Smart Bear Implementation Guide - Local Development build (v0.3.2). See the Directory of published versions
Resource Profile: Smart Bear Adverse Event
| Official URL: https://smart-bear.eu/fhir/StructureDefinition/AdverseEventSB | Version: 0.3.2 | |||
| Active as of 2023-11-21 | Computable Name: AdversEventSB | |||
Adverse Event for Smart Bear project
Usage:
- Examples for this Resource Profile: AdverseEvent/AdverseEvent001, AdverseEvent/AdverseEvent002
Formal Views of Profile Content
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 | actual or potential | |
| event | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text | |
 subject | S | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event |
| seriousness | S | 1..1 | CodeableConcept | serious or non-serious |
| severity | S | 1..1 | CodeableConcept | mild | moderate | severe |
 suspectEntity | S | 1..1 | BackboneElement | The suspected agent causing the adverse event |
  instance | ||||
  reference | 0..1 | string | it could specify whether it is a medication or a device for example | |
| causality | ||||
| assessment | 1..1 | CodeableConcept | Indicate causality, Possible, yes or not. | |
| Documentation for this format | ||||
| 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 | actual or potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
 event | Σ | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
| subject | SΣ | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event |
| seriousness | SΣ | 1..1 | CodeableConcept | serious or non-serious Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
| severity | SΣ | 1..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. |
| suspectEntity | SΣ | 1..1 | 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(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| reference | ΣC | 0..1 | string | it could specify whether it is a medication or a device for example |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| AdverseEvent.actuality | required | AdverseEventActuality |
| AdverseEvent.event | example | SNOMEDCTClinicalFindings |
| AdverseEvent.seriousness | example | AdverseEventSeriousness |
| AdverseEvent.severity | required | AdverseEventSeverity |
| 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 | actual or potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category | Σ | 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): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
| subject | SΣ | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | 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(Condition) | Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | serious or non-serious Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity | SΣ | 1..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(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | SΣ | 1..1 | 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(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | ΣC | 0..1 | string | it could specify whether it is a medication or a device for example | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| causality | Σ | 0..* | 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 | 1..1 | CodeableConcept | Indicate causality, Possible, yes or not. 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(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| 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.instance.type | extensible | ResourceType | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
This structure is derived from AdverseEvent
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 | actual or potential | |
| event | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text | |
| subject | S | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event |
| seriousness | S | 1..1 | CodeableConcept | serious or non-serious |
| severity | S | 1..1 | CodeableConcept | mild | moderate | severe |
| suspectEntity | S | 1..1 | BackboneElement | The suspected agent causing the adverse event |
| instance | ||||
| reference | 0..1 | string | it could specify whether it is a medication or a device for example | |
| causality | ||||
| assessment | 1..1 | CodeableConcept | Indicate causality, Possible, yes or not. | |
| Documentation for this format | ||||
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 | actual or potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
| event | Σ | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
| subject | SΣ | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event |
| seriousness | SΣ | 1..1 | CodeableConcept | serious or non-serious Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
| severity | SΣ | 1..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. |
| suspectEntity | SΣ | 1..1 | 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(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| reference | ΣC | 0..1 | string | it could specify whether it is a medication or a device for example |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| AdverseEvent.actuality | required | AdverseEventActuality |
| AdverseEvent.event | example | SNOMEDCTClinicalFindings |
| AdverseEvent.seriousness | example | AdverseEventSeriousness |
| AdverseEvent.severity | required | AdverseEventSeverity |
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 | actual or potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category | Σ | 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): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 0..1 | CodeableConcept | Adverse Event with Snomed CT code and eventually text Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
| subject | SΣ | 1..1 | Reference(Smart Bear Patient) | Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | 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(Condition) | Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | serious or non-serious Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity | SΣ | 1..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(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | SΣ | 1..1 | 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(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | ΣC | 0..1 | string | it could specify whether it is a medication or a device for example | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| causality | Σ | 0..* | 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 | 1..1 | CodeableConcept | Indicate causality, Possible, yes or not. 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(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| 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.instance.type | extensible | ResourceType | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
This structure is derived from AdverseEvent
Other representations of profile: CSV, Excel, Schematron