HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0 - CI Build International flag

HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/adr-ig/ and changes regularly. See the Directory of published versions

Resource Profile: Perfil para notificação de RAM

Official URL: https://hl7.pt/fhir/ADR/StructureDefinition/ReacaoAdversa Version: 1.0.0
Active as of 2024-10-22 Computable Name: ReacaoAdversa

Perfil para notificação de RAM

Usage:

  • This Resource Profile is not used by any profiles in this Implementation Guide

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 An event that may be related to unintended effects on a patient or research participant
... identifier S 1..* Identifier Business identifier for the event
... subject S 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... recorder S 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
.... instance[x] S 1..1 CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Refers to the specific entity that caused the adverse event

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent An event that may be related to unintended effects on a patient or research participant
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.

... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
... 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[x] SΣ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.statusrequiredAdverseEventStatus
http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0
from the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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..* AdverseEvent An event that may be related to unintended effects on a patient or research participant
... 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Business identifier for the event
... status ?!Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.

... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.


... code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
Binding: AdverseEventType (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent
... occurrence[x] Σ 0..1 When the event occurred
.... occurrenceDateTime dateTime
.... occurrencePeriod Period
.... occurrenceTiming Timing
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingEffect Σ 0..* Reference(Condition | Observation) 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 or gravity of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... outcome Σ 0..* CodeableConcept Type of outcome from the adverse event
Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.


... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
... participant Σ 0..* BackboneElement Who was involved in the adverse event or the potential adverse event and what they did
.... 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
.... function Σ 0..1 CodeableConcept Type of involvement
Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.

.... actor Σ 1..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) Who was involved in the adverse event or the potential adverse event
... study Σ 0..* Reference(ResearchStudy) Research study that the subject is enrolled in
... expectedInResearchStudy 0..1 boolean Considered likely or probable or anticipated in the research study
... 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[x] SΣ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
.... causality Σ 0..1 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
..... assessmentMethod Σ 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event
Binding: AdverseEventCausalityMethod (example): TODO.

..... entityRelatedness Σ 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... author Σ 0..1 Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) Author of the information on the possible cause of the event
... contributingFactor Σ 0..* BackboneElement Contributing factors suspected to have increased the probability or severity of 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
.... item[x] Σ 1..1 Item suspected to have increased the probability or severity of the adverse event
Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

..... itemReference Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
..... itemCodeableConcept CodeableConcept
... preventiveAction Σ 0..* BackboneElement Preventive actions that contributed to avoiding 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
.... item[x] Σ 1..1 Action that contributed to avoiding the adverse event
Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.

..... itemReference Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConcept CodeableConcept
... mitigatingAction Σ 0..* BackboneElement Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
.... 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
.... item[x] Σ 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.

..... itemReference Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConcept CodeableConcept
... supportingInfo Σ 0..* BackboneElement Supporting information relevant to 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
.... item[x] Σ 1..1 Subject medical history or document relevant to this adverse event
Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.

..... itemReference Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
..... itemCodeableConcept CodeableConcept
... note Σ 0..* Annotation Comment on adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
AdverseEvent.statusrequiredAdverseEventStatus
http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0
from the FHIR Standard
AdverseEvent.categoryexampleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.codeexampleAdverseEventType
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.outcomeexampleAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome
from the FHIR Standard
AdverseEvent.participant.functionexampleAdverseEventParticipantFunction
http://hl7.org/fhir/ValueSet/adverse-event-participant-function
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatednessexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.contributingFactor.item[x]exampleAdverseEventContributingFactor
http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor
from the FHIR Standard
AdverseEvent.preventiveAction.item[x]exampleAdverseEventPreventiveAction
http://hl7.org/fhir/ValueSet/adverse-event-preventive-action
from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]exampleAdverseEventMitigatingAction
http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action
from the FHIR Standard
AdverseEvent.supportingInfo.item[x]exampleAdverseEventSupportingInforation
http://hl7.org/fhir/ValueSet/adverse-event-supporting-info
from the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent An event that may be related to unintended effects on a patient or research participant
... identifier S 1..* Identifier Business identifier for the event
... subject S 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... recorder S 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
.... instance[x] S 1..1 CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent An event that may be related to unintended effects on a patient or research participant
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.

... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
... 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[x] SΣ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.statusrequiredAdverseEventStatus
http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0
from the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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..* AdverseEvent An event that may be related to unintended effects on a patient or research participant
... 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Business identifier for the event
... status ?!Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.

... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.


... code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
Binding: AdverseEventType (example): Detailed type of event.

... subject SΣ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent
... occurrence[x] Σ 0..1 When the event occurred
.... occurrenceDateTime dateTime
.... occurrencePeriod Period
.... occurrenceTiming Timing
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingEffect Σ 0..* Reference(Condition | Observation) 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 or gravity of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... outcome Σ 0..* CodeableConcept Type of outcome from the adverse event
Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.


... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) Who recorded the adverse event
... participant Σ 0..* BackboneElement Who was involved in the adverse event or the potential adverse event and what they did
.... 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
.... function Σ 0..1 CodeableConcept Type of involvement
Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.

.... actor Σ 1..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) Who was involved in the adverse event or the potential adverse event
... study Σ 0..* Reference(ResearchStudy) Research study that the subject is enrolled in
... expectedInResearchStudy 0..1 boolean Considered likely or probable or anticipated in the research study
... 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[x] SΣ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
.... causality Σ 0..1 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
..... assessmentMethod Σ 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event
Binding: AdverseEventCausalityMethod (example): TODO.

..... entityRelatedness Σ 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... author Σ 0..1 Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) Author of the information on the possible cause of the event
... contributingFactor Σ 0..* BackboneElement Contributing factors suspected to have increased the probability or severity of 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
.... item[x] Σ 1..1 Item suspected to have increased the probability or severity of the adverse event
Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

..... itemReference Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
..... itemCodeableConcept CodeableConcept
... preventiveAction Σ 0..* BackboneElement Preventive actions that contributed to avoiding 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
.... item[x] Σ 1..1 Action that contributed to avoiding the adverse event
Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.

..... itemReference Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConcept CodeableConcept
... mitigatingAction Σ 0..* BackboneElement Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
.... 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
.... item[x] Σ 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.

..... itemReference Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConcept CodeableConcept
... supportingInfo Σ 0..* BackboneElement Supporting information relevant to 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
.... item[x] Σ 1..1 Subject medical history or document relevant to this adverse event
Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.

..... itemReference Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
..... itemCodeableConcept CodeableConcept
... note Σ 0..* Annotation Comment on adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
AdverseEvent.statusrequiredAdverseEventStatus
http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0
from the FHIR Standard
AdverseEvent.categoryexampleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.codeexampleAdverseEventType
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.outcomeexampleAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome
from the FHIR Standard
AdverseEvent.participant.functionexampleAdverseEventParticipantFunction
http://hl7.org/fhir/ValueSet/adverse-event-participant-function
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatednessexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.contributingFactor.item[x]exampleAdverseEventContributingFactor
http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor
from the FHIR Standard
AdverseEvent.preventiveAction.item[x]exampleAdverseEventPreventiveAction
http://hl7.org/fhir/ValueSet/adverse-event-preventive-action
from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]exampleAdverseEventMitigatingAction
http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action
from the FHIR Standard
AdverseEvent.supportingInfo.item[x]exampleAdverseEventSupportingInforation
http://hl7.org/fhir/ValueSet/adverse-event-supporting-info
from the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 5 elements

 

Other representations of profile: CSV, Excel, Schematron