This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . 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
id	S	0..1	id	Logical id of this artifact
contained	S	0..*	Resource	Contained, inline Resources
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
effective[x]	S	0..1	dateTime, Period	Clinically relevant time/time-period for report
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

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
id	SΣ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained	S	0..*	Resource	Contained, inline Resources
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: LOINCDiagnosticReportCodes (preferred): LOINC Codes for Diagnostic Reports
effective[x]	SΣ	0..1		Clinically relevant time/time-period for report
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
DiagnosticReport.status	required	DiagnosticReportStatus
DiagnosticReport.code	preferred	LOINCDiagnosticReportCodes (a valid code from LOINC)

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
id	SΣ	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
extension		0..*	Extension	Additional content defined by implementations
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: LOINCDiagnosticReportCodes (preferred): LOINC Codes for Diagnostic Reports
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
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
DiagnosticReport.language	required	AllLanguages
DiagnosticReport.status	required	DiagnosticReportStatus
DiagnosticReport.category	example	DiagnosticServiceSectionCodes
DiagnosticReport.code	preferred	LOINCDiagnosticReportCodes (a valid code from LOINC)
DiagnosticReport.supportingInfo.type	example	Hl7VSVSObservationType
DiagnosticReport.conclusionCode	example	SNOMEDCTClinicalFindings

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: 9 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)

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
id	S	0..1	id	Logical id of this artifact
contained	S	0..*	Resource	Contained, inline Resources
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
effective[x]	S	0..1	dateTime, Period	Clinically relevant time/time-period for report
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

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
id	SΣ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained	S	0..*	Resource	Contained, inline Resources
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: LOINCDiagnosticReportCodes (preferred): LOINC Codes for Diagnostic Reports
effective[x]	SΣ	0..1		Clinically relevant time/time-period for report
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
DiagnosticReport.status	required	DiagnosticReportStatus
DiagnosticReport.code	preferred	LOINCDiagnosticReportCodes (a valid code from LOINC)

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
id	SΣ	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
extension		0..*	Extension	Additional content defined by implementations
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: LOINCDiagnosticReportCodes (preferred): LOINC Codes for Diagnostic Reports
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
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
DiagnosticReport.language	required	AllLanguages
DiagnosticReport.status	required	DiagnosticReportStatus
DiagnosticReport.category	example	DiagnosticServiceSectionCodes
DiagnosticReport.code	preferred	LOINCDiagnosticReportCodes (a valid code from LOINC)
DiagnosticReport.supportingInfo.type	example	Hl7VSVSObservationType
DiagnosticReport.conclusionCode	example	SNOMEDCTClinicalFindings

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: 9 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)

Other representations of profile: CSV, Excel, Schematron