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

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

Resource Profile: JP_Observation_LabResult - Detailed Descriptions

Active as of 2023-10-31

Definitions for the jp-observation-labresult resource profile.

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

0. Observation
Definition

検体検査結果の格納に使用する。


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

Short検体検査結果Measurements and simple assertions
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.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

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

この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.

Short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Business Identifier for observation
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])

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Allows observations to be distinguished and referenced.

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

この識別子の目的。


The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

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。


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

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.3.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.3.0)
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

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

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Observation.identifier.value
Definition

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。


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

ShortThe value that is unique
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.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Observation.basedOn
Definition

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.

ShortこのObservationが実施されることになった依頼や計画、提案に関する情報Fulfills plan, proposal or order
Comments

【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。

Control0..*
TypeReference(ServiceRequest, CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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

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

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.

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

【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.

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

結果値の状態。


The status of the result value.

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

【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.

Control1..1
BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.3.0
(required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

Codes providing the status of an observation.

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

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

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

このObservationを分類するコード


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

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

階層的にカテゴリーを設定することで粒度のレベルを概念定義できる。


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

Control10..*
BindingThe codes SHOULD be taken from JP Core Simple Observation Category ValueSethttp://hl7.org/fhir/ValueSet/observation-category
(preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

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

    コード化されたカテゴリー


    A reference to a code defined by a terminology system.

    Shortコード化されたカテゴリーCode defined by a terminology system
    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.

    Control0..*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

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

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

    検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。


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

    Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。Classification of type of observation
    Comments

    【JP Core仕様】推奨コード表「JP Core Simple Observation Category CodeSystem」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.

    Control10..1*
    BindingThe codes SHALL be taken from The codes SHOULD be taken from JP Core Simple Observation Category ValueSethttp://hl7.org/fhir/ValueSet/observation-category
    (required to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Used for filtering what observations are retrieved and displayed.

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

    コード化されたカテゴリー


    A reference to a code defined by a terminology system.

    Shortコード化されたカテゴリーCode defined by a terminology system
    Comments

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


    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.

    Control10..1*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

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

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

    検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。


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

    Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。Identity of the terminology system
    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.

    Control10..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

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

    Fixed Valuehttp://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Observation.category:laboratory.coding.code
    Definition

    検体検査を表すコード laboratory を設定する。


    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).

    Short検体検査を表すコード laboratory を設定する。Symbol in syntax defined by the system
    Control10..1
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Need to refer to a particular code in the system.

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

    検査の内容の説明。検査名称。


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

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

    *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.

    Control1..1
    BindingThe codes SHOULD be taken from For example codes, see JP Core Observation LabResult Code ValueSethttp://hl7.org/fhir/ValueSet/observation-codes
    (preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_ObservationLabResultCode_VS)

    MEDIS 臨床検査マスター


    Codes identifying names of simple observations.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

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

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

    コード体系によって定義されたコードへの参照。


    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    【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)。


    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.

    Control10..*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

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

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

    コード体系。


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

    ShortIdentity of the terminology system
    Comments

    【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 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.

    Control0..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

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

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

    ShortSymbol in syntax defined by the system
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

    Control0..1
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Need to refer to a particular code in the system.

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

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

    ShortRepresentation defined by the system
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

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

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

    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。


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

    ShortIf this coding was chosen directly by the user
    Comments

    【JP Core仕様】当面は未使用とする。


    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.

    Control0..1
    Typeboolean
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    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.

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

    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。


    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.

    ShortPlain text representation of the concept
    Comments

    【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。


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

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    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.

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

    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.

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

    【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.

    Control10..1
    TypeReference(JP Core Patient Profile, Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

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

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

    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.

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

    【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.

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

    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.

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

    【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).

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

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

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

    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.

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

    【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.

    Control10..1
    TypeChoice of: dateTime, Period, Timing, instant
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

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

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

    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.

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

    【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.

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

    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".

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

    【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。

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

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

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

    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.

    Short同じ検査項目でも、システム(施設)により、使うデータ型が異なる可能性あり【詳細参照】Actual result
    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.

    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] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

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

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
    • type @ $this
    • 60. Observation.value[x]:valueQuantity
      Slice NamevalueQuantity
      Definition

      取得された結果


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

      Short検査結果が「数値」の場合、値、単位を設定する。 SS-MIX2/HL7 V2.5→ OBX-2=「NM」の時の OBX-5(結果値)、OBX-6(単位)【詳細参照】Actual result
      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.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Requirements

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

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

      取得された結果


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

      Short検査結果が「コード値」の場合、コード、テキスト、コードのValue setを定義する。 SS-MIX2/HL7 V2.5→ OBX-2=「CWE」の時の OBX-5(結果値)【詳細参照】Actual result
      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.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Requirements

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

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

      取得された結果


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

      Short検査結果値が「文字列」の場合、その文字列を指定する。SS-MIX2/HL7 V2.5→ OBX-2=「ST」の時の OBX-5(結果値)Actual result
      Comments

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

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

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

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

      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.

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

      【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.

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

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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

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

      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.

      ShortHigh, low, normal, etc. 高、低、正常など
      Comments

      【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/R4B/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.

      Control0..*
      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation
      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

      Codes identifying interpretations of observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

      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.

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

      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.

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

      Control0..*
      TypeAnnotation
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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


      Need to be able to provide free text additional information.

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

      Indicates when this particular annotation was made.

      ShortWhen the annotation was made
      Control0..1
      TypedateTime
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. Observation.note.text
      Definition

      The text of the annotation in markdown format.

      ShortThe annotation - text content (as markdown)
      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/

      Control1..1
      Typemarkdown
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. Observation.bodySite
      Definition

      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。


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

      Short対象となった身体部位Observed body part
      Comments

      【JP Core仕様】当面は未使用とする。


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

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

      Control0..1
      BindingFor example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site
      (example to http://hl7.org/fhir/ValueSet/body-site)

      SNOMED CT Body site concepts

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

      検体検査の検査方法、測定方法。


      Indicates the mechanism used to perform the observation.

      Short実施の方法How it was done
      Comments

      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。


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

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

      Methods for simple observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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


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

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

      この検査に使用された検体(標本)。


      The specimen that was used when this observation was made.

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

      【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).

      Control10..1
      TypeReference(Specimen)
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. Observation.device
      Definition

      検査装置、機器。


      The device used to generate the observation data.

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

      【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.

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

      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。


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

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

      【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.

      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

      どの値が「正常」と見なされるかを知ることは、特定の結果の意義を評価するのに役立つ。さまざまなコンテキストに対応するため複数の参照範囲を提供できる必要がある。


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

      Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
      obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
      86. Observation.referenceRange.modifierExtension
      Definition

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

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

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

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

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

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

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

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

      ShortLow Range, if relevant
      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.

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

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

      ShortHigh Range, if relevant
      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.

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

      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。


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

      ShortReference range qualifier
      Comments

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

      Control0..1
      BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaning
      (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

      Code for the meaning of a reference range.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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

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

      基準値が適用される母集団を示すコード。人種、性別など。


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

      ShortReference range population
      Comments

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

      Control0..*
      BindingFor example codes, see ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliesto
      (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

      Codes identifying the population the reference range applies to.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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

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

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

      ShortApplicable age range, if relevant
      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.

      Control0..1
      TypeRange
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

      Some analytes vary greatly over age.

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

      量的範囲で表せない場合などに使用する。


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

      ShortText based reference range in an observation
      Comments

      Note that FHIR strings SHALL NOT exceed 1MB in size

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

      グループ検査の場合、この検査に含まれる複数の検査結果項目を示す。


      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.

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

      【JP Core仕様】この1検査結果で複数の検査結果項目を含むような場合、value[x]には結果値を設定せず、それら検査結果項目を示すJP_Observation_LabResultへのReferenceをhasMemberに設定する。


      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.

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

      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.

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

      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.

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

      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.

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

      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.

      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Requirements

      コンポーネントobservation は プライマリobservation としてのobservation リソースの中で同じ属性を共有し、常に単一のobservation の一部として扱われる(つまりそれらは分離可能ではないん)。ただし、プライマリobservationのreference rangeはコンポーネント値に継承されないため、reference rangeは各コンポーネントobservation に適切であれば必要である。


      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

      Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
      106. Observation.component.modifierExtension
      Definition

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

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

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

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

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

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

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

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

      ShortType of component observation (code / type)
      Comments

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

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

      Codes identifying names of simple observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Requirements

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

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

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

      0. Observation
      Definition

      検体検査結果の格納に使用する。

      Short検体検査結果
      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.identifier
      Definition

      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。

      Short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
      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])

      NoteThis is a business identifier, not a resource identifier (see discussion)
      4. Observation.identifier.use
      Definition

      この識別子の目的。

      Comments

      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。

      6. Observation.identifier.system
      8. Observation.identifier.value
      Definition

      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。

      10. Observation.basedOn
      Definition

      このプロファイルでは、検体検査オーダに関する情報。

      Comments

      【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。

      TypeReference(ServiceRequest)
      12. Observation.partOf
      Definition

      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。

      Comments

      【JP Core仕様】当面は使用しない。

      14. Observation.status
      Definition

      結果値の状態。

      Comments

      【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)

      16. Observation.category
      Control1..?
      SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ $this
      • 18. Observation.category.coding
        Definition

        コード化されたカテゴリー

        Shortコード化されたカテゴリー
        20. Observation.category:laboratory
        Slice Namelaboratory
        Definition

        検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。

        Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。
        Comments

        【JP Core仕様】推奨コード表「JP Core Simple Observation Category CodeSystem」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)

        Control1..1
        BindingThe codes SHALL be taken from JP Core Simple Observation Category ValueSet
        (required to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
        22. Observation.category:laboratory.coding
        Comments

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

        Control1..1
        24. Observation.category:laboratory.coding.system
        Definition

        検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。

        Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。
        Control1..?
        Fixed Valuehttp://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS
        26. Observation.category:laboratory.coding.code
        Definition

        検体検査を表すコード laboratory を設定する。

        Short検体検査を表すコード laboratory を設定する。
        Control1..?
        Fixed Valuelaboratory
        28. Observation.code
        Definition

        検査の内容の説明。検査名称。

        Comments

        *JLAC10

        BindingThe codes SHOULD be taken from JP Core Observation LabResult Code ValueSet
        (preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_ObservationLabResultCode_VS)

        MEDIS 臨床検査マスター

        30. Observation.code.coding
        Definition

        コード体系によって定義されたコードへの参照。

        Comments

        【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)。

        Control1..?
        32. Observation.code.coding.system
        Definition

        コード体系。

        Comments

        【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。

        34. Observation.code.coding.code
        Comments

        Note that FHIR strings SHALL NOT exceed 1MB in size

        36. Observation.code.coding.display
        Comments

        Note that FHIR strings SHALL NOT exceed 1MB in size

        38. Observation.code.coding.userSelected
        Definition

        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。

        Comments

        【JP Core仕様】当面は未使用とする。

        40. Observation.code.text
        Definition

        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。

        Comments

        【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。

        Control1..?
        42. Observation.subject
        Definition

        検体検査の対象となる患者。

        Comments

        【JP Core仕様】このプロファイルでは、Patient 限定、かつ必須とする。

        Control1..?
        TypeReference(JP Core Patient Profile)
        44. Observation.focus
        Definition

        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。

        Comments

        【JP Core仕様】当面は未使用とする。

        46. Observation.encounter
        Definition

        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。

        Comments

        【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。

        48. Observation.effective[x]
        Definition

        検体検査の場合は、検体採取日時。

        Comments

        【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。

        Control1..?
        TypeChoice of: dateTime, Period, Timing, instant
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        50. Observation.issued
        Definition

        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。

        Comments

        【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。

        52. Observation.performer
        Definition

        検査値を確認した責任者。検査実施責任者情報。

        Comments

        【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。

        54. Observation.value[x]
        Definition

        検体検査の結果として決定された情報。

        Short同じ検査項目でも、システム(施設)により、使うデータ型が異なる可能性あり【詳細参照】
        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

        TypeChoice of: Quantity, CodeableConcept, string, dateTime, boolean, SampledData, Period, Ratio, integer, time, Range
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • type @ $this
        • 56. Observation.value[x]:valueQuantity
          Slice NamevalueQuantity
          Short検査結果が「数値」の場合、値、単位を設定する。 SS-MIX2/HL7 V2.5→ OBX-2=「NM」の時の OBX-5(結果値)、OBX-6(単位)【詳細参照】
          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

          Control0..1
          TypeQuantity
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          58. Observation.value[x]:valueCodeableConcept
          Slice NamevalueCodeableConcept
          Short検査結果が「コード値」の場合、コード、テキスト、コードのValue setを定義する。 SS-MIX2/HL7 V2.5→ OBX-2=「CWE」の時の OBX-5(結果値)【詳細参照】
          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。

          Control0..1
          TypeCodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          60. Observation.value[x]:valueString
          Slice NamevalueString
          Short検査結果値が「文字列」の場合、その文字列を指定する。SS-MIX2/HL7 V2.5→ OBX-2=「ST」の時の OBX-5(結果値)
          Control0..1
          Typestring
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          62. Observation.dataAbsentReason
          Definition

          検査結果値が欠落している理由。

          Comments

          【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)

          64. Observation.interpretation
          Definition

          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。

          ShortHigh, low, normal, etc. 高、低、正常など
          Comments

          【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/R4B/valueset-observation-interpretation.html

          Requirements

          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。

          66. Observation.note
          Definition

          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

          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.

          68. Observation.note.time
          70. Observation.note.text
          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/

          72. Observation.bodySite
          Definition

          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

          【JP Core仕様】当面は未使用とする。

          74. Observation.method
          Definition

          検体検査の検査方法、測定方法。

          Short実施の方法
          Comments

          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。

          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。

          76. Observation.specimen
          Definition

          この検査に使用された検体(標本)。

          Comments

          【JP Core仕様】検体検査プロファイルでは必須とする。

          Control1..?
          78. Observation.device
          Definition

          検査装置、機器。

          Comments

          【JP Core仕様】検査に使用した機器等の情報に使用する。

          80. Observation.referenceRange
          Definition

          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

          【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。

          82. 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.

          84. 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.

          86. Observation.referenceRange.type
          Definition

          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。

          88. Observation.referenceRange.appliesTo
          Definition

          基準値が適用される母集団を示すコード。人種、性別など。

          90. Observation.referenceRange.age
          Definition

          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.

          92. Observation.referenceRange.text
          Definition

          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

          94. Observation.hasMember
          Definition

          グループ検査の場合、この検査に含まれる複数の検査結果項目を示す。

          Comments

          【JP Core仕様】この1検査結果で複数の検査結果項目を含むような場合、value[x]には結果値を設定せず、それら検査結果項目を示すJP_Observation_LabResultへのReferenceをhasMemberに設定する。

          96. Observation.derivedFrom
          Definition

          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。

          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.

          98. Observation.component
          Definition

          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)。

          Comments

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

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

          0. Observation
          Definition

          検体検査結果の格納に使用する。

          Short検体検査結果
          Comments

          すべてのObservation(検査測定や観察事実)の制約プロファイル

          Control0..*
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate NamesVital Signs, Measurement, Results, Tests
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
          obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
          2. Observation.id
          Definition

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

          ShortLogical id of this artifact
          Comments

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

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

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

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

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

          ShortA set of rules under which this content was created
          Comments

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

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

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

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

          Control0..1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          IETF language tag

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

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

          ShortText summary of the resource, for human interpretation
          Comments

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

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

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

          ShortContained, inline Resources
          Comments

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

          Control0..*
          TypeResource
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          Invariantsdom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))
          14. Observation.extension
          Definition

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

          ShortAdditional content defined by implementations
          Comments

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

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

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

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

          ShortExtensions that cannot be ignored
          Comments

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

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

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

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

          この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。

          Short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
          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])

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Requirements

          Allows observations to be distinguished and referenced.

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

          ShortUnique id for inter-element referencing
          Control0..1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          22. 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.

          ShortAdditional content defined by implementations
          Comments

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

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 24. Observation.identifier.use
            Definition

            この識別子の目的。

            Shortusual | official | temp | secondary | old (If known)
            Comments

            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。

            Control0..1
            BindingThe codes SHALL be taken from IdentifierUse
            (required to http://hl7.org/fhir/ValueSet/identifier-use|4.3.0)
            Typecode
            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

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

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

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

            ShortDescription of identifier
            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.

            Control0..1
            BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
            (extensible to http://hl7.org/fhir/ValueSet/identifier-type)
            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

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

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

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

            ShortThe namespace for the identifier value
            Comments

            Identifier.system is always case sensitive.

            Control0..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            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.

            Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            30. Observation.identifier.value
            Definition

            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。

            ShortThe value that is unique
            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.

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Example<br/><b>General</b>:123456
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. Observation.identifier.period
            Definition

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

            ShortTime period when id is/was valid for use
            Control0..1
            TypePeriod
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            34. Observation.identifier.assigner
            Definition

            Organization that issued/manages the identifier.

            ShortOrganization that issued id (may be just text)
            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.

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

            このプロファイルでは、検体検査オーダに関する情報。

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

            【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。

            Control0..*
            TypeReference(ServiceRequest)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

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

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

            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。

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

            【JP Core仕様】当面は使用しない。

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

            結果値の状態。

            Short結果の状態
            Comments

            【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)

            Control1..1
            BindingThe codes SHALL be taken from ObservationStatus
            (required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

            Codes providing the status of an observation.

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

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

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

            このObservationを分類するコード

            ShortこのObservationを分類するコード
            Comments

            階層的にカテゴリーを設定することで粒度のレベルを概念定義できる。

            Control1..*
            BindingThe codes SHOULD be taken from JP Core Simple Observation Category ValueSet
            (preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ $this
            • 44. 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.

              ShortUnique id for inter-element referencing
              Control0..1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              46. 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.

              ShortAdditional content defined by implementations
              Comments

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

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 48. Observation.category.coding
                Definition

                コード化されたカテゴリー

                Shortコード化されたカテゴリー
                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.

                Control0..*
                TypeCoding
                Is Modifierfalse
                Summarytrue
                Requirements

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

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

                ShortPlain text representation of the concept
                Comments

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

                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                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.

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

                検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。

                Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表から"laboratory"を設定する。
                Comments

                【JP Core仕様】推奨コード表「JP Core Simple Observation Category CodeSystem」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)

                Control1..1
                BindingThe codes SHALL be taken from JP Core Simple Observation Category ValueSet
                (required to http://jpfhir.jp/fhir/core/ValueSet/JP_SimpleObservationCategory_VS)
                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                Used for filtering what observations are retrieved and displayed.

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

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

                ShortUnique id for inter-element referencing
                Control0..1
                Typeid
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                56. Observation.category:laboratory.extension
                Definition

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

                ShortAdditional content defined by implementations
                Comments

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

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on Observation.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 58. Observation.category:laboratory.coding
                  Definition

                  コード化されたカテゴリー

                  Shortコード化されたカテゴリー
                  Comments

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

                  Control1..1
                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Requirements

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

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

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typeid
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  62. Observation.category:laboratory.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.

                  ShortAdditional content defined by implementations
                  Comments

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

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on Observation.category.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 64. Observation.category:laboratory.coding.system
                    Definition

                    検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。

                    Short検体検査では、http://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS のコード表を使用する。
                    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.

                    Control1..1
                    Typeuri
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

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

                    Fixed Valuehttp://jpfhir.jp/fhir/core/CodeSystem/JP_SimpleObservationCategory_CS
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. Observation.category:laboratory.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.

                    ShortVersion of the system - if relevant
                    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.

                    NoteThis is a business version Id, not a resource version Id (see discussion)
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    68. Observation.category:laboratory.coding.code
                    Definition

                    検体検査を表すコード laboratory を設定する。

                    Short検体検査を表すコード laboratory を設定する。
                    Control1..1
                    Typecode
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    Need to refer to a particular code in the system.

                    Fixed Valuelaboratory
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    70. Observation.category:laboratory.coding.display
                    Definition

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

                    ShortRepresentation defined by the system
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

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

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

                    ShortIf this coding was chosen directly by the user
                    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.

                    Control0..1
                    Typeboolean
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    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.

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

                    ShortPlain text representation of the concept
                    Comments

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

                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    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.

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

                    検査の内容の説明。検査名称。

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

                    *JLAC10

                    Control1..1
                    BindingThe codes SHOULD be taken from JP Core Observation LabResult Code ValueSet
                    (preferred to http://jpfhir.jp/fhir/core/ValueSet/JP_ObservationLabResultCode_VS)

                    MEDIS 臨床検査マスター

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Requirements

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

                    Alternate NamesName
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    78. 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.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typeid
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    80. 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.

                    ShortAdditional content defined by implementations
                    Comments

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

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on Observation.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 82. Observation.code.coding
                      Definition

                      コード体系によって定義されたコードへの参照。

                      ShortCode defined by a terminology system
                      Comments

                      【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)。

                      Control1..*
                      TypeCoding
                      Is Modifierfalse
                      Summarytrue
                      Requirements

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

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

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

                      ShortAdditional content defined by implementations
                      Comments

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

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on Observation.code.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 88. Observation.code.coding.system
                        Definition

                        コード体系。

                        ShortIdentity of the terminology system
                        Comments

                        【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。

                        Control0..1
                        Typeuri
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

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

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        90. 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.

                        ShortVersion of the system - if relevant
                        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.

                        NoteThis is a business version Id, not a resource version Id (see discussion)
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        92. 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).

                        ShortSymbol in syntax defined by the system
                        Comments

                        Note that FHIR strings SHALL NOT exceed 1MB in size

                        Control0..1
                        Typecode
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

                        Need to refer to a particular code in the system.

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

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

                        ShortRepresentation defined by the system
                        Comments

                        Note that FHIR strings SHALL NOT exceed 1MB in size

                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

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

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

                        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。

                        ShortIf this coding was chosen directly by the user
                        Comments

                        【JP Core仕様】当面は未使用とする。

                        Control0..1
                        Typeboolean
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        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.

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

                        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。

                        ShortPlain text representation of the concept
                        Comments

                        【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。

                        Control1..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        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.

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

                        検体検査の対象となる患者。

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

                        【JP Core仕様】このプロファイルでは、Patient 限定、かつ必須とする。

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

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

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

                        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。

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

                        【JP Core仕様】当面は未使用とする。

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

                        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。

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

                        【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。

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

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

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

                        検体検査の場合は、検体採取日時。

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

                        【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。

                        Control1..1
                        TypeChoice of: dateTime, Period, Timing
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Requirements

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

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

                        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。

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

                        【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。

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

                        検査値を確認した責任者。検査実施責任者情報。

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

                        【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。

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

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

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

                        検体検査の結果として決定された情報。

                        Short同じ検査項目でも、システム(施設)により、使うデータ型が異なる可能性あり【詳細参照】
                        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

                        Control0..1
                        This element is affected by the following invariants: obs-7
                        TypeChoice of: Quantity, CodeableConcept, string
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Requirements

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

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                        • type @ $this
                        • 114. Observation.value[x]:valueQuantity
                          Slice NamevalueQuantity
                          Definition

                          取得された結果

                          Short検査結果が「数値」の場合、値、単位を設定する。 SS-MIX2/HL7 V2.5→ OBX-2=「NM」の時の OBX-5(結果値)、OBX-6(単位)【詳細参照】
                          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

                          Control0..1
                          This element is affected by the following invariants: obs-7
                          TypeQuantity
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Requirements

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

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

                          取得された結果

                          Short検査結果が「コード値」の場合、コード、テキスト、コードのValue setを定義する。 SS-MIX2/HL7 V2.5→ OBX-2=「CWE」の時の OBX-5(結果値)【詳細参照】
                          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。

                          Control0..1
                          This element is affected by the following invariants: obs-7
                          TypeCodeableConcept
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Requirements

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

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

                          取得された結果

                          Short検査結果値が「文字列」の場合、その文字列を指定する。SS-MIX2/HL7 V2.5→ OBX-2=「ST」の時の OBX-5(結果値)
                          Comments

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

                          Control0..1
                          This element is affected by the following invariants: obs-7
                          Typestring
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supportfalse
                          Summarytrue
                          Requirements

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

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

                          検査結果値が欠落している理由。

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

                          【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)

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

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

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Requirements

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

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

                          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。

                          ShortHigh, low, normal, etc. 高、低、正常など
                          Comments

                          【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/R4B/valueset-observation-interpretation.html

                          Control0..*
                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                          Codes identifying interpretations of observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Requirements

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

                          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。

                          ShortこのObservationに関するコメント
                          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.

                          Control0..*
                          TypeAnnotation
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Requirements

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

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          126. 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.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          128. 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.

                          ShortAdditional content defined by implementations
                          Comments

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

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Observation.note.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 130. Observation.note.author[x]
                            Definition

                            The individual responsible for making the annotation.

                            ShortIndividual responsible for the annotation
                            Comments

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

                            Control0..1
                            TypeChoice of: Reference(Practitioner, Patient, RelatedPerson, Organization), string
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            132. Observation.note.time
                            Definition

                            Indicates when this particular annotation was made.

                            ShortWhen the annotation was made
                            Control0..1
                            TypedateTime
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            134. Observation.note.text
                            Definition

                            The text of the annotation in markdown format.

                            ShortThe annotation - text content (as markdown)
                            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/

                            Control1..1
                            Typemarkdown
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            136. Observation.bodySite
                            Definition

                            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。

                            Short対象となった身体部位
                            Comments

                            【JP Core仕様】当面は未使用とする。

                            Control0..1
                            BindingFor example codes, see SNOMEDCTBodyStructures
                            (example to http://hl7.org/fhir/ValueSet/body-site)

                            SNOMED CT Body site concepts

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

                            検体検査の検査方法、測定方法。

                            Short実施の方法
                            Comments

                            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。

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

                            Methods for simple observations.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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

                            この検査に使用された検体(標本)。

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

                            【JP Core仕様】検体検査プロファイルでは必須とする。

                            Control1..1
                            TypeReference(Specimen)
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            142. Observation.device
                            Definition

                            検査装置、機器。

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

                            【JP Core仕様】検査に使用した機器等の情報に使用する。

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

                            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。

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

                            【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。

                            Control0..*
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

                            どの値が「正常」と見なされるかを知ることは、特定の結果の意義を評価するのに役立つ。さまざまなコンテキストに対応するため複数の参照範囲を提供できる必要がある。

                            Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                            obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                            146. Observation.referenceRange.id
                            Definition

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

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

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

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

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

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

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

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

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

                            ShortLow Range, if relevant
                            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.

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

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

                            ShortHigh Range, if relevant
                            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.

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

                            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。

                            ShortReference range qualifier
                            Comments

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

                            Control0..1
                            BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                            (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                            Code for the meaning of a reference range.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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

                            基準値が適用される母集団を示すコード。人種、性別など。

                            ShortReference range population
                            Comments

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

                            Control0..*
                            BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                            (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                            Codes identifying the population the reference range applies to.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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

                            基準値が適用される年齢。新生児の場合、週数もありうる。

                            ShortApplicable age range, if relevant
                            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.

                            Control0..1
                            TypeRange
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

                            Some analytes vary greatly over age.

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

                            量的範囲で表せない場合などに使用する。

                            ShortText based reference range in an observation
                            Comments

                            Note that FHIR strings SHALL NOT exceed 1MB in size

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

                            グループ検査の場合、この検査に含まれる複数の検査結果項目を示す。

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

                            【JP Core仕様】この1検査結果で複数の検査結果項目を含むような場合、value[x]には結果値を設定せず、それら検査結果項目を示すJP_Observation_LabResultへのReferenceをhasMemberに設定する。

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

                            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。

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

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

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

                            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)。

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

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

                            Control0..*
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Requirements

                            コンポーネントobservation は プライマリobservation としてのobservation リソースの中で同じ属性を共有し、常に単一のobservation の一部として扱われる(つまりそれらは分離可能ではないん)。ただし、プライマリobservationのreference rangeはコンポーネント値に継承されないため、reference rangeは各コンポーネントobservation に適切であれば必要である。

                            Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                            170. Observation.component.id
                            Definition

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

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

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

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

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

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

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

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

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

                            ShortType of component observation (code / type)
                            Comments

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

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

                            Codes identifying names of simple observations.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Requirements

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

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

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

                            ShortActual component result
                            Comments

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

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

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

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

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

                            ShortWhy the component result is missing
                            Comments

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

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

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

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

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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

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

                            ShortHigh, low, normal, etc.
                            Comments

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

                            Control0..*
                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                            Codes identifying interpretations of observations.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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

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

                            ShortProvides guide for interpretation of component result
                            Comments

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

                            Control0..*
                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Requirements

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

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