HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction United States of America flag

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

Resource Profile: ICSR Composition

Official URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition Version: 1.0.1
Draft as of 2023-08-30 Computable Name: ICSRComposition

The fields needed to represent the document metadata of a ICSR Report.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..*CompositionA set of resources composed into a single coherent clinical statement with clinical attestation
... Slices for extension 4..*ExtensionExtension
Slice: Unordered, Open by value:url
... firstReceiveDate S0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate
... mostRecentInfoDate S0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate
... expeditedReport S1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport
... otherCaseIdentifier S0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier
... firstSenderType S1..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype
... previousCaseIdentifier S0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier
... reportAmendment S0..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment
... combinationProductReport S1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport
... identifier S1..1IdentifierVersion-independent identifier for the Composition
.... system 1..1uriThe namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1
.... value 1..1stringThe value that is unique
... status 1..1codepreliminary | final | amended | entered-in-error
Required Pattern: final
... type 1..1CodeableConceptKind of composition (LOINC if possible)
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 85893-6
..... display1..1stringRepresentation defined by the system
Fixed Value: Adverse event note
... category S1..1CodeableConceptCategorization of Composition
... subject S1..1Reference(ICSR Patient)Who and/or what the composition is about
... date S1..1dateTimeComposition editing time
... author S1..1Reference(PractitionerRole Author | ICSR Patient | RelatedPerson Author)Who and/or what authored the composition
.... extension 1..*ExtensionExtension
.... primarySource S1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource
... title 1..1stringHuman Readable name/title
Required Pattern: ICSR Submission
... Slices for section S3..13BackboneElementComposition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... title S1..1stringLabel for section (e.g. for ToC)
..... code S1..1CodeableConceptClassification of section (recommended)
..... text S0..1NarrativeText summary of the section, for human interpretation
..... entry S0..*Reference(Resource)A reference to data that supports this section
.... section:PatientInformation S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Patient Information
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: PatientInformation
..... entry 0..*Reference(Patient Body Height in cm | Patient Body Weight in kg | Descriptive Age Group for the Patient | Patient's Date of Last Menstrual Period)A reference to data that supports this section
.... section:RelevantMedicalHistory S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Medical History
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantMedicalHistory
..... entry 0..*Reference(Condition)A reference to data that supports this section
.... section:RelevantPastDrugHistory S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Past Drug History
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantPastDrugHistory
..... entry 0..*Reference(MedicationStatement)A reference to data that supports this section
.... section:InCaseOfDeath S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: In Case of Death
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: InCaseOfDeath
..... entry 0..*Reference(Observation)A reference to data that supports this section
.... section:ParentInformation S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Parent Information
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ParentInformation
..... entry 0..*Reference(Patient | Condition | MedicationStatement)A reference to data that supports this section
.... section:ReactionEvent S1..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Reaction/Event
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ReactionEvent
..... entry 0..*Reference(Vaccination Adverse Event | Transfusion Adverse Event)A reference to data that supports this section
.... section:RelevantLabTestResults S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Lab Test Results
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantLabTestResults
..... entry 0..*Reference(Observation)A reference to data that supports this section
.... section:DrugInformation S1..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Drug Information
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DrugInformation
..... entry 0..*Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion)A reference to data that supports this section
.... section:Vaccines S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Vaccines given within 4 weeks
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: Vaccines
..... entry 0..*Reference(ICSR Immunization)A reference to data that supports this section
.... section:CaseNarrative S1..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Summary Narrative
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSummaryNarrative
..... text 1..1NarrativeText summary of the section, for human interpretation
..... entry 0..0
.... section:CaseReporterComments S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Reporter's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseReporterComments
..... text 1..1NarrativeText summary of the section, for human interpretation
..... entry 0..0
.... section:CaseSenderDiagnosis S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Diagnosis
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderDiagnosis
..... entry 0..*Reference(Condition)A reference to data that supports this section
.... section:CaseSenderComments S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderComments
..... text 1..1NarrativeText summary of the section, for human interpretation
..... entry 0..0
.... section:DataSourceInformation S0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Information about the Data Source of the AE information
..... code 0..1CodeableConceptClassification of section (recommended)
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DataSourceInformation
..... entry 0..*Reference(AECountObservation | ExposureCountObservation)A reference to data that supports this section

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron