disease confirmation. Limitations should be identified and addressed.
The type of diagnostic test and cutoff point or dilution used to define
categories of cases may be included in the case definition.
The type of test (e.g. ELISA, PCR, etc.), and any additional particulars
specific to the testing, should be included if applicable.)
The test should adapt to changing technology as new methods are
established and are determined superior to older methods.
Case classification
(definition
categories)
Case classifications usually represent various levels of certainty and
include categories such as suspect, probable, and confirmed.
Categories should be clearly defined and mutually exclusive.
Levels of certainty may be defined using clinical signs identified
through physical examination of the animal, antemortem or
postmortem laboratory diagnostic tests, gross necropsy findings,
histopathology, or the opinion of a recognized expert such as a
foreign animal disease diagnostician (FADD).
Reporting criteria may vary depending on level of certainty.
Required
comments
Surveillance plans may require certain forms of disease to be
reported (e.g., fever, encephalitis, or meningitis); documentation of
the vaccination status of the animal, herd, or flock; type of vaccine
used; or lot number. Environmental exposure history of the animal,
flock, or herd; history of arthropod exposure; or history of importation
of animals, semen, or embryos from an endemic country or state may
also be needed. Other information such as feedstuff or water source,
evidence of foreign animal disease exposure or intentional release, or
reproductive status could also be included in the case definition.
1.8 Data Sources
Standard:
All data sources for the surveillance system are clearly identified.
Supporting Information:
Surveillance efforts typically rely on data from multiple sources. Some examples of data
sources include:
Producers
Private practitioners or veterinary teaching hospitals
Veterinary diagnostic laboratories, (e.g., university, State, Federal, or private)
Government agencies, Federal, State, and local (e.g., animal health and agriculture
agencies: FSIS, NASS, ERS, CSREES, FSA, RMA, RD, NRCS, etc., U.S. customs or
border patrol, EPA, USGS, DHS, DHHS, Census Bureau, and others)
Brand
inspectors
Affiliations or
professional organizations, (e.g., milk marketing boards, registries)
Businesses, (e.g., abattoirs, packing plants, pharmaceutical companies, zoos)
Livestock
markets
Slaughter
plants
Renderers
Business reporting services
Surrogate/proxy
data
Aerial
imagery
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The surveillance documents should clearly describe all data sources that the surveillance
system is expected to include, as well as associated strengths and limitations.
1.9 Sampling Methods
Standard:
Sampling methods are thoroughly detailed in a surveillance plan or equivalent
document.
a. The sampling methods include methods to assure: geographic
representation without introducing spatial bias, an appropriate level of
sampling, and a measurement method that ensures appropriate
denominator information for analysis.
b. Sample size is determined with appropriate mathematical and
epidemiological justification including measures of overall sensitivity
such as design prevalence, detection limit, and level of confidence.
c. Sampling methods include information on modes of data collection,
triggers for data collection, frequency of data collection, and transmittal
of field or laboratory data to program managers or coordinators.
d. Sampling strategy should address and avoid unintentional bias, (e.g.,
sample selection, collection, reporting, and confounders.)
e. Test sensitivity, specificity, and predictive values are considered in the
sample strategy.
f.
Methods of data collection are described for each identified data source.
g. Sampling methods carefully consider data sensitivity and confidentiality
issues. See Chapter 3 for data confidentiality standards. Applicable
Federal regulations should be noted.
h. Changes to sampling methods for the surveillance system are
appropriately documented and include a rationale for the change.
Supporting Information:
All sampling procedures and protocols, including field and laboratory data collection
techniques, should be documented, including changes to data collection procedures as new
procedures are identified to enhance the system. This information may be found in
surveillance plans, uniform methods and rules, the code of Federal regulations, or annual or
progress reports. See Chapter 3 for additional information on training staff for data collection
and data confidentiality standards.
Population parameters are clearly described, including populations involved in the study and
surveillance as well as populations for which inferences are being made. See standard 1.6,
population characteristics.
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