ChanjoKE Immunization Implementation Guide, published by Intellisoft Consulting Ltd. 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/IntelliSOFT-Consulting/ChanjoKe-FHIR-IG/ and changes regularly. See the Directory of published versions
Resource Profile: AdverseEventProfile
| Official URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/AdverseEventProfile | Version: 0.1.0 | |||
| Draft as of 2024-11-08 | Computable Name: AdverseEventProfile | |||
Profile for Adverse Event
Usage:
- Examples for this Resource Profile: AdverseEvent/ExampleAdverseEvent
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | |
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG |
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | |
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard |
Constraints
| 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 | |||||
  Slices for extension |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
   types-of-aefi |
S | 0..1 | code | Extension for types of AEFI URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/types-of-aefi Binding: Type of AEFI (required) | ||||
| eventDetails |
S | 0..1 | string | Extension for Event Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/event-details | ||||
| actionTaken |
S | 0..1 | code | Extension for Action Taken URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/action-taken Binding: AEFI Action Taken (required) | ||||
| facility-reported |
S | 0..1 | string | Extension for Facility Reported URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/facility-reported | ||||
| treatmentGiven |
S | 0..1 | string | Extension for Treatment Given URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-given | ||||
| treatmentDetails |
S | 0..1 | string | Extension for Treatment Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-details | ||||
| specimenCollected |
S | 0..1 | string | Extension for Specimen collected for investigation URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-collected | ||||
| specimenDetails |
S | 0..1 | string | Extension for Specimen Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-details | ||||
 reactionSeverity |
S | 1..1 | (Complex) | ReactionSeverityExtension URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity | ||||
  id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..0 | |||||||
| url |
1..1 | uri | "https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity" | |||||
 value[x] |
0..1 | code | Life Threatening | Mild | Moderate | Severe | Fatal Binding: Reaction Severity (required) | |||||
 aefiOutcome |
S | 1..1 | (Complex) | AefiOutcomeExtension URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome | ||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..0 | |||||||
| url |
1..1 | uri | "https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome" | |||||
| value[x] |
0..1 | code | Recovered | Recovering | Not Recovered | Unknown | Died Binding: AEFI Outcome (required) | |||||
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 1..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!SΣ | 1..1 | code | actual | 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 | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
 subject |
Σ | 1..1 | Reference(KenyanImmunizationRegistryPatient) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
SΣ | 1..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
SΣ | 1..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 |
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(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 | 0..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 |
SΣ | 1..1 | Reference(Substance) | Refers to the specific entity that caused the adverse event | ||||
 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 | 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 |
SΣ | 1..1 | Reference(Condition | Observation | Immunization | 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 | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | ||||
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG | ||||
| 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 | example | 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 |
Constraints
| 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: 6 elements
Must-Support: 17 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/types-of-aefi
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/event-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/action-taken
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/facility-reported
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-given
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-collected
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome
Differential View
This structure is derived from AdverseEvent
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | |
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG |
Key Elements View
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | |
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard |
Constraints
| 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 | |||||
| Slices for extension |
2..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| types-of-aefi |
S | 0..1 | code | Extension for types of AEFI URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/types-of-aefi Binding: Type of AEFI (required) | ||||
| eventDetails |
S | 0..1 | string | Extension for Event Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/event-details | ||||
| actionTaken |
S | 0..1 | code | Extension for Action Taken URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/action-taken Binding: AEFI Action Taken (required) | ||||
| facility-reported |
S | 0..1 | string | Extension for Facility Reported URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/facility-reported | ||||
| treatmentGiven |
S | 0..1 | string | Extension for Treatment Given URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-given | ||||
| treatmentDetails |
S | 0..1 | string | Extension for Treatment Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-details | ||||
| specimenCollected |
S | 0..1 | string | Extension for Specimen collected for investigation URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-collected | ||||
| specimenDetails |
S | 0..1 | string | Extension for Specimen Details URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-details | ||||
| reactionSeverity |
S | 1..1 | (Complex) | ReactionSeverityExtension URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..0 | |||||||
| url |
1..1 | uri | "https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity" | |||||
| value[x] |
0..1 | code | Life Threatening | Mild | Moderate | Severe | Fatal Binding: Reaction Severity (required) | |||||
| aefiOutcome |
S | 1..1 | (Complex) | AefiOutcomeExtension URL: https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..0 | |||||||
| url |
1..1 | uri | "https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome" | |||||
| value[x] |
0..1 | code | Recovered | Recovering | Not Recovered | Unknown | Died Binding: AEFI Outcome (required) | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 1..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!SΣ | 1..1 | code | actual | 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 | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. | ||||
| subject |
Σ | 1..1 | Reference(KenyanImmunizationRegistryPatient) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
SΣ | 1..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
SΣ | 1..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 |
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(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 | 0..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 |
SΣ | 1..1 | Reference(Substance) | Refers to the specific entity that caused the adverse event | ||||
| 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 | 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 |
SΣ | 1..1 | Reference(Condition | Observation | Immunization | 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 | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.extension:reactionSeverity.value[x] | required | IMMZFDE26VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVSfrom this IG | ||||
| AdverseEvent.extension:aefiOutcome.value[x] | required | IMMZFDE33VShttps://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVSfrom this IG | ||||
| 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 | example | 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 |
Constraints
| 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: 6 elements
Must-Support: 17 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/types-of-aefi
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/event-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/action-taken
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/facility-reported
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-given
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/treatment-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-collected
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/specimen-details
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity
- https://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome
Other representations of profile: CSV, Excel, Schematron