Justification for Addition of Disease-Specific Data Elements

Attachment 9. Justification for the Addition of Disease-Specific Data Elements
107 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for 4 conditions: 2019 Novel Coronavirus (COVID-19), Carbon
Monoxide (CO) Poisoning, Congenital Syphilis, and STD (not congenital). 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:

COVID-19: 46 Data Elements
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 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. Nationwide disease surveillance is
necessary to provide consistent case identification and classification, measure the potential burden of illness,
characterize the epidemiology of medically attended and moderate to severe COVID-19 in the United States,
detect community transmission, and inform public health response to clusters of illness and efficacy of
population-based non-pharmaceutical interventions on the epidemic.

Value Set Code
Data Element
Name

Data Element Description

COVID-19 ID

ID to link all case information on
patient

Interviewer Last
Name

Last name of interviewer

Interviewer First
Name

First name of interviewer

Interviewer
Organization

CDC
Priority
(New)

N/A

1

N/A

1

N/A

1

The affiliation or organization of
the interviewer.

N/A

1

Interviewer
Telephone

Telephone number of interviewer

N/A

1

Interviewer Email

Email of interviewer

N/A

1

Probable
Classification
Reason

If probable case classification
status, provide reason for
classification.

TBD

1

1

Process for Case
Identification

Under what process was the case
first identified?

TBD

1

DGMQID

N/A

1

Positive
Collection Date

If EpiX notification of traveler,
provide the DGMQID.
Date of first positive specimen
collection.

N/A

1

Hospital
Translator

If hospitalized, was a translator
required?

PHVS_YesNoUnknown_CDC

1

Translator
Language

If translator required in the
hospital, specify which language?

TBD

1

Intensive Care
Unit Admittance

Was patient admitted to an
intensive care unit (ICU)?

PHVS_YesNoUnknown_CDC

1

ICU Admission
Date

If patient was admitted to an ICU,
provide the admission date.

N/A

1

ICU Discharge
Date

If patient was admitted to an ICU,
provide the discharge date.

N/A

1

Housing Type

Select the best description of
where the patient lived at the time
of illness onset.
Is the patient a health care worker
in the U.S.?

TBD

1

PHVS_YesNoUnknown_CDC

1

Health Care
Worker Job Type

If patient is a health care worker,
select their occupation. If other,
specify in text.

TBD

1

Health Care
Worker Job
Setting

If patient is a health care worker,
select their job setting. If other,
specify in text.

TBD

1

Exposure of
Interest

In the 14 days prior to illness onset,
did the patient have any of the
following exposures? Select all that
apply.
If domestic travel outside of state
of normal residence, specify the
state.
If patient traveled internationally,
specify country.

TBD

1

N/A

1

N/A

1

If exposed on a cruise ship or
vessel, specify the name of the
cruise ship.

N/A

1

Health Care
Worker

State of Travel
Exposure
Country of Travel
Exposure
Cruise Ship or
Vessel

2

Workplace Critical If the patient was exposed at their
workplace, is the workplace critical
Infrastructure
infrastructure?
Workplace
If workplace exposure, specify the
workplace setting (e.g., long term
Exposure
healthcare setting, hospital,
grocery store)
Animal Case
If an animal with confirmed or
suspected COVID-19, specify the
animal.
Type of Contact
If the patient had contact with a
known COVID-19 case, specify the
with COVID-19
type of contact.
Case

PHVS_YesNoUnknown_CDC

1

TBD

1

N/A

1

TBD

1

Contact with U.S.
COVID-19 Case

Was this person a U.S. case?

TBD

1

COVID-19 Case
Identifier

If patient had contact with a known
COVID-19 case, specify the COVID19 ID(s).
Select which mechanisms were
used for the collection of the
clinical course, symptoms, past
medical history and social history.
Symptoms present during course of
illness.
Did the patient’s symptoms
resolve?

N/A

1

TBD

1

TBD

1

TBD

1

Clinical Symptoms Indicate the symptoms associated
with this illness.
Clinical Symptoms Indicator for each symptom.
Indicator

TBD

1

PHVS_YesNoUnknown_CDC

1

Diagnostic

Select the diagnostic tests that
were performed.
Indicator for each diagnostic test
result.
Indicate the treatment received.

TBD

1

TBD

1

TBD

1

Treatment
Indicator

Indicator for each treatment.

N/A

1

Days of
Mechanical
Ventilation

If patient received mechanical
ventilation intubation, specify the
total days of treatment.

N/A

1

Underlying Risk
Factors

Specify any of the underlying
medical conditions and/or risk
behaviors.

TBD

1

Clinical History
Collection
Mechanism
Symptomatic
Symptoms
Resolved

Diagnostic Result
Treatment

3

Underlying Risk
Factors Indicator

Indicator for each medical
condition and risk behaviors.

PHVS_YesNoUnknown_CDC

1

Chronic Disease

If other chronic diseases, please
specify.
If other underlying condition,
please specify.

N/A

1

N/A

1

If other underlying risk behavior,
please specify
If disability (neurologic,
neurodevelopmental, intellectual,
physical, vision or hearing
impairment, please specify.
If psychological or psychiatric
condition, please specify.

N/A

1

N/A

1

N/A

1

Underlying
Condition
Risk Behavior
Disability

Psychological or
Psychiatric
Condition

CO Poisoning: 45 Data Elements
45 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for CO Poisoning. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: The 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 CO Poisoning. Tracking CO Poisoning
cases in a standard manner over time will assist the program to: better understand the health consequences of
CO Poisoning across the United States, learn about the effects of long-term exposures to low levels of CO,
monitor trends, identify high risk groups, and determine the impact of public health policy aimed at preventing
CO Poisoning. This additional data would help to better target outreach activities to those at increased risk for
CO Poisoning, such as during large-scale power outages in post-disaster settings.
Value Set Code
Data Element Name

Data Element Description

CDC
Priority

PHVS_Language_ISO_6392_Alpha3

P

What is the patient's current marital
status?

PHVS_MaritalStatus_HL7_2x

P

Indicate the highest degree or level of
school completed at the time of the event.

PHVS_Education_CO

P

Primary Language

What is the patient's primary language?

Marital Status
Education

4

Poison Control Center
Record

Does the patient have a poison control
record indicating exposure to carbon
monoxide?

PHVS_YesNoUnknown_CDC

P

Outcome of Poison
Control Center Record

If patient has a poison control record,
select the outcome identified in the Poison
Control Center Record.

PHVS_PoisonControlCenterR
ecord_CO

P

Treatment
Management Type

If patient has a poison control record,
indicate how the care was managed.

PHVS_TreatmentSite_CO

P

PHVS_YesNoUnknown_CDC

P

Workers Compensation
Record

Does the patient have a worker’s
compensation record with a finding,
problem, diagnosis or other indication of
exposure to carbon monoxide or carbon
monoxide poisoning?

P

Type of Workers
Compensation Claim

Indicate the type of claim if patient has a
PHVS_WorkersCompensatio
worker’s compensation claim with a
nRecord_CO
finding, problem, diagnosis or other
indication of exposure to carbon monoxide
or carbon monoxide poisoning.

Fire Related Exposure

Was the carbon monoxide exposure
related to a fire?

PHVS_YesNoUnknown_CDC

P

Power Outage Event

Was the carbon monoxide exposure
related to a power outage?

PHVS_YesNoUnknown_CDC

P

Extreme Weather

Was the carbon monoxide exposure
related to an extreme weather event?

PHVS_YesNoUnknown_CDC

P

Identify the extreme weather event(s)
occurring when the patient was exposed
to carbon monoxide.

PHVS_ExtremeWeatherType
_CO

P

Extreme Weather Type

Immediately before or during the extreme
weather event, did patient hear or read
about any warnings on the danger of
carbon monoxide poisoning?

PHVS_YesNoUnknown_CDC

P

Warning
Announcement

PHVS_ExposureSource_CO

P

Exposure Source

If patient was physically and temporally
associated with a CO-emitting source,
specify the source.

Generator Location

If the exposure source is generator, where
was it placed while it was running?

PHVS_GeneratorLocation_C
O

P

Generator Distance

If the exposure source was a generator,
how many feet was the generator placed
from the (house/attached

PHVS_GeneratorDistance_C
O

P

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garage/detached garage or other location
of event)?
Carbon Monoxide
Alarm Present

Patient was in a location where a carbon
monoxide alarm was present.

PHVS_YesNoUnknown_CDC

P

Carbon Monoxide
Alarm Sounded

The carbon monoxide alarm sounded.

PHVS_YesNoUnknown_CDC

P

Carbon Monoxide
Elevated Exposure

Exposure to an elevated level of CO based
on a dedicated or multi-gas
meter/instrument (e.g., fire department
measurement)?

PHVS_YesNoUnknown_CDC

P

Air Concentration of
CO Level

Air concentration of CO Level in parts per
million (PPM) at exposure site.

N/A

P

Person/Organization
Taking CO Reading

If air concentration of CO level was taken,
indicate the person or organization taking
the CO reading.

PHVS_PersonOrgTakingReadi
ng_CO

P

Date of Reading

What was the date and time, if known, of
the CO reading?

N/A

P

Exposure Site Category

Categorize the location of exposure.

PHVS_ExposureSiteCategory
_CO

P

Public Site of Exposure

If a public setting where the exposure
occurred, please indicate specific site.

PHVS_SiteofExposure_CO

P

Residential Site of
Exposure

If a residential setting where the exposure
occurred, please indicate specific site.

PHVS_ResidentialSiteofExpos
ure_CO

P

PHVS_YesNoUnknown_CDC

P

Epi-Linked

Patient was present and exposed in the
same event as that of a carbon monoxide
poisoning case.

Date and Time of
Incident

Please provide the date and time, if
known, of the carbon monoxide incident.

N/A

P

Address of
Establishment Where
Exposure Occurred

Street address of the location or
N/A
establishment where the carbon monoxide
exposure occurred.

P

City of Establishment
Where Exposure
Occurred

City of the location or establishment
where the carbon monoxide occurred.

N/A

P

State of Establishment
Where Exposure
Occurred

State of the location or establishment
where the carbon monoxide occurred.

PHVS_State_FIPS_5-2

P

6

Zip Code of
Establishment Where
Exposure Occurred

Zip code of the location or establishment
where the carbon monoxide occurred.

N/A

P

County of
Establishment Where
Exposure Occurred

County of the location or establishment
where the carbon monoxide occurred.

N/A

P

Event Notes

Description of incident.

N/A

P

Number of Exposed
Cases

Total number of exposed persons
(including case patient).

N/A

P

Average Number of
Cigarettes Smoked per
Day

During the past 30 days, please specify the
average number of cigarettes smoked per
day. There are 20 cigarettes per pack.

PHVS_NumberofCigarettesS
mokedperDay_CO

P

Marijuana Smoking
Status

Does the patient currently smoke
marijuana?

PHVS_YesNoUnkRefused_NN P
D

Other Substance

Type of other substance used (e.g., ecigarette tobacco, e-cigarette THC)

TBD

P

Underlying Condition(s)

Select the patient's preexisting
condition(s).

PHVS_UnderlyingConditions
_CO

P

Signs and Symptoms

Signs and symptoms associated with the
carbon monoxide exposure or poisoning.

PHVS_SignsandSymptoms_C
O

P

ICD Codes List

ICD Codes in patient's report.

PHVS_ICDCodesList_CO

P

Treatment Provided

Was patient treated for carbon monoxide
exposure?

PHVS_YesNoUnknown_CDC

P

Treatment Type

Specify the treatment type.

PHVS_TreatmentType_CO

P

Treatment Location

Where did the patient receive treatment?

PHVS_TreatmentLocation_C
O

P

Start Date of
Treatment or Therapy

Provide the date and time of when the
treatment started.

N/A

P

Occupation Related to
Exposure

Is the patient's carbon monoxide exposure
related to their current occupation?

PHVS_YesNoUnknown_CDC

P

Congenital Syphilis: 2 Data Elements
2 data elements were added for Congenital Syphilis. Names, descriptions, value set codes, and justification for
the addition of these new data elements are below:

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Justification: Congenital syphilis (CS) occurs when a mother with syphilis passes the infection to her infant during
pregnancy. When syphilis is diagnosed in a pregnant woman, CDC receives a case notification for noncongenital (adult) syphilis. If the resulting infant meets the CS case definition, CDC receives a separate CS case
notification for the infant. State and local surveillance information systems allow for the linkage of these two
records—mother (adult syphilis) and child (CS)—to inform disease investigation, but notifications transmitted to
CDC using the STD and CS MMGs do not contain the information necessary for linking these records at the
national level. As such, the clinical and sociodemographic characteristics currently reported for pregnant
females (e.g., drug use, incarceration history) cannot be evaluated as risk factors for CS nor be used to identify
intervention opportunities. Linking maternal and CS case notifications at the national level would involve the
addition of two maternal data elements to the CS case notification. These data elements are already collected
locally and are already included in the mother’s non-congenital syphilis case notification. Providing these
maternal data elements on the CS case notification will allow for record-linkage at CDC and will advance the
understanding of CS epidemiology & prevention.
Data Element
Name

Maternal Local
Record ID
Maternal
Notification
Reporting
Jurisdiction

Value Set Code

CDC Priority

Data Element Description
Sending system-assigned
local ID of the case
investigation with which the
subject is associated

TBD

O

National jurisdiction
reporting the notification to
the CDC

TBD

O

STD (not congenital): 14 Data Elements
14 data elements that were not included in the previously reviewed ICR or approved through non-substantive
change requests were added for STD (not congenital). Names, descriptions, value set codes, and justification for
the addition of these new data elements are below:
Justification: CDC recommends specific regimens to treat STDs. Patients not receiving appropriate treatment are
at risk for treatment failure and/or contributing to on-going transmission; treatment with non-recommended
regimens also contributes to the emergence of antimicrobial resistance. There are no national surveillance
systems that systematically track treatment among persons diagnosed and reported with bacterial STDs. These
data are often captured at the state/local level and the addition of these data elements will allow reporting

8

jurisdictions to report these to CDC associated with cases of bacterial STDs for national surveillance of treatment
adherence.

Lymphogranuloma venereum (LGV) is a clinical complication of chlamydia, disseminated gonococcal infection
(DGI) is a severe complication of gonorrhea, and pelvic inflammatory disease (PID) and neonatorum ophthalmia
are complications of gonorrhea and chlamydia. Although these complications are rare, there are no national
surveillance systems that systematically track these sequelae among persons diagnosed and reported with an
STD. These data are often captured at the state/local level and the addition of this data element will allow
reporting jurisdictions to report these to CDC associated with cases of bacterial STDs for national surveillance of
STD-related sequalae.
Data Element
Name

Value Set Code

CDC Priority

Data Element Description
TBD

O

Date Treatment
was Prescribed

Date treatment associated
with the condition was
prescribed

TBD

O

Date Treatment
was Administered

Date treatment associated
with the condition was
administered

Medication
Administered

Name of the antibiotic
administered

TBD

O

Medication
Administered Dose

Dose of the antibiotic
administered

TBD

O

Treatment
Duration

Prescribed duration of
antibiotic

TBD

O

Type of
Complication

Complications associated
with the illness being
reported

TBD

O

TBD

O

Treatment Dosage

Dose of the treatment
associated with the
condition

TBD

O

Treatment Dosage
Unit

Unit of measure for the
treatment associated with
the condition

TBD

O

Type of
Complication
Indicator

Indicator for associated
complication

9

Treatment Route
of Delivery

Route of delivery of
treatment

TBD

O

Treatment Drug
Frequency

Frequency of treatment
drug

TBD

O

Treatment Drug
Frequency Unit

Unit of measure for the
frequency of treatment
associated with the
condition

TBD

O

Treatment
Duration Units

Unit of measure for the
duration of treatment
associated with the
condition

TBD

O

Drug Use Route of
Delivery

Route of delivery of drug(s)
used

TBD

O

4/23/2020

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