Justification for Disease Specific Data

Attachment 10. Justification for the Addition of Disease-Specific Data Elements
208 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for 16 conditions: Anthrax, Brucellosis, Campylobacteriosis, Cholera,
Cryptosporidiosis, Hansen’s Disease, Leptospirosis, Melioidosis, Multisystem Inflammatory Syndrome (MIS)
associated with Coronavirus Disease 2019 (COVID-19), 2019 Novel Coronavirus Disease (COVID-19), S. Paratyphi
Infection, S. Typhi Infection, Salmonellosis, Shiga toxin-producing Escherichia Coli (STEC), Shigellosis, and
Vibriosis. Names, descriptions, value set codes (the answer list for coded data elements from CDC vocabulary
server (PHIN VADS) which can be accessed at http://phinvads.cdc.gov), and justification for the addition of these
new data elements are below:
Anthrax: 25 Data Elements
The impetus/urgency for CDC
to add data elements for this
condition

Data Element Name
Route of Infection

1

•

To allow Bacterial Special Pathogens Branch (BSPB) to conduct
enhanced domestic surveillance for anthrax due to the potential for
Bacillus anthracis to be used as a bioweapon, the likelihood for severe
illness; and the potential need to distribute antitoxin, other medical
supplies, and materiel support from federal assets.
• To aid in identifying other individuals who may be at risk of infection
and to identify an area of potential exposure, information about route
of infection, occupation, sources of exposure, and location of potential
exposures is needed. The source and location exposure data elements
also will inform if the source is naturally acquired or is a potentially
intentional spore release.
• Treatment type and hospital testing will guide decisions on whether
additional medical countermeasures are needed to be deployed to
hospitals and understand severity of disease.
• To help with determining specific risk factors for severe illness, which
will aid with case triage algorithms to ensure people at greater risk can
be seen more rapidly for treatment.
• All source and location exposure data elements will only be asked for
cases that are naturally acquired (domestically or internationally), and
for the first cases during an intentional spore release to identify the
exposure area. Once the exposure area is defined, these additional
questions will not be asked unless a case does not have any known
associations with the known exposure area.
Value Set Code
CDC
Data Element Description
Priority1

Suspected primary route of
infection at time of evaluation
(select all that apply):

R=Required; 1=Priority 1, 2=Priority 2, 3=Priority 3

1

TBD

1

International
Destination(s) of Recent
Travel

List all international
destinations (country)
traveled during the 14 days
prior to illness onset

2

Travel State

List all domestic destinations PHVS_State_FIPS_5-2
(state) traveled to during the
14 days prior to illness onset

Public Transportation
Route

Specify public transportation
route (e.g. name/number)

N/A

3

Date Using Public
Transportation

Specify date(s) using public
transportation

N/A

3

Exposure Source

Indicate the type of exposure
the patient had in the 14 days
prior to illness onset.

TBD

1

Type of Animal Exposure

Types of exposure to animal.

TBD

3

Animal Type

If exposure type is Animal
contact, specify animal the
subject had contact with in
the 14 days prior to illness
onset. If the subject had
contact with multiple animals
complete separate repeating
groups for each one.

TBD

2

Lab Name

If worked in a clinical,
microbiological, or animal
research laboratory, specify
lab.

N/A

2

Contact Type

If linked to confirmed case or
contact with similar illness or
sign and symptoms, indicate
type of contact.

TBD

2

Location of Contact

If linked to confirmed case or
contact with similar illness or
sign and symptoms, indicate
geographic location where
contact occurred (e.g. city,
country, state).

N/A

2

2

PHVS_Country_ISO_3166-1

2

Illicit Drug Specify

If subject had contact with
illicit drugs, specify the name
or type of the drug.

N/A

2

Location Name

Location name of place or
event.

N/A

2

Location Address

Location address of place or
event (e.g. country, city, state,
county.)

N/A

3

Attendance Date

List all date(s) of event or
place attendance.

N/A

2

Locations Routinely
Visited

Specify the name of a place
that was routinely visited in
the 14 days prior to illness
onset, such as a place of
worship, volunteer, gym, etc.

N/A

3

Time of Day

List the time period during the
day when the place was
visited

TBD

3

Date of last dose

Date last received anthrax
vaccine

N/A

2

Post-exposure or
Treatment

Indicates if medication
received is for post-exposure
or anthrax treatment.

TBD

1

Alcohol use frequency

In the past 30 days, how often
does the patient take
alcoholic drinks?

TBD

3

Alcohol use quantity

On the days when the case
patient drank, about how
many drinks did the case
patient drink on average?

N/A

3

Hospital Procedure

If subject was hospitalized,
were any of the following
procedures or treatments
done?

TBD

3

Diagnostic Test Findings

Results from procedures or
treatments done in the
hospital.

TBD

3

3

Treatment Type

Listing of treatment or
medical intervention the
subject received for this
illness.

TBD

3

Treatment Type Indicator

Indicate if treatment was
administered.

PHVS_YesNoUnknown_CDC

3

Brucellosis: 9 Data Elements
The impetus/urgency for CDC
to add data elements for this
condition

Data Element
Name

•

To allow Bacterial Special Pathogens Branch (BSPB) to conduct
enhanced domestic surveillance for brucellosis.
• Monitoring Brucella spp.-related exposures and infections is important,
due to the pathogen’s select agent status and the potential for the
pathogen to cause severe illness.
• To allow for appropriate follow-up and monitoring of exposures to
Brucella spp. in laboratory and occupational settings which can lead to
infection.
• To help BSPB learn more about risk factors for brucellosis, track cases’
treatment to reduce the risk of relapse, identify situations where
others may have been exposed (and potentially identify case clusters),
and track exposure events to mitigate the risk of developing brucellosis.
• To help BSPB update recommendations for case and exposure
monitoring, inform outreach activities, and target health
communications to populations that are at higher risk of being exposed
to Brucella.
Value Set Code
CDC
Data Element Description
Priority1

Name of the physician or
clinician who diagnosed and/or
treated the subject

N/A

3

Physician Name

Physician Phone

Phone number of the patient's
clinician/provider of care

N/A

3

PHVS_YesNoUnknown_CDC

2

Treatment Drug
Indicator

Were antimicrobials prescribed
or administered to the subject
for this illness or following an
exposure?

Antibiotic dose
units

Dose units of the antimicrobial
prescribed or administered

PHVS_UnitsOfMeasure_CDC

2

Medication Stop
Date

What was the date that the
case patient stopped taking
antimicrobials

N/A

3

4

International
Destination(s) of
Recent Travel

List all international destination PHVS_Country_ISO_3166-1
(country) traveled to during six
months before symptom onset
or diagnosis

1

Travel State

List all domestic destination
(state) traveled to during six
months before symptom onset
or diagnosis.

PHVS_State_FIPS_5-2

2

Travel County

List all intrastate destination
(county) traveled to during six
months before symptom onset
or diagnosis.

PHVS_County_FIPS_6-4

3

PHVS_YesNoUnknown_CDC

2

Specimen
Was the specimen for culture
Collected Prior to collected prior to antimicrobial
Therapy
therapy?

Campylobacteriosis: 1 Data
Element
The impetus/urgency for
CDC to add data elements
for this condition

Data Element Name
PulseNet ID

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodbore and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code
CDC
Data Element Description
Priority1
State lab ID submitted to
PulseNet

N/A

1

Cholera: 2 Data Elements
The impetus/urgency for
CDC to add data elements
for this condition

Data Element Name

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code
CDC
Data Element Description
Priority1

5

PulseNet ID

State lab ID submitted to
PulseNet

N/A

1

WGS ID Number

Whole Genome Sequencing
(WGS) ID Number

N/A

1

Cryptosporidiosis: 2 Data
Elements
The impetus/urgency for
CDC to add data elements
for this condition

Data Element Name

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code
CDC
Data Element Description
Priority1
N/A

1

CryptoNet ID

Unique CryptoNet ID (formed by
concatenating [Case Year]-[State
Lab ID]-[Specimen Type][Reporting State]-[Reporting
Country]) where Specimen Type
is: ES for Environmental, HS for
Human, or AS for Animal.

WGS ID Number

Whole Genome Sequencing
(WGS) ID Number

N/A

1

Hansen’s Disease: 5 Data
Elements
The impetus/urgency for
CDC to add data elements
for this condition

•
•

•

To improve CDC’s understanding of Hansen’s disease
epidemiology
To identify challenges to diagnoses
To possibly prevent further transmission and lifelong disability
given the increase in disease incidence and lack of information
related to type of leprosy, family or household contacts,
treatment received, or even history or previous diagnosis that is
currently received via current notifications to CDC
Value Set Code

Data Element Name
Location of Initial
Diagnosis

Data Element Description
Indicate the location of the
initial diagnosis of Hansen's
Disease

CDC
Priority1

PHVS_LocationofInitialDiagnosis_Hansen 3

6

What was the date that the
case patient stopped taking
antimicrobials

N/A

2

Medication Stop Date

Indicates if medication
received is for postexposure or Hansen's
treatment.

TBD

2

Post-exposure or
Treatment
Post-Exposure
Prophylaxis Medication

If answer is yes to the
previous question regarding
household contacts of the
patient receiving
prophylaxis, please specify
PEP

N/A

2

History of Treatment
for Latent or Active TB

Does the case patient have
a history of being on
treatment for latent or
active TB?

PHVS_YesNoUnknown_CDC

3

Leptospirosis: 5 Data
Elements
The impetus/urgency for CDC
to add data elements for this
condition

Data Element Name

•

To better understand the clinical presentation and severity of
leptospirosis cases in the U.S., which will in turn help: evaluate and
revise, if necessary, the U.S. case definition for leptospirosis, inform
improved identification of leptospirosis cases by clinicians, and help
quantify the burden and outcome of leptospirosis cases in the U.S.
• To identify adverse effects of leptospirosis in pregnant patients and
their fetus/neonate
• To identify potential hotspots for leptospirosis exposure/infection by
linking exposure types with exposure location
• To detect emerging risk factors/risk groups for leptospirosis in the U.S.
• To clarify the questions in the case report form and improve the quality
and usefulness of the data collected to better inform public health
practice
• To inform CDC recommendations on leptospirosis case identification
and management, control and prevention, and inform local outreach
and prevention efforts
Value Set Code
CDC
Data Element Description
Priority1

Patient Address City

Patient Address City

N/A

2

Immunocompromised
Associated Condition or
Treatment

If the patient has an
immunosuppressive condition,
specify the condition.

N/A

3

7

Days Missed Due to
Illness

Number of days of work or school
the patient missed due to this
illness?

N/A

3

Container Lid

If the subject had contact with well
water, cistern water, or rainwater
collected in a drum or other
container, did the well, cistern or
other container have a lid?

PHVS_YesNoUnknown_CDC

3

Rodent Location

Where did the subject see rodents
or evidence of rodents?

TBD

3

Melioidosis: 103 Data
Elements
The impetus/urgency for CDC
to add data elements for this
condition

Data Element Name

•

Although B. pseudomallei is a Tier 1 overlap Select Agent, melioidosis is
not nationally notifiable. Consequently, CDC receives reports from
jurisdictions on a voluntary basis.
• The disease is most commonly associated with areas of Southeast Asia
and Northern Australia but predicted to have a wider global distribution.
Most cases reported in the United States are those who have traveled to
endemic areas, but the CDC has recently identified cases of melioidosis
from travel within the Americas and in areas outside these historically
known endemic regions.
• CDC recently identified the first documented transmission of B.
pseudomallei from a freshwater aquarium to a human.
• The proposed additional data elements are necessary to improve
understanding of the risk factors for as well as the temporal and
geographic occurrence of melioidosis, and aid in facilitating its
prevention and control.
Value Set Code
CDC Priority1
Data Element Description

State or Local Public
Health Laboratory/LRN
POC- Name

Name of the laboratory
person who is the lab POC for
this investigation

N/A

1

State or Local Public
Health Laboratory/LRN
POC- Phone number

Phone number of the
laboratory person who is the
lab POC for this investigation

N/A

1

State or Local Public
Health Lab/LRN POC
Email Address

Email address of person who is N/A
reporting cases to CDC

1

State or Local Public
Health Lab/LRN POCAffiliation

Affiliated Facility of the state
LRN/lab POC

1

8

N/A

Case origin/type

Is this a human or animal
case?

TBD

1

Country of travel
destination

Choose a country for each
destination

International Region

Enter region (list multiple if
applicable)

N/A

3

Dates of International
Travel

Enter dates of travel (multiple
if applicable)

N/A

2

Contact with soil or
water in International
travel destination

Was the subject contact with
soil or water during this visit?

Specific location of
exposure for
International Travel

If yes to Question above,
indicate specific location of
exposure

Other close contacts
with same soil/water
exposures (International
Travel)

If yes to Question above,
indicate whether other close
contacts also had the same
soil/water exposure

Number of close
contacts (International
Travel)

If yes to Question above, list
the total number of close
contacts

Relationship
(International Travel)

If yes to Question above,
select relationship to subject
(select all that apply)

2
PHVS_Country_ISO_3166-1

2
PHVS_YesNoUnknown_CDC

Significant weather or
environmental events
during this visit
(International Travel)

Were there any significant
weather or environmental
events during this visit?

Specific weather or
environmental events
(International Travel)

If yes to Question above,
select all
weather/environmental
events

3
N/A
3

PHVS_YesNoUnknown_CDC
3
N/A
3
TBD
2

PHVS_YesNoUnknown_CDC
3

TBD

Contact with soil or
water in melioidosisendemic areas

Has subject ever been in
contact with soil or water in
melioidosis-endemic areas?

PHVS_YesNoUnknown_CDC

2

Contact with soil or
water in melioidosis-

If yes, date of contact in
YYYYMM format.

N/A

2

9

endemic areas service
Date
Travel within U.S. but
>50 miles from
residence

Did the subject travel 50 miles
or more outside his or her
normal residence but within
the U.S. 30 days prior to
onset?

2

PHVS_YesNoUnknown_CDC

State

Choose a state each
destination

PHVS_State_FIPS_5-2

2

City/town

Please indicate city/town (list
multiple if applicable)

N/A

3

Dates of Travel

Enter dates of travel

N/A

2

Contact with soil or
water in travel
destination

Was the subject contact with
soil or water during this visits?

Specific location of
exposure

If yes to Question above,
indicate specific location of
exposure

Other close contacts
with same soil/water
exposures

If yes to Question above, were
there other close contacts also
had the same soil/water
exposure

2
PHVS_YesNoUnknown_CDC
N/A

3

3

PHVS_YesNoUnknown_CDC

Number of close
contacts

If yes to Question above, list
the total number of close
contacts

N/A

3

Relationship

If yes to Question above,
select relationship to subject
(select all that apply)

TBD

3

Significant weather or
environmental events
during this visit

Were there any significant
weather or environmental
events during this visit?

Specific weather or
environmental events

If yes to Question above,
select all
weather/environmental
events

2
PHVS_YesNoUnknown_CDC
TBD

10

3

Travel (in the last 10
years)

In the 10 years before
symptoms onset, did the
patient travel outside of the
continental U.S. or to an area
in the U.S. where the
endemicity is possible

2

PHVS_YesNoUnknown_CDC

Country of travel
destination (in the last
10 years)

Choose a country for each
destination

N/A

2

Region of travel in last
10 years

Enter region (list multiple if
applicable)

N/A

2

Dates of Travel (in the
last 10 years)

Enter dates of travel

N/A

2

Contact with soil or
water in travel
destination (in the last
10 years)

Was the subject contact with
soil or water during this visit?

Specific location of
exposure (in the last 10
years)

If yes to Question above,
indicate specific location of
exposure

N/A

3

Other close contacts
with same soil/water
exposures (International
Travel)

If yes to Question above,
indicate whether other close
contacts also had the same
soil/water exposure

PHVS_YesNoUnknown_CDC

3

Number of close
contacts (International
Travel)

If yes to Question above list
the total number of close
contacts

N/A

3

Relationship
(International Travel)

If yes to Question above,
select relationship to subject
(select all that apply)

TBD

3

Significant weather or
environmental events
during this visit
(International Travel)

Were there any significant
weather or environmental
events during this visit?

PHVS_YesNoUnknown_CDC

2

Specific weather or
environmental events
(International Travel)

If yes to Question above,
select all
weather/environmental
events

TBD

2

2

PHVS_YesNoUnknown_CDC

11

Specify other or abscess
for "specimen source"

If abscess or other specimen
selected, please specify

N/A

2

Date of LRN
confirmation, if
applicable

Enter Date of Confirmation by
LRN

N/A

3

AST Request

Is the jurisdiction requesting
AST on the isolate

TBD

3

Dates of Hospitalization

Give reporting jurisdiction
ability to enter multiple
hospitalizations if needed

2
N/A

Pneumonia/pleural
effusion

Did the subject have
pneumonia/pleural effusion

PHVS_YesNoUnknown_CDC

2

Skin/soft tissue
infections

Did the subject have skin/soft
tissue infection

PHVS_YesNoUnknown_CDC

2

Genitourinary infection

Did the subject have
genitourinary infection

PHVS_YesNoUnknown_CDC

2

Neurologic infection

Did the subject have
neurologic infection

PHVS_YesNoUnknown_CDC

2

Pericardial effusion

Did the subject have
pericardial effusion

PHVS_YesNoUnknown_CDC

2

Bone or joint infection

Did the subject have
bone/joint infection

PHVS_YesNoUnknown_CDC

2

Internal abscesses

Did the patient have internal
abscesses

PHVS_YesNoUnknown_CDC

2

Select or specify
location of abscesses

If yes, for internal abscesses,
please select all that apply

TBD

2

Additional notes
describing abscesses

If yes for internal abscesses,
additional notes (number,
location of abscesses)

N/A

2

Septic Shock

Did the subject have septic
shock

PHVS_YesNoUnknown_CDC

2

Bacteremia

Did the subject have
bacteremia

PHVS_YesNoUnknown_CDC

2

Date antimicrobial
Treatment ended

Indicate the date antimicrobial
treatment ended

N/A

2

12

Liver disease

Does subject have liver
disease

PHVS_YesNoUnknown_CDC

2

Excess alcohol abuse

Does subject have history
chronic alcohol abuse?

PHVS_YesNoUnknown_CDC

2

Chronic granulomatous
disease

Does the subject have chronic
granulomatous disease?

PHVS_YesNoUnknown_CDC

2

Malignancy

Does the subject have
malignancy?

PHVS_YesNoUnknown_CDC

2

Systemic lupus
erythematous

Does the subject have
systemic lupus erythematous?

PHVS_YesNoUnknown_CDC

2

Prior splenectomy

Does the subject have a
history of prior splenectomy

PHVS_YesNoUnknown_CDC

2

Immunosuppressing
drugs

Is the subject on any
immunosuppressing
medication

PHVS_YesNoUnknown_CDC

2

Other
immunocompromising
condition

Does the patient have any
other immunocompromising
conditions

PHVS_YesNoUnknown_CDC

2

Patient's Occupation

What is the patient's
occupation

N/A

2

Recreational Gardener

Is the patient a recreational
gardener?

PHVS_YesNoUnknown_CDC

2

Is this case part of a
cluster?

Is this case part of a cluster?

PHVS_YesNoUnknown_CDC

3

Exposure to Iguanas

In the 30 days prior to
symptoms onset did the
patient own or have direct
contact with an iguana?

PHVS_YesNoUnknown_CDC

2

Type of Iguana

Indicate type of iguana if yes
to previous question

N/A

2

Type of exposure

Indicate type of exposure if
yes to exposure to iguana

TBD

2

If owned, how acquired

If owned an iguana, indicate
how case patient acquired

TBD

2

Location of purchase or
where acquired

Location of purchase/where
acquired (name of river, lake,

N/A

2

13

park, or location of pet store,
for example)
Exposure to Pet Fish

In the 30 days prior to
symptoms onset did the
patient own or have direct
contact with pet fish?

PHVS_YesNoUnknown_CDC

2

Type of pet fish

Indicate type of pet fish if yes
to previous question

N/A

2

Type of exposure

Indicate type of exposure if
yes to exposure to pet fish

TBD

2

If owned, how acquired

If owned a pet fish, indicate
how case patient acquired

TBD

2

Location of purchase or
where acquired

Location of purchase/where
acquired (name of river, lake,
park, or location of pet store,
for example)

N/A

2

Exposure to Aquatic
Plants

In the 30 days prior to
symptoms onset did the
patient own or have direct
contact with aquatic plants?

PHVS_YesNoUnknown_CDC

2

Type of aquatic plant

Indicate type of aquatic plant
if yes to previous question

N/A

2

Type of exposure

Indicate type of exposure if
yes to exposure to aquatic
plants

TBD

2

If owned, how acquired

If owned aquatic plant,
indicate how case patient
acquired

TBD

2

Location of purchase or
where acquired

Location of purchase/where
acquired (name of river, lake,
park, or location of pet store,
for example)

N/A

2

Exposure to Other
Animals

In the 30 days prior to
symptoms onset did the
patient own or have direct
contact with other animals

PHVS_YesNoUnknown_CDC

2

Type of "Other Animal"

Indicate type of other animal if N/A
yes to previous question
14

2

Type of exposure

Indicate type of exposure if
yes to exposure to "other
animal"

TBD

2

If owned, how acquired

If owned "other animal",
indicate how case patient
acquired

TBD

2

Location of purchase or
where acquired

Location of purchase/where
acquired (name of river, lake,
park, or location of pet store,
for example)

N/A

2

Laboratory exposures
identified

Were potential laboratory
exposures identified in this
investigation

PHVS_YesNoUnknown_CDC

1

Name of Facility
(Exposures)

Name of facility/hospital
where exposures were
identified

N/A

2

City/town (Exposures)

City of facility where
exposures were identified

N/A

2

State (Exposures)

State where the facility where
the exposures were identified

PHVS_State_FIPS_5-2

2

Number of
laboratorians exposed

Total number of laboratory
personnel exposures

N/A

1

High Risk

Number of laboratory
personnel with high-risk
exposures

N/A

2

Low Risk

Number of laboratory
personnel with low-risk
exposures

N/A

2

Minimal Risk

Number of laboratory
personnel with minimal
exposures

N/A

2

Date of Exposure

For each laboratory personnel,
date of exposures

N/A

2

Risk Factors

Does the laboratory personnel
have risk factors for
melioidosis

TBD

2

Laboratory Activity

Select activity that resulted in
exposure

TBD

2

15

Risk Category

For each laboratory personnel
and each activity, select risk
category

TBD

2

Serologic Monitoring

Did the laboratory personnel
undergo serologic monitoring

TBD

2

Received post-exposure
prophylaxis

Did the laboratory personnel
receive post-exposure
prophylaxis

TBD

2

Reported Symptoms
(lab exposures)

Did the laboratory personnel
report symptoms within 21
days of exposure

TBD

2

Onset Date (lab
exposure)

If the laboratory personnel
reported symptoms, please
provide onset date

N/A

2

Describe Symptoms

If the laboratory personnel
reported symptoms, describe

N/A

2

Multisystem Inflammatory
Syndrome (MIS) associated
with Coronavirus Disease
2019 (COVID-19): 44 Data
Elements
The impetus/urgency for
CDC to add data elements
for this condition

•

•

•
•

To allow the CDC COVID-19 response to conduct enhanced domestic
surveillance Multisystem inflammatory syndrome in children (MIS-C)
which was first identified in April 2020 and was reported out of the UK.
This new but severe condition has temporal association with SARS-CoV2. Due to the urgency in collecting these cases to learn more about this
condition a national surveillance system was rapidly developed.
This new syndrome does not have a diagnostic test and relies on the CDC
MIS-C case definition for diagnosis. Due to the reliance on the case
definition the data elements listed below need to be completed on the
case report form to gather the necessary details to decide if a case
meets the case definition or not.
Obesity has been shown as a comorbidity for SARS-CoV-2 so we are
collecting related data elements, this allows us to learn more about a
potential link with obesity and increased risk of MIS-C.
To assist with determination of timeline from COVID-19 to MIS-C to
better determine the course of illness. Determination of which children
are at risk for MIS-C and those that have MIS-C which specific risk factors
lead to severe illness. This will allow for more rapid diagnosis, and
treatment of MIS-C.
16

•

Data Element
Name

Data elements will allow for better characterization of MIS-C, potentially
leading to an update of the case definition and more streamlined
diagnosis.
• All health departments have set up their reporting databases to align
with the requested data elements for streamlined reporting and
standardization of reporting.
Value Set Code
CDC
Data Element Description
Priority1
Multisystem inflammatory
syndrome identifier.

N/A

1

Health
Department ID

Health Department identifier.

N/A

1

NCOV ID

COVID-19 identifier (if available)

N/A

1

Abstractor name

Name of person compiling
medical records and/or
interviews.

N/A

1

Date of
abstraction

Date of abstraction

Temperature if
fever

Fever >38.0°C for ≥24 hours, or
report of subjective fever lasting
≥24 hours

MIS ID

1
N/A
1
N/A

Inflammation
Laboratory markers of
laboratory markers inflammation (including, but not
limited to one or more; an
elevated C-reactive protein
(CRP), erythrocyte
sedimentation rate (ESR),
fibrinogen, procalcitonin, ddimer, ferritin, lactic acid
dehydrogenase (LDH), or
interleukin 6 (IL-6), elevated
neutrophils, reduced
lymphocytes and low albumin),

TBD

1

Signs and
symptoms

Evidence of clinically severe
illness requiring hospitalization,
with multisystem (>2) organ
involvement.

TBD

1

Signs and
symptoms
indicator

Indicator for associated sign and
symptom

1
PHVS_YesNoUnknown_CDC

17

No alternative
plausible diagnosis

Is there no alternative plausible
diagnosis?

SARS-COV-2 test

Positive for current or recent
SARS-COV-2 infection (select all
applicable tests)

PHVS_YesNoUnknown_CDC

1

1
TBD

Symptom onset
within 4 weeks of
exposure

COVID-19 exposure within the 4
weeks prior to the onset of
symptoms

1

Date of symptom
onset

If yes, date of first exposure
within the 4 weeks prior

N/A

Height

Height specified in inches

N/A

1

Weight

Weight in pounds

N/A

1

Body Mass Index

Body Mass Index

N/A

1

Patient
Epidemiological
Risk Factors

Underlying medical conditions
or risk behaviors for the case
patient.

Patient
Epidemiological
Risk Factors
Indicator

Provide a response for each
value in the risk factors value
set.

Type of
complication

Complications associated with
the illness being reported

Type of
complication
indicator

Provide a response for each
complication.

ICU Admission
Date

If admitted to the ICU, ICU
admission date

N/A

Days in ICU

Number of days in ICU

N/A

1

Patient outcome

Patient outcome

TBD

1

Preceding COVIDlike illness

Did the patient have preceding
COVID-like illness?

Date of onset of
preceding COVIDlike illness

If yes, date of onset of
preceding illness

PHVS_YesNoUnknown_CDC
1

1
TBD
1

PHVS_YesNoUnknown_CDC
1
TBD
1
PHVS_YesNoUnknown_CDC
1

1
PHVS_YesNoUnknown_CDC
1
N/A

18

Fever

Fever ≥ 38.0°C

Date of fever
onset

Date of fever onset

Highest
temperature

Highest temperature ©

Number of days
febrile

Number of days febrile

Clinical finding

Clinical finding

Clinical finding
indicator

Provide a response for each
clinical finding.

Treatment Type

Listing of treatment or medical
intervention the subject
received for this illness

PHVS_YesNoUnknown_CDC

1
N/A
1
N/A
1
N/A
TBD

PHVS_YesNoUnknown_CDC
1
TBD

Provide a response for each
treatment type.

Vasoactive
medications

Specify vasoactive medications

Immune
modulators

Specify immune modulators
treatment

TBD

Antiplatelets

Specify antiplatelets treatment

TBD

Anticoagulation

Specify anticoagulation
treatment

TBD

Max coronary
artery Z-score

1
1

Treatment type
indicator

Echocardiogram

1

1
PHVS_YesNoUnknown_CDC
1
TBD
1

1

Select any echocardiogram that
apply.

1
TBD

If coronary artery aneurysms,
state max coronary artery Zscore.

Cardiac
dysfunction

If cardiac ventricular
dysfunction, specify type.

Mitral
regurgitation

Specify type of mitral
regurgitation.

Date of coronary
artery aneurysm

Date of first test showing
coronary artery aneurysm or
dilatation.

1

1
N/A
1
TBD
1
TBD
1
N/A
19

Abdominal
imaging type

Type of abdominal imaging
(ultrasound, CT)

1
TBD

Chest imaging type

Type of chest imaging (chest xray, CT)

TBD

1

2019 Novel Coronavirus
Disease (COVID-19): 3 Data
Elements
The impetus/urgency for CDC
to add data elements for this
condition

Data Element Name

Introduction of SARS-CoV-2, the virus that causes 2019 novel coronavirus
disease (COVID-19), into the United States has resulted in the need for
national notifiable disease surveillance to assist in understanding the
transmission and epidemiology of the disease in U.S. jurisdictions. Public
health agencies are investigating reported respiratory illnesses and
identifying infected people (cases) through laboratory testing.
These data elements are necessary:
• To provide consistent case identification and classification, measure the
potential burden of illness
• To characterize the epidemiology of medically attended and moderate to
severe COVID-19 in the United States
• To detect community transmission
• To inform public health response to clusters of illness and efficacy of
population-based non-pharmaceutical interventions on the epidemic
Value Set Code
CDC
Priority
Data Element Description
(New)

Primary Language

What's case's primary
language? Please indicate for
both hospitalized and not
hospitalized cases.

PHVS_Language_ISO_639-2_Alpha3

2

Information Source for
Data

Clinical information collected
from which source(s)? Check
all that apply

PHVS_DataReportingSource_COVID-19

3

Did they have any underlying
medical conditions and/or risk
behaviors?

PHVS_YesNoUnknown_CDC

1

Did Underlying
Condition(s) Exist

S. Paratyphi Infection: 2
Data Elements
The impetus/urgency for
CDC to add data elements
for this condition

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
20

Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code
Data Element Name

CDC
Priority1

Data Element Description

PulseNet ID

State lab ID submitted to
PulseNet

N/A

1

WGS ID Number

Whole Genome Sequencing
(WGS) ID Number

N/A

1

S. Typhi Infection: 2 Data
Elements
The impetus/urgency for
CDC to add data elements
for this condition

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code

Data Element Name

CDC
Priority1

Data Element Description

PulseNet ID

State lab ID submitted to
PulseNet

N/A

1

WGS ID Number

Whole Genome Sequencing
(WGS) ID Number

N/A

1

Salmonellosis: 1 Data
Element
The impetus/urgency for
CDC to add data elements
for this condition

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.

21

Value Set Code
Data Element Name
PulseNet ID

CDC
Priority1

Data Element Description
State lab ID submitted to
PulseNet

N/A

1

Shiga toxin-producing
Escherichia Coli (STEC): 1
Data Element
The impetus/urgency for
CDC to add data elements
for this condition

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code

Data Element Name
WGS ID Number

CDC
Priority1

Data Element Description
Whole Genome Sequencing
(WGS) ID Number

N/A

1

Shigellosis: 1 Data Element
The impetus/urgency for
CDC to add data elements
for this condition

Data Element Name
PulseNet ID

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.
Value Set Code
CDC
Data Element Description
Priority1
State lab ID submitted to
PulseNet

N/A

1

Vibriosis: 2 Data Elements
The impetus/urgency for
CDC to add data elements
for this condition

•

The proposed data elements are necessary to facilitate linking between
laboratory data submitted to the CDC (including whole-genome
sequencing data) and enhanced case-patient data transmitted per the
Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG).
Routine linking between lab and epi data is fundamental to outbreak
response and epidemiologic analysis.

22

Value Set Code
Data Element Name

CDC
Priority1

Data Element Description

PulseNet ID

State lab ID submitted to
PulseNet

N/A

1

WGS ID Number

Whole Genome Sequencing
(WGS) ID Number

N/A

1

23