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: Graphic Reference ( Abstract )

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: GraphicReference
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.57

A Document Reference to any attachment that contains a graphical representation

Usages:

- Use this Profile: CMC eCTD 32P10 Document, CMC eCTD 32P55 Document, CMC eCTD 32S10 Document and CMC eCTD 32S3 Document
- Refer to this 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.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference | C | 0..* | Base64DocumentReference | This is an abstract profile. A reference to a document Constraints: docRef-1, docRef-2
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status | ?!Σ | 1..1 | code | current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.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 | S Σ | 1..* | BackboneElement | Document referenced
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
attachment | S Σ | 1..1 | GraphicAttachment | Where to access the document
Documentation for this format

#### Terminology Bindings

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

#### 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 Base64DocumentReference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference |  |  | Base64DocumentReference | This is an abstract profile.
content |  |  |  |
attachment |  | 1..1 | GraphicAttachment | Where to access the document
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference | C | 0..* | Base64DocumentReference | This is an abstract profile. A reference to a document Constraints: docRef-1, docRef-2
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
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: Modality (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 | S Σ | 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 | S Σ | 1..1 | GraphicAttachment | 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 / Code | URI
DocumentReference.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
DocumentReference.status | required | Pattern Value: 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 | Modality `http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html` From http://tx.fhir.org/r5
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
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)

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference | C | 0..* | Base64DocumentReference | This is an abstract profile. A reference to a document Constraints: docRef-1, docRef-2
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 | S Σ | 1..* | BackboneElement | Document referenced
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
attachment | S Σ | 1..1 | GraphicAttachment | Where to access the document
Documentation for this format

#### Terminology Bindings

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

#### 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() |

Differential View

This structure is derived from Base64DocumentReference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference |  |  | Base64DocumentReference | This is an abstract profile.
content |  |  |  |
attachment |  | 1..1 | GraphicAttachment | Where to access the document
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DocumentReference | C | 0..* | Base64DocumentReference | This is an abstract profile. A reference to a document Constraints: docRef-1, docRef-2
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
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: Modality (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 | S Σ | 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 | S Σ | 1..1 | GraphicAttachment | 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 / Code | URI
DocumentReference.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
DocumentReference.status | required | Pattern Value: 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 | Modality `http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html` From http://tx.fhir.org/r5
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
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)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron