基于FHIR标准的健康档案共享文档实施指南
0.8.0.2022705 - 持续集成版

基于FHIR的健康档案共享文档实施时必须严格遵循本实施指南的规定。

Resource Profile: 通用观察结构定义

Defining URL:http://hl7.org.cn/fhir/sd/ehr/StructureDefinition/profile-general-observation
Version:0.8.0.2022705
Name:GeneralObservation
Title:通用观察结构定义
Status:Active as of 2022-07-05T13:46:42+08:00
Definition:

通用观察资源本地化定义。

Publisher:CHIMA&HL7中国委员会
Source Resource:XML / JSON / Turtle

通用观察结构定义的正式唯一标识为: 

http://hl7.org.cn/fhir/sd/ehr/StructureDefinition/profile-general-observation

简介

通用观察使用 Observation资源进行表示。该资源的本地化结构定义声明了对适用于健康医疗信息平台中通用观察的最低要求。它确定在使用此资源时应包含哪些核心元素、扩展和术语

快速实施指导

通用观察是用于记录WS363通用数据元的资源。 通用观察的结果取值的数据类型可以通过数据元定义推定，由具体的通用观察实施者确定。

定义内容的视图

通用观察结构定义是在FHIR标准的Observation基础上进行更加详细的规则约束，下表展示了通用观察结构定义的结构表示。

关于定义、差异、快照以及如何解读这些表示法。

这种结构源自 Observation

Summary

Mandatory: 2 elements
Must-Support: 1 element

Slices

This structure defines the following Slices:

  • The element Observation.code.coding is sliced based on the value of value:system

这种结构源自 Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationMeasurements and simple assertions
... status 1..1code观察的状态，默认值可以设为final
... code 1..1CodeableConcept观察的编码
.... coding 0..*(Slice Definition)Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:Local S0..1Coding编码限定为卫生行业标准定义的数据元标准
Binding: 卫生标准数据元代码表 (required)
... subject 1..1Reference(Patient | Group | Device | Location)指向患者的引用

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!Σ1..1code观察的状态，默认值可以设为final
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..*CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code Σ1..1CodeableConcept观察的编码
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*(Slice Definition)Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:Local SΣ0..1Coding编码限定为卫生行业标准定义的数据元标准
Binding: 卫生标准数据元代码表 (required)
.... text Σ0..1stringPlain text representation of the concept
... subject Σ1..1Reference(Patient | Group | Device | Location)指向患者的引用
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ1..1Reference(Encounter)指向诊疗或健康活动资源
... effective[x] Σ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] ΣI0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason I0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange I0..*BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component Σ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
... code Σ1..1CodeableConcept观察的编码
.... coding:Local Σ0..1Coding编码限定为卫生行业标准定义的数据元标准
Binding: 卫生标准数据元代码表 (required)

doco Documentation for this format

这种结构源自 Observation

Summary

Mandatory: 2 elements
Must-Support: 1 element

Slices

This structure defines the following Slices:

  • The element Observation.code.coding is sliced based on the value of value:system

差异视图

这种结构源自 Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationMeasurements and simple assertions
... status 1..1code观察的状态，默认值可以设为final
... code 1..1CodeableConcept观察的编码
.... coding 0..*(Slice Definition)Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:Local S0..1Coding编码限定为卫生行业标准定义的数据元标准
Binding: 卫生标准数据元代码表 (required)
... subject 1..1Reference(Patient | Group | Device | Location)指向患者的引用

doco Documentation for this format

快照视图

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!Σ1..1code观察的状态，默认值可以设为final
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..*CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code Σ1..1CodeableConcept观察的编码
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*(Slice Definition)Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:Local SΣ0..1Coding编码限定为卫生行业标准定义的数据元标准
Binding: 卫生标准数据元代码表 (required)
.... text Σ0..1stringPlain text representation of the concept
... subject Σ1..1Reference(Patient | Group | Device | Location)指向患者的引用
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ1..1Reference(Encounter)指向诊疗或健康活动资源
... effective[x] Σ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] ΣI0..1Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason I0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange I0..*BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component Σ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

 

本定义的其它表示法: Schematron

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Max Binding: AllLanguages
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.codeexampleLOINCCodes
Observation.code.coding:LocalrequiredWSDE
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdPathDetailsRequirements
dom-2ObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3ObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4ObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5ObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6ObservationA resource should have narrative for robust management
: text.`div`.exists()
obs-6ObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7ObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
ele-1Observation.metaAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.implicitRulesAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.languageAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.textAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.identifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.basedOnAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.partOfAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.statusAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.categoryAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.codeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.code.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.code.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.code.codingAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.code.coding:LocalAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.code.textAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.subjectAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.focusAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.encounterAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.effective[x]All FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.issuedAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.performerAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.value[x]All FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.dataAbsentReasonAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.interpretationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.noteAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.bodySiteAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.methodAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.specimenAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.deviceAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRangeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
obs-3Observation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
ele-1Observation.referenceRange.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.referenceRange.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.referenceRange.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.referenceRange.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.referenceRange.lowAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRange.highAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRange.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRange.appliesToAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRange.ageAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.referenceRange.textAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.hasMemberAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.derivedFromAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.componentAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.component.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.component.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.component.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Observation.component.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Observation.component.codeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.component.value[x]All FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.component.dataAbsentReasonAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.component.interpretationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Observation.component.referenceRangeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())