Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## Resource Profile: eCTD Specification

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151 | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | 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.

Usages:

- Use this Profile: CMC eCTD SP4151 Document

### Formal Views of Profile Content

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

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
date | Σ | 1..1 | dateTime | Composition editing time
author | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
title | S Σ | 1..1 | string | Human Readable name/title
section | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
title | S | 1..1 | string | Label for section (e.g. for ToC)
entry | S C | 0..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | FHIRDocumentTypeCodes `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard

#### Constraints

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  |  | Composition |
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 | S | 1..1 | CodeableConcept | Kind of composition (LOINC if possible)
author | S | 1..1 | LiteralReference(Basic Organization) {b} | 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)
entry | S | 0..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
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
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
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 | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
name | Σ | 0..1 | string | Name for this Composition (computer friendly)
title | S Σ | 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 | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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 |  | 0..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 | C | 0..1 | Narrative | Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | S C | 0..* | LiteralReference(Quality Specification) {b} | 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

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | FHIRDocumentTypeCodes `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.category | example | ReferencedItemCategoryValueSet `http://hl7.org/fhir/ValueSet/referenced-item-category` From the FHIR Standard
Composition.attester.mode | preferred | CompositionAttestationMode `http://hl7.org/fhir/ValueSet/composition-attestation-mode` From the FHIR Standard
Composition.event.detail | example | ActCode `http://terminology.hl7.org/ValueSet/v3-ActCode`
Composition.section.code | example | DocumentSectionCodes `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard

#### Constraints

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

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Quality Specification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification)

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
date | Σ | 1..1 | dateTime | Composition editing time
author | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
title | S Σ | 1..1 | string | Human Readable name/title
section | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
title | S | 1..1 | string | Label for section (e.g. for ToC)
entry | S C | 0..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | FHIRDocumentTypeCodes `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard

#### Constraints

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() |

Differential View

This structure is derived from Composition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  |  | Composition |
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 | S | 1..1 | CodeableConcept | Kind of composition (LOINC if possible)
author | S | 1..1 | LiteralReference(Basic Organization) {b} | 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)
entry | S | 0..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
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
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | S Σ | 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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
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 | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
name | Σ | 0..1 | string | Name for this Composition (computer friendly)
title | S Σ | 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 | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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 |  | 0..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 | C | 0..1 | Narrative | Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | S C | 0..* | LiteralReference(Quality Specification) {b} | 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

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | FHIRDocumentTypeCodes `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.category | example | ReferencedItemCategoryValueSet `http://hl7.org/fhir/ValueSet/referenced-item-category` From the FHIR Standard
Composition.attester.mode | preferred | CompositionAttestationMode `http://hl7.org/fhir/ValueSet/composition-attestation-mode` From the FHIR Standard
Composition.event.detail | example | ActCode `http://terminology.hl7.org/ValueSet/v3-ActCode`
Composition.section.code | example | DocumentSectionCodes `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard

#### Constraints

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

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Quality Specification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron