QI-Core Implementation Guide
8.0.0-ballot - STU 8 - ballot

QI-Core Implementation Guide, published by HL7 International / Clinical Quality Information. This guide is not an authorized publication; it is the continuous build for version 8.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-qi-core/ and changes regularly. See the Directory of published versions

## Resource Profile: QICore AdverseEvent

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent | Version: 8.0.0-ballot
Standards status: Trial-use Active as of 2018-08-22 | Maturity Level: 4 | Computable Name: QICoreAdverseEvent

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.

"Must Have", "QI Elements" and "primary code path" are defined in the QI-Core Must Support section.
QI Elements:

- 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
- severity: (QI) mild | moderate | severe
- resultingCondition: (QI) Effect on the subject due to this event
- event: (QI) Type of the event itself in relation to the subject
- encounter: (QI) Encounter created as part of
- date: (QI) When the event occurred
- seriousness: (QI) Seriousness of the event
- recordedDate: (QI) When the event was recorded
- subject: (QI) Subject impacted by event
- actuality: (QI) actual | potential

Primary code path: event
(PCPath) This element is the primary code path for this resource CQL Retrieve
Usage

See the patterns page for implementation and usage patterns.

### Examples

Mild Rash Example

Usages:

- Examples for this Profile: AdverseEvent/example

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
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 | (QI) 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
seriousness | Σ | 0..1 | CodeableConcept | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | (QI) mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
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
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
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.

#### 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()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
subject |  | 1..1 | Reference(QICore Patient) | (QI) Subject impacted by event
encounter |  | 0..1 | Reference(QICore Encounter) | (QI) Encounter created as part of
date |  | 0..1 | dateTime | (QI) 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
seriousness |  | 0..1 | CodeableConcept | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity |  | 0..1 | CodeableConcept | (QI) mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
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
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.seriousness | Base | example | AdverseEventSeriousness | 📦4.0.1 | FHIR Std.
AdverseEvent.severity | Base | required | AdverseEventSeverity | 📦4.0.1 | FHIR Std.

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 Bindings | Purpose
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 | (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 | (QI) 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 | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | (QI) 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
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: 2 elements

Structures

This structure refers to these other structures:

- QICore Patient (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient)
- QICore Encounter (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-encounter)
- QICore Condition Problems Health Concerns (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-problems-health-concerns)
- QICore Condition Encounter Diagnosis (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-encounter-diagnosis)
- QICore Location (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location)
- QICore RelatedPerson (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson)
- QICore Practitioner (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner)
- QICore PractitionerRole (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole)
- QICore Device (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device)
- US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device)
- QICore Immunization (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization)
- QICore Procedure (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure)
- QICore Substance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance)
- QICore Medication (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication)
- QICore MedicationAdministration (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration)
- QICore MedicationStatement (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement)
- QICore Simple Observation (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-simple-observation)
- QICore AllergyIntolerance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-allergyintolerance)
- QICore FamilyMemberHistory (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-familymemberhistory)

Maturity: 4

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
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 | (QI) 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
seriousness | Σ | 0..1 | CodeableConcept | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | (QI) mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
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
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
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.

#### 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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
subject |  | 1..1 | Reference(QICore Patient) | (QI) Subject impacted by event
encounter |  | 0..1 | Reference(QICore Encounter) | (QI) Encounter created as part of
date |  | 0..1 | dateTime | (QI) 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
seriousness |  | 0..1 | CodeableConcept | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity |  | 0..1 | CodeableConcept | (QI) mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
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
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.seriousness | Base | example | AdverseEventSeriousness | 📦4.0.1 | FHIR Std.
AdverseEvent.severity | Base | required | AdverseEventSeverity | 📦4.0.1 | FHIR Std.

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 Bindings | Purpose
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 | (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 | (QI) 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 | (QI) Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | (QI) 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
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: 2 elements

Structures

This structure refers to these other structures:

- QICore Patient (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient)
- QICore Encounter (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-encounter)
- QICore Condition Problems Health Concerns (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-problems-health-concerns)
- QICore Condition Encounter Diagnosis (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-encounter-diagnosis)
- QICore Location (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location)
- QICore RelatedPerson (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson)
- QICore Practitioner (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner)
- QICore PractitionerRole (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole)
- QICore Device (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device)
- US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device)
- QICore Immunization (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization)
- QICore Procedure (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure)
- QICore Substance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance)
- QICore Medication (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication)
- QICore MedicationAdministration (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration)
- QICore MedicationStatement (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement)
- QICore Simple Observation (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-simple-observation)
- QICore AllergyIntolerance (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-allergyintolerance)
- QICore FamilyMemberHistory (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-familymemberhistory)

Maturity: 4

Other representations of profile: CSV, Excel, Schematron