooms, clinics, health maintenance organizations (HMOs), managed health care organizations, laboratories, poison control, and urgent-care centers. An effective and active way to foster interaction is to provide sampling kits to facilities such as emergency rooms (ERs). The facilities will use the kits to collect samples from food brought in by patients or for collecting any clinical specimens. Remember: No samples - No lab tests - No information.

You also need to develop a list of people, addresses, and telephone and fax numbers, and if possible, e-mail addresses for notifying appropriate personnel during emergencies. It's extremely important to encourage others to notify your department when they encounter or suspect foodborne illness. Another way to improve surveillance is to have a prominent telephone listing for reporting foodborne illness, like a 24-hour hot line, an answering service, or some other innovative means of receiving and answering after-hour calls.

FoodNet

Working together, the CDC, U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA) have implemented an active foodborne disease sentinel site surveillance program called FoodNet. FoodNet is the name given to the laboratory-based active surveillance system for tracking sporadic cases of foodborne disease. The CDC, FDA, and the USDA established FoodNet in 1995, and the system operates in portions of California, New York, and Maryland and is statewide in Oregon, Minnesota, Connecticut, and Georgia.

The pathogens tracked by FoodNet include Salmonella, Shigella, and Campylobacter, E. coli O157:H7, Yersinia, Vibrios, Listeria monocytogenes, Cyclospora and Cryptosporidium. FoodNet has several components including a survey of clinical laboratories that receive specimens from persons who reside in the geographic catchment areas to determine what organisms the labs are testing for.

Components of FoodNet include the following:

  • Survey of clinical

  • Routine contacting of labs

  • Survey of physicians who see patients with diarrheal disease

  • Population survey of persons in catchment area

  • Case-control studies

FoodNet provides a survey of physicians who see patients with diarrheal disease to determine their criteria for requesting stool testing. FoodNet also gives you a population survey of persons who reside in the catchment area to determine the frequency of diarrheal disease and risk behaviors, and finally it provides case-control studies on the patients to identify risk factors and other epidemiologic features for the various organisms of concern.

When we put all these components together, we get a kind of insight that we could never get before. We're now able to estimate actual levels of illness in the general population by calculating backward from the clinical laboratory findings. By spreading our coverage over several states, we can detect some of the very widespread sources of illness, and we can also tell whether anyone of our sites is experiencing an unusual upturn or downturn in a particular disease.

PulseNet

In addition to FoodNet, an electronic bacterial subtyping and communication system called PulseNet has been set up between the State health departments, FDA, USDA, and CDC. PulseNet is a multiagency effort that was officially launched in May 1998. This partnership is designed to assist in epidemiological analyses such as tracebacks and cluster identification. This network was made possible by the conjunction of three powerful tools: the highly discriminating DNA fingerprinting method of Pulsed-Field Gel Electrophoresis (PFGE); the use of a customized software that allows computerized analysis and databasing of the PFGE patterns; and the Internet, which allows us to transfer large image files and data between participants. These tools, harnessed using standard protocols, now allow for the rapid comparison of foodborne bacteria isolated from different parts of the country. Currently, the system includes the CDC, USDA, FDA, two counties, and more than 25 State health departments. It will expand to cover most of the United States by the year 2000. At present, the system is monitoring all E.coli O157:H7 isolates, while other species are analyzed on a case-by-case basis. The system tracks clinical, food, and environmental isolates from food production facilities that are implicated in outbreaks. Eventually, the system will cover most of the key foodborne bacterial pathogens and will be linked to similar networks overseas.

DNA fingerprinting (Pulsed-Field Gel Electrophoresis; PFGE)

The PFGE method, developed in the 80's and recently condensed to a one-day procedure, uses a special electrophoresis technique to separate mixtures of very large DNA molecules into a barcode-like pattern called a DNA fingerprint.

Bacterial cells are imbedded in a gel matrix. Then a series of enzymes and chemicals are used to remove all the cellular components except the DNA, which is obtained in an intact and pure form. This DNA is digested with a restriction enzyme that cuts it into a specific set of fragments. These fragments are separated by PFGE, and the resulting pattern is digitally imaged after staining. By comparing the PFGE patterns of two or more isolates, we can determine how closely related they are; this relationship analysis is key in cluster analysis as most point-source clusters are caused by clones of a single PFGE pattern type.

In the Pulsed-field Gel Electrophoretic analysis of enterohaemorragic E. coli (EHEC) isolates, significant differences were visible among the genomic patterns of strains representing serogroups O:H11, 026:H, 068:H and 0157:H7. Marked differences were also noted between the two 026:H isolates (lanes 2 & 3) as well as amongst 0157:H7 strains isolated between 1984-86 in the USA (lanes 6-10). This reveals that genomic restriction pattern heterogeneity exists not only among different serogroups of EHEC but also within serogroups. This diversity adds to the value of PFGE in subtyping EHEC isolates. Further, illnesses in the United States attributed to EHEC are not caused by a single strain.

Roles of Computerized Pattern Recognition and the Internet in the PulseNet Project

The DNA fingerprints generated by a participating site are relayed to a central computer at CDC in Atlanta. Here, after a quick QA/QC check, they are stored and then compared, using software specifically designed for PFGE pattern analysis, against all the fingerprints of that species submitted by the other sites. If a close match is found between fingerprints submitted within 30 days of each other, an automated e-mail is sent to all the sites, alerting them and providing the basic epidemiological data associated with those isolates, such as the food implicated. This allows outbreak investigators to better focus efforts and resources in their quest to identify and control the sources involved.

PulseNet and Public Health Microbiology

PulseNet speeds up the comparison of isolates that are suspected of being linked. Previous to PulseNet, the only way two isolates could be compared was if they were analyzed at the same location; this required the mailing of isolates from one site to another, with an additional delay while DNA was repurified at the new location. Also, while the epidemiological analysis of large outbreaks that occur in a short period of time is relatively easy, small clusters of cases that share a common cause were often misidentified as sporadic. The steady flow of data from what appears to be sporadic cases allows us now, using PulseNet, to spot diffuse clusters and take remedial action in a timely manner. Such genetic monitoring of apparently sporadic cases also serves as an early warning system for emerging pathogens, such as multidrug-resistant strains, that are of elevated public health importance.

Example of PulseNet Success

Even though PulseNet is still in its infancy, it has already proven its value in a number of cases. A good example is where an unambiguous match was found between the DNA fingerprints of Shigella sonnei isolated and analyzed by a number of PulseNet participants in the US. In some of these cases, imported parsley was implicated, while in others the responsible food was not clear. After PulseNet linked the various cases together, detailed traceback analysis showed that either parsley or cilantro from the same operation in a foreign country was involved; the PFGE provided the definite evidence needed for a regulatory response to the situation, thus preventing further cases of illness from this source. Similarly, PulseNet has been invaluable in tying together multistate outbreaks caused by E. coli, Listeria monocytogenes and Salmonella agona.

Planning the Investigation

Objectives

On completion of this module, participants will be able to:

  • Identify the equipment necessary to investigate foodborne illness.

  • Understand the need for a multi-disciplinary outbreak investigation team.

  • Understand the need for coordinated efforts between agencies during outbreak investigations.

Equipment

Part of surveillance is being prepared for emergencies because we all know, sooner or later, you'll have an outbreak. Being prepared for an outbreak includes having your equipment and team ready to go. The investigation will go a lot smoother if you have the necessary equipment, documentation forms, and sampling kits ready for use when you need them. In this module we're going to talk about developing an equipment checklist and collecting the necessary supplies so you can be ready to go at a moment's notice.

Make sure that you have your aseptic sampling equipment all set to go. An important point to remember is some sterile equipment and supplies have a limited shelf life, so pay attention to expiration dates. Talk with the laboratory and develop replacement schedules for supplies. Restock supplies as they are used up or exceed the expiration date. Sample integrity can be questioned if improper equipment or out-of-date supplies are used to collect the sample.

By following proper sample collection procedures, you will ensure that any microbial contamination found during analysis did not come from the sampling equipment. After all, it's better to be part of the solution than part of the problem! Sampling guidelines will identify the equipment used for collecting various samples. You can use the guidelines for organizing the outbreak equipment.

Food and environmental samples are collected primarily to identify or verify the agent. In other words, if your suspect pathogens are, let's say, Campy or Salmonella or Shigella, your environmental samples are taken to prove your suspicions. There is an extensive list of forms and equipment in the course manual.

Having the necessary equipment to perform the inspection and aseptically collect samples is important. If improper equipment is used to collect samples, then sample integrity will be questioned and samples will be meaningless. The following is a suggested equipment checklist. The list should be modified depending on product and inspection requirements.

  • affidavits

  • alcohol wipes

  • batteries

  • Betadine solution

  • boots

  • camera

  • check strips for checking sanitizing solutions: Chlorine, Iodine, Quaternary, Ammonia

  • Cups

  • dippers

  • drill and drill bits for taking core samples

  • embargo and detention tags

  • enteric stool kits (sterile)

  • film

  • flash (for camera)

  • flashlight, with extra bulbs

  • forceps

  • garbage bags

  • gloves

  • hair net

  • hammer

  • hat

  • inspection and observation forms

  • jars (plastic, wide-mouth with screw lids)

  • knife

  • lab coat

  • labels (stick-on type)

  • FDA-482 - Notice of Inspection

  • FDA-483 - List of Observations

  • FDA-484 - Receipt for Samples

  • laboratory submission forms

  • masking tape

  • money

  • notices (voluntary condemnation, correction and closure)

  • packing tape

  • paint cans, gallon size (sterile)

  • paper clips

  • paper bags

  • parasitic stool kits

  • plastic bags (sterile)

  • rubber bands

  • scoops (sterile)

  • small propane torch (for on-site sterilization or disinfection)

  • spark igniter

  • spoons (sterile)

  • stop Watch

  • swabs (sterile)

  • tape (stretch type)

  • temperature measuring devices; a bayonet thermometer, a thermocouple, a thermistor, a temperature data-logger, and maximum registering thermometers

  • tongs (sterile)

  • tongue depressors (sterile)

  • waterproof markers

  • Collect Report

  • FDA-525

  • Sample Seals

  • Government shipping stickers/bus bills

  • Copies of information from files

Outbreak Investigation Teams

Let's not forget the people when preparing for an outbreak. Conducting a foodborne illness investigation can be a huge, time-consuming task; don't go it alone. Your team should be composed of professionals from multiple disciplines such as epidemiologists, sanitarians, inspectors, investigators, environmental health specialists, public health nurses, microbiologists and other laboratory scientists, public information specialists, and office support personnel. As with assembling the investigational equipment prior to an outbreak, assemble your team. Once an outbreak occurs, it's more difficult to get organized.

Teams work best when there is a common understanding, respect, and trust among the team members with all parties focusing on the goals of resolving the outbreak. This means working together and focusing on the outbreak. The goal is to stop the outbreak and learn from the experience. Work cooperatively, focus on the task, and respect differences of opinion. It's a matter of being attentive and maintaining constructive relationships. Take the initiative to make things better: lead by example.

With the different disciplines involved, who does what on the team will vary. The important thing is that the various tasks and responsibilities involved with the investigation are assigned to individual team members before the next outbreak. Each member should be accountable to the team to follow through with assignments and participate in the group process. Roles and responsibilities should be established ahead of time. Questions like: Who is team leader? Who are the backups? Who is point person for the media? How do we coordinate these activities and notify each other? ...should be considered before you're in an emergency situation.

Outbreak Team Leader

How your team is formed with the breakdown of roles and responsibilities will depend upon how it works best for you. For example, not every jurisdiction has an epidemiologist, but every state has one. Many teams will have to establish protocols in consultation with their state epidemiologist, lab, and nurses and others. Someone has to be the leader and central hub for the flow of information and open the lines of communication. The position of team leader is not necessarily a supervisory role. Typically the team leader may not have direct authority over the individuals comprising the team. The members should view the arrangement as a temporary job matrix during the outbreak where team members provide input, perform specialty functions, and report findings to the team leader. At the conclusion of the investigation, individuals return to their routine assignments.

The team atmosphere should be open for consensus building. Encourage constructive input and brainstorming to generate all those wild and sometimes crazy ideas and potential "could be's" or "what if" scenarios in trying to figure out what happened. Also with this process, the pros and cons of a decision can be weighed by the group before its implementation: a kind of check-and-balance process to reduce the chance of error or overlook possibilities that should be considered.

Between outbreaks, team meetings can be regularly scheduled to build rapport within the team and fine-tune procedures. After your next outbreak, evaluate the investigation as a team, keep what worked well, refine what didn't work, and conduct in-house training to enhance skills. Attending seminars keeps staff current and provides opportunities for networking with other agency personnel. It's also a good idea to start a library with information on foodborne illness and keep it current as new and emerging pathogens are reported. Once an outbreak occurs, the team should be prepared to go. Holding daily meetings to review findings and keep everyone up to date is important.

The foodborne illness investigation can be visualized as a three-legged stool. The investigation process has three components: EPI, laboratory, and environmental.

Without all three legs secure, the stool will fall over, toppling the team. Sometimes an outbreak will cross jurisdictional lines and require cooperation between investigation teams on the local, state, and federal levels. For example, in 1997, a Hepatitis-A outbreak in the Midwest involved strawberries served with the school lunch program. What started out as a local outbreak went multistate, and the investigation ended up including many state and federal agencies. When multiple agencies are working on the same outbreak, interagency communication becomes extremely important. Before the next outbreak, identify cooperating agencies, establish two-way communication and coordination procedures with these agencies, and include a contact person, emergency phone and fax numbers, and e-mail addresses.

The success of an investigation comes down to thorough work, notification protocols, and networking. Leaving a department out of the loop can hinder an investigation; besides, it's an exercise in courtesy and diplomacy. Would you rather be questioned on a pending outbreak by the press or informed by a counterpart? Everyone knows the answer to that question. Typically, large outbreaks initiated at the local level progress to the state level.

Depending on the circumstances such as interstate commerce, the size of the outbreak, and the agent involved, federal notification by the state may take place.

USDA/FSIS/Meatborne Hazard Control Center; 1-800-535-4555

If the implicated or suspected food item is meat, poultry, or some egg products from a USDA-regulated plant, then the USDA would be notified through compliance officers in the field or directly into USDA's Consumer Surveillance Information System. Consumer complaints are also received on USDA's Meat and Poultry Hotline. So there are several channels through which information can flow.

Generally speaking, all other food products except domestic meat, poultry, and some egg products in interstate commerce fall under the FDA's jurisdiction. Typically, the state would contact its FDA District Office, and the district office would then notify the Division of Emergency and Investigational Operations in the FDA's headquarters. The district offices and DEIO also receive complaints from the public. If a complaint goes to the wrong agency, both FDA and USDA forward appropriate complaints back and forth and work together in investigations as necessary. Another example of teamwork!

EPA

In waterborne and environmental related outbreaks, the state may notify the Environmental Protection Agency (EPA). If there is a potential of contaminated drinking water coming into contact with foods in a processing plant or slaughterhouse, then both FDA and USDA would become involved. An example of interagency cooperation was the Cryptosporidium waterborne outbreak in Milwaukee, Wisconsin.

FORC-G

Depending on the size and nature of the outbreak, the pathogen involved or the need for certain lab tests, CDC can provide expert advice and assistance when requested. All federal agencies network and assist each other and the states, as appropriate, for foodborne illness investigations. The federal, state, and local agencies have developed a network called FORC-G, (pronounced "force-gee") "Foodborne Outbreak Response Coordination - Group." This outbreak evaluation group consists of the heads of various federal, state and local agencies to improve and coordinate the approach to multistate outbreaks. The FORC-G group reviews operations and networking after interstate outbreak investigations to see what worked well and what procedures could be improved or refined to develop standard operating procedures.

Good teamwork and strong communication are vital for resolving foodborne outbreaks. If your department does not already have a foodborne illness investigation team, then develop a plan. If you already have a team, then reevaluate procedures to make sure everything is the way it's supposed to be. Now that we've discussed planning for the investigation, let's move on to beginning the investigation.

Beginning the Investigation

Objectives

On completion of this module, participants will be able to:

  • Gather useful information on complaints.

  • Understand the significance of time of onset of symptoms, as well as, associations by time, place, and person.

  • Be able to develop a hypothesis and case definition.

  • Be able to outline an appropriate follow-up strategy to a potential foodborne illness outbreak.

Gathering Complaint Information

Reports of illness can come into the health department piecemeal. When a complaint is received, try to get as much information as possible up front. Trying to establish the relevant facts is difficult enough when you have all the information, but trying to establish the facts when reports are incomplete is next to impossible. To standardize data collection, most departments use a general complaint form to record information.

The booklet entitled Procedures To Investigate Foodborne Illness, published by IAMFES, the International Association Of Milk, Food and Environmental Sanitarians, shows an example of a general illness complaint form.

Categories in illness complaint form include the following:

  • identification

  • demographics

  • clinical information

  • exposure information

  • reporter information

Whether you are using a paper copy of the illness complaint form or computer program, the form can be broken down into categories such as personal identification, demographic, clinical, and exposure information.

Identification

Start with basic identification information on the caller such as name, address, and phone number for home and work. Additional information may be needed from the caller as the investigation progresses. Plan a follow-up contact. If the caller wants to remain anonymous, tell them it may be difficult to keep in touch as the investigation continues. Attempt to identify additional cases. Ask if the caller knows of anyone else who is ill. If you suspect an outbreak, get information about the event, the exposure, the number affected. Ask for the names of both ill and well individuals who attended the event, and be sure to get telephone numbers of the persons affected. The goal of a case investigation is to get as much relevant information as possible. Timing is important. Each bit of information may lead to more cases or contacts. If you can't get all the information on the first contact, then get the basics on the caller, the illness, and the food operation.

Demographics

Knowing demographic characteristics allows you to describe the people affected by an outbreak. Some demographic characteristics include, for example, age, gender, occupation, race, and education.

Clinical Information

Take time to talk with the caller about their clinical signs and symptoms. Discuss initial impressions and find out how the caller learned about the illness, possible diagnosis and any medical assistance sought, specific symptoms, time of onset, duration of illness. Have they seen a doctor? If yes, who? What was the diagnosis? Were they hospitalized? What tests or samples were done? What were the results? Was any treatment provided? Also ask about chronic conditions, allergies, or medications that could mimic the symptoms of foodborne illness.

Find out if samples were submitted for analysis and if results are available. If samples have not been submitted, you may want to request a sample. A follow-up call to the physician can confirm the information you have, and you may be able to obtain the results of any pending tests.

Let the caller tell you what they believe happened. Then work to obtain the full history. When you're busy, you may not want to spend a lot of time on a single case that could be a dead-end. But you never know. The single report could be the tip of an iceberg. If a second case is identified and verified, you won't want to waste time re-interviewing the initial caller. So when a complaint is received, get as much information as possible up front. Remember, the better the initial information, the more likely your chances of early identification of an outbreak.

Exposure

For a variety of reasons, when foodborne disease is suspected, information of foods consumed in the 72 hours prior to the onset of symptoms is requested. People have trouble remembering what they have eaten. It's not easy to obtain a food history, but the details contained in the food history are necessary for identifying potential exposures. The 72-hour time frame is used because recall gets very unreliable for foods consumed more than two to three days before an interview. Most people lead fairly routine lives, and a five- to seven-day food history could capture virtually everything they ever ate, increasing the difficulty in implicating a food vehicle. Also, the incubation period for many foodborne pathogens is 72-hours or less. Of course, there are exceptions. The incubation period for Hepatitis-A is 15 to 50 days; E. coli O157:H7 has an incubation of 3 to 8 days; and Trichinosis has an incubation range of 5 to 45 days.

The 72-hour food history should include all meals, snacks, and beverages, including water and ice eaten at commercial operations, as well as in the home. Find out where the foods came from. Were meals prepared on-site or catered, and did food come from outside sources? Ask if they noticed anything unusual about the foods, such as, off taste, texture, color, or odor. Find out if hot foods appeared fully cooked and were served hot and if cold foods were cold. If there is leftover food, give instructions for labeling and storing the food before it is taken to the lab for analysis.

When individuals can't recall the specific foods they ate, see if you can help them out: Ask about their food preferences, what they usually eat and where they have eaten lately. If you can't obtain a full 72-hour history, then try to obtain a facility-specific history. Ask about meals eaten out and then ask about meals eaten at home. A good wrap-up question could be "Is there any other information that may be relevant that you could provide?" Make sure that the caller knows that you may be calling them back if you need additional information. Also ask them to call you if they remember any other information about the event.

Many callers will attribute their illness to the last place they ate and may have already decided what food made them ill. We often assume that illnesses are foodborne in nature, but we need to keep an open mind to the idea that other factors may play a role. You don't want to put all your eggs in one basket. For example: there was a Salmonellosis outbreak, but the investigation did not reveal any food associations. The EPI evidence showed the common item among the cases was marijuana. The lab found the same type of Salmonella in both the marijuana and cases. So remember, the source of illness may not be food-related. Ask the caller if they have done anything unique or different recently. Ask about domestic or international travel and whether they've had contact with ill persons or with animals.

When an illness complaint is received, examine the symptoms, onset times, and the 72-hour food history. Use the food history to see what was consumed prior to onset of symptoms. Try to match up foods, incubation times, and symptoms that could be associated with the possible pathogens. Of course, you should go through this exercise when the caller reports a self-diagnosis and the pathogen and source are unknown. But even if you do have a medical diagnosis with a known pathogen and possible source, play "devil's advocate" and review the data for consistency. (Editor's comment: Make a distinction between an investigation that supports the first plausible explanation you think of and a legitimate investigation. It is bad form to identify a food vehicle and cause of illness based on incubation period and symptoms and then to design an investigation to prove the association.)

Symptoms One Hour After Eating

For example, say the illness report concerns a person complaining of tingling and burning sensations around the mouth, facial flushing, dizziness, headache, and vomiting about one hour after consuming a large tuna steak. Is this complaint plausible? A review of reference materials would indicate they are plausible. These symptoms and onset time suggests a toxin or chemical poisoning. Specifically, the symptoms and onset are similar to that of scombroid-type poisoning, where histidine is converted to histamine. That type of poisoning is most often associated with fish in the Scombroid family, of which tuna is a member. As a general rule, symptoms of chemical and toxin poisonings occur within one hour of ingestion. But keep in mind that some toxins and poisons can have a longer incubation period.

Nausea and Vomiting Less than Six Hours After Eating

Here's another situation. Say the illness report concerns a person complaining of only nausea and vomiting. You have a 72-hour food history. What part of the food history would you concentrate on? Look at what was consumed in the six hours prior to onset. Pathogens such as Staphylococcus aureus or the emetic form of Bacillus cereus would be good candidates for this time frame.

Cramps and Diarrhea, Six to 20 Hours After Eating

Say the illness report concerns a person complaining of only cramps and diarrhea. What incubation times would you expect? In general, for cramps and diarrhea only, look at what was consumed between six and 20 hours prior to symptom onset. Possible suspects may be Clostridium perfringens or the diarrhetic form of Bacillus cereus. If fever and diarrhea are symptoms, consider a possible infection. Illness with fever generally indicates an infection rather than intoxication.

Diarrhea and Fever, 12 to 72 Hours After Eating

Pathogens that infect typically require a longer incubation time to allow the organism to multiply in the body. Look at foods consumed about 12 to 72 hours prior to onset. Keep in mind that these are general rules. They give us a place to start; they're not absolutes.

Decide whether further investigation of a complaint is warranted.

There's a lot to consider here, including the number of cases, the agent, the severity of illness, and how long ago the illness occurred, not to mention the department's policies, investigation criteria, and resources. Determining whether you actually have a foodborne illness outbreak and deciding when to initiate action can be challenging. If you' re investigating a serious illness, the investigation could begin based on a single report. But for a less-serious illness, follow-up may be postponed until additional reports are received. Analysis and interpretation of surveillance data can help identify potential problems. For example, if a decision to follow up is made based on analysis of log entries, the investigator should determine whether an increase has actually occurred and whether the increase can be linked to an obvious common exposure. Evaluate the data to ensure that there is a plausible basis for the potential association and verify the diagnosis. It may be necessary to find more cases, collect more data.

Verify the Complaint

To verify a complaint, let your fingers do the walking! If the report says they saw a physician, call the physician; diagnosis may have been made based on symptoms. If clinical specimens were submitted, check with the lab.

Here's an example of a problem resulting from not verifying the complaint (a generic story). A complaint was called in, foods, symptoms, incubation times; it looked like they had a "textbook" case of staph or emetic Bacillus cereus. Two were hospitalized. The investigators rushed out to investigate. A few hours later at the facility, they received a call from the office telling them that those two at the hospital didn't exist and the caller's phone number was disconnected. He said that they felt set up. In their discussions with the facility owner, they were told that there was some guy in the previous night who ate $20 worth of food. After finishing it, he said he didn't like the food and shouldn't have to pay for it. I guess he ended up having to pay for the meal and thought it would be a great prank to phone in a complaint the next morning. If only they had made a phone call to verify before going out to investigate! Verify before you act.

Surveillance

Public health surveillance is a systematic way to keep your finger on the pulse of the community. To detect disease patterns and to control the spread of disease in the community, you must become familiar with your surveillance data. Data must be analyzed to identify individuals with similar symptoms or the same diagnosis. The description of community health that emerges from surveillance data should be communicated to health professionals on an ongoing basis.

Associations by Time, Place, and Person

 

Case report data from the surveillance log can be organized with respect to time, place, and person to find possible associations among cases with the same diagnosis or similar symptoms. For example, when you review reports, trust that "deja-vu" feeling. If individuals experience similar symptoms and onset times, they may have a common association with a particular place or event.

If there appears to be a meal in common that is associated with the illnesses, then the time between ingestion of the agent and the onset time provides the incubation period. The incubation period and symptoms are helpful clues in determining which diseases "could be" or "definitely are not" involved with the illness. Incubation times will vary among cases. That's why incubation periods are given over a range of time. The time frame the investigation team is concerned with is related to the suspected agent's incubation time. For example, let's say several reports of confirmed Salmonellosis were received over the last week and onsets for these cases occurred within 60 hours of each other. It is possible that these cases could share a common source of exposure, because all the onsets fall within one incubation period for Salmonella, typically 12 to 72 hours.

Associations by Time

When illness complaints are organized by time, the data may be displayed on a graph. Graphs show visually the relative size and trend of the problem and can be constructed to show daily or seasonal trends or time intervals that span several years. Graphing the data a few different ways will help you decide on the most appropriate and revealing time interval to use. Graphs are very useful for showing past trends and for predicting future trends. They can also provide insights into what may have caused the problem.

Reports of diarrhea onset by day of week in college students, November 3-9

Let's say several reports for a cluster of suspected Shigella illnesses were received, and the diarrhea onset times for the ill college students were graphed. The illnesses occurred Saturday, Sunday, and Monday. The typical incubation period for Shigella is between 24 and 72 hours. It is possible that the students shared a common source of exposure, as all of the cases fall within one incubation period. So if they ate any meals together Friday, one or more of the meals could be associated with the illnesses.

Association by Place

Reviewing illness reports with the same diagnosis or similar symptoms and onset times may show a common association with a particular place or event. Association by place refers to the attributes or factors that describe the environment in which the disease occurred, such as geographic location, county, town, food-service facility, business, residence, social event, purchasing food from the same place, or consumption of a specific brand of food. The data can be mapped, graphed, or tabulated to help you gain insight into the geographic extent of the problem.

Analyzing data by place may help you identify the most likely pathogen and may give you insight as to how illness could be spread. If the illness is associated with a particular place, then it's a safe place to start investigating to see whether the risk factors of illness are or were present.

If the students ate a meal together, the place associated with the illness can be determined as well. However, the only information the team may know about the source of illness is that cases are currently occurring over a broad locality such as the state, county, township, or college campus.

Associations by Person

Person associations refers the characteristics of ill individuals with similar symptoms or diagnoses of those who were exposed to the agent or suspect agent. Some categories used to group data by person are age group, gender, occupation, immune status, affiliations or group membership, extracurricular activities, or any other unique characteristic. It turns out that personal characteristics sometimes can be used to predict who is at greatest risk of becoming ill from a particular pathogen. You may have to group your data several different ways before deciding on the most appropriate and revealing person-category to use to get a better picture of the situation.

There are times when an outbreak may not be limited to a particular group of people. For example, the students who reported diarrhea may have eaten off campus, and possibly there are other nonstudents out there who may have also become ill. Once the associations for time, place, and person are known, control and prevention methods can be implemented.

Refer the example of the surveillance log. Remember, we had three entries of Hepatitis-A in two weeks with all having some association with the Hillside day-care center. Here, the association by place is easily identified, but sometimes the cases must be interviewed before time, place, and person associations can be identified. The question, "What is the correlation between Hepatitis-A and the day care?" can be answered only with follow-up.

Questions to Be Answered

These questions need to be answered: Who? What Disease? Where? When? Why? and How Many? to explain the illnesses and also Who else is at risk?

Who is Ill?

Three cases: a four-year-old boy, a four-year-old girl, and the day-care center cook -- a 42-year-old female.

What's the Disease or Agent?

The diagnoses were reported as Hepatitis-A.

Example of a Surveillance Log, Week 2

Case

#

Reported by Time of report Signs & symptoms, and lab results Time of onset Case's name, address, occupation & telephone # Age Sex Possible sources of exposure, per reporting individual Other similar cases
11 W. Hogan, MD

297-6834

1-17

3 p.m.

Hepatitis A

Dark urine, clay colored stool, tired, jaundice

1-12 Billy Michaels

4211 Maple Drive

4 M Unknown - attends Hillside Day Care Center X
12 G.M. Miller, MD

458-2211

1-18

10:30 am

Meningacaccal

Meningitis - headache, pain in legs, chills, fever, vomiting

1-14

5 p.m.

Anna Wilson

Bay City

17 F Unknown  
13 Anna Lewis

543-7918

1-18

10:45 am

Dog bite - puncture wound on left leg 1-18

am

Bobby Lewis

950 Rancho

543-7918

8 M Dog's owner - Fred Allgood

695 E Rancho

543-8842

 
14 W. Hogan, MD

297-6834

1-18

11:45 am

Hepatitis A

Vomiting, fever, dark urine, jaundice

12-31

7 p.m.

Idda May Jones

127 Hill Circle

Cook at Hillside Day Care Center

42 F Unknown - visited relative early in December X
15 F. Diaz, MD

223-8846

1-18

2 p.m.

Measles, fever, rash 1-14

8 am

Joey Hernandez

72 Rancho Road

224-7713

3 M Unknown - attends Hillside Day Care Center  
16 S. Menousek, MD

764-0241

1-18

2:45 p.m.

Hepatitis A 1-13 Susie Smith

238 Taft Street

448-7283

4 F Unknown - attends Hillside Day Care Center X
17 James, Mitchell, MD

Brassfield Hospital

247-8900

1-18

3 p.m.

Post op., staphylococcal infection 5 cases since

1-1

5 cases - hospital has records   F All are post op in general surgery wing  

Where Are Cases Occurring?

So far the only association for place is the Hillside Day Care.

When Did the Time of Onset for Each Report Take Place?

The four-year-old boy's time of onset was January 12; the young girl's was January 13; and the cook's was December 31.

Well, we know Hepatitis-A can be transmitted person-to-person or fecal-orally with food and water. The average incubation period is 28 to 30 days, with a range of 15 to 50 days. An infected person begins shedding the virus about half way through their incubation period and can continue for up to a week or more after onset. Based on onset times, it's conceivable that the cook may have been the source and food could be the vehicle of transmission. That sounds like a reasonable hypothesis and a good starting point for beginning an investigation. Once the associations for time, place, and person are known for a particular agent, control and prevention methods can be implemented.

So Who Is at Risk?

If Hillside Day Care is the actual source of exposure, then anyone attending the day care who has not already had the disease and all those not vaccinated against Hepatitis-A are at risk. Also, because secondary spread can occur with Hepatitis-A, anyone exposed to these cases, such as household contacts, could also be at risk too. Be on the lookout for more reports of Hepatitis-A as a result of secondary spread.

Remaining questions such as "How did the exposure occur?" and "Was Hillside Day Care the source of exposure?" can be answered only after follow up with these three cases and the day care center.

Taking Action

How do you know when you've reached a critical juncture to initiate action? The answer to that question is not straightforward. Some departments follow up every single foodborne illness complaint, while others may only follow up obvious outbreaks.

Begin by looking at the terms outbreak, cluster, and epidemic. They all refer to the frequency of a disease that is above background levels for an area or is above expected numbers over some time period. Typically the term cluster or outbreak is the preferred term over epidemic, because outbreak or cluster sound less provocative to the public.

Definition of Foodborne Illness Outbreak

The definition of a foodborne illness outbreak can be generally defined as "two or more people experiencing a similar illness resulting from the ingestion of a common food." The definition of an outbreak could also be expanded to specify that the foods are epidemiologically linked to the illnesses. But the epidemiological link won't be known until the investigation is well underway or completed.

However, that does not mean that a single case of suspected botulism, mushroom poisoning, ciguatera, paralytic shellfish poisoning, chemical or other toxin poisoning should not or could not be investigated. Many departments use this definition of an outbreak as a guide for developing their policies, but response to a situation also depends on the number of cases, the severity of the agent and how long ago illness occurred, as well as the department's resources.

Some jurisdictions require that more than two people meet the outbreak definition before starting an investigation while others will act on two, and some might even respond to a single report of illness. There is really no right answer when you are dealing with just a few illness reports. All food safety organizations should have or should develop policies for investigating foodborne illness. The important thing is to be flexible and not process-driven.

Decision to Follow Up

Many factors influence the decision to follow up. For example, is the affected population considered high-risk for exposure or serious illness? Are illnesses associated with the immunocompromised; for example, a nursing home or day-care center? Has anyone been hospitalized? What is the severity of the illness associated with the agent? Are the symptoms typical of foodborne illnesses, or are there neurological symptoms involved or bloody diarrhea? Remember, symptoms of foodborne illness can resemble underlying medical conditions, and because of the biological variability, everyone will not have exactly the same symptoms. Most infected people will have a similar range of symptoms, but some people may be asymptomatic (not show any symptoms). All of these factors can affect the timing and level of response.

Depending on the circumstances of the illness complaints, there may be several response options. Here are a few examples. A health department may receive a report from a doctor or lab regarding someone who works in food service who has been diagnosed with Salmonellosis, Hepatitis-A, or Shigellosis. Since an infected employee could be a potential for illness, sending an investigator to the facility and restricting the employee's activities or excluding them from work until they are no longer a health threat would be prudent.

Consider the situation in which the department receives a single illness complaint on a facility or one in which they may have received a string of sporadic complaints over the last few months. One option is to review the history of the food operation and send a sanitarian to investigate. The primary job of the inspector is to ensure that the operator is in compliance with safe food-preparation procedures. In essence, if any problems with food preparation procedures are noted and corrected, then any additional illnesses would be prevented.

A problem with passive surveillance is that some claims of illness are reported late, sometimes weeks after the event and the trail has turned cold. People who were ill no longer have symptoms. They can't remember everything they ate, and food samples are no longer available. In a situation like this, the sanitarian or investigator can simply follow up at the facility to ensure that safe food practices are in place.

Another problem situation is trying to follow up on claims of illness when people are uncooperative. People contact you initially and report the illnesses. Then, when the investigation begins and you need more information such as a list of names, food histories, symptoms, or specimens, they are not interested in participating. In situations like this, when you do not have enough information, you can at least evaluate the facility's food-preparation procedures.

Sometimes it's easy to tell when you have an outbreak. The calls come from several people who are ill after eating at a wedding reception, or a hospital emergency room calls to say they have several people sick who all ate at the same restaurant. Even in this type of situation don't forget to consider associations between person, place, and time. Don't have tunnel vision. Leave the blinders to skittish horses! Cast a wide net initially to make sure you haven't missed anything. In a situation where you have ongoing illnesses and people may continue to be exposed to contaminated food, a rapid response is critical. Activate your outbreak team early in the process. Involve the epidemiologist, public health nurse, sanitarian, and laboratory personnel, and thoroughly investigate the event. Exactly what the level of response is depends on your department policies.

That's some good advice. There are a lot of factors to consider when determining how to respond to complaints of illness. And, of course, using good old common "horse sense" helps, too. Unfortunately, most of the time we don't have very good information to start with.

Once you believe that there is sufficient information to initiate a foodborne outbreak investigation, verify the existence of a group of possible related cases that may be linked by a common food. Verify the diagnosis and reevaluate the information. If the information seems reasonably sound, then contact the team leader or supervisor as applicable. Also, depending on the circumstances, notify other state or local health officials.

Once a decision has been made to investigate, the facts concerning time, person, and place associations should be shared with those conducting the investigation. The team member who has the role of the epidemiologist should begin developing an initial hypothesis and initial working case definition. The search to find additional cases should also begin. As the investigation expands, the various steps of the investigation can be done simultaneously by different members of the team. You know the investigation will involve interviewing, developing EPI data, an environmental investigation, sample collection and analysis, and implementing control measures. Collect food and clinical samples early before potential samples are lost forever. Recognize that many of these steps just depend on the circumstances, and keep an open mind as you work through the investigation.

Use your investigative skills along with your understanding of the relationships between the agent, host, and environment for the known or suspect agents. Don't set out to just find a foodborne disease outbreak. The common exposure may be food, water, air, animals, or something in the environment. It's also possible that more than one pathogen may be involved.

Outbreak objectives:

  • Gather data as fast as possible

  • Define the problem

  • Identify the agent

  • Determine the cause or contributing factors

  • Control the risk of secondary transmission

  • Stop propagation of the agent

  • Prevent recurrence

Remember, the objectives of the investigation are to gather data quickly, accurately define the problem, identify the agent, determine the cause or contributing factors, control the risk of transmission from person to person, stop further propagation of the agent, and prevent the situation from recurring, and you also want to learn from the experience. Do not forget an important field axiom, "Get it while you can," before potential food and clinical samples are lost forever.

At the start of an investigation, there is a lot of missing information concerning the who, what, where, when, and why of the outbreak. One of the first steps is to organize what is known and develop the initial hypothesis. (Editor's note: This is probably true for the majority of simple outbreak investigations. However, in more complex situations, neglecting to do detailed hypothesis-generating interviews and not consulting with experts may lead to unsuccessful outcomes.) A hypothesis is a theory or speculation that is formulated in an attempt to explain how an event occurred. Often, cursory observations can appear to be facts, when they may or may not be true.

Usually the preliminary information is sketchy, but you have to start somewhere and have a rough idea as to where you're trying to go. The team needs some leads to follow. Whether the illness complaint is a self-diagnosis or medical diagnosis, examine the symptoms, onset times and 72-hour food history. Look back at what was consumed prior to onset, and try to match up possible incubation times, symptoms, and foods with possible agents and the illness. The first hypothesis may need to be broad in scope and cover all the plausible "could-be's." Obviously, there will be many missing pieces at this point.

The hypothesis should address, as well as possible with the limited information, the agent, source, mode of transmission, exposure periods, and possible contributing factors that caused the illness. As the investigation progresses, expect to update hypotheses as more facts are uncovered and the set of possibilities diminishes as previous "could-be's" are eliminated or modified. Keep in mind that it's possible for more than one pathogen, meal, menu item, or other environmental exposure to be implicated.

Example of Initial Hypothesis

Consider the scenario in which complaints are received on four individuals with symptoms of diarrhea, and two of them also had abdominal cramps. Food histories were completed on all four, and the only time, place, and person associations were eating at Albee-Jon's Restaurant on March 1. Three of the individuals had lunch, and the other had dinner there. If these meals at Albee-Jon's Restaurant were associated with the illness, then based on onset times, possible incubation periods are ranging from 11 to 20 hours. With this sketchy outline of information, we could develop an initial hypothesis of: Individuals eating at Albee-Jon's Restaurant on March 1 experienced diarrhea or diarrhea with abdominal cramps within 20 hours. Possible agents could be Clostridium perfringens or Bacillus cereus. The hypothesis was intentionally kept broad by i