HL7 FHIR JP Core ImplementationGuide
1.1.1 - ci-build Japan flag

HL7 FHIR JP Core ImplementationGuide - Local Development build (v1.1.1). See the Directory of published versions

Resource Profile: JP_Observation_LabResult - Detailed Descriptions

Active as of 2022-10-24

Definitions for the jp-observation-labresult resource profile.

1. Observation
Definition

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

検体検査結果の格納に使用する。

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)。

Comments

すべてのObservation(検査測定や観察事実)の制約プロファイル

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

A unique identifier assigned to this observation.

この検査項目に割り当てられた一意の識別子。リソースの識別子やシステム的なシーケンスではなく、ビジネスID。

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

NoteThis is a business identifier, not a resource identifier (see discussion)
Comments

【JP Core仕様】当該検査項目に対して、施設内で割り振られる一意の識別子があればそれを使用する。なければ次のルールを参考に一意となる識別子を生成し設定する。

アプリケーション側のデータベースにおけるフィールド長の定義については、最低64バイトを確保すること。

--- 参考 ---

次の項目を順にセパレータ「_(アンダースコア)」で連結し、 identifier.value に設定する。グループ項目でない場合など、該当コード/番号がない場合はセパレータを連続で連結する。各コードはローカルコードを使用し、必ず設定できること。

 1.ORC-2(依頼者オーダ番号) SS-MIX2の15桁前ゼロ形式の番号

 2.OBR-4(検査項目ID) 検査セットの識別コード

 3.SPM-4(検体タイプ)

 4.OBX-3(検査項目)

 5.OBX-4(検査副ID)・・・オプション。必要に応じて使用。

形式:[ORC-2][OBR-4][SPM-4][OBX-3]([OBX-4])

3. Observation.identifier.use
Definition

The purpose of this identifier.

この識別子の目的。

Control0..?
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

アプリケーションは、identifierが一時的であると明示的に述べられない限り、永続的であると想定できる。

4. Observation.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

システムのコンテキスト内で一意の識別子となる文字列を設定。

Control0..?
5. 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.

このプロファイルでは、検体検査オーダに関する情報。

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. 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。

TypeReference(ServiceRequest|CarePlan|DeviceRequest|ImmunizationRecommendation|JP_MedicationRequest|JP_MedicationRequest_Injection|NutritionOrder))
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.

【JP Core仕様】オーダ情報がある場合、このプロファイルでは ServiceRequest のリソースを参照する。オーダIDの情報はここで使用する。

6. 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.

このリソースが一部として、あるいは手順の一つとして含まれるより大きなイベント。

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。

Comments

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

【JP Core仕様】当面は使用しない。

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。

7. Observation.status
Definition

The status of the result value.

結果値の状態。

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

Comments

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

【JP Core仕様】v2.5の「F」に相当する値は「final」であるが、ここでは 必須コード表「ObservationStatus」より、全てのコード値を使用可とする。

(registered | preliminary | final | amended | corrected | cancelled | entered-in-error | unknown)

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。

8. Observation.category
Definition

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

行われた検査の一般的なタイプの分類。取得、表示の際のフィルタリングに使用。

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

Control10..*
Comments

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.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

(social-history | vital-signs | imaging | laboratory | procedure | survey | exam | therapy | activity)

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. 必要なカテゴリ値セットに加えて、この要素を使用すると、所有者のカテゴリの定義に基づいたさまざまなカテゴリ化スキームが可能になり、複数のカテゴリを一度に効果的に使用できる。粒度のレベルは、値セットのカテゴリの概念によって定義される。

SlicingThis element introduces a set of slices on Observation.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
9. Observation.category.coding
Control0..?
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

10. Observation.category:laboratory
SliceNamelaboratory
Control1..1
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="laboratory"/>
  </coding>
</valueCodeableConcept>
11. Observation.code
Definition

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

検査の内容の説明。検査名称。

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。

BindingThe codes SHOULD be taken from JP Core Observation LabResult Code ValueSetFor example codes, see LOINCCodes

MEDIS 臨床検査マスター

Codes identifying names of simple observations.

Comments

*JLAC10

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. 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。

12. Observation.code.coding
Definition

A reference to a code defined by a terminology system.

コード体系によって定義されたコードへの参照。

Control1..?
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】SS-MIX2にならい、標準コード、ローカルコードの2つを設定可能とし、いずれか一方は必須とする。さらにJLAC10とJLAC11などの複数の標準コードも設定できるよう、上限は設けない。

標準コード、ローカルコードの2つまで格納可。順不同。 SS-MIX2だとCWE.1 ~CWE.3に標準コード、CWE.4~CWE.6にローカルコード、など(順不同)。

13. Observation.code.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

コード体系。

Control0..?
Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

【JP Core仕様】標準コードの場合、JLAC10を表すURIを設定。

URIは本WGで定義する。

14. Observation.code.coding.code
Control0..?
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

15. Observation.code.coding.display
Control0..?
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

16. Observation.code.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

このコードが利用者によって、例えば利用可能なコードの選択リストから、など、直接選択されたものであることを示す。

Control0..?
Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

【JP Core仕様】当面は未使用とする。

17. Observation.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

コードの表示名。報告書などに記載する場合に使用する表示名。コードを複数指定した場合(標準コード、ローカルコード)、その一般的な表現。

Control1..?
Comments

Very often the text is the same as a displayName of one of the codings.

【JP Core仕様】このプロファイルでは、表示名として必須とする。

多くの場合、coding.display と同一になるが、coding.display に異なる複数の表現が格納される場合を想定し、code間で共通の表現として必須とする。

18. 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.

検体検査の対象となる患者。

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。

Control10..1
TypeReference(JP_Patient|Group|Device|JP_Location))
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】このプロファイルでは、Patient 限定、かつ必須とする。

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. 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。

19. 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.

患者当人ではなく、患者の胎児、親、ドナーなどの検査、観察の場合、その対象を示す。

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。

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. 【JP Core仕様】当面は未使用とする。

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. 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。

20. Observation.encounter
Definition

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

この検査が行われるヘルスケアイベント。医療提供者と患者の接点。

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)。

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】入院外来の区別や所在場所、担当診療科の情報に使用する。

※このプロファイルの用途では通常は必須と考えられるが、ユースケースにより使用されない場合を考慮し、1..1に制約しない。

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). 通常、イベントが発生したEncounterであるが、一部のイベントは、エン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)。

21. 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.

検体検査の場合は、検体採取日時。

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。

Control10..1
TypeChoice of: , , , instant
[x] NoteSee Choice of Data Types for further information about how to use [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】このプロファイルでは、検体採取日時を設定し、必須とする。

effectiveInstant

instant型はイベント発生のログ時間であり、未使用とする。

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. 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。

22. 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.

この情報の発生日時。システム時刻であり、人が報告する時刻ではないことに注意。このリソースの発生時間と同じになる場合がある。

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。

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.

【JP Core仕様】検査結果がシステムによりObservationリソースに格納または更新された日時。

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。

23. Observation.performer
Definition

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

検査値を確認した責任者。検査実施責任者情報。

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

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.

【JP Core仕様】検査に直接責任を負う個人(つまり検査を実行、もしくは検証した人)の識別子。

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。

24. Observation.value[x]
Definition

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

検体検査の結果として決定された情報。

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。

TypeChoice of: , , , dateTime, boolean, SampledData, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

以下のデータ型はSS-MIX2では未使用のため、未使用とした。今後の議論で使用の必要性が出れば復活させる。

valueBoolean

valueInteger :検査結果値を整数値(Integer)で定義したい場合に指定する。ただし、valueQuantityで単位付き数値を示すので、通常は使わない。 SS-MIX2/HL7 V2.5→ OBX-2=「NW」の時の OBX-5(結果値)

valueRange

valueRatio

valueSampledData

valueTime :検査結果値が「時間」の場合、その時間を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「TM」の時の OBX-5(結果値)

valueDateTime :検査結果値が「日時」の場合、その日時を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「DT」の時の OBX-5(結果値)

valuePeriod

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.

SlicingThis element introduces a set of slices on Observation.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
25. Observation.valueQuantity
Control0..1
TypeQuantity
Comments

valueQuantity.value :結果値(数値)を定義。 SS-MIX2/HL7 V2.5:OBX-5(結果値)

valueQuantity.comparator :QuantityComparator Value setから設定。 SS-MIX2/HL7 V2.5→ 検体検査結果メッセージでは未使用となっているデータ型だが、SN型のSN.1(比較演算子)が該当する。検査値の「0未満」の場合の「未満」などに相当するコードを設定。

valueQuantity.unit :.systemで示す単位のValue setの文字列を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.2 テキスト

valueQuantity.system :単位のValue set名を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.3 コード体系 HL7では「ISO+」だが、ローカルコード99zzzのHL7標準の「ISO+」が示すOID、ローカルコードの場合はOIDを別途取得必要

valueQuantity.code :.systemで示す単位のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.1 識別子

26. Observation.valueCodeableConcept
Control0..1
TypeCodeableConcept
Comments

valueCodeableConcept.coding :ローカルコードと国際標準コードなど複数指定できる。 SS-MIX2/HL7 V2.5→ CWEは正規コード+代替コードの2種類登録可能。

valueCodeableConcept.coding.system :対象のValue set名を指定。 SS-MIX2/HL7 V2.5→ CWE.3 or 6 コード体系。対象コードの OIDを設定

valueCodeableConcept.coding.version :対象のValue setのバージョンを指定。 SS-MIX2/HL7 V2.5→ CWE.7 コード体系バージョン ID valueCodeableConcept.coding.code :対象のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ CWE.1 or 4 識別子。対象コードシステムのコード

valueCodeableConcept.coding.display :対象のValue setのテキストを指定。 SS-MIX2/HL7 V2.5→ CWE.2 or 5 テキスト。対象コードの名称

valueCodeableConcept.coding.userselected :未使用。

valueCodeableConcept.text :コードが示す意味を指定する。通常は.coding.displayの値を指定するが、複数ある場合は適宜編集すること。 SS-MIX2/HL7 V2.5→ CWE.2 テキスト。coding.display と同じ。

27. Observation.valueString
Control0..1
Typestring
28. Observation.dataAbsentReason
Definition

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

検査結果値が欠落している理由。

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。

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.

【JP Core仕様】SS-MIX2で未使用だが、valueの欠落時に使用する必要があり、重要な項目である。

制約「obs-6」に示す通り、valueが存在する場合、当該項目は存在してはならない。

textのみでの使用は基本的に不可とし、必ずcodingを設定すること。

(unknown | asked-unknown | temp-unknown | not-asked | asked-declined | masked | not-applicable | unsupported | as-text | error | not-a-number | negative-infinity | positive-infinity | not-performed | not-permitted)

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。

29. Observation.interpretation
Definition

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

検査結果値の、(高、低、正常)といったカテゴリー評価。結果報告書に記載されることもある情報。

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。

Requirements

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

特に数値結果については、結果の重要性を完全に理解するために解釈を必要とする場合がある。

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。

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.

【JP Core仕様】拡張可コード表「ObservationInterpretationCodes」を使用する。

コード表が大きいため、下記参照。

https://www.hl7.org/fhir/R4/valueset-observation-interpretation.html

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。

30. Observation.note
Definition

Comments about the observation or the results.

検査、あるいは結果に関するコメント。フリーテキストの追加情報として使用可能。

Comments about the observation or the results. 観測値、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.

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。

31. Observation.note.time
Control0..?
32. Observation.note.text
Control0..?
Comments

Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

33. Observation.bodySite
Definition

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

検査が行われた患者の体の部位。検体検査に関しては、当面は使用しない。

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.

【JP Core仕様】当面は未使用とする。

34. Observation.method
Definition

Indicates the mechanism used to perform the observation.

検体検査の検査方法、測定方法。

Requirements

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

場合により、測定方法は結果に影響を与える可能性があるため、結果を比較できるかどうかを判断したり、結果の重要性を判断したりするために使用される。

Comments

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

Observation.code の code から測定方法が暗黙的でない場合にのみ使用する。

【JP Core仕様】Observation.code に JLAC10コードを使用する場合、測定方法コードが含まれているため method は使用しない。Observation.code から測定方法が判明しない場合や、実際の測定方法が異なる場合に使用することになるが、現状では運用が困難と想定されるため、当面は未使用とする。

35. Observation.specimen
Definition

The specimen that was used when this observation was made.

この検査に使用された検体(標本)。

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

Control10..1
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).

【JP Core仕様】検体検査プロファイルでは必須とする。

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。

36. Observation.device
Definition

The device used to generate the observation data.

検査装置、機器。

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

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.

【JP Core仕様】検査に使用した機器等の情報に使用する。

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. 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。

37. 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.

推奨範囲として結果値を解釈するためのガイダンス。基準値。

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.

【JP Core仕様】可能な限りlow、highに構造化すべき。構造化できない場合、あるいはlow、highに該当しない場合はtextを使用。

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。

38. Observation.referenceRange.low
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

39. Observation.referenceRange.high
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

40. 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.

対象となる母集団のどの部分に適用するかを示すコード。正常範囲、要治療範囲、など。

41. 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.

基準値が適用される母集団を示すコード。人種、性別など。

42. 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.

基準値が適用される年齢。新生児の場合、週数もありうる。

Comments

The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

43. 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".

量的範囲で表せない場合などに使用する。

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

44. 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.

この検査が含まれるグループを示す。

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。

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】1検査で複数の検査項目が実施される場合の親検査項目を設定する。

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. 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。

45. 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.

この検査値の発生元である関連リソース。例えば他のObservation を受けて、本検査値が発生した場合など。

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。

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.

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. 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。

46. 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.

一度のタイミングでの1回の検査で複数の結果を同時に得る場合にのみ使用される。例えば、血圧の収縮期、拡張期。新生児のApgarスコア。質問に対する複数の回答(飲んだアルコールの種類、など)。

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。

Comments

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

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。

1. Observation
Definition

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

検体検査結果の格納に使用する。

Control0..*
Alternate NamesVital Signs, Measurement, Results, Tests
Comments

すべてのObservation(検査測定や観察事実)の制約プロファイル

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.

InvariantsDefined on this element
dom-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.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.

Control0..1
Typeuri
Is Modifiertrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
4. Observation.identifier
Definition

A unique identifier assigned to this observation.

この検査項目に割り当てられた一意の識別子。リソースの識別子やシステム的なシーケンスではなく、ビジネスID。

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Requirements

Allows observations to be distinguished and referenced.

Comments

【JP Core仕様】当該検査項目に対して、施設内で割り振られる一意の識別子があればそれを使用する。なければ次のルールを参考に一意となる識別子を生成し設定する。

アプリケーション側のデータベースにおけるフィールド長の定義については、最低64バイトを確保すること。

--- 参考 ---

次の項目を順にセパレータ「_(アンダースコア)」で連結し、 identifier.value に設定する。グループ項目でない場合など、該当コード/番号がない場合はセパレータを連続で連結する。各コードはローカルコードを使用し、必ず設定できること。

 1.ORC-2(依頼者オーダ番号) SS-MIX2の15桁前ゼロ形式の番号

 2.OBR-4(検査項目ID) 検査セットの識別コード

 3.SPM-4(検体タイプ)

 4.OBX-3(検査項目)

 5.OBX-4(検査副ID)・・・オプション。必要に応じて使用。

形式:[ORC-2][OBR-4][SPM-4][OBX-3]([OBX-4])

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. Observation.identifier.use
Definition

The purpose of this identifier.

この識別子の目的。

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

アプリケーションは、identifierが一時的であると明示的に述べられない限り、永続的であると想定できる。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. Observation.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

システムのコンテキスト内で一意の識別子となる文字列を設定。

Control0..1
Typestring
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. 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.

このプロファイルでは、検体検査オーダに関する情報。

Control0..*
TypeReference(ServiceRequest|CarePlan|DeviceRequest|ImmunizationRecommendation|MedicationRequest|NutritionOrder))
Requirements

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

Alternate NamesFulfills
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.

【JP Core仕様】オーダ情報がある場合、このプロファイルでは ServiceRequest のリソースを参照する。オーダIDの情報はここで使用する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
8. 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.

このリソースが一部として、あるいは手順の一つとして含まれるより大きなイベント。

Control0..*
TypeReference(JP_MedicationAdministration|JP_MedicationAdministration_Injection|JP_MedicationDispenseBase|MedicationStatement|JP_Procedure|JP_Immunization|ImagingStudy|MedicationAdministration|MedicationDispense|Procedure|Immunization))
Alternate NamesContainer
Comments

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

【JP Core仕様】当面は使用しない。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
9. Observation.status
Definition

The status of the result value.

結果値の状態。

Control1..1
BindingThe codes SHALL be taken from ObservationStatus

Codes providing the status of an observation.

Typecode
Is Modifiertrue
Requirements

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

Comments

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

【JP Core仕様】v2.5の「F」に相当する値は「final」であるが、ここでは 必須コード表「ObservationStatus」より、全てのコード値を使用可とする。

(registered | preliminary | final | amended | corrected | cancelled | entered-in-error | unknown)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
10. Observation.category
Definition

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

行われた検査の一般的なタイプの分類。取得、表示の際のフィルタリングに使用。

Control10..*
BindingThe codes SHOULD be taken from ObservationCategoryCodes

Codes for high level observation categories.

TypeCodeableConcept
Requirements

Used for filtering what observations are retrieved and displayed.

Comments

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.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

(social-history | vital-signs | imaging | laboratory | procedure | survey | exam | therapy | activity)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
11. Observation.category.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. Observation.category:laboratory
SliceNamelaboratory
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.

Control10..1*
BindingThe codes SHOULD be taken from ObservationCategoryCodes

Codes for high level observation categories.

TypeCodeableConcept
Requirements

Used for filtering what observations are retrieved and displayed.

Comments

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. 必要なカテゴリ値セットに加えて、この要素を使用すると、所有者のカテゴリの定義に基づいたさまざまなカテゴリ化スキームが可能になり、複数のカテゴリを一度に効果的に使用できる。粒度のレベルは、値セットのカテゴリの概念によって定義される。

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.

Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="laboratory"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. Observation.code
Definition

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

検査の内容の説明。検査名称。

Control1..1
BindingThe codes SHOULD be taken from JP Core Observation LabResult Code ValueSetFor example codes, see LOINCCodes

MEDIS 臨床検査マスター

Codes identifying names of simple observations.

TypeCodeableConcept
Requirements

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

Alternate NamesName
Comments

*JLAC10

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. Observation.code.coding
Definition

A reference to a code defined by a terminology system.

コード体系によって定義されたコードへの参照。

Control10..*
TypeCoding
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】SS-MIX2にならい、標準コード、ローカルコードの2つを設定可能とし、いずれか一方は必須とする。さらにJLAC10とJLAC11などの複数の標準コードも設定できるよう、上限は設けない。

標準コード、ローカルコードの2つまで格納可。順不同。 SS-MIX2だとCWE.1 ~CWE.3に標準コード、CWE.4~CWE.6にローカルコード、など(順不同)。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. Observation.code.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

コード体系。

Control0..1
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

【JP Core仕様】標準コードの場合、JLAC10を表すURIを設定。

URIは本WGで定義する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. Observation.code.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Requirements

Need to refer to a particular code in the system.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. Observation.code.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. Observation.code.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

このコードが利用者によって、例えば利用可能なコードの選択リストから、など、直接選択されたものであることを示す。

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

【JP Core仕様】当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. Observation.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

コードの表示名。報告書などに記載する場合に使用する表示名。コードを複数指定した場合(標準コード、ローカルコード)、その一般的な表現。

Control10..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

【JP Core仕様】このプロファイルでは、表示名として必須とする。

多くの場合、coding.display と同一になるが、coding.display に異なる複数の表現が格納される場合を想定し、code間で共通の表現として必須とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. 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.

検体検査の対象となる患者。

Control10..1
TypeReference(JP_Patient|Patient|Group|Device|Location))
Requirements

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

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】このプロファイルでは、Patient 限定、かつ必須とする。

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. 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.

患者当人ではなく、患者の胎児、親、ドナーなどの検査、観察の場合、その対象を示す。

Control0..*
TypeReference(Resource))
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. 【JP Core仕様】当面は未使用とする。

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. Observation.encounter
Definition

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

この検査が行われるヘルスケアイベント。医療提供者と患者の接点。

Control0..1
TypeReference(JP_Encounter|Encounter))
Requirements

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

Alternate NamesContext
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】入院外来の区別や所在場所、担当診療科の情報に使用する。

※このプロファイルの用途では通常は必須と考えられるが、ユースケースにより使用されない場合を考慮し、1..1に制約しない。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. 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.

検体検査の場合は、検体採取日時。

Control10..1
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

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

Alternate NamesOccurrence
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】このプロファイルでは、検体採取日時を設定し、必須とする。

effectiveInstant

instant型はイベント発生のログ時間であり、未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. 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.

この情報の発生日時。システム時刻であり、人が報告する時刻ではないことに注意。このリソースの発生時間と同じになる場合がある。

Control0..1
Typeinstant
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.

【JP Core仕様】検査結果がシステムによりObservationリソースに格納または更新された日時。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. Observation.performer
Definition

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

検査値を確認した責任者。検査実施責任者情報。

Control0..*
TypeReference(JP_Practitioner|JP_PractitionerRole|JP_Organization|CareTeam|JP_Patient|RelatedPerson|Practitioner|PractitionerRole|Organization|Patient))
Requirements

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

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.

【JP Core仕様】検査に直接責任を負う個人(つまり検査を実行、もしくは検証した人)の識別子。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. Observation.value[x]
Definition

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

検体検査の結果として決定された情報。

Control0..1 This element is affected by the following invariants: obs-7
TypeChoice of: Quantity, CodeableConcept, string, dateTime, boolean, SampledData, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

以下のデータ型はSS-MIX2では未使用のため、未使用とした。今後の議論で使用の必要性が出れば復活させる。

valueBoolean

valueInteger :検査結果値を整数値(Integer)で定義したい場合に指定する。ただし、valueQuantityで単位付き数値を示すので、通常は使わない。 SS-MIX2/HL7 V2.5→ OBX-2=「NW」の時の OBX-5(結果値)

valueRange

valueRatio

valueSampledData

valueTime :検査結果値が「時間」の場合、その時間を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「TM」の時の OBX-5(結果値)

valueDateTime :検査結果値が「日時」の場合、その日時を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「DT」の時の OBX-5(結果値)

valuePeriod

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
27. Observation.value[x]:valueQuantity
SliceNamevalueQuantity
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。

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

Control0..1 This element is affected by the following invariants: obs-7
TypeChoice of: Quantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

valueQuantity.value :結果値(数値)を定義。 SS-MIX2/HL7 V2.5:OBX-5(結果値)

valueQuantity.comparator :QuantityComparator Value setから設定。 SS-MIX2/HL7 V2.5→ 検体検査結果メッセージでは未使用となっているデータ型だが、SN型のSN.1(比較演算子)が該当する。検査値の「0未満」の場合の「未満」などに相当するコードを設定。

valueQuantity.unit :.systemで示す単位のValue setの文字列を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.2 テキスト

valueQuantity.system :単位のValue set名を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.3 コード体系 HL7では「ISO+」だが、ローカルコード99zzzのHL7標準の「ISO+」が示すOID、ローカルコードの場合はOIDを別途取得必要

valueQuantity.code :.systemで示す単位のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.1 識別子

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. Observation.value[x]:valueCodeableConcept
SliceNamevalueCodeableConcept
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。

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

Control0..1 This element is affected by the following invariants: obs-7
TypeChoice of: CodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

valueCodeableConcept.coding :ローカルコードと国際標準コードなど複数指定できる。 SS-MIX2/HL7 V2.5→ CWEは正規コード+代替コードの2種類登録可能。

valueCodeableConcept.coding.system :対象のValue set名を指定。 SS-MIX2/HL7 V2.5→ CWE.3 or 6 コード体系。対象コードの OIDを設定

valueCodeableConcept.coding.version :対象のValue setのバージョンを指定。 SS-MIX2/HL7 V2.5→ CWE.7 コード体系バージョン ID valueCodeableConcept.coding.code :対象のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ CWE.1 or 4 識別子。対象コードシステムのコード

valueCodeableConcept.coding.display :対象のValue setのテキストを指定。 SS-MIX2/HL7 V2.5→ CWE.2 or 5 テキスト。対象コードの名称

valueCodeableConcept.coding.userselected :未使用。

valueCodeableConcept.text :コードが示す意味を指定する。通常は.coding.displayの値を指定するが、複数ある場合は適宜編集すること。 SS-MIX2/HL7 V2.5→ CWE.2 テキスト。coding.display と同じ。

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. Observation.value[x]:valueString
SliceNamevalueString
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。

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

Control0..1 This element is affected by the following invariants: obs-7
TypeChoice of: string, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. Observation.dataAbsentReason
Definition

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

検査結果値が欠落している理由。

Control0..1 This element is affected by the following invariants: obs-6
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable

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

TypeCodeableConcept
Requirements

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

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.

【JP Core仕様】SS-MIX2で未使用だが、valueの欠落時に使用する必要があり、重要な項目である。

制約「obs-6」に示す通り、valueが存在する場合、当該項目は存在してはならない。

textのみでの使用は基本的に不可とし、必ずcodingを設定すること。

(unknown | asked-unknown | temp-unknown | not-asked | asked-declined | masked | not-applicable | unsupported | as-text | error | not-a-number | negative-infinity | positive-infinity | not-performed | not-permitted)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. Observation.interpretation
Definition

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

検査結果値の、(高、低、正常)といったカテゴリー評価。結果報告書に記載されることもある情報。

Control0..*
BindingThe codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable

Codes identifying interpretations of observations.

TypeCodeableConcept
Requirements

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

特に数値結果については、結果の重要性を完全に理解するために解釈を必要とする場合がある。

Alternate NamesAbnormal Flag
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.

【JP Core仕様】拡張可コード表「ObservationInterpretationCodes」を使用する。

コード表が大きいため、下記参照。

https://www.hl7.org/fhir/R4/valueset-observation-interpretation.html

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. Observation.note
Definition

Comments about the observation or the results.

検査、あるいは結果に関するコメント。フリーテキストの追加情報として使用可能。

Control0..*
TypeAnnotation
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. Observation.note.time
Definition

Indicates when this particular annotation was made.

Control0..1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. Observation.note.text
Definition

The text of the annotation in markdown format.

Control1..1
Typemarkdown
Comments

Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. Observation.bodySite
Definition

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

検査が行われた患者の体の部位。検体検査に関しては、当面は使用しない。

Control0..1
BindingFor example codes, see SNOMEDCTBodyStructures

Codes describing anatomical locations. May include laterality.

TypeCodeableConcept
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.

【JP Core仕様】当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. Observation.method
Definition

Indicates the mechanism used to perform the observation.

検体検査の検査方法、測定方法。

Control0..1
BindingFor example codes, see ObservationMethods

Methods for simple observations.

TypeCodeableConcept
Requirements

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

場合により、測定方法は結果に影響を与える可能性があるため、結果を比較できるかどうかを判断したり、結果の重要性を判断したりするために使用される。

Comments

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

Observation.code の code から測定方法が暗黙的でない場合にのみ使用する。

【JP Core仕様】Observation.code に JLAC10コードを使用する場合、測定方法コードが含まれているため method は使用しない。Observation.code から測定方法が判明しない場合や、実際の測定方法が異なる場合に使用することになるが、現状では運用が困難と想定されるため、当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. Observation.specimen
Definition

The specimen that was used when this observation was made.

この検査に使用された検体(標本)。

Control10..1
TypeReference(Specimen))
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).

【JP Core仕様】検体検査プロファイルでは必須とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. Observation.device
Definition

The device used to generate the observation data.

検査装置、機器。

Control0..1
TypeReference(Device|DeviceMetric))
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.

【JP Core仕様】検査に使用した機器等の情報に使用する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. 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.

推奨範囲として結果値を解釈するためのガイダンス。基準値。

Control0..*
TypeBackboneElement
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。

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.

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.

【JP Core仕様】可能な限りlow、highに構造化すべき。構造化できない場合、あるいはlow、highに該当しない場合はtextを使用。

InvariantsDefined on this element
ele-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())
40. 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
41. 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).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. 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).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. 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.

対象となる母集団のどの部分に適用するかを示すコード。正常範囲、要治療範囲、など。

Control0..1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes

Code for the meaning of a reference range.

TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. 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.

基準値が適用される母集団を示すコード。人種、性別など。

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes

Codes identifying the population the reference range applies to.

TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. 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.

基準値が適用される年齢。新生児の場合、週数もありうる。

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

Comments

The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. 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".

量的範囲で表せない場合などに使用する。

Control0..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
47. 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.

この検査が含まれるグループを示す。

Control0..*
TypeReference(JP_Observation_Common|QuestionnaireResponse|MolecularSequence|Observation))
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】1検査で複数の検査項目が実施される場合の親検査項目を設定する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. 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.

この検査値の発生元である関連リソース。例えば他のObservation を受けて、本検査値が発生した場合など。

Control0..*
TypeReference(DocumentReference|ImagingStudy|Media|QuestionnaireResponse|JP_Observation_Common|MolecularSequence|Observation))
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. 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.

一度のタイミングでの1回の検査で複数の結果を同時に得る場合にのみ使用される。例えば、血圧の収縮期、拡張期。新生児のApgarスコア。質問に対する複数の回答(飲んだアルコールの種類、など)。

Control0..*
TypeBackboneElement
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。

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.

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
50. 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
51. Observation.component.code
Definition

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

Control1..1
BindingFor example codes, see LOINCCodes

Codes identifying names of simple observations.

TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
1. Observation
Definition

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

検体検査結果の格納に使用する。

Control0..*
Alternate NamesVital SignsMeasurementResultsTests
Comments

すべてのObservation(検査測定や観察事実)の制約プロファイル

2. Observation.id
Definition

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

Control0..1
Typeid
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.

3. 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.

Control0..1
TypeMeta
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. 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.

Control0..1
Typeuri
Is Modifiertrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. Observation.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages A human language
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. 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.

Control0..1
TypeNarrative
Alternate Namesnarrativehtmlxhtmldisplay
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. 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.

Control0..*
TypeResource
Alternate Namesinline resourcesanonymous resourcescontained 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.

8. 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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
9. 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).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
10. Observation.identifier
Definition

A unique identifier assigned to this observation.

この検査項目に割り当てられた一意の識別子。リソースの識別子やシステム的なシーケンスではなく、ビジネスID。

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Requirements

Allows observations to be distinguished and referenced.

Comments

【JP Core仕様】当該検査項目に対して、施設内で割り振られる一意の識別子があればそれを使用する。なければ次のルールを参考に一意となる識別子を生成し設定する。

アプリケーション側のデータベースにおけるフィールド長の定義については、最低64バイトを確保すること。

--- 参考 ---

次の項目を順にセパレータ「_(アンダースコア)」で連結し、 identifier.value に設定する。グループ項目でない場合など、該当コード/番号がない場合はセパレータを連続で連結する。各コードはローカルコードを使用し、必ず設定できること。

 1.ORC-2(依頼者オーダ番号) SS-MIX2の15桁前ゼロ形式の番号

 2.OBR-4(検査項目ID) 検査セットの識別コード

 3.SPM-4(検体タイプ)

 4.OBX-3(検査項目)

 5.OBX-4(検査副ID)・・・オプション。必要に応じて使用。

形式:[ORC-2][OBR-4][SPM-4][OBX-3]([OBX-4])

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. Observation.identifier.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
12. Observation.identifier.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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Observation.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
13. Observation.identifier.use
Definition

The purpose of this identifier.

この識別子の目的。

Control0..1
BindingThe codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known
Typecode
Is Modifiertrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

アプリケーションは、identifierが一時的であると明示的に述べられない限り、永続的であると想定できる。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. Observation.identifier.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Control0..1
BindingThe codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable A coded type for an identifier that can be used to determine which identifier to use for a specific purpose
TypeCodeableConcept
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. Observation.identifier.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Control0..1
Typeuri
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. Observation.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

システムのコンテキスト内で一意の識別子となる文字列を設定。

Control0..1
Typestring
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. Observation.identifier.period
Definition

Time period during which identifier is/was valid for use.

Control0..1
TypePeriod
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. Observation.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..1
TypeReference(Organization))
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. 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.

このプロファイルでは、検体検査オーダに関する情報。

Control0..*
TypeReference(ServiceRequest))
Requirements

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

Alternate NamesFulfills
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.

【JP Core仕様】オーダ情報がある場合、このプロファイルでは ServiceRequest のリソースを参照する。オーダIDの情報はここで使用する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. 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.

このリソースが一部として、あるいは手順の一つとして含まれるより大きなイベント。

Control0..*
TypeReference(JP_MedicationAdministrationJP_MedicationAdministration_InjectionJP_MedicationDispenseBaseMedicationStatementJP_ProcedureJP_ImmunizationImagingStudy))
Alternate NamesContainer
Comments

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

【JP Core仕様】当面は使用しない。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. Observation.status
Definition

The status of the result value.

結果値の状態。

Control1..1
BindingThe codes SHALL be taken from ObservationStatus Codes providing the status of an observation
Typecode
Is Modifiertrue
Requirements

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

Comments

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

【JP Core仕様】v2.5の「F」に相当する値は「final」であるが、ここでは 必須コード表「ObservationStatus」より、全てのコード値を使用可とする。

(registered | preliminary | final | amended | corrected | cancelled | entered-in-error | unknown)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. Observation.category
Definition

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

行われた検査の一般的なタイプの分類。取得、表示の際のフィルタリングに使用。

Control1..*
BindingThe codes SHOULD be taken from ObservationCategoryCodes Codes for high level observation categories
TypeCodeableConcept
Requirements

Used for filtering what observations are retrieved and displayed.

Comments

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.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

(social-history | vital-signs | imaging | laboratory | procedure | survey | exam | therapy | activity)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
23. Observation.category.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
24. Observation.category.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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Observation.category.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
25. Observation.category.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】推奨コード表「ObservationCategoryCodes」より、このプロファイルでは「laboratory」固定とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. Observation.category.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. Observation.category:laboratory
SliceNamelaboratory
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

Control1..1
BindingThe codes SHOULD be taken from ObservationCategoryCodes Codes for high level observation categories
TypeCodeableConcept
Requirements

Used for filtering what observations are retrieved and displayed.

Comments

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. 必要なカテゴリ値セットに加えて、この要素を使用すると、所有者のカテゴリの定義に基づいたさまざまなカテゴリ化スキームが可能になり、複数のカテゴリを一度に効果的に使用できる。粒度のレベルは、値セットのカテゴリの概念によって定義される。

Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="laboratory"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-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".

検査の内容の説明。検査名称。

Control1..1
BindingThe codes SHOULD be taken from JP Core Observation LabResult Code ValueSet MEDIS 臨床検査マスタ
TypeCodeableConcept
Requirements

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

Alternate NamesName
Comments

*JLAC10

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. Observation.code.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
30. Observation.code.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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Observation.code.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
31. Observation.code.coding
Definition

A reference to a code defined by a terminology system.

コード体系によって定義されたコードへの参照。

Control1..*
TypeCoding
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

【JP Core仕様】SS-MIX2にならい、標準コード、ローカルコードの2つを設定可能とし、いずれか一方は必須とする。さらにJLAC10とJLAC11などの複数の標準コードも設定できるよう、上限は設けない。

標準コード、ローカルコードの2つまで格納可。順不同。 SS-MIX2だとCWE.1 ~CWE.3に標準コード、CWE.4~CWE.6にローカルコード、など(順不同)。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. Observation.code.coding.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
33. Observation.code.coding.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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Observation.code.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
34. Observation.code.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

コード体系。

Control0..1
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

【JP Core仕様】標準コードの場合、JLAC10を表すURIを設定。

URIは本WGで定義する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. Observation.code.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. Observation.code.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Requirements

Need to refer to a particular code in the system.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. Observation.code.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. Observation.code.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

このコードが利用者によって、例えば利用可能なコードの選択リストから、など、直接選択されたものであることを示す。

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

【JP Core仕様】当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. Observation.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

コードの表示名。報告書などに記載する場合に使用する表示名。コードを複数指定した場合(標準コード、ローカルコード)、その一般的な表現。

Control1..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

【JP Core仕様】このプロファイルでは、表示名として必須とする。

多くの場合、coding.display と同一になるが、coding.display に異なる複数の表現が格納される場合を想定し、code間で共通の表現として必須とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. 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.

検体検査の対象となる患者。

Control1..1
TypeReference(JP_Patient))
Requirements

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

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】このプロファイルでは、Patient 限定、かつ必須とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. 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.

患者当人ではなく、患者の胎児、親、ドナーなどの検査、観察の場合、その対象を示す。

Control0..*
TypeReference(Resource))
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. 【JP Core仕様】当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. Observation.encounter
Definition

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

この検査が行われるヘルスケアイベント。医療提供者と患者の接点。

Control0..1
TypeReference(JP_Encounter))
Requirements

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

Alternate NamesContext
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】入院外来の区別や所在場所、担当診療科の情報に使用する。

※このプロファイルの用途では通常は必須と考えられるが、ユースケースにより使用されない場合を考慮し、1..1に制約しない。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. 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.

検体検査の場合は、検体採取日時。

Control1..1
TypeChoice of: dateTime, Period, Timing
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

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

Alternate NamesOccurrence
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】このプロファイルでは、検体採取日時を設定し、必須とする。

effectiveInstant

instant型はイベント発生のログ時間であり、未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. 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.

この情報の発生日時。システム時刻であり、人が報告する時刻ではないことに注意。このリソースの発生時間と同じになる場合がある。

Control0..1
Typeinstant
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.

【JP Core仕様】検査結果がシステムによりObservationリソースに格納または更新された日時。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. Observation.performer
Definition

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

検査値を確認した責任者。検査実施責任者情報。

Control0..*
TypeReference(JP_PractitionerJP_PractitionerRoleJP_OrganizationCareTeamJP_PatientRelatedPerson))
Requirements

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

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.

【JP Core仕様】検査に直接責任を負う個人(つまり検査を実行、もしくは検証した人)の識別子。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. Observation.value[x]
Definition

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

検体検査の結果として決定された情報。

Control0..1 This element is affected by the following invariants: obs-7
TypeChoice of: Quantity, CodeableConcept, string
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

以下のデータ型はSS-MIX2では未使用のため、未使用とした。今後の議論で使用の必要性が出れば復活させる。

valueBoolean

valueInteger :検査結果値を整数値(Integer)で定義したい場合に指定する。ただし、valueQuantityで単位付き数値を示すので、通常は使わない。 SS-MIX2/HL7 V2.5→ OBX-2=「NW」の時の OBX-5(結果値)

valueRange

valueRatio

valueSampledData

valueTime :検査結果値が「時間」の場合、その時間を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「TM」の時の OBX-5(結果値)

valueDateTime :検査結果値が「日時」の場合、その日時を指定する。 SS-MIX2/HL7 V2.5→ OBX-2=「DT」の時の OBX-5(結果値)

valuePeriod

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
47. Observation.value[x]:valueQuantity
SliceNamevalueQuantity
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。

Control0..1 This element is affected by the following invariants: obs-7
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

valueQuantity.value :結果値(数値)を定義。 SS-MIX2/HL7 V2.5:OBX-5(結果値)

valueQuantity.comparator :QuantityComparator Value setから設定。 SS-MIX2/HL7 V2.5→ 検体検査結果メッセージでは未使用となっているデータ型だが、SN型のSN.1(比較演算子)が該当する。検査値の「0未満」の場合の「未満」などに相当するコードを設定。

valueQuantity.unit :.systemで示す単位のValue setの文字列を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.2 テキスト

valueQuantity.system :単位のValue set名を指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.3 コード体系 HL7では「ISO+」だが、ローカルコード99zzzのHL7標準の「ISO+」が示すOID、ローカルコードの場合はOIDを別途取得必要

valueQuantity.code :.systemで示す単位のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ OBX-6(単位) CWE.1 識別子

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. Observation.value[x]:valueCodeableConcept
SliceNamevalueCodeableConcept
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。

Control0..1 This element is affected by the following invariants: obs-7
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

Comments

valueCodeableConcept.coding :ローカルコードと国際標準コードなど複数指定できる。 SS-MIX2/HL7 V2.5→ CWEは正規コード+代替コードの2種類登録可能。

valueCodeableConcept.coding.system :対象のValue set名を指定。 SS-MIX2/HL7 V2.5→ CWE.3 or 6 コード体系。対象コードの OIDを設定

valueCodeableConcept.coding.version :対象のValue setのバージョンを指定。 SS-MIX2/HL7 V2.5→ CWE.7 コード体系バージョン ID valueCodeableConcept.coding.code :対象のValue setのコードを指定。 SS-MIX2/HL7 V2.5→ CWE.1 or 4 識別子。対象コードシステムのコード

valueCodeableConcept.coding.display :対象のValue setのテキストを指定。 SS-MIX2/HL7 V2.5→ CWE.2 or 5 テキスト。対象コードの名称

valueCodeableConcept.coding.userselected :未使用。

valueCodeableConcept.text :コードが示す意味を指定する。通常は.coding.displayの値を指定するが、複数ある場合は適宜編集すること。 SS-MIX2/HL7 V2.5→ CWE.2 テキスト。coding.display と同じ。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. Observation.value[x]:valueString
SliceNamevalueString
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。

Control0..1 This element is affected by the following invariants: obs-7
Typestring
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
50. Observation.dataAbsentReason
Definition

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

検査結果値が欠落している理由。

Control0..1 This element is affected by the following invariants: obs-6
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable Codes specifying why the result (Observation.value[x]) is missing
TypeCodeableConcept
Requirements

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

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.

【JP Core仕様】SS-MIX2で未使用だが、valueの欠落時に使用する必要があり、重要な項目である。

制約「obs-6」に示す通り、valueが存在する場合、当該項目は存在してはならない。

textのみでの使用は基本的に不可とし、必ずcodingを設定すること。

(unknown | asked-unknown | temp-unknown | not-asked | asked-declined | masked | not-applicable | unsupported | as-text | error | not-a-number | negative-infinity | positive-infinity | not-performed | not-permitted)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. Observation.interpretation
Definition

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

検査結果値の、(高、低、正常)といったカテゴリー評価。結果報告書に記載されることもある情報。

Control0..*
BindingThe codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable Codes identifying interpretations of observations
TypeCodeableConcept
Requirements

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

特に数値結果については、結果の重要性を完全に理解するために解釈を必要とする場合がある。

Alternate NamesAbnormal Flag
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.

【JP Core仕様】拡張可コード表「ObservationInterpretationCodes」を使用する。

コード表が大きいため、下記参照。

https://www.hl7.org/fhir/R4/valueset-observation-interpretation.html

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. Observation.note
Definition

Comments about the observation or the results.

検査、あるいは結果に関するコメント。フリーテキストの追加情報として使用可能。

Control0..*
TypeAnnotation
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。

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
53. Observation.note.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
54. Observation.note.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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Observation.note.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
55. Observation.note.author[x]
Definition

The individual responsible for making the annotation.

Control0..1
TypeChoice of: Reference(PractitionerPatientRelatedPersonOrganization)), string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

Organization is used when there's no need for specific attribution as to who made the comment.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. Observation.note.time
Definition

Indicates when this particular annotation was made.

Control0..1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. Observation.note.text
Definition

The text of the annotation in markdown format.

Control1..1
Typemarkdown
Comments

Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
58. Observation.bodySite
Definition

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

検査が行われた患者の体の部位。検体検査に関しては、当面は使用しない。

Control0..1
BindingFor example codes, see SNOMEDCTBodyStructures Codes describing anatomical locations. May include laterality
TypeCodeableConcept
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.

【JP Core仕様】当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
59. Observation.method
Definition

Indicates the mechanism used to perform the observation.

検体検査の検査方法、測定方法。

Control0..1
BindingFor example codes, see ObservationMethods Methods for simple observations
TypeCodeableConcept
Requirements

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

場合により、測定方法は結果に影響を与える可能性があるため、結果を比較できるかどうかを判断したり、結果の重要性を判断したりするために使用される。

Comments

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

Observation.code の code から測定方法が暗黙的でない場合にのみ使用する。

【JP Core仕様】Observation.code に JLAC10コードを使用する場合、測定方法コードが含まれているため method は使用しない。Observation.code から測定方法が判明しない場合や、実際の測定方法が異なる場合に使用することになるが、現状では運用が困難と想定されるため、当面は未使用とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
60. Observation.specimen
Definition

The specimen that was used when this observation was made.

この検査に使用された検体(標本)。

Control1..1
TypeReference(Specimen))
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).

【JP Core仕様】検体検査プロファイルでは必須とする。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. Observation.device
Definition

The device used to generate the observation data.

検査装置、機器。

Control0..1
TypeReference(DeviceDeviceMetric))
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.

【JP Core仕様】検査に使用した機器等の情報に使用する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
62. 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.

推奨範囲として結果値を解釈するためのガイダンス。基準値。

Control0..*
TypeBackboneElement
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。

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.

【JP Core仕様】可能な限りlow、highに構造化すべき。構造化できない場合、あるいはlow、highに該当しない場合はtextを使用。

InvariantsDefined on this element
ele-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())
63. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
64. 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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
65. 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).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensionsuser contentmodifiers
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.

InvariantsDefined on this element
ele-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).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
67. 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).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
68. 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.

対象となる母集団のどの部分に適用するかを示すコード。正常範囲、要治療範囲、など。

Control0..1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes Code for the meaning of a reference range
TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
69. 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.

基準値が適用される母集団を示すコード。人種、性別など。

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes Codes identifying the population the reference range applies to
TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
70. 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.

基準値が適用される年齢。新生児の場合、週数もありうる。

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

Comments

The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
71. 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".

量的範囲で表せない場合などに使用する。

Control0..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
72. 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.

この検査が含まれるグループを示す。

Control0..*
TypeReference(JP_Observation_CommonQuestionnaireResponseMolecularSequence))
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】1検査で複数の検査項目が実施される場合の親検査項目を設定する。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
73. 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.

この検査値の発生元である関連リソース。例えば他のObservation を受けて、本検査値が発生した場合など。

Control0..*
TypeReference(DocumentReferenceImagingStudyMediaQuestionnaireResponseJP_Observation_CommonMolecularSequence))
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
74. 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.

一度のタイミングでの1回の検査で複数の結果を同時に得る場合にのみ使用される。例えば、血圧の収縮期、拡張期。新生児のApgarスコア。質問に対する複数の回答(飲んだアルコールの種類、など)。

Control0..*
TypeBackboneElement
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。

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
75. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
76. 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.

Control0..*
TypeExtension
Alternate Namesextensionsuser content
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.

InvariantsDefined on this element
ele-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())
77. 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).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensionsuser contentmodifiers
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.

InvariantsDefined on this element
ele-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())
78. Observation.component.code
Definition

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

Control1..1
BindingFor example codes, see LOINCCodes Codes identifying names of simple observations
TypeCodeableConcept
Requirements

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

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
79. Observation.component.value[x]
Definition

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

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]
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
80. Observation.component.dataAbsentReason
Definition

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

Control0..1 This element is affected by the following invariants: obs-6
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable Codes specifying why the result (Observation.value[x]) is missing
TypeCodeableConcept
Requirements

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

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
81. Observation.component.interpretation
Definition

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

Control0..*
BindingThe codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable Codes identifying interpretations of observations
TypeCodeableConcept
Requirements

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

Alternate NamesAbnormal Flag
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
82. Observation.component.referenceRange
Definition

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

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))