Source | hl7.fhir.us.icsr-ae-reporting#current:HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting (v4.0.1) |
resourceType | StructureDefinition |
id | icsr-composition |
canonical | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition |
version | 1.0.1 |
status | draft |
publisher | Biomedical Research & Regulation WG |
name | ICSRComposition |
title | ICSR Composition |
date | 2023-08-30T17:02:44+00:00 |
description | The fields needed to represent the document metadata of a ICSR Report. |
jurisdictions | us |
fhirVersion | 4.0.1 |
kind | resource |
abstract | false |
sdTtype | Composition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/Composition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | Composition | |||
Slices for extension | 4.. | Slice: Unordered, Open by value:url | ||
firstReceiveDate | S | 0..1 | dateTime |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate |
mostRecentInfoDate | S | 0..1 | dateTime |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate |
additionalDocuments | S | 1..1 | (Complex) |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation |
expeditedReport | S | 1..1 | (Complex) |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport |
otherCaseIdentifier | S | 0..* | Identifier |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier |
firstSenderType | S | 1..1 | CodeableConcept |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype |
previousCaseIdentifier | S | 0..* | Identifier |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier |
reportAmendment | S | 0..1 | (Complex) |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment |
combinationProductReport | S | 1..1 | boolean |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport |
identifier | S | 1.. | ||
system | 1.. | Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1 | ||
value | 1.. | |||
status | Required Pattern: final | |||
type | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://loinc.org |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 85893-6 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Adverse event note |
|
category | S | 1..1 | ||
subject | S | 1.. | Reference (ICSR Patient) | |
date | S | |||
author | S | ..1 | Reference (PractitionerRole Author | ICSR Patient | RelatedPerson Author) | |
extension | 1.. | |||
primarySource | S | 1..1 | boolean |
Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource |
title | Required Pattern: ICSR Submission | |||
Slices for section | S | 3 .. 13 | Slice: Unordered, Open by value:code | |
section:All Slices | Content/Rules for all slices | |||
title | S | 1.. | ||
code | S | 1.. | ||
text | S | |||
entry | S | |||
section:PatientInformation | S | 0..1 | ||
title | Required Pattern: Patient Information | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: PatientInformation |
|
entry | Reference (Patient Body Height in cm | Patient Body Weight in kg | Descriptive Age Group for the Patient | Patient's Date of Last Menstrual Period) | |||
section:RelevantMedicalHistory | S | 0..1 | ||
title | Required Pattern: Relevant Medical History | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: RelevantMedicalHistory |
|
entry | Reference ( Condition ) | |||
section:RelevantPastDrugHistory | S | 0..1 | ||
title | Required Pattern: Relevant Past Drug History | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: RelevantPastDrugHistory |
|
entry | Reference ( MedicationStatement ) | |||
section:InCaseOfDeath | S | 0..1 | ||
title | Required Pattern: In Case of Death | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: InCaseOfDeath |
|
entry | Reference ( Observation ) | |||
section:ParentInformation | S | 0..1 | ||
title | Required Pattern: Parent Information | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: ParentInformation |
|
entry | Reference ( Patient | Condition | MedicationStatement ) | |||
section:ReactionEvent | S | 1..1 | ||
title | Required Pattern: Reaction/Event | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: ReactionEvent |
|
entry | Reference (Vaccination Adverse Event | Transfusion Adverse Event) | |||
section:RelevantLabTestResults | S | 0..1 | ||
title | Required Pattern: Relevant Lab Test Results | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: RelevantLabTestResults |
|
entry | Reference ( Observation ) | |||
section:DrugInformation | S | 1..1 | ||
title | Required Pattern: Drug Information | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: DrugInformation |
|
entry | Reference (ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion) | |||
section:Vaccines | S | 0..1 | ||
title | Required Pattern: Vaccines given within 4 weeks | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: Vaccines |
|
entry | Reference (ICSR Immunization) | |||
section:CaseNarrative | S | 1..1 | ||
title | Required Pattern: Case Summary Narrative | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: CaseSummaryNarrative |
|
text | 1.. | |||
entry | .. 0 | |||
section:CaseReporterComments | S | 0..1 | ||
title | Required Pattern: Case Reporter's Comments | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: CaseReporterComments |
|
text | 1.. | |||
entry | .. 0 | |||
section:CaseSenderDiagnosis | S | 0..1 | ||
title | Required Pattern: Case Sender's Diagnosis | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: CaseSenderDiagnosis |
|
entry | Reference ( Condition ) | |||
section:CaseSenderComments | S | 0..1 | ||
title | Required Pattern: Case Sender's Comments | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: CaseSenderComments |
|
text | 1.. | |||
entry | .. 0 | |||
section:DataSourceInformation | S | 0..1 | ||
title | Required Pattern: Information about the Data Source of the AE information | |||
code | Required Pattern: At least the following | |||
coding | 1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: DataSourceInformation |
|
entry | Reference (AECountObservation | ExposureCountObservation) | |||
Documentation for this format |
Produced 08 Sep 2023