This page is part of the Quality Improvement Core Framework (v4.1.1: STU 4) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings

Resource Profile: QICoreAdverseEvent

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent				Version: 4.1.1
Draft as of 2018-08-22				Computable Name: QICoreAdverseEvent

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/List_of_SREs.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.

Usage:

• Examples for this Resource Profile: AdverseEvent/example

Formal Views of Profile Content

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

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path	Conformance	ValueSet
AdverseEvent.language	preferred	CommonLanguages Max Binding: AllLanguages
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	example	AdverseEventSeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

Constraints

Id	Grade	Path	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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	AdverseEvent.meta	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.implicitRules	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.language	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.text	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.identifier	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.actuality	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.category	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.event	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.subject	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.encounter	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.date	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.detected	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.recordedDate	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.resultingCondition	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.location	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.seriousness	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.severity	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.outcome	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.recorder	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.contributor	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.suspectEntity.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.suspectEntity.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.suspectEntity.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.suspectEntity.instance	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.causality	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.causality.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.suspectEntity.causality.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.suspectEntity.causality.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	AdverseEvent.suspectEntity.causality.assessment	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.causality.productRelatedness	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.causality.author	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.suspectEntity.causality.method	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.subjectMedicalHistory	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.referenceDocument	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	AdverseEvent.study	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())