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

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Resource Profile: SpecimenDefinition - Drug

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

Usage:

• Use this Resource Profile: Bundle – Analytical Procedure PQ and Bundle – Drug Stability PQ
• Examples for this Resource Profile: SpecimenDefinition/specimenDefStoredAt30, SpecimenDefinition/specimenDefStoredAt40 and SpecimenDefinition/specimendefinition-drug-pq-ex1

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
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This structure is derived from SpecimenDefinition

Name	Flags	Card.	Type	Description & Constraints
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
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
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
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes identifying the status of a SpecimenDefinition resource.
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SpecimenDefinition.status	required	PublicationStatus
SpecimenDefinition.typeTested.preference	required	SpecimenContainedPreference

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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 Bindings Purpose 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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SpecimenDefinition.language	required	AllLanguages
SpecimenDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm
SpecimenDefinition.status	required	PublicationStatus
SpecimenDefinition.jurisdiction	extensible	JurisdictionValueSet
SpecimenDefinition.typeCollected	example	Hl7VSSpecimenType
SpecimenDefinition.patientPreparation	example	PreparePatient
SpecimenDefinition.collection	example	SpecimenCollection
SpecimenDefinition.typeTested.type	example	Hl7VSSpecimenType
SpecimenDefinition.typeTested.preference	required	SpecimenContainedPreference
SpecimenDefinition.typeTested.container.material	example	ContainerMaterials
SpecimenDefinition.typeTested.container.type	example	SpecimenContainerType
SpecimenDefinition.typeTested.container.cap	example	ContainerCap
SpecimenDefinition.typeTested.container.additive.additive[x]	example	Hl7VSAdditivePreservative
SpecimenDefinition.typeTested.rejectionCriterion	example	RejectionCriterion
SpecimenDefinition.typeTested.handling.temperatureQualifier	example	HandlingConditionSet
SpecimenDefinition.typeTested.testingDestination	example	DiagnosticServiceSectionCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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 SpecimenDefinition

Summary

Must-Support: 2 elements

Differential View

This structure is derived from SpecimenDefinition

Name	Flags	Card.	Type	Description & Constraints
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
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes identifying the status of a SpecimenDefinition resource.
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SpecimenDefinition.status	required	PublicationStatus
SpecimenDefinition.typeTested.preference	required	SpecimenContainedPreference

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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 Bindings Purpose 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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
SpecimenDefinition.language	required	AllLanguages
SpecimenDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm
SpecimenDefinition.status	required	PublicationStatus
SpecimenDefinition.jurisdiction	extensible	JurisdictionValueSet
SpecimenDefinition.typeCollected	example	Hl7VSSpecimenType
SpecimenDefinition.patientPreparation	example	PreparePatient
SpecimenDefinition.collection	example	SpecimenCollection
SpecimenDefinition.typeTested.type	example	Hl7VSSpecimenType
SpecimenDefinition.typeTested.preference	required	SpecimenContainedPreference
SpecimenDefinition.typeTested.container.material	example	ContainerMaterials
SpecimenDefinition.typeTested.container.type	example	SpecimenContainerType
SpecimenDefinition.typeTested.container.cap	example	ContainerCap
SpecimenDefinition.typeTested.container.additive.additive[x]	example	Hl7VSAdditivePreservative
SpecimenDefinition.typeTested.rejectionCriterion	example	RejectionCriterion
SpecimenDefinition.typeTested.handling.temperatureQualifier	example	HandlingConditionSet
SpecimenDefinition.typeTested.testingDestination	example	DiagnosticServiceSectionCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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 SpecimenDefinition

Summary

Must-Support: 2 elements

Other representations of profile: CSV, Excel, Schematron