Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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: Specimen - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: SpecimenDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.37

This Specimen profile represents identifying information about an individual specimen (an instance).

Usage:

Formal Views of Profile Content

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

This structure is derived from Specimen

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... subject S 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... processing S 0..* BackboneElement Processing and processing step details
.... time[x] 0..1 dateTime, Period Date and time of specimen processing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... subject SΣ 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... processing S 0..* BackboneElement Processing and processing step details
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... time[x] 0..1 Date and time of specimen processing
..... time[x]:All Types Content/Rules for all Types
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
..... timeDateTime dateTime
..... timePeriod Period

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSpecimenIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSpecimenIf 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-4errorSpecimenIf 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-5errorSpecimenIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSpecimenA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier External Identifier
... accessionIdentifier Σ 0..1 Identifier Identifier assigned by the lab
... status ?!Σ 0..1 code available | unavailable | unsatisfactory | entered-in-error
Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.

... type Σ 0..1 CodeableConcept Kind of material that forms the specimen
Binding: hl7VS-specimenType (example): The type of the specimen.

... subject SΣ 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... receivedTime Σ 0..1 dateTime The time when specimen is received by the testing laboratory
... parent 0..* Reference(Specimen) Specimen from which this specimen originated
... request 0..* Reference(ServiceRequest) Why the specimen was collected
... combined Σ 0..1 code grouped | pooled
Binding: SpecimenCombined (required): Codes for the combined status of a specimen.

... role 0..* CodeableConcept The role the specimen serves
Binding: SpecimenRole (preferred): Codes describing specimen role.


... feature 0..* BackboneElement The physical feature of a specimen
.... 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 Highlighted feature
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

.... description 1..1 string Information about the feature
... collection 0..1 BackboneElement Collection details
.... 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
.... collector Σ 0..1 Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) Who collected the specimen
.... collected[x] Σ 0..1 Collection time
..... collectedDateTime dateTime
..... collectedPeriod Period
.... duration Σ 0..1 Duration How long it took to collect specimen
.... quantity 0..1 SimpleQuantity The quantity of specimen collected
.... method 0..1 CodeableConcept Technique used to perform collection
Binding: FHIRSpecimenCollectionMethod (example): The technique that is used to perform the procedure.

.... device 0..1 CodeableReference(Device) Device used to perform collection
Binding: (unbound) (example): The device that was used to obtain the specimen (e.g. a catheter or catheter part used to draw the blood via a central line).

.... procedure 0..1 Reference(Procedure) The procedure that collects the specimen
.... bodySite 0..1 CodeableReference(BodyStructure) Anatomical collection site
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

.... fastingStatus[x] Σ 0..1 Whether or how long patient abstained from food and/or drink
Binding: hl7VS-relevantClincialInformation (extensible): Codes describing the fasting status of the patient.

..... fastingStatusCodeableConcept CodeableConcept
..... fastingStatusDuration Duration
... processing S 0..* BackboneElement Processing and processing step details
.... 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
.... description 0..1 string Textual description of procedure
.... method 0..1 CodeableConcept Indicates the treatment step applied to the specimen
Binding: SpecimenProcessingMethod (example): Type indicating the technique used to process the specimen.

.... additive 0..* Reference(Substance) Material used in the processing step
.... time[x] 0..1 Date and time of specimen processing
..... time[x]:All Types Content/Rules for all Types
...... id 0..1 string Unique id for inter-element referencing
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
..... timeDateTime dateTime
..... timePeriod Period
... container 0..* BackboneElement Direct container of specimen (tube/slide, etc.)
.... 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
.... device 1..1 Reference(Device) Device resource for the container
.... location 0..1 Reference(Location) Where the container is
.... specimenQuantity 0..1 SimpleQuantity Quantity of specimen within container
... condition Σ 0..* CodeableConcept State of the specimen
Binding: hl7VS-specimenCondition (extensible): Codes describing the state of the specimen.


... note 0..* Annotation Comments

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|5.0.0
from the FHIR Standard
Specimen.typeexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
Specimen.combinedrequiredSpecimenCombined
http://hl7.org/fhir/ValueSet/specimen-combined|5.0.0
from the FHIR Standard
Specimen.rolepreferredSpecimenRole
http://hl7.org/fhir/ValueSet/specimen-role
from the FHIR Standard
Specimen.feature.typeexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.methodexampleFHIRSpecimenCollectionMethod
http://hl7.org/fhir/ValueSet/specimen-collection-method
from the FHIR Standard
Specimen.collection.deviceexample
Specimen.collection.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.fastingStatus[x]extensibleHl7VSRelevantClincialInformation
http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.methodexampleSpecimenProcessingMethod
http://hl7.org/fhir/ValueSet/specimen-processing-method
from the FHIR Standard
Specimen.conditionextensibleHl7VSSpecimenCondition
http://terminology.hl7.org/ValueSet/v2-0493

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSpecimenIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSpecimenIf 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-4errorSpecimenIf 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-5errorSpecimenIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSpecimenA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Specimen

Summary

Must-Support: 3 elements

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from Specimen

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... subject S 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... processing S 0..* BackboneElement Processing and processing step details
.... time[x] 0..1 dateTime, Period Date and time of specimen processing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... subject SΣ 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... processing S 0..* BackboneElement Processing and processing step details
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... time[x] 0..1 Date and time of specimen processing
..... time[x]:All Types Content/Rules for all Types
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
..... timeDateTime dateTime
..... timePeriod Period

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSpecimenIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSpecimenIf 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-4errorSpecimenIf 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-5errorSpecimenIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSpecimenA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* Specimen Sample for analysis
... 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier External Identifier
... accessionIdentifier Σ 0..1 Identifier Identifier assigned by the lab
... status ?!Σ 0..1 code available | unavailable | unsatisfactory | entered-in-error
Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.

... type Σ 0..1 CodeableConcept Kind of material that forms the specimen
Binding: hl7VS-specimenType (example): The type of the specimen.

... subject SΣ 0..1 Reference(Patient | Group | Device | BiologicallyDerivedProduct | Substance | Location) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance, a biologically-derived product, or a device
... receivedTime Σ 0..1 dateTime The time when specimen is received by the testing laboratory
... parent 0..* Reference(Specimen) Specimen from which this specimen originated
... request 0..* Reference(ServiceRequest) Why the specimen was collected
... combined Σ 0..1 code grouped | pooled
Binding: SpecimenCombined (required): Codes for the combined status of a specimen.

... role 0..* CodeableConcept The role the specimen serves
Binding: SpecimenRole (preferred): Codes describing specimen role.


... feature 0..* BackboneElement The physical feature of a specimen
.... 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 Highlighted feature
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

.... description 1..1 string Information about the feature
... collection 0..1 BackboneElement Collection details
.... 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
.... collector Σ 0..1 Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) Who collected the specimen
.... collected[x] Σ 0..1 Collection time
..... collectedDateTime dateTime
..... collectedPeriod Period
.... duration Σ 0..1 Duration How long it took to collect specimen
.... quantity 0..1 SimpleQuantity The quantity of specimen collected
.... method 0..1 CodeableConcept Technique used to perform collection
Binding: FHIRSpecimenCollectionMethod (example): The technique that is used to perform the procedure.

.... device 0..1 CodeableReference(Device) Device used to perform collection
Binding: (unbound) (example): The device that was used to obtain the specimen (e.g. a catheter or catheter part used to draw the blood via a central line).

.... procedure 0..1 Reference(Procedure) The procedure that collects the specimen
.... bodySite 0..1 CodeableReference(BodyStructure) Anatomical collection site
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

.... fastingStatus[x] Σ 0..1 Whether or how long patient abstained from food and/or drink
Binding: hl7VS-relevantClincialInformation (extensible): Codes describing the fasting status of the patient.

..... fastingStatusCodeableConcept CodeableConcept
..... fastingStatusDuration Duration
... processing S 0..* BackboneElement Processing and processing step details
.... 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
.... description 0..1 string Textual description of procedure
.... method 0..1 CodeableConcept Indicates the treatment step applied to the specimen
Binding: SpecimenProcessingMethod (example): Type indicating the technique used to process the specimen.

.... additive 0..* Reference(Substance) Material used in the processing step
.... time[x] 0..1 Date and time of specimen processing
..... time[x]:All Types Content/Rules for all Types
...... id 0..1 string Unique id for inter-element referencing
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... batch-storage-duration S 0..* Duration batch-storage-duration
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
..... timeDateTime dateTime
..... timePeriod Period
... container 0..* BackboneElement Direct container of specimen (tube/slide, etc.)
.... 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
.... device 1..1 Reference(Device) Device resource for the container
.... location 0..1 Reference(Location) Where the container is
.... specimenQuantity 0..1 SimpleQuantity Quantity of specimen within container
... condition Σ 0..* CodeableConcept State of the specimen
Binding: hl7VS-specimenCondition (extensible): Codes describing the state of the specimen.


... note 0..* Annotation Comments

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|5.0.0
from the FHIR Standard
Specimen.typeexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
Specimen.combinedrequiredSpecimenCombined
http://hl7.org/fhir/ValueSet/specimen-combined|5.0.0
from the FHIR Standard
Specimen.rolepreferredSpecimenRole
http://hl7.org/fhir/ValueSet/specimen-role
from the FHIR Standard
Specimen.feature.typeexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.methodexampleFHIRSpecimenCollectionMethod
http://hl7.org/fhir/ValueSet/specimen-collection-method
from the FHIR Standard
Specimen.collection.deviceexample
Specimen.collection.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.fastingStatus[x]extensibleHl7VSRelevantClincialInformation
http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.methodexampleSpecimenProcessingMethod
http://hl7.org/fhir/ValueSet/specimen-processing-method
from the FHIR Standard
Specimen.conditionextensibleHl7VSSpecimenCondition
http://terminology.hl7.org/ValueSet/v2-0493

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorSpecimenIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSpecimenIf 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-4errorSpecimenIf 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-5errorSpecimenIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSpecimenA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Specimen

Summary

Must-Support: 3 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron