Justification for Disease-specific Data

78 new data elements that were not included in the previously reviewed ICR or approved through non-substantive
change requests were added for 3 conditions: 75 new disease-specific data elements for Cronobacter, 2 new
disease-specific data elements for Leptospirosis, and 1 new disease-specific data elements for Hansen’s Disease.
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:

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

•

•
•
•

•

Cronobacter spp. are opportunistic pathogens, and infections can be lifethreatening, particularly in infants. Outbreaks of Cronobacter infections
have been associated with neonatal intensive care units, and neonates
and infants are at greatest risk for morbidity and mortality from invasive
infections such as meningitis and sepsis.
Surveillance for Cronobacter is necessary to help estimate incidence,
identify risk factors, promptly detect and trace outbreaks, and inform
control and prevention measures.
The increased reporting and submission of isolates to CDC is expected
to enable rapid and accurate species identification and outbreak
detection.
To provide more information about risk factors (related cases and
conditions, high acuity care needs, healthcare facility exposure, travel,
and specimen testing) that have been associated with colonization or
infection
To monitor epidemiology

Value Set Code

CDC Priorityi

State lab ID submitted to
PulseNet

N/A

1

Date Case Report
Form Completed
Patient Or
Surrogate Able To
Be Interviewed

Date case report form was
completed

N/A

2

PHVS_YesNoUnknown_CDC

2

Healthcare Setting
Exposure Type

Type of exposure to
healthcare setting
Clinical Syndrome is the
type of clinical presentation
the case had.

TBD

2

TBD

1

TBD

2

N/A

1

Data Element
Name

Data Element Description

PulseNet ID

Clinical Syndrome
Obstetric Delivery
Method
Gestational Age

Was patient or surrogate
able to be interviewed?

Type of delivery
Gestational age (weeks)

1

N/A

2

Birth Weight

Birth weight (in grams)

Antibiotics Given
to Mother

Were intrapartum antibiotics
given to mother?

TBD

3

Treatment
Received
Antimicrobial
Susceptibility
Testing Performed
At The Laboratory

Was treatment received for
this condition?

TBD

2

PHVS_YesNoUnknown_CDC

3

Hospitalization At
Onset

Was patient hospitalized at
time of illness onset?
Was infant single, multiple
or unknown number of
births?
Did patient receive any
medication by mouth or
feeding tube in the 10 days
prior to illness onset?

TBD

2

TBD

3

PHVS_YesNoUnknown_CDC

2

PHVS_YesNoUnknown_CDC

3

PHVS_YesNoUnknown_CDC

3

Gastric Acid
Suppressing
Medication Given

Has patient ever been
treated with steroids
Did infant receive gastric
acid suppressing medication
in the 10 days prior to
illness onset

Infant Feeding
Method

How was infant fed 10 days
prior to illness onset?

TBD

1

Specify Feeding
Tube Type

TBD

1

PHVS_YesNoUnknown_CDC

1

Fed Breast Milk

If infant was fed via feeding
tube, specify tube type
In the 10 days before illness
began, was infant ever fed
breast milk?

TBD

2

Breast Milk Source

If yes, what source of breast
milk?
Was infant exclusively
breast fed?
Was expressed breast milk
consumed (i.e., pumped and
fed through bottle or tube)?
If yes, was pumped milk
from multiple pumping
sessions ever combined and
then stored for later use?
Did infant consume liquid
formula in the 10 days
before illness began?
Did infant consume any
solid foods, including
cereal, in the 10 days before

PHVS_YesNoUnknown_CDC

1

PHVS_YesNoUnknown_CDC

2

PHVS_YesNoUnknown_CDC

1

PHVS_YesNoUnknown_CDC

1

PHVS_YesNoUnknown_CDC

1

Birth Multiplicity
Medication By
Mouth Or Feeding
Tube
Steroids Given

Exclusively Breast
Fed
Consumed
Expressed Breast
Milk

Combined Milk
Consumed Liquid
Formula
Consumed Solid
Food

Was antimicrobial
sensitivity testing done at
the laboratory?

2

illness began?
TBD

2

TBD

2

Specify Liquid
Formula

If yes, specify type of solid
food
If infant cereal was
consumed, type of liquid
used for preparing infant
cereal

Formula Prepared
With Water

Was water used to prepare
infant formula

PHVS_YesNoUnknown_CDC

1

Formula Water
Type

Type of water used for
preparing infant formula
Was water boiled and
cooled before adding to
formula

Specify Solid Food
Type

Formula Water
Boiled
Formula Water
Mix Method

Breast Milk or
Formula Additive
Formula
Preparation
Frequency

How were formula and
water mixed
Was anything ever added to
breast milk or formula
(besides water) during the
10 days before illness

1
PHVS_YesNoUnknown_CDC

1

TBD

3

PHVS_YesNoUnknown_CDC

2

TBD

3

What frequency was
formula prepared

Formula Storage
Location
Maximum
Refrigerated
Storage Time
Maximum Room
Temperature
Storage Time

Where was prepared
formula stored
Maximum storage time of
prepared, refrigerated
formula
Maximum storage time of
prepared, room temperature
formula

TBD

3

TBD

1

TBD

1

Formula
Temperature

What temperature was
formula at time of feeding
Was prepared feed ever left
in a crib with infant
overnight?
Was a partially consumed
bottle that was at room
temperature for more than 2
hours ever saved and given
to the infant later
Was the lid of the formula
container ever placed on the
counter, in the sink, or on
another surface
Was the formula scoop ever
placed on the counter, in the
sink, or on another surface

TBD

3

PHVS_YesNoUnknown_CDC

3

PHVS_YesNoUnknown_CDC

3

PHVS_YesNoUnknown_CDC

3

PHVS_YesNoUnknown_CDC

3

Formula Left In
Crib

Formula Reused

Formula Lid
Surface Contact
Formula Scoop
Surface Contact

3

Were bottles, nipples, and
rings always completely
dissembled before cleaning

PHVS_YesNoUnknown_CDC

2

Equipment
Disassembled

PHVS_YesNoUnknown_CDC

2

Bottle Cleaned

Were bottles cleaned after
each use

TBD

3

TBD

2

PHVS_YesNoUnknown_CDC

2

TBD

2

PHVS_YesNoUnknown_CDC

2

TBD

2

TBD

3

TBD

3

PHVS_YesNoUnknown_CDC

2

PHVS_YesNoUnknown_CDC

2

TBD

2

PHVS_YesNoUnknown_CDC

2

Bottle Cleaning
Method

How were bottles cleaned

Bottle Scrub
Method

Were bottles scrubbed using

Bottle Cleaned
With Soap

Was soap used when
cleaning bottles

Bottle Drying
Method
Equipment
Sanitized
Equipment
Sanitized
Frequency
Equipment
Sanitized Method

How were bottle parts dried
Were bottles, nipples,
and/or rings sanitized
If yes, how often were they
sanitized
How were parts sanitized

Pump Cleaned

What type of pump was
used
Were flanges, valves,
membranes, and connector
tubing always completely
disassembled before
cleaning
Was the pump kit, not
including tubing, cleaned
after each use

Pump Cleaning
Frequency

If no, how many times was
it used before being cleaned

Pump Type

Pump
Disassembled

Pump Rinsed

Was kit rinsed between uses

Pump Storage
Location

Where was unwashed kit
stored between uses

TBD

3

Pump Cleaning
Method

How were pump and parts
cleaned

TBD

2

Pump Scrubbing
Method

Were pump and parts
scrubbed using

PHVS_YesNoUnknown_CDC

2

Pump Cleaned
With Soap

Was soap always used when
washing pump kit and parts

PHVS_YesNoUnknown_CDC

2

TBD

3

PHVS_YesNoUnknown_CDC

3

Pump Drying
Method
Pump Sanitized

How were pump parts dried
Was pump kit ever sanitized

4

Pump Sanitized
Frequency
Pump Sanitized
Method
Pump Reassembled
When Damp

Product Name
Product
Manufacturer
Product Type
Product Size
Lot Number

How were parts sanitized
Was clean pump kit ever
reassembled while still
damp
Complete product name
(including brand, type, and
variety)

Date Last
Consumed
Dates Consumed
Unknown
Antibiotics With
Intermediate
Resistance
Antibiotics With
Complete
Resistance

TBD

3

PHVS_YesNoUnknown_CDC

3

TBD

1

TBD

1

TBD

1

TBD

2

N/A

1

N/A

1

N/A

1

N/A

1

TBD

1

N/A

3

N/A

2

Type of product
Size of container
Lot number(s), if known
Use by Date
Date first consumed
Date last consumed
Dates Consumed Unknown
If yes, antibiotics with
intermediate resistance:
If yes, antibiotics with
complete resistance:

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

•

•

Data Element
Name
Congregant Living
Setting

3

Product manufacturer

Use By Date
Date First
Consumed

TBD

If yes, how often were they
sanitized

To provide more information about risk factors (related cases and
conditions, high acuity care needs, healthcare facility exposure, travel,
and specimen testing) that have been associated with colonization or
infection
To update guidance on infection control and prevention

CDC Priorityi

Value Set Code
Data Element Description
In the 30 days prior to
illness onset, did the subject

TBD

5

3

Homelessness

ever reside in any of these
congregate living settings:
In the 30 days prior to
illness onset, did the subject
ever sleep in:

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

•
•
•

Data Element
Name

Sequelae of
Hansen's Disease

TBD

2

To monitor the frequency of complications developed due to Hansen’s
Disease.
To provide more information on types of disabilities developed due to
Hansen’s Disease.
To monitor epidemiology of Hansen’s Disease.

CDC Priorityi

Value Set Code
Data Element Description
Hansen’s Disease
complications leading to
disabilities such as any
sensory abnormalities or
deformities of the hands,
eyes, or feet.

TBD

i

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

6

2