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-ballot 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

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Graphic Reference ( Abstract )

A Document Reference to any attachment tha contains a graphical representation

Usage:

• Use this Resource Profile: CMC eCTD 32P10 Document, CMC eCTD 32P55 Document, CMC eCTD 32S10 Document and CMC eCTD 32S3 Document
• Refer to this Resource Profile: ContainerClosure, Component Substance, Drug Substance Impurity, Substance General Information and Polymorphic Form

Formal Views of Profile Content

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

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

This structure is derived from Base64DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference			Base64DocumentReference	This is an abstractprofile.
content
attachment		1..1	GraphicAttachment	Content in a format defined elsewhere
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DocumentReference	C	0..*	Base64DocumentReference	This is an abstractprofile. A reference to a document docRef-1: facilityType SHALL only be present if context is not an encounter docRef-2: practiceSetting SHALL only be present if context is not present
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
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference. Required Pattern: current
context	C	0..*	Reference(Appointment | Encounter | EpisodeOfCare)	Context of the document content
content	SΣ	1..*	BackboneElement	Document referenced
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
attachment	SC	1..1	GraphicAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DocumentReference.status	required	Pattern: current http://hl7.org/fhir/ValueSet/document-reference-status|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
att-1	error	DocumentReference.content.attachment	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
dom-2	error	DocumentReference	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DocumentReference	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	DocumentReference	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	DocumentReference	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DocumentReference	A resource should have narrative for robust management : text.`div`.exists()
docRef-1	warning	DocumentReference	facilityType SHALL only be present if context is not an encounter : facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2	warning	DocumentReference	practiceSetting SHALL only be present if context is not present : practiceSetting.empty() or context.where(resolve() is Encounter).empty()
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
DocumentReference	C	0..*	Base64DocumentReference	This is an abstractprofile. A reference to a document docRef-1: facilityType SHALL only be present if context is not an encounter docRef-2: practiceSetting SHALL only be present if context is not present
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 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
identifier	Σ	0..*	Identifier	Business identifiers for the document
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the DocumentReference
basedOn		0..*	Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription)	Procedure that caused this media to be created
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference. Required Pattern: current
docStatus	Σ	0..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): Status of the underlying document.
modality	Σ	0..*	CodeableConcept	Imaging modality used Binding: http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html (extensible): Type of acquired data in the instance.
type	Σ	0..1	CodeableConcept	Kind of document (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
category	Σ	0..*	CodeableConcept	Categorization of document Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
subject	Σ	0..1	Reference(Resource)	Who/what is the subject of the document
context	C	0..*	Reference(Appointment | Encounter | EpisodeOfCare)	Context of the document content
event		0..*	CodeableReference()	Main clinical acts documented Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
bodySite	Σ	0..*	CodeableReference(BodyStructure)	Body part included Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
facilityType	C	0..1	CodeableConcept	Kind of facility where patient was seen Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
practiceSetting	C	0..1	CodeableConcept	Additional details about where the content was created (e.g. clinical specialty) Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
period	Σ	0..1	Period	Time of service that is being documented
date	Σ	0..1	instant	When this document reference was created
author	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam)	Who and/or what authored the document
attester		0..*	BackboneElement	Attests to accuracy of the document
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 document.
time		0..1	dateTime	When the document was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the document
custodian		0..1	Reference(Organization)	Organization which maintains the document
relatesTo	Σ	0..*	BackboneElement	Relationships to other documents
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	The relationship type with another document Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
target	Σ	1..1	Reference(DocumentReference)	Target of the relationship
description	Σ	0..1	markdown	Human-readable description
securityLabel	Σ	0..*	CodeableConcept	Document security-tags Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
content	SΣ	1..*	BackboneElement	Document referenced
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
attachment	SC	1..1	GraphicAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
profile	Σ	0..*	BackboneElement	Content profile rules for the document
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
value[x]	Σ	1..1		Code|uri|canonical Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
valueCoding			Coding
valueUri			uri
valueCanonical			canonical(Any)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DocumentReference.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
DocumentReference.status	required	Pattern: current http://hl7.org/fhir/ValueSet/document-reference-status|5.0.0 from the FHIR Standard
DocumentReference.docStatus	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
DocumentReference.modality	extensible	http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html
DocumentReference.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
DocumentReference.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
DocumentReference.event	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
DocumentReference.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
DocumentReference.facilityType	example	FacilityTypeCodeValueSet http://hl7.org/fhir/ValueSet/c80-facilitycodes from the FHIR Standard
DocumentReference.practiceSetting	example	PracticeSettingCodeValueSet http://hl7.org/fhir/ValueSet/c80-practice-codes from the FHIR Standard
DocumentReference.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
DocumentReference.relatesTo.code	extensible	DocumentRelationshipType http://hl7.org/fhir/ValueSet/document-relationship-type from the FHIR Standard
DocumentReference.securityLabel	example	SecurityLabelExamples http://hl7.org/fhir/ValueSet/security-label-examples from the FHIR Standard
DocumentReference.content.profile.value[x]	preferred	HL7FormatCodes http://terminology.hl7.org/ValueSet/v3-HL7FormatCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
att-1	error	DocumentReference.content.attachment	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
dom-2	error	DocumentReference	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DocumentReference	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	DocumentReference	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	DocumentReference	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DocumentReference	A resource should have narrative for robust management : text.`div`.exists()
docRef-1	warning	DocumentReference	facilityType SHALL only be present if context is not an encounter : facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2	warning	DocumentReference	practiceSetting SHALL only be present if context is not present : practiceSetting.empty() or context.where(resolve() is Encounter).empty()
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 Base64DocumentReference

Summary

Structures

This structure refers to these other structures:

• Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)

Differential View

This structure is derived from Base64DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference			Base64DocumentReference	This is an abstractprofile.
content
attachment		1..1	GraphicAttachment	Content in a format defined elsewhere
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
DocumentReference	C	0..*	Base64DocumentReference	This is an abstractprofile. A reference to a document docRef-1: facilityType SHALL only be present if context is not an encounter docRef-2: practiceSetting SHALL only be present if context is not present
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
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference. Required Pattern: current
context	C	0..*	Reference(Appointment | Encounter | EpisodeOfCare)	Context of the document content
content	SΣ	1..*	BackboneElement	Document referenced
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
attachment	SC	1..1	GraphicAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DocumentReference.status	required	Pattern: current http://hl7.org/fhir/ValueSet/document-reference-status|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
att-1	error	DocumentReference.content.attachment	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
dom-2	error	DocumentReference	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DocumentReference	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	DocumentReference	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	DocumentReference	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DocumentReference	A resource should have narrative for robust management : text.`div`.exists()
docRef-1	warning	DocumentReference	facilityType SHALL only be present if context is not an encounter : facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2	warning	DocumentReference	practiceSetting SHALL only be present if context is not present : practiceSetting.empty() or context.where(resolve() is Encounter).empty()
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
DocumentReference	C	0..*	Base64DocumentReference	This is an abstractprofile. A reference to a document docRef-1: facilityType SHALL only be present if context is not an encounter docRef-2: practiceSetting SHALL only be present if context is not present
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 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
identifier	Σ	0..*	Identifier	Business identifiers for the document
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the DocumentReference
basedOn		0..*	Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription)	Procedure that caused this media to be created
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference. Required Pattern: current
docStatus	Σ	0..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): Status of the underlying document.
modality	Σ	0..*	CodeableConcept	Imaging modality used Binding: http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html (extensible): Type of acquired data in the instance.
type	Σ	0..1	CodeableConcept	Kind of document (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
category	Σ	0..*	CodeableConcept	Categorization of document Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
subject	Σ	0..1	Reference(Resource)	Who/what is the subject of the document
context	C	0..*	Reference(Appointment | Encounter | EpisodeOfCare)	Context of the document content
event		0..*	CodeableReference()	Main clinical acts documented Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
bodySite	Σ	0..*	CodeableReference(BodyStructure)	Body part included Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
facilityType	C	0..1	CodeableConcept	Kind of facility where patient was seen Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
practiceSetting	C	0..1	CodeableConcept	Additional details about where the content was created (e.g. clinical specialty) Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
period	Σ	0..1	Period	Time of service that is being documented
date	Σ	0..1	instant	When this document reference was created
author	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam)	Who and/or what authored the document
attester		0..*	BackboneElement	Attests to accuracy of the document
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 document.
time		0..1	dateTime	When the document was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the document
custodian		0..1	Reference(Organization)	Organization which maintains the document
relatesTo	Σ	0..*	BackboneElement	Relationships to other documents
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	The relationship type with another document Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
target	Σ	1..1	Reference(DocumentReference)	Target of the relationship
description	Σ	0..1	markdown	Human-readable description
securityLabel	Σ	0..*	CodeableConcept	Document security-tags Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
content	SΣ	1..*	BackboneElement	Document referenced
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
attachment	SC	1..1	GraphicAttachment	Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType
profile	Σ	0..*	BackboneElement	Content profile rules for the document
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
value[x]	Σ	1..1		Code|uri|canonical Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
valueCoding			Coding
valueUri			uri
valueCanonical			canonical(Any)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DocumentReference.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
DocumentReference.status	required	Pattern: current http://hl7.org/fhir/ValueSet/document-reference-status|5.0.0 from the FHIR Standard
DocumentReference.docStatus	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
DocumentReference.modality	extensible	http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html
DocumentReference.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
DocumentReference.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
DocumentReference.event	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
DocumentReference.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
DocumentReference.facilityType	example	FacilityTypeCodeValueSet http://hl7.org/fhir/ValueSet/c80-facilitycodes from the FHIR Standard
DocumentReference.practiceSetting	example	PracticeSettingCodeValueSet http://hl7.org/fhir/ValueSet/c80-practice-codes from the FHIR Standard
DocumentReference.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
DocumentReference.relatesTo.code	extensible	DocumentRelationshipType http://hl7.org/fhir/ValueSet/document-relationship-type from the FHIR Standard
DocumentReference.securityLabel	example	SecurityLabelExamples http://hl7.org/fhir/ValueSet/security-label-examples from the FHIR Standard
DocumentReference.content.profile.value[x]	preferred	HL7FormatCodes http://terminology.hl7.org/ValueSet/v3-HL7FormatCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
att-1	error	DocumentReference.content.attachment	If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists()
dom-2	error	DocumentReference	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DocumentReference	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	DocumentReference	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	DocumentReference	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DocumentReference	A resource should have narrative for robust management : text.`div`.exists()
docRef-1	warning	DocumentReference	facilityType SHALL only be present if context is not an encounter : facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2	warning	DocumentReference	practiceSetting SHALL only be present if context is not present : practiceSetting.empty() or context.where(resolve() is Encounter).empty()
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 Base64DocumentReference

Summary

Structures

This structure refers to these other structures:

• Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)

Other representations of profile: CSV, Excel, Schematron