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
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
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:
This structure is derived from Composition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
Slices for extension | 4..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-firstreceivedate | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate | |
ibm-fda-icsr-ext-mostrecentdate | 0..1 | dateTime | Extension 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..* | Identifier | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier | |
ibm-fda-icsr-ext-firstsendertype | 1..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype | |
ibm-fda-icsr-ext-previouscaseidentifier | 0..* | Identifier | Extension 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..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport | |
identifier | S | 1..1 | Identifier | Version-independent identifier for the Composition |
system | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1 | |
value | 1..1 | string | The value that is unique | |
status | 1..1 | code | preliminary | final | amended | entered-in-error Required Pattern: final | |
type | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 85893-6 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Adverse event note | |
category | S | 1..1 | CodeableConcept | Categorization of Composition |
subject | S | 1..1 | Reference(ICSR Patient) | Who and/or what the composition is about |
date | S | 1..1 | dateTime | Composition editing time |
author | S | 1..1 | Reference(PractitionerRole | ICSR Patient | RelatedPerson) | Who and/or what authored the composition |
extension | 1..* | Extension | Extension | |
ibm-fda-icsr-ext-authorprimarysource | 1..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource | |
title | 1..1 | string | Human Readable name/title Required Pattern: ICSR Submission | |
Slices for section | S | 3..13 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code |
section:All Slices | Content/Rules for all slices | |||
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..1 | CodeableConcept | Classification of section (recommended) |
text | S | 0..1 | Narrative | Text summary of the section, for human interpretation |
entry | S | 0..* | Reference(Resource) | A reference to data that supports this section |
section:PatientInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Patient Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PatientInformation | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:RelevantMedicalHistory | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Medical History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantMedicalHistory | |
entry | 0..* | Reference(Condition) | A reference to data that supports this section | |
section:RelevantPastDrugHistory | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Past Drug History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantPastDrugHistory | |
entry | 0..* | Reference(MedicationStatement) | A reference to data that supports this section | |
section:InCaseOfDeath | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: In Case of Death | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: InCaseOfDeath | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:ParentInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Parent Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ParentInformation | |
entry | 0..* | Reference(Patient | Condition | MedicationStatement) | A reference to data that supports this section | |
section:ReactionEvent | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Reaction/Event | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ReactionEvent | |
entry | 0..* | Reference(VAERS Adverse Event | FAERS Adverse Event) | A reference to data that supports this section | |
section:RelevantLabTestResults | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Lab Test Results | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantLabTestResults | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:DrugInformation | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Drug Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DrugInformation | |
entry | 0..* | Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion) | A reference to data that supports this section | |
section:VAERSVaccines | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: VAERS Vaccines given within 4 weeks | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: VAERSVaccines | |
entry | 0..* | Reference(ICSR Immunization) | A reference to data that supports this section | |
section:CaseNarrative | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Summary Narrative | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSummaryNarrative | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:CaseReporterComments | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Reporter's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseReporterComments | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:CaseSenderDiagnosis | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Diagnosis | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderDiagnosis | |
entry | 0..* | Reference(Condition) | A reference to data that supports this section | |
section:CaseSenderComments | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderComments | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:DataSourceInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Information about the Data Source of the AE information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DataSourceInformation | |
entry | 0..* | Reference(AECountObservation | ExposureCountObservation) | A reference to data that supports this section | |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
id | Σ | 0..1 | string | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 4..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-firstreceivedate | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate | |
ibm-fda-icsr-ext-mostrecentdate | 0..1 | dateTime | Extension 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..* | Identifier | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier | |
ibm-fda-icsr-ext-firstsendertype | 1..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype | |
ibm-fda-icsr-ext-previouscaseidentifier | 0..* | Identifier | Extension 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..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 1..1 | Identifier | Version-independent identifier for the Composition |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
type | Σ | 0..1 | CodeableConcept | Description 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 | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1 |
value | Σ | 1..1 | string | The value that is unique Example General: 123456 |
period | Σ | 0..1 | Period | Time period when id is/was valid for use |
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
status | ?!Σ | 1..1 | code | preliminary | final | amended | entered-in-error Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final |
type | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 85893-6 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Adverse event note | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
category | SΣ | 1..1 | CodeableConcept | Categorization of Composition Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level. |
subject | SΣ | 1..1 | Reference(ICSR Patient) | Who and/or what the composition is about |
encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition |
date | SΣ | 1..1 | dateTime | Composition editing time |
author | SΣ | 1..1 | Reference(PractitionerRole | ICSR Patient | RelatedPerson) | Who and/or what authored the composition |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-authorprimarysource | 1..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource | |
reference | ΣI | 0..1 | string | Literal reference, Relative, internal or absolute URL |
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
display | Σ | 0..1 | string | Text alternative for the resource |
title | Σ | 1..1 | string | Human Readable name/title Required Pattern: ICSR Submission |
confidentiality | Σ | 0..1 | code | As defined by affinity domain Binding: v3.ConfidentialityClassification (2014-03-26) (required): Codes specifying the level of confidentiality of the composition. |
attester | 0..* | BackboneElement | Attests to accuracy of composition | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
mode | 1..1 | code | personal | professional | legal | official Binding: CompositionAttestationMode (required): The way in which a person authenticated a composition. | |
time | 0..1 | dateTime | When the composition was attested | |
party | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | |
custodian | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition |
relatesTo | 0..* | BackboneElement | Relationships to other compositions/documents | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | 1..1 | code | replaces | transforms | signs | appends Binding: DocumentRelationshipType (required): The type of relationship between documents. | |
target[x] | 1..1 | Target of the relationship | ||
targetIdentifier | Identifier | |||
targetReference | Reference(Composition) | |||
event | Σ | 0..* | BackboneElement | The clinical service(s) being documented |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | Σ | 0..* | CodeableConcept | Code(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 | Σ | 0..1 | Period | The period covered by the documentation |
detail | Σ | 0..* | Reference(Resource) | The event(s) being documented |
Slices for section | SI | 3..13 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code |
section:All Slices | Content/Rules for all slices | |||
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..1 | CodeableConcept | Classification 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..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | SI | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | SI | 0..* | Reference(Resource) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:PatientInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Patient Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PatientInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantMedicalHistory | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Medical History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantMedicalHistory | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Condition) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantPastDrugHistory | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Past Drug History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantPastDrugHistory | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(MedicationStatement) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:InCaseOfDeath | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: In Case of Death | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: InCaseOfDeath | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:ParentInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Parent Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ParentInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Patient | Condition | MedicationStatement) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:ReactionEvent | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Reaction/Event | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ReactionEvent | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(VAERS Adverse Event | FAERS Adverse Event) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantLabTestResults | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Lab Test Results | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantLabTestResults | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:DrugInformation | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Drug Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DrugInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:VAERSVaccines | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: VAERS Vaccines given within 4 weeks | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: VAERSVaccines | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(ICSR Immunization) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseNarrative | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Summary Narrative | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSummaryNarrative | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseReporterComments | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Reporter's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseReporterComments | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseSenderDiagnosis | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Diagnosis | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderDiagnosis | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Condition) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseSenderComments | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderComments | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:DataSourceInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Information about the Data Source of the AE information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DataSourceInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(AECountObservation | ExposureCountObservation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
identifier | Σ | 1..1 | Identifier | Version-independent identifier for the Composition |
category | Σ | 1..1 | CodeableConcept | Categorization of Composition Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level. |
subject | Σ | 1..1 | Reference(ICSR Patient) | Who and/or what the composition is about |
date | Σ | 1..1 | dateTime | Composition editing time |
author | Σ | 1..1 | Reference(PractitionerRole | ICSR Patient | RelatedPerson) | Who and/or what authored the composition |
Slices for section | I | 3..13 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code |
section:All Slices | Content/Rules for all slices | |||
title | 1..1 | string | Label for section (e.g. for ToC) | |
code | 1..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
entry | I | 0..* | Reference(Resource) | A reference to data that supports this section |
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:
Differential View
This structure is derived from Composition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
Slices for extension | 4..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-firstreceivedate | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate | |
ibm-fda-icsr-ext-mostrecentdate | 0..1 | dateTime | Extension 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..* | Identifier | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier | |
ibm-fda-icsr-ext-firstsendertype | 1..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype | |
ibm-fda-icsr-ext-previouscaseidentifier | 0..* | Identifier | Extension 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..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport | |
identifier | S | 1..1 | Identifier | Version-independent identifier for the Composition |
system | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1 | |
value | 1..1 | string | The value that is unique | |
status | 1..1 | code | preliminary | final | amended | entered-in-error Required Pattern: final | |
type | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 85893-6 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Adverse event note | |
category | S | 1..1 | CodeableConcept | Categorization of Composition |
subject | S | 1..1 | Reference(ICSR Patient) | Who and/or what the composition is about |
date | S | 1..1 | dateTime | Composition editing time |
author | S | 1..1 | Reference(PractitionerRole | ICSR Patient | RelatedPerson) | Who and/or what authored the composition |
extension | 1..* | Extension | Extension | |
ibm-fda-icsr-ext-authorprimarysource | 1..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource | |
title | 1..1 | string | Human Readable name/title Required Pattern: ICSR Submission | |
Slices for section | S | 3..13 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code |
section:All Slices | Content/Rules for all slices | |||
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..1 | CodeableConcept | Classification of section (recommended) |
text | S | 0..1 | Narrative | Text summary of the section, for human interpretation |
entry | S | 0..* | Reference(Resource) | A reference to data that supports this section |
section:PatientInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Patient Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PatientInformation | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:RelevantMedicalHistory | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Medical History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantMedicalHistory | |
entry | 0..* | Reference(Condition) | A reference to data that supports this section | |
section:RelevantPastDrugHistory | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Past Drug History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantPastDrugHistory | |
entry | 0..* | Reference(MedicationStatement) | A reference to data that supports this section | |
section:InCaseOfDeath | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: In Case of Death | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: InCaseOfDeath | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:ParentInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Parent Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ParentInformation | |
entry | 0..* | Reference(Patient | Condition | MedicationStatement) | A reference to data that supports this section | |
section:ReactionEvent | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Reaction/Event | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ReactionEvent | |
entry | 0..* | Reference(VAERS Adverse Event | FAERS Adverse Event) | A reference to data that supports this section | |
section:RelevantLabTestResults | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Lab Test Results | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantLabTestResults | |
entry | 0..* | Reference(Observation) | A reference to data that supports this section | |
section:DrugInformation | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Drug Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DrugInformation | |
entry | 0..* | Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion) | A reference to data that supports this section | |
section:VAERSVaccines | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: VAERS Vaccines given within 4 weeks | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: VAERSVaccines | |
entry | 0..* | Reference(ICSR Immunization) | A reference to data that supports this section | |
section:CaseNarrative | 1..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Summary Narrative | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSummaryNarrative | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:CaseReporterComments | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Reporter's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseReporterComments | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:CaseSenderDiagnosis | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Diagnosis | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderDiagnosis | |
entry | 0..* | Reference(Condition) | A reference to data that supports this section | |
section:CaseSenderComments | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderComments | |
text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
entry | 0..0 | |||
section:DataSourceInformation | 0..1 | BackboneElement | Composition is broken into sections | |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Information about the Data Source of the AE information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DataSourceInformation | |
entry | 0..* | Reference(AECountObservation | ExposureCountObservation) | A reference to data that supports this section | |
Documentation for this format |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
id | Σ | 0..1 | string | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 4..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-firstreceivedate | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate | |
ibm-fda-icsr-ext-mostrecentdate | 0..1 | dateTime | Extension 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..* | Identifier | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier | |
ibm-fda-icsr-ext-firstsendertype | 1..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype | |
ibm-fda-icsr-ext-previouscaseidentifier | 0..* | Identifier | Extension 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..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 1..1 | Identifier | Version-independent identifier for the Composition |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
type | Σ | 0..1 | CodeableConcept | Description 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 | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.3.989.2.1.3.1 |
value | Σ | 1..1 | string | The value that is unique Example General: 123456 |
period | Σ | 0..1 | Period | Time period when id is/was valid for use |
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
status | ?!Σ | 1..1 | code | preliminary | final | amended | entered-in-error Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final |
type | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. Required Pattern: At least the following |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 85893-6 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Adverse event note | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
category | SΣ | 1..1 | CodeableConcept | Categorization of Composition Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level. |
subject | SΣ | 1..1 | Reference(ICSR Patient) | Who and/or what the composition is about |
encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition |
date | SΣ | 1..1 | dateTime | Composition editing time |
author | SΣ | 1..1 | Reference(PractitionerRole | ICSR Patient | RelatedPerson) | Who and/or what authored the composition |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
ibm-fda-icsr-ext-authorprimarysource | 1..1 | boolean | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource | |
reference | ΣI | 0..1 | string | Literal reference, Relative, internal or absolute URL |
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
display | Σ | 0..1 | string | Text alternative for the resource |
title | Σ | 1..1 | string | Human Readable name/title Required Pattern: ICSR Submission |
confidentiality | Σ | 0..1 | code | As defined by affinity domain Binding: v3.ConfidentialityClassification (2014-03-26) (required): Codes specifying the level of confidentiality of the composition. |
attester | 0..* | BackboneElement | Attests to accuracy of composition | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
mode | 1..1 | code | personal | professional | legal | official Binding: CompositionAttestationMode (required): The way in which a person authenticated a composition. | |
time | 0..1 | dateTime | When the composition was attested | |
party | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | |
custodian | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition |
relatesTo | 0..* | BackboneElement | Relationships to other compositions/documents | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | 1..1 | code | replaces | transforms | signs | appends Binding: DocumentRelationshipType (required): The type of relationship between documents. | |
target[x] | 1..1 | Target of the relationship | ||
targetIdentifier | Identifier | |||
targetReference | Reference(Composition) | |||
event | Σ | 0..* | BackboneElement | The clinical service(s) being documented |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | Σ | 0..* | CodeableConcept | Code(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 | Σ | 0..1 | Period | The period covered by the documentation |
detail | Σ | 0..* | Reference(Resource) | The event(s) being documented |
Slices for section | SI | 3..13 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code |
section:All Slices | Content/Rules for all slices | |||
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..1 | CodeableConcept | Classification 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..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | SI | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | SI | 0..* | Reference(Resource) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:PatientInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Patient Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PatientInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantMedicalHistory | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Medical History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantMedicalHistory | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Condition) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantPastDrugHistory | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Past Drug History | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantPastDrugHistory | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(MedicationStatement) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:InCaseOfDeath | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: In Case of Death | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: InCaseOfDeath | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:ParentInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Parent Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ParentInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Patient | Condition | MedicationStatement) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:ReactionEvent | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Reaction/Event | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ReactionEvent | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(VAERS Adverse Event | FAERS Adverse Event) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:RelevantLabTestResults | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Relevant Lab Test Results | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: RelevantLabTestResults | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Observation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:DrugInformation | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Drug Information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DrugInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(ICSR MedicationAdministration | ICSR Immunization | DeviceUseStatement | ICSR Transfusion) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:VAERSVaccines | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: VAERS Vaccines given within 4 weeks | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: VAERSVaccines | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(ICSR Immunization) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseNarrative | I | 1..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Summary Narrative | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSummaryNarrative | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseReporterComments | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Reporter's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseReporterComments | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseSenderDiagnosis | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Diagnosis | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderDiagnosis | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(Condition) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:CaseSenderComments | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Case Sender's Comments | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CaseSenderComments | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 1..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
section:DataSourceInformation | I | 0..1 | BackboneElement | Composition is broken into sections |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Information about the Data Source of the AE information | |
code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. Required Pattern: At least the following | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS | |
version | 0..1 | string | Version of the system - if relevant | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DataSourceInformation | |
display | 0..1 | string | Representation defined by the system | |
userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |
text | 0..1 | string | Plain text representation of the concept | |
author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | |
focus | 0..1 | Reference(Resource) | Who/what the section is about, when it is not about the subject of composition | |
text | I | 0..1 | Narrative | Text summary of the section, for human interpretation |
mode | 0..1 | code | working | snapshot | changes Binding: ListMode (required): The processing mode that applies to this section. | |
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |
entry | I | 0..* | Reference(AECountObservation | ExposureCountObservation) | A reference to data that supports this section |
emptyReason | I | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. |
section | I | 0..* | See section (Composition) | Nested Section |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
Path | Conformance | ValueSet / Code |
Composition.language | preferred | CommonLanguages Max Binding: AllLanguages |
Composition.identifier.use | required | IdentifierUse |
Composition.identifier.type | extensible | Identifier Type Codes |
Composition.status | required | Pattern: final |
Composition.type | preferred | Pattern: LOINC code 85893-6("Adverse event note") |
Composition.category | example | DocumentClassValueSet |
Composition.author.type | extensible | ResourceType |
Composition.confidentiality | required | v3.ConfidentialityClassification |
Composition.attester.mode | required | CompositionAttestationMode |
Composition.relatesTo.code | required | DocumentRelationshipType |
Composition.event.code | example | v3.ActCode |
Composition.section.code | example | DocumentSectionCodes |
Composition.section.mode | required | ListMode |
Composition.section.orderedBy | preferred | ListOrderCodes |
Composition.section.emptyReason | preferred | ListEmptyReasons |
Composition.section:PatientInformation.code | example | Pattern: PatientInformation |
Composition.section:PatientInformation.mode | required | ListMode |
Composition.section:PatientInformation.orderedBy | preferred | ListOrderCodes |
Composition.section:PatientInformation.emptyReason | preferred | ListEmptyReasons |
Composition.section:RelevantMedicalHistory.code | example | Pattern: RelevantMedicalHistory |
Composition.section:RelevantMedicalHistory.mode | required | ListMode |
Composition.section:RelevantMedicalHistory.orderedBy | preferred | ListOrderCodes |
Composition.section:RelevantMedicalHistory.emptyReason | preferred | ListEmptyReasons |
Composition.section:RelevantPastDrugHistory.code | example | Pattern: RelevantPastDrugHistory |
Composition.section:RelevantPastDrugHistory.mode | required | ListMode |
Composition.section:RelevantPastDrugHistory.orderedBy | preferred | ListOrderCodes |
Composition.section:RelevantPastDrugHistory.emptyReason | preferred | ListEmptyReasons |
Composition.section:InCaseOfDeath.code | example | Pattern: InCaseOfDeath |
Composition.section:InCaseOfDeath.mode | required | ListMode |
Composition.section:InCaseOfDeath.orderedBy | preferred | ListOrderCodes |
Composition.section:InCaseOfDeath.emptyReason | preferred | ListEmptyReasons |
Composition.section:ParentInformation.code | example | Pattern: ParentInformation |
Composition.section:ParentInformation.mode | required | ListMode |
Composition.section:ParentInformation.orderedBy | preferred | ListOrderCodes |
Composition.section:ParentInformation.emptyReason | preferred | ListEmptyReasons |
Composition.section:ReactionEvent.code | example | Pattern: ReactionEvent |
Composition.section:ReactionEvent.mode | required | ListMode |
Composition.section:ReactionEvent.orderedBy | preferred | ListOrderCodes |
Composition.section:ReactionEvent.emptyReason | preferred | ListEmptyReasons |
Composition.section:RelevantLabTestResults.code | example | Pattern: RelevantLabTestResults |
Composition.section:RelevantLabTestResults.mode | required | ListMode |
Composition.section:RelevantLabTestResults.orderedBy | preferred | ListOrderCodes |
Composition.section:RelevantLabTestResults.emptyReason | preferred | ListEmptyReasons |
Composition.section:DrugInformation.code | example | Pattern: DrugInformation |
Composition.section:DrugInformation.mode | required | ListMode |
Composition.section:DrugInformation.orderedBy | preferred | ListOrderCodes |
Composition.section:DrugInformation.emptyReason | preferred | ListEmptyReasons |
Composition.section:VAERSVaccines.code | example | Pattern: VAERSVaccines |
Composition.section:VAERSVaccines.mode | required | ListMode |
Composition.section:VAERSVaccines.orderedBy | preferred | ListOrderCodes |
Composition.section:VAERSVaccines.emptyReason | preferred | ListEmptyReasons |
Composition.section:CaseNarrative.code | example | Pattern: CaseSummaryNarrative |
Composition.section:CaseNarrative.mode | required | ListMode |
Composition.section:CaseNarrative.orderedBy | preferred | ListOrderCodes |
Composition.section:CaseNarrative.emptyReason | preferred | ListEmptyReasons |
Composition.section:CaseReporterComments.code | example | Pattern: CaseReporterComments |
Composition.section:CaseReporterComments.mode | required | ListMode |
Composition.section:CaseReporterComments.orderedBy | preferred | ListOrderCodes |
Composition.section:CaseReporterComments.emptyReason | preferred | ListEmptyReasons |
Composition.section:CaseSenderDiagnosis.code | example | Pattern: CaseSenderDiagnosis |
Composition.section:CaseSenderDiagnosis.mode | required | ListMode |
Composition.section:CaseSenderDiagnosis.orderedBy | preferred | ListOrderCodes |
Composition.section:CaseSenderDiagnosis.emptyReason | preferred | ListEmptyReasons |
Composition.section:CaseSenderComments.code | example | Pattern: CaseSenderComments |
Composition.section:CaseSenderComments.mode | required | ListMode |
Composition.section:CaseSenderComments.orderedBy | preferred | ListOrderCodes |
Composition.section:CaseSenderComments.emptyReason | preferred | ListEmptyReasons |
Composition.section:DataSourceInformation.code | example | Pattern: DataSourceInformation |
Composition.section:DataSourceInformation.mode | required | ListMode |
Composition.section:DataSourceInformation.orderedBy | preferred | ListOrderCodes |
Composition.section:DataSourceInformation.emptyReason | preferred | ListEmptyReasons |