Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
| Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq | Version: 1.0.0 | ||||
| Active as of 2026-05-10 | Computable Name: ObservationDefinitionTestMethodPq | ||||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.70 | |||||
This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria.
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
| ObservationDefinition.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter:   | ||||
|---|---|---|---|---|---|---|---|---|
  ObservationDefinition |
C | 0..* | ObservationDefinition | Definition of an observation Interfaces Implemented: MetadataResource Constraints: cnl-0, obd-0 | ||||
  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
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| 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 | |||||
  extension: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 (preferred) | ||||
| 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 | |||||
 extension:qualified-value-text |
S | 0..* | string | qualified-value-text URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq | ||||
| extension:qualified-value-display |
S | 0..* | string | qualified-value-display URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq | ||||
| extension:qualified-value-target |
S | 0..* | Quantity | qualified-value-target URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq | ||||
| extension: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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension: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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension: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(5.0.0) | Low limit | ||||
| high |
ΣC | 0..1 | SimpleQuantity(5.0.0) | 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 Constraints: obd-1 | ||||
 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 | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.versionAlgorithm[x] | Base | extensible | Version Algorithm | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.jurisdiction | Base | extensible | Jurisdiction ValueSet | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.category | Base | example | Observation Category Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
| ObservationDefinition.permittedDataType | Base | required | Observation Data Type | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.bodySite | Base | example | SNOMED CT Body Structures | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.permittedUnit | Base | preferred | UCUM Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.context | Base | extensible | Observation Reference Range Meaning Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.gender | Base | required | AdministrativeGender | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.rangeCategory | Base | required | Observation Range Category | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.code | Base | example | LOINC Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.permittedDataType | Base | required | Observation Data Type | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.permittedUnit | Base | preferred | UCUM Codes | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Summary
Must-Support: 14 elements
Extensions
This structure refers to these extensions:
Key Elements View
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
| ObservationDefinition.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Differential View
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ObservationDefinition |
C | 0..* | ObservationDefinition | Definition of an observation Interfaces Implemented: MetadataResource Constraints: cnl-0, obd-0 | ||||
| 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
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| 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 | |||||
| extension: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 (preferred) | ||||
| 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 | |||||
| extension:qualified-value-text |
S | 0..* | string | qualified-value-text URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq | ||||
| extension:qualified-value-display |
S | 0..* | string | qualified-value-display URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq | ||||
| extension:qualified-value-target |
S | 0..* | Quantity | qualified-value-target URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq | ||||
| extension: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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension: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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension: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(5.0.0) | Low limit | ||||
| high |
ΣC | 0..1 | SimpleQuantity(5.0.0) | 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 Constraints: obd-1 | ||||
| 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 | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ObservationDefinition.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.versionAlgorithm[x] | Base | extensible | Version Algorithm | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.jurisdiction | Base | extensible | Jurisdiction ValueSet | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.category | Base | example | Observation Category Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.code | Base | preferred | Test Method | 📦1.0.0 | This IG |
| ObservationDefinition.permittedDataType | Base | required | Observation Data Type | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.bodySite | Base | example | SNOMED CT Body Structures | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.permittedUnit | Base | preferred | UCUM Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.context | Base | extensible | Observation Reference Range Meaning Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.gender | Base | required | AdministrativeGender | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.qualifiedValue.rangeCategory | Base | required | Observation Range Category | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.code | Base | example | LOINC Codes | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.permittedDataType | Base | required | Observation Data Type | 📍5.0.0 | FHIR Std. |
| ObservationDefinition.component.permittedUnit | Base | preferred | UCUM Codes | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Summary
Must-Support: 14 elements
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
Links: Table of Contents |
QA Report
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