Justification for Addition of Data Elements

September 13, 2017

Attachment 9. Justification for the Addition of Disease-Specific Data Elements
143 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Congenital Rubella Syndrome (CRS), Salmonellosis, Shigellosis,
Campylobacteriosis, Shiga toxin-producing Escherichia coli (STEC), Hepatitis, and Hantavirus Pulmonary
Syndrome (HPS). Names, descriptions, value sets, and justification for the addition of these new data elements
are below:
Congenital Rubella Syndrome (CRS): 8 Data Elements
Justification: The addition of these 8 data elements will contribute to enhanced surveillance efforts on the part
of the CDC program and allow the program to perform additional epidemiological analyses for CRS.

PHINU-ID

Data Element Name

Data Element Description

INV323

At the time of cessation of
pregnancy, what was the
age of the fetus (in weeks)?

If applicable, at the time of cessation of
pregnancy, what was the age of the fetus (in
weeks)?

DEM124

Birth State

State where the subject was born

MTH167

Mother's Country of
Residence

What is the mother's country of residence?

TBD

Mother's pre-pregnancy
serological test date.

If pre-pregnancy serological testing was
performed, what was the date of mother's
pre-pregnancy serological test?

TBD

Mother's pre-pregnancy
serological test
interpretation.

If pre-pregnancy serological testing was
performed, what was the interpretation of
mother's pre-pregnancy serological test?

63893-2

Pregnancy outcome

What was the outcome of the current
pregnancy

VAC129

Number of doses received
on or after 1st birthday

The number of vaccine doses against this
disease which the mother received on or after
their first birthday

VAC142

Date of last dose prior to
illness onset

Date of mother's last vaccine dose against this
disease prior to illness onset

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September 13, 2017

Salmonellosis: 11 Data Elements
Justification: The addition of these 11 data elements will enable the program to collect the minimum
information required to determine if a case had a high risk of exposure and determine case classification.

PHINU-ID

TBD

Data Element Name

Data Element Description

Occupation/Industry/Place
of Business

Is patient employed in a high risk occupation
(e.g., food handler, healthcare worker, daycare
worker)?

Child care attendee

Did patient have a high risk exposure related to
child care facility?

Long term care facility
resident

Did patient have a high risk exposure related to
residence in a long term care facility?

Contact of a Salmonellosis
case

Did patient have a high risk exposure related to
contact with a Salmonellosis case?

Method(s) of laboratory
testing

Type of laboratory testing performed

Name of test

Name of laboratory test performed

Name of test manufacturer

Name of test manufacturer

Probable case from CIDT
testing

Probable case status confirmed by CIDT testing

Probable case from Epilinkage

Probable case confirmed by Epi-linkage

Reported symptoms and
signs of illness

Symptoms and signs associated with illness

WGS (Whole-Genome
Sequencing) ID

The identifier used in PulseNet for the whole
genome sequenced isolate that corresponds to
the reported case

TBD

TBD

TBD

TBD
TBD

TBD

TBD

TBD

TBD

TBD

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Shigellosis: 12 Data Elements
Justification: The addition of these 12 data elements will enable the program to collect the minimum
information required to determine if a case had a high risk of exposure and determine case classification.

PHINU-ID

TBD

TBD

Data Element Name

Data Element Description

International travel in the 7
days prior to onset

Did patient travel internationally within 7 days
of illness onset?

Occupation/Industry/Place
of Business

Is patient employed in a high risk occupation
(e.g., food handler, healthcare worker, daycare
worker)?

Child care attendee

Did patient have a high risk exposure related to
attendance at a child care facility?

Long term care facility
resident

Did patient have a high risk exposure related to
residence in a long term care facility?

Contact of a Shigellosis case

Did patient have a high risk exposure related to
contact with a Shigellosis case?

Method(s) of laboratory
testing

Type of laboratory testing performed

Name of test

Name of laboratory test performed

Name of test manufacturer

Name of test manufacturer

Probable case from CIDT

Probable case status confirmed by CIDT
(Culture Independent Diagnostic Testing)

Probable case from Epilinkage

Probable case confirmed by Epi-linkage

Reported symptoms and
signs of illness

Symptoms and signs associated with illness

TBD

TBD

TBD

TBD

TBD

TBD

TBD

TBD

TBD

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TBD

WGS (Whole-Genome
Sequencing) ID

The identifier used in PulseNet for the whole
genome sequenced isolate that corresponds to
the reported case

Campylobacteriosis: 11 Data Elements
Justification: The addition of these 11 data elements will allow the program to collect the minimum information
required to determine if a case has a high risk of exposure and determine case classification.

PHINU-ID

Data Element Name

Data Element Description

TBD

Reported symptoms and
signs of illness

Symptoms and signs associated with illness

TBD

Travel in 10 days prior to
illness

Did the case have travel outside of the U.S. in
the 10 days before the illness began?

TBD

Consumption of
undercooked/ raw meat

Did the case eat undercooked or raw meat
before the illness began?

TBD

Consumption of
undercooked/ raw poultry

Did the case eat undercooked or raw poultry
before the illness began?

TBD

Drinking untreated water

Did the case drink untreated water before the
illness began?

TBD

Contact with untreated
recreational water

Did the case have contact with untreated
recreational water before the illness began?

TBD

Consumption of raw milk
or unpasteurized dairy

Did the case consume raw milk or
unpasteurized dairy before the illness began?

TBD

Contact with pets, farm
animals with
Campylobacter species

Did the case have contact with pets or farm
animals from which Campylobacter species
were isolated?

TBD

Contact with
confirmed/probable case
of Campylobacteriosis

Did the case have contact with another
probable or confirmed case of
Campylobacteriosis?

TBD

Consumption or exposure
to implicated vehicle

Did the case consume or have exposure to a
vehicle implicated in an outbreak or a location
in which an implicated food vehicle was
prepared or eaten?

TBD

WGS (Whole-Genome
Sequencing) ID

The identifier used in PulseNet for the whole
genome sequenced isolate that corresponds to
the reported case
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September 13, 2017

Shiga toxin-producing Escherichia coli (STEC): 85 Data Elements
Justification: The addition of these 85 data elements will allow the program to address: 1) efforts to improve
responsiveness to outbreak-related infections, 2) emerging or newly discovered vehicles for infection, and 3)
disease-specific outcomes of public health importance. Inclusion of these variables align with recommendations
by the Council for State and Territorial Epidemiologists (CSTE) and additional input from state and local public
health agencies that reflect the variety of data elements routinely collected by the state public health
departments during patient interviews.

PHINU-ID

Data Element Name

Data Element Description

Probable – laboratorydiagnosed

Probable case is laboratory-diagnosed

Probable – epi-linked

Probable case is epidemiologically linked

TTP

Patient had a diagnosis of TTP (Thrombotic
thrombocytopenic purpura)

Ill contact

Patient had close contact with anyone with diarrhea or
vomiting in the 7 days prior to illness onset

Gourmet cheese

Patient consumed artisanal or gourmet cheese in the 7
days before illness onset

TBD

Specify other leafy greens

Specify other leafy greens

TBD

Sprouts location

Purchase location of sprouts

TBD

Sprouts brand

Brand and variety of sprouts

Treated recreational water

Visit or swim in any treated recreational water facilities in
7 days prior to illness onset

TBD

Untreated recreational
water

Visit or swim in any untreated recreational water
facilities in 7 days prior to illness onset
Location of treated recreational water facilities

TBD

Treated recreational water
location
Untreated recreational
water location

Location of untreated recreational water facilities

TBD
TBD

Other related diagnosis

Other related diagnosis

TBD

TBD
INV937
FDD_Q_1013

TBD

TBD

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September 13, 2017
Specify other related
diagnosis

Specify other related diagnosis

Shopper card consent

Consent to retrieve purchases based on shopper card
information

TBD

Ground beef at home brand

Brand and variety of ground beef consumed at home

TBD

Steak at home brand

Brand and variety of steak consumed at home

TBD

Steak at home frozen

Steak consumed at home was purchased frozen

TBD

Steak at home fresh

Steak consumed at home was purchased fresh

TBD

Bison brand

Brand and variety of bison

TBD

Wild game brand

Brand and variety of wild game

TBD

Dried meat brand

Brand and variety of dried or fermented meat

TBD

Other dried meat brand

Brand and variety of other dried or fermented meat

TBD

Pork

Patient consumed pork in 7 days prior to illness onset

Pork at home

Patient consumed pork at home in 7 days prior to illness
onset

Pork at home purchase
location

Purchase location of pork consumed at home

TBD
TBD

Pork at home brand

Brand and variety of pork consumed at home

TBD

Pork at home ground

Pork consumed at home was ground

TBD

Pork at home whole

Pork consumed at home was whole pig

TBD

Pork at home other form

Pork consumed at home was other form

Specify other form of pork
at home

Specify other type of pork consumed at home

TBD

Pork away from home

Patient consumed pork away from home in 7 days prior
to illness onset
Purchase location of pork consumed away from home

TBD

Pork away from home
location

TBD

Pork away from home dish

Dish in which pork was consumed away from home

TBD

Raw milk location

Purchase location of raw milk

TBD

Raw milk brand

Brand and variety of raw milk

TBD
TBD

TBD

TBD

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TBD

Raw cheese

Purchase location of cheese made from raw milk

TBD

Raw cheese brand

Brand and variety of cheese made from raw milk

TBD

Raw cheese aged

Cheese made from raw milk was aged for 60 days

TBD

Gourmet cheese location

Purchase location of artisanal or gourmet cheese

TBD

Gourmet cheese brand

Brand and variety of artisanal or gourmet cheese

TBD

Raw juice location

Purchase location of unpasteurized juice or cider

TBD

Raw juice brand

Brand and variety of unpasteurized juice or cider

Other raw dairy product

Patient consumed any other unpasteurized dairy product
in 7 days prior to illness onset
Specify other unpasteurized dairy product

TBD

Specify other raw dairy
product
Other raw dairy product
location

Purchase location of other unpasteurized dairy product

TBD

Brand and variety of other unpasteurized dairy product

TBD

Other raw dairy product
brand
Raw dough

Patient ate, tasted, or licked uncooked or unbaked dough
or batter

Leafy greens

Patient consumed fresh, uncooked leafy greens in 7 days
prior to illness onset

TBD

Leafy greens location

Purchase location of fresh, uncooked leafy greens

TBD

Leafy greens brand

Brand and variety of fresh, uncooked leafy greens

TBD

Loose leafy greens

Patient consumed loose fresh, uncooked leafy greens

Prepackaged leafy greens

Patient consumed prepackaged fresh, uncooked leafy
greens

TBD

Cabbage

Patient consumed cabbage in 7 days prior to illness onset

TBD

Cabbage location

Purchase location of cabbage

TBD

Cabbage brand

Brand and variety of cabbage

TBD

Arugula

Patient consumed arugula in 7 days prior to illness onset

TBD

Arugula location

Purchase location of arugula

TBD

Arugula brand

Brand and variety of arugula

TBD

TBD
TBD

TBD

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TBD

Kale

Patient consumed kale in 7 days prior to illness onset

TBD

Kale location

Purchase location of kale

TBD

Kale brand

Brand and variety of kale

Premade salad

Patient consumed pre-made, single-serving salads in 7
days prior to illness onset

TBD

Premade salad location

Purchase location of pre-made, single-serving salads

TBD

Premade salad brand

Brand and variety of pre-made, single-serving salads

TBD

Other prepackaged leafy
greens

Patient consumed other pre-packaged leafy greens or
salad kits

TBD

Other prepackaged leafy
greens location

Purchase location of other pre-packaged leafy greens or
salad kits

TBD

Other prepackaged leafy
greens brand

Brand and variety of other pre-packaged leafy greens or
salad kits

TBD

Other leafy greens location

Purchase location of other leafy greens

TBD

Other leafy greens brand

Brand and variety of other leafy greens

Herbs

Patient consumed fresh herbs in 7 days prior to illness
onset

TBD

Specify herbs

Specify fresh herbs

TBD

Herbs location

Purchase location of fresh herbs

TBD

Herbs brand

Brand and variety of fresh herbs

TBD

Specify petting zoo

Specify petting zoo

TBD

Specify type of livestock

Specify type of livestock

TBD

Specify fair

Specify fair or event with animals

TBD

Pet

Patient has a pet of their own

TBD

Specify pet

Specify pet

TBD

Specify institution

Specify institution

Treated recreational water
type

Types of treated recreational water facilities

TBD

Types of untreated recreational water facilities

TBD

Untreated recreational
water type

TBD

TBD

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September 13, 2017
TBD

Occupation

Patient’s occupation

TBD

Food allergy

Does the patient have a food allergy?

TBD

Special diet

Is the patient on a special diet?

Hepatitis: 12 Data Elements
Justification: The addition of these 12 data elements will allow the program to collect the minimum information
required to meet CSTE reporting requirements for the case definitions of Perinatal Hepatitis. The concepts
determine possible maternal infection with hepatitis, maternal treatment for hepatitis that may mitigate infant
hepatitis exposure, additional risks to infant, determine outbreak clusters, infant health at time of birth, and to
evaluate effectiveness of maternal therapy for Hepatitis prior to infant delivery and determining proper
administration of immunoglobulin.

PHINU-ID

Data Element Name

Data Element Description

TBD

Maternal HBeAg result, date

Maternal HBeAg result, date

TBD

Maternal HBV DNA (or
genotype), result, date

Maternal HBV DNA (or genotype), result, date

TBD

Maternal Alanine
aminotransferase (ALT)

Maternal Alanine aminotransferase (ALT)

TBD

Maternal antiviral therapy, if any

Maternal antiviral therapy, if any

TBD

Maternal Coinfection with
human immunodeficiency virus
or hepatitis C virus

Maternal Coinfection with human
immunodeficiency virus or hepatitis C virus

TBD

Maternal State/Territory of
residence at time of infant’s
diagnosis

Maternal State/Territory of residence at time of
infant’s diagnosis

TBD

Infant Birthweight

Infant Birthweight

TBD

Infant Time of birth (military
time)

Infant Time of birth (military time)

TBD

Infant State/Territory of birth

Infant State/Territory of birth
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TBD

HCV RNA (NAAT) test results

HCV RNA (NAAT) test results and timing of test
performance

TBD

HCV genotype test results

HCV genotype test results and timing of test
performance

TBD

HCV antigen test results

HCV antigen test results and timing of test
performance

Hantavirus Pulmonary Syndrome (HPS): 4 Data Elements
Justification: The data elements included in this change request allow the program to information on: whether a
pet exposure has occurred, whether blood was noted in a patient’s urine, and whether protein was noted in a
patient’s urine. If the site of exposure was the residence, the addition of the street address data element allows
CDC to geo-tag the location and represent it on a map. This adds an enhanced degree of detail not captured
with zip codes along. Including these data elements will allow CDC to improve data quality, better understand
the epidemiological contexts for exposure, and better delineate symptomology for HPS.

PHINU-ID

Data Element Name

Data Element Description

TBD

Proteinuria

Was Proteinuria detected?

TBD

Hematuria

Was Hematuria detected?

TBD

Exposure occurred from
pet rodent

Did exposure occur from a pet rodent?

DEM225

Street address

What is the patient’s street address?

10