HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: ICSR Composition

Defining URL:http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition
Version:0.1.0
Name:ICSRComposition
Title:ICSR Composition
Status:Active as of 2021-08-05T14:34:06+00:00
Definition:

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

Publisher:Biomedical Research & Regulation WG
Source Resource:XML / JSON / Turtle

The official URL for this profile is:

http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition

Formal Views of Profile Content

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

This structure is derived from Composition

Summary

Mandatory: 17 elements (2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Composition.section is sliced based on the value of value:code

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
... ibm-fda-icsr-ext-firstreceivedate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate
... ibm-fda-icsr-ext-mostrecentdate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate
... ibm-fda-icsr-ext-expeditedreport 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport
... ibm-fda-icsr-ext-caseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier
... ibm-fda-icsr-ext-firstsendertype 1..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype
... ibm-fda-icsr-ext-previouscaseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier
... ibm-fda-icsr-ext-reportamendment 0..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment
... ibm-fda-icsr-ext-combinationproductreport 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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 | ICSR Patient | RelatedPerson)Who and/or what authored the composition
.... extension 1..*ExtensionExtension
.... ibm-fda-icsr-ext-authorprimarysource 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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 0..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(Observation)A reference to data that supports this section
.... section:RelevantMedicalHistory 0..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 0..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 0..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 0..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 1..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(VAERS Adverse Event | FAERS Adverse Event)A reference to data that supports this section
.... section:RelevantLabTestResults 0..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 1..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:VAERSVaccines 0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: VAERS 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: VAERSVaccines
..... entry 0..*Reference(ICSR Immunization)A reference to data that supports this section
.... section:CaseNarrative 1..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 0..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 0..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 0..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 0..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
NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..*CompositionA set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 4..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-firstreceivedate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate
... ibm-fda-icsr-ext-mostrecentdate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate
... ibm-fda-icsr-ext-additionaldocumentinformation 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation
... ibm-fda-icsr-ext-expeditedreport 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport
... ibm-fda-icsr-ext-caseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier
... ibm-fda-icsr-ext-firstsendertype 1..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype
... ibm-fda-icsr-ext-previouscaseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier
... ibm-fda-icsr-ext-reportamendment 0..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment
... ibm-fda-icsr-ext-combinationproductreport 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ1..1IdentifierVersion-independent identifier for the Composition
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

.... system Σ1..1uriThe namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... status ?!Σ1..1codepreliminary | final | amended | entered-in-error
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ1..1CodeableConceptKind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 85893-6
..... display1..1stringRepresentation defined by the system
Fixed Value: Adverse event note
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... category SΣ1..1CodeableConceptCategorization of Composition
Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level.


... subject SΣ1..1Reference(ICSR Patient)Who and/or what the composition is about
... encounter Σ0..1Reference(Encounter)Context of the Composition
... date SΣ1..1dateTimeComposition editing time
... author SΣ1..1Reference(PractitionerRole | ICSR Patient | RelatedPerson)Who and/or what authored the composition
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-authorprimarysource 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource
.... reference ΣI0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... title Σ1..1stringHuman Readable name/title
Required Pattern: ICSR Submission
... confidentiality Σ0..1codeAs defined by affinity domain
Binding: v3.ConfidentialityClassification (2014-03-26) (required): Codes specifying the level of confidentiality of the composition.

... attester 0..*BackboneElementAttests to accuracy of composition
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... mode 1..1codepersonal | professional | legal | official
Binding: CompositionAttestationMode (required): The way in which a person authenticated a composition.

.... time 0..1dateTimeWhen the composition was attested
.... party 0..1Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)Who attested the composition
... custodian Σ0..1Reference(Organization)Organization which maintains the composition
... relatesTo 0..*BackboneElementRelationships to other compositions/documents
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code 1..1codereplaces | transforms | signs | appends
Binding: DocumentRelationshipType (required): The type of relationship between documents.

.... target[x] 1..1Target of the relationship
..... targetIdentifierIdentifier
..... targetReferenceReference(Composition)
... event Σ0..*BackboneElementThe clinical service(s) being documented
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ0..*CodeableConceptCode(s) that apply to the event being documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.


.... period Σ0..1PeriodThe period covered by the documentation
.... detail Σ0..*Reference(Resource)The event(s) being documented
... Slices for section SI3..13BackboneElementComposition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title S1..1stringLabel for section (e.g. for ToC)
..... code S1..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text SI0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry SI0..*Reference(Resource)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:PatientInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Patient Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: PatientInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantMedicalHistory I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Medical History
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantMedicalHistory
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Condition)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantPastDrugHistory I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Past Drug History
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantPastDrugHistory
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(MedicationStatement)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:InCaseOfDeath I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: In Case of Death
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: InCaseOfDeath
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:ParentInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Parent Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ParentInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Patient | Condition | MedicationStatement)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:ReactionEvent I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Reaction/Event
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ReactionEvent
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(VAERS Adverse Event | FAERS Adverse Event)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantLabTestResults I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Lab Test Results
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantLabTestResults
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:DrugInformation I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Drug Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DrugInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:VAERSVaccines I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: VAERS Vaccines given within 4 weeks
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: VAERSVaccines
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(ICSR Immunization)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseNarrative I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Summary Narrative
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSummaryNarrative
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseReporterComments I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Reporter's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseReporterComments
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseSenderDiagnosis I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Diagnosis
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderDiagnosis
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Condition)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseSenderComments I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderComments
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:DataSourceInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... 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)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DataSourceInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(AECountObservation | ExposureCountObservation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..*CompositionA set of resources composed into a single coherent clinical statement with clinical attestation
... identifier Σ1..1IdentifierVersion-independent identifier for the Composition
... category Σ1..1CodeableConceptCategorization of Composition
Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level.


... subject Σ1..1Reference(ICSR Patient)Who and/or what the composition is about
... author Σ1..1Reference(PractitionerRole | ICSR Patient | RelatedPerson)Who and/or what authored the composition
... Slices for section I3..13BackboneElementComposition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... title 1..1stringLabel for section (e.g. for ToC)
..... code 1..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

..... text I0..1NarrativeText summary of the section, for human interpretation
..... entry I0..*Reference(Resource)A reference to data that supports this section

doco Documentation for this format

This structure is derived from Composition

Summary

Mandatory: 17 elements (2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Composition.section is sliced based on the value of value:code

Differential View

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
... ibm-fda-icsr-ext-firstreceivedate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate
... ibm-fda-icsr-ext-mostrecentdate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate
... ibm-fda-icsr-ext-expeditedreport 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport
... ibm-fda-icsr-ext-caseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier
... ibm-fda-icsr-ext-firstsendertype 1..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype
... ibm-fda-icsr-ext-previouscaseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier
... ibm-fda-icsr-ext-reportamendment 0..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment
... ibm-fda-icsr-ext-combinationproductreport 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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 | ICSR Patient | RelatedPerson)Who and/or what authored the composition
.... extension 1..*ExtensionExtension
.... ibm-fda-icsr-ext-authorprimarysource 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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 0..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(Observation)A reference to data that supports this section
.... section:RelevantMedicalHistory 0..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 0..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 0..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 0..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 1..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(VAERS Adverse Event | FAERS Adverse Event)A reference to data that supports this section
.... section:RelevantLabTestResults 0..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 1..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:VAERSVaccines 0..1BackboneElementComposition is broken into sections
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: VAERS 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: VAERSVaccines
..... entry 0..*Reference(ICSR Immunization)A reference to data that supports this section
.... section:CaseNarrative 1..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 0..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 0..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 0..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 0..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

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..*CompositionA set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 4..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-firstreceivedate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate
... ibm-fda-icsr-ext-mostrecentdate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate
... ibm-fda-icsr-ext-additionaldocumentinformation 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation
... ibm-fda-icsr-ext-expeditedreport 1..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport
... ibm-fda-icsr-ext-caseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier
... ibm-fda-icsr-ext-firstsendertype 1..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype
... ibm-fda-icsr-ext-previouscaseidentifier 0..*IdentifierExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier
... ibm-fda-icsr-ext-reportamendment 0..1(Complex)Extension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment
... ibm-fda-icsr-ext-combinationproductreport 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ1..1IdentifierVersion-independent identifier for the Composition
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

.... system Σ1..1uriThe namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... status ?!Σ1..1codepreliminary | final | amended | entered-in-error
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ1..1CodeableConceptKind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 85893-6
..... display1..1stringRepresentation defined by the system
Fixed Value: Adverse event note
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... category SΣ1..1CodeableConceptCategorization of Composition
Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level.


... subject SΣ1..1Reference(ICSR Patient)Who and/or what the composition is about
... encounter Σ0..1Reference(Encounter)Context of the Composition
... date SΣ1..1dateTimeComposition editing time
... author SΣ1..1Reference(PractitionerRole | ICSR Patient | RelatedPerson)Who and/or what authored the composition
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-authorprimarysource 1..1booleanExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource
.... reference ΣI0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... title Σ1..1stringHuman Readable name/title
Required Pattern: ICSR Submission
... confidentiality Σ0..1codeAs defined by affinity domain
Binding: v3.ConfidentialityClassification (2014-03-26) (required): Codes specifying the level of confidentiality of the composition.

... attester 0..*BackboneElementAttests to accuracy of composition
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... mode 1..1codepersonal | professional | legal | official
Binding: CompositionAttestationMode (required): The way in which a person authenticated a composition.

.... time 0..1dateTimeWhen the composition was attested
.... party 0..1Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)Who attested the composition
... custodian Σ0..1Reference(Organization)Organization which maintains the composition
... relatesTo 0..*BackboneElementRelationships to other compositions/documents
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code 1..1codereplaces | transforms | signs | appends
Binding: DocumentRelationshipType (required): The type of relationship between documents.

.... target[x] 1..1Target of the relationship
..... targetIdentifierIdentifier
..... targetReferenceReference(Composition)
... event Σ0..*BackboneElementThe clinical service(s) being documented
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ0..*CodeableConceptCode(s) that apply to the event being documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.


.... period Σ0..1PeriodThe period covered by the documentation
.... detail Σ0..*Reference(Resource)The event(s) being documented
... Slices for section SI3..13BackboneElementComposition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title S1..1stringLabel for section (e.g. for ToC)
..... code S1..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text SI0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry SI0..*Reference(Resource)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:PatientInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Patient Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: PatientInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantMedicalHistory I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Medical History
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantMedicalHistory
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Condition)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantPastDrugHistory I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Past Drug History
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantPastDrugHistory
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(MedicationStatement)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:InCaseOfDeath I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: In Case of Death
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: InCaseOfDeath
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:ParentInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Parent Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ParentInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Patient | Condition | MedicationStatement)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:ReactionEvent I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Reaction/Event
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: ReactionEvent
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(VAERS Adverse Event | FAERS Adverse Event)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:RelevantLabTestResults I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Relevant Lab Test Results
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: RelevantLabTestResults
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Observation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:DrugInformation I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Drug Information
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DrugInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:VAERSVaccines I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: VAERS Vaccines given within 4 weeks
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: VAERSVaccines
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(ICSR Immunization)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseNarrative I1..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Summary Narrative
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSummaryNarrative
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseReporterComments I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Reporter's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseReporterComments
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseSenderDiagnosis I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Diagnosis
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderDiagnosis
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(Condition)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:CaseSenderComments I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringLabel for section (e.g. for ToC)
Required Pattern: Case Sender's Comments
..... code 0..1CodeableConceptClassification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: CaseSenderComments
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I1..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section
.... section:DataSourceInformation I0..1BackboneElementComposition is broken into sections
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... 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)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: DataSourceInformation
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... author 0..*Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)Who and/or what authored the section
..... focus 0..1Reference(Resource)Who/what the section is about, when it is not about the subject of composition
..... text I0..1NarrativeText summary of the section, for human interpretation
..... mode 0..1codeworking | snapshot | changes
Binding: ListMode (required): The processing mode that applies to this section.

..... orderedBy 0..1CodeableConceptOrder of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry I0..*Reference(AECountObservation | ExposureCountObservation)A reference to data that supports this section
..... emptyReason I0..1CodeableConceptWhy the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section I0..*See section (Composition)Nested Section

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet / Code
Composition.languagepreferredCommonLanguages
Max Binding: AllLanguages
Composition.identifier.userequiredIdentifierUse
Composition.identifier.typeextensibleIdentifier Type Codes
Composition.statusrequiredPattern: final
Composition.typepreferredPattern: LOINC code 85893-6("Adverse event note")
Composition.categoryexampleDocumentClassValueSet
Composition.author.typeextensibleResourceType
Composition.confidentialityrequiredv3.ConfidentialityClassification
Composition.attester.moderequiredCompositionAttestationMode
Composition.relatesTo.coderequiredDocumentRelationshipType
Composition.event.codeexamplev3.ActCode
Composition.section.codeexampleDocumentSectionCodes
Composition.section.moderequiredListMode
Composition.section.orderedBypreferredListOrderCodes
Composition.section.emptyReasonpreferredListEmptyReasons
Composition.section:PatientInformation.codeexamplePattern: PatientInformation
Composition.section:PatientInformation.moderequiredListMode
Composition.section:PatientInformation.orderedBypreferredListOrderCodes
Composition.section:PatientInformation.emptyReasonpreferredListEmptyReasons
Composition.section:RelevantMedicalHistory.codeexamplePattern: RelevantMedicalHistory
Composition.section:RelevantMedicalHistory.moderequiredListMode
Composition.section:RelevantMedicalHistory.orderedBypreferredListOrderCodes
Composition.section:RelevantMedicalHistory.emptyReasonpreferredListEmptyReasons
Composition.section:RelevantPastDrugHistory.codeexamplePattern: RelevantPastDrugHistory
Composition.section:RelevantPastDrugHistory.moderequiredListMode
Composition.section:RelevantPastDrugHistory.orderedBypreferredListOrderCodes
Composition.section:RelevantPastDrugHistory.emptyReasonpreferredListEmptyReasons
Composition.section:InCaseOfDeath.codeexamplePattern: InCaseOfDeath
Composition.section:InCaseOfDeath.moderequiredListMode
Composition.section:InCaseOfDeath.orderedBypreferredListOrderCodes
Composition.section:InCaseOfDeath.emptyReasonpreferredListEmptyReasons
Composition.section:ParentInformation.codeexamplePattern: ParentInformation
Composition.section:ParentInformation.moderequiredListMode
Composition.section:ParentInformation.orderedBypreferredListOrderCodes
Composition.section:ParentInformation.emptyReasonpreferredListEmptyReasons
Composition.section:ReactionEvent.codeexamplePattern: ReactionEvent
Composition.section:ReactionEvent.moderequiredListMode
Composition.section:ReactionEvent.orderedBypreferredListOrderCodes
Composition.section:ReactionEvent.emptyReasonpreferredListEmptyReasons
Composition.section:RelevantLabTestResults.codeexamplePattern: RelevantLabTestResults
Composition.section:RelevantLabTestResults.moderequiredListMode
Composition.section:RelevantLabTestResults.orderedBypreferredListOrderCodes
Composition.section:RelevantLabTestResults.emptyReasonpreferredListEmptyReasons
Composition.section:DrugInformation.codeexamplePattern: DrugInformation
Composition.section:DrugInformation.moderequiredListMode
Composition.section:DrugInformation.orderedBypreferredListOrderCodes
Composition.section:DrugInformation.emptyReasonpreferredListEmptyReasons
Composition.section:VAERSVaccines.codeexamplePattern: VAERSVaccines
Composition.section:VAERSVaccines.moderequiredListMode
Composition.section:VAERSVaccines.orderedBypreferredListOrderCodes
Composition.section:VAERSVaccines.emptyReasonpreferredListEmptyReasons
Composition.section:CaseNarrative.codeexamplePattern: CaseSummaryNarrative
Composition.section:CaseNarrative.moderequiredListMode
Composition.section:CaseNarrative.orderedBypreferredListOrderCodes
Composition.section:CaseNarrative.emptyReasonpreferredListEmptyReasons
Composition.section:CaseReporterComments.codeexamplePattern: CaseReporterComments
Composition.section:CaseReporterComments.moderequiredListMode
Composition.section:CaseReporterComments.orderedBypreferredListOrderCodes
Composition.section:CaseReporterComments.emptyReasonpreferredListEmptyReasons
Composition.section:CaseSenderDiagnosis.codeexamplePattern: CaseSenderDiagnosis
Composition.section:CaseSenderDiagnosis.moderequiredListMode
Composition.section:CaseSenderDiagnosis.orderedBypreferredListOrderCodes
Composition.section:CaseSenderDiagnosis.emptyReasonpreferredListEmptyReasons
Composition.section:CaseSenderComments.codeexamplePattern: CaseSenderComments
Composition.section:CaseSenderComments.moderequiredListMode
Composition.section:CaseSenderComments.orderedBypreferredListOrderCodes
Composition.section:CaseSenderComments.emptyReasonpreferredListEmptyReasons
Composition.section:DataSourceInformation.codeexamplePattern: DataSourceInformation
Composition.section:DataSourceInformation.moderequiredListMode
Composition.section:DataSourceInformation.orderedBypreferredListOrderCodes
Composition.section:DataSourceInformation.emptyReasonpreferredListEmptyReasons