Justification for Disease Specific Data

Att 9 - Justification for Disease-Specific Data.pdf

National Notifiable Diseases Surveillance System (NNDSS)

Justification for Disease Specific Data

OMB: 0920-0728

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Attachment 9. Justification for the Addition of Disease-Specific Data Elements

24 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for 6 conditions: Alpha-gal Syndrome, Coronavirus Disease
(COVID-19), Cryptosporidiosis, Cyclosporiasis, Hepatitis 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:
Alpha-gal Syndrome
The impetus/urgency for
CDC to add data elements
for this condition

•

•

•
•

Alpha-gal syndrome (AGS) is an emerging syndrome only
recently identified in 2007. Last year, a CSTE national
surveillance case definition was approved to standardize reporting,
however, AGS is not a nationally notifiable condition.
The MMG that the CDC Program would like to develop would be
used by states that would like to include AGS in their list of
reportable conditions and to make surveillance more
comprehensive and informative for public health actions.
These data elements would help inform the burden and trends of
AGS, especially regarding exposure history, clinical outcomes,
severeness of disease, and laboratory test results.
It is important to continue monitoring the epidemiology and
emergence of AGS as more states report on it.
Value Set Code

Data Element Name
Date of most recent
occurrence
Prior occurrence
Date of first occurrence
Signs and Symptoms

Signs and Symptoms
Indicator

Data Element Description
Date of most recent reaction
that prompted this report
(mm/dd/yyyy)
Has the patient had prior
reactions?
Date of first reaction
(mm/dd/yyyy)
Signs and symptoms
associated with the illness
being reported
Indicator for associated sign
and symptom

Allergy to food (finding) Has the patient ever
experienced signs or
symptoms of an allergic
1

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

1

N/A

CDC
Priority1
1

PHVS_YesNoUnknown_CDC

2

N/A

2

TBD

1

TBD

1

TBD

1

reaction after consumption of
any of the following?
Allergy to drug (finding) Has the patient ever
experienced signs or
symptoms of an allergic
reaction after receiving any
of the following
pharmaceutical or medical
products?
Anaphylaxis (disorder)
Has the patient ever
experienced anaphylaxis due
to this condition?
Tick bite
In the 12 months before first
diagnosis, did the patient
notice any tick bites?
Performing laboratory
Testing laboratory
name
Coronavirus Disease
(COVID-19)
The impetus/urgency for
CDC to add data elements
for this condition

Data Element
Name
Lineage

•

1

PHVS_YesNoUnknown_CDC

2

PHVS_YesNoUnknown_CDC

2

TBD

3

To make surveillance more comprehensive and informative for
public health actions
To provide lineage data rapidly for surveillance monitoring and
efforts.
Value Set Code

Data Element Description
Lineage designation or sublineage, if available.

Cryptosporidiosis
The impetus/urgency for
CDC to add data elements
for this condition

Data Element
Name
Travel Outside
USA Prior to
Illness Onset
within Program
Specific

•

TBD

N/A

•

CDC
Priority1
2

To make surveillance more comprehensive and informative for
public health actions
• To provide more information about risk factors that have been
associated outbreaks
• To monitor epidemiology
• To align exposure and risk factor information with that collected
on CDC’s CryptoNet case investigation form
Value Set Code
CDC
1
Priority
Data Element Description
Did the case patient travel
PHVS_YesNoUnknown_CDC
2
internationally?

2

Timeframe
Did The Case
Travel
Domestically
Prior To Illness
Onset?
Specify
Different
Travel
Exposure
Window

Indicates whether the case
PHVS_YesNoUnknown_CDC
traveled domestically prior to
illness onset and within
program specific timeframe

2

If the travel exposure
window used by the
jurisdiction is different from
that stated in the travel
exposure questions, specify
the time interval in days
here. Otherwise, leave blank.

2

Cyclosporiasis
The impetus/urgency for
CDC to add data elements
for this condition

Data Element
Name
Fresh Lettuce
Packaging

•

During 2020 and 2021, several cyclosporiasis outbreaks likely
related to leafy greens were identified, but investigations were
impeded by a lack of details necessary to specify a source.
• Packaging information will help provide more specific data to
inform the identification and investigation of outbreaks related to
leafy greens.
Value Set Code
CDC
1
Priority
Data Element Description
For each fresh lettuce
TBD
1
exposure reported, indicate
the type of packaging of the
fresh lettuce

Hepatitis
The impetus/urgency for
CDC to add data elements
for this condition

Data Element
Name
Type of
Outbreak

N/A

•

The data elements will contribute to enhanced surveillance efforts
for those jurisdictions funded through PS21-2103 “Integrated
Viral Hepatitis Surveillance and Prevention Funding for Health
Departments”.
• These data elements will improve standardization of data
collection for CDC surveillance.
• These data elements will improve the overall understanding of the
population and factors contributing to viral hepatitis infection.
• The enhanced surveillance will be more comprehensive and
informative for public health actions and will improve guidance on
infection control and prevention.
Value Set Code
CDC
1
Priority
Data Element Description
If the person is suspected of
PHVS_CSOutbreak_HepatitisB (Per
1
being part of an outbreak,
condition)
3

Other Reported
Cases(s) Prior
Years

Test
Conversion

Birth Sex
Sexual
Orientation

Gender Identity

please select the source of
the outbreak.
Select the relevant conditions TBD
for which the patient met the
CSTE case definition(s) in
any previous reporting year.
Select all that apply.
Did the patient meet the
PHVS_YesNoUnknown_CDC
program criteria for test
conversion for the condition
of interest?
Sex assigned at birth
TBD (to align with USCDI standards)
A person’s identification of
their emotional, romantic,
sexual, or affectional
attraction to another person
A person’s internal sense of
being a man, woman, both,
or neither

STD (not congenital)
The impetus/urgency for
CDC to add data elements
for this condition

Data Element Name
Birth Sex
Sexual Orientation

Gender Identity

1

1

1

TBD (to align with USCDI standards)

1

TBD (to align with USCDI standards)

1

•

These data elements will improve standardization of data collection for
CDC surveillance and improve the overall understanding of the
population and factors contributing to STD infections. The enhanced
surveillance will be more comprehensive and informative for public
health actions and will improve guidance on infection control and
prevention.
Value Set Code
CDC
Priority1
Data Element Description
Sex assigned at birth
TBD (to align with USCDI
1
standards)
A person’s identification of
TBD (to align with USCDI
1
their emotional, romantic,
standards)
sexual, or affectional attraction
to another person
TBD (to align with USCDI
1
A person’s internal sense of
being a man, woman, both, or standards)
neither

4


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File Modified2022-04-21
File Created2022-04-21

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