HL7 FHIR JP Core ImplementationGuide
2.0.0-dev - ci-build Japan flag

HL7 FHIR JP Core ImplementationGuide - Local Development build (v2.0.0-dev) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: JP_Observation_Common - Detailed Descriptions

Active as of 2023-10-31

Definitions for the jp-observation-common resource profile.

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

0. Observation
Definition

患者、デバイス、またはその他の対象について行われた測定と簡単な観察事実(assertion)。


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

Short測定や簡単な観察事実(assertion)Measurements and simple assertions
Comments

すべてのObservation(検査測定や観察事実)の共通部分のプロファイル


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
Must Supportfalse
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.exists() and ('#'+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(uri) = '#').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.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
Must Supportfalse
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
Must Supportfalse
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.identifier
Definition

このObservationリソースの一意な識別ID


A unique identifier assigned to this observation.

ShortこのObservationリソースの一意な識別IDBusiness Identifier for observation
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
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()))
8. Observation.basedOn
Definition

このObservationが実施されることになった依頼や計画、提案に関する情報


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.

ShortこのObservationが実施されることになった依頼や計画、提案に関する情報Fulfills plan, proposal or order
Control0..*
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, JP Core MedicationRequest Profile, JP Core MedicationRequest Injection Profile, NutritionOrder, ServiceRequest, MedicationRequest)
Is Modifierfalse
Must Supportfalse
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()))
10. Observation.partOf
Definition

このObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報


A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

ShortこのObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報Part of referenced event
Comments

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。


To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

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, MedicationAdministration, MedicationDispense, Procedure, Immunization)
Is Modifierfalse
Must Supportfalse
Summarytrue
Alternate NamesContainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.status
Definition

結果の状態


The status of the result value.

Short結果の状態registered | preliminary | final | amended +
Comments

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|4.3.0
(required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

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
Must Supportfalse
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()))
14. Observation.category
Definition

このObservationを分類するコード


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

ShortこのObservationを分類するコードClassification of type of observation
Comments

階層的にカテゴリーを設定することで粒度のレベルを概念定義できる。


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.

Control0..*
BindingThe codes SHOULD be taken from JP Core Simple Observation Category ValueSethttp://hl7.org/fhir/ValueSet/observation-category
(preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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()))
16. Observation.code
Definition

このObservationの対象を特定するコード


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

ShortこのObservationの対象を特定するコードType of observation (code / type)
Comments

observationの意味を正しく理解するには、すべてのcode-valueペアと、さらに存在する場合にはcomponent.code-component.valueのペアが、考慮される必要がある。


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
BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
(example to http://hl7.org/fhir/ValueSet/observation-codes)

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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()))
18. Observation.subject
Definition

このObservationの対象となる患者や患者群、機器、場所に関する情報


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.

ShortこのObservationの対象となる患者や患者群、機器、場所に関する情報Who and/or what the observation is about
Comments

この要素は1..1のcardinalityになるはずと考えられる。この要素が欠損値になる唯一の状況は、対象患者が不明なデバイスによって観察が行われるケースである。この場合、観察は何らかのコンテキスト/チャネルマッチング技術を介して患者にマッチングされる必要があり、患者にマッチングされれば、その時点で本要素を更新する必要がある。


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.

Control0..1
TypeReference(JP Core Patient Profile, Group, Device, JP Core Location Profile, Patient, Location, Organization, Procedure, Practitioner, Medication, Substance)
Is Modifierfalse
Must Supportfalse
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()))
20. Observation.focus
Definition

配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報


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.

Short配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報What the observation is about, when it is not about the subject of record
Comments

T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。


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.

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

診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報


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

Short診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報Healthcare event during which this observation is made
Comments

通常、イベントが発生したEncounterであるが、一部のイベントは、Encounterの正式な完了の前または後に開始される場合があり、その場合でもEncounterのコンテキストに関連付けられている(例:入院前の臨床検査)。


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
Must Supportfalse
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()))
24. Observation.effective[x]
Definition

取得された結果が臨床的に確定された日時または期間


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.

Short取得された結果が臨床的に確定された日時または期間Clinically relevant time/time-period for observation
Comments

この観察結果が過去の報告でない限り、少なくとも日付が存在する必要がある。不正確または「あいまいな」時間を記録するには(たとえば、「朝食後」に行われた血糖測定)、[Timing](datatypes.html#timing)データ型を使用して、測定を通常のライフイベントに関連付けることができる。


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] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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()))
26. Observation.issued
Definition

このバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時


The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

ShortこのバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時Date/Time this version was made available
Comments

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。


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.

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

このObservationの責任者/実施者に関する情報


Who was responsible for asserting the observed value as "true".

ShortこのObservationの責任者/実施者に関する情報Who is responsible for the observation
Comments

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, Practitioner, PractitionerRole, Organization, Patient)
Is Modifierfalse
Must Supportfalse
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()))
30. Observation.value[x]
Definition

取得された結果


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

Short取得された結果Actual result
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] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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()))
32. Observation.dataAbsentReason
Definition

このObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由


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

ShortこのObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由Why the result is missing
Comments

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。


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.

Control0..1
This element is affected by the following invariants: obs-6
BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
(extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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()))
34. Observation.interpretation
Definition

高、低、正常等の結果のカテゴリ分けした評価


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

Short高、低、正常等の結果のカテゴリ分けした評価High, low, normal, etc.
Comments

「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。


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 ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation
(extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

Codes identifying interpretations of observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

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。


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()))
36. Observation.note
Definition

このObservationに関するコメント


Comments about the observation or the results.

ShortこのObservationに関するコメントComments about the observation
Comments

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。


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.

Control0..*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
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。


Need to be able to provide free text additional information.

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

対象となった身体部位


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

Short対象となった身体部位Observed body part
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 SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site
(example to http://hl7.org/fhir/ValueSet/body-site)

SNOMED CT Body site concepts

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

このObservationの実施方法


Indicates the mechanism used to perform the observation.

ShortこのObservationの実施方法How it was done
Comments

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

Control0..1
BindingFor example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods
(example to http://hl7.org/fhir/ValueSet/observation-methods)

Methods for simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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()))
42. Observation.specimen
Definition

このObservationに使われた検体/標本に関する情報


The specimen that was used when this observation was made.

ShortこのObservationに使われた検体/標本に関する情報Specimen used for this observation
Comments

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。


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).

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

このObservationでデータを得るために使われた測定機器に関する情報


The device used to generate the observation data.

ShortこのObservationでデータを得るために使われた測定機器に関する情報(Measurement) Device
Comments

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。


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.

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

基準範囲との比較による結果の解釈方法のガイダンス


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.

Short基準範囲との比較による結果の解釈方法のガイダンスProvides guide for interpretation
Comments

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。


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..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

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。


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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
48. 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())
50. Observation.hasMember
Definition

このObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループ


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.

ShortこのObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループRelated resource that belongs to the Observation group
Comments

この要素を使用する場合、observationには通常、値または関連するリソースのセットのいじれかを含む。その両方を含む場合もある。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[メモ](observation.html#obsgrouping)を参照せよ。システムは、[QuestionnaireResponse](questionnaireresponse.html)からの結果を計算して最終スコアにし、そのスコアをobservationとして表す場合があることに注意。


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, Observation)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Observation.derivedFrom
Definition

このObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソース


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.

ShortこのObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソースRelated measurements the observation is made from
Comments

この要素にリストされているすべての参照の選択肢は、派生値の元のデータなる可能性のある臨床観察やその他の測定値を表すことができる。最も一般的な参照先は、別のobservationである。observationをグループに一緒にまとめる方法については、以下の[メモ](observation.html#obsgrouping)を参照すること。


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, Observation)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Observation.component
Definition

複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせ


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.

Short複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせComponent results
Comments

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。


For a discussion on the ways Observations can be assembled in groups together see Notes below.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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。


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.

Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
56. 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())
58. 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
BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
(example to http://hl7.org/fhir/ValueSet/observation-codes)

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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()))

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

0. Observation
Definition

患者、デバイス、またはその他の対象について行われた測定と簡単な観察事実(assertion)。

Short測定や簡単な観察事実(assertion)
Comments

すべてのObservation(検査測定や観察事実)の共通部分のプロファイル

2. Observation.identifier
Definition

このObservationリソースの一意な識別ID

ShortこのObservationリソースの一意な識別ID
NoteThis is a business identifier, not a resource identifier (see discussion)
4. Observation.basedOn
Definition

このObservationが実施されることになった依頼や計画、提案に関する情報

ShortこのObservationが実施されることになった依頼や計画、提案に関する情報
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, JP Core MedicationRequest Profile, JP Core MedicationRequest Injection Profile, NutritionOrder, ServiceRequest)
6. Observation.partOf
Definition

このObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報

ShortこのObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報
Comments

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。

TypeReference(JP Core MedicationAdministration Profile, JP Core MedicationAdministration Injection Profile, JP Core MedicationDispenseBase Profile, MedicationStatement, JP Core Procedure Profile, JP Core Immunization Profile, ImagingStudy)
8. Observation.status
Definition

結果の状態

Short結果の状態
Comments

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。

10. Observation.category
Definition

このObservationを分類するコード

ShortこのObservationを分類するコード
Comments

階層的にカテゴリーを設定することで粒度のレベルを概念定義できる。

BindingThe codes SHOULD be taken from JP Core Simple Observation Category ValueSet
(preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
12. Observation.code
Definition

このObservationの対象を特定するコード

ShortこのObservationの対象を特定するコード
Comments

observationの意味を正しく理解するには、すべてのcode-valueペアと、さらに存在する場合にはcomponent.code-component.valueのペアが、考慮される必要がある。

14. Observation.subject
Definition

このObservationの対象となる患者や患者群、機器、場所に関する情報

ShortこのObservationの対象となる患者や患者群、機器、場所に関する情報
Comments

この要素は1..1のcardinalityになるはずと考えられる。この要素が欠損値になる唯一の状況は、対象患者が不明なデバイスによって観察が行われるケースである。この場合、観察は何らかのコンテキスト/チャネルマッチング技術を介して患者にマッチングされる必要があり、患者にマッチングされれば、その時点で本要素を更新する必要がある。

TypeReference(JP Core Patient Profile, Group, Device, JP Core Location Profile)
16. Observation.focus
Definition

配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報

Short配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報
Comments

T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。

18. Observation.encounter
Definition

診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報

Short診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報
Comments

通常、イベントが発生したEncounterであるが、一部のイベントは、Encounterの正式な完了の前または後に開始される場合があり、その場合でもEncounterのコンテキストに関連付けられている(例:入院前の臨床検査)。

TypeReference(JP Core Encounter Profile)
20. Observation.effective[x]
Definition

取得された結果が臨床的に確定された日時または期間

Short取得された結果が臨床的に確定された日時または期間
Comments

この観察結果が過去の報告でない限り、少なくとも日付が存在する必要がある。不正確または「あいまいな」時間を記録するには(たとえば、「朝食後」に行われた血糖測定)、[Timing](datatypes.html#timing)データ型を使用して、測定を通常のライフイベントに関連付けることができる。

[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
22. Observation.issued
Definition

このバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時

ShortこのバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時
Comments

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。

24. Observation.performer
Definition

このObservationの責任者/実施者に関する情報

ShortこのObservationの責任者/実施者に関する情報
Comments

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。

TypeReference(JP Core Practitioner Profile, JP Core PractitionerRole Profile, JP Core Organization Profile, CareTeam, JP Core Patient Profile, RelatedPerson)
26. Observation.value[x]
Definition

取得された結果

Short取得された結果
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
28. Observation.dataAbsentReason
Definition

このObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由

ShortこのObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由
Comments

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。

30. Observation.interpretation
Definition

高、低、正常等の結果のカテゴリ分けした評価

Short高、低、正常等の結果のカテゴリ分けした評価
Comments

「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。

Requirements

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。

32. Observation.note
Definition

このObservationに関するコメント

ShortこのObservationに関するコメント
Comments

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。

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。

34. Observation.bodySite
Definition

対象となった身体部位

Short対象となった身体部位
36. Observation.method
Definition

このObservationの実施方法

ShortこのObservationの実施方法
38. Observation.specimen
Definition

このObservationに使われた検体/標本に関する情報

ShortこのObservationに使われた検体/標本に関する情報
Comments

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。

40. Observation.device
Definition

このObservationでデータを得るために使われた測定機器に関する情報

ShortこのObservationでデータを得るために使われた測定機器に関する情報
Comments

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。

42. Observation.referenceRange
Definition

基準範囲との比較による結果の解釈方法のガイダンス

Short基準範囲との比較による結果の解釈方法のガイダンス
Comments

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。

Requirements

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。

44. Observation.hasMember
Definition

このObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループ

ShortこのObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループ
Comments

この要素を使用する場合、observationには通常、値または関連するリソースのセットのいじれかを含む。その両方を含む場合もある。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[メモ](observation.html#obsgrouping)を参照せよ。システムは、[QuestionnaireResponse](questionnaireresponse.html)からの結果を計算して最終スコアにし、そのスコアをobservationとして表す場合があることに注意。

TypeReference(JP Core Observation Common Profile, QuestionnaireResponse, MolecularSequence)
46. Observation.derivedFrom
Definition

このObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソース

ShortこのObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソース
Comments

この要素にリストされているすべての参照の選択肢は、派生値の元のデータなる可能性のある臨床観察やその他の測定値を表すことができる。最も一般的な参照先は、別のobservationである。observationをグループに一緒にまとめる方法については、以下の[メモ](observation.html#obsgrouping)を参照すること。

TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, JP Core Observation Common Profile, MolecularSequence)
48. Observation.component
Definition

複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせ

Short複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせ
Comments

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。

Requirements

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。

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

0. Observation
Definition

患者、デバイス、またはその他の対象について行われた測定と簡単な観察事実(assertion)。

Short測定や簡単な観察事実(assertion)
Comments

すべてのObservation(検査測定や観察事実)の共通部分のプロファイル

Control0..*
Is Modifierfalse
Must Supportfalse
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.exists() and ('#'+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(uri) = '#').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
Must Supportfalse
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
Must Supportfalse
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
Must Supportfalse
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
(preferred to http://hl7.org/fhir/ValueSet/languages)

IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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
Must Supportfalse
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
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Invariantsdom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))
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
Must Supportfalse
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
Must Supportfalse
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

このObservationリソースの一意な識別ID

ShortこのObservationリソースの一意な識別ID
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
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

このObservationが実施されることになった依頼や計画、提案に関する情報

ShortこのObservationが実施されることになった依頼や計画、提案に関する情報
Control0..*
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, JP Core MedicationRequest Profile, JP Core MedicationRequest Injection Profile, NutritionOrder, ServiceRequest)
Is Modifierfalse
Must Supportfalse
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

このObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報

ShortこのObservationが親イベントの一部を成す要素であるとき、その親イベントに関する情報
Comments

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
Must Supportfalse
Summarytrue
Alternate NamesContainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.status
Definition

結果の状態

Short結果の状態
Comments

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
(required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

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
Must Supportfalse
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

このObservationを分類するコード

ShortこのObservationを分類するコード
Comments

階層的にカテゴリーを設定することで粒度のレベルを概念定義できる。

Control0..*
BindingThe codes SHOULD be taken from JP Core Simple Observation Category ValueSet
(preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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

このObservationの対象を特定するコード

ShortこのObservationの対象を特定するコード
Comments

observationの意味を正しく理解するには、すべてのcode-valueペアと、さらに存在する場合にはcomponent.code-component.valueのペアが、考慮される必要がある。

Control1..1
BindingFor example codes, see LOINCCodes
(example to http://hl7.org/fhir/ValueSet/observation-codes)

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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

このObservationの対象となる患者や患者群、機器、場所に関する情報

ShortこのObservationの対象となる患者や患者群、機器、場所に関する情報
Comments

この要素は1..1のcardinalityになるはずと考えられる。この要素が欠損値になる唯一の状況は、対象患者が不明なデバイスによって観察が行われるケースである。この場合、観察は何らかのコンテキスト/チャネルマッチング技術を介して患者にマッチングされる必要があり、患者にマッチングされれば、その時点で本要素を更新する必要がある。

Control0..1
TypeReference(JP Core Patient Profile, Group, Device, JP Core Location Profile)
Is Modifierfalse
Must Supportfalse
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

配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報

Short配偶者、親、胎児、ドナーなど、このObservationのsubject要素が実際の対象でない場合、その実際の対象に関する情報
Comments

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

診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報

Short診察や入院など、このObservationが実施されるきっかけとなった診療イベントに関する情報
Comments

通常、イベントが発生したEncounterであるが、一部のイベントは、Encounterの正式な完了の前または後に開始される場合があり、その場合でもEncounterのコンテキストに関連付けられている(例:入院前の臨床検査)。

Control0..1
TypeReference(JP Core Encounter Profile)
Is Modifierfalse
Must Supportfalse
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

取得された結果が臨床的に確定された日時または期間

Short取得された結果が臨床的に確定された日時または期間
Comments

この観察結果が過去の報告でない限り、少なくとも日付が存在する必要がある。不正確または「あいまいな」時間を記録するには(たとえば、「朝食後」に行われた血糖測定)、[Timing](datatypes.html#timing)データ型を使用して、測定を通常のライフイベントに関連付けることができる。

Control0..1
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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

このバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時

ShortこのバージョンのObservationが医療者に提供された日時。通常、結果を確認し検証後に提供される日時
Comments

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
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Observation.performer
Definition

このObservationの責任者/実施者に関する情報

ShortこのObservationの責任者/実施者に関する情報
Comments

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
Must Supportfalse
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

取得された結果

Short取得された結果
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] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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

このObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由

ShortこのObservationのvalue[x]要素に期待される結果が存在しなかった場合、その理由
Comments

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
(extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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

高、低、正常等の結果のカテゴリ分けした評価

Short高、低、正常等の結果のカテゴリ分けした評価
Comments

「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
(extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

Codes identifying interpretations of observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

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

このObservationに関するコメント

ShortこのObservationに関するコメント
Comments

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
Must Supportfalse
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

対象となった身体部位

Short対象となった身体部位
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
(example to http://hl7.org/fhir/ValueSet/body-site)

SNOMED CT Body site concepts

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

このObservationの実施方法

ShortこのObservationの実施方法
Comments

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

Control0..1
BindingFor example codes, see ObservationMethods
(example to http://hl7.org/fhir/ValueSet/observation-methods)

Methods for simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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

このObservationに使われた検体/標本に関する情報

ShortこのObservationに使われた検体/標本に関する情報
Comments

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
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Observation.device
Definition

このObservationでデータを得るために使われた測定機器に関する情報

ShortこのObservationでデータを得るために使われた測定機器に関する情報
Comments

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

基準範囲との比較による結果の解釈方法のガイダンス

Short基準範囲との比較による結果の解釈方法のガイダンス
Comments

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
Must Supportfalse
Summaryfalse
Requirements

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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
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
Must Supportfalse
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
Must Supportfalse
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
(preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

Code for the meaning of a reference range.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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
(example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

Codes identifying the population the reference range applies to.

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

このObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループ

ShortこのObservationに関連する子リソースに関する情報。このObservationに関連する/属するパネル検査や検査セットなどのObservationグループ
Comments

この要素を使用する場合、observationには通常、値または関連するリソースのセットのいじれかを含む。その両方を含む場合もある。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[メモ](observation.html#obsgrouping)を参照せよ。システムは、[QuestionnaireResponse](questionnaireresponse.html)からの結果を計算して最終スコアにし、そのスコアをobservationとして表す場合があることに注意。

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

このObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソース

ShortこのObservationの結果の導出元に関する情報。例えば、画像検査から取得された結果となる場合その導出元となる画像検査結果を示すImagingStudyリソース
Comments

この要素にリストされているすべての参照の選択肢は、派生値の元のデータなる可能性のある臨床観察やその他の測定値を表すことができる。最も一般的な参照先は、別のobservationである。observationをグループに一緒にまとめる方法については、以下の[メモ](observation.html#obsgrouping)を参照すること。

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

複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせ

Short複合的な結果。例えば、血圧測定値ではそれを構成する収縮期および拡張期の値の組み合わせ
Comments

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
Must Supportfalse
Summarytrue
Requirements

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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
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
BindingFor example codes, see LOINCCodes
(example to http://hl7.org/fhir/ValueSet/observation-codes)

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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
(extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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
(extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

Codes identifying interpretations of observations.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
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..*
TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
Is Modifierfalse
Must Supportfalse
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()))
本実装ガイドへのご質問・ご指摘については、GitHub IssueおよびGitHub PullRequestにて受け付けております。