This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: DocumentReference - Drug

This DocumentReference profile references a document of any kind, including a diagram or image, that is necessary for pharmaceutical quality (PQ) data exchange.

Usage:

• Use this Resource Profile: Bundle - Product Impurities PQ and Bundle - Product Manufacturing PQ
• Refer to this Resource Profile: Extension - Plan Document Reference PQ
• Examples for this Resource Profile: DocumentReference/documentreference-drug-pq-process-flow-diagram

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 DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
identifier	S	0..*	Identifier	Business identifiers for the document
status	S	1..1	code	current | superseded | entered-in-error
type	S	0..1	CodeableConcept	Kind of document (LOINC if possible)
content	S	1..*	BackboneElement	Document referenced
attachment	S	1..1	Attachment	Where to access the document
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DocumentReference	C	0..*	DocumentReference	A reference to a document
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business identifiers for the document
status	?!SΣ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
type	SΣ	0..1	CodeableConcept	Kind of document (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
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	SΣ	1..1	Attachment	Where to access the document
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DocumentReference.status	required	DocumentReferenceStatus
DocumentReference.type	preferred	FHIRDocumentTypeCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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..*	DocumentReference	A reference to a document
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	SΣ	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	?!SΣ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
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	SΣ	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	SΣ	1..1	Attachment	Where to access the document
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
DocumentReference.language	required	AllLanguages
DocumentReference.status	required	DocumentReferenceStatus
DocumentReference.docStatus	required	CompositionStatus
DocumentReference.modality	extensible	http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html
DocumentReference.type	preferred	FHIRDocumentTypeCodes
DocumentReference.category	example	ReferencedItemCategoryValueSet
DocumentReference.event	example	ActCode
DocumentReference.bodySite	example	SNOMEDCTBodyStructures
DocumentReference.facilityType	example	FacilityTypeCodeValueSet
DocumentReference.practiceSetting	example	PracticeSettingCodeValueSet
DocumentReference.attester.mode	preferred	CompositionAttestationMode
DocumentReference.relatesTo.code	extensible	DocumentRelationshipType
DocumentReference.securityLabel	example	SecurityLabelExamples
DocumentReference.content.profile.value[x]	preferred	HL7FormatCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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 DocumentReference

Summary

Must-Support: 5 elements

Differential View

This structure is derived from DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
identifier	S	0..*	Identifier	Business identifiers for the document
status	S	1..1	code	current | superseded | entered-in-error
type	S	0..1	CodeableConcept	Kind of document (LOINC if possible)
content	S	1..*	BackboneElement	Document referenced
attachment	S	1..1	Attachment	Where to access the document
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
DocumentReference	C	0..*	DocumentReference	A reference to a document
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business identifiers for the document
status	?!SΣ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
type	SΣ	0..1	CodeableConcept	Kind of document (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
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	SΣ	1..1	Attachment	Where to access the document
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DocumentReference.status	required	DocumentReferenceStatus
DocumentReference.type	preferred	FHIRDocumentTypeCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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..*	DocumentReference	A reference to a document
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	SΣ	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	?!SΣ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
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	SΣ	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	SΣ	1..1	Attachment	Where to access the document
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
DocumentReference.language	required	AllLanguages
DocumentReference.status	required	DocumentReferenceStatus
DocumentReference.docStatus	required	CompositionStatus
DocumentReference.modality	extensible	http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html
DocumentReference.type	preferred	FHIRDocumentTypeCodes
DocumentReference.category	example	ReferencedItemCategoryValueSet
DocumentReference.event	example	ActCode
DocumentReference.bodySite	example	SNOMEDCTBodyStructures
DocumentReference.facilityType	example	FacilityTypeCodeValueSet
DocumentReference.practiceSetting	example	PracticeSettingCodeValueSet
DocumentReference.attester.mode	preferred	CompositionAttestationMode
DocumentReference.relatesTo.code	extensible	DocumentRelationshipType
DocumentReference.securityLabel	example	SecurityLabelExamples
DocumentReference.content.profile.value[x]	preferred	HL7FormatCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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 DocumentReference

Summary

Must-Support: 5 elements

Other representations of profile: CSV, Excel, Schematron