2026 US Quality Core Implementation Guide
0.5.0 - release

2026 US Quality Core Implementation Guide - Downloaded Version 0.5.0 See the Directory of published versions

## Resource Profile: US Quality Core AdverseEvent

Official URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-adverseevent | Version: 0.5.0 | Highlight text changes?
Active as of 2026-06-05 | Computable Name: USQualityCoreAdverseEvent

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.

### USCDI+ Quality Element Support Expectations

Systems are expected to support this profile as part of implementing USCDI+ Quality V1 in FHIR and meeting the conformance requirements of this guide.

The following elements are specifically relevant to USCDI+ Quality V1 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 tagged as (USCDI+ Quality) in the formal profile views.

USCDI+ Quality Elements:

- category: (USCDI+ Quality) 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: (USCDI+ Quality) Type of the event itself in relation to the subject
- date: (USCDI+ Quality)
- detected: (USCDI+ Quality) When the event was detected
- recordedDate: (USCDI+ Quality) When the event was recorded
- suspectEntity.instance: (USCDI+ Quality) Refers to the specific entity that caused the adverse event

The Formal Views section also provides the formal summary, definitions, terminology requirements, and mandatory element requirements.

Usages:

- Examples for this Profile: AdverseEvent/example
- CapabilityStatements using this Profile: US Quality Core Client CapabilityStatement and US Quality Core Server CapabilityStatement

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 | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | (USCDI+ Quality) 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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | 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)
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.
recorder | Σ | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core 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.

#### 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 | actual | potential
category |  | 0..* | CodeableConcept | (USCDI+ Quality) 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 | (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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event
encounter |  | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of
date |  | 0..1 | dateTime | (USCDI+ Quality)
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
seriousness |  | 0..1 | CodeableConcept | Seriousness of the event
recorder |  | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor |  | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core 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.

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 | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | (USCDI+ Quality) 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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | 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)
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 | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder | Σ | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | 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
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:

- US Quality Core Patient (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-patient)
- US Quality Core Practitioner (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitioner)
- US Quality Core RelatedPerson (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-relatedperson)
- US Quality Core Encounter (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-encounter)
- US Quality Core Condition Problems Health Concerns (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-condition-problems-health-concerns)
- US Quality Core Condition Encounter Diagnosis (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-condition-encounter-diagnosis)
- US Quality Core Location (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-location)
- US Quality Core PractitionerRole (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitionerrole)
- US Quality Core Device (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-device)
- US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device|6.1.0)
- US Quality Core Immunization (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-immunization)
- US Quality Core Procedure (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-procedure)
- US Quality Core Substance (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-substance)
- US Quality Core Medication (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medication)
- US Quality Core MedicationAdministration (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medicationadministration)
- US Quality Core MedicationStatement (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medicationstatement)
- US Quality Core Simple Observation (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-simple-observation)
- US Quality Core AllergyIntolerance (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-allergyintolerance)
- US Quality Core FamilyMemberHistory (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-familymemberhistory)

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 | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | (USCDI+ Quality) 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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | 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)
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.
recorder | Σ | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core 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.

#### 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 | actual | potential
category |  | 0..* | CodeableConcept | (USCDI+ Quality) 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 | (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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event
encounter |  | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of
date |  | 0..1 | dateTime | (USCDI+ Quality)
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
seriousness |  | 0..1 | CodeableConcept | Seriousness of the event
recorder |  | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor |  | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | US Quality Core Immunization | US Quality Core Procedure | US Quality Core Condition Problems Health Concerns | US Quality Core 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.

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 | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | (USCDI+ Quality) 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 | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | 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)
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 | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder | Σ | 0..1 | Reference(US Quality Core Patient | US Quality Core RelatedPerson | US Quality Core Practitioner | US Quality Core PractitionerRole) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | 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 | US Quality Core Substance | US Quality Core Medication | US Quality Core MedicationAdministration | US Quality Core MedicationStatement | US Quality Core Device | US Core Implantable Device Profile(6.1.0)) | (USCDI+ Quality) 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(US Quality Core Simple Observation | US Quality Core AllergyIntolerance | US Quality Core FamilyMemberHistory | 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
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:

- US Quality Core Patient (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-patient)
- US Quality Core Practitioner (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitioner)
- US Quality Core RelatedPerson (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-relatedperson)
- US Quality Core Encounter (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-encounter)
- US Quality Core Condition Problems Health Concerns (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-condition-problems-health-concerns)
- US Quality Core Condition Encounter Diagnosis (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-condition-encounter-diagnosis)
- US Quality Core Location (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-location)
- US Quality Core PractitionerRole (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-practitionerrole)
- US Quality Core Device (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-device)
- US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device|6.1.0)
- US Quality Core Immunization (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-immunization)
- US Quality Core Procedure (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-procedure)
- US Quality Core Substance (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-substance)
- US Quality Core Medication (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medication)
- US Quality Core MedicationAdministration (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medicationadministration)
- US Quality Core MedicationStatement (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-medicationstatement)
- US Quality Core Simple Observation (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-simple-observation)
- US Quality Core AllergyIntolerance (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-allergyintolerance)
- US Quality Core FamilyMemberHistory (http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-familymemberhistory)

Other representations of profile: CSV, Excel, Schematron