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

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: ObservationDefinition - Test Method

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

Usage:

• Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle – Batch Analysis PQ, Bundle – Container Closure System PQ, Bundle - Drug Product Compatibility PQ... Show 6 more, Bundle – Drug Product Specification PQ, Bundle – Drug Reference Standards PQ, Bundle – Drug Stability PQ, Bundle – Drug Substance Characterization PQ, Bundle – Drug Substance Specification PQ and Bundle - Product Process Validation PQ
• Refer to this Resource Profile: ActivityDefinition - Test Drug PQ
• Examples for this Resource Profile: ObservationDefinition/Assay, ObservationDefinition/Degradation, ObservationDefinition/Description, ObservationDefinition/Identification... Show 12 more, ObservationDefinition/Impurities, ObservationDefinition/Microbiological, ObservationDefinition/Uniformity, ObservationDefinition/Water, ObservationDefinition/accelerated40X, ObservationDefinition/accelerated40Y, ObservationDefinition/accelerated40Z, ObservationDefinition/longTerm25X, ObservationDefinition/longTerm25Y, ObservationDefinition/longTerm25Z, ObservationDefinition/longTerm30X and ObservationDefinition/longTerm30Y

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ObservationDefinition

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

Terminology Bindings (Differential)

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

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

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ObservationDefinition.code	example	VsTestMethodPQ (a valid code from Example Local Codes - Drug) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq from this IG
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ObservationDefinition	Name 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-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()
obd-0	error	ObservationDefinition	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

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

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ObservationDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
ObservationDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ObservationDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ObservationDefinition.category	example	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
ObservationDefinition.code	example	VsTestMethodPQ (a valid code from Example Local Codes - Drug) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq from this IG
ObservationDefinition.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0 from the FHIR Standard
ObservationDefinition.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.permittedUnit	preferred	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.qualifiedValue.context	extensible	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
ObservationDefinition.qualifiedValue.gender	required	AdministrativeGender http://hl7.org/fhir/ValueSet/administrative-gender|5.0.0 from the FHIR Standard
ObservationDefinition.qualifiedValue.rangeCategory	required	ObservationRangeCategory http://hl7.org/fhir/ValueSet/observation-range-category|5.0.0 from the FHIR Standard
ObservationDefinition.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
ObservationDefinition.component.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0 from the FHIR Standard
ObservationDefinition.component.permittedUnit	preferred	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ObservationDefinition	Name 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-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()
obd-0	error	ObservationDefinition	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()
obd-1	error	ObservationDefinition.component	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

This structure is derived from ObservationDefinition

Summary

Must-Support: 14 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq

Differential View

This structure is derived from ObservationDefinition

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

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ObservationDefinition.code	example	VsTestMethodPQ (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

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

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ObservationDefinition.code	example	VsTestMethodPQ (a valid code from Example Local Codes - Drug) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq from this IG
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ObservationDefinition	Name 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-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()
obd-0	error	ObservationDefinition	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

Snapshot View

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

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ObservationDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
ObservationDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ObservationDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ObservationDefinition.category	example	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
ObservationDefinition.code	example	VsTestMethodPQ (a valid code from Example Local Codes - Drug) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-test-method-pq from this IG
ObservationDefinition.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0 from the FHIR Standard
ObservationDefinition.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.permittedUnit	preferred	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.qualifiedValue.context	extensible	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
ObservationDefinition.qualifiedValue.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
ObservationDefinition.qualifiedValue.gender	required	AdministrativeGender http://hl7.org/fhir/ValueSet/administrative-gender|5.0.0 from the FHIR Standard
ObservationDefinition.qualifiedValue.rangeCategory	required	ObservationRangeCategory http://hl7.org/fhir/ValueSet/observation-range-category|5.0.0 from the FHIR Standard
ObservationDefinition.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
ObservationDefinition.component.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|5.0.0 from the FHIR Standard
ObservationDefinition.component.permittedUnit	preferred	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	ObservationDefinition	Name 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-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()
obd-0	error	ObservationDefinition	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()
obd-1	error	ObservationDefinition.component	If permittedUnit exists, then permittedDataType=Quantity must exist. : permittedUnit.exists() implies (permittedDataType = 'Quantity').exists()

This structure is derived from ObservationDefinition

Summary

Must-Support: 14 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq

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