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

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: DiagnosticReport - Drug Analysis

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	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

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	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

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	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

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	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

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