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

## 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 2024-05-08 | 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:

- 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 | S Σ | 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 | Σ C | 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 | S Σ | 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 | Σ C | 0..1 | SimpleQuantity | Low limit
high | Σ C | 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 | S Σ | 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 | Σ C | 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 | S Σ | 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 | Σ C | 0..1 | SimpleQuantity | Low limit
high | Σ C | 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

Other representations of profile: CSV, Excel, Schematron