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: SpecimenDefinition - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: SpecimenDefinitionDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.38

This SpecimenDefinition profile represents information about the treatment of a specimen, such as storage conditions and test duration.

Usage:

Formal Views of Profile Content

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

This structure is derived from SpecimenDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... status S 1..1 code draft | active | retired | unknown
... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... 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
... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... preference 1..1 code preferred | alternate
Binding: SpecimenContainedPreference (required): Degree of preference of a type of conditioned specimen.


Example General: preferred, alternate

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SpecimenDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
SpecimenDefinition.typeTested.preferencerequiredSpecimenContainedPreference
http://hl7.org/fhir/ValueSet/specimen-contained-preference|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
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
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... 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 BindingsPurpose
CommonLanguages Starter Set
... 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
... url Σ 0..1 uri Logical canonical URL to reference this SpecimenDefinition (globally unique)
... identifier Σ 0..1 Identifier Business identifier
... version Σ 0..1 string Business version of the SpecimenDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name Σ 0..1 string Name for this {{title}} (computer friendly)
... title Σ 0..1 string Name for this SpecimenDefinition (Human friendly)
... derivedFromCanonical Σ 0..* canonical(SpecimenDefinition) Based on FHIR definition of another SpecimenDefinition
... derivedFromUri Σ 0..* uri Based on external definition
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the status of a SpecimenDefinition resource.

... experimental Σ 0..1 boolean If this SpecimenDefinition is not for real usage
... subject[x] Σ 0..1 Type of subject for specimen collection
.... subjectCodeableConcept CodeableConcept
.... subjectReference Reference(Group)
... date Σ 0..1 dateTime Date status first applied
... publisher Σ 0..1 string The name of the individual or organization that published the SpecimenDefinition
... contact Σ 0..* ContactDetail Contact details for the publisher
... description 0..1 markdown Natural language description of the SpecimenDefinition
... useContext 0..* UsageContext Content intends to support these contexts
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for this SpecimenDefinition (if applicable)
Binding: JurisdictionValueSet (extensible): Codes for country, country subdivision and region for indicating where a resource is intended to be used.


... purpose 0..1 markdown Why this SpecimenDefinition is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel 0..1 string Copyright holder and year(s)
... approvalDate 0..1 date When SpecimenDefinition was approved by publisher
... lastReviewDate 0..1 date The date on which the asset content was last reviewed by the publisher
... effectivePeriod Σ 0..1 Period The effective date range for the SpecimenDefinition
... typeCollected Σ 0..1 CodeableConcept Kind of material to collect
Binding: hl7VS-specimenType (example): The type of the specimen to be collected.

... patientPreparation Σ 0..* CodeableConcept Patient preparation for collection
Binding: PreparePatient (example): SCT descendants of 703763000 |Precondition value (qualifier value)|


... timeAspect Σ 0..1 string Time aspect for collection
Example General: 24 hour, 20' post charge
... collection Σ 0..* CodeableConcept Specimen collection procedure
Binding: SpecimenCollection (example): SCT actions and procedures for specimen collection


... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab
.... 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
.... isDerived 0..1 boolean Primary or secondary specimen
Example General: false
.... type 0..1 CodeableConcept Type of intended specimen
Binding: hl7VS-specimenType (example): The type of specimen conditioned in a container for lab testing.

.... preference 1..1 code preferred | alternate
Binding: SpecimenContainedPreference (required): Degree of preference of a type of conditioned specimen.


Example General: preferred, alternate
.... container 0..1 BackboneElement The specimen's container
..... 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
..... material 0..1 CodeableConcept The material type used for the container
Binding: ContainerMaterials (example): SCT 32039001 |Glass|, 61088005 |Plastic|, 425620007 |Metal|

..... type 0..1 CodeableConcept Kind of container associated with the kind of specimen
Binding: SpecimenContainerType (example): SCT descendants of 706041008 |Device for body fluid and tissue collection/transfer/processing (physical object)|

..... cap 0..1 CodeableConcept Color of container cap
Binding: ContainerCap (example): Color of the container cap.

..... description 0..1 markdown The description of the kind of container
Example General: Blue top tube with citrate
..... capacity 0..1 SimpleQuantity The capacity of this kind of container
..... minimumVolume[x] 0..1 Minimum volume
...... minimumVolumeQuantity Quantity(SimpleQuantity)
...... minimumVolumeString string
..... additive 0..* BackboneElement Additive associated with container
...... 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
...... additive[x] 1..1 Additive associated with container
Binding: hl7VS-additivePreservative (example): Substance added to specimen container.

....... additiveCodeableConcept CodeableConcept
....... additiveReference Reference(SubstanceDefinition)
..... preparation 0..1 markdown Special processing applied to the container for this specimen type
.... requirement 0..1 markdown Requirements for specimen delivery and special handling
.... retentionTime 0..1 Duration The usual time for retaining this kind of specimen
.... singleUse 0..1 boolean Specimen for single use only
.... rejectionCriterion 0..* CodeableConcept Criterion specified for specimen rejection
Binding: RejectionCriterion (example): Criterion for rejection of the specimen by laboratory.


.... handling 0..* BackboneElement Specimen handling before testing
..... 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
..... temperatureQualifier 0..1 CodeableConcept Qualifies the interval of temperature
Binding: HandlingConditionSet (example): Set of handling instructions prior testing of the specimen.

..... temperatureRange 0..1 Range Temperature range for these handling instructions
..... maxDuration 0..1 Duration Maximum preservation time
..... instruction 0..1 markdown Preservation instruction
Example General: freeze within 4 hours
.... testingDestination 0..* CodeableConcept Where the specimen will be tested
Binding: DiagnosticServiceSectionCodes (example): Codes specifying where the specimen will be tested.



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SpecimenDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SpecimenDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
SpecimenDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
SpecimenDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SpecimenDefinition.typeCollectedexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
SpecimenDefinition.patientPreparationexamplePreparePatient
http://hl7.org/fhir/ValueSet/prepare-patient-prior-specimen-collection
from the FHIR Standard
SpecimenDefinition.collectionexampleSpecimenCollection
http://hl7.org/fhir/ValueSet/specimen-collection
from the FHIR Standard
SpecimenDefinition.typeTested.typeexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
SpecimenDefinition.typeTested.preferencerequiredSpecimenContainedPreference
http://hl7.org/fhir/ValueSet/specimen-contained-preference|5.0.0
from the FHIR Standard
SpecimenDefinition.typeTested.container.materialexampleContainerMaterials
http://hl7.org/fhir/ValueSet/container-material
from the FHIR Standard
SpecimenDefinition.typeTested.container.typeexampleSpecimenContainerType
http://hl7.org/fhir/ValueSet/specimen-container-type
from the FHIR Standard
SpecimenDefinition.typeTested.container.capexampleContainerCap
http://hl7.org/fhir/ValueSet/container-cap
from the FHIR Standard
SpecimenDefinition.typeTested.container.additive.additive[x]exampleHl7VSAdditivePreservative
http://terminology.hl7.org/ValueSet/v2-0371
SpecimenDefinition.typeTested.rejectionCriterionexampleRejectionCriterion
http://hl7.org/fhir/ValueSet/rejection-criteria
from the FHIR Standard
SpecimenDefinition.typeTested.handling.temperatureQualifierexampleHandlingConditionSet
http://hl7.org/fhir/ValueSet/handling-condition
from the FHIR Standard
SpecimenDefinition.typeTested.testingDestinationexampleDiagnosticServiceSectionCodes
http://hl7.org/fhir/ValueSet/diagnostic-service-sections
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
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 SpecimenDefinition

Summary

Must-Support: 2 elements

Differential View

This structure is derived from SpecimenDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... status S 1..1 code draft | active | retired | unknown
... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... 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
... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... preference 1..1 code preferred | alternate
Binding: SpecimenContainedPreference (required): Degree of preference of a type of conditioned specimen.


Example General: preferred, alternate

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SpecimenDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
SpecimenDefinition.typeTested.preferencerequiredSpecimenContainedPreference
http://hl7.org/fhir/ValueSet/specimen-contained-preference|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
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
.. SpecimenDefinition 0..* SpecimenDefinition Kind of specimen
... 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 BindingsPurpose
CommonLanguages Starter Set
... 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
... url Σ 0..1 uri Logical canonical URL to reference this SpecimenDefinition (globally unique)
... identifier Σ 0..1 Identifier Business identifier
... version Σ 0..1 string Business version of the SpecimenDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name Σ 0..1 string Name for this {{title}} (computer friendly)
... title Σ 0..1 string Name for this SpecimenDefinition (Human friendly)
... derivedFromCanonical Σ 0..* canonical(SpecimenDefinition) Based on FHIR definition of another SpecimenDefinition
... derivedFromUri Σ 0..* uri Based on external definition
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the status of a SpecimenDefinition resource.

... experimental Σ 0..1 boolean If this SpecimenDefinition is not for real usage
... subject[x] Σ 0..1 Type of subject for specimen collection
.... subjectCodeableConcept CodeableConcept
.... subjectReference Reference(Group)
... date Σ 0..1 dateTime Date status first applied
... publisher Σ 0..1 string The name of the individual or organization that published the SpecimenDefinition
... contact Σ 0..* ContactDetail Contact details for the publisher
... description 0..1 markdown Natural language description of the SpecimenDefinition
... useContext 0..* UsageContext Content intends to support these contexts
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for this SpecimenDefinition (if applicable)
Binding: JurisdictionValueSet (extensible): Codes for country, country subdivision and region for indicating where a resource is intended to be used.


... purpose 0..1 markdown Why this SpecimenDefinition is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel 0..1 string Copyright holder and year(s)
... approvalDate 0..1 date When SpecimenDefinition was approved by publisher
... lastReviewDate 0..1 date The date on which the asset content was last reviewed by the publisher
... effectivePeriod Σ 0..1 Period The effective date range for the SpecimenDefinition
... typeCollected Σ 0..1 CodeableConcept Kind of material to collect
Binding: hl7VS-specimenType (example): The type of the specimen to be collected.

... patientPreparation Σ 0..* CodeableConcept Patient preparation for collection
Binding: PreparePatient (example): SCT descendants of 703763000 |Precondition value (qualifier value)|


... timeAspect Σ 0..1 string Time aspect for collection
Example General: 24 hour, 20' post charge
... collection Σ 0..* CodeableConcept Specimen collection procedure
Binding: SpecimenCollection (example): SCT actions and procedures for specimen collection


... typeTested S 0..* BackboneElement Specimen in container intended for testing by lab
.... 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
.... isDerived 0..1 boolean Primary or secondary specimen
Example General: false
.... type 0..1 CodeableConcept Type of intended specimen
Binding: hl7VS-specimenType (example): The type of specimen conditioned in a container for lab testing.

.... preference 1..1 code preferred | alternate
Binding: SpecimenContainedPreference (required): Degree of preference of a type of conditioned specimen.


Example General: preferred, alternate
.... container 0..1 BackboneElement The specimen's container
..... 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
..... material 0..1 CodeableConcept The material type used for the container
Binding: ContainerMaterials (example): SCT 32039001 |Glass|, 61088005 |Plastic|, 425620007 |Metal|

..... type 0..1 CodeableConcept Kind of container associated with the kind of specimen
Binding: SpecimenContainerType (example): SCT descendants of 706041008 |Device for body fluid and tissue collection/transfer/processing (physical object)|

..... cap 0..1 CodeableConcept Color of container cap
Binding: ContainerCap (example): Color of the container cap.

..... description 0..1 markdown The description of the kind of container
Example General: Blue top tube with citrate
..... capacity 0..1 SimpleQuantity The capacity of this kind of container
..... minimumVolume[x] 0..1 Minimum volume
...... minimumVolumeQuantity Quantity(SimpleQuantity)
...... minimumVolumeString string
..... additive 0..* BackboneElement Additive associated with container
...... 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
...... additive[x] 1..1 Additive associated with container
Binding: hl7VS-additivePreservative (example): Substance added to specimen container.

....... additiveCodeableConcept CodeableConcept
....... additiveReference Reference(SubstanceDefinition)
..... preparation 0..1 markdown Special processing applied to the container for this specimen type
.... requirement 0..1 markdown Requirements for specimen delivery and special handling
.... retentionTime 0..1 Duration The usual time for retaining this kind of specimen
.... singleUse 0..1 boolean Specimen for single use only
.... rejectionCriterion 0..* CodeableConcept Criterion specified for specimen rejection
Binding: RejectionCriterion (example): Criterion for rejection of the specimen by laboratory.


.... handling 0..* BackboneElement Specimen handling before testing
..... 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
..... temperatureQualifier 0..1 CodeableConcept Qualifies the interval of temperature
Binding: HandlingConditionSet (example): Set of handling instructions prior testing of the specimen.

..... temperatureRange 0..1 Range Temperature range for these handling instructions
..... maxDuration 0..1 Duration Maximum preservation time
..... instruction 0..1 markdown Preservation instruction
Example General: freeze within 4 hours
.... testingDestination 0..* CodeableConcept Where the specimen will be tested
Binding: DiagnosticServiceSectionCodes (example): Codes specifying where the specimen will be tested.



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SpecimenDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SpecimenDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
SpecimenDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
SpecimenDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SpecimenDefinition.typeCollectedexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
SpecimenDefinition.patientPreparationexamplePreparePatient
http://hl7.org/fhir/ValueSet/prepare-patient-prior-specimen-collection
from the FHIR Standard
SpecimenDefinition.collectionexampleSpecimenCollection
http://hl7.org/fhir/ValueSet/specimen-collection
from the FHIR Standard
SpecimenDefinition.typeTested.typeexampleHl7VSSpecimenType
http://terminology.hl7.org/ValueSet/v2-0487
SpecimenDefinition.typeTested.preferencerequiredSpecimenContainedPreference
http://hl7.org/fhir/ValueSet/specimen-contained-preference|5.0.0
from the FHIR Standard
SpecimenDefinition.typeTested.container.materialexampleContainerMaterials
http://hl7.org/fhir/ValueSet/container-material
from the FHIR Standard
SpecimenDefinition.typeTested.container.typeexampleSpecimenContainerType
http://hl7.org/fhir/ValueSet/specimen-container-type
from the FHIR Standard
SpecimenDefinition.typeTested.container.capexampleContainerCap
http://hl7.org/fhir/ValueSet/container-cap
from the FHIR Standard
SpecimenDefinition.typeTested.container.additive.additive[x]exampleHl7VSAdditivePreservative
http://terminology.hl7.org/ValueSet/v2-0371
SpecimenDefinition.typeTested.rejectionCriterionexampleRejectionCriterion
http://hl7.org/fhir/ValueSet/rejection-criteria
from the FHIR Standard
SpecimenDefinition.typeTested.handling.temperatureQualifierexampleHandlingConditionSet
http://hl7.org/fhir/ValueSet/handling-condition
from the FHIR Standard
SpecimenDefinition.typeTested.testingDestinationexampleDiagnosticServiceSectionCodes
http://hl7.org/fhir/ValueSet/diagnostic-service-sections
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
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 SpecimenDefinition

Summary

Must-Support: 2 elements

 

Other representations of profile: CSV, Excel, Schematron