HL7 FHIR JP Core ImplementationGuide
1.1.1 - release Japan flag

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Resource Profile: JP_Observation_VitalSigns - Detailed Descriptions

Active as of 2022-10-24

Definitions for the jp-observation-vitalsigns resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Observation
Definition

バイタルサインに関する測定と簡単な観察事実(assertion)。

Shortバイタルサインに関する測定や簡単な観察事実(assertion)
Comments

バイタルサインに関するObservation(検査測定や観察事実)の制約プロフィール

2. Observation.category
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「焦点」

Control1..?
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Category ValueSet
4. Observation.code
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「観察名称」

BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Code ValueSet
6. Observation.subject
Comments

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

【JP Core仕様】患者

Control1..?
TypeReference(JP Core Patient Profile)
8. Observation.encounter
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

【JP Core仕様】診察

10. Observation.effective[x]
Comments

At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

【JP Core仕様】effectiveDateTime:医療者が確認した日時

effectivePeriod:医療者が確認した期間

TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
12. Observation.hasMember
Comments

When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

【JP Core仕様】関連する参照リソースにJP_Observation_VitalSignsを追加

TypeReference(JP Core Observation Common Profile, QuestionnaireResponse, MolecularSequence, JP Core Observation VitalSigns Profile)
14. Observation.derivedFrom
Comments

All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

【JP Core仕様】導出元の参照リソースにJP_Observation_VitalSignsを追加

TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, JP Core Observation Common Profile, MolecularSequence, JP Core Observation VitalSigns Profile)
16. Observation.component
18. Observation.component.code
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Code ValueSet

Guidance on how to interpret the contents of this table can be found here

0. Observation
Definition

バイタルサインに関する測定と簡単な観察事実(assertion)。


Measurements and simple assertions made about a patient, device or other subject.

Shortバイタルサインに関する測定や簡単な観察事実(assertion)Measurements and simple assertions
Comments

バイタルサインに関するObservation(検査測定や観察事実)の制約プロフィール


Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If 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-4: If 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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If 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())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If 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())
2. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Observation.status
Definition

The status of the result value. 結果値のステータス。


The status of the result value.

Shortregistered | preliminary | final | amended +
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. このリソースは現在有効でないというマークをするコードを含んでいるため、この要素はモディファイアー(修飾的要素)として位置づけられている。


This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1

Codes providing the status of an observation.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Observation.category
Definition

A code that classifies the general type of observation being made. 実施されているobservationの一般的なタイプを分類するコード


A code that classifies the general type of observation being made.

ShortClassification of type of observation Observationの種類(タイプ)の分類
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「焦点」


In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control10..*
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Category ValueSethttp://hl7.org/fhir/ValueSet/observation-category
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name".

observationの対象物を記述する。 observation の名前で呼ばれることもある。


Describes what was observed. Sometimes this is called the observation "name".

ShortType of observation (code / type) observation のタイプ(コードまたはタイプ)
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「観察名称」


All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Control1..1
BindingThe codes SHOULD be taken from For example codes, see JP Core Observation VitalSigns Code ValueSethttp://hl7.org/fhir/ValueSet/observation-codes
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

Alternate NamesName
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.subject
Definition

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation. この観察が行われた対象となる患者、または患者のグループ、場所、またはデバイス、あるいはそれらの記録。 もし観察の実際の焦点が対象(または対象のサンプル、一部、または領域)と異なる場合、 focus要素または code自体が観察の実際の焦点を指し示す。


The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

ShortWho and/or what the observation is about 観察対象者
Comments

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

【JP Core仕様】患者


One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

Control10..1
TypeReference(JP Core Patient Profile, Patient, Group, Device, Location)
Is Modifierfalse
Summarytrue
Requirements

Observations have no value if you don't know who or what they're about.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Observation.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. このobservationが行われるヘルスケアイベント(患者とヘルスケアプロバイダの相互作用など)(受診、入院など)。


The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

ShortHealthcare event during which this observation is made このobservationが行われるヘルスケアイベント
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

【JP Core仕様】診察


This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

Control0..1
TypeReference(JP Core Encounter Profile, Encounter)
Is Modifierfalse
Summarytrue
Requirements

For some observations it may be important to know the link between an observation and a particular encounter.

Alternate NamesContext
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Observation.effective[x]
Definition

The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself. 観測値が関連する時間または期間。レポートの対象が患者である場合、これは通常、処置や検体採取の時刻のいずれかであるが、日付/時刻の出処は不明であり、日付/時刻自体のみのことがある。


The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

ShortClinically relevant time/time-period for observation 臨床的に関連する時刻または時間
Comments

At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

【JP Core仕様】effectiveDateTime:医療者が確認した日時

effectivePeriod:医療者が確認した期間


At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

Control0..1
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Knowing when an observation was deemed true is important to its relevance as well as determining trends.

Alternate NamesOccurrence
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Observation.hasMember
Definition

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group. このobservationは、グループのメンバーとしてターゲットを含むグループobservation(たとえば、一連検査セット、パネル検査、バイタルサイン測定値のセット)である。


This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

ShortRelated resource that belongs to the Observation group observationグループに属する関連リソース
Comments

When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

【JP Core仕様】関連する参照リソースにJP_Observation_VitalSignsを追加


When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

Control0..*
TypeReference(JP Core Observation Common Profile, QuestionnaireResponse, MolecularSequence, JP Core Observation VitalSigns Profile, Observation)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Observation.derivedFrom
Definition

The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image. このobservation が導出される元の測定値を表すターゲットリソース。たとえば、超音波画像に基づいて計算されたアニオンギャップまたは胎児の測定値の場合、この要素には、元となった超音波画像検査結果への参照を設定する。


The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

ShortRelated measurements the observation is made from observation が作られる元の関連する測定
Comments

All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

【JP Core仕様】導出元の参照リソースにJP_Observation_VitalSignsを追加


All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

Control0..*
TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, JP Core Observation Common Profile, MolecularSequence, JP Core Observation VitalSigns Profile, Observation)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. Observation
Definition

バイタルサインに関する測定と簡単な観察事実(assertion)。

Shortバイタルサインに関する測定や簡単な観察事実(assertion)
Comments

バイタルサインに関するObservation(検査測定や観察事実)の制約プロフィール

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If 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-4: If 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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If 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())
2. Observation.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. Observation.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Observation.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
TypeNarrative
Is Modifierfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. Observation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. Observation.identifier
Definition

A unique identifier assigned to this observation. Observationに割り当てられたユニーク(一意)の識別ID

ShortBusiness Identifier for observation Observationのためのビジネス識別子
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows observations to be distinguished and referenced.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Observation.basedOn
Definition

A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed. このイベントによって全体または部分的に実施されるプラン、提案、依頼。たとえばMedicationRequest は調剤される前に臨床検査を患者に行う必要があるかもしれない。

ShortFulfills plan, proposal or order 実施されるプラン、提案、依頼
Control0..*
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, JP Core MedicationRequest Profile, JP Core MedicationRequest Injection Profile, NutritionOrder, ServiceRequest)
Is Modifierfalse
Summarytrue
Requirements

Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

Alternate NamesFulfills
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Observation.partOf
Definition

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. この特定のObservationが別のより大きなイベントの要素あるいは一段階であるような親イベント。たとえば、一連の処置手順の一部としてのObservation。

ShortPart of referenced event 参照されるイベントの一部分
Comments

To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation. ObservationをEncounterにencounter要素を使ってリンクする。もうひとつ別のObservationを参照することについては、以降にあるt Notes をガイダンスとして参照のこと。

Control0..*
TypeReference(JP Core MedicationAdministration Profile, JP Core MedicationAdministration Injection Profile, JP Core MedicationDispenseBase Profile, MedicationStatement, JP Core Procedure Profile, JP Core Immunization Profile, ImagingStudy)
Is Modifierfalse
Summarytrue
Alternate NamesContainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.status
Definition

The status of the result value. 結果値のステータス。

Shortregistered | preliminary | final | amended +
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. このリソースは現在有効でないというマークをするコードを含んでいるため、この要素はモディファイアー(修飾的要素)として位置づけられている。

Control1..1
BindingThe codes SHALL be taken from ObservationStatus

Codes providing the status of an observation.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Observation.category
Definition

A code that classifies the general type of observation being made. 実施されているobservationの一般的なタイプを分類するコード

ShortClassification of type of observation Observationの種類(タイプ)の分類
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「焦点」

Control1..*
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Category ValueSet
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name".

observationの対象物を記述する。 observation の名前で呼ばれることもある。

ShortType of observation (code / type) observation のタイプ(コードまたはタイプ)
Comments

MEDISの看護実践用語標準マスター<看護観察編>の大分類1.バイタルサイン・基本情報、中分類1.バイタルサインの「観察名称」

Control1..1
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Code ValueSet
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

Alternate NamesName
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Observation.subject
Definition

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation. この観察が行われた対象となる患者、または患者のグループ、場所、またはデバイス、あるいはそれらの記録。 もし観察の実際の焦点が対象(または対象のサンプル、一部、または領域)と異なる場合、 focus要素または code自体が観察の実際の焦点を指し示す。

ShortWho and/or what the observation is about 観察対象者
Comments

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

【JP Core仕様】患者

Control1..1
TypeReference(JP Core Patient Profile)
Is Modifierfalse
Summarytrue
Requirements

Observations have no value if you don't know who or what they're about.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Observation.focus
Definition

The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus. 配偶者、親、胎児、ドナーなど、患者に関連する何かまたは誰かを表す記録の患者ではない場合の、観察の実際の焦点。たとえば、母親の記録にある胎児の観察。観察の焦点はまた、既存の状態、介入、対象の食事、対象の別の観察、または腫瘍または埋め込まれた装置などの体の構造であり得る。使用例はobservationリソースを使用して、母親が子供の気管切開チューブを交換するように訓練されているかどうかをキャプチャすることである。この例では、子供が記録の患者であり、母親が焦点(focus)となる。

ShortWhat the observation is about, when it is not about the subject of record subject 要素が実際のobservationの対象でない場合に、observation の対象物
Comments

Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode. 通常、observationは対象(患者、または患者のグループ、場所、またはデバイス)について行われ、対象とobservationのために直接測定されるものとの区別は、observationコード自体(例:「血糖値」 )で記述され、この要素を使用して個別に表す必要はない。検体(標本)への参照が必要な場合は、 specimen要素を使用する。リソースの代わりにコードが必要な場合は、人体部位にはbodysite要素を使用するか、標準の拡張機能[focusCode](extension-observation-focuscode.html)を使用する。

Control0..*
TypeReference(Resource)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Observation.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. このobservationが行われるヘルスケアイベント(患者とヘルスケアプロバイダの相互作用など)(受診、入院など)。

ShortHealthcare event during which this observation is made このobservationが行われるヘルスケアイベント
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

【JP Core仕様】診察

Control0..1
TypeReference(JP Core Encounter Profile)
Is Modifierfalse
Summarytrue
Requirements

For some observations it may be important to know the link between an observation and a particular encounter.

Alternate NamesContext
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Observation.effective[x]
Definition

The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself. 観測値が関連する時間または期間。レポートの対象が患者である場合、これは通常、処置や検体採取の時刻のいずれかであるが、日付/時刻の出処は不明であり、日付/時刻自体のみのことがある。

ShortClinically relevant time/time-period for observation 臨床的に関連する時刻または時間
Comments

At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

【JP Core仕様】effectiveDateTime:医療者が確認した日時

effectivePeriod:医療者が確認した期間

Control0..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Knowing when an observation was deemed true is important to its relevance as well as determining trends.

Alternate NamesOccurrence
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Observation.issued
Definition

The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. このバージョンのレポートが医療者に提供された日時。通常、レポートがレビューおよび検証された後となる。

ShortDate/Time this version was made available このバージョンが利用可能となった日時
Comments

For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again. レビューと検証を必要としないobservationの場合、リソース自体の[lastUpdated](resource-definitions.html#Meta.lastUpdated)日時と同じになる場合がある。特定の更新のレビューと検証が必要なobservationの場合、新しいバージョンを再度レビューして検証する必要がないような臨床的に重要でない更新がなされたために、リソース自体の「lastUpdated」時間はこれと異なる場合がある。

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Observation.performer
Definition

Who was responsible for asserting the observed value as "true". そのobservationは真だと言える責任者

ShortWho is responsible for the observation observationに責任をもつ者
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. 参照は、実際のFHIRリソースへの参照である必要があり、解決可能(内容に到達可能)である必要がある(アクセス制御、一時的な使用不可などを考慮に入れる)。解決は、URLから取得するか、リソースタイプによって該当する場合は、絶対参照を正規URLとして扱い、ローカルレジストリ/リポジトリで検索することによって行うことができる。

Control0..*
TypeReference(JP Core Practitioner Profile, JP Core PractitionerRole Profile, JP Core Organization Profile, CareTeam, JP Core Patient Profile, RelatedPerson)
Is Modifierfalse
Summarytrue
Requirements

May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Observation.value[x]
Definition

The information determined as a result of making the observation, if the information has a simple value. 結果情報が単純な値である場合、observationを行った結果として決定された情報。

ShortActual result 実際の結果値
Comments

An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

Control0..1
This element is affected by the following invariants: obs-7
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Observation.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.value[x] is missing. Observation.value[x] 要素に期待される結果が存在しない理由を設定する。

ShortWhy the result is missing 結果が欠損値である理由
Comments

Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

ヌル値または例外値は、FHIRオブザベーションで2つの方法で表すことができる。 1つの方法は、それらを値セットに含めて、値の例外を表す方法である。たとえば、血清学的検査の測定値は、「検出された」、「検出されなかった」、「決定的でない」、または「検体が不十分」である可能性がある。別の方法は、実際の観測にvalue要素を使用し、明示的なdataAbsentReason要素を使用して例外的な値を記録することである。たとえば、測定が完了しなかった場合、dataAbsentReasonコード「error」を使用できる。この場合には、観測値は、報告する値がある場合にのみ報告される可能性があることに注意する必要がある。たとえば、差分セルカウント値は> 0の場合にのみ報告される場合がある。これらのオプションのため、nullまたは例外値の一般的な観測値を解釈するにはユースケースの合意が必要である。

Control0..1
This element is affected by the following invariants: obs-6
BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason

Codes specifying why the result (Observation.value[x]) is missing.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For many results it is necessary to handle exceptional values in measurements.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Observation.interpretation
Definition

A categorical assessment of an observation value. For example, high, low, normal. 観測値のカテゴリ別評価。たとえば、高、低、通常。

ShortHigh, low, normal, etc.
Comments

Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

「異常フラグ」として呼ばれる検査結果解釈コードが従来から使用されており、その使用はコード化された解釈が関連するような他の場合でも拡大して使われている。多くの場合、1つ以上の単純でコンパクトなコードとして報告され、この要素は、結果の意味や正常かどうかを示すために、レポートや時系列表で結果値の隣に配置されることがよくある。

Control0..*
BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes

Codes identifying interpretations of observations.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 一部の結果、特に数値結果については、結果の意義を完全に理解するためには解釈コードが必要である。

Alternate NamesAbnormal Flag
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Observation.note
Definition

Comments about the observation or the results. 観測値、結果に対するコメント

ShortComments about the observation 結果に対するコメント
Comments

May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

観察(結果)に関する一般的な記述、重要な、予期しない、または信頼できない結果値に関する記述、またはその解釈に関連する場合はそのソースに関する情報が含まれる場合がある。

Control0..*
TypeAnnotation
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to provide free text additional information. フリーテキストの追加情報を提供できる必要がある。

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Observation.bodySite
Definition

Indicates the site on the subject's body where the observation was made (i.e. the target site).

ShortBindingについてはユースケースに応じて各プロファイルで定義すること
Comments

Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

Control0..1
BindingFor example codes, see SNOMEDCTBodyStructures

Codes describing anatomical locations. May include laterality.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Observation.method
Definition

Indicates the mechanism used to perform the observation.

ShortBindingについてはユースケースに応じて各プロファイルで定義すること
Comments

Only used if not implicit in code for Observation.code.

Control0..1
BindingFor example codes, see ObservationMethods

Methods for simple observations.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Observation.specimen
Definition

The specimen that was used when this observation was made. この観察(観測、検査)が実施されたときに使われた検体材料

ShortSpecimen used for this observation 観察(観測、検査)に使われた検体材料
Comments

Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report). Observation.codeにあるコードで暗黙的に示されない場合にのみ使用する必要がある。検体自体の観察は行われない。観察(観測、検査)対象者に対して実施されるが、多くの場合には対象者から得られた検体に対して実施される。検体が奥の場合に関わるが、それらは常に追跡され、明示的に報告されるとは限らないことに注意すること。またobservationリソースは、検体を明示的に記述するような状況下(診断レポートなど)で使用される場合があることに注意。

Control0..1
TypeReference(Specimen)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Observation.device
Definition

The device used to generate the observation data. 観察データを生成するために使われた機器

Short(Measurement) Device 測定機器
Comments

Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant. これは、結果の送信に関与するデバイス(ゲートウェイなど)を表すことを意図したものではない。そのようなデバイスは、必要に応じてProvenanceリソースを使用して文書化する。

Control0..1
TypeReference(Device, DeviceMetric)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Observation.referenceRange
Definition

Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

ShortProvides guide for interpretation 解釈のためのガイドを与える
Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties. 通常の範囲または推奨範囲と比較して値を解釈する方法に関するガイダンス。複数の参照範囲は「OR」として解釈される。つまり、2つの異なるターゲット母集団を表すために、2つの referenceRange要素が使用される。

Control0..*
TypeBackboneElement
Is Modifierfalse
Summaryfalse
Requirements

Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts. どの値が「正常」と見なされるかを知ることは、特定の結果の意義を評価するのに役立つ。さまざまなコンテキストに対応するため複数の参照範囲を提供できる必要がある。

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
60. Observation.referenceRange.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
62. Observation.referenceRange.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
64. Observation.referenceRange.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
66. Observation.referenceRange.low
Definition

The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

ShortLow Range, if relevant
Control0..1
This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Observation.referenceRange.high
Definition

The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

ShortHigh Range, if relevant
Control0..1
This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Observation.referenceRange.type
Definition

Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

ShortReference range qualifier
Comments

This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

Control0..1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes

Code for the meaning of a reference range.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Observation.referenceRange.appliesTo
Definition

Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

ShortReference range population
Comments

This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes

Codes identifying the population the reference range applies to.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Need to be able to identify the target population for proper interpretation.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Observation.referenceRange.age
Definition

The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

ShortApplicable age range, if relevant
Control0..1
TypeRange
Is Modifierfalse
Summaryfalse
Requirements

Some analytes vary greatly over age.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Observation.referenceRange.text
Definition

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

ShortText based reference range in an observation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Observation.hasMember
Definition

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group. このobservationは、グループのメンバーとしてターゲットを含むグループobservation(たとえば、一連検査セット、パネル検査、バイタルサイン測定値のセット)である。

ShortRelated resource that belongs to the Observation group observationグループに属する関連リソース
Comments

When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

【JP Core仕様】関連する参照リソースにJP_Observation_VitalSignsを追加

Control0..*
TypeReference(JP Core Observation Common Profile, QuestionnaireResponse, MolecularSequence, JP Core Observation VitalSigns Profile)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Observation.derivedFrom
Definition

The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image. このobservation が導出される元の測定値を表すターゲットリソース。たとえば、超音波画像に基づいて計算されたアニオンギャップまたは胎児の測定値の場合、この要素には、元となった超音波画像検査結果への参照を設定する。

ShortRelated measurements the observation is made from observation が作られる元の関連する測定
Comments

All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

【JP Core仕様】導出元の参照リソースにJP_Observation_VitalSignsを追加

Control0..*
TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, JP Core Observation Common Profile, MolecularSequence, JP Core Observation VitalSigns Profile)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Observation.component
Definition

Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations. 一部の観測には、複数のコンポーネントの観測がある。これらのコンポーネントの観察結果は、同じ属性を共有する個別のコード値のペアとして表される。例としては、血圧測定のための収縮期および拡張期のコンポーネントの観察や、遺伝学の観察のための複数のコンポーネントの観察がある。

ShortComponent results  コンポーネント結果
Comments

For a discussion on the ways Observations can be assembled in groups together see Notes below. 複数のObservation をグループに一緒にまとめる方法については、以下の[Notes](observation.html#notes)を参照すること。

Control0..*
TypeBackboneElement
Is Modifierfalse
Summarytrue
Requirements

Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation. コンポーネントobservation は プライマリobservation としてのobservation リソースの中で同じ属性を共有し、常に単一のobservation の一部として扱われる(つまりそれらは分離可能ではないん)。ただし、プライマリobservationのreference rangeはコンポーネント値に継承されないため、reference rangeは各コンポーネントobservation に適切であれば必要である。

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Observation.component.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
86. Observation.component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
88. Observation.component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
90. Observation.component.code
Definition

Describes what was observed. Sometimes this is called the observation "code".

ShortType of component observation (code / type)
Comments

All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Control1..1
BindingThe codes SHOULD be taken from JP Core Observation VitalSigns Code ValueSet
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Observation.component.value[x]
Definition

The information determined as a result of making the observation, if the information has a simple value.

ShortActual component result
Comments

Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

Control0..1
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Observation.component.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.component.value[x] is missing.

ShortWhy the component result is missing
Comments

"Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

Control0..1
This element is affected by the following invariants: obs-6
BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason

Codes specifying why the result (Observation.value[x]) is missing.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For many results it is necessary to handle exceptional values in measurements.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Observation.component.interpretation
Definition

A categorical assessment of an observation value. For example, high, low, normal.

ShortHigh, low, normal, etc.
Comments

Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes

Codes identifying interpretations of observations.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Alternate NamesAbnormal Flag
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Observation.component.referenceRange
Definition

Guidance on how to interpret the value by comparison to a normal or recommended range.

ShortProvides guide for interpretation of component result
Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
Is Modifierfalse
Summaryfalse
Requirements

Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))