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。

すべてのObservation（検査測定や観察事実）の制約プロファイル

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。

【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]）

The purpose of this identifier.

この識別子の目的。

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。

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。

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。

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。

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。

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。

The status of the result value.

結果値の状態。

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)

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。

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)

• pattern @ $this

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。

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

検査の内容の説明。検査名称。

MEDIS 臨床検査マスター

*JLAC10

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。

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）。

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

コード体系。

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。

Note that FHIR strings SHALL NOT exceed 1MB in size

Note that FHIR strings SHALL NOT exceed 1MB in size

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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。

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

• type @ $this

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

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。

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。

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)

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。

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。

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

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。

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.

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/

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。

【JP Core仕様】当面は未使用とする。

検体検査の検査方法、測定方法。

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。

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。

The specimen that was used when this observation was made.

この検査に使用された検体（標本）。

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。

The device used to generate the observation data.

検査装置、機器。

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。

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。

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。

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.

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.

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。

基準値が適用される母集団を示すコード。人種、性別など。

基準値が適用される年齢。新生児の場合、週数もありうる。

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.

量的範囲で表せない場合などに使用する。

Note that FHIR strings SHALL NOT exceed 1MB in size

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。

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。

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。

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.

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）。

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

検体検査結果の格納に使用する。

すべてのObservation（検査測定や観察事実）の制約プロファイル

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。

【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]）

この識別子の目的。

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。

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。

このプロファイルでは、検体検査オーダに関する情報。

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。

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。

【JP Core仕様】当面は使用しない。

結果値の状態。

【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)

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。

【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)

• pattern @ $this

【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。

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

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。

検査の内容の説明。検査名称。

MEDIS 臨床検査マスター

*JLAC10

コード体系によって定義されたコードへの参照。

【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）。

コード体系。

【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。

Note that FHIR strings SHALL NOT exceed 1MB in size

Note that FHIR strings SHALL NOT exceed 1MB in size

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。

【JP Core仕様】当面は未使用とする。

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。

【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。

検体検査の対象となる患者。

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated. 【JP Core仕様】このプロファイルでは、Patient 限定、かつ必須とする。

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。

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。

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。

【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。

検体検査の場合は、検体採取日時。

【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。

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。

【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。

検査値を確認した責任者。検査実施責任者情報。

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。

検体検査の結果として決定された情報。

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

• type @ $this

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。

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

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。

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。

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。

検査結果値が欠落している理由。

【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)

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。

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。

【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

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。

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。

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/

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。

【JP Core仕様】当面は未使用とする。

検体検査の検査方法、測定方法。

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。

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。

この検査に使用された検体（標本）。

【JP Core仕様】検体検査プロファイルでは必須とする。

検査装置、機器。

【JP Core仕様】検査に使用した機器等の情報に使用する。

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。

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。

【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。

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.

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.

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。

基準値が適用される母集団を示すコード。人種、性別など。

基準値が適用される年齢。新生児の場合、週数もありうる。

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.

量的範囲で表せない場合などに使用する。

Note that FHIR strings SHALL NOT exceed 1MB in size

この検査が含まれるグループを示す。

【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。

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。

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）。

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。

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。

すべてのObservation（検査測定や観察事実）の制約プロファイル

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

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

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.

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.

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.

The base language in which the resource is written.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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。

Allows observations to be distinguished and referenced.

【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]）

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

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.

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.

• value @ url

The purpose of this identifier.

この識別子の目的。

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

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。

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

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

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.

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

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.

Identifier.system is always case sensitive.

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。

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.

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

Organization that issued/manages the identifier.

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.

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。

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

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。

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。

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。

The status of the result value.

結果値の状態。

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

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)

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。

Used for filtering what observations are retrieved and displayed.

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)

• pattern @ $this

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

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.

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.

• value @ url

A reference to a code defined by a terminology system.

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

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。

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.

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.

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

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

Used for filtering what observations are retrieved and displayed.

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。

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

検査の内容の説明。検査名称。

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

*JLAC10

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

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.

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.

• value @ url

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。

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

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）。

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

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.

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.

• value @ url

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

コード体系。

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

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。

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.

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.

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).

Need to refer to a particular code in the system.

Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

Note that FHIR strings SHALL NOT exceed 1MB in size

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。

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.

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。

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。

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.

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。

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。

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

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。

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。

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。

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。

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

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。

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。

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

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。

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。

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。

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。

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

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。

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。

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

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

• type @ $this

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。

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

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

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。

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

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。

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。

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

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.

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。

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

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)

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。

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。

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

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。

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。

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.

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

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.

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.

• value @ url

The individual responsible for making the annotation.

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

Indicates when this particular annotation was made.

The text of the annotation in markdown format.

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/

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。

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。

Indicates the mechanism used to perform the observation.

検体検査の検査方法、測定方法。

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。

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。

The specimen that was used when this observation was made.

この検査に使用された検体（標本）。

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。

The device used to generate the observation data.

検査装置、機器。

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。

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。

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。

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。

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

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.

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.

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).

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.

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.

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).

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.

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).

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.

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。

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

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

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。

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

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

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。

Some analytes vary greatly over age.

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.

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。

Note that FHIR strings SHALL NOT exceed 1MB in size

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。

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。

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。

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.

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）。

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。

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

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

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.

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.

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).

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.

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.

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

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

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

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

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

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.

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

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

"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.

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

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

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.

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

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.

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.