EXAMPLE.FHIR.AZ.IG\AZ AdverseEvent Profile

AstraZeneca Adverse Event Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: AZ AdverseEvent Profile

Defining URL:

https://semalexa.github.io/igpopdemo/StructureDefinition/AdverseEvent

Version:

0.1.0

Name:

AZAdverseEventProfile

Title:

AZ AdverseEvent Profile

Status:

Active as of 2020-09-30

Definition:

Defines AZ constraints and extensions on the AdverseEvent resource

Publisher:

AstraZeneca - Adverse Event Work Group

Source Resource:

XML / JSON / Turtle

The official URL for this profile is:

https://semalexa.github.io/igpopdemo/StructureDefinition/AdverseEvent

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

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

This structure is derived from AdverseEvent

Summary

Must-Support: 14 elements

Extensions

This structure refers to these extensions:

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
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
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
hl7.fhir.ae-AdverseEvent-AZEmployeeReporter	S	0..*	string	AZ Employee Reporter URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-AZEmployeeReporter
hl7.fhir.ae-AdverseEvent-reporterType	S	0..*	string	Reporter Type URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-reporterType
hl7.fhir.ae-AdverseEvent-programNumber	S	0..*	string	Program Number URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-programNumber
hl7.fhir.ae-AdverseEvent-localReference	S	0..*	string	Local Ref No URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-localReference
hl7.fhir.ae-AdverseEvent-sourceType	S	0..*	code	Source Type URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-sourceType
hl7.fhir.ae-AdverseEvent-surveyStatus	S	0..*	code	Survey Status URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-surveyStatus
hl7.fhir.ae-AdverseEvent-lateReason	S	0..*	string	Late reason for raising adverse event URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-lateReason
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual \| potential Binding: AdverseEventActuality (required)
category	Σ	0..*	CodeableConcept	product-problem \| product-quality \| product-use-error \| wrong-dose \| incorrect-prescribing-information \| wrong-technique \| wrong-route-of-administration \| wrong-rate \| wrong-duration \| wrong-time \| expired-drug \| medical-device-use-error \| problem-different-manufacturer \| unsafe-physical-environment Binding: AdverseEventCategory (extensible)
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example)
subject	Σ	1..1	Reference(Patient \| Group \| Practitioner \| RelatedPerson)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	Σ	0..*	Reference(Condition)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example)
severity	Σ	0..1	CodeableConcept	mild \| moderate \| severe Binding: AdverseEventSeverity (required)
outcome	Σ	0..1	CodeableConcept	resolved \| recovering \| ongoing \| resolvedWithSequelae \| fatal \| unknown Binding: AdverseEventOutcome (required)
recorder	Σ	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner \| PractitionerRole \| Device)	Who was involved in the adverse event or the potential adverse event
suspectEntity	SΣ	0..*	BackboneElement	The suspected agent causing the adverse event
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
instance	Σ	1..1	Reference(Immunization \| Procedure \| Substance \| Medication \| MedicationAdministration \| MedicationStatement \| Device)	Refers to the specific entity that caused the adverse event
causality	SΣ	0..*	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
hl7.fhir.ae-AdverseEvent-positiveDechallenge	S	0..*	string	Positive Dechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-positiveDechallenge
hl7.fhir.ae-AdverseEvent-positiveRechallenge	S	0..*	string	Positive Rechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-positiveRechallenge
hl7.fhir.ae-AdverseEvent-rechallenge	S	0..*	string	Rechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-rechallenge
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example)
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner \| PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale \| Bayesian \| Checklist Binding: AdverseEventCausalityMethod (example)
subjectMedicalHistory	Σ	0..*	Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Media \| DocumentReference)	AdverseEvent.subjectMedicalHistory
referenceDocument	Σ	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
study	Σ	0..*	Reference(ResearchStudy)	AdverseEvent.study
Documentation for this format

This structure is derived from AdverseEvent

Summary

Must-Support: 14 elements

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from AdverseEvent

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
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
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
hl7.fhir.ae-AdverseEvent-AZEmployeeReporter	S	0..*	string	AZ Employee Reporter URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-AZEmployeeReporter
hl7.fhir.ae-AdverseEvent-reporterType	S	0..*	string	Reporter Type URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-reporterType
hl7.fhir.ae-AdverseEvent-programNumber	S	0..*	string	Program Number URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-programNumber
hl7.fhir.ae-AdverseEvent-localReference	S	0..*	string	Local Ref No URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-localReference
hl7.fhir.ae-AdverseEvent-sourceType	S	0..*	code	Source Type URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-sourceType
hl7.fhir.ae-AdverseEvent-surveyStatus	S	0..*	code	Survey Status URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-surveyStatus
hl7.fhir.ae-AdverseEvent-lateReason	S	0..*	string	Late reason for raising adverse event URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-lateReason
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual \| potential Binding: AdverseEventActuality (required)
category	Σ	0..*	CodeableConcept	product-problem \| product-quality \| product-use-error \| wrong-dose \| incorrect-prescribing-information \| wrong-technique \| wrong-route-of-administration \| wrong-rate \| wrong-duration \| wrong-time \| expired-drug \| medical-device-use-error \| problem-different-manufacturer \| unsafe-physical-environment Binding: AdverseEventCategory (extensible)
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example)
subject	Σ	1..1	Reference(Patient \| Group \| Practitioner \| RelatedPerson)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	Σ	0..*	Reference(Condition)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example)
severity	Σ	0..1	CodeableConcept	mild \| moderate \| severe Binding: AdverseEventSeverity (required)
outcome	Σ	0..1	CodeableConcept	resolved \| recovering \| ongoing \| resolvedWithSequelae \| fatal \| unknown Binding: AdverseEventOutcome (required)
recorder	Σ	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner \| PractitionerRole \| Device)	Who was involved in the adverse event or the potential adverse event
suspectEntity	SΣ	0..*	BackboneElement	The suspected agent causing the adverse event
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
instance	Σ	1..1	Reference(Immunization \| Procedure \| Substance \| Medication \| MedicationAdministration \| MedicationStatement \| Device)	Refers to the specific entity that caused the adverse event
causality	SΣ	0..*	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
hl7.fhir.ae-AdverseEvent-positiveDechallenge	S	0..*	string	Positive Dechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-positiveDechallenge
hl7.fhir.ae-AdverseEvent-positiveRechallenge	S	0..*	string	Positive Rechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-positiveRechallenge
hl7.fhir.ae-AdverseEvent-rechallenge	S	0..*	string	Rechallenge URL: https://semalexa.github.io/ig-az/StructureDefinition/hl7.fhir.ae-AdverseEvent-rechallenge
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessment	Σ	0..1	CodeableConcept	Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example)
productRelatedness	Σ	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
author	Σ	0..1	Reference(Practitioner \| PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
method	Σ	0..1	CodeableConcept	ProbabilityScale \| Bayesian \| Checklist Binding: AdverseEventCausalityMethod (example)
subjectMedicalHistory	Σ	0..*	Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Media \| DocumentReference)	AdverseEvent.subjectMedicalHistory
referenceDocument	Σ	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
study	Σ	0..*	Reference(ResearchStudy)	AdverseEvent.study
Documentation for this format

Other representations of profile: Schematron

Terminology Bindings

Path	Conformance	ValueSet
AdverseEvent.language	preferred	CommonLanguages Max Binding: AllLanguages
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	example	AdverseEventSeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

Constraints

Id	Path	Details	Requirements
dom-2	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	AdverseEvent	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	AdverseEvent	A resource should have narrative for robust management : text.`div`.exists()
ele-1	AdverseEvent.meta	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.implicitRules	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.language	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.text	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:AZEmployeeReporter	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:AZEmployeeReporter	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:reporterType	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:reporterType	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:programNumber	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:programNumber	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:localReference	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:localReference	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:sourceType	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:sourceType	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:surveyStatus	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:surveyStatus	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.extension:lateReason	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.extension:lateReason	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.identifier	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.actuality	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.category	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.event	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.subject	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.encounter	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.date	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.detected	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.recordedDate	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.resultingCondition	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.location	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.seriousness	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.severity	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.outcome	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.recorder	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.contributor	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.instance	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.causality	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.causality.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.causality.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.causality.extension:positiveDechallenge	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.causality.extension:positiveDechallenge	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.causality.extension:positiveRechallenge	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.causality.extension:positiveRechallenge	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.causality.extension:rechallenge	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.causality.extension:rechallenge	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.causality.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	AdverseEvent.suspectEntity.causality.assessment	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.causality.productRelatedness	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.causality.author	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.suspectEntity.causality.method	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.subjectMedicalHistory	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.referenceDocument	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	AdverseEvent.study	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())