This page is part of the Quality Improvement Core Framework (v2.0.0: STU 2) based on FHIR R3. The current version which supercedes this version is 4.1.1. For a full list of available versions, see the Directory of published versions
Mild Rash Example |
The official URL for this profile is:
http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent
This profile builds on AdverseEvent.
This profile was published on Mon Aug 21 00:00:00 AEST 2017 as a draft by Health Level Seven International (Clinical Quality Information - QICore).
Description of Profiles, Differentials, and Snapshots.
Summary
Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 3 elements
Structures
This structure refers to these other structures:
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | I | 0..* | An incident, near miss, unsafe condition, or untoward occurrence during treatment. | |
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: Common Languages (extensible) | |
text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | Additional Content defined by implementations | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..1 | Identifier | Business identifier for the event |
category | Σ | 0..1 | code | AE | PAE Binding: AdverseEventCategory (required) |
type | SΣ | 1..1 | CodeableConcept | actual | potential Binding: SNOMED CT Clinical Findings (example) |
subject | SΣ | 1..1 | Reference(QICore-Patient), Reference(ResearchSubject), Reference(QICore-Medication), Reference(QICore-Device) | Subject or group impacted by event |
date | Σ | 0..1 | dateTime | When the event occurred |
reaction | Σ | 0..* | Reference(QICore-Condition) | Adverse Reaction Events linked to exposure to substance |
location | Σ | 0..1 | Reference(QICore-Location) | Location where adverse event occurred |
seriousness | Σ | 0..1 | CodeableConcept | Mild | Moderate | Severe Binding: AdverseEventSeriousness (example) |
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
recorder | Σ | 0..1 | Reference(QICore-Patient), Reference(QICore-RelatedPerson), Reference(QICore-Practitioner) | Who recorded the adverse event |
eventParticipant | Σ | 0..1 | Reference(Practitioner), Reference(Device) | Who was involved in the adverse event or the potential adverse event |
description | Σ | 0..1 | string | Description of the adverse event |
suspectEntity | ΣI | 0..* | BackboneElement | The suspected agent causing the adverse event |
id | 0..1 | string | xml:id (or equivalent in JSON) | |
extension | 0..* | Extension | Additional Content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
instance | SΣ | 1..1 | Reference(QICore-Substance), Reference(QICore-Medication), Reference(QICore-MedicationAdministration), Reference(QICore-MedicationStatement), Reference(QICore-Device) | Refers to the specific entity that caused the adverse event |
causality | Σ | 0..1 | code | causality1 | causality2 Binding: AdverseEventCausality (required) |
causalityAssessment | Σ | 0..1 | CodeableConcept | assess1 | assess2 Binding: AdverseEventCausalityAssessment (example) |
causalityProductRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
causalityMethod | Σ | 0..1 | CodeableConcept | method1 | method2 Binding: AdverseEventCausalityMethod (example) |
causalityAuthor | Σ | 0..1 | Reference(Practitioner), Reference(PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
causalityResult | Σ | 0..1 | CodeableConcept | result1 | result2 Binding: AdverseEventCausalityResult (example) |
subjectMedicalHistory | Σ | 0..* | Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure) | AdverseEvent.subjectMedicalHistory |
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
Documentation for this format |
Summary
Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 3 elements
Structures
This structure refers to these other structures:
Differential View
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | I | 0..* | An incident, near miss, unsafe condition, or untoward occurrence during treatment. | |
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: Common Languages (extensible) | |
text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | Additional Content defined by implementations | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..1 | Identifier | Business identifier for the event |
category | Σ | 0..1 | code | AE | PAE Binding: AdverseEventCategory (required) |
type | SΣ | 1..1 | CodeableConcept | actual | potential Binding: SNOMED CT Clinical Findings (example) |
subject | SΣ | 1..1 | Reference(QICore-Patient), Reference(ResearchSubject), Reference(QICore-Medication), Reference(QICore-Device) | Subject or group impacted by event |
date | Σ | 0..1 | dateTime | When the event occurred |
reaction | Σ | 0..* | Reference(QICore-Condition) | Adverse Reaction Events linked to exposure to substance |
location | Σ | 0..1 | Reference(QICore-Location) | Location where adverse event occurred |
seriousness | Σ | 0..1 | CodeableConcept | Mild | Moderate | Severe Binding: AdverseEventSeriousness (example) |
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
recorder | Σ | 0..1 | Reference(QICore-Patient), Reference(QICore-RelatedPerson), Reference(QICore-Practitioner) | Who recorded the adverse event |
eventParticipant | Σ | 0..1 | Reference(Practitioner), Reference(Device) | Who was involved in the adverse event or the potential adverse event |
description | Σ | 0..1 | string | Description of the adverse event |
suspectEntity | ΣI | 0..* | BackboneElement | The suspected agent causing the adverse event |
id | 0..1 | string | xml:id (or equivalent in JSON) | |
extension | 0..* | Extension | Additional Content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
instance | SΣ | 1..1 | Reference(QICore-Substance), Reference(QICore-Medication), Reference(QICore-MedicationAdministration), Reference(QICore-MedicationStatement), Reference(QICore-Device) | Refers to the specific entity that caused the adverse event |
causality | Σ | 0..1 | code | causality1 | causality2 Binding: AdverseEventCausality (required) |
causalityAssessment | Σ | 0..1 | CodeableConcept | assess1 | assess2 Binding: AdverseEventCausalityAssessment (example) |
causalityProductRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
causalityMethod | Σ | 0..1 | CodeableConcept | method1 | method2 Binding: AdverseEventCausalityMethod (example) |
causalityAuthor | Σ | 0..1 | Reference(Practitioner), Reference(PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
causalityResult | Σ | 0..1 | CodeableConcept | result1 | result2 Binding: AdverseEventCausalityResult (example) |
subjectMedicalHistory | Σ | 0..* | Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure) | AdverseEvent.subjectMedicalHistory |
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
Documentation for this format |
Path | Name | Conformance | ValueSet |
AdverseEvent.language | Common Languages | extensible | Common Languages |
AdverseEvent.category | AdverseEventCategory | required | AdverseEventCategory |
AdverseEvent.type | SNOMED CT Clinical Findings | example | SNOMED CT Clinical Findings |
AdverseEvent.seriousness | AdverseEventSeriousness | example | AdverseEventSeriousness |
AdverseEvent.outcome | AdverseEventOutcome | required | AdverseEventOutcome |
AdverseEvent.suspectEntity.causality | AdverseEventCausality | required | AdverseEventCausality |
AdverseEvent.suspectEntity.causalityAssessment | AdverseEventCausalityAssessment | example | AdverseEventCausalityAssessment |
AdverseEvent.suspectEntity.causalityMethod | AdverseEventCausalityMethod | example | AdverseEventCausalityMethod |
AdverseEvent.suspectEntity.causalityResult | AdverseEventCausalityResult | example | AdverseEventCausalityResult |
Id | Path | Details | Requirements |
dom-2 | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-1 | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain any narrative : contained.text.empty() | |
dom-4 | 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-3 | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource : contained.where(('#'+id in %resource.descendants().reference).not()).empty() | |
ele-1 | AdverseEvent.suspectEntity | All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count()) |