Qi-Core Implementation Guide (Release 2.1 Trial-Use Ballot)

This page is part of the Quality Improvement Core Framework (v2.1.0: STU 3 Ballot 1) 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

D.4.1 StructureDefinition: qicore-adverseevent

Examples:

Mild Rash Example

D.4.1.1 Formal Views of Profile Content

The official URL for this profile is: 

http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent

An adverse event is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/ListofSREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as "recurring headaches" but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.

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.

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent I0..*An incident, near miss, unsafe condition, or untoward occurrence during treatment.
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... category Σ0..1codeAE | PAE
Binding: AdverseEventCategory (required)
... type SΣ1..1CodeableConceptactual | potential
Binding: SNOMED CT Clinical Findings (example)
... subject SΣ1..1Reference(QICore-Patient), Reference(ResearchSubject), Reference(QICore-Medication), Reference(QICore-Device)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(QICore-Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(QICore-Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
Binding: AdverseEventSeriousness (example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
... recorder Σ0..1Reference(QICore-Patient), Reference(QICore-RelatedPerson), Reference(QICore-Practitioner)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner), Reference(Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity ΣI0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... instance SΣ1..1Reference(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 Σ0..1codecausality1 | causality2
Binding: AdverseEventCausality (required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
Binding: AdverseEventCausalityAssessment (example)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
Binding: AdverseEventCausalityMethod (example)
.... causalityAuthor Σ0..1Reference(Practitioner), Reference(PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
Binding: AdverseEventCausalityResult (example)
... subjectMedicalHistory Σ0..*Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent I0..*An incident, near miss, unsafe condition, or untoward occurrence during treatment.
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... category Σ0..1codeAE | PAE
Binding: AdverseEventCategory (required)
... type SΣ1..1CodeableConceptactual | potential
Binding: SNOMED CT Clinical Findings (example)
... subject SΣ1..1Reference(QICore-Patient), Reference(ResearchSubject), Reference(QICore-Medication), Reference(QICore-Device)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(QICore-Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(QICore-Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
Binding: AdverseEventSeriousness (example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
... recorder Σ0..1Reference(QICore-Patient), Reference(QICore-RelatedPerson), Reference(QICore-Practitioner)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner), Reference(Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity ΣI0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... instance SΣ1..1Reference(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 Σ0..1codecausality1 | causality2
Binding: AdverseEventCausality (required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
Binding: AdverseEventCausalityAssessment (example)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
Binding: AdverseEventCausalityMethod (example)
.... causalityAuthor Σ0..1Reference(Practitioner), Reference(PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
Binding: AdverseEventCausalityResult (example)
... subjectMedicalHistory Σ0..*Reference(Condition), Reference(Observation), Reference(AllergyIntolerance), Reference(FamilyMemberHistory), Reference(Immunization), Reference(Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

 

D.4.1.2 Terminology Bindings

Terminology Bindings

PathNameConformanceValueSet
AdverseEvent.languageCommon LanguagesextensibleCommon Languages
AdverseEvent.categoryAdverseEventCategoryrequiredAdverseEventCategory
AdverseEvent.typeSNOMED CT Clinical FindingsexampleSNOMED CT Clinical Findings
AdverseEvent.seriousnessAdverseEventSeriousnessexampleAdverseEventSeriousness
AdverseEvent.outcomeAdverseEventOutcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causalityAdverseEventCausalityrequiredAdverseEventCausality
AdverseEvent.suspectEntity.causalityAssessmentAdverseEventCausalityAssessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causalityMethodAdverseEventCausalityMethodexampleAdverseEventCausalityMethod
AdverseEvent.suspectEntity.causalityResultAdverseEventCausalityResultexampleAdverseEventCausalityResult

D.4.1.3 Constraints

Constraints

IdPathDetailsRequirements
dom-2AdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-1AdverseEventIf the resource is contained in another resource, it SHALL NOT contain any narrative
: contained.text.empty()
dom-4AdverseEventIf 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-3AdverseEventIf 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-1AdverseEvent.suspectEntityAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())