/* MAIN PROFILE */ Profile: ICSRComposition Parent: Composition Id: icsr-composition Title: "ICSR Composition" Description: "The fields needed to represent the document metadata of a ICSR Report." /* FIXED FIELDS */ * status = #final * type = LOINC#85893-6 "Adverse event note" * title = "ICSR Submission" /* CONSTRAINTS ON FIELDS */ * date MS * category 1..1 MS * identifier 1..1 MS * identifier.system 1..1 * identifier.value 1..1 * identifier.system = "urn:oid:2.16.840.1.113883.3.989.2.1.3.1" * subject 1..1 MS * subject only Reference(ICSRPatient) * author 1..1 MS * author only Reference(AuthorPractitionerRole or ICSRPatient or AuthorRelatedPerson) * author.extension contains AuthorPrimarySource named primarySource 1..1 MS /* EXTENSIONS - SEE BELOW FOR DEFINITIONS */ * extension contains FirstReceiveDate named firstReceiveDate 0..1 MS * extension contains MostRecentDate named mostRecentInfoDate 0..1 MS * extension contains AdditionalDocumentInformation named additionalDocuments 1..1 MS * extension contains ExpeditedReport named expeditedReport 1..1 MS * extension contains CaseIdentifier named otherCaseIdentifier 0..* MS * extension contains FirstSenderType named firstSenderType 1..1 MS * extension contains PreviousCaseIdentifier named previousCaseIdentifier 0..* MS * extension contains ReportAmendment named reportAmendment 0..1 MS * extension contains CombinationProductReport named combinationProductReport 1..1 MS /* SECTION SLICES */ * section 3..13 MS * section.code 1..1 MS * section.title 1..1 MS * section.text MS * section.entry MS * section ^slicing.discriminator.type = #value * section ^slicing.discriminator.path = "code" * section ^slicing.rules = #open * section ^slicing.description = "Slice based on the different sections that are needed in an ICSR document." * section contains PatientInformation 0..1 MS and RelevantMedicalHistory 0..1 MS and RelevantPastDrugHistory 0..1 MS and InCaseOfDeath 0..1 MS and ParentInformation 0..1 MS and ReactionEvent 1..1 MS and RelevantLabTestResults 0..1 MS and DrugInformation 1..1 MS and Vaccines 0..1 MS and CaseNarrative 1..1 MS and CaseReporterComments 0..1 MS and CaseSenderDiagnosis 0..1 MS and CaseSenderComments 0..1 MS and DataSourceInformation 0..1 MS * section[PatientInformation] ^.definition = "Observations that give further information about the patient, eg. height, weight, age group, last menstrual period." * section[PatientInformation].code = ICSRSectionCodeCS#PatientInformation * section[PatientInformation].title = "Patient Information" * section[PatientInformation].entry only Reference(PatientHeight or PatientWeight or PatientAgeGroup or PatientLastMenstrualPeriod) * section[RelevantMedicalHistory] ^.definition = "Current or historical Conditions that are relevant to the adverse event." * section[RelevantMedicalHistory].code = ICSRSectionCodeCS#RelevantMedicalHistory * section[RelevantMedicalHistory].title = "Relevant Medical History" * section[RelevantMedicalHistory].entry only Reference(Condition) * section[RelevantPastDrugHistory] ^.definition = "Current or historical Medication Statements that are relevant to the adverse event." * section[RelevantPastDrugHistory].code = ICSRSectionCodeCS#RelevantPastDrugHistory * section[RelevantPastDrugHistory].title = "Relevant Past Drug History" * section[RelevantPastDrugHistory].entry only Reference(MedicationStatement) * section[InCaseOfDeath] ^.definition = "Observations that give further information about the death of the adverse event subject." * section[InCaseOfDeath].code = ICSRSectionCodeCS#InCaseOfDeath * section[InCaseOfDeath].title = "In Case of Death" * section[InCaseOfDeath].entry only Reference(Observation) * section[PatientInformation] ^.definition = "Information about the adverse event subject's parent (demographics, relevant conditions, drug history)." * section[ParentInformation].code = ICSRSectionCodeCS#ParentInformation * section[ParentInformation].title = "Parent Information" * section[ParentInformation].entry only Reference(Patient or Condition or MedicationStatement) * section[ReactionEvent] ^.definition = "The actual Adverse Event details." * section[ReactionEvent].code = ICSRSectionCodeCS#ReactionEvent * section[ReactionEvent].title = "Reaction/Event" * section[ReactionEvent].entry only Reference(VaccinationAdverseEvent or TransfusionAdverseEvent) * section[RelevantLabTestResults] ^.definition = "Lab Test results that are relevant to the adverse event." * section[RelevantLabTestResults].code = ICSRSectionCodeCS#RelevantLabTestResults * section[RelevantLabTestResults].title = "Relevant Lab Test Results" * section[RelevantLabTestResults].entry only Reference(Observation) * section[DrugInformation] ^.definition = "The actual event that is presumed to have caused the adverse event (eg. drug administration, immunization, transfusion, etc.)." * section[DrugInformation].code = ICSRSectionCodeCS#DrugInformation * section[DrugInformation].title = "Drug Information" * section[DrugInformation].entry only Reference(ICSRMedicationAdministration or ICSRImmunization or DeviceUseStatement or ICSRTransfusion) * section[Vaccines] ^.definition = "Any vaccines that were given with the past 4 weeks (required for vaccination case reports)." * section[Vaccines].code = ICSRSectionCodeCS#Vaccines * section[Vaccines].title = "Vaccines given within 4 weeks" * section[Vaccines].entry only Reference(ICSRImmunization) * section[CaseNarrative] ^.definition = "The full narrative about the adverse event." * section[CaseNarrative].code = ICSRSectionCodeCS#CaseSummaryNarrative * section[CaseNarrative].title = "Case Summary Narrative" * section[CaseNarrative].entry 0..0 * section[CaseNarrative].text 1..1 * section[CaseReporterComments] ^.definition = "Additional comments provided by the case reporter." * section[CaseReporterComments].code = ICSRSectionCodeCS#CaseReporterComments * section[CaseReporterComments].title = "Case Reporter's Comments" * section[CaseReporterComments].entry 0..0 * section[CaseReporterComments].text 1..1 * section[CaseSenderComments] ^.definition = "Additional comments provided by the case sender." * section[CaseSenderComments].code = ICSRSectionCodeCS#CaseSenderComments * section[CaseSenderComments].title = "Case Sender's Comments" * section[CaseSenderComments].entry 0..0 * section[CaseSenderComments].text 1..1 * section[CaseSenderDiagnosis] ^.definition = "Any diagnoses that are provided by the Case Sender that are deemed relevant to the adverse event." * section[CaseSenderDiagnosis].code = ICSRSectionCodeCS#CaseSenderDiagnosis * section[CaseSenderDiagnosis].title = "Case Sender's Diagnosis" * section[CaseSenderDiagnosis].entry only Reference(Condition) * section[DataSourceInformation] ^.definition = "IG-specific information about the algorithm that determined the Adverse Event information." * section[DataSourceInformation].code = ICSRSectionCodeCS#DataSourceInformation * section[DataSourceInformation].title = "Information about the Data Source of the AE information" * section[DataSourceInformation].entry only Reference(AECountObservation or ExposureCountObservation) /* SAMPLES */ // Sample Vaccination Report Instance: SampleVaccinationReport InstanceOf: ICSRComposition Title: "Sample ICSR Vaccination Report" Description: "A sample Composition that represents Vaccination ICSR header information." * date = 2020-02-10T17:18:00-05:00 * author = Reference(SampleAuthorRole) * author.extension[primarySource].valueBoolean = true * category = ReportType#1 "Spontaneous report" * identifier.value = "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a" * subject = Reference(SampleICSRPatient) * extension[firstReceiveDate].valueDateTime = 2020-02-10T17:18:00-05:00 * extension[mostRecentInfoDate].valueDateTime = 2020-02-10T17:18:00-05:00 * extension[additionalDocuments].extension[availableFlag].valueBoolean = false * extension[expeditedReport].extension[localCriteriaFlag].valueBoolean = false * extension[expeditedReport].extension[localCriteriaReportType].valueCodeableConcept = LocalCriteriaReportType#C53578 "Non-Expedited AE" * extension[otherCaseIdentifier].valueIdentifier.system = "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" * extension[otherCaseIdentifier].valueIdentifier.value = "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee" * extension[firstSenderType].valueCodeableConcept = SenderType#2 "Other" * extension[previousCaseIdentifier].valueIdentifier.value = "Other-case-identifier" * extension[previousCaseIdentifier].valueIdentifier.assigner.display = "Case identifier source name" * extension[reportAmendment].extension[amendmentType].valueCodeableConcept = urn:oid:2.16.840.1.113883.3.989.2.1.1.5#2 * extension[reportAmendment].extension[amendmentReason].valueString = "Fixed some identifiers" * extension[combinationProductReport].valueBoolean = false * section[ReactionEvent].text.status = #generated * section[ReactionEvent].text.div = "
No events
" * section[DrugInformation].text.status = #generated * section[DrugInformation].text.div = "
No drugs taken
" * section[CaseNarrative].text.status = #generated * section[CaseNarrative].text.div = "
No adverse event happened. Not sure why I'm sending this report.
il n'y a eu aucun événement indésirable
" // Sample Transfusion Report Instance: SampleTransfusionReport InstanceOf: ICSRComposition Title: "Sample ICSR Transfusion Report" Description: "A sample Composition that represents Transfusion ICSR header information." * date = 2020-02-10T17:18:00-05:00 * author = Reference(SampleAuthorRole) * author.extension[primarySource].valueBoolean = true * category = ReportType#1 "Spontaneous report" * identifier.value = "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a" * subject = Reference(SampleICSRPatient) * extension[firstReceiveDate].valueDateTime = 2020-02-10T17:18:00-05:00 * extension[mostRecentInfoDate].valueDateTime = 2020-02-10T17:18:00-05:00 * extension[additionalDocuments].extension[availableFlag].valueBoolean = false * extension[expeditedReport].extension[localCriteriaFlag].valueBoolean = false * extension[expeditedReport].extension[localCriteriaReportType].valueCodeableConcept = LocalCriteriaReportType#C53578 "Non-Expedited AE" * extension[otherCaseIdentifier].valueIdentifier.system = "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" * extension[otherCaseIdentifier].valueIdentifier.value = "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee" * extension[firstSenderType].valueCodeableConcept = SenderType#2 "Other" * extension[previousCaseIdentifier].valueIdentifier.value = "Other-case-identifier" * extension[previousCaseIdentifier].valueIdentifier.assigner.display = "Case identifier source name" * extension[reportAmendment].extension[amendmentType].valueCodeableConcept = urn:oid:2.16.840.1.113883.3.989.2.1.1.5#2 * extension[reportAmendment].extension[amendmentReason].valueString = "Fixed some identifiers" * extension[combinationProductReport].valueBoolean = false * section[ReactionEvent].text.status = #generated * section[ReactionEvent].text.div = "
No events
" * section[DrugInformation].text.status = #generated * section[DrugInformation].text.div = "
No drugs taken
" * section[CaseNarrative].text.status = #generated * section[CaseNarrative].text.div = "
No adverse event happened. Not sure why I'm sending this report.
il n'y a eu aucun événement indésirable
" * section[DataSourceInformation].entry[0] = Reference(SampleAECountObservation) * section[DataSourceInformation].entry[1] = Reference(SampleExposureCountObservation) Instance: SampleAECountObservation InstanceOf: AECountObservation Title: "Sample Adverse Event Count Observation" Description: "An example of an Adverse Event Count Observation" * valueInteger = 20 Instance: SampleExposureCountObservation InstanceOf: ExposureCountObservation Title: "Sample Exposure Count Observation" Description: "An example of an Exposure Count Observation" * valueInteger = 25432 Instance: SamplePatientHeight InstanceOf: PatientHeight Title: "Sample Patient Height Observation" Description: "An example of a Patient's Height in cm" * status = #final * effectiveDateTime = "2020-02-10" * valueQuantity = 150 'cm' "cm" * subject = Reference(SampleICSRPatient) Instance: SamplePatientWeight InstanceOf: PatientWeight Title: "Sample Patient Weight Observation" Description: "An example of a Patient's Weight in kg" * status = #final * effectiveDateTime = "2020-02-10" * valueQuantity = 120 'kg' "kg" * subject = Reference(SampleICSRPatient) Instance: SamplePatientLastMenstrualPeriod InstanceOf: PatientLastMenstrualPeriod Title: "Sample Patient Menstrual Period Date Observation" Description: "An example of a Patient's Last Menstrual Period Date" * status = #final * effectiveDateTime = "2020-02-10" * valueDateTime = "2020-01-25" * subject = Reference(SampleICSRPatient) /* EXTENSION DEFINITIONS */ Extension: AuthorPrimarySource Id: icsr-ext-authorprimarysource Description: "Whether an author is the primary source of a composition" * ^context.type = #element * ^context.expression = "Composition.author" * value[x] 1..1 MS * value[x] only boolean Extension: FirstReceiveDate Id: icsr-ext-firstreceivedate Description: "The date when the report was first received from the source" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only dateTime Extension: MostRecentDate Id: icsr-ext-mostrecentdate Description: "The date of the most recent information for this report" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only dateTime Extension: CaseIdentifier Id: icsr-ext-caseidentifier Description: "Other identifiers used to identify the ICSR report" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only Identifier Extension: CombinationProductReport Id: icsr-ext-combinationproductreport Description: "A flag to indicate whether the ICSR report is for a combination product" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only boolean Extension: AdditionalDocumentInformation Id: icsr-ext-additionaldocumentinformation Description: "A set of information to indicate what additional documentation exists." * ^context.type = #element * ^context.expression = "Composition" * extension contains availableFlag 1..1 MS and document 0..* MS * extension[availableFlag].value[x] 1..1 MS * extension[availableFlag].value[x] only boolean * extension[document].value[x] 1..1 MS * extension[document].value[x] only Attachment * extension[document].valueAttachment.contentType MS * extension[document].valueAttachment.url 1..1 MS * extension[document].valueAttachment.title 1..1 MS Extension: ExpeditedReport Id: icsr-ext-expeditedreport Description: "Information on whether the ICSR report meets criteria of an expedited report" * ^context.type = #element * ^context.expression = "Composition" * extension contains localCriteriaFlag 1..1 MS and localCriteriaReportType 1..1 MS * extension[localCriteriaFlag].value[x] 1..1 MS * extension[localCriteriaFlag].value[x] only boolean * extension[localCriteriaReportType].value[x] 1..1 MS * extension[localCriteriaReportType].value[x] only CodeableConcept Extension: FirstSenderType Id: icsr-ext-firstsendertype Description: "Identifies the type of the first sender of the ICSR report" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only CodeableConcept Extension: PreviousCaseIdentifier Id: icsr-ext-previouscaseidentifier Description: "Previous identifiers used to reference this case" * ^context.type = #element * ^context.expression = "Composition" * value[x] 1..1 MS * value[x] only Identifier * valueIdentifier.system 1..1 * valueIdentifier.system = "urn:oid:2.16.840.1.113883.3.989.2.1.3.3" * valueIdentifier.value 1..1 MS * valueIdentifier.assigner 1..1 MS Extension: ReportAmendment Id: icsr-ext-reportamendment Description: "Information about report amendments that have been made" * ^context.type = #element * ^context.expression = "Composition" * extension contains amendmentType 1..1 MS and amendmentReason 1..1 MS * extension[amendmentType].value[x] 1..1 MS * extension[amendmentType].value[x] only CodeableConcept * extension[amendmentReason].value[x] 1..1 MS * extension[amendmentReason].value[x] only string /* COMPOSITION-SPECIFIC OBSERVATIONS */ Profile: AECountObservation Parent: Observation Id: icsr-aecountobservation Description: "Recording the number of Adverse Events that were detected by the algorithm" * status 1..1 MS * status = #final * code 1..1 MS * code = DataSourceObservationCodeCS#AdverseEventCount * value[x] 1..1 MS * value[x] only integer Profile: ExposureCountObservation Parent: Observation Id: icsr-exposurecountobservation Description: "Recording the number of Exposures that were detected by the algorithm" * status 1..1 MS * status = #final * code 1..1 MS * code = DataSourceObservationCodeCS#ExposureCount * value[x] 1..1 MS * value[x] only integer /* TERMINOLOGY ARTIFACTS */ CodeSystem: ICSRSectionCodeCS Title: "ICSR Section Codes Code System" Description: "Codes for each of the sections in an ICSR report" * ^caseSensitive = true * ^experimental = false * #PatientInformation * #RelevantMedicalHistory * #RelevantPastDrugHistory * #InCaseOfDeath * #ParentInformation * #ReactionEvent * #RelevantLabTestResults * #DrugInformation * #Vaccines * #CaseSummaryNarrative * #CaseReporterComments * #CaseSenderDiagnosis * #CaseSenderComments * #DataSourceInformation ValueSet: ICSRSectionCodeVS Title: "ICSR Section Codes Value Set" Description: "Codes for each of the sections in an ICSR report" * ^experimental = false * codes from system ICSRSectionCodeCS CodeSystem: DataSourceObservationCodeCS Title: "ICSR Data Source Observation Codes Code System" Description: "Codes to describe information about the ICSR data source" * ^caseSensitive = true * ^experimental = false * #AdverseEventCount "Adverse Event Count (Algorithm Numerator)" * #ExposureCount "Exposure Count (Algorithm Denominator)"