QI-Core Implementation Guide
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This page is part of the Quality Improvement Core Framework (v6.0.0-ballot: STU6 (v6.0.0) Ballot 1) based on FHIR R4. The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: QICore AdverseEvent

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent Version: 6.0.0-ballot
Active as of 2018-08-22 Computable Name: QICoreAdverseEvent

An adverse event is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as “recurring headaches” but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.

Usage

See the patterns page for implementation and usage patterns.

Examples

Mild Rash Example

Usage:

Formal Views of Profile Content

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

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... actuality S1..1codeactual | potential
... category S0..*CodeableConceptproduct-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
... event S1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... encounter S0..1Reference(QICore Encounter)Encounter created as part of
... date 0..1dateTimeWhen the event occurred
... resultingCondition S0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location 0..1Reference(QICore Location)Location where adverse event occurred
... recorder 0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor 0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity 0..*BackboneElementThe suspected agent causing the adverse event
.... instance S1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality 0..1BackboneElementInformation on the possible cause of the event
... subjectMedicalHistory 0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject SΣ1..1Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson)Subject impacted by event
... encounter SΣ0..1Reference(QICore Encounter)Encounter created as part of
... date Σ0..1dateTimeWhen the event occurred
... resultingCondition SΣ0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location Σ0..1Reference(QICore Location)Location where adverse event occurred
... recorder Σ0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor Σ0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
... subjectMedicalHistory Σ0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ0..*CodeableConceptproduct-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): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject SΣ1..1Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson)Subject impacted by event
... encounter SΣ0..1Reference(QICore Encounter)Encounter created as part of
... date Σ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition SΣ0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location Σ0..1Reference(QICore Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor Σ0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... actuality S1..1codeactual | potential
... category S0..*CodeableConceptproduct-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
... event S1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... encounter S0..1Reference(QICore Encounter)Encounter created as part of
... date 0..1dateTimeWhen the event occurred
... resultingCondition S0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location 0..1Reference(QICore Location)Location where adverse event occurred
... recorder 0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor 0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity 0..*BackboneElementThe suspected agent causing the adverse event
.... instance S1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality 0..1BackboneElementInformation on the possible cause of the event
... subjectMedicalHistory 0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject SΣ1..1Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson)Subject impacted by event
... encounter SΣ0..1Reference(QICore Encounter)Encounter created as part of
... date Σ0..1dateTimeWhen the event occurred
... resultingCondition SΣ0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location Σ0..1Reference(QICore Location)Location where adverse event occurred
... recorder Σ0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor Σ0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
... subjectMedicalHistory Σ0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category SΣ0..*CodeableConceptproduct-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): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject SΣ1..1Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson)Subject impacted by event
... encounter SΣ0..1Reference(QICore Encounter)Encounter created as part of
... date Σ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition SΣ0..*Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)Effect on the subject due to this event
... location Σ0..1Reference(QICore Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole)Who recorded the adverse event
... contributor Σ0..*Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile)Refers to the specific entity that caused the adverse event
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredAdverseEventActuality
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron