Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), 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 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq | Version: 1.0.0 | |||
| Active as of 2024-05-08 | Computable Name: DiagnosticReportAnalysisDrugPQ | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.25 | ||||
This DiagnosticReport profile represents results from a batch analysis, stability study, characterization study, impurities analysis, manufacturing process validation study, etc.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from DiagnosticReport
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  DiagnosticReport |
0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports | |
  contained |
S | 0..* | Resource | Contained, inline Resources |
 Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy |
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq |
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) |
| identifier |
S | 0..* | Identifier | Business identifier for report |
| status |
S | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown |
| code |
S | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) |
 effective[x] |
S | 0..1 | dateTime, Period | Clinically relevant time/time-period for report |
  extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) |
| performer |
S | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service |
 result |
S | 0..* | Reference(Observation - Test Result Drug PQ) | Observations |
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DiagnosticReport |
C | 0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports dgr-1: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
S | 0..* | Resource | Contained, inline Resources |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy |
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq |
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
SΣ | 0..* | Identifier | Business identifier for report |
| status |
?!SΣ | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown Binding: DiagnosticReportStatus (required): The status of the diagnostic report. |
| code |
SΣ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) |
 effective[x] |
SΣ | 0..1 | Clinically relevant time/time-period for report | |
| effective[x]:All Types |
Content/Rules for all Types | |||
 extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) |
| effectiveDateTime |
dateTime | |||
| effectivePeriod |
Period | |||
| performer |
SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service |
| result |
SC | 0..* | Reference(Observation - Test Result Drug PQ) | Observations |
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.status | required | DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0from the FHIR Standard | |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dgr-1 | error | DiagnosticReport | When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` : composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference)) | |
| dom-2 | error | DiagnosticReport | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DiagnosticReport | 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 | DiagnosticReport | 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 | DiagnosticReport | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DiagnosticReport | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| DiagnosticReport |
C | 0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports dgr-1: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` | ||||
| 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
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
S | 0..* | Resource | Contained, inline Resources | ||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy | ||||
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq | ||||
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..* | Identifier | Business identifier for report | ||||
| basedOn |
0..* | Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | What was requested | |||||
| status |
?!SΣ | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown Binding: DiagnosticReportStatus (required): The status of the diagnostic report. | ||||
| category |
Σ | 0..* | CodeableConcept | Service category Binding: DiagnosticServiceSectionCodes (example): HL7 V2 table 0074 | ||||
| code |
SΣ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) | ||||
| subject |
Σ | 0..1 | Reference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct) | The subject of the report - usually, but not always, the patient | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Health care event when test ordered | ||||
| effective[x] |
SΣ | 0..1 | Clinically relevant time/time-period for report | |||||
| effective[x]:All Types |
Content/Rules for all Types | |||||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) | ||||
| effectiveDateTime |
dateTime | |||||||
| effectivePeriod |
Period | |||||||
| issued |
Σ | 0..1 | instant | DateTime this version was made | ||||
| performer |
SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service | ||||
| resultsInterpreter |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Primary result interpreter | ||||
| specimen |
0..* | Reference(Specimen) | Specimens this report is based on | |||||
| result |
SC | 0..* | Reference(Observation - Test Result Drug PQ) | Observations | ||||
| note |
0..* | Annotation | Comments about the diagnostic report | |||||
| study |
0..* | Reference(GenomicStudy | ImagingStudy) | Reference to full details of an analysis associated with the diagnostic report | |||||
| supportingInfo |
0..* | BackboneElement | Additional information supporting the diagnostic report | |||||
| 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 | ||||
| type |
1..1 | CodeableConcept | Supporting information role code Binding: hl7VS-VS-observationType (example): The code value for the role of the supporting information in the diagnostic report. | |||||
| reference |
1..1 | Reference(Procedure | Observation | DiagnosticReport | Citation) | Supporting information reference | |||||
| media |
Σ | 0..* | BackboneElement | Key images or data associated with this report | ||||
| 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 | ||||
| comment |
0..1 | string | Comment about the image or data (e.g. explanation) | |||||
| link |
Σ | 1..1 | Reference(DocumentReference) | Reference to the image or data source | ||||
| composition |
C | 0..1 | Reference(Composition) | Reference to a Composition resource for the DiagnosticReport structure | ||||
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results | ||||
| conclusionCode |
0..* | CodeableConcept | Codes for the clinical conclusion of test results Binding: SNOMEDCTClinicalFindings (example): SNOMED CT Clinical Findings | |||||
| presentedForm |
0..* | Attachment | Entire report as issued | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DiagnosticReport.status | required | DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0from the FHIR Standard | |
| DiagnosticReport.category | example | DiagnosticServiceSectionCodeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sectionsfrom the FHIR Standard | |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG | |
| DiagnosticReport.supportingInfo.type | example | Hl7VSVSObservationTypehttp://terminology.hl7.org/ValueSet/v2-0936 | |
| DiagnosticReport.conclusionCode | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/clinical-findingsfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dgr-1 | error | DiagnosticReport | When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` : composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference)) | |
| dom-2 | error | DiagnosticReport | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DiagnosticReport | 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 | DiagnosticReport | 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 | DiagnosticReport | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DiagnosticReport | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 DiagnosticReport
Summary
Must-Support: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from DiagnosticReport
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DiagnosticReport |
0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports | |
| contained |
S | 0..* | Resource | Contained, inline Resources |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy |
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq |
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) |
| identifier |
S | 0..* | Identifier | Business identifier for report |
| status |
S | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown |
| code |
S | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) |
| effective[x] |
S | 0..1 | dateTime, Period | Clinically relevant time/time-period for report |
| extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) |
| performer |
S | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service |
| result |
S | 0..* | Reference(Observation - Test Result Drug PQ) | Observations |
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DiagnosticReport |
C | 0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports dgr-1: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
S | 0..* | Resource | Contained, inline Resources |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy |
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq |
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
SΣ | 0..* | Identifier | Business identifier for report |
| status |
?!SΣ | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown Binding: DiagnosticReportStatus (required): The status of the diagnostic report. |
| code |
SΣ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) |
| effective[x] |
SΣ | 0..1 | Clinically relevant time/time-period for report | |
| effective[x]:All Types |
Content/Rules for all Types | |||
| extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) |
| effectiveDateTime |
dateTime | |||
| effectivePeriod |
Period | |||
| performer |
SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service |
| result |
SC | 0..* | Reference(Observation - Test Result Drug PQ) | Observations |
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.status | required | DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0from the FHIR Standard | |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dgr-1 | error | DiagnosticReport | When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` : composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference)) | |
| dom-2 | error | DiagnosticReport | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DiagnosticReport | 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 | DiagnosticReport | 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 | DiagnosticReport | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DiagnosticReport | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| DiagnosticReport |
C | 0..* | DiagnosticReport | A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports dgr-1: When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` | ||||
| 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
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
S | 0..* | Resource | Contained, inline Resources | ||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| workflow-triggeredBy |
S | 0..1 | canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri | A ‘step’ dictated within the protocol. URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy | ||||
| statistical-model |
S | 0..* | CodeableConcept | Information about the statistical model utilized to interpret results. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq | ||||
| container-orientation |
S | 0..* | CodeableConcept | The spatial orientaton of the container when tested, for instance horizontal or vertical. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq Binding: Container Orientations (example) | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..* | Identifier | Business identifier for report | ||||
| basedOn |
0..* | Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | What was requested | |||||
| status |
?!SΣ | 1..1 | code | registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown Binding: DiagnosticReportStatus (required): The status of the diagnostic report. | ||||
| category |
Σ | 0..* | CodeableConcept | Service category Binding: DiagnosticServiceSectionCodes (example): HL7 V2 table 0074 | ||||
| code |
SΣ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example) | ||||
| subject |
Σ | 0..1 | Reference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct) | The subject of the report - usually, but not always, the patient | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Health care event when test ordered | ||||
| effective[x] |
SΣ | 0..1 | Clinically relevant time/time-period for report | |||||
| effective[x]:All Types |
Content/Rules for all Types | |||||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension-time-point-description |
S | 0..1 | CodeableConcept | A code that further describes a time point, such as ‘delayed start’. URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq Binding: Time Point Description (example) | ||||
| effectiveDateTime |
dateTime | |||||||
| effectivePeriod |
Period | |||||||
| issued |
Σ | 0..1 | instant | DateTime this version was made | ||||
| performer |
SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service | ||||
| resultsInterpreter |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Primary result interpreter | ||||
| specimen |
0..* | Reference(Specimen) | Specimens this report is based on | |||||
| result |
SC | 0..* | Reference(Observation - Test Result Drug PQ) | Observations | ||||
| note |
0..* | Annotation | Comments about the diagnostic report | |||||
| study |
0..* | Reference(GenomicStudy | ImagingStudy) | Reference to full details of an analysis associated with the diagnostic report | |||||
| supportingInfo |
0..* | BackboneElement | Additional information supporting the diagnostic report | |||||
| 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 | ||||
| type |
1..1 | CodeableConcept | Supporting information role code Binding: hl7VS-VS-observationType (example): The code value for the role of the supporting information in the diagnostic report. | |||||
| reference |
1..1 | Reference(Procedure | Observation | DiagnosticReport | Citation) | Supporting information reference | |||||
| media |
Σ | 0..* | BackboneElement | Key images or data associated with this report | ||||
| 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 | ||||
| comment |
0..1 | string | Comment about the image or data (e.g. explanation) | |||||
| link |
Σ | 1..1 | Reference(DocumentReference) | Reference to the image or data source | ||||
| composition |
C | 0..1 | Reference(Composition) | Reference to a Composition resource for the DiagnosticReport structure | ||||
| conclusion |
S | 0..1 | markdown | Clinical conclusion (interpretation) of test results | ||||
| conclusionCode |
0..* | CodeableConcept | Codes for the clinical conclusion of test results Binding: SNOMEDCTClinicalFindings (example): SNOMED CT Clinical Findings | |||||
| presentedForm |
0..* | Attachment | Entire report as issued | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| DiagnosticReport.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| DiagnosticReport.status | required | DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0from the FHIR Standard | |
| DiagnosticReport.category | example | DiagnosticServiceSectionCodeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sectionsfrom the FHIR Standard | |
| DiagnosticReport.code | example | VsReportTypePQ (a valid code from Pharmaceutical Report Type Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-reportType-pqfrom this IG | |
| DiagnosticReport.supportingInfo.type | example | Hl7VSVSObservationTypehttp://terminology.hl7.org/ValueSet/v2-0936 | |
| DiagnosticReport.conclusionCode | example | SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/clinical-findingsfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dgr-1 | error | DiagnosticReport | When a Composition is referenced in `Diagnostic.composition`, all Observation resources referenced in `Composition.entry` must also be referenced in `Diagnostic.entry` or in the references Observations in `Observation.hasMember` : composition.exists() implies (composition.resolve().section.entry.reference.where(resolve() is Observation) in (result.reference|result.reference.resolve().hasMember.reference)) | |
| dom-2 | error | DiagnosticReport | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DiagnosticReport | 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 | DiagnosticReport | 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 | DiagnosticReport | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DiagnosticReport | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 DiagnosticReport
Summary
Must-Support: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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