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

## Resource Profile: DiagnosticReport - Drug Analysis

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:

- Use this Resource Profile: Bundle – Batch Analysis PQ, Bundle - Drug Product Compatibility PQ, Bundle – Drug Product Microbiological Attributes PQ, Bundle – Drug Reference Standards PQ... Show 4 more, Bundle – Drug Stability PQ, Bundle – Drug Substance Characterization PQ, Bundle - Product Impurities PQ and Bundle - Product Process Validation PQ
- Examples for this Resource Profile: DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod

### Formal Views of Profile Content

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

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

This structure is derived from 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

#### Terminology Bindings (Differential)

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-pq` from 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 | S Σ | 0..* | Identifier | Business identifier for report
status | ?!S Σ | 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 | S Σ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example)
effective[x] | S Σ | 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 | S Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service
result | S C | 0..* | Reference(Observation - Test Result Drug PQ) | Observations
conclusion | S | 0..1 | markdown | Clinical conclusion (interpretation) of test results
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DiagnosticReport.status | required | DiagnosticReportStatus `http://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0` from 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-pq` from this IG

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
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 | S Σ | 0..* | Identifier | Business identifier for report
basedOn |  | 0..* | Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | What was requested
status | ?!S Σ | 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 | S Σ | 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] | S Σ | 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 | S Σ | 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 | S C | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DiagnosticReport.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
DiagnosticReport.status | required | DiagnosticReportStatus `http://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0` from the FHIR Standard
DiagnosticReport.category | example | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from 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-pq` from this IG
DiagnosticReport.supportingInfo.type | example | Hl7VSVSObservationType `http://terminology.hl7.org/ValueSet/v2-0936`
DiagnosticReport.conclusionCode | example | SNOMEDCTClinicalFindings `http://hl7.org/fhir/ValueSet/clinical-findings` from the FHIR Standard

#### Constraints

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:

- Observation - Test Result Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq

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

#### Terminology Bindings (Differential)

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-pq` from 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 | S Σ | 0..* | Identifier | Business identifier for report
status | ?!S Σ | 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 | S Σ | 1..1 | CodeableConcept | Name/Code for this diagnostic report Binding: Report Type (example)
effective[x] | S Σ | 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 | S Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam) | Responsible Diagnostic Service
result | S C | 0..* | Reference(Observation - Test Result Drug PQ) | Observations
conclusion | S | 0..1 | markdown | Clinical conclusion (interpretation) of test results
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DiagnosticReport.status | required | DiagnosticReportStatus `http://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0` from 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-pq` from this IG

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
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 | S Σ | 0..* | Identifier | Business identifier for report
basedOn |  | 0..* | Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | What was requested
status | ?!S Σ | 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 | S Σ | 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] | S Σ | 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 | S Σ | 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 | S C | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DiagnosticReport.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
DiagnosticReport.status | required | DiagnosticReportStatus `http://hl7.org/fhir/ValueSet/diagnostic-report-status|5.0.0` from the FHIR Standard
DiagnosticReport.category | example | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from 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-pq` from this IG
DiagnosticReport.supportingInfo.type | example | Hl7VSVSObservationType `http://terminology.hl7.org/ValueSet/v2-0936`
DiagnosticReport.conclusionCode | example | SNOMEDCTClinicalFindings `http://hl7.org/fhir/ValueSet/clinical-findings` from the FHIR Standard

#### Constraints

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:

- Observation - Test Result Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq
- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq

Other representations of profile: CSV, Excel, Schematron