QI-Core Implementation Guide: STU 4 (v4.0.0 for FHIR 4.0.1)
QI-Core Implementation Guide - This is the current published version.. See the Directory of published versions
| Mild Rash Example |
The official URL for this profile is:
http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent
An adverse event 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.
This profile builds on AdverseEvent.
This profile was published on Wed Aug 22 00:00:00 UTC 2018 as a draft by Health Level Seven, Inc. - CQI WG.
Description of Profiles, Differentials, and Snapshots.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdverseEvent | I | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury |
  id | Σ | 0..1 | string | Logical id of this artifact |
 meta | ΣI | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!ΣI | 0..1 | uri | A set of rules under which this content was created |
| language | I | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages |
| text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| contained | 0..* | Resource | Contained, inline Resources | |
 extension | I | 0..* | Extension | Additional content defined by implementations |
 modifierExtension | ?!I | 0..* | Extension | Extensions that cannot be ignored |
| identifier | ΣI | 0..1 | Identifier | Business identifier for the event |
| actuality | ?!SΣI | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) |
| category | SΣI | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible) |
| event | SΣI | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example) |
 subject | SΣI | 1..1 | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event |
| encounter | SΣI | 0..1 | Reference(QICoreEncounter) | Encounter created as part of |
| date | ΣI | 0..1 | dateTime | When the event occurred |
| detected | ΣI | 0..1 | dateTime | When the event was detected |
| recordedDate | ΣI | 0..1 | dateTime | When the event was recorded |
| resultingCondition | ΣI | 0..* | Reference(Condition) | Effect on the subject due to this event |
| location | ΣI | 0..1 | Reference(QICoreLocation) | Location where adverse event occurred |
| seriousness | ΣI | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example) |
| severity | ΣI | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required) |
| outcome | ΣI | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
| recorder | ΣI | 0..1 | Reference(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event |
| contributor | ΣI | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | ΣI | 0..* | BackboneElement | The suspected agent causing the adverse event |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣI | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event |
 causality | ΣI | 0..1 | BackboneElement | Information on the possible cause of the event |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessment | ΣI | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example) |
| productRelatedness | ΣI | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| author | ΣI | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
| method | ΣI | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example) |
| subjectMedicalHistory | ΣI | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory |
| referenceDocument | ΣI | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
| study | ΣI | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
Differential View
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | I | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | ΣI | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!ΣI | 0..1 | uri | A set of rules under which this content was created |
| language | I | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages |
| text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!I | 0..* | Extension | Extensions that cannot be ignored |
| identifier | ΣI | 0..1 | Identifier | Business identifier for the event |
| actuality | ?!SΣI | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) |
| category | SΣI | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible) |
| event | SΣI | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example) |
| subject | SΣI | 1..1 | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson) | Subject impacted by event |
| encounter | SΣI | 0..1 | Reference(QICoreEncounter) | Encounter created as part of |
| date | ΣI | 0..1 | dateTime | When the event occurred |
| detected | ΣI | 0..1 | dateTime | When the event was detected |
| recordedDate | ΣI | 0..1 | dateTime | When the event was recorded |
| resultingCondition | ΣI | 0..* | Reference(Condition) | Effect on the subject due to this event |
| location | ΣI | 0..1 | Reference(QICoreLocation) | Location where adverse event occurred |
| seriousness | ΣI | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example) |
| severity | ΣI | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required) |
| outcome | ΣI | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
| recorder | ΣI | 0..1 | Reference(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole) | Who recorded the adverse event |
| contributor | ΣI | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | ΣI | 0..* | BackboneElement | The suspected agent causing the adverse event |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣI | 1..1 | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice) | Refers to the specific entity that caused the adverse event |
| causality | ΣI | 0..1 | BackboneElement | Information on the possible cause of the event |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessment | ΣI | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example) |
| productRelatedness | ΣI | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| author | ΣI | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
| method | ΣI | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example) |
| subjectMedicalHistory | ΣI | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory |
| referenceDocument | ΣI | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
| study | ΣI | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| AdverseEvent.language | preferred | CommonLanguages Max Binding: AllLanguages |
| AdverseEvent.actuality | required | AdverseEventActuality |
| AdverseEvent.category | extensible | AdverseEventCategory |
| AdverseEvent.event | example | SNOMEDCTClinicalFindings |
| AdverseEvent.seriousness | example | AdverseEventSeriousness |
| AdverseEvent.severity | required | AdverseEventSeverity |
| AdverseEvent.outcome | required | AdverseEventOutcome |
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment |
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
| Id | Path | Details | Requirements |
| dom-2 | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | 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 | 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 | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | AdverseEvent.meta | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.implicitRules | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.language | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.text | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.identifier | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.actuality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.category | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.event | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.subject | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.encounter | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.date | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.detected | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.recordedDate | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.resultingCondition | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.location | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.seriousness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.severity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.outcome | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.recorder | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.contributor | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.suspectEntity.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.suspectEntity.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.suspectEntity.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.suspectEntity.instance | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.causality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.causality.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.suspectEntity.causality.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.suspectEntity.causality.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AdverseEvent.suspectEntity.causality.assessment | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.causality.productRelatedness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.causality.author | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.suspectEntity.causality.method | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.subjectMedicalHistory | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.referenceDocument | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AdverseEvent.study | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
© HL7.org 2011+. (Clinical Quality Improvement WG). hl7.fhir.us.qicore#4.0.0 based on FHIR v4.0.1 Generated 2020-03-24.
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