Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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

Resource Profile: eCTD Batch Formula

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32 Version: 1.1.6
Active as of 2024-09-22 Computable Name: EctdComposition32P32
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.38

The fields needed to represent the Product Batch Formula to be included under the eCTD. References Sponsor Organization and Batch Formula

Usage:

Formal Views of Profile Content

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

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 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
.... 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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
... author S 1..1 Reference(Basic Organization) Who and/or what authored the composition
... 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
.... entry S 1..1 Reference(Batch Formula Drug Product Identification) A reference to data that supports this section

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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: FHIRDocumentTypeCodes (preferred): Type of a composition.


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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
... date Σ 1..1 dateTime Composition editing time
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title Σ 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
.... entry SC 1..1 Reference(Batch Formula Drug Product Identification) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.section.codeexamplePattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.sectionA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.sectionA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf 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-4errorCompositionIf 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-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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

Additional BindingsPurpose
CommonLanguages Starter Set
... 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: 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://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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... 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 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 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
...... 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 1..1 Reference(Batch Formula Drug Product Identification) 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Composition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
from the FHIR Standard
Composition.attester.modepreferredCompositionAttestationMode
http://hl7.org/fhir/ValueSet/composition-attestation-mode
from the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeexamplePattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.sectionA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.sectionA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf 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-4errorCompositionIf 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-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
.... 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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
... author S 1..1 Reference(Basic Organization) Who and/or what authored the composition
... 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
.... entry S 1..1 Reference(Batch Formula Drug Product Identification) A reference to data that supports this section

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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: FHIRDocumentTypeCodes (preferred): Type of a composition.


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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
... date Σ 1..1 dateTime Composition editing time
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title Σ 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
.... entry SC 1..1 Reference(Batch Formula Drug Product Identification) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.section.codeexamplePattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.sectionA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.sectionA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf 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-4errorCompositionIf 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-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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

Additional BindingsPurpose
CommonLanguages Starter Set
... 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: 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://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: 32P32
..... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... 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 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 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: 32P32
...... display 1..1 string Representation defined by the system
Fixed Value: Product Batch Formula
...... 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 1..1 Reference(Batch Formula Drug Product Identification) 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Composition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
from the FHIR Standard
Composition.attester.modepreferredCompositionAttestationMode
http://hl7.org/fhir/ValueSet/composition-attestation-mode
from the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeexamplePattern: 32P32("Product Batch Formula")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.sectionA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.sectionA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf 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-4errorCompositionIf 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-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

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