QI-Core Implementation Guide
6.0.0 - STU6
QI-Core Implementation Guide
6.0.0 - STU6
This page is part of the Quality Improvement Core Framework (v6.0.0: STU6 (v6.0.0)) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent | Version: 6.0.0 | |||
| Active as of 2018-08-22 | Computable Name: QICoreAdverseEvent | |||
An adverse event (AE) is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as “recurring headaches” but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdverseEvent | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
  actuality | 1..1 | code | (QI-Core) actual | potential | |
| category | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment | |
| event | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | |
 subject | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event | |
| encounter | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of | |
| date | 0..1 | dateTime | When the event occurred | |
| resultingCondition | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event | |
| location | 0..1 | Reference(QICore Location) | Location where adverse event occurred | |
| recorder | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | |
| contributor | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | |
 suspectEntity | 0..* | BackboneElement | The suspected agent causing the adverse event | |
 instance | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event | |
 causality | 0..1 | BackboneElement | Information on the possible cause of the event | |
| subjectMedicalHistory | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality | ?!Σ | 1..1 | code | (QI-Core) actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
 category | Σ | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. |
| event | Σ | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. |
| subject | Σ | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event |
| encounter | Σ | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of |
| date | Σ | 0..1 | dateTime | When the event occurred |
| resultingCondition | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event |
| location | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred |
| recorder | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event |
| contributor | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event |
 causality | Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!Σ | 1..1 | code | (QI-Core) actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category | Σ | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | ||||
| subject | Σ | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of | ||||
| date | Σ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred | ||||
| seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
| outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event | ||||
| causality | Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event. | ||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | ||||
| AdverseEvent.seriousness | example | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1from the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assessfrom the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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:
Differential View
This structure is derived from AdverseEvent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
| actuality | 1..1 | code | (QI-Core) actual | potential | |
| category | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment | |
| event | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | |
| subject | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event | |
| encounter | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of | |
| date | 0..1 | dateTime | When the event occurred | |
| resultingCondition | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event | |
| location | 0..1 | Reference(QICore Location) | Location where adverse event occurred | |
| recorder | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | |
| contributor | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | |
| suspectEntity | 0..* | BackboneElement | The suspected agent causing the adverse event | |
| instance | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event | |
| causality | 0..1 | BackboneElement | Information on the possible cause of the event | |
| subjectMedicalHistory | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality | ?!Σ | 1..1 | code | (QI-Core) actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
| category | Σ | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. |
| event | Σ | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. |
| subject | Σ | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event |
| encounter | Σ | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of |
| date | Σ | 0..1 | dateTime | When the event occurred |
| resultingCondition | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event |
| location | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred |
| recorder | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event |
| contributor | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event |
| causality | Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!Σ | 1..1 | code | (QI-Core) actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category | Σ | 0..* | CodeableConcept | (QI-Core) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 1..1 | CodeableConcept | (QI-Core) Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (preferred): Detailed type of event. | ||||
| subject | Σ | 1..1 | Reference(QICore Patient | Group | QICore Practitioner | QICore RelatedPerson) | (QI-Core) Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(QICore Encounter) | (QI-Core) Encounter created as part of | ||||
| date | Σ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI-Core) Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred | ||||
| seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
| outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI-Core) Refers to the specific entity that caused the adverse event | ||||
| causality | Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event. | ||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | preferred | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | ||||
| AdverseEvent.seriousness | example | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1from the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assessfrom the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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
IG © 2019+ HL7 International / Clinical Quality Information. Package hl7.fhir.us.qicore#6.0.0 based on FHIR 4.0.1. Generated 2024-03-01
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