QI-Core Implementation Guide
7.0.0-ballot - STU7 Ballot United States of America flag

This page is part of the Quality Improvement Core Framework (v7.0.0-ballot: STU7 (v7.0.0) Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 6.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: QICore AdverseEvent

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent Version: 7.0.0-ballot
Active as of 2018-08-22 Computable Name: QICoreAdverseEvent

An adverse event (AE) 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.

QI Elements:
  • actuality: (QI) actual | potential
  • category: (QI) 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
  • event: (QI) Type of the event itself in relation to the subject
  • subject: (QI) Subject impacted by event
  • encounter: (QI) Encounter created as part of
  • recordedDate: (QI) When the event was recorded
  • resultingCondition: (QI) Effect on the subject due to this event
  • suspectEntity.instance: (QI) Refers to the specific entity that caused the adverse event
Primary code path: event
(PCPath) This element is the primary code path for this resource CQL Retrieve


NOTE TO BALLOT REVIEWERS:
  • US Core 7.0, and thus QI-Core 7.0, has a new approach to USCDI requirements.
    • As noted in the US Core 7.0 Must Support section, US Core 7.0 no longer highlights mandatory (cardinality 1..* or 1..1) and Must Support elements with a (USCDI) indicator as such items must be supported for interoperability.
    • Those USCDI elements that are not mandatory or Must Support now include an indicator (ADDITIONAL USCDI) in US Core. QI-Core 7.0 does not reference USCDI elements; rather, users should access US Core 7.0 to understand its implementation of USCDI version 4.
  • We invite comments about the approach and suggestions for other options that would also avoid unnecessary noise or reading load to the QI-Core profile representation.
  • Further, QI-Core 7.0 does not discuss USCDI+Quality because at the time of ballot preparation, no published version of USCDI+Quality is available. We seek reviewer advice regarding how QI-Core might address future USCDI+Quality.

Usage

See the patterns page for implementation and usage patterns.

Examples

Mild Rash Example

Usage:

Formal Views of Profile Content

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

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code (QI) actual | potential
... category 0..* CodeableConcept (QI) 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
... event 1..1 CodeableConcept (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... encounter 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date 0..1 dateTime When the event occurred
... recordedDate 0..1 dateTime (QI) When the event was recorded
... resultingCondition 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location 0..1 Reference(QICore Location) Location where adverse event occurred
... recorder 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... causality 0..1 BackboneElement Information on the possible cause of the event
... subjectMedicalHistory 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 (QI) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... event Σ 1..1 CodeableConcept (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject Σ 1..1 Reference(QICore Patient) (QI) Subject impacted by event
... encounter Σ 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... recordedDate Σ 0..1 dateTime (QI) When the event was recorded
... resultingCondition Σ 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location Σ 0..1 Reference(QICore Location) Location where adverse event occurred
... recorder Σ 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor Σ 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... causality Σ 0..1 BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... subjectMedicalHistory Σ 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 (QI) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept (QI) 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 (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject Σ 1..1 Reference(QICore Patient) (QI) Subject impacted by event
... encounter Σ 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime (QI) When the event was recorded
... resultingCondition Σ 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location Σ 0..1 Reference(QICore 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 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor Σ 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... 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
..... 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): TODO.

... subjectMedicalHistory Σ 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore 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

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... actuality 1..1 code (QI) actual | potential
... category 0..* CodeableConcept (QI) 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
... event 1..1 CodeableConcept (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... encounter 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date 0..1 dateTime When the event occurred
... recordedDate 0..1 dateTime (QI) When the event was recorded
... resultingCondition 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location 0..1 Reference(QICore Location) Location where adverse event occurred
... recorder 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... causality 0..1 BackboneElement Information on the possible cause of the event
... subjectMedicalHistory 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 (QI) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... event Σ 1..1 CodeableConcept (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject Σ 1..1 Reference(QICore Patient) (QI) Subject impacted by event
... encounter Σ 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... recordedDate Σ 0..1 dateTime (QI) When the event was recorded
... resultingCondition Σ 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location Σ 0..1 Reference(QICore Location) Location where adverse event occurred
... recorder Σ 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor Σ 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... causality Σ 0..1 BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... subjectMedicalHistory Σ 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 (QI) actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ 0..* CodeableConcept (QI) 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 (QI) Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event.

... subject Σ 1..1 Reference(QICore Patient) (QI) Subject impacted by event
... encounter Σ 0..1 Reference(QICore Encounter) (QI) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime (QI) When the event was recorded
... resultingCondition Σ 0..* Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) (QI) Effect on the subject due to this event
... location Σ 0..1 Reference(QICore 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 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ 0..1 Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) Who recorded the adverse event
... contributor Σ 0..* Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) 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(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) (QI) Refers to the specific entity that caused the adverse event
.... 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
..... 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): TODO.

... subjectMedicalHistory Σ 0..* Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore 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

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventpreferredSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/adverse-event-type
from the FHIR Standard
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron