description: The fields needed to represent the document metadata of a ICSR Report.
package_name: hl7.fhir.us.icsr-ae-reporting
derivation: constraint
name: ICSRComposition
type: Composition
elements:
  category: {mustSupport: true, index: 15}
  date: {mustSupport: true, index: 17}
  section:
    mustSupport: true
    array: true
    min: 3
    max: 13
    index: 22
    elements:
      title: {mustSupport: true, index: 23}
      code: {mustSupport: true, index: 24}
      text: {mustSupport: true, index: 25}
      entry: {mustSupport: true, index: 26}
    required: [title, code]
    slicing:
      rules: open
      description: Slice based on the different sections that are needed in an ICSR document.
      discriminator:
      - {path: code, type: value}
      min: 3
      max: 13
      slices:
        RelevantLabTestResults:
          match:
            code:
              coding:
              - {code: RelevantLabTestResults, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 51
            elements:
              title:
                pattern: {type: String, value: Relevant Lab Test Results}
                index: 52
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: RelevantLabTestResults, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 53
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/Observation']
                index: 54
        DrugInformation:
          match:
            code:
              coding:
              - {code: DrugInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            _required: true
            index: 55
            elements:
              title:
                pattern: {type: String, value: Drug Information}
                index: 56
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: DrugInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 57
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/DeviceUseStatement', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion']
                index: 58
        InCaseOfDeath:
          match:
            code:
              coding:
              - {code: InCaseOfDeath, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 39
            elements:
              title:
                pattern: {type: String, value: In Case of Death}
                index: 40
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: InCaseOfDeath, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 41
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/Observation']
                index: 42
        CaseSenderDiagnosis:
          match:
            code:
              coding:
              - {code: CaseSenderDiagnosis, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 73
            elements:
              title:
                pattern: {type: String, value: Case Sender's Diagnosis}
                index: 74
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: CaseSenderDiagnosis, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 75
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/Condition']
                index: 76
        CaseSenderComments:
          match:
            code:
              coding:
              - {code: CaseSenderComments, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 77
            elements:
              title:
                pattern: {type: String, value: Case Sender's Comments}
                index: 78
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: CaseSenderComments, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 79
              text: {index: 80}
              entry: {index: 81}
            required: [text]
        ReactionEvent:
          match:
            code:
              coding:
              - {code: ReactionEvent, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            _required: true
            index: 47
            elements:
              title:
                pattern: {type: String, value: Reaction/Event}
                index: 48
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: ReactionEvent, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 49
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/transfusion-adverseevent', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaccination-adverseevent']
                index: 50
        PatientInformation:
          match:
            code:
              coding:
              - {code: PatientInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 27
            elements:
              title:
                pattern: {type: String, value: Patient Information}
                index: 28
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: PatientInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 29
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientagegroup', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientheight', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientlastmenstrualperiod', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientweight']
                index: 30
        Vaccines:
          match:
            code:
              coding:
              - {code: Vaccines, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 59
            elements:
              title:
                pattern: {type: String, value: Vaccines given within 4 weeks}
                index: 60
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: Vaccines, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 61
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization']
                index: 62
        CaseNarrative:
          match:
            code:
              coding:
              - {code: CaseSummaryNarrative, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            _required: true
            index: 63
            elements:
              title:
                pattern: {type: String, value: Case Summary Narrative}
                index: 64
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: CaseSummaryNarrative, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 65
              text: {index: 66}
              entry: {index: 67}
            required: [text]
        ParentInformation:
          match:
            code:
              coding:
              - {code: ParentInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 43
            elements:
              title:
                pattern: {type: String, value: Parent Information}
                index: 44
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: ParentInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 45
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/Condition', 'http://hl7.org/fhir/StructureDefinition/MedicationStatement', 'http://hl7.org/fhir/StructureDefinition/Patient']
                index: 46
        CaseReporterComments:
          match:
            code:
              coding:
              - {code: CaseReporterComments, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 68
            elements:
              title:
                pattern: {type: String, value: Case Reporter's Comments}
                index: 69
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: CaseReporterComments, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 70
              text: {index: 71}
              entry: {index: 72}
            required: [text]
        DataSourceInformation:
          match:
            code:
              coding:
              - {code: DataSourceInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 82
            elements:
              title:
                pattern: {type: String, value: Information about the Data Source of the AE information}
                index: 83
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: DataSourceInformation, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 84
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-aecountobservation', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-exposurecountobservation']
                index: 85
        RelevantPastDrugHistory:
          match:
            code:
              coding:
              - {code: RelevantPastDrugHistory, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 35
            elements:
              title:
                pattern: {type: String, value: Relevant Past Drug History}
                index: 36
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: RelevantPastDrugHistory, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 37
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/MedicationStatement']
                index: 38
        RelevantMedicalHistory:
          match:
            code:
              coding:
              - {code: RelevantMedicalHistory, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
          schema:
            mustSupport: true
            index: 31
            elements:
              title:
                pattern: {type: String, value: Relevant Medical History}
                index: 32
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: RelevantMedicalHistory, system: 'http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS'}
                index: 33
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/StructureDefinition/Condition']
                index: 34
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: 85893-6, system: 'http://loinc.org', display: Adverse event note}
    index: 14
  title:
    pattern: {type: String, value: ICSR Submission}
    index: 21
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorrelatedperson', 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient']
    index: 18
    extensions:
      primarySource: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource', min: 1, max: 1, type: Extension, mustSupport: true, index: 20}
    elements:
      extension:
        index: 19
        slicing:
          slices:
            primarySource:
              match: {}
              schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource', index: 20}
              min: 1
              max: 1
    required: [extension]
  extension:
    array: true
    min: 4
    index: 0
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: 4
      slices:
        firstSenderType:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype', index: 6}
          min: 1
          max: 1
        otherCaseIdentifier:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier', index: 5}
          min: 0
        additionalDocuments:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation', index: 3}
          min: 1
          max: 1
        reportAmendment:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment', index: 8}
          min: 0
          max: 1
        mostRecentInfoDate:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate', index: 2}
          min: 0
          max: 1
        combinationProductReport:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport', index: 9}
          min: 1
          max: 1
        firstReceiveDate:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate', index: 1}
          min: 0
          max: 1
        previousCaseIdentifier:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier', index: 7}
          min: 0
        expeditedReport:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport', index: 4}
          min: 1
          max: 1
  status:
    pattern: {type: Code, value: final}
    index: 13
  identifier:
    mustSupport: true
    index: 10
    elements:
      system:
        pattern: {type: Uri, value: 'urn:oid:2.16.840.1.113883.3.989.2.1.3.1'}
        index: 11
      value: {index: 12}
    required: [value, system]
  subject:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient']
    index: 16
package_version: 1.0.1
extensions:
  firstSenderType: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype', min: 1, max: 1, type: Extension, mustSupport: true, index: 6}
  otherCaseIdentifier: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier', min: 0, type: Extension, mustSupport: true, index: 5}
  additionalDocuments: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation', min: 1, max: 1, type: Extension, mustSupport: true, index: 3}
  reportAmendment: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment', min: 0, max: 1, type: Extension, mustSupport: true, index: 8}
  mostRecentInfoDate: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate', min: 0, max: 1, type: Extension, mustSupport: true, index: 2}
  combinationProductReport: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport', min: 1, max: 1, type: Extension, mustSupport: true, index: 9}
  firstReceiveDate: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate', min: 0, max: 1, type: Extension, mustSupport: true, index: 1}
  previousCaseIdentifier: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier', min: 0, type: Extension, mustSupport: true, index: 7}
  expeditedReport: {url: 'http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport', min: 1, max: 1, type: Extension, mustSupport: true, index: 4}
class: profile
kind: resource
url: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 1.0.1
required: [identifier, subject, category]