Adverse Event Clinical Care
0.2.0 - ci-build
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
| 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.
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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 | ||||
| Path | Conformance | ValueSet |
| AdverseEvent.status | required | AdverseEventStatus |
| AdverseEvent.actuality | required | AdverseEventActuality |
| 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 | ||||
| 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 |
| 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
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 | ||||
| Path | Conformance | ValueSet |
| AdverseEvent.status | required | AdverseEventStatus |
| AdverseEvent.actuality | required | AdverseEventActuality |
| 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 | ||||
| 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 |
| 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
Other representations of profile: CSV, Excel, Schematron