HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent | Version: 1.0.1 | |||
| Draft as of 2023-08-30 | Computable Name: ICSRAdverseEvent | |||
The fields needed to submit an AdverseEvent for a ICSR Report.
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 | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent | ||
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
 identifier | S | 0..1 | Identifier | Business identifier for the event |
| actuality | S | 1..1 | code | actual | potential Fixed Value: actual |
| category | S | 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 |
 event | S | 1..1 | CodeableConcept | Type of the event itself in relation to the subject |
  coding | ||||
  system | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | |
 subject | S | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
| encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
| date | S | 0..1 | dateTime | When the event occurred |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
| location | S | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
| seriousness | S | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
| outcome | S | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown |
| recorder | S | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
| suspectEntity | S | 1..* | BackboneElement | The suspected agent causing the adverse event |
| instance | S | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
| causality | S | 1..1 | BackboneElement | Information on the possible cause of the event |
| productRelatedness | S | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| AdverseEvent.seriousness | required | ICSRAESeriousness |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, 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 |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
 identifier | SΣ | 0..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. Fixed Value: actual |
| category | SΣ | 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 | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
| date | SΣ | 0..1 | dateTime | When the event occurred |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
| location | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
| seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| recorder | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
| suspectEntity | SΣ | 1..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣ | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
| causality | SΣ | 1..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productRelatedness | SΣ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| AdverseEvent.actuality | required | Fixed Value: actual |
| AdverseEvent.category | extensible | AdverseEventCategory |
| AdverseEvent.event | example | SNOMEDCTClinicalFindings |
| AdverseEvent.seriousness | required | ICSRAESeriousness |
| AdverseEvent.outcome | required | AdverseEventOutcome |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, 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 | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | SΣ | 0..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. Fixed Value: actual | ||||
| category | SΣ | 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 | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of 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 | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event | ||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of | ||||
| date | SΣ | 0..1 | dateTime | When the event occurred | ||||
| id | 0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration | ||||
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate | ||||
| value | 0..1 | dateTime | Primitive value for dateTime | |||||
| 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 | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) | ||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| 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 | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | SΣ | 0..1 | Reference(Practitioner Author) | 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..* | 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(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event | ||||
| causality | SΣ | 1..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 | SΣ | 1..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 | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| AdverseEvent.actuality | required | Fixed Value: actual | ||||
| AdverseEvent.category | extensible | AdverseEventCategory | ||||
| AdverseEvent.event | example | SNOMEDCTClinicalFindings | ||||
| AdverseEvent.seriousness | required | ICSRAESeriousness | ||||
| AdverseEvent.severity | required | AdverseEventSeverity | ||||
| AdverseEvent.outcome | required | AdverseEventOutcome | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
This structure is derived from AdverseEvent
Summary
Mandatory: 5 elements
Must-Support: 18 elements
Fixed Value: 2 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from AdverseEvent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent | ||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
| identifier | S | 0..1 | Identifier | Business identifier for the event |
| actuality | S | 1..1 | code | actual | potential Fixed Value: actual |
| category | S | 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 |
| event | S | 1..1 | CodeableConcept | Type of the event itself in relation to the subject |
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | |
| subject | S | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
| encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
| date | S | 0..1 | dateTime | When the event occurred |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
| location | S | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
| seriousness | S | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
| outcome | S | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown |
| recorder | S | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
| suspectEntity | S | 1..* | BackboneElement | The suspected agent causing the adverse event |
| instance | S | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
| causality | S | 1..1 | BackboneElement | Information on the possible cause of the event |
| productRelatedness | S | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| AdverseEvent.seriousness | required | ICSRAESeriousness |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, 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 |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 0..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. Fixed Value: actual |
| category | SΣ | 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 | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
| date | SΣ | 0..1 | dateTime | When the event occurred |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
| location | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
| seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| recorder | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
| suspectEntity | SΣ | 1..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣ | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
| causality | SΣ | 1..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productRelatedness | SΣ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| AdverseEvent.actuality | required | Fixed Value: actual |
| AdverseEvent.category | extensible | AdverseEventCategory |
| AdverseEvent.event | example | SNOMEDCTClinicalFindings |
| AdverseEvent.seriousness | required | ICSRAESeriousness |
| AdverseEvent.outcome | required | AdverseEventOutcome |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, 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 | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| ageAtTimeOfOnset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | SΣ | 0..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. Fixed Value: actual | ||||
| category | SΣ | 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 | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of 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 | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event | ||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of | ||||
| date | SΣ | 0..1 | dateTime | When the event occurred | ||||
| id | 0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| eventDuration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration | ||||
| endDate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate | ||||
| value | 0..1 | dateTime | Primitive value for dateTime | |||||
| 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 | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| seriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) | ||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| 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 | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | SΣ | 0..1 | Reference(Practitioner Author) | 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..* | 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(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event | ||||
| causality | SΣ | 1..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 | SΣ | 1..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 | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| AdverseEvent.actuality | required | Fixed Value: actual | ||||
| AdverseEvent.category | extensible | AdverseEventCategory | ||||
| AdverseEvent.event | example | SNOMEDCTClinicalFindings | ||||
| AdverseEvent.seriousness | required | ICSRAESeriousness | ||||
| AdverseEvent.severity | required | AdverseEventSeverity | ||||
| AdverseEvent.outcome | required | AdverseEventOutcome | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
This structure is derived from AdverseEvent
Summary
Mandatory: 5 elements
Must-Support: 18 elements
Fixed Value: 2 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-30
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