Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
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 1.0.0-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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference | Version: 1.0.0-ballot | |||
| Active as of 2024-04-04 | Computable Name: Base64DocumentReference | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.1 | ||||
A profile that represents the document or diagram in base64.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from DocumentReference
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  DocumentReference |
0..* | DocumentReference | A reference to a document | |
  meta |
||||
  profile |
S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 status |
1..1 | code | current | superseded | entered-in-error Required Pattern: current | |
 content |
S | 1..* | BackboneElement | Document referenced |
 attachment |
S | 1..1 | Attachment | Where to access the document |
| contentType |
S | 1..1 | code | Mime type of the content, with charset etc. |
| data |
S | 1..1 | base64Binary | Data inline, base64ed |
| title |
S | 1..1 | string | Document file name including the file extension |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DocumentReference |
C | 0..* | DocumentReference | 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 |
 meta |
Σ | 0..1 | Meta | Metadata about the resource |
 profile |
SΣ | 1..1 | 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 | |
 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 |
SΣ | 1..1 | Attachment | Where to access the document |
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png |
| data |
SC | 1..1 | base64Binary | Data inline, base64ed |
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| DocumentReference.status | required | Pattern: currenthttp://hl7.org/fhir/ValueSet/document-reference-status|5.0.0from the FHIR Standard | |
| DocumentReference.content.attachment.contentType | required | MimeTypes (a valid code from urn:ietf:bcp:13)http://hl7.org/fhir/ValueSet/mimetypes|5.0.0from the FHIR Standard |
| 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 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 | ||||
| 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 | 1..1 | 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
| |||||
| 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 |
SΣ | 1..1 | Attachment | Where to access the document | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png | ||||
| language |
Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
| data |
SC | 1..1 | base64Binary | Data inline, base64ed | ||||
| url |
Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
| size |
Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
| hash |
Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
| creation |
Σ | 0..1 | dateTime | Date attachment was first created | ||||
| height |
0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
| width |
0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
| frames |
0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
| duration |
0..1 | decimal | Length in seconds (audio / video) | |||||
| pages |
0..1 | positiveInt | Number of printed pages | |||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| DocumentReference.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| DocumentReference.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| DocumentReference.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DocumentReference.status | required | Pattern: currenthttp://hl7.org/fhir/ValueSet/document-reference-status|5.0.0from the FHIR Standard | |
| DocumentReference.docStatus | required | CompositionStatushttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| DocumentReference.modality | extensible | http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.htmlhttp://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html | |
| DocumentReference.type | preferred | FHIRDocumentTypeCodeshttp://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| DocumentReference.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-categoryfrom the FHIR Standard | |
| DocumentReference.event | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
| DocumentReference.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | |
| DocumentReference.facilityType | example | FacilityTypeCodeValueSethttp://hl7.org/fhir/ValueSet/c80-facilitycodesfrom the FHIR Standard | |
| DocumentReference.practiceSetting | example | PracticeSettingCodeValueSethttp://hl7.org/fhir/ValueSet/c80-practice-codesfrom the FHIR Standard | |
| DocumentReference.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-modefrom the FHIR Standard | |
| DocumentReference.relatesTo.code | extensible | DocumentRelationshipTypehttp://hl7.org/fhir/ValueSet/document-relationship-typefrom the FHIR Standard | |
| DocumentReference.securityLabel | example | SecurityLabelExampleshttp://hl7.org/fhir/ValueSet/security-label-examplesfrom the FHIR Standard | |
| DocumentReference.content.attachment.contentType | required | MimeTypes (a valid code from urn:ietf:bcp:13)http://hl7.org/fhir/ValueSet/mimetypes|5.0.0from the FHIR Standard | |
| DocumentReference.content.attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DocumentReference.content.profile.value[x] | preferred | HL7FormatCodeshttp://terminology.hl7.org/ValueSet/v3-HL7FormatCodes |
| 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
Differential View
This structure is derived from DocumentReference
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DocumentReference |
0..* | DocumentReference | A reference to a document | |
| meta |
||||
| profile |
S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| status |
1..1 | code | current | superseded | entered-in-error Required Pattern: current | |
| content |
S | 1..* | BackboneElement | Document referenced |
| attachment |
S | 1..1 | Attachment | Where to access the document |
| contentType |
S | 1..1 | code | Mime type of the content, with charset etc. |
| data |
S | 1..1 | base64Binary | Data inline, base64ed |
| title |
S | 1..1 | string | Document file name including the file extension |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DocumentReference |
C | 0..* | DocumentReference | 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 |
| meta |
Σ | 0..1 | Meta | Metadata about the resource |
| profile |
SΣ | 1..1 | 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 | |
| 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 |
SΣ | 1..1 | Attachment | Where to access the document |
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png |
| data |
SC | 1..1 | base64Binary | Data inline, base64ed |
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| DocumentReference.status | required | Pattern: currenthttp://hl7.org/fhir/ValueSet/document-reference-status|5.0.0from the FHIR Standard | |
| DocumentReference.content.attachment.contentType | required | MimeTypes (a valid code from urn:ietf:bcp:13)http://hl7.org/fhir/ValueSet/mimetypes|5.0.0from the FHIR Standard |
| 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 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 | ||||
| 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 | 1..1 | 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
| |||||
| 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 |
SΣ | 1..1 | Attachment | Where to access the document | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png | ||||
| language |
Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
| data |
SC | 1..1 | base64Binary | Data inline, base64ed | ||||
| url |
Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
| size |
Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
| hash |
Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
| creation |
Σ | 0..1 | dateTime | Date attachment was first created | ||||
| height |
0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
| width |
0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
| frames |
0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
| duration |
0..1 | decimal | Length in seconds (audio / video) | |||||
| pages |
0..1 | positiveInt | Number of printed pages | |||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| DocumentReference.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| DocumentReference.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| DocumentReference.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DocumentReference.status | required | Pattern: currenthttp://hl7.org/fhir/ValueSet/document-reference-status|5.0.0from the FHIR Standard | |
| DocumentReference.docStatus | required | CompositionStatushttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| DocumentReference.modality | extensible | http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.htmlhttp://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_33.html | |
| DocumentReference.type | preferred | FHIRDocumentTypeCodeshttp://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| DocumentReference.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-categoryfrom the FHIR Standard | |
| DocumentReference.event | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
| DocumentReference.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | |
| DocumentReference.facilityType | example | FacilityTypeCodeValueSethttp://hl7.org/fhir/ValueSet/c80-facilitycodesfrom the FHIR Standard | |
| DocumentReference.practiceSetting | example | PracticeSettingCodeValueSethttp://hl7.org/fhir/ValueSet/c80-practice-codesfrom the FHIR Standard | |
| DocumentReference.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-modefrom the FHIR Standard | |
| DocumentReference.relatesTo.code | extensible | DocumentRelationshipTypehttp://hl7.org/fhir/ValueSet/document-relationship-typefrom the FHIR Standard | |
| DocumentReference.securityLabel | example | SecurityLabelExampleshttp://hl7.org/fhir/ValueSet/security-label-examplesfrom the FHIR Standard | |
| DocumentReference.content.attachment.contentType | required | MimeTypes (a valid code from urn:ietf:bcp:13)http://hl7.org/fhir/ValueSet/mimetypes|5.0.0from the FHIR Standard | |
| DocumentReference.content.attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DocumentReference.content.profile.value[x] | preferred | HL7FormatCodeshttp://terminology.hl7.org/ValueSet/v3-HL7FormatCodes |
| 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
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-04
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