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: ObservationDefinition - Test Method

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq Version: 1.0.0
Active as of 2024-04-22 Computable Name: ObservationDefinitionTestMethodPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.32

This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria.

Usage:

Formal Views of Profile Content

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

This structure is derived from ObservationDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..* ObservationDefinition Definition of an observation
... title 0..1 string Name for this ObservationDefinition (human friendly)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
... code S 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... method S 0..1 CodeableConcept Method used to produce the observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... appliesTo
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... range S 0..1 Range The range for continuous or ordinal observations
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition C 0..* ObservationDefinition Definition of an observation
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
obd-0: If permittedUnit exists, then permittedDataType=Quantity must exist.
... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the state of an ObservationDefinition.

... code SΣ 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... method S 0..1 CodeableConcept Method used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..* Reference(SpecimenDefinition) Kind of specimen used by this type of observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... appliesTo 0..* CodeableConcept Targetted population for the set of qualified values
Binding: ObservationReferenceRangeAppliesToCodes (example)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... range S 0..1 Range The range for continuous or ordinal observations
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ObservationDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG
ObservationDefinition.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cnl-0warningObservationDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
obd-0errorObservationDefinitionIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition C 0..* ObservationDefinition Definition of an observation
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
obd-0: If permittedUnit exists, then permittedDataType=Quantity must exist.
... 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 ObservationDefinition (globally unique)
... identifier Σ 0..1 Identifier Business identifier of the ObservationDefinition
... version Σ 0..1 string Business version of the ObservationDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name ΣC 0..1 string Name for this ObservationDefinition (computer friendly)
... title Σ 0..1 string Name for this ObservationDefinition (human friendly)
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... value 0..1 string Primitive value for string
Max Length: 1048576
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the state of an ObservationDefinition.

... experimental Σ 0..1 boolean If for testing purposes, not real usage
... date Σ 0..1 dateTime Date last changed
... publisher Σ 0..1 string The name of the individual or organization that published the ObservationDefinition
... contact Σ 0..* ContactDetail Contact details for the publisher
... description 0..1 markdown Natural language description of the ObservationDefinition
... useContext Σ 0..* UsageContext Content intends to support these contexts
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for this ObservationDefinition (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 ObservationDefinition 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 ObservationDefinition was approved by publisher
... lastReviewDate 0..1 date Date on which the asset content was last reviewed by the publisher
... effectivePeriod Σ 0..1 Period The effective date range for the ObservationDefinition
... derivedFromCanonical Σ 0..* canonical(ObservationDefinition) Based on FHIR definition of another observation
... derivedFromUri Σ 0..* uri Based on external definition
... subject Σ 0..* CodeableConcept Type of subject for the defined observation
... performerType Σ 0..1 CodeableConcept Desired kind of performer for such kind of observation
... category Σ 0..* CodeableConcept General type of observation
Binding: ObservationCategoryCodes (example): Codes for high level observation categories.


... code SΣ 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... permittedDataType C 0..* code Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
... multipleResultsAllowed 0..1 boolean Multiple results allowed for conforming observations
Example General: true
... bodySite 0..1 CodeableConcept Body part to be observed
Binding: SNOMEDCTBodyStructures (example): SNOMED CT body structures.

... method S 0..1 CodeableConcept Method used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..* Reference(SpecimenDefinition) Kind of specimen used by this type of observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... preferredReportName 0..1 string The preferred name to be used when reporting the observation results
... permittedUnit C 0..* Coding Unit for quantitative results
Binding: UCUMCodes (preferred): Codes identifying units of measure.


... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... context 0..1 CodeableConcept Context qualifier for the set of qualified values
Binding: ObservationReferenceRangeMeaningCodes (extensible)
.... appliesTo 0..* CodeableConcept Targetted population for the set of qualified values
Binding: ObservationReferenceRangeAppliesToCodes (example)
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
..... coding Σ 0..* Coding Code defined by a terminology system
..... text Σ 0..1 string Plain text representation of the concept
.... gender 0..1 code male | female | other | unknown
Binding: AdministrativeGender (required)
Example General: female
.... age 0..1 Range Applicable age range for the set of qualified values
.... gestationalAge 0..1 Range Applicable gestational age range for the set of qualified values
.... condition 0..1 string Condition associated with the set of qualified values
.... rangeCategory 0..1 code reference | critical | absolute
Binding: ObservationRangeCategory (required)
Example General: critical
.... range S 0..1 Range The range for continuous or ordinal observations
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
..... low ΣC 0..1 SimpleQuantity Low limit
..... high ΣC 0..1 SimpleQuantity High limit
.... validCodedValueSet 0..1 canonical(ValueSet) Value set of valid coded values as part of this set of qualified values
.... normalCodedValueSet 0..1 canonical(ValueSet) Value set of normal coded values as part of this set of qualified values
.... abnormalCodedValueSet 0..1 canonical(ValueSet) Value set of abnormal coded values as part of this set of qualified values
.... criticalCodedValueSet 0..1 canonical(ValueSet) Value set of critical coded values as part of this set of qualified values
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group
... component C 0..* BackboneElement Component results
obd-1: If permittedUnit exists, then permittedDataType=Quantity must exist.
.... 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
.... code 1..1 CodeableConcept Type of observation
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... permittedDataType C 0..* code Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
.... permittedUnit C 0..* Coding Unit for quantitative results
Binding: UCUMCodes (preferred): Codes identifying units of measure.


.... qualifiedValue 0..* See qualifiedValue (ObservationDefinition) Set of qualified values for observation results

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ObservationDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
ObservationDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
ObservationDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ObservationDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ObservationDefinition.categoryexampleObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG
ObservationDefinition.permittedDataTyperequiredObservationDataType
http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0
from the FHIR Standard
ObservationDefinition.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
ObservationDefinition.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
ObservationDefinition.permittedUnitpreferredUCUMCodes (a valid code from UCUM)
http://hl7.org/fhir/ValueSet/ucum-units
from the FHIR Standard
ObservationDefinition.qualifiedValue.contextextensibleObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
ObservationDefinition.qualifiedValue.genderrequiredAdministrativeGender
http://hl7.org/fhir/ValueSet/administrative-gender|5.0.0
from the FHIR Standard
ObservationDefinition.qualifiedValue.rangeCategoryrequiredObservationRangeCategory
http://hl7.org/fhir/ValueSet/observation-range-category|5.0.0
from the FHIR Standard
ObservationDefinition.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
ObservationDefinition.component.permittedDataTyperequiredObservationDataType
http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0
from the FHIR Standard
ObservationDefinition.component.permittedUnitpreferredUCUMCodes (a valid code from UCUM)
http://hl7.org/fhir/ValueSet/ucum-units
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cnl-0warningObservationDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
obd-0errorObservationDefinitionIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()
obd-1errorObservationDefinition.componentIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

Differential View

This structure is derived from ObservationDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..* ObservationDefinition Definition of an observation
... title 0..1 string Name for this ObservationDefinition (human friendly)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
... code S 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... method S 0..1 CodeableConcept Method used to produce the observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... appliesTo
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... range S 0..1 Range The range for continuous or ordinal observations
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition C 0..* ObservationDefinition Definition of an observation
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
obd-0: If permittedUnit exists, then permittedDataType=Quantity must exist.
... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the state of an ObservationDefinition.

... code SΣ 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... method S 0..1 CodeableConcept Method used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..* Reference(SpecimenDefinition) Kind of specimen used by this type of observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... appliesTo 0..* CodeableConcept Targetted population for the set of qualified values
Binding: ObservationReferenceRangeAppliesToCodes (example)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... range S 0..1 Range The range for continuous or ordinal observations
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ObservationDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG
ObservationDefinition.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cnl-0warningObservationDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
obd-0errorObservationDefinitionIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition C 0..* ObservationDefinition Definition of an observation
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
obd-0: If permittedUnit exists, then permittedDataType=Quantity must exist.
... 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 ObservationDefinition (globally unique)
... identifier Σ 0..1 Identifier Business identifier of the ObservationDefinition
... version Σ 0..1 string Business version of the ObservationDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name ΣC 0..1 string Name for this ObservationDefinition (computer friendly)
... title Σ 0..1 string Name for this ObservationDefinition (human friendly)
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... test-comment-title S 0..1 string test-comment-title
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
.... value 0..1 string Primitive value for string
Max Length: 1048576
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes identifying the state of an ObservationDefinition.

... experimental Σ 0..1 boolean If for testing purposes, not real usage
... date Σ 0..1 dateTime Date last changed
... publisher Σ 0..1 string The name of the individual or organization that published the ObservationDefinition
... contact Σ 0..* ContactDetail Contact details for the publisher
... description 0..1 markdown Natural language description of the ObservationDefinition
... useContext Σ 0..* UsageContext Content intends to support these contexts
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for this ObservationDefinition (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 ObservationDefinition 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 ObservationDefinition was approved by publisher
... lastReviewDate 0..1 date Date on which the asset content was last reviewed by the publisher
... effectivePeriod Σ 0..1 Period The effective date range for the ObservationDefinition
... derivedFromCanonical Σ 0..* canonical(ObservationDefinition) Based on FHIR definition of another observation
... derivedFromUri Σ 0..* uri Based on external definition
... subject Σ 0..* CodeableConcept Type of subject for the defined observation
... performerType Σ 0..1 CodeableConcept Desired kind of performer for such kind of observation
... category Σ 0..* CodeableConcept General type of observation
Binding: ObservationCategoryCodes (example): Codes for high level observation categories.


... code SΣ 1..1 CodeableConcept Type of observation
Binding: Test Method (example)
... permittedDataType C 0..* code Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
... multipleResultsAllowed 0..1 boolean Multiple results allowed for conforming observations
Example General: true
... bodySite 0..1 CodeableConcept Body part to be observed
Binding: SNOMEDCTBodyStructures (example): SNOMED CT body structures.

... method S 0..1 CodeableConcept Method used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..* Reference(SpecimenDefinition) Kind of specimen used by this type of observation
... device S 0..* Reference(DeviceDefinition | Device) Measurement device or model of device
... preferredReportName 0..1 string The preferred name to be used when reporting the observation results
... permittedUnit C 0..* Coding Unit for quantitative results
Binding: UCUMCodes (preferred): Codes identifying units of measure.


... qualifiedValue S 0..* BackboneElement Set of qualified values for observation results
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... qualified-value-text S 0..* string qualified-value-text
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
.... qualified-value-display S 0..* string qualified-value-display
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
.... qualified-value-target S 0..* Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
.... qualified-value-criticality S 0..* CodeableConcept qualified-value-criticality
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
Binding: Qualified Value Criticality (example)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... context 0..1 CodeableConcept Context qualifier for the set of qualified values
Binding: ObservationReferenceRangeMeaningCodes (extensible)
.... appliesTo 0..* CodeableConcept Targetted population for the set of qualified values
Binding: ObservationReferenceRangeAppliesToCodes (example)
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... test-comment S 0..1 string test-comment
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
..... coding Σ 0..* Coding Code defined by a terminology system
..... text Σ 0..1 string Plain text representation of the concept
.... gender 0..1 code male | female | other | unknown
Binding: AdministrativeGender (required)
Example General: female
.... age 0..1 Range Applicable age range for the set of qualified values
.... gestationalAge 0..1 Range Applicable gestational age range for the set of qualified values
.... condition 0..1 string Condition associated with the set of qualified values
.... rangeCategory 0..1 code reference | critical | absolute
Binding: ObservationRangeCategory (required)
Example General: critical
.... range S 0..1 Range The range for continuous or ordinal observations
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... qualified-value-target S 0..1 Quantity qualified-value-target
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
..... low ΣC 0..1 SimpleQuantity Low limit
..... high ΣC 0..1 SimpleQuantity High limit
.... validCodedValueSet 0..1 canonical(ValueSet) Value set of valid coded values as part of this set of qualified values
.... normalCodedValueSet 0..1 canonical(ValueSet) Value set of normal coded values as part of this set of qualified values
.... abnormalCodedValueSet 0..1 canonical(ValueSet) Value set of abnormal coded values as part of this set of qualified values
.... criticalCodedValueSet 0..1 canonical(ValueSet) Value set of critical coded values as part of this set of qualified values
... hasMember S 0..* Reference(ObservationDefinition | Questionnaire) Definitions of related resources belonging to this kind of observation group
... component C 0..* BackboneElement Component results
obd-1: If permittedUnit exists, then permittedDataType=Quantity must exist.
.... 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
.... code 1..1 CodeableConcept Type of observation
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... permittedDataType C 0..* code Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
.... permittedUnit C 0..* Coding Unit for quantitative results
Binding: UCUMCodes (preferred): Codes identifying units of measure.


.... qualifiedValue 0..* See qualifiedValue (ObservationDefinition) Set of qualified values for observation results

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ObservationDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
ObservationDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
ObservationDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ObservationDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ObservationDefinition.categoryexampleObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
ObservationDefinition.codeexampleVsTestMethodPQ (a valid code from Example Local Codes - Drug)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq
from this IG
ObservationDefinition.permittedDataTyperequiredObservationDataType
http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0
from the FHIR Standard
ObservationDefinition.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
ObservationDefinition.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
ObservationDefinition.permittedUnitpreferredUCUMCodes (a valid code from UCUM)
http://hl7.org/fhir/ValueSet/ucum-units
from the FHIR Standard
ObservationDefinition.qualifiedValue.contextextensibleObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
ObservationDefinition.qualifiedValue.genderrequiredAdministrativeGender
http://hl7.org/fhir/ValueSet/administrative-gender|5.0.0
from the FHIR Standard
ObservationDefinition.qualifiedValue.rangeCategoryrequiredObservationRangeCategory
http://hl7.org/fhir/ValueSet/observation-range-category|5.0.0
from the FHIR Standard
ObservationDefinition.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
ObservationDefinition.component.permittedDataTyperequiredObservationDataType
http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0
from the FHIR Standard
ObservationDefinition.component.permittedUnitpreferredUCUMCodes (a valid code from UCUM)
http://hl7.org/fhir/ValueSet/ucum-units
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cnl-0warningObservationDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
obd-0errorObservationDefinitionIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()
obd-1errorObservationDefinition.componentIf permittedUnit exists, then permittedDataType=Quantity must exist.
: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

 

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