US Quality Core Implementation Guide, published by ASTP. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/FHIR/us-quality-core/ and changes regularly. See the Directory of published versions
| Official URL: http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-adverseevent | Version: 0.1.0 | |||
| Active as of 2026-03-31 | 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 Elements:
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
![]() ![]() |
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. |
![]() ![]() |
Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. |
![]() ![]() |
Σ | 1..1 | Reference(US Quality Core Patient | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event |
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was detected |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was recorded |
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) | Effect on the subject due to this event |
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Location) | Location where adverse event occurred |
![]() ![]() |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
![]() ![]() |
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 |
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event |
![]() ![]() |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
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) | (USCDI+ Quality) Refers to the specific entity that caused the adverse event |
![]() ![]() ![]() |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() |
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 | ||||
| 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. |
| 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()
|
This structure is derived from AdverseEvent
| 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: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
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 | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
![]() ![]() |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
![]() ![]() |
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. | ||||
![]() ![]() |
Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | ||||
![]() ![]() |
Σ | 1..1 | Reference(US Quality Core Patient | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event | ||||
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was detected | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was recorded | ||||
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) | Effect on the subject due to this event | ||||
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Location) | Location where adverse event occurred | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
![]() ![]() |
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 | ||||
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | ||||
![]() ![]() |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
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) | (USCDI+ Quality) Refers to the specific entity that caused the adverse event | ||||
![]() ![]() ![]() |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
![]() ![]() |
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 | ||||
![]() ![]() |
Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
![]() ![]() |
Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
Documentation for this format | ||||||||
| 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. |
| 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()
|
This structure is derived from AdverseEvent
Summary
Mandatory: 2 elements
Structures
This structure refers to these other structures:
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
![]() ![]() |
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. |
![]() ![]() |
Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. |
![]() ![]() |
Σ | 1..1 | Reference(US Quality Core Patient | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event |
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was detected |
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was recorded |
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) | Effect on the subject due to this event |
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Location) | Location where adverse event occurred |
![]() ![]() |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
![]() ![]() |
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 |
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event |
![]() ![]() |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
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) | (USCDI+ Quality) Refers to the specific entity that caused the adverse event |
![]() ![]() ![]() |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() |
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 | ||||
| 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. |
| 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
This structure is derived from AdverseEvent
| Path | Status | Usage | ValueSet | Version | Source |
| AdverseEvent.event | Base | preferred | SNOMED CT Clinical Findings | 📦4.0.1 | FHIR Std. |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
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 | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
![]() ![]() |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
![]() ![]() |
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. | ||||
![]() ![]() |
Σ | 1..1 | CodeableConcept | (USCDI+ Quality) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | ||||
![]() ![]() |
Σ | 1..1 | Reference(US Quality Core Patient | Group | US Quality Core Practitioner | US Quality Core RelatedPerson) | Subject impacted by event | ||||
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Encounter) | Encounter created as part of | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was detected | ||||
![]() ![]() |
Σ | 0..1 | dateTime | (USCDI+ Quality) When the event was recorded | ||||
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Condition Problems Health Concerns | US Quality Core Condition Encounter Diagnosis) | Effect on the subject due to this event | ||||
![]() ![]() |
Σ | 0..1 | Reference(US Quality Core Location) | Location where adverse event occurred | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
![]() ![]() |
Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
![]() ![]() |
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 | ||||
![]() ![]() |
Σ | 0..* | Reference(US Quality Core Practitioner | US Quality Core PractitionerRole | US Quality Core Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | ||||
![]() ![]() |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
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) | (USCDI+ Quality) Refers to the specific entity that caused the adverse event | ||||
![]() ![]() ![]() |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
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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 | ||||
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Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
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Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
Documentation for this format | ||||||||
| 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. |
| 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()
|
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