Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151 | Version: 1.1.6 | |||
Active as of 2024-09-22 | Computable Name: EctdCompositionSP4151 | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.11 |
The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Composition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | Composition | |||
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | Version-independent identifier for the Composition |
status | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final | |
type | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: Specification Section Type Terminology (required) | |
author | S | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition |
title | S | 1..1 | string | Human Readable name/title |
section | S | 1..1 | BackboneElement | Composition is broken into sections |
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |
entry | S | 0..* | Reference(Quality Specification) | A reference to data that supports this section |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..1 | Identifier | Version-independent identifier for the Composition |
status | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown 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: Specification Section Type Terminology (required) |
date | Σ | 1..1 | dateTime | Composition editing time |
author | SΣ | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition |
title | SΣ | 1..1 | string | Human Readable name/title |
section | SC | 1..1 | BackboneElement | Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty |
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. 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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |
entry | SC | 0..* | Reference(Quality Specification) | A reference to data that supports this section |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard | |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG | |
Composition.section.code | example | Pattern: SP4151("Quality Specification")http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmp-1 | error | Composition.section | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() | |
cmp-2 | error | Composition.section | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() | |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Composition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
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 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
versionId | Σ | 0..1 | id | Version specific identifier | ||||
lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
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: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
url | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) | ||||
identifier | SΣ | 0..1 | Identifier | Version-independent identifier for the Composition | ||||
version | Σ | 0..1 | string | An explicitly assigned identifer of a variation of the content in the Composition | ||||
status | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown 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: Specification Section Type Terminology (required) | ||||
category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level. | ||||
subject | Σ | 0..* | Reference(Resource) | Who and/or what the composition is about | ||||
encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition | ||||
date | Σ | 1..1 | dateTime | Composition editing time | ||||
useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | ||||
author | SΣ | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition | ||||
name | Σ | 0..1 | string | Name for this Composition (computer friendly) | ||||
title | SΣ | 1..1 | string | Human Readable name/title | ||||
note | 0..* | Annotation | For any additional notes | |||||
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 | CodeableConcept | personal | professional | legal | official Binding: CompositionAttestationMode (preferred): 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..* | RelatedArtifact | Relationships to other compositions/documents | |||||
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 | ||||
period | Σ | 0..1 | Period | The period covered by the documentation | ||||
detail | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented. | ||||
section | SC | 1..1 | BackboneElement | Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty | ||||
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. 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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |||||
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 | C | 0..1 | Narrative | Text summary of the section, for human interpretation | ||||
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |||||
entry | SC | 0..* | Reference(Quality Specification) | A reference to data that supports this section | ||||
emptyReason | C | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. | ||||
section | 0..* | See section (Composition) | Nested Section | |||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Composition.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | |
Composition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
Composition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard | |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG | |
Composition.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard | |
Composition.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard | |
Composition.event.detail | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
Composition.section.code | example | Pattern: SP4151("Quality Specification")http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard | |
Composition.section.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-order from the FHIR Standard | |
Composition.section.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmp-1 | error | Composition.section | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() | |
cmp-2 | error | Composition.section | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() | |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Composition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Composition
Differential View
This structure is derived from Composition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | Composition | |||
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | Version-independent identifier for the Composition |
status | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final | |
type | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: Specification Section Type Terminology (required) | |
author | S | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition |
title | S | 1..1 | string | Human Readable name/title |
section | S | 1..1 | BackboneElement | Composition is broken into sections |
title | S | 1..1 | string | Label for section (e.g. for ToC) |
code | S | 1..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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |
entry | S | 0..* | Reference(Quality Specification) | A reference to data that supports this section |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..1 | Identifier | Version-independent identifier for the Composition |
status | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown 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: Specification Section Type Terminology (required) |
date | Σ | 1..1 | dateTime | Composition editing time |
author | SΣ | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition |
title | SΣ | 1..1 | string | Human Readable name/title |
section | SC | 1..1 | BackboneElement | Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty |
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. 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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |
entry | SC | 0..* | Reference(Quality Specification) | A reference to data that supports this section |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard | |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG | |
Composition.section.code | example | Pattern: SP4151("Quality Specification")http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmp-1 | error | Composition.section | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() | |
cmp-2 | error | Composition.section | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() | |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Composition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
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 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
versionId | Σ | 0..1 | id | Version specific identifier | ||||
lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
profile | SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
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: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
url | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) | ||||
identifier | SΣ | 0..1 | Identifier | Version-independent identifier for the Composition | ||||
version | Σ | 0..1 | string | An explicitly assigned identifer of a variation of the content in the Composition | ||||
status | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown 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: Specification Section Type Terminology (required) | ||||
category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level. | ||||
subject | Σ | 0..* | Reference(Resource) | Who and/or what the composition is about | ||||
encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition | ||||
date | Σ | 1..1 | dateTime | Composition editing time | ||||
useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | ||||
author | SΣ | 1..1 | Reference(Basic Organization) | Who and/or what authored the composition | ||||
name | Σ | 0..1 | string | Name for this Composition (computer friendly) | ||||
title | SΣ | 1..1 | string | Human Readable name/title | ||||
note | 0..* | Annotation | For any additional notes | |||||
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 | CodeableConcept | personal | professional | legal | official Binding: CompositionAttestationMode (preferred): 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..* | RelatedArtifact | Relationships to other compositions/documents | |||||
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 | ||||
period | Σ | 0..1 | Period | The period covered by the documentation | ||||
detail | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented. | ||||
section | SC | 1..1 | BackboneElement | Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty | ||||
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. 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/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | |||||
version | 0..1 | string | Version of the system - if relevant | |||||
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SP4151 | |||||
display | 1..1 | string | Representation defined by the system Fixed Value: Quality Specification | |||||
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 | C | 0..1 | Narrative | Text summary of the section, for human interpretation | ||||
orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry. | |||||
entry | SC | 0..* | Reference(Quality Specification) | A reference to data that supports this section | ||||
emptyReason | C | 0..1 | CodeableConcept | Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty. | ||||
section | 0..* | See section (Composition) | Nested Section | |||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Composition.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | |
Composition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
Composition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard | |
Composition.type | required | PqcmcQualitySpecificationSectionTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs from this IG | |
Composition.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard | |
Composition.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard | |
Composition.event.detail | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
Composition.section.code | example | Pattern: SP4151("Quality Specification")http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard | |
Composition.section.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-order from the FHIR Standard | |
Composition.section.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmp-1 | error | Composition.section | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() | |
cmp-2 | error | Composition.section | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() | |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Composition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Composition
Other representations of profile: CSV, Excel, Schematron