Smart Bear Implementation Guide
3.4.1 - ci-build

Smart Bear Implementation Guide - Local Development build (v3.4.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Smart Bear Adverse Event

Official URL: https://smart-bear.eu/fhir/StructureDefinition/SBAdverseEvent Version: 3.4.1
Active as of 2024-09-17 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..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code only actual value
Required Pattern: actual
... category 0..* CodeableConcept Not 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..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... date S 0..1 dateTime When the event occurred
... severity S 1..1 CodeableConcept mild | moderate | severe
... outcome S 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... suspectEntity S 1..1 BackboneElement The suspected agent causing the adverse event
.... instance
..... reference 0..1 string it could specify whether it is a medication or a device for example
.... causality
..... assessment 1..1 CodeableConcept Indicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
https://smart-bear.eu/fhir/ValueSet/CausalityAdverseEvent
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code only actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event Σ 0..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Smart Bear subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... severity SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... suspectEntity SΣ 1..1 BackboneElement The suspected agent causing the adverse event
.... 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
..... reference ΣC 0..1 string it could specify whether it is a medication or a device for example

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id 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): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... 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..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code only actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept Not 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 Σ 0..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Smart Bear subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 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): Overall seriousness of this event for the patient.

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

... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be 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 1..1 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
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC 0..1 string it could specify whether it is a medication or a device for example
..... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

..... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
..... display Σ 0..1 string Text alternative for the resource
.... causality Σ 0..* BackboneElement Information on the possible cause of the 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
..... assessment Σ 1..1 CodeableConcept Indicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)
..... 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): TODO.

... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.instance.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
https://smart-bear.eu/fhir/ValueSet/CausalityAdverseEvent
from this IG
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

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..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code only actual value
Required Pattern: actual
... category 0..* CodeableConcept Not 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..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... date S 0..1 dateTime When the event occurred
... severity S 1..1 CodeableConcept mild | moderate | severe
... outcome S 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... suspectEntity S 1..1 BackboneElement The suspected agent causing the adverse event
.... instance
..... reference 0..1 string it could specify whether it is a medication or a device for example
.... causality
..... assessment 1..1 CodeableConcept Indicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
https://smart-bear.eu/fhir/ValueSet/CausalityAdverseEvent
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code only actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event Σ 0..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Smart Bear subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... severity SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... suspectEntity SΣ 1..1 BackboneElement The suspected agent causing the adverse event
.... 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
..... reference ΣC 0..1 string it could specify whether it is a medication or a device for example

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id 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): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... 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..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code only actual value
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept Not 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 Σ 0..1 CodeableConcept Adverse Event with Snomed CT code and eventually text
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Smart Bear subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 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): Overall seriousness of this event for the patient.

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

... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be 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 1..1 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
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC 0..1 string it could specify whether it is a medication or a device for example
..... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

..... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
..... display Σ 0..1 string Text alternative for the resource
.... causality Σ 0..* BackboneElement Information on the possible cause of the 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
..... assessment Σ 1..1 CodeableConcept Indicate causality, Possible, yes or not.
Binding: Category of Adverse Events (required)
..... 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): TODO.

... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryrequiredCategoryAdverseEvent
https://smart-bear.eu/fhir/ValueSet/CategoryAdverseEvent
from this IG
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.instance.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentrequiredCausalityAdverseEvent (a valid code from Causality of Adverse Events in Smart Bear)
https://smart-bear.eu/fhir/ValueSet/CausalityAdverseEvent
from this IG
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

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