Chapter Three
Chapter Three
an Outbreak
Section One: The 10 Steps in Investigating an Outbreak
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STEPS IN INVESTIGATING AN OUTBREAK
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Introduction
When an outbreak has been identified, the local health department (LHD) should
immediately notify the Infectious Disease Branch, Reportable Disease Section
at the Kentucky Department for Public Health (KDPH) and/or any other state
level office (e.g., Division of Public Health Protection and Safety, Division of
Laboratory Services, etc.) that might have expertise that could bear on the
investigation. The toll free number is 1-888-973-7678. These offices may assist
in coordinating the investigation, assist in the investigation itself if requested by
the LHD, and can be consulted on collection of food, clinical, and/or
environmental specimens.
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STEPS IN INVESTIGATING AN OUTBREAK
NOTE 2: Depending on staffing, resources and time, all the steps may not be
covered thoroughly or even covered at all. As stated previously, KDPH is
available for guidance and assistance. (Telephone numbers for KDPH are
included in this chapter and in Appendix A.)
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Once an outbreak is identified, final preparation for field work must occur. What
will be needed in the field? Who should go? Will food, water, money, or hotel
reservations be needed? Who needs to be informed in the office and at the
investigation site? How will communications occur and are contact information
sheets and clear directions available? What will be the goal of the field work?
What is the timeline? Who are the interested parties or stakeholders? Answers
to these types of questions will be crucial to a successful investigation.
Once the health department staff have been alerted to the possibility of some
unusual cases, or an unexpected increase in the number of cases of a particular
disease or group of symptoms, the first step is to make sure that the information
is correct and that there truly is an outbreak to investigate. What determines the
existence of an outbreak? The general rule is to compare the current rate of
occurrence of the disease to what “normally” occurs to determine if there is a
rise in cases beyond what is normally experienced. However, for diseases not
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STEPS IN INVESTIGATING AN OUTBREAK
often seen in a given area, two or more cases are usually the general rule for
declaring an outbreak.
Reporting of cases of illness can occur for any number of reasons that don’t
relate to a true outbreak. Misdiagnosis is a common occurrence and usually
happens in the absence of proper lab testing. Increases in reporting cases of a
disease may happen because a specialist starts practice in an area and identifies
and reports previously unrecognized cases. Media coverage may cause clinicians
to suspect a particular disease more often and report cases. The reportable
disease case definition (see Step 4) may change to include more people as
cases. Lab testing can bring about many false increases. For instance, a new lab
test may be created making testing possible, a more sensitive lab test might be
developed, more samples might be gathered and sent for testing because of
increased awareness among clinicians, or an increase in inappropriate testing of
people will naturally increase the false positive rate bringing about higher lab
reports of the disease. In all of these cases, the rate of occurrence of the
disease didn’t actually increase, but the number of reported cases appears to
indicate that it did.
Thus, one should always strive to establish the true existence of an outbreak by
comparing the incidence of the disease in a specified population during a
comparable previous time period. Often, individuals may exaggerate the
number or severity of cases related to a particular event or report “lots of people
have it” for a particular disease and once investigated this is not borne out by
the facts. It is often unclear when to conduct a full epidemiologic investigation.
There is usually no question when the team is notified about a large number of
people getting ill at approximately the same time after eating at the same
establishment or attending the same event. However, uncertainty arises when
sporadic complaints are reported. The response team will need to consider
whether the reports indicate that the affected cases are all suffering from the
same illness and whether there is any evidence of an association between them.
This underscores the need to follow-up (i.e., determine the validity of and initiate
further action if necessary) on every complaint received. It often occurs that
single complaints are actually related to an outbreak.
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When notified of an incident in which illness has resolved and no new cases have
been identified, the decision to conduct an epidemiologic investigation should be
based on an assessment of what will be gained. As stated above, an
investigation always serves as a learning tool. But, if resources (time, personnel,
etc.) are limited, a full investigation may not be warranted. Rather, one should
ensure that appropriate control measures have been implemented to prevent
future outbreaks.
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STEPS IN INVESTIGATING AN OUTBREAK
KDPH Contacts
Division of Public Health For policy and technical assistance with the
Protection and Safety, environmental investigation such as initiating
Food Safety Branch enforcement actions and collecting food samples. On-site
(502) 564-7181 investigation assistance is available to coordinate multi-
county or interstate outbreaks.
Division of Public Health For technical assistance with water sample collection.
Protection and Safety,
Environmental Management
Branch
(502) 564-4856
Division of Epidemiology For technical assistance with the epidemiologic
and Health Planning, investigation such as obtaining medical histories and
Reportable Disease developing questionnaires. On-site investigation
Section assistance is often available for larger outbreaks.
j or technical assistance
with the collection protocol
for food and
(502) 564-
4446
I stool specimens.
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The important elements to cover when obtaining initial clinical histories include
anything that might lead to the determination of a specific disease entity that is
responsible for this outbreak. Primary among these are specific symptoms of the
illness, details that could help determine the incubation period, contacts with
other sick people who might already be diagnosed or offer a broader symptom
profile, and prominent exposures that may have led to infection or poisoning. All
of these categories of information could indicate what kind of disease is the
etiologic agent in this outbreak. Remember, the information gathered is
confidential and should be shared with only those individuals involved
in the investigation.
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STEPS IN INVESTIGATING AN OUTBREAK
It is important to notify the lab prior to the submission of food samples and other
specimens. Food pathogen testing is time consuming and involved and the lab
needs time to plan and prepare. Each food pathogen has a unique protocol of
media and incubation temperature. Media is made on demand because it is
expensive and has short expirations.
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3.1.4 Step Four: Define a Case and Identify and Count Cases
A case definition is a set of criteria for deciding whether an individual ill person
should be classified as a case. The case definition places boundaries on who will
be counted as a case, so the investigation does not include those with illnesses
unrelated to the outbreak. This step helps to get an idea of the magnitude of the
problem and records all cases for follow-up in the investigation.
Symptoms: People with the same illness do not always have the same
symptoms, but they will experience similar ones. It is important to
remember that the symptoms of some foodborne and waterborne
illnesses can mimic other foodborne and waterborne diseases. For
assistance in determining the incubation period and possible etiologic
agent, please refer to the Kentucky Field Guide for Foodborne and
Waterborne Diseases in Appendix C as well as the Control of
Communicable Diseases Manual.
c) Person: The outbreak may or may not take place within a particular
group of people. Therefore, characteristics such as age, sex, occupation,
ethnic group, social affiliations or function attendance greatly assist in
qualifying the case definition.
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STEPS IN INVESTIGATING AN OUTBREAK
The initial case definition is usually general so that potential cases are not left
out. Once more information is obtained about the outbreak and the team is
more certain of the characteristics of true cases, the case definition may be
refined to “weed out” extraneous cases. This allows analysis to be more sensitive
to true risk factors because ill persons who are probably not related to the
current outbreak are excluded.
Case definitions are often broken into sub-categories based on the strength of
evidence that this is a true case of the disease or is truly related to the particular
outbreak being investigated. These designations are usually, “suspect,”
“probable,” and “confirmed.” A suspect case is usually one that has some
symptoms similar to known cases, but may be missing a crucial symptom or may
not link clearly to known cases and is not lab-confirmed. A probable case usually
has all the crucial characteristics but is missing a final component of
confirmation, such as a required final lab test, or an epidemiologic link to a
known case. A confirmed case meets all the characteristics established in the
case definition for a true case. CDC has established guidelines for the suspect,
probable and confirmed case definitions for many diseases. Investigators may
want to modify these for a particular outbreak investigation to fit the current
investigation needs.
Finding Cases
With the case definition in place, the next half of the equation is to decide how
to find additional cases, (i.e., routine methods versus more intensive methods).
Is it reasonable to rely on telephone reporting from physicians? Should case
reports be actively solicited from area physicians, laboratories, or hospitals?
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Should the help of the local media be enlisted? These are all “judgment calls”
which must be made while taking into account the severity of the disease, how
widespread it is, the urgency of intervention, and the manpower available to find
and interview case patients.
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x What are the symptoms, date of onset, their order of occurrence and
duration?
x What medical treatment has been sought and received?
x Did anyone affected get a diagnosis or do they have laboratory results?
x Who else has been exposed to a case during his or her infectious period?
(secondary contacts)
x What foods were consumed in the last 72 hours, or other appropriate time
frame, before the time of onset? It is also important to interview and obtain
food histories from those who ate the same suspect food and did not get sick.
These questions are intended as a guide. They will require modification to fit the
particular circumstances surrounding the investigation. Questionnaires can be
designed for personal or telephone interviews by the investigator
(epidemiologist, nurse, sanitarian, health agent, etc.). Once again, it is
important to administer the questionnaire to all associated with the exposure
event, both ill and well.
The KDPH Enteric Disease Investigation Form should be completed for all
confirmed or suspect Campylobacter, Cryptosporidium, Salmonella, Shiga toxin-
producing E. coli (STEC), and Shigella cases. This form may also be used for
suspected foodborne or waterborne outbreaks when the specific source or
pathogen is not known. See Appendix I for the KDPH Enteric Disease
Investigation Form.
NOTE: The KDPH Enteric Disease Investigation Form can be found in Appendix
I.
There is a computer software program called Epi InfoTM which can be used to
develop questionnaires and analyze data. (The software is free. A copy can be
obtained via the internet at www.cdc.gov/epiinfo ). For more information about
when to use a questionnaire, contact the Division of Epidemiology and Health
Planning, Reportable Disease Section at (502) 564-3261.
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NOTE: An epidemic curve is a graph that depicts the association of the time
of illness onset of all cases that are associated with the outbreak. It helps to
determine whether the outbreak originated from a common source or is spread
person-to-person. Time is plotted on the horizontal axis and the number of cases
is plotted on the vertical axis.
http://cphp.sph.unc.edu/focus/vol1/issue5/1-5EpiCurves_flash.pdf
From the line listing and/or survey described above (Steps 3 and 4), information
will have been collected on the characteristics of the ill persons (age, sex,
occupation, exposures to specific foods or other items). Very often, simply by
knowing these descriptive aspects and the diagnosis, and then plotting an
epidemic curve, the source, mode of transmission, and who is at risk can be
determined. Once the population at risk has been determined, appropriate
control measures can be targeted.
The shape of the epidemic curve may suggest what kind of outbreak is
occurring. A common-source or point-source outbreak looks different than a
propagated-source, a person-to-person outbreak or a continual source outbreak.
Definitions of these kinds of outbreaks, and an example of each epidemic curve
are found below. Epidemic curves are not only useful in pursuit of the
investigation but are also helpful when communicating to lay persons
(consumers, restaurant operators, etc.) the nature and magnitude of the
outbreak spread.
NOTE: The following pages contain definitions and examples of the different
kinds of outbreaks:
x Common-Source or Point-Source Outbreak
x Propagated-Source Outbreak or Person-to-Person Outbreak
x Continual-Source Outbreak
x Intermittent-Source Outbreak
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STEPS IN INVESTIGATING AN OUTBREAK
Example 3.1
Point Source Outbreak Epidemic Curve
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Example 3.2
Propagated-Source Outbreak Epidemic Curve
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Example 3.3
Continual-Source Outbreak Epidemic Curve
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Example 3.4
Intermittent Source Outbreak Epidemic Curve
Using the information gathered so far, the next step is to consider which specific
exposure(s) may have caused the disease and develop a hypothesis (or several
hypotheses). A useful hypothesis is testable, sensible, and fits the full picture of
what has been learned as much as is possible. One example of a simple
hypothesis is: The cases became ill after eating at a local restaurant. A more
specific example, arrived at after further investigation, might be: The illness was
caused by eating the potato salad at the Restaurant X’s salad bar on Tuesday,
June 5th.
As stated in Step 5 above, very often simply by knowing the descriptive aspects,
the diagnosis, and then plotting an epidemic curve, the source, mode of
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One very important point in hypothesis development is that it is the job of the
team to find the actual cause of the outbreak and not to prove or disprove any
particular theory. Many times, a cause may seem obvious at first review but as
the investigation progresses facts seem to conflict with this theory. It can be a
strong temptation, especially when a scenario fits into the category of “what
usually happens” in a certain type of outbreak, to bend the facts to fit the theory
rather than bending the theory to fit the facts. The latter course is what should
happen and needs to be protected against over-exuberant team members who
have a pet hypothesis to prove.
Cohort Study
Cohort studies are used when a whole group of people who might have been
exposed can be surveyed to test hypotheses about what caused the illness. This
is the typical study done in foodborne outbreaks when one can identify all who
ate at a restaurant, for example. All people had an equal chance of being
exposed but only some got sick. This type of study can be done retrospectively,
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and commonly is in foodborne outbreak investigations. All people who ate at the
restaurant during a given period of time are asked what specific food items they
ate and if they became ill. We then compare food exposures to illness status to
determine what food items might have caused the outbreak.
When doing analysis in a cohort study design, the common measure of exposure
is the Relative Risk (RR). When several sources of exposure are implicated
(a fairly common situation), the epidemiologist can run a model on the computer
that compares all the food items at once and arrives at relative risks for each
item compared to all the others so that the one with the greatest likelihood of
being the culprit can be identified.
Risk
Risk is the percentage of people who become ill divided by all who were at risk
and in an acute outbreak setting is represented by the Attack Rate.
And
Relative Risk (RR)
A Relative Risk is a proportion. It is the risk among those exposed to some risk
factor divided by the risk among those who are not exposed. For example, in a
restaurant outbreak, if 28 of 90 people who ate asparagus got ill (31.11%) while
only 3 of 98 who didn’t eat it got sick (3.06%), the RR is 31.11 / 3.06 = 10.2. In
other words, people who ate asparagus were 10.2 times more likely to become ill
than those who did not eat asparagus.
Case/Control Study
Case/control studies are used primarily when the illness is rare or when it is
easier to select participants for the study based on illness status. This is
different from a cohort study because participants are selected not on where
they ate, or swam, or lived, but on whether they got sick or not. This can be
used in the typical restaurant outbreak when there are so many patrons that
surveying them all would not be possible. In this case, all or a random selection
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of sick patrons can be enrolled in the study and then controls, or well people
who also ate at the restaurant, can be selected randomly from restaurant
patrons or groups of patrons. The primary measure of association that is used
with case/control studies is the Odds Ratio (OR). This compares the “odds of
exposure” to particular sources of infection between cases and controls,
indicating the most likely sources.
Odds
An “Odds” of something happening is the probability of it happening divided by
the probability of it not happening. In the case of outbreak investigation, it is
applied to the probability of having a risk factor among those who are ill or not
ill. For example, if we have 31 sick people in a particular outbreak and 28 of
them ate the asparagus, then the odds of exposure to asparagus among the sick
is (28/31) / {1 – (28/31)} = 9.33.
and
Odds Ratio (OR)
The Odds Ratio is a ratio of the odds of having exposure to a particular risk
factor among the sick divided by the odds of having the risk factor among those
who are not ill. To continue the example above, if we find additionally that 26
ate asparagus among 62 people who did not get sick then the odds of exposure
to asparagus among these controls is (26/62) / {1 – (26/62)} or 0.72. Thus, the
Odds Ratio for the odds of exposure to asparagus between the ill (cases) and not
ill (controls) is 9.33 / 0.72 or 12.96. Interpreting this, ill people were nearly 13
times as likely as not ill people to have eaten asparagus.
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Analytic studies often reveal results that require modifications of, or fail to
confirm, the hypotheses that were originally generated. Additional sources of
infection may be identified through the investigation. The existing hypotheses
may need to be modified or new hypotheses generated. In either case, the
hypotheses will need to be tested requiring further studies be conducted.
For example, based on evidence gathered, the team generates a hypothesis that
the salad was the vehicle of transmission in a salmonella outbreak. The next
logical questions are, “How did the salad become contaminated with salmonella
and could this be verified with the results of the environmental investigation?” In
other words, are the epidemiologic results plausible and consistent with other
investigational findings? For instance, salad is not usually a food that harbors
salmonella. However, it can become contaminated when ill or infected food
handlers prepare the salad without adequate hand washing or use of gloves.
Compare hypotheses to the results of the environmental investigation. Did the
inspector note how the salad was made and served? Was it possible for this
scenario to have happened? Was any of the salad available for lab testing? Can
laboratory results confirm that salmonella found on the salad matches that found
in a patient’s stool specimen? Some of the questions that need to be addressed
to make sure that the hypothesis is not only statistically sound, but makes sense
in the real world are:
NOTE: Not all outbreaks have a resolution. In fact, it is rare when everything
comes together and a cause can be definitively determined. Investigators should
not become discouraged. Careful development of epidemiologic inferences
coupled with persuasive clinical and environmental evidence will almost always
provide convincing evidence of the source and mode of the spread of a disease.
In most cases, there will be enough evidence to present a plausible hypothesis.
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Control Measures
Once an outbreak is identified, control measures are important for interrupting
disease transmission and/or limiting exposure to the source of infection. If a
pathogen or other suspected source of the outbreak is identified, control
measures should target specific agents, sources, or reservoirs of infection.
The objectives of foodborne and waterborne outbreak control measures are:
x Control of Source
x Control of Secondary Transmission
x Prevention Future Outbreaks
Control of Source
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Although the business may have already issued a press release, the Public
Health agency may decide to notify the public. Ideally, this should be
coordinated with the business and done on the same day as the decision
to close a facility or recall a food product. Information given to the public
should include:
o Actions the consumers should take to prevent further exposure and
illness
o Name and brand of the food product (including labeling) being
recalled
o Name and location of the implicated facility (e.g. swimming pool
name, city, state)
o The nature of the problem, the reason for the facility closure or
recall of the product, and information about how the problem was
discovered
o Names and locations of the food producing establishment and point
of contact
o Locations where the product is likely to be found
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Public Advice
If contamination of the water or food product cannot be controlled at the source,
or a facility cannot be temporarily closed, steps need to be taken to eliminate or
minimize the opportunities for further transmission of the pathogen. Depending
on the situation, appropriate public advice may be issued during a period of
hazard. For example:
x Cleaning/disinfecting high-touch or high-risk areas, such as, areas in the
bathroom
x Boiling microbiologically contaminated water or avoidance of chemically
contaminated water
x Advice on proper preparation of foods
o Avoid cross-contamination
o Thoroughly wash fruits and vegetables prior to cutting
x Advice on proper disposal of implicated foods
x Emphasizing personal hygiene measures (e.g. washing hands after
defecation and urination and before preparing or consuming food)
x Avoid eating food that has not been handled properly (e.g. hot food that
has not been kept hot, cold food that has not been kept cold)
x If an individual has diarrhea, do not prepare food for others, until
symptoms have stopped
x If an individual has diarrhea, do not swim in pools or hot tubs, until
symptoms have stopped
x Public notices to avoid swimming/bathing in suspected bodies of water
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*When making decisions to exclude individuals, the legal and economic impact of
exclusion of individuals from work or school should be considered.
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Mode of transmission
Prevention of spread
o Infection control precautions
Procedures for proper food handling
Proper personal hygiene practices
Personal Protective Equipment (PPE)
Cleaning/Sanitizing surfaces and equipment
Isolation of ill individuals in hospitals, healthcare facilities, or
institutions
Disposal or decontamination of contaminated clothing,
surfaces, or bedding
The report should follow one of two suggested formats: 1) scientific format or
2) After Action Report format. The usual scientific format follows the
following outline: introduction, background, methods, results, discussion,
recommendations, and references. The After Action Report format should be
used if an LHD Operations Center or State Health Operations Center (SHOC) is
activated and should follow this outline: Handling Instructions; Contents;
Executive Summary; Section 1: Event Overview, including Event Details, Event
Leadership, and Participating Organizations; Section 2: Event Summary,
including Event Purpose, Objectives, Capabilities and Activities, Scenario
Summary, Supporting Events or Event; Section 3: Analysis of Capabilities;
Section 4: Conclusion; and the following appendices, as appropriate: Appendix A:
Improvement Plan
Appendix B: Lessons Learned (optional); Appendix C: Participant Feedback
Summary (optional); Appendix D: Event Summary Table (optional); Appendix E:
Performance Ratings (optional); Appendix F: Acronyms.
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NOTE: For detailed information on writing a report and sample reports see
Chapter 4.
NORS
Command
All large-scale outbreaks, outbreaks involving multiple jurisdictions, or multiple
outbreaks occurring simultaneously should be managed using the Incident
Command System (ICS). The Incident Command System is a standardized,
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The following is a basic command structure that may be used when the KDPH
SHOC is activated in response to disease outbreaks.
The KDPH SHOC Plan provides the framework for management of any type of
incident of public health significance, including disease outbreaks. The KDPH
SHOC Plan provides detailed information related to activation levels and
operations during any event of public health significance, including multiple
outbreaks occurring simultaneously.
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Support Agencies:
x Local Health Departments
x Regional Child Care Consultants
x KDPH Division of Epidemiology and Health Planning
o Public Health Preparedness Branch
x KDPH Division of Public Health Protection and Safety
o Food Safety Branch
o Environmental Management Branch
x KDPH Division of Laboratory Services
x KDPH Division of Maternal and Child Health – Early Childhood
Development Branch – Early Childhood Promotion Section
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x Cabinet for Health and Family Services (CHFS) Office of the Inspector
General
x CHFS Office of Communications
x Kentucky Department of Corrections
x Kentucky Department of Agriculture
x Kentucky Department of Fish and Wildlife
x Kentucky Energy and Environment Cabinet
x Kentucky Emergency Management
x Centers for Disease Control and Prevention (CDC)
x U.S. Food and Drug Administration (FDA)
x U.S. Department of Agriculture (USDA)
Surge Capacity
When LHDs and KDPH have exceeded their ability to respond, there are
resources available to assist in the response.
x Epidemiology Rapid Response Team (ERRT) – the ERRT is a state-
wide cadre of individuals, environmentalists, nurses, and epidemiologists,
who are trained in epidemiological methods and have the expertise to
conduct outbreak investigations. Each ERRT member has a sign-off sheet
on file with KDPH signifying agreement by their health department that
they may be used as surge capacity during epidemiological investigations
anywhere in the Commonwealth of Kentucky.
o This resource may be accessed by making a request the
respective LHD housing the ERRT members. This process is
further outlined in the Disease Outbreak Investigation
Support Plan (under development).
x KDPH Program Staff – In addition to the ERRT, there are KDPH staff
members who can assist with data entry, data analysis, interviews, and
other epidemiological activities. These individuals are employed in various
Divisions across the Department and may be accessed by a request to
their supervisor.
x Other Departments and Agencies – staff from other departments or
agencies in the State may be available to assist with various aspects of
outbreak investigations, these may include regulatory and inspection
functions related to food or water.
x Medical Reserve Corps – Kentucky maintains a volunteer program,
sponsored by the Office of the Surgeon General of the United States, for
both medical and non-medical volunteers. Each county in Kentucky is
covered by a Medical Reserve Corps unit, with most units being sponsored
by local health departments in conjunction with local emergency
management agencies. All MRC volunteers are pre-credentialed and
trained to respond during large-scale public health emergencies to provide
surge capacity. These volunteers may be called upon during large-scale
outbreaks; outbreaks involving multiple jurisdictions; or multiple outbreaks
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After Action Reports and Corrective Action Plans from all foodborne and/or
waterborne outbreak investigations shall be reviewed on an annual basis in
conjunction with the annual review of this manual, thereby allowing any
corrections or additions to be addressed during the manual update.
Reporting Requirements
Report all outbreaks in NORS and as appropriate, the AAR/IP should be recorded
in the Homeland Security Exercise and Evaluation Program (HSEEP) Corrective
Action Program System (CAP).
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