Justification for Addition of Disease-specific Data Elements

Attachment 12. Justification for the Addition of Disease-Specific Data Elements
451 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for 22 conditions: Carbapenemase-Producing Carbapenem-Resistant
Enterobacteriaceae (CP-CRE), Carbon Monoxide (CO) Poisoning; Tuberculosis (TB) Disease, Latent TB Infection
(TB Infection), Shiga Toxin-Producing Escherichia coli (STEC), Salmonellosis, Shigellosis, Campylobacteriosis,
Cryptosporidiosis, Cyclosporiasis, Cholera, Vibriosis, S. Typhi Infection, S. Paratyphi Infection, Lyme Disease,
Invasive Haemophilus influenzae Disease, Meningococcal Disease, Invasive Pneumococcal Disease, Psittacosis,
Legionellosis, Tickborne Rickettsial Diseases (TBRD), and Hepatitis. 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:

CP-CRE: 8 Data Elements
8 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for CP-CRE. Names, descriptions, value set codes, and justification for
the addition of these new data elements are below:
Justification: CP-CRE are an emerging public health problem in the United States. Early detection and aggressive
implementation of infection prevention and control strategies are necessary to prevent further spread of CPCRE, especially novel CP-CRE. These data elements will contribute to enhanced public health surveillance efforts
on the part of the CDC program which will allow for timely public health action. Data elements included in this
request will help report CP-CRE to CDC with all available testing results (positive, negative, intermediate) of
phenotypic carbapenemase production tests as well as results (positive and negative) of any tests performed for
resistance mechanisms (e.g., KPC PCR).

Value Set Code

Data Element Name

Data Element Description

TBD

Type of case

Type of case (i.e., was case identified based on
testing of a clinical specimen or screening
specimen)

TBD

State lab isolate id

Lab isolate identifier from public health lab for
mechanism testing

TBD

Phenotypic Test Method

Phenotypic Test Name (phenotypic methods for
carbapenemase production)

TBD

Phenotypic Test Result

Result of Phenotypic test
1

TBD

Genotypic Test Name

Test performed to identify carbapenemase
(molecular methods for resistance mechanism)

TBD

Genotypic Test Result

Result of test to identify carbapenemase

TBD

County of facility

County of facility where specimen was collected

TBD

State of facility

State of facility where specimen was collected

CO Poisoning: 4 Data Elements
4 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.

Value Set Code

Data Element Name

Data Element Description

TBD

Smoking status

Current smoker (yes, no, unknown)






TBD
Source of data for case
ascertainment

TBD

Carboxyhemoglobin
(COHb) level

TBD

Intent

Hospital/emergency department
Poison control center
Laboratory report
Death certificate
Provider/medical examiner report

Laboratory test result (%)



Intentional
Unintentional

TB Disease: 95 Data Elements
95 data elements including 36 that are highlighted in yellow that were not included in the ICR (OMB No. 09200026), Report of Verified Case of Tuberculosis (RVCT), were added for TB Disease. Names, descriptions, value set
codes, and justification for the addition of these new data elements are below:
Justification: Additional data elements are needed to better characterize the evolving epidemiology of TB
Disease in the United States, improve surveillance for drug resistant TB Disease as required by the 2015 National
Action Plan for Multidrug-Resistant TB Disease, and recommendations of the Council of State and Territorial

2

Epidemiologists (CSTE). These additional data elements were selected with substantial input from the state and
local public health agencies that will be responsible for collecting and submitting the data.

Value Set Code

Data Element Name

Data Element Description

N/A

TB State Case Number

N/A

City or County Case
Number
Birth Sex

State case number for the case specific to TB
investigations (4 digit report year + 2 letter state +
9 digit alphanumeric number)
City or county case number assigned to this case

PHVS_Sex_MFU
PHVS_CaseCount
Status_TB
N/A

Patient Address City

Has this case already been counted by another
reporting area?
If case previously counted, provide the state case
number from the other reporting area.
If the case was previously reported by another
country, specify the country.
Patient address city

PHVS_YesNoUnkn
own_CDC
N/A

Inside City Limits

Is the patient's residence within city limits?

Census Tract of CasePatient Residence

PHVS_Race_CDC

Detailed Race

N/A

Date Arrived in US

PHVS_YesNoUnkn
own_CDC
PHVS_BirthCountr
y_CDC

US Born

PHVS_YesNoUnkn
own_CDC
PHVS_PrimaryRea
sonForEvaluation_
TB
PHVS_LabTestTyp
e_TB

Remain in US After Report

Census tract where the address is located is a
unique identifier associated with a small statistical
subdivision of a county. Census tract data allows
a user to find population and housing statistics
about a specific part of an urban area.
Provide the detailed race information for the
patient.
If country of birth is NOT United States,
regardless of citizenship, indicate the date when
the patient first arrived in the US.
Was the patient eligible for US citizenship at
birth?
Indicates the birth country of the primary
guardian(s) of patient (pediatric [<15 years old]
cases only)
If not US reporting area, did patient remain in the
United States for >= 90 days after report date?
What was the initial reason the patient was
evaluated for TB?

PHVS_LabTestInte
rpretation_TB

Test Result

N/A

Date/Time of Lab Result

PHVS_BirthCountr
y_CDC
N/A

Previously Counted Case

What was the patient's sex at birth?

Previously Reported State
Case Number
Country of Verified Case

Primary Guardian(s)
Country of Birth

Initial Reason for
Evaluation
Test Type

Epidemiologic interpretation of the type of test(s)
performed for this case. Please provide a
response for each of the main test types (culture,
smear, pathology/cytology, NAA, TST, IGRA, HIV,
diabetes) If test was not done please indicate so.
Epidemiologic interpretation of the results of the
test(s) performed for this case - This is a
qualitative test result. (e.g., positive, detected,
negative)
Date result sent from reporting laboratory. Time of
result is an optional addition to date.

3

PHVS_Microscopic
ExamCultureSite_T
B
N/A

Specimen Source Site

This indicates the anatomical source of the
specimen tested.

Specimen Collection
Date/Time

N/A

Test Result Quantitative

Date of collection of laboratory specimen used for
diagnosis of health event reported in this case
report. Time of collection is an optional addition to
date.
Quantitative test result value

PHVS_UnitofMeas
ure_TB
PHVS_TypeofRadi
ologyStudy_CDC

Result Units

PHVS_ResultofRad
iologyStudy_TB
PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC
N/A

Result of Chest Study

Units of measure for the Quantitative Test Result
Value
Indicate the type of chest study performed.
Please provide a response for each of the main
test types (plain chest radiograph, chest CT Scan)
and if test was not done please indicate so.
Result of chest diagnostic testing

Evidence of Cavity

Did test show evidence of cavity?

Evidence of Miliary TB

Did test show evidence of miliary TB?

Date of Chest Study

Date of the chest diagnostic study

PHVS_Epidemiolog
icalRiskFactors_TB

Patient Epidemiological
Risk Factors

PHVS_YesNoUnkn
own_CDC
PHVS_Correctional
FacilityType_NND

Patient Epidemiological
Risk Factors Indicator
Type of Correctional Facility

PHVS_LongTermC
areFacilityType_NN
D
PHVS_SmokingSta
tus_CDC
PHVS_YesNoUnkn
own_CDC

Type of Long-Term Care
Facility

PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC

Identified During Contact
Investigation
Evaluation During Contact
Investigation

N/A

Linked Case Number

N/A

Date Treatment or Therapy
Started
Treatment Administration
Type

Exposed risk factors for the patient - Please
provide a response for all risk factors in the value
set with an associated indicator
Provide a response for each value in the patient
epidemiological risk factors value set
If patient was a Resident of Correctional Facility
at Diagnostic Evaluation, indicate the type of
correctional facility.
If patient was a Resident of Long Term Care
Facility at Diagnostic Evaluation, indicate the type
of long term care facility.
What is the patient's current tobacco smoking
status?
Residence or Travel in countries other than the
United States, Canada, Australia, New Zealand,
or countries in northern or western Europe for >60
consecutive days at any point in the patient's
lifetime.
Was the patient identified during the contact
investigation around the likely source case?
If patient was identified during contact
investigation, was the patient evaluated for TB
during the contact investigation?
State case numbers for epidemiologically linked
cases
Date the initial treatment regimen was started

PHVS_TreatmentA
dministrationType_
TB
N/A

Type of Chest Study

Smoking Status
Patient lived outside of US
for more than 2 months

Date Treatment or Therapy
Stopped

Choose all treatment administration types that
apply to the case, such as DOT, eDOT, or SAT.
Date treatment stopped

4

PHVS_CaseVerific
ation_TB

Case Verification Category

PHVS_GeneralCon
ditionStatus_TB
PHVS_AdditionalDi
seaseSite_TB
PHVS_YesNoUnkn
own_CDC
PHVS_DiagnosisTy
pe_TB

Status at Diagnosis of TB

PHVS_YesNoUnkn
own_CDC
N/A

History of Previous Illness

Was a contact investigation conducted around
this case?
Previous TB or LTBI Diagnosis - Provide only 1
response for LTBI, multiple responses for TB are
allowed
Did the subject have a history of TB or LTBI?

Date of Previous Illness

Date of previous diagnosis

N/A

Previous State Case
Number
Completed Treatment for
Previous Diagnosis
Initially Treated with RIPE

Previous TB or LTBI State Case Number

PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC
PHVS_ReasonNot
TreatedwithRIPE_T
B
PHVS_ReasonTher
apyStopped_TB

Site of Disease
Contact Investigation
Diagnosis Type

Reason Not Treated with
RIPE
Reason Therapy Stopped

Indicates case verification criteria result based on
factors such as culture results, smear results,
major and additional sites of the disease, x-ray
results, TST, IDR, reason therapy was stopped.
Was the patient alive or dead at the time of
diagnostic evaluation?
What was the site of the patient's TB disease?

Completed Treatment for Previous Diagnosis
Was the patient initially treated with the
recommended four-drug therapy (RIPE)?
If not initially treated with RIPE, why not?

Indicate the primary reason that therapy was
stopped or never started; specify this data when
the case is closed.
Select the reason the therapy extended beyond
12 months.
Final TB disease case outcome

PHVS_TherapyExt
endedReason_TB
PHVS_FinalTreatm
entOutcome_TB
PHVS_Medications
_TB

Reason Therapy Extended

PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC
N/A

Initial Drug Regimen
Indicator
Isolate Submitted for
Genotyping
Accession Number for
Genotyping

PHVS_YesNoUnkn
own_CDC

Phenotypic Drug
Susceptibility Completed

If an isolate was submitted for genotyping to a
CDC laboratory only, list the accession number
for genotyping.
Was phenotypic/growth-based drug susceptibility
testing done?

PHVS_YesNoUnkn
own_CDC

Molecular Drug
Susceptibility Completed

Was genotypic/molecular drug susceptibility
testing done?

PHVS_Susceptibilit
yTestType_TB

Antimicrobial Susceptibility
Test Type

Antimicrobial Susceptibility Test Type of TB
drugs. For the initial susceptibility testing please
send a response for each values in the value set.
Changes in susceptibility should be reported for
each individual drug when change is identified.

Final Disease Outcome
Initial Drug Regimen

Initial drug regimen for the patient: Please provide
a response for each of the values in the value set
using the associated indicator.
Indicator response for the initial drug regimen
question
Was an isolate submitted for genotyping?

5

N/A

Antimicrobial Susceptibility
Specimen Collection Date

Antimicrobial Susceptibility Specimen Collection
Date

N/A

Antimicrobial Susceptibility
Result Reported Date

Antimicrobial susceptibility result reported date

PHVS_Microscopic
ExamCultureSite_T
B

Antimicrobial Susceptibility
Specimen Type

Antimicrobial Susceptibility Specimen Type (e.g.
Exudate, Blood, Serum, Urine)

PHVS_Susceptibilit
yTestResultQuantit
ative_TB

Antimicrobial Susceptibility
Test Interpretation

Antimicrobial Susceptibility Test Interpretation
(e.g. Susceptible, Resistant, Intermediate, Not
tested)

PHVS_Susceptibilit
yTestMethod_TB

Antimicrobial Susceptibility
Test Method

Antimicrobial Susceptibility Test Method (e.g. ETest, MIC, Disk Diffusion)

PHVS_GeneName
_TB

Gene Identifier

N/A

Molecular Susceptibility
Specimen Collection Date

Gene identifier - Please report the full test results
for the samples that have unique features, such
as specimen type (sputum or another anatomic
site), test type (sequencing or non-sequencing) or
mutation (detected or not detected). There is no
need to report test results that differ only by date
or laboratory and where all other aspects are
identical in regards to specimen type, test type,
and/or the results of mutation.
Molecular Susceptibility Specimen Collection
Date

N/A

Molecular Susceptibility
Date Reported

Molecular Susceptibility Date Reported

PHVS_Microscopic
ExamCultureSite_T
B

Molecular Susceptibility
Specimen Type

Molecular Susceptibility Specimen Type

PHVS_MolecularTe
stResults_TB

Molecular Susceptibility
Test Result

Molecular Susceptibility Test Result

N/A

Molecular Susceptibility
Nucleic Acid Change

Molecular Susceptibility Nucleic Acid Change

N/A

Molecular Susceptibility
Amino Acid Change

Molecular Susceptibility Amino Acid Change

PHVS_MolecularIn
del_TB
PHVS_MolecularTe
stMethods_TB

Molecular Susceptibility
Indel
Molecular Susceptibility
Test Method

Molecular Susceptibility Indel

PHVS_YesNoUnkn
own_CDC

Culture Conversion
Documented

Did the patient's sputum become culture
negative?

Molecular Susceptibility Test Method

6

N/A

Date of First Consistently
Negative Culture

Date the first consistently negative sputum culture
was collected.

PHVS_SputumCult
ureConversionNotD
ocumentedReason
_TB
PHVS_YesNoUnkn
own_CDC
PHVS_MovedWher
eDuringTherapy_T
B
PHVS_State_FIPS
_5-2
PHVS_Country_IS
O_3166-1
PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC

Reason for Not
Documenting Sputum
Culture Conversion

Indicate the one reason for not documenting the
sputum culture conversion.

Patient Move During TB
Therapy
Moved to Where

Did the patient move during therapy?

N/A

Date MDR Treatment
Started
Drug Used to Treat MDR
TB

PHVS_Medications
_TB

PHVS_LengthofTi
meDrugTaken_TB
N/A
PHVS_YesNoUnkn
own_CDC
N/A
PHVS_SideEffectof
Treatment_TB

PHVS_YesNoUnkn
own_CDC
PHVS_SideEffectTi
metoOnset_TB
Usual Occupation
and Industry
Meets Binational
Reporting Criteria
Patient Treated as
MDR Case

Out of State Move
Out of Country Move
Transnational Referral
History of Treatment

Length of Time Drug Was
Administered
Date Injectable Medication
Stopped
Surgery to Treat MDR TB
Surgery to Treat MDR TB
Date
Adverse Event Description

Adverse Event Indicator
Adverse Event
Manifestation Time
Usual occupation and
industry
Does case meet binational
reporting criteria?
Was the Patient Treated as
an MDR TB Case

If the patient moved to a different reporting area
during TB therapy, select all that apply to where
the patient moved.
If moved out of state, then specify the new state
jurisdiction.
If moved out of country, then specify the new
country jurisdiction.
If moved out of the US, indicate whether a
transnational referral was made.
History of treatment before current episode with
second-line TB drugs for the treatment of TB
disease (not LTBI)
Date MDR TB therapy started for current episode
Drugs ever used for MDR TB treatment, from
MDR start date: Please provide a response for
each medication in the value set with an
associated indicator. Medications should be
recorded as part of the regimen beginning with
the MDR TB therapy start date.
Indicate length of time drug was taken or if it was
not taken
Date injectable medication stopped. If no
injectable drugs were used leave blank.
Surgery to Treat MDR TB
Surgery to Treat MDR TB Date
Did patient experience any of the following side
effects during treatment that resulted in a
permanent discontinuation of medication or at the
end of treatment were there any of the following
side effects related to MDR-TB treatment
present? Please provide a response for all side
effects in the value set with an associated
indicator.
Side Effects of Treatment Indicator
Did the side effect manifest during treatment or at
the end of treatment?
TBD
PHVS_YesNoUnknown_CDC
PHVS_YesNoUnknown_CDC

7

(Regardless of DST
Results?

TB Infection: 51 Data Elements
51 data elements that were not included in the previously reviewed ICR or approved through non-substantive
change requests were added for TB Infection. Names, descriptions, value set codes, and justification for the
addition of these new data elements are below:
Justification: TB Infection is under standardized surveillance following a recommendation from CSTE. The
majority of the selected data elements are identical to the elements selected in collaboration with state and
local partners for TB Disease surveillance. A small number of additional TB Infection-specific elements are
included to collect information on TB Infection treatment regimens and case outcome information, which are
substantially different from the corresponding information collected for TB Disease cases.

Value Set Code

Data Element Name

Data Element Description

N/A

TB State Case Number

N/A

City or County Case
Number
Birth Sex
Previously Counted Case

State case number for the case specific to TB
investigations (4 digit report year + 2 letter state
+ 9 digit alphanumeric number)
City or county case number assigned to this
case
What was the patient's sex at birth?
Has this case already been counted by another
reporting area?
If case previously counted, provide the state
case number from the other reporting area.
If the case was previously reported by another
country, specify the country.
Patient address city
Is the patient's residence within city limits?

PHVS_Sex_MFU
PHVS_CaseCount
Status_TB
N/A
PHVS_BirthCountr
y_CDC
N/A
PHVS_YesNoUnkn
own_CDC
N/A

Previously Reported State
Case Number
Country of Verified Case
Patient Address City
Inside City Limits
Census Tract of CasePatient Residence

PHVS_Race_CDC

Detailed Race

N/A

Date Arrived in US

PHVS_YesNoUnkn
own_CDC
PHVS_BirthCountr
y_CDC

US Born
Primary Guardian(s)
Country of Birth

Census tract where the address is located is a
unique identifier associated with a small
statistical subdivision of a county. Census tract
data allows a user to find population and
housing statistics about a specific part of an
urban area.
Provide the detailed race information for the
patient.
If country of birth is NOT United States,
regardless of citizenship, indicate the date when
the patient first arrived in the US.
Was the patient eligible for US citizenship at
birth?
Indicates the birth country of the primary
guardian(s) of patient (pediatric [<15 years old]
cases only)

8

PHVS_YesNoUnkn
own_CDC

Remain in US After Report

PHVS_PrimaryRea
sonForEvaluation_
TB
PHVS_LabTestTyp
e_TB

Initial Reason for
Evaluation

PHVS_LabTestInte
rpretation_TB

Test Result

N/A

Date/Time of Lab Result

PHVS_Microscopic
ExamCultureSite_T
B
N/A

Specimen Source Site

N/A

Test Result Quantitative

PHVS_UnitofMeas
ure_TB
PHVS_TypeofRadi
ologyStudy_CDC

Result Units

PHVS_ResultofRad
iologyStudy_TB
PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC
N/A
N/A

Result of Chest Study

Units of measure for the Quantitative Test
Result Value
Indicate the type of chest study performed.
Please provide a response for each of the main
test types (plain chest radiograph, chest CT
Scan) and if test was not done please indicate
so.
Result of chest diagnostic testing

Evidence of Cavity

Did test show evidence of cavity?

Evidence of Miliary TB

Did test show evidence of miliary TB?

Date of Chest Study
Current Occupation

PHVS_Occupation
_CDC_Census201
0

Current Occupation
Standardized

Date of the chest diagnostic study
This data element is used to capture the
narrative text of a subject's current occupation.
This data element is used to capture the CDC
NIOSH standard occupation code based upon
the narrative text of a subject's current
occupation.

Test Type

Specimen Collection
Date/Time

Type of Chest Study

If not US reporting area, did patient remain in
the United States for >= 90 days after report
date?
What was the initial reason the patient was
evaluated for TB?
Epidemiologic interpretation of the type of
test(s) performed for this case. Please provide a
response for each of the main test types
(culture, smear, pathology/cytology, NAA, TST,
IGRA, HIV, diabetes) If test was not done
please indicate so.
Epidemiologic interpretation of the results of the
test(s) performed for this case - This is a
qualitative test result. (e.g., positive, detected,
negative)
Date result sent from reporting laboratory. Time
of result is an optional addition to date.
This indicates the anatomical source of the
specimen tested.
Date of collection of laboratory specimen used
for diagnosis of health event reported in this
case report. Time of collection is an optional
addition to date.
Quantitative test result value

(The National Institute for Occupational Safety
and Health (NIOSH) has developed a webbased software tool designed to translate
industry and occupation text to standardized
Industry and Occupation codes. The NIOSH
Industry and Occupational Computerized
Coding System (NIOCCS) is available here:
http://www.cdc.gov/niosh/topics/coding/overvie
w.html

9

N/A

Current Industry

PHVS_Industry_C
DC_Census2010

Current Industry
Standardized

PHVS_Epidemiolog
icalRiskFactors_TB

Patient Epidemiological
Risk Factors

PHVS_YesNoUnkn
own_CDC
PHVS_Correctional
FacilityType_NND

Patient Epidemiological
Risk Factors Indicator
Type of Correctional Facility

PHVS_LongTermC
areFacilityType_NN
D
PHVS_SmokingSta
tus_CDC
PHVS_YesNoUnkn
own_CDC

Type of Long-Term Care
Facility

PHVS_YesNoUnkn
own_CDC
PHVS_YesNoUnkn
own_CDC

Identified During Contact
Investigation
Evaluation During Contact
Investigation

N/A

Linked Case Number

N/A

Date Treatment or Therapy
Started
Treatment Administration
Type

PHVS_TreatmentA
dministrationType_
TB
N/A
PHVS_YesNoUnkn
own_CDC
PHVS_LTBIDrugR
egimen_TB
PHVS_ReasonLTB
INotStarted_TB
PHVS_ReasonLTB
ITreatmentStopped
_TB

Smoking Status
Patient lived outside of US
for more than 2 months

This data element is used to capture the
narrative text of subject's current industry.
This data element is used to capture the CDC
NIOSH standard industry code based upon the
narrative text of a subject's current industry.
(The National Institute for Occupational Safety
and Health (NIOSH) has developed a webbased software tool designed to translate
industry and occupation text to standardized
Industry and Occupation codes. The NIOSH
Industry and Occupational Computerized
Coding System (NIOCCS) is available here:
http://www.cdc.gov/niosh/topics/coding/overvie
w.html
Exposed risk factors for the patient - Please
provide a response for all risk factors in the
value set with an associated indicator
Provide a response for each value in the patient
epidemiological risk factors value set
If patient was a Resident of Correctional Facility
at Diagnostic Evaluation, indicate the type of
correctional facility.
If patient was a Resident of Long Term Care
Facility at Diagnostic Evaluation, indicate the
type of long term care facility.
What is the patient's current tobacco smoking
status?
Residence or Travel in countries other than the
United States, Canada, Australia, New Zealand,
or countries in northern or western Europe for
>60 consecutive days at any point in the
patient's lifetime.
Was the patient identified during the contact
investigation around the likely source case?
If patient was identified during contact
investigation, was the patient evaluated for TB
during the contact investigation?
State case numbers for epidemiologically linked
cases
Date the initial treatment regimen was started
Choose all treatment administration types that
apply to the case, such as DOT, eDOT, or SAT.

Date Treatment or Therapy
Stopped
Treatment Started

Date treatment stopped

Initial LTBI Drug Regimen

If treatment was started indicate the initial LTBI
drug regimen.
If treatment was not started, what was the
primary reason LTBI treatment was not started?
Reason LTBI treatment stopped

Primary Reason LTBI
Treatment Not Started
Reason LTBI Treatment
Stopped

Was treatment started for LTBI?

10

N/A

NTSS State Case Number

PHVS_AdverseEve
ntSeverity_TB
Usual Occupation
and Industry
Meets Binational
Reporting Criteria

Adverse Event Severity
Usual occupation and
industry
Does case meet binational
reporting criteria?

If patient developed TB from LTBI, list the NTSS
state case number
If treatment was stopped due to adverse event
from LTBI treatment indicate the severity.
TBD
PHVS_YesNoUnknown_CDC

STEC: 2 Data Elements
2 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for STEC. Names, descriptions, value set codes, and justification for the
addition of these new data elements are below:
Justification: CDC would like to collect information about travel and epidemiologic exposure windows, and
would like to add 2 data elements with a numeric response option to obtain this information. The exact
timeframe for exposures can vary between states and it is necessary for CDC to know of the differences in
timeframe as this influences the analyses that can be conducted at CDC. Multiple states have already reported a
deviation from the recommended CDC timeframe during an external review of program data elements. By
adding in these two data elements, CDC will be better able to determine the relationships of travel and
epidemiologic exposure to illness and can work to create timeframe standards in the future.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Exposure
Window

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

N/A

Specify Different Travel
Exposure Window

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.

Salmonellosis: 1 Data Element
1 new data element that was not included in the previously reviewed ICR or approved through non-substantive
change requests was added for Salmonellosis. Names, descriptions, value set codes, and justification for the
addition of the new data elements are below:

11

Justification: CDC would like to collect information about the travel exposure window, and would like to add 1
data element with a numeric response option to obtain this information. The exact timeframe for exposures can
vary between states and it is necessary for CDC to know of the differences in timeframe as this influences the
analyses that can be conducted at CDC. Multiple states have already reported a deviation from the
recommended CDC timeframe during an external review of program data elements. By adding in this data
element CDC will be better able to determine the relationship of travel to illness and can work to create
timeframe standards in the future.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Travel
Exposure Window

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.

Shigellosis: 4 Data Elements
4 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Shigellosis. Names, descriptions, value set codes, and justification
for the addition of these new data elements are below:
Justification: CDC would like to collect information about domestic and international travel exposure. By
knowing travel history, CDC will be able to determine where a person may have been exposed to Shigella, which
is important for contact tracing, public health follow up, and understanding geographic patterns of disease and
antimicrobial resistance. The exact timeframe for exposures can vary between states and it is necessary for CDC
to know of the differences in timeframe as this influences the analyses that can be conducted at CDC. Multiple
states have already reported a deviation from the recommended CDC timeframe during an external review of
program data elements. By adding in these data elements CDC will be better able to determine the relationship
of travel to illness.

Value Set Code

Data Element Name

Data Element Description

PHVS_YesNoUnknown_CDC Did The Case Travel
Domestically Prior To
Illness Onset?

Did the case patient travel domestically
within program specific timeframe?

12

N/A

Specify Different Travel
Exposure Window

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.

PHVS_State_FIPS_5-2

Travel State

Domestic destination, state(s) traveled
to

PHVS_Country_ISO_3166-1

International
Destination(S) Of Recent
Travel

International destination or countries
the patient traveled to

Campylobacteriosis: 2 Data Elements
2 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Campylobacteriosis. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: CDC would like to distinguish cases that meet probable case criteria by epidemiologic linkage from
those that qualify by laboratory data. This is necessary to assist in outbreak detection and investigation and to
make appropriate adjustments to estimates of incidence and disease burden, as these types of probable cases
are handled differently.

Value Set Code

Data Element Name

Data Element Description

PHVS_YesNo_HL7_2x

Probable – Laboratory Diagnosed

Probable case is laboratory
diagnosed

PHVS_YesNo_HL7_2x

Probable – Epi Linked

Probable case is epi linked

Cryptosporidiosis: 1 Data Element
1 new data element that was not included in the previously reviewed ICR or approved through non-substantive
change requests were added for Cryptosporidiosis. Names, descriptions, value set codes, and justification for the
addition of these new data elements are below:
Justification: CDC would like to collect information about the epidemiologic exposure window, and would like to
add 1 data element with a numeric response option to obtain this information. The exact timeframe for
exposures can vary between states and it is necessary for CDC to know of the differences in timeframe as this
influences the analyses that can be conducted at CDC. Multiple states have already reported a deviation from
13

the recommended CDC timeframe during an external review of program data elements. By adding in this data
element CDC will be better able to determine the relationship of travel to illness and can work to create
timeframe standards in the future.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Exposure
Window

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

Cyclosporiasis: 3 Data Elements
3 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Cyclosporiasis. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: CDC would like to collect information about domestic travel exposure. By knowing travel history,
CDC will be able to determine where a person may have been exposed to Cyclosporiasis, which is important for
contact tracing, public health follow up, and understanding geographic patterns of disease and antimicrobial
resistance. Additionally, CDC would like to collect 2 numeric variables related to the travel exposure and
epidemiologic exposure timeframes. The exact timeframe for exposures can vary between states and it is
necessary for CDC to know of the differences in timeframe as this influences the analyses that can be conducted
at CDC. Multiple states have already reported a deviation from the recommended CDC timeframe during an
external review of program data elements. By adding in these data elements CDC will be better able to
determine the relationship of travel to illness.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Exposure
Window

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

14

N/A

Specify Different Travel Exposure
Window

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.

PHVS_YesNoUnknown_CDC

Did The Case Travel Domestically
Prior To Illness Onset?

Did the case patient travel
domestically within program
specific timeframe?

Cholera: 1 Data Element
1 new data element that was not included in the previously reviewed ICR or approved through non-substantive
change requests was added for Cholera. Names, descriptions, value set codes, and justification for the addition
of these new data elements are below:
Justification: CDC would like to collect information about the epidemiologic exposure window, and would like to
add 1 data element with a numeric response option to obtain this information. The exact timeframe for
exposures can vary between states and it is necessary for CDC to know of the differences in timeframe as this
influences the analyses that can be conducted at CDC. Multiple states have already reported a deviation from
the recommended CDC timeframe during an external review of program data elements. By adding in this data
element CDC will be better able to determine the relationship of travel to illness and can work to create
timeframe standards in the future.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Exposure
Window

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

Vibriosis: 1 Data Element
1 new data element that was not included in the previously reviewed ICR or approved through non-substantive
change requests was added for Vibriosis. Names, descriptions, value set codes, and justification for the addition
of these new data elements are below:

15

Justification: CDC would like to collect information about the epidemiologic exposure window, and would like to
add 1 data element with a numeric response option to obtain this information. The exact timeframe for
exposures can vary between states and it is necessary for CDC to know of the differences in timeframe as this
influences the analyses that can be conducted at CDC. Multiple states have already reported a deviation from
the recommended CDC timeframe during an external review of program data elements. By adding in this data
element CDC will be better able to determine the relationship of travel to illness and can work to create
timeframe standards in the future.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Different Exposure
Window

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

S. Typhi Infection: 4 Data Elements
4 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for S. Typhi Infection. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: CDC would like to collect information about the travel exposure window, and would like to add 1
data element with a numeric response option to obtain this information. The exact timeframe for exposures can
vary between states and it is necessary for CDC to know of the differences in timeframe as this influences the
analyses that can be conducted at CDC. Multiple states have already reported a deviation from the
recommended CDC timeframe during an external review of program data elements. By adding the “Specify
Different Travel Exposure Window” data element, CDC will be better able to determine the relationship of travel
to illness and can work to create timeframe standards in the future. CDC would like to also collect the following
risk factors: (a) health care worker, (b) day care attendee and (c) day care worker as suggested by the position
statement.

Value Set Code

Data Element Name

Data Element Description

N/A

Specify Travel Different Exposure
Window

If the travel exposure window
used by the jurisdiction is different
from that stated in the travel

16

exposure questions, specify the
time interval in days here.
Otherwise, leave blank.
TBD

Health care worker

Was the patient a health care
provider?

TBD

Day care attendee

Was the patient a day care
attendee?

TBD

Day care worker

Was the patient a day care
provider?

S. Paratyphi Infection: 60 Data Elements
60 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for S. Paratyphi Infection. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: In addition to 56 data elements previously approved for Typhoid Fever (renamed S. Typhi in this
ICR) which are also necessary for national surveillance of S. Paratyphi infections, CDC would like to collect
information about the patient travel exposure window, and would like to add 1 data element, with a numeric
response option, to obtain this information. The calculation of the timeframe for exposures can vary between
states so it is necessary for CDC to know of the differences in timeframes since they can influence the data
analyses that can be conducted at CDC. During an external review of program data elements, multiple states
reported a deviation from the recommended CDC travel exposure timeframe. By adding the “Specify Different
Travel Exposure Window” data element, CDC will be better able to determine the relationship of travel to
illness, and can work to create timeframe standards in the future. CDC would also like to collect the following
risk factors: (a) health care worker, (b) day care attendee and (c) day care worker, as suggested by the 2018
CSTE position statement.

Value Set Code

Data Element Name

Data Element Description

TBD

Formtype

Type of form reported on

TBD

CDCNUM

CDC Number

TBD

StateEpiNumber

State Epi Number

TBD

SLABSID

State Lab Isolate ID Number

TBD

SLABSID2

State Lab Isolate ID Number 2, if another entry is
associated in NARMS data
17

TBD

SpecNumber

NARMS Isolate Identification Number

TBD

SpecNumber2

NARMS Isolate Identification Number- for duplicate
sample from a single patient

TBD

SpecNumber3

NARMS Isolate Identification Number- for duplicate
sample from a single patient

TBD

Year

Year of report (based on date onset)

TBD

Date Entered

Date Form was entered into database

TBD

Date Rec CDC

Date Form was received to CDC

TBD

Name

First three letters of patient's last name

TBD

Foodhand

Work as foodhandler?

TBD

Citizen

U.S. Citizen?

TBD

Othcitzn

Other citizenship

TBD

Ill

Ill with paratyphoid fever?

TBD

Dtonset

Date of onset of Symptoms

TBD

Outcome

Outcome of case

TBD

Dtisol

Date Salmonella first isolated

TBD

Site

Sites of isolation

TBD

Othsite

Other site of isolation

TBD

Serotype

Serotype of isolate

TBD

Sensi

Was sensitivity testing done?

TBD

Ampr

Resistant to ampicillin?

TBD

Chlorr

Resistant to chloramphenicol?

TBD

Tmpsmxr

Resistant to trimethoprim-sulfamethoxazole?

TBD

quinol

Resistant to fluoroquinolone on?

TBD

Ceft

Resistant to ceftriaxone?

TBD

outbreak

Did case occur as part of outbreak?

TBD

vac5yr

Vaccinated within 5 yrs?

TBD

stanvax

Standard Killed typhoid shot?
18

TBD

yrstanvx

Year standard vaccine received

TBD

ty21vax

Oral Ty 21a or Vivotof four pill series?

TBD

yrty21

Year of Oral Ty 21a or Vivotof four pill series received

TBD

vicps

VICPS or Typhium VI shot?

TBD

yrvicps

Year VICPS or Typhium VI shot received

TBD

outus

Travel outside of US?

TBD

country1

Country 1 visited

TBD

country2

Country 2 visited

TBD

country3

Country 3 visited

TBD

country4

Country 4 visited

TBD

country1oth

Country 1 other

TBD

country2oth

Country 2 other

TBD

country3oth

Country 3 other

TBD

country4oth

Country 4 other

TBD

dtentus

Date of most return or entry in the US

TBD

business

Business is purpose of international travel?

TBD

tourism

Tourism is purpose of international travel?

TBD

visitfam

Visiting relatives or friends is purpose of international
travel?

TBD

immigrat

Immigration to the US is purpose of international travel?

TBD

othtrav

Other travel is purpose of international travel?

TBD

travreas

Reason for other travel

TBD

anycarr

Case traced to typhoid carrier?

TBD

prevcarr

Carrier previously known to health dept?

TBD

comment

Comments

TBD

dtform

Date PH Dept completed form

TBD

Specify Different Travel
Exposure Window

If the travel exposure window used by the jurisdiction is
different from that stated in the travel exposure
19

questions, specify the time interval in days here.
Otherwise, leave blank.
TBD

Health care worker

Was the patient a health care provider?

TBD

Day care attendee

Was the patient a day care attendee?

TBD

Day care worker

Was the patient a day care provider?

Lyme disease: 7 Data Elements
7 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Lyme disease. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: The data elements included in this change request will contribute to enhanced surveillance efforts
on the part of the CDC program and allow the program to perform additional epidemiological analyses for Lyme
disease. The new data elements collect information about where exposure occurred, if symptom onset was
greater than 30 days before specimen collection date, and medication type, date and duration. The clinical
manifestation and clinical manifestation indicator data elements update how clinical information is collected.

Value Set Code

TBD

TBD

TBD

Data Element Name

Exposure in high incidence state

Did patient live in or visit a state
defined as high incidence within
30 days prior to onset of
symptoms?

Symptom onset greater than 30
days

Did onset of symptoms occur
more than 30 days prior to
diagnosis?

Clinical Manifestation

Clinical manifestation of Lyme
disease

Clinical Manifestation Indicator

For each clinical manifestation
reported, indicate whether the
subject developed the specified
manifestation as a result of the
illness.

Medication Administered

What antibiotic did the patient
receive for this episode?

TBD

TBD

Data Element Description

20

TBD

Date Treatment or Therapy Started

Date the treatment or therapy
was initiated

Treatment Duration

Number of days the patient
actually took the antibiotic
referenced

TBD

Invasive Haemophilus influenzae Disease: 33 Data Elements
33 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Invasive Haemophilus influenzae disease. Names, descriptions,
value set codes, and justification for the addition of these new data elements are below:
Justification: The inclusion of the Haemophilus influenzae disease specific elements will contribute to enhanced
surveillance efforts on the part of the CDC program and allow for timely public health action. Included variables
aim to identify secondary transmission of non-b H. influenzae, confirm laboratory testing conducted by the
states, link the laboratory data to epidemiological data, and provide vaccination information.

Value Set Code

Data Element
Name

Data Element Description

PHVS_InfectionType_RIBD

Bacterial
Infection
Syndrome
Pregnancy
Status at the
Time of First
Positive
Culture
Pregnancy
Outcome
Gestational
Age

Types of infection caused by organism

N/A

Birth Weight

If patient <1 month of age, indicate birth weight

PHVS_WeightUnit_UCUM

Birth Weight
Units

Birth Weight Units

PHVS_YesNoUnknown_CDC

Previous
Contact With
Hib Disease
Hib Contact
Type

Is there a known previous contact(s) with Hib disease
within the preceding two months?

PHVS_PregnacyStatus_RIBD

PHVS_FetalOutcome_RIBD
N/A

PHVS_ContactType_RIBD

At the time of first positive culture, was the patient
pregnant or postpartum? (The postpartum period is
defined as the 30 days following a delivery or
miscarriage)
If pregnant or postpartum, what was the outcome of
fetus?
If patient <1 month of age, indicate gestational age (in
weeks)

Type of previous contact(s) with Hib disease within
the preceding two months.
21

PHVS_YesNoUnknown_CDC

PHVS_ContactType_RIBD

PHVS_YesNoUnknown_CDC

N/A

PHVS_FormStatus_RIBD
N/A

Previous
Contact With
Non-b or
Nontypeable
H. influenzae
Case
Non-b or
Nontypeable
Contact Type
Recurrent
Disease with
Same
Pathogen

Previous State
ID (Recurrent
Case)
Case Report
Form Status
Illness Onset
Age

Did patient have known previous contact(s) with a
non-b or nontypeable case of H. influenzae disease
within the preceding 2 months?

Specify type of contact(s) with non-b or nontypeable
case of H. influenzae
Does this case have recurrent disease with the same
pathogen? (For Streptococcus pneumoniae, the
specimen from the current case must have been
isolated 8 or more days after any previous case due to
the same pathogen. For all other pathogens, the
specimen from the current case must have been
isolated 30 or more days after any previous case due
to the same pathogen.)
StateID of 1st occurrence for this pathogen and
person.
Case Report Form Status
Illness onset age

PHVS_AgeUnit_UCUM

Illness Onset
Age Units

Illness onset age units

PHVS_ResidenceLocation_RIBD

Residence

Where was the patient a resident at time of initial
culture?

PHVS_YesNoUnknown_CDC

Premature at birth (for children ≤2 years old)

PHVS_YesNoUnknown_CDC

Premature
Infant
Epi-Linked to a
LaboratoryConfirmed
Case
ABCs Case

N/A

ABCs State ID

ABCs State ID

PHVS_YesNoUnknown_CDC

Laboratory
Testing
Performed
Laboratory
Confirmed

Was laboratory testing done to confirm the
diagnosis?

Test
Manufacturer

Test Manufacturer

PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC

N/A

Is this case epi-linked to a laboratory-confirmed case?

ABCs case

Was the case laboratory confirmed?

22

N/A

Lab Accession
Number

Lab Accession Number (including CDC Lab ID)

PHVS_YesNoUnknown_CDC

Did the
Subject Ever
Receive a
Vaccine
Against This
Disease
Date of Last
Dose Prior to
Illness Onset
Vaccination
Doses Prior to
Onset
Vaccine
History
Comments
Age at
Vaccination

Did the subject ever receive a vaccine against this
disease?

Age at
Vaccination
Units
Vaccine
History
Information
Source
Vaccine
Information
Source
Indicator
Susceptibility
Test

The age units of the person at the time the vaccine
was given

N/A

N/A

N/A

N/A
PHVS_AgeUnit_UCUM

PHVS_InformationSource_RIBD

PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC

Date of last vaccine dose against this disease prior to
illness onset
Number of vaccine doses against this disease prior to
illness onset
Vaccine History Comments

The persons age at the time the vaccine was given

What sources were used for vaccination history?

Vaccination History Information Source Indicator

Was any susceptibility data available?

Meningococcal Disease: 37 Data Elements
37 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for meningococcal disease. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: The inclusion of meningococcal disease specific elements will contribute to enhanced surveillance
efforts on the part of the CDC program and allow for timely public health action. Included variables aim to
evaluate the effectiveness of routine public health management of meningococcal disease cases, define the
population at increased risk of meningococcal disease, assess the impact vaccine recommendations, link the
laboratory data to epidemiological data, and monitor resistance.

23

Value Set Code

Data Element
Name

Data Element Description

PHVS_InfectionType_RIBD

Bacterial
Infection
Syndrome
Gestational
Age
Birth Weight

Types of infection caused by organism

N/A
N/A
PHVS_WeightUnit_UCUM
PHVS_YesNoUnknown_CDC
PHVS_YesNoUnknown_CDC

N/A

Birth Weight
Units
Secondary Case
Recurrent
Disease with
Same Pathogen

PHVS_HIVStatus_STD

Previous State
ID (Recurrent
Case)
Case Report
Form Status
Had Sex with a
Male within
the Past 12
Months
Had Sex with a
Female within
the Past 12
Months
Number of
Male Sexual
Partners
HIV Status

PHVS_YesNoUnknown_CDC

Homeless

PHVS_SignsSymptoms_RIBD

Signs and
Symptoms

PHVS_FormStatus_RIBD
PHVS_YNRD_CDC

PHVS_YNRD_CDC

N/A

If patient <1 month of age, indicate gestational
age (in weeks)
If patient <1 month of age, indicate birth
weight (grams)
Birth Weight Units
Is this a secondary case?
Does this case have recurrent disease with the
same pathogen? (For Streptococcus
pneumoniae, the specimen from the current
case must have been isolated 8 or more days
after any previous case due to the same
pathogen. For all other pathogens, the
specimen from the current case must have
been isolated 30 or more days after any
previous case due to the same pathogen.)
StateID of 1st occurrence for this pathogen
and person.
Case Report Form Status
Had sex with a male within the past 12
months?

Had sex with a female within the past 12
months?

In the 3 months prior to the onset of
symptoms, number of male sex partners the
person had?
Documented or self-reported HIV status at the
time of event
Was the patient homeless at time of symptom
onset?
Indicate what symptoms of interest the patient
had during the course of the illness

24

PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC

Signs and
Symptoms
Indicator
Eculizumab

Indicator for associated sign and symptom

Was the patient taking eculizumab/Soliris at
the time of disease onset?
Illness onset age

N/A

Illness Onset
Age

PHVS_AgeUnit_UCUM

Illness Onset
Age Units

Illness onset age units

PHVS_ResidenceLocation_RIBD

Residence

Where was the patient a resident at time of
initial culture?

PHVS_YesNoUnknown_CDC

Is this case epi-linked to a laboratoryconfirmed case?

PHVS_YesNoUnknown_CDC

Epi-Linked to a
LaboratoryConfirmed
Case
ABCS Case

N/A

ABCS State ID

ABCS State ID

PHVS_YesNoUnknown_CDC

Laboratory
Testing
Performed
Laboratory
Confirmed

Was laboratory testing done to confirm the
diagnosis?

Serogroup
Method
Test
Manufacturer
Lab Accession
Number
Susceptibility
Test
Did the Subject
Ever Receive a
Vaccine Against
This Disease
Date of Last
Dose Prior to
Illness Onset
Vaccination
Doses Prior to
Onset
Vaccine History
Comments
Vaccine Name

Serogroup method

PHVS_YesNoUnknown_CDC

PHVS_SerogroupMethod_RIBD
N/A
N/A
PHVS_YesNoUnknown_CDC
PHVS_YesNoUnknown_CDC

N/A

N/A

N/A
N/A

ABCs Case

Was the case laboratory confirmed?

Test Manufacturer
Lab Accession Number (including CDC Lab ID)
Was any susceptibility data available?
Did the subject ever receive a vaccine against
this disease?

Date of last vaccine dose against this disease
prior to illness onset
Number of vaccine doses against this disease
prior to illness onset
Vaccine History Comments
Vaccine Name

25

N/A
PHVS_AgeUnit_UCUM

PHVS_InformationSource_RIBD

PHVS_YesNoUnknown_CDC

Age at
Vaccination
Age at
Vaccination
Units
Vaccine History
Information
Source
Vaccine
Information
Source
Indicator

The persons age at the time the vaccine was
given
The age units of the person at the time the
vaccine was given
What sources were used for vaccination
history?
Vaccination History Information Source
Indicator

Invasive Pneumococcal Disease: 32 Data Elements
32 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Invasive Pneumococcal Disease. Names, descriptions, value set
codes, and justification for the addition of these new data elements are below:
Justification: The inclusion of Invasive Pneumococcal Disease-specific elements will contribute to enhanced
surveillance efforts on the part of the CDC program and allow for timely public health action. Included data
elements aim to identify risk factors such as daycare facilities, underlying conditions and illness onset, risk
factors for infection, determine disease severity and how the case was discovered, vaccination information and
monitor for resistance.

Value Set Code

Data Element Data Element Description
Name

PHVS_YesNoUnknown_CDC

In Day Care

Does this patient attend a day care facility?

PHVS_UnderlyingConditions_RIBD

Underlying
Condition(s)

Listing of underlying causes or prior
illnesses

PHVS_YesNoUnknown_CDC

Underlying
Conditions
Indicator
Illness Onset
Age
Illness Onset
Age Units
Hospital ICU

Underlying Conditions Indicator

N/A
PHVS_AgeUnit_UCUM
PHVS_YesNoUnknown_CDC

26

Illness onset age
Illness onset age units
During any part of the hospitalization, did
the subject stay in an Intensive Care Unit
(ICU) or a Critical Care Unit (CCU)

PHVS_ResidenceLocation_RIBD

Residence

Where was the patient a resident at time
of initial culture?

PHVS_PregnacyStatus_RIBD

Pregnancy
Status at the
Time of First
Positive
Culture
Pregnancy
Outcome
Gestational
Age
Birth Weight

At the time of first positive culture, was
the patient pregnant or postpartum? (The
postpartum period is defined as the 30
days following a delivery or miscarriage)

PHVS_FetalOutcome_RIBD
N/A
N/A
PHVS_WeightUnit_UCUM
PHVS_YesNoUnknown_CDC
PHVS_InsuranceType_RIBD
PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC
N/A
PHVS_YesNoUnknown_CDC

N/A

PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC

Birth Weight
Units
Premature
Infant
Insurance
Epi-Linked to
a LaboratoryConfirmed or
Probable
Case
ABCs Case
ABCs State ID
Recurrent
Disease with
Same
Pathogen

Previous
State ID
(Recurrent
Case)
Laboratory
Testing
Performed
Laboratory
Confirmed

If pregnant or postpartum, what was the
outcome of fetus?
If patient <1 month of age, indicate
gestational age (in weeks)
If patient <1 month of age, indicate birth
Weight
Birth Weight Units
Premature at birth (for children ≤2 years
old)
Insurance
Is this case Epi linked to a confirmed or
probable case?

ABCs case
ABCs State ID
Does this case have recurrent disease with
the same pathogen? (For Streptococcus
pneumoniae, the specimen from the
current case must have been isolated 8 or
more days after any previous case due to
the same pathogen. For all other
pathogens, the specimen from the current
case must have been isolated 30 or more
days after any previous case due to the
same pathogen.)
StateID of 1st occurrence for this pathogen
and person.

Was laboratory testing done to confirm
the diagnosis?
Was the case laboratory confirmed?

27

N/A
N/A
PHVS_YesNoUnknown_CDC

N/A

N/A

N/A

N/A
PHVS_AgeUnit_UCUM

PHVS_InformationSource_RIBD

PHVS_YesNoUnknown_CDC

PHVS_YesNoUnknown_CDC

Test
Manufacturer
Lab Accession
Number
Did the
Subject Ever
Receive a
Vaccine
Against This
Disease
Date of Last
Dose Prior to
Illness Onset
Vaccination
Doses Prior
to Onset
Vaccine
History
Comments
Age at
Vaccination
Age at
Vaccination
Units
Vaccine
History
Information
Source
Vaccine
Information
Source
Indicator
Susceptibility
Test

Test Manufacturer
Lab Accession Number (including CDC Lab
ID)
Did the subject ever receive a vaccine
against this disease?

Date of last vaccine dose against this
disease prior to illness onset
Number of vaccine doses against this
disease prior to illness onset
Vaccine History Comments

The persons age at the time the vaccine
was given
The age units of the person at the time the
vaccine was given
What sources were used for vaccination
history?

Vaccination History Information Source
Indicator

Was any susceptibility data available?

Psittacosis: 27 new data elements
27 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Psittacosis. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: The inclusion of the Psittacosis disease-specific elements will contribute to enhanced
surveillance efforts on the part of the CDC program and allow for timely public health action. New
data elements include patient signs, symptoms, treatment, and exposure history to identify underlying
risk factors. Additional elements address current challenges with diagnostic testing and prevention
and control strategies.
28

Value Set Code

Data Element
Name

Data Element Description

PHVS_SignsSymptoms_RIBD

Signs and
Symptoms

PHVS_YesNoUnknown_CDC

Signs and
Symptoms
Indicator
Highest
Measured
Temperature
Temperature
Units
Antibiotics
given
Treatment
Start Date
Treatment
End Date
Treatment
Duration

Indicate what symptoms of interest
the patient had during the course of
the illness
Indicator for associated sign and
symptom

N/A

PHVS_TemperatureUnit_UCUM
PHVS_YesNoUnknown_CDC
N/A
N/A
N/A

PHVS_YesNoUnknown_CDC

Hospital ICU

PHVS_YesNoUnknown_CDC

Laboratory
Testing
Performed
Laboratory
Confirmed

PHVS_YesNoUnknown_CDC

N/A
PHVS_SpecimenSite_RIBD

N/A
N/A

Test
Manufacturer
Autopsy
Specimen
Type
Autopsy
Result
Date of
Autopsy
29

What was the subject's highest
measured temperature during this
illness?
Units for highest measured
temperature
Did the subject take antibiotics as
treatment for this illness?
Start date of antibiotic
Stop date of antibiotic
Number of days the patient actually
took the antibiotic
During any part of the hospitalization,
did the subject stay in an Intensive
Care Unit (ICU) or a Critical Care Unit
(CCU)?
Was laboratory testing done to
confirm the diagnosis?
Was the case laboratory confirmed?

Test Manufacturer
Type of autopsy specimen

Autopsy result
Date of autopsy (date autopsy
specimen collected)

N/A

Autopsy
Laboratory
Name
PHVS_Industry_CDC_Census2010
Industry at
Date of Onset
PHVS_PersonalProtectiveEquipment_RIBD
Personal
Protective
Equipment
PHVS_RespiratoryProtectiveEquipment_RIBD Respiratory
Protective
Equipment
PHVS_YesNoUnknown_CDC
Annual
Respirator Fit
Testing and
Training
PHVS_GloveMaterial_RIBD
Glove
Material
PHVS_ContactType_RIBD
Contact Type

PHVS_BirdType_RIBD

Bird Type

N/A

Bird Species

N/A

Number of
Birds
Illness Onset
Age
Illness Onset
Age Units

N/A
PHVS_AgeUnit_UCUM

Autopsy Laboratory Name

Industry at date of onset
At the time of exposure, which of the
following personal protective
equipment was used by the patient?
If respiratory protective equipment
was used at the time of exposure,
specify what kind
Does the patient get annual respirator
fit testing and training?

If gloves were used, specify glove
material
Indicate which of the following
contacts patient had during 5 weeks
prior to onset
What type of bird did the patient have
contact with during the 5 weeks prior
to onset?
Bird species

Approximate number of birds
Illness onset age
Illness onset age units

Legionellosis: 38 Data Elements
38 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Legionellosis. Names, descriptions, value set codes, and
justification for the addition of these new data elements are below:
Justification: The inclusion of these disease specific elements for Legionellosis will contribute to enhanced
surveillance efforts on the part of the CDC program and allow for timely public health action. Included variables
aim to better characterize patient's exposure history, identify underlying risk factors, and confirm whether the
patient sample was taken during the acute or convalescent phase, which is required to satisfy the case
definition.

30

Value Set Code

Data Element
Name

Data Element Description

N/A

Illness Onset
Age

Age at illness onset

PHVS_AgeUnit_UCUM

Illness Onset
Age Units

Age units at illness onset

N/A

Accommodation
Comments
Address of
Healthcare
Facility
Zip Code of
Healthcare
Facility
Healthcare
Setting
Exposure
Comments
Healthcare
Facility Water
Management
Program
Street Address
of
Assisted/Senior
Living Facility
Zip Code of
Assisted/Senior
Living Facility
Assisted/Senior
Living Facility
Comments
Assisted/Senior
Living Facility
Water
Management
Program
Exposure

Comments or information about nights away
from home not collected elsewhere
Street Address of healthcare facility visited by
the patient in the 10 days before onset

Exposure
Indicator

Exposure Indicator

N/A

N/A

N/A

PHVS_YesNoUnknown_CDC

N/A

N/A

N/A

PHVS_YesNoUnknown_CDC

PHVS_LegionellaExposure_RIBD

PHVS_YesNoUnknown_CDC

31

Zip code of healthcare facility visited by the
patient in the 10 days before onset
Comments or information about healthcare
setting exposure not collected elsewhere

Did the healthcare facility have a water
management program to reduce the risk of
Legionella growth and spread in place?
Street address of assisted/senior living facility
visited/lived in by the patient during exposure

Zip code of assisted/senior living facility
visited/lived in by the patient during exposure
Comments or information about
assisted/senior living facility exposure not
collected elsewhere
Did the assisted/senior living facility have a
water management program to reduce the
risk of Legionella growth and spread in place?

Was the patient exposed to any of the
following during the 10 days prior to onset?

N/A

Location of
Exposure

Location of exposure (e.g. facility name, city ,
state)

N/A

Date(s) of
Exposure

Date(s) of exposure

PHVS_YesNoUnknown_CDC

Recent Cruise
Travel
Name of
Cruiseline
Name of Ship
Cruise
Departure City
Cruise
Departure State
Cruise
Departure
Country
Date of Cruise
Departure
Cruise Return
City
Cruise Return
State
Cruise Return
Country
Date of Cruise
Return
Cabin Number
Port of Call City
Port of Call
Country
Port of Call
State
Port of Call Date
CDC NORS
Outbreak ID#
Did Underlying
Condition(s)
Exist
Underlying
Condition(s)
Underlying
Conditions
Indicator

In the 10 days before onset, did patient take a
cruise?
Name of cruiseline patient sailed with

PHVS_CruiseLine_RIBD
N/A
N/A
PHVS_State_FIPS_5-2
PHVS_Country_ISO_3166-1

N/A
N/A
PHVS_State_FIPS_5-2
PHVS_Country_ISO_3166-1
N/A
N/A
N/A
PHVS_Country_ISO_3166-1
PHVS_State_FIPS_5-2
N/A
N/A
PHVS_YesNoUnknown_CDC

PHVS_UnderlyingConditions_RIBD
PHVS_YesNoUnknown_CDC

32

Name of ship patient sailed on
Cruise departure city
Cruise departure state
Cruise departure country

Cruise departure date
Cruise return city
Cruise return state
Cruise return country
Cruise return date
Patient's cruise ship cabin number
Port of call city
Port of call country
Port of call state
Date for port of call
CDC National Outbreak Reporting System
(NORS) Outbreak ID#
Did the patient have any underlying causes or
prior illnesses?
Listing of underlying causes or prior illnesses
Underlying conditions indicator

PHVS_TiterTestType_RIBD

Titer Test Type

N/A

Test
Manufacturer
Test Brand
Name

N/A

If this is a titer, indicate if this is an
initial/acute or convalescent titer (Titer Test
Type)
Test Manufacturer
Test Brand Name

TBRD: 35 Data Elements
35 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for TBRD. Names, descriptions, value set codes, and justification for
the addition of these new data elements are below:
Justification: These new 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 TBRD. The data elements
Physician Name and Physician Phone are collected on case-patients to inform prevention and control efforts,
allowing for targeted outreach to at-risk populations. The CSTE position statements for TBRD surveillance
indicates clinical manifestation criteria for the diagnosis and classification of cases. The information collected by
Clinical Manifestation and Clinical Manifestation Indicator are key data elements of the case definitions and is
essential both for case management and surveillance. Data elements Experienced Complication and Type of
Complication are collected as markers of severity and are used to assess the burden of TBRD. The Patient
Immunocompromised data element collects information on immune status of cases. Patients who are
immunocompromised have been shown to be more likely to have severe illness and complications from TBRD,
and these data are used to assess burden of TBRD. Treatment Drug Indicator, Medication Administered, Date
Treatment or Therapy Started, and Treatment Duration data elements are collected to determine healthcare
provider awareness and knowledge of these potentially fatal conditions. Risk factor data elements (Occupation
related to exposure, Travel, International Destination(s) of Recent Travel, Travel State, Travel Country, Date of
Arrival to Travel Destination, Date of Departure from Travel Destination, Tick Bite Location, Tick Bite Date) are
needed to provide information on the temporal, geographic, and demographic occurrence of TBRD to facilitate
its prevention and control. There have been known cases of transfusion- and transplant-related cases of TBRD.
Data elements related to blood product transfusions, organ transplants, and blood donations (Blood
Transfusion, Blood Transfusion Date, Transfusion Associated, Transfused Product, Organ Transplant, Transplant
type, Transplant Date, Transplant Associated infection, Blood Donor, Blood Donation Date, Blood Donor
Implicated During Investigation, Donated Product, Blood bank notified) are needed to inform decisions
regarding blood screening policies that may be developed, as well as other intervention strategies. There have
been documented cases of TBRD co-infections with Lyme and Babesiosis. The Co-infection and Co-infection type
33

data elements are needed to provide information on the temporal, geographic, and demographic occurrence of
these co-infections to facilitate its prevention and control.

Value Set Code

Data Element Name

Data Element Description

TBD

Physician Name

TBD

Physician Phone

Name of subject's clinician/provider of care
Provide the name in the following format:
,
Phone number of subject's clinician/provider
of care

TBD

Clinical Manifestation

Clinical manifestation of TBRD

TBD

Clinical Manifestation
Indicator

TBD

Experienced
Complication

For each clinical manifestation reported,
indicate (YNU) whether the subject
developed the specified manifestation as a
result of the illness.
Did the subject experience any complications
due to this episode?

TBD

Type of Complication

TBD

Patient
At the time of diagnosis, was the subject
Immunocompromised immunocompromised?

TBD

Treatment Drug
Indicator

Did the subject receive antimicrobial
treatment for this infection?

TBD

Medication
Administered

What antibiotic did the patient receive for
this episode?

TBD

Date Treatment or
Therapy Started

Date the treatment was initiated

TBD

Treatment Duration

Number of days the patient actually took the
antibiotic referenced

TBD

Occupation related to
exposure

Is the subject's current occupation related to
the exposure?

TBD

Travel

TBD

TBD

International
Destination(s) of
Recent Travel
Travel State

In the two weeks before symptom onset or
diagnosis (use earlier date), did the subject
travel out of their county, state, or country of
residence?
International destination, countries traveled
to

TBD

Travel County

If the subject experienced complications due
to this episode, what was the complication?

Domestic destination, state(s) traveled to
Intrastate destination, counties traveled to

34

TBD

Date of Arrival to
Travel Destination

If the subject traveled, when did they arrive
to their travel destination?

TBD

If the subject traveled, when did they depart
from their travel destination?

TBD

Date of Departure
from Travel
Destination
Tick Bite Location

TBD

Tick Bite Date

If subject noticed tick bite, when did the bite
occur?

TBD

Blood Transfusion

TBD

Blood Transfusion
Date

In the year before symptom onset or
diagnosis (use earlier date), did the subject
receive a blood transfusion?
Date(s) of blood transfusion(s)

TBD

Transfusion
Associated

Was the subject’s infection transfusion
associated?

TBD

Transfused Product

TBD

Organ Transplant

TBD

Transplant type

If a transfused blood product was implicated
in an investigation, specify which type(s) of
product.
In the year before symptom onset or
diagnosis (use earlier date), did the subject
receive an organ transplant(s)?
If the subject received an organ transplant,
what was the organ?

TBD

Transplant date

Date(s) of organ transplant(s)

TBD

Transplant associated
infection

Was the subject's infection transplantrelated?

TBD

Blood Donor

Did the subject donate blood in the 30 days
prior to symptom onset?

TBD

Blood Donation Date

Date(s) of blood donation(s)

TBD

Blood Donor
Implicated During
Investigation

TBD

Donated Product

TBD

Blood bank notified

Was the subject a blood donor identified
during a transfusion investigation (i.e., had
positive test results and was linked to an
infected recipient)?
If a donated blood product was implicated in
an investigation, specify which type(s) of
product.
Was the blood bank/hospital/transplant
service notified?

TBD

Co-infection

Was the subject diagnosed with a coinfection?

TBD

Co-infection type

Specify coinfection

35

If subject noticed tick bite, where did the bite
occur (geographic location)?

Hepatitis: 5 Data Elements
5 new data elements that were not included in the previously reviewed ICR or approved through nonsubstantive change requests were added for Hepatitis. Names, descriptions, value set codes, and justification for
the addition of these new data elements are below:
Justification: The inclusion of these disease specific elements for Hepatitis A will contribute to enhanced
surveillance efforts on the part of the CDC program and allow for timely public health action. Included variables
aim to better characterize patient's status and identify an underlying risk factor, which is required to satisfy the
case definition:

Value Set Code

Data Element
Name

Data Element Description

PHVS_LabTestResultQualitative_CDC

hepatitis A RNA

Nucleic acid amplification test (NAAT; such as
PCR or genotyping) for hepatitis A virus RNA

N/A

Date of hepatitis
A RNA test

Date of hepatitis A RNA test

N/A

Total bilirubin

Total bilirubin levels

N/A

Date of bilirubin
test

Date of bilirubin test

PHVS_YesNoUnknown_CDC

Experienced
homelessness

In the 2-6 weeks prior to symptom onset, was
the patient homeless?

36