US Quality Core Implementation Guide
1.0.0-ballot - STU 1 - ballot United States of America flag

US Quality Core Implementation Guide, published by HL7 International / Clinical Quality Information. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-us-quality-core/ and changes regularly. See the Directory of published versions

Resource Profile: US Quality Core AdverseEvent

Official URL: http://hl7.org/fhir/us/quality-core/StructureDefinition/us-quality-core-adverseevent Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 4 Computable Name: USQualityCoreAdverseEvent
Other Identifiers: OID:2.16.840.1.113883.4.642.40.78.42.1

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

USCDI+ Quality Element Support Expectations

Systems are expected to support this profile as part of implementing USCDI+ Quality V2 in FHIR and meeting the conformance requirements of this guide.

The following elements are specifically relevant to USCDI+ Quality V2 data classes and elements. Systems are expected to support these elements as applicable to their role in US Quality Core data exchange. See the Must Support section of this guide for more information. These elements are flagged as (USCDI+ Quality) in the formal profile views.

USCDI+ Quality Elements:

Profile element Description USCDI+ Quality Data Element(s)
actuality actual | potential Adverse Events: Adverse Event Condition
date When the event occurred Adverse Events: Adverse Event Condition
detected When the event was detected Adverse Events: Adverse Event Condition
event Type of the event itself in relation to the subject Adverse Events: Adverse Event Condition
outcome resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Adverse Events: Adverse Event Outcome
recordedDate When the event was recorded Adverse Events: Adverse Event Condition
recorder Who recorded the adverse event Provenance: Author
subject Subject impacted by event Adverse Events: Adverse Event Condition

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code (USCDI+ Quality) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... subject Σ 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... encounter Σ 0..1 Reference(US Quality Core Encounter) Encounter created as part of
... date Σ 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected Σ 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate Σ 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition Σ 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location Σ 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder Σ 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor Σ 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory Σ 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code (USCDI+ Quality) actual | potential
... event 1..1 CodeableConcept (USCDI+ Quality) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.
... subject 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... date 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... severity 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) Who was involved in the adverse event or the potential adverse event
... suspectEntity 0..* BackboneElement The suspected agent causing the adverse event
.... instance 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality 0..* BackboneElement Information on the possible cause of the event
..... method 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... 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: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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
... actuality ?!Σ 1..1 code (USCDI+ Quality) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
... event Σ 1..1 CodeableConcept (USCDI+ Quality) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.
... subject Σ 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... encounter Σ 0..1 Reference(US Quality Core Encounter) Encounter created as part of
... date Σ 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected Σ 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate Σ 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition Σ 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location Σ 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder Σ 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor Σ 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) 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 Σ 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* 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
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory Σ 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.seriousness Base example AdverseEventSeriousness 📍4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **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()

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

Maturity: 4

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... actuality ?!Σ 1..1 code (USCDI+ Quality) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... subject Σ 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... encounter Σ 0..1 Reference(US Quality Core Encounter) Encounter created as part of
... date Σ 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected Σ 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate Σ 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition Σ 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location Σ 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder Σ 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor Σ 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory Σ 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **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()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code (USCDI+ Quality) actual | potential
... event 1..1 CodeableConcept (USCDI+ Quality) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.
... subject 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... date 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... severity 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) Who was involved in the adverse event or the potential adverse event
... suspectEntity 0..* BackboneElement The suspected agent causing the adverse event
.... instance 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality 0..* BackboneElement Information on the possible cause of the event
..... method 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... 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: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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
... actuality ?!Σ 1..1 code (USCDI+ Quality) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
... event Σ 1..1 CodeableConcept (USCDI+ Quality) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.
... subject Σ 1..1 Reference(US Quality Core Patient) (USCDI+ Quality) Subject impacted by event
... encounter Σ 0..1 Reference(US Quality Core Encounter) Encounter created as part of
... date Σ 0..1 dateTime (USCDI+ Quality) When the event occurred
... detected Σ 0..1 dateTime (USCDI+ Quality) When the event was detected
... recordedDate Σ 0..1 dateTime (USCDI+ Quality) When the event was recorded
... resultingCondition Σ 0..* Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) Effect on the subject due to this event
... location Σ 0..1 Reference(US Quality Core Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept (USCDI+ Quality) resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): Type of outcome from the adverse event
... recorder Σ 0..1 Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) (USCDI+ Quality) Who recorded the adverse event
... contributor Σ 0..* Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Core Device Profile(9.0.0)) 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 Σ 1..1 Reference(US Quality Core Immunization | US Quality Core Procedure | Substance | US Quality Core Medication | US Quality Core MedicationAdministration | MedicationStatement | US Core Device Profile(9.0.0)) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* 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
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): Method used to assess event causality
... subjectMedicalHistory Σ 0..* Reference(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Core FamilyMemberHistory Profile(9.0.0) | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base preferred SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.seriousness Base example AdverseEventSeriousness 📍4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **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()

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

Maturity: 4

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Element Conformance Indicators by Profile Layer

Badges identify the profile layer where each conformance indicator is first introduced. Indicators introduced in an earlier layer remain applicable in later derived profiles.

Element conformance indicators organized by the profile layer where they are first introduced
Profile element FHIR US Quality Core
actuality Mandatory USCDI+ Quality
event Mandatory USCDI+ Quality
subject Mandatory USCDI+ Quality
date USCDI+ Quality
detected USCDI+ Quality
recordedDate USCDI+ Quality
outcome USCDI+ Quality
recorder USCDI+ Quality
suspectEntity.instance Mandatory

Cardinality note: “Mandatory” means the element has a minimum cardinality greater than zero. For nested elements, the cardinality indicator applies when the containing element is present.

Mandatory US Quality Core Server Search Parameters

The searches below are the focused set identified by US Quality Core as needed to retrieve USCDI+ Quality data for quality measurement and reporting. See the US Core FHIR RESTful Search API Requirements for detailed information on requirements by search parameter type.

See the US Quality Core Server CapabilityStatement for complete requirements for the underlying AdverseEvent resource and Search Requirement Selection for how this focused set was selected.

Servers supporting this profile SHALL support the following search parameters and search parameter combinations:

  1. SHALL support searching for all AdverseEvent resources for a patient using the subject search parameter.

    GET [base]/AdverseEvent?subject={Patient/}[id]

    Example:

    GET [base]/AdverseEvent?subject=Patient/example

    Implementation Notes: Fetches a bundle of US Quality Core AdverseEvent resources matching the specified search criteria. See how to search by reference.

    Rationale for inclusion: Supports subject-scoped retrieval of AdverseEvent resources for USCDI+ Quality workflows.

  2. SHALL support searching for all AdverseEvent resources for a patient using the combination of the subject and event search parameters.

    • Including optional support for OR search on event (e.g.event={system|}[search_code],{system|}[search_code],...).

    GET [base]/AdverseEvent?subject={Patient/}[id]&event={system|}[search_code]

    Example:

    GET [base]/AdverseEvent?subject=Patient/example&event=http://snomed.info/sct|725119006

    Implementation Notes: Fetches a bundle of US Quality Core AdverseEvent resources matching the specified search criteria. See how to search by reference and how to search by token.

    Rationale for inclusion: Supports subject-scoped retrieval of AdverseEvent resources filtered by event for USCDI+ Quality workflows.

  3. SHALL support searching for all AdverseEvent resources for a patient using the combination of the subject and recorded-date search parameters.

    • Including optional support for AND search on recorded-date (e.g.recorded-date=[date]&recorded-date=[date]&...).

    • Including support for these recorded-date comparators: "gt", "lt", "ge", "le".

    GET [base]/AdverseEvent?subject={Patient/}[id]&recorded-date={gt|lt|ge|le}[dateTime]

    Example:

    GET [base]/AdverseEvent?subject=Patient/example&recorded-date=ge2020-01-01T00:00:00Z

    Implementation Notes: Fetches a bundle of US Quality Core AdverseEvent resources matching the specified search criteria. See how to search by reference and how to search by date.

    Rationale for inclusion: Supports subject-scoped retrieval of AdverseEvent resources filtered by recorded date so quality workflows can constrain results to relevant reporting periods.