Smart Bear Implementation Guide
0.3.4 - ci-build

Smart Bear Implementation Guide - Local Development build (v0.3.4). See the Directory of published versions

Resource Profile: Smart Bear Adverse Event

Official URL: https://smart-bear.eu/fhir/StructureDefinition/SBAdverseEvent Version: 0.3.4
Active as of 2024-04-22 Computable Name: SBAdversEvent

Adverse Event for Smart Bear project (actual value)

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 1..1codeonly actual value
Required Pattern: actual
... category 0..*CodeableConceptNot only: 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 . But also : Adverse Event (AE), Adverse Device Effect (ADE), Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), Unanticipated Serious Adverse Device Effect (USADE), Device Deficiency (DD)
Binding: Category of Adverse Events (required)
... event 0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
... encounter S0..1Reference(Encounter)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
... severity S1..1CodeableConceptmild | moderate | severe
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... suspectEntity S1..1BackboneElementThe suspected agent causing the adverse event
.... instance
..... reference 0..1stringit could specify whether it is a medication or a device for example
.... causality
..... assessment 1..1CodeableConceptIndicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
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 ?!Σ1..1codeonly actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event Σ0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Smart Bear subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... severity SΣ1..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... suspectEntity SΣ1..1BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
..... reference ΣC0..1stringit could specify whether it is a medication or a device for example

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
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 ?!Σ1..1codeonly actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ0..*CodeableConceptNot only: 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 . But also : Adverse Event (AE), Adverse Device Effect (ADE), Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), Unanticipated Serious Adverse Device Effect (USADE), Device Deficiency (DD)
Binding: Category of Adverse Events (required)
... event Σ0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

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

... severity SΣ1..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ1..1BackboneElementThe 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 Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC0..1stringit could specify whether it is a medication or a device for example
..... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

..... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
..... display Σ0..1stringText alternative for the resource
.... causality Σ0..*BackboneElementInformation 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 Σ1..1CodeableConceptIndicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)
..... 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(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.instance.typeextensibleResourceType
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 6 elements

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 1..1codeonly actual value
Required Pattern: actual
... category 0..*CodeableConceptNot only: 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 . But also : Adverse Event (AE), Adverse Device Effect (ADE), Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), Unanticipated Serious Adverse Device Effect (USADE), Device Deficiency (DD)
Binding: Category of Adverse Events (required)
... event 0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
... encounter S0..1Reference(Encounter)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
... severity S1..1CodeableConceptmild | moderate | severe
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... suspectEntity S1..1BackboneElementThe suspected agent causing the adverse event
.... instance
..... reference 0..1stringit could specify whether it is a medication or a device for example
.... causality
..... assessment 1..1CodeableConceptIndicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)

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 ?!Σ1..1codeonly actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event Σ0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Smart Bear subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... severity SΣ1..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... suspectEntity SΣ1..1BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
..... reference ΣC0..1stringit could specify whether it is a medication or a device for example

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome

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 ?!Σ1..1codeonly actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ0..*CodeableConceptNot only: 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 . But also : Adverse Event (AE), Adverse Device Effect (ADE), Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), Unanticipated Serious Adverse Device Effect (USADE), Device Deficiency (DD)
Binding: Category of Adverse Events (required)
... event Σ0..1CodeableConceptAdverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

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

... severity SΣ1..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ1..1BackboneElementThe 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 Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC0..1stringit could specify whether it is a medication or a device for example
..... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

..... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
..... display Σ0..1stringText alternative for the resource
.... causality Σ0..*BackboneElementInformation 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 Σ1..1CodeableConceptIndicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)
..... 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(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryrequiredCategoryAdverseEvent
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.instance.typeextensibleResourceType
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 6 elements

 

Other representations of profile: CSV, Excel, Schematron