Introduction

The Case Based Surveillance Epi Questionnaire Panel provides an extensible manner to collect and organize epidemiological questions into a structured set of Observation resources.

Examples for use:

• Atypical or niche subject demographic information to support epidemiological study.
• Tracking of patient residence and travel history in line with a program’s specific guidelines. (Example: Migration during tuberculosis treatment.)
• Public health focused social history questions and answers. (Examples: Sexual history or illicit drug use.)
• Recent food consumption and other relevant data used in identifying food bourne illness outbreaks.

This profile should not be used to capture standard clinical data or notifiable case meta data. In the case of more standard clinical information, appropriate FHIR base resources or other profiles should be used. In the case of notifiable case meta data, the Case Based Surveillance Case Notification Panel should be used.

Mandatory and Must Support Data Elements

The following elements must always be present or must be supported.

Each Discrete Panel Structure must have:

1. A single [1..1] top level observation with:
   • A code element defined to describe the questionnaire in the context of a program. This should be considered the cannonical name for the questionnaire as a whole. Please see the note below this section for additional guidance if a code cannot be defined.
   • HasMember element references to every observation which falls within the questionnaire.
2. A single consistent subject reference across all observations.
3. If applicable, a single consistent focus reference across all observations.
4. A single consistent relevant time.
5. A user (surveillance program) defined valueset which includes the top level cannonical name value, if available, as well as a value for each question item within the questionnaire panel. If an appropriate valueset cannot be defined, a Questionnaire resource should be considered instead of this profile.

Handling Undefined Cannonical Name Codes: As many questions may already be defined in the PHIN Questions code system, there may be cases in which only the cannonical name value cannot be properly expressed as a code. If an appropriate code cannot be defined through a system such as PHIN, the text element of the CodeableConcept may be used to provide a summary. In this case, the generic code “undefined-epi-questionnaire-cannonical-name” as defined as part of this implementation guide’s central code system should be used to indicate the lack of defined coding and need to reference the text element of the CodeableConcept. Be aware that by failing to define a specific code, it may make searching for a specific questionnaire set difficult if the server does not support search by text or if the text representation is not consistently known.

Each Observation must have:

1. A status.
2. A category code of “epi-questionnaire”.
3. A code representing the epi question item or concept being answered, typically from the PHIN Questions code system or a code representing the cannonical name of the questionnaire.
4. A subject reference to a Case Based Surveillance Patient profile for which the question items are being answered. In the case of a surveillance program which may capture multiple patients, this is not required to be the central subject of the case report. One example of this is in the case of Congenital Syphilis, in which a child is the central subject of the case report where there is additional data collected on the mother (who is represented as a separate Case Based Surveillance Patient profile and linked to a RelatedPerson resource which defines the relationship to the central subject).
   • A discrete Epi Questionnaire Panel with member observations must not provide a subject reference to more than one patient. All references between the top level panel resource and the member resources must have consistent subject references.
5. One of the following:
   • If the code element is a canonical name for the questionnaire, hasMember references to all other included observations in the questionnaire value set.
   • An answer to the coded provided as value[x] or as component value[x] as agreed upon by a program in the definition of their questionnaire items. (Note: This is left up to surveillance programs to define and dessiminate to users within their workflow. If this cannot be done, a Questionnaire resource to provide explicit requirements should be considered instead.)
6. A relevant time.

Relationship to Other Profiles and Resources

Relationship with Questionnaire

This profile provides an alternative to using a Questionnaire resource to capture equivalent data. As Questionnaires require both the Questionnaire itself and a QuestionnaireResponse, along with strict version controlling of the Questionnaire resources, they may lead to implementation and maintenance concerns depending on individual use cases. This profile is intended a flexible yet still structured alternative for surveillance programs to utilize in the case that maintaining a Questionnaire is not appropriate or possible.

Users may opt to utilize a standard Questionnaire resource in place of this profile, though should carefully weight the benefits of each approach. Users may also leverage both this profile and a Questionnaire together.

In contrast to a Questionnaire, this profile captures information in explicitly coded observations and groups them together using a structure similar to other panel profiles, such as Vital Signs, allowing for meaning to be derived from the coding without need to interpret additional the additional resource. This also allows for more granular access to the data as each observation, representing a question, may be transfered individually whereas this is not possible with a Questionnaire. Additionally, as many of these questions are already defined within the PHIN Question code system, this also provides alignment with existing approaches and faciliates direct mappings from HL7v2 Message Mapping Guide structured messages when required.

Relationship with Case Based Surveillance Case Notification Panel

The CBS Epi Questionnaire Panel provides for a logical separation of data content from “meta data” related to general case management or the reporting workflow. For information of that nature, the CBS Case Notification Panel profile should be used. When looking at the data elements present in Message Mapping Guides, this line can largely be drawn between what exists in the Generic v2 MMG, which is represented in the Case Notification Panel, and what exists in individual surveillance program MMGs.

Examples with Use Case

In surveillance of sexually transmitted diseases, data is collected around the subject’s recent sexual history and other areas such as drug abuse. An abbreviated example based on the Public Health STD Message Mapping Guide is provided here. The valueset used for this is provided as part of this Implementation Guide and bound to this profile with a binding strength of example. For more information, please see http://hl7.org/fhir/R4/valueset-binding-strength.html.

TODO: Create Example Resources and link here.

Panel Structure

The following diagram provides a brief look at the intended structure of a discrete questionnaire panel. Only display elements are shown for coded elements.

• Text Summary
• Differential Table
• Snapshot Table
• Snapshot Table (Must Support)
• All

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	Measurements and simple assertions
status	S	1..1	code	registered | preliminary | final | amended +
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:coding.code, value:coding.system
category:EQCat	S	1..1	CodeableConcept	Classification of type of observation
coding	S	1..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://cbsig.chai.gatech.edu/CodeSystem/cbs-temp-code-system
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: epi-questionnaire
code	S	1..1	CodeableConcept	Coded Questionnaire Items from Surveillance Program Specified Valueset Binding: STD Sexual History and Drug Use Questionnaire Panel (example): This identifies the coded questionnaire item.
subject	S	1..1	Reference(Case Based Surveillance Patient Profile)	Who and/or what the observation is about
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result
hasMember		0..*	Reference(Case Based Surveillance Epi Questionnaire Panel)	Related resource that belongs to the Observation group
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	Observation	Measurements and simple assertions
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:coding.code, value:coding.system Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:EQCat	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://cbsig.chai.gatech.edu/CodeSystem/cbs-temp-code-system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: epi-questionnaire
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Coded Questionnaire Items from Surveillance Program Specified Valueset Binding: STD Sexual History and Drug Use Questionnaire Panel (example): This identifies the coded questionnaire item.
subject	SΣ	1..1	Reference(Case Based Surveillance Patient Profile)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	Σ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣI	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	I	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	I	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	I	0..1	SimpleQuantity	Low Range, if relevant
high	I	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Case Based Surveillance Epi Questionnaire Panel)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	I	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	Observation	Measurements and simple assertions
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:coding.code, value:coding.system Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:EQCat		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..*	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://cbsig.chai.gatech.edu/CodeSystem/cbs-temp-code-system
code	Σ	1..1	code	Symbol in syntax defined by the system Fixed Value: epi-questionnaire
code	Σ	1..1	CodeableConcept	Coded Questionnaire Items from Surveillance Program Specified Valueset Binding: STD Sexual History and Drug Use Questionnaire Panel (example): This identifies the coded questionnaire item.
subject	Σ	1..1	Reference(Case Based Surveillance Patient Profile)	Who and/or what the observation is about
value[x]	ΣI	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
Documentation for this format

This structure is derived from Observation

Summary

Mandatory: 6 elements
Must-Support: 9 elements
Fixed Value: 2 elements

Structures

This structure refers to these other structures:

• Case Based Surveillance Patient Profile (http://cbsig.chai.gatech.edu/StructureDefinition/cbs-patient)
• Case Based Surveillance Epi Questionnaire Panel (http://cbsig.chai.gatech.edu/StructureDefinition/cbs-epi-questionnaire-panel)

Slices

This structure defines the following Slices:

• The element Observation.category is sliced based on the values of value:coding.code, value:coding.system

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	Measurements and simple assertions
status	S	1..1	code	registered | preliminary | final | amended +
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:coding.code, value:coding.system
category:EQCat	S	1..1	CodeableConcept	Classification of type of observation
coding	S	1..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://cbsig.chai.gatech.edu/CodeSystem/cbs-temp-code-system
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: epi-questionnaire
code	S	1..1	CodeableConcept	Coded Questionnaire Items from Surveillance Program Specified Valueset Binding: STD Sexual History and Drug Use Questionnaire Panel (example): This identifies the coded questionnaire item.
subject	S	1..1	Reference(Case Based Surveillance Patient Profile)	Who and/or what the observation is about
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result
hasMember		0..*	Reference(Case Based Surveillance Epi Questionnaire Panel)	Related resource that belongs to the Observation group
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	Observation	Measurements and simple assertions
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:coding.code, value:coding.system Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:EQCat	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://cbsig.chai.gatech.edu/CodeSystem/cbs-temp-code-system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: epi-questionnaire
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Coded Questionnaire Items from Surveillance Program Specified Valueset Binding: STD Sexual History and Drug Use Questionnaire Panel (example): This identifies the coded questionnaire item.
subject	SΣ	1..1	Reference(Case Based Surveillance Patient Profile)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	Σ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	SΣI	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	I	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	I	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	I	0..1	SimpleQuantity	Low Range, if relevant
high	I	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Case Based Surveillance Epi Questionnaire Panel)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	I	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format