Adverse Event Clinical Care
0.2.0 - ci-build

Adverse Event Clinical Care, published by HL7 International - Patient Care Work Group, Vulcan AdverseEvent groups. This is not an authorized publication; it is the continuous build for version 0.2.0). This version is based on the current content of https://github.com/HL7/fhir-ae-care-ig/ and changes regularly. See the Directory of published versions

## Resource Profile: Adverse Event Clinical Care

Official URL: http://hl7.org/fhir/uv/adverseeventclinicalcare/StructureDefinition/AdverseEvent-clinical-care | Version: 0.2.0
Standards status: Informative | Maturity Level: 1 | Computable Name: AdverseEventClinicalCare

A profile of AdverseEvent for Clinical care, such as in incident reporting.

### Scope and Usage

The Clinical Research adverse event profile of AdverseEvent, is for the clinical research setting. Adverse events are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects, potential adverse events are not reported (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

Usage:

- Examples for this Resource Profile: AdverseEvent/clinicalcareexample1stage1, AdverseEvent/clinicalcareexample1stage2, AdverseEvent/clinicalcareexample2mom, AdverseEvent/clinicalcareexample2patient and AdverseEvent/clinicalcareexample2phlebotomist

### Formal Views of Profile Content

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

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant
subject |  | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
seriousness |  | 0..0 |  |
recorder |  | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | Who recorded the adverse event
participant |  |  |  |
actor |  | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson) | Who was involved in the adverse event or the potential adverse event
study |  | 0..0 |  |
expectedInResearchStudy |  | 0..0 |  |
suspectEntity |  |  |  |
causality |  |  |  |
author |  | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) | Author of the information on the possible cause of the event
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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 | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
recorder | Σ | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | Who recorded the adverse event
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
AdverseEvent.status | required | AdverseEventStatus
AdverseEvent.actuality | required | AdverseEventActuality

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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
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 | Σ | 0..* | 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 | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | 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
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 | Σ | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | 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) | Who was involved in the adverse event or the potential adverse event
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance[x] | Σ | 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) | 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
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
AdverseEvent.language | required | AllLanguages
AdverseEvent.status | required | AdverseEventStatus
AdverseEvent.actuality | required | AdverseEventActuality
AdverseEvent.category | example | AdverseEventCategory
AdverseEvent.code | example | AdverseEventType
AdverseEvent.outcome | example | AdverseEventOutcome
AdverseEvent.participant.function | example | AdverseEventParticipantFunction
AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness | example | AdverseEventCausalityAssessment
AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactor
AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveAction
AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingAction
AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforation

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from AdverseEvent

Summary

Prohibited: 3 elements

Maturity: 1

Differential View

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant
subject |  | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
seriousness |  | 0..0 |  |
recorder |  | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | Who recorded the adverse event
participant |  |  |  |
actor |  | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson) | Who was involved in the adverse event or the potential adverse event
study |  | 0..0 |  |
expectedInResearchStudy |  | 0..0 |  |
suspectEntity |  |  |  |
causality |  |  |  |
author |  | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) | Author of the information on the possible cause of the event
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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 | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
recorder | Σ | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | Who recorded the adverse event
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
AdverseEvent.status | required | AdverseEventStatus
AdverseEvent.actuality | required | AdverseEventActuality

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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
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 | Σ | 0..* | 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 | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | 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
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 | Σ | 0..1 | Reference(Patient | PractitionerRole | Practitioner | RelatedPerson) | 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) | Who was involved in the adverse event or the potential adverse event
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance[x] | Σ | 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) | 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
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
AdverseEvent.language | required | AllLanguages
AdverseEvent.status | required | AdverseEventStatus
AdverseEvent.actuality | required | AdverseEventActuality
AdverseEvent.category | example | AdverseEventCategory
AdverseEvent.code | example | AdverseEventType
AdverseEvent.outcome | example | AdverseEventOutcome
AdverseEvent.participant.function | example | AdverseEventParticipantFunction
AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness | example | AdverseEventCausalityAssessment
AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactor
AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveAction
AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingAction
AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforation

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from AdverseEvent

Summary

Prohibited: 3 elements

Maturity: 1

Other representations of profile: CSV, Excel, Schematron