Observation | I | | Observation | Element IdShort description 検体検査結果 Alternate names Vital Signs, Measurement, Results, Tests Definition Measurements and simple assertions made about a patient, device or other subject.
検体検査結果の格納に使用する。
Comments すべてのObservation(検査測定や観察事実)の制約プロファイル
Data Type Observation Constraints- dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.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-3:If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() - dom-6:A resource should have narrative for robust management
text.`div`.exists() - dom-5:If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() - obs-7:If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() - obs-6:dataAbsentReason SHALL only be present if Observation.value[x] is not present
dataAbsentReason.empty() or value.empty()
Mappings- rim:Entity. Role, or Act
- workflow:Event
- sct-concept:< 363787002 |Observable entity|
- v2:OBX
- rim:Observation[classCode=OBS, moodCode=EVN]
|
identifier | Σ | 0..* | Identifier | Element IdShort description Business Identifier for observation Observationのためのビジネス識別子 Definition A unique identifier assigned to this observation.
この検査項目に割り当てられた一意の識別子。リソースの識別子やシステム的なシーケンスではなく、ビジネスID。
Requirements Allows observations to be distinguished and referenced.
Comments 【JP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])
【要検討】
identifier.system に格納されるコード体系について。本WGでURIを定義する。
Data Type Identifier Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CX / EI (occasionally, more often EI maps to a resource id or a URL)
- rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
- servd:Identifier
- workflow:Event.identifier
- w5:FiveWs.identifier
- v2:OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4.
- rim:id
|
use | Σ ?! | 0..1 | codeBinding | Element IdObservation.identifier.use Short description usual | official | temp | secondary | old (If known) Definition The purpose of this identifier.
この識別子の目的。
Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
アプリケーションは、identifierが一時的であると明示的に述べられない限り、永続的であると想定できる。
Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Role.code or implied by context
|
type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Requirements Allows users to make use of identifiers when the identifier system is not known.
Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:CX.5
- rim:Role.code or implied by context
|
system | Σ | 0..1 | uri | Element IdObservation.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Comments Identifier.system is always case sensitive.
【要検討】URIを本WGで決定する。
院内識別コードを使用する場合、JP仕様に合わせて設定する場合、同じURIになるか?
Data Type uri Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples Generalhttp://www.acme.com/identifiers/patient Mappings- rim:n/a
- v2:CX.4 / EI-2-4
- rim:II.root or Role.id.root
- servd:./IdentifierType
|
value | Σ | 0..1 | string | Element IdObservation.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system.
システムのコンテキスト内で一意の識別子となる文字列を設定。
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.
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Examples Mappings- rim:n/a
- v2:CX.1 / EI.1
- rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
- servd:./Value
|
period | Σ I | 0..1 | Period | There are no (further) constraints on this element Element IdObservation.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use.
Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See Duration.
Data Type Period Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - per-1:If present, start SHALL have a lower value than end
start.hasValue().not() or end.hasValue().not() or (start <= end)
Mappings- rim:n/a
- v2:DR
- rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
- v2:CX.7 + CX.8
- rim:Role.effectiveTime or implied by context
- servd:./StartDate and ./EndDate
|
assigner | Σ I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element IdObservation.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier.
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.
Data Type Reference(Organization) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- v2:CX.4 / (CX.4,CX.9,CX.10)
- rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
- servd:./IdentifierIssuingAuthority
|
basedOn | Σ I | 0..* | Reference(ServiceRequest) | Element IdShort description Fulfills plan, proposal or order 実施されるプラン、提案、依頼 Alternate names Fulfills Definition A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.
本プロファイルでは、検体検査オーダに関する情報。
Requirements Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.
Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
【JP仕様】
オーダ情報がある場合、本プロファイルでは 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。
Data Type Reference(ServiceRequest) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.basedOn
- v2:ORC
- rim:.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
|
partOf | Σ I | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Element IdShort description Part of referenced event 参照されるイベントの一部分 Alternate names Container Definition A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.
このリソースが一部として、あるいは手順の一つとして含まれるより大きなイベント。
Comments To link an Observation to an Encounter use encounter . See the Notes below for guidance on referencing another Observation.
【JP仕様】
当面は使用しない。
Data Type Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.partOf
- v2:Varies by domain
- rim:.outboundRelationship[typeCode=FLFS].target
|
status | Σ ?! | 1..1 | codeBinding | Element IdShort description registered | preliminary | final | amended + Definition The status of the result value.
結果値の状態。
Requirements Need to track the status of individual results. Some results are finalized before the whole report is finalized.
Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
---SS-MIX2メモ--- OBX-11(検査結果状態) 「F」(最終結果)を使用する。
【JP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)
Data Type code Binding Codes providing the status of an observation. ObservationStatus (required)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- workflow:Event.status
- w5:FiveWs.status
- sct-concept:< 445584004 |Report by finality status|
- v2:OBX-11
- rim:status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
|
category | | 1..1 | CodeableConceptBinding | Element IdShort description Classification of type of observation Obserbationの種類(タイプ)の分類 Definition A code that classifies the general type of observation being made.
行われた検査の一般的なタイプの分類。取得、表示の際のフィルタリングに使用。
Requirements Used for filtering what observations are retrieved and displayed.
Comments In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.
【JP仕様】
推奨コード表「ObservationCategoryCodes」より、本プロファイルでは「laboratory」固定とする。
(social-history | vital-signs | imaging | laboratory | procedure | survey | exam | therapy | activity)
Data Type CodeableConcept Binding Codes for high level observation categories. ObservationCategoryCodes (preferred)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- w5:FiveWs.class
- rim:.outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
|
coding | Σ | 1..1 | Coding | Element IdObservation.category.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system.
Requirements Allows for alternative encodings within a code system, and translations to other code systems.
Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
【JP仕様】
推奨コード表「ObservationCategoryCodes」より、本プロファイルでは「laboratory」固定とする。
Data Type Coding Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
- rim:CV
- orim:fhir:Coding rdfs:subClassOf dt:CDCoding
- v2:C*E.1-8, C*E.10-22
- rim:union(., ./translation)
- orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
|
text | Σ | 0..1 | string | There are no (further) constraints on this element Element IdObservation.category.text Short description Plain text representation of the concept 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.
Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Comments Very often the text is the same as a displayName of one of the codings.
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.9. But note many systems use C*E.2 for this
- rim:./originalText[mediaType/code="text/plain"]/data
- orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
|
code | Σ | 1..1 | CodeableConceptBinding | Element IdShort description Type of observation (code / type) observation のタイプ(コードまたはタイプ) Alternate names Name Definition Describes what was observed. Sometimes this is called the observation "name".
検査の内容の説明。検査名称。
Requirements Knowing what kind of observation is being made is essential to understanding the observation.
Comments 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.
【JP仕様】
【要検討】
標準コードとして何を推奨、指定するか。JLAC10で良いか。
---SS-MIX2メモ--- OBX-3(検査項目) 検査結果の場合、標準コードは「日本臨床検査医学会臨床検査項目分類コード体系(JLAC10)」を使用
Data Type CodeableConcept Binding MEDIS 臨床検査マスター http://jpfhir.jp/fhir/Common/ValueSet/labResult-code (preferred)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- workflow:Event.code
- w5:FiveWs.what[x]
- sct-concept:< 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|
- v2:OBX-3
- rim:code
- sct-attr:116680003 |Is a|
|
coding | Σ | 1..* | Coding | Element IdShort description Code defined by a terminology system Definition A reference to a code defined by a terminology system.
コード体系によって定義されたコードへの参照。
Requirements Allows for alternative encodings within a code system, and translations to other code systems.
Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
【JP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。
---SS-MIX2メモ--- 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)。
Data Type Coding Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
- rim:CV
- orim:fhir:Coding rdfs:subClassOf dt:CDCoding
- v2:C*E.1-8, C*E.10-22
- rim:union(., ./translation)
- orim:fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
|
system | Σ | 0..1 | uri | Element IdObservation.code.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code.
コード体系。
Requirements Need to be unambiguous about the source of the definition of the symbol.
Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
【JP仕様】
【暫定】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。
---SS-MIX2メモ--- CWE.3 コード体系名称
Data Type uri Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.3
- rim:./codeSystem
- orim:fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
|
version | Σ | 0..1 | string | Element IdObservation.code.coding.version Short description Version of the system - if relevant 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.
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.
---SS-MIX2メモ--- CWE.7 コード体系バージョン ID
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.7
- rim:./codeSystemVersion
- orim:fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
|
code | Σ | 0..1 | code | Element IdObservation.code.coding.code Short description Symbol in syntax defined by the system 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).
Requirements Need to refer to a particular code in the system.
Comments Note that FHIR strings SHALL NOT exceed 1MB in size
---SS-MIX2メモ--- CWE.1 識別子 標準コードの場合、JLAC10のコード
Data Type code Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.1
- rim:./code
- orim:fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
|
display | Σ | 0..1 | string | Element IdObservation.code.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system.
Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Comments Note that FHIR strings SHALL NOT exceed 1MB in size
---SS-MIX2メモ--- CWE.2 テキストに相当する。
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.2 - but note this is not well followed
- rim:CV.displayName
- orim:fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
|
userSelected | Σ | 0..1 | boolean | Element IdObservation.code.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
このコードが利用者によって、例えば利用可能なコードの選択リストから、など、直接選択されたものであることを示す。
Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
【JP仕様】
当面は未使用とする。
Data Type boolean Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:Sometimes implied by being first
- rim:CD.codingRationale
- orim:fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
|
text | Σ | 1..1 | string | Element IdShort description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
コードの表示名。報告書などに記載する場合に使用する表示名。コードを複数指定した場合(標準コード、ローカルコード)、その一般的な表現。
Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Comments Very often the text is the same as a displayName of one of the codings.
【JP仕様】
本プロファイルでは、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。
---SS-MIX2メモ--- CWE.2 テキスト
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:C*E.9. But note many systems use C*E.2 for this
- rim:./originalText[mediaType/code="text/plain"]/data
- orim:fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
|
subject | Σ I | 1..1 | Reference(Patient) | Element IdShort description Who and/or what the observation is about 観察対象者 Definition The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.
検体検査の対象となる患者。
Requirements Observations have no value if you don't know who or what they're about.
Comments One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.
【JP仕様】
本プロファイルでは、Patient 限定、かつ必須とする。
---SS-MIX2メモ--- PID-3(患者IDリスト)
Data Type Reference(Patient) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.subject
- w5:FiveWs.subject[x]
- v2:PID-3
- rim:participation[typeCode=RTGT]
- w5:FiveWs.subject
|
focus | Σ I | 0..* | Reference(Resource) | Element IdShort description What the observation is about, when it is not about the subject of record subject 要素が実際のobservationの対象でない場合に、observation の対象物。 Definition The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.
患者当人ではなく、患者の胎児、親、ドナーなどの検査、観察の場合、その対象を示す。
Comments Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.
【JP仕様】
当面は未使用とする。
---SS-MIX2メモ--- v2.5 Mappingでは OBX-3(検査項目) が該当するが、SS-MIX2にはこの意味での該当はなし。
Data Type Reference(Resource) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- w5:FiveWs.subject[x]
- v2:OBX-3
- rim:participation[typeCode=SBJ]
- w5:FiveWs.subject
|
encounter | Σ I | 0..1 | Reference(Encounter) | Element IdShort description Healthcare event during which this observation is made このobservationが行われるヘルスケアイベント Alternate names Context Definition The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.
この検査が行われるヘルスケアイベント。医療提供者と患者の接点。
Requirements For some observations it may be important to know the link between an observation and a particular encounter.
Comments This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).
【JP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。
※本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。
---SS-MIX2メモ--- PV1セグメントに相当する。
Data Type Reference(Encounter) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.context
- w5:FiveWs.context
- v2:PV1
- rim:inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
|
effective[x] | Σ | 1..1 | | Element IdShort description Clinically relevant time/time-period for observation 臨床的に関連する時刻または時間 Alternate names Occurrence Definition The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.
検体検査の場合は、検体採取日時。
Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends.
Comments At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.
【JP仕様】
本プロファイルでは、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。
---SS-MIX2メモ--- OBX-14(検査日時) OBX-19(分析日時) 検体検査の場合は、OBX-14が該当。
OBX-14(検査日時)のSS-MIX2仕様書内での説明:
実際に検査された日時を示す。
検体に対して行われる検査の場合、検体採取日時であり、患者に対して行われる測定の場合には、測定が行われた日時を設定する。
effective[x].effectiveDateTime
OBX-14(検査日時)
effective[x].effectivePeriod
検査結果の有効期限。例えば院内でルールがあれば設定してもよい。
effective[x].effectiveTiming
正確な採取時間が不明な場合、例えば「午前中」などの設定。SS-MIXでは該当なしだが、使用できても良い
effective[x].effectiveInstant
イベント発生のログ時間。SS-MIXでは使用しない。
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- workflow:Event.occurrence[x]
- w5:FiveWs.done[x]
- v2:OBX-14, and/or OBX-19 after v2.4 (depends on who observation made)
- rim:effectiveTime
|
effectiveDateTime | | | dateTime | Data Type dateTime |
effectivePeriod | | | Period | Data Type Period |
effectiveTiming | | | Timing | Data Type Timing |
issued | Σ | 0..1 | instant | Element IdShort description Date/Time this version was made available このバージョンが利用可能となった日時 Definition The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.
この情報の発生日時。システム時刻であり、人が報告する時刻ではないことに注意。このリソースの発生時間と同じになる場合がある。
Comments For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.
【JP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。
---SS-MIX2メモ---
OBR-22(結果報告/状態変更-日時)
MSH-7(メッセージ日時)
OBX-14(検査日時)
OBX-19(分析日時)
検査結果に発生した最終イベント日時。検査結果がレビューされた時間等も含む。SS-MIX2の場合は、検査値が確定した時間に相当すると考えられる。
Data Type instant Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- w5:FiveWs.recorded
- v2:OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made)
- rim:participation[typeCode=AUT].time
|
performer | Σ I | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Element IdShort description Who is responsible for the observation observationに責任をもつ者 Definition Who was responsible for asserting the observed value as "true".
検査値を確認した責任者。検査実施責任者情報。
Requirements May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.
Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
【JP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。
---SS-MIX2メモ---
SS-MIX2ではいずれも未使用であるが、v2.5では次が該当する。
OBX-15(実施者ID) OBX-16(検査責任者) OBX-18(装置ID)
Data Type Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- workflow:Event.performer.actor
- w5:FiveWs.actor
- v2:OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'
- rim:participation[typeCode=PRF]
|
value[x] | Σ I | 0..1 | | Element IdShort description Actual result 実際の結果値 Definition The information determined as a result of making the observation, if the information has a simple value.
検体検査の結果として決定された情報。
Requirements An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.
Comments An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.
【JP仕様】
valueQuantity :OBX-2=「NM」の時の OBX-5(結果値)、OBX-6(単位)
valueQuantity.value :OBX-5(結果値)
valueQuantity.comparator :SS-MIX2 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 :OBX-6(単位) CWE.2 テキスト
valueQuantity.system :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 :OBX-6(単位) CWE.1 識別子
valueCodeableConcept :OBX-2=「CWE」の時の OBX-5(結果値)
valueCodeableConcept.coding :SS-MIXの場合、CWEは正規コード+代替コードの2種類登録可能。
valueCodeableConcept.coding.system :CWE.3 or 6 コード体系。対象コードの OIDを設定
valueCodeableConcept.coding.version :CWE.7 コード体系バージョン ID
valueCodeableConcept.coding.code :CWE.1 or 4 識別子。対象コードシステムのコード
valueCodeableConcept.coding.display :CWE.2 or 5 テキスト。対象コードの名称
valueCodeableConcept.coding.userselected :未使用とする。
valueCodeableConcept.text :CWE.2 テキスト。coding.display と同じ。
valueString :OBX-2=「ST」の時の OBX-5(結果値)
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 :OBX-2=「NW」の時の OBX-5(結果値)
valueRange
valueRatio
valueSampledData
valueTime :OBX-2=「TM」の時の OBX-5(結果値)
valueDateTime :OBX-2=「DT」の時の OBX-5(結果値)
valuePeriod
---SS-MIX2メモ--- OBX-2(値型) OBX-5(結果値) OBX-6(単位)
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- sct-concept:< 441742003 |Evaluation finding|
- v2:OBX.2, OBX.5, OBX.6
- rim:value
- sct-attr:363714003 |Interprets|
|
valueQuantity | | | Quantity | Data Type Quantity |
valueCodeableConcept | | | CodeableConcept | Data Type CodeableConcept |
valueString | | | string | Data Type string |
dataAbsentReason | I | 0..1 | CodeableConceptBinding | Element IdObservation.dataAbsentReason Short description Why the result is missing 結果が欠損値である理由 Definition Provides a reason why the expected value in the element Observation.value[x] is missing.
検査結果値が欠落している理由。
Requirements For many results it is necessary to handle exceptional values in measurements.
Comments Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".
The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.
【JP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。
【要検討】
拡張可コード体系「DataAbsentReason」を拡張の要否を含め検討。
(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)
---SS-MIX2メモ--- SS-MIX2では該当なし。
Data Type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:N/A
- rim:value.nullFlavor
|
interpretation | | 0..* | CodeableConceptBinding | Element IdObservation.interpretation Short description High, low, normal, etc. 高、低、正常、など。 Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal.
検査結果値の、(高、低、正常)といったカテゴリー評価。結果報告書に記載されることもある情報。
Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
特に数値結果については、結果の重要性を完全に理解するために解釈を必要とする場合がある。
Comments Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.
【JP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/valueset-observation-interpretation.html
---SS-MIX2メモ--- OBX-8(異常フラグ) に相当する。
Data Type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values|
- v2:OBX-8
- rim:interpretationCode
- sct-attr:363713009 |Has interpretation|
|
note | | 0..* | Annotation | Element IdShort description Comments about the observation 結果に対するコメント Definition Comments about the observation or the results.
検査、あるいは結果に関するコメント。フリーテキストの追加情報として使用可能。
Requirements Need to be able to provide free text additional information.
フリーテキストの追加情報を提供できる必要がある。
Comments May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.
【要検討】検体検査の親要素のコメントと子要素のコメントの取り扱いをどうするか(血算の中のAlb値、等)
---SS-MIX2メモ--- NTE-3(コメント)(JAHIS標準) SS-MIX2では未使用。JAHISではOBXに対して設定できるNTEセグメント内容。
Data Type Annotation Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Act
- v2:NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX)
- rim:subjectOf.observationEvent[code="annotation"].value
|
author[x] | Σ | 0..1 | | Element IdObservation.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation.
Comments Organization is used when there's no need for specific attribution as to who made the comment. ---SS-MIX2メモ--- v2 NTE セグメントでは該当なし。よって未使用。(2020/1/15)
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Act.participant[typeCode=AUT].role
|
authorString | | | string | There are no (further) constraints on this element Data Type string |
authorReference | | | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) |
time | Σ | 0..1 | dateTime | Element IdShort description When the annotation was made Definition Indicates when this particular annotation was made.
Comments ---SS-MIX2メモ--- v2 NTE セグメントでは該当なし。よって未使用。(2020/1/15)
Data Type dateTime Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Act.effectiveTime
|
text | Σ | 1..1 | markdown | Element IdShort description The annotation - text content (as markdown) Definition The text of the annotation in markdown format.
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/ ---SS-MIX2メモ--- コメント内容(NTE-3 または、NTE-4(CWE)の場合は、NTE-4.2 を設定)(2020/1/15)
Data Type markdown Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:N/A
- rim:Act.text
|
bodySite | | 0..1 | CodeableConcept | Element IdShort description Observed body part 観察された身体部位 Definition Indicates the site on the subject's body where the observation was made (i.e. the target site).
検査が行われた患者の体の部位。検体検査に関しては、当面は使用しない。
Comments Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.
If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.
【JP仕様】
当面は未使用とする。
---SS-MIX2メモ--- SPM-10 (CWE) が該当。SS-MIX2では未使用。
Data Type CodeableConcept Binding Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 123037004 |Body structure|
- v2:OBX-20
- rim:targetSiteCode
- sct-attr:718497002 |Inherent location|
|
method | | 0..1 | CodeableConcept | Element IdShort description How it was done 実施の方法 Definition Indicates the mechanism used to perform the observation.
検体検査の検査方法、測定方法。
Requirements In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.
場合により、測定方法は結果に影響を与える可能性があるため、結果を比較できるかどうかを判断したり、結果の重要性を判断したりするために使用される。
Comments Only used if not implicit in code for Observation.code.
Observation.code の code から測定方法が暗黙的でない場合にのみ使用する。
【JP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。
---SS-MIX2メモ--- OBX-17(検査方法) (CWE) SS-MIX2では未使用。
Data Type CodeableConcept Binding Methods for simple observations. ObservationMethods (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:OBX-17
- rim:methodCode
|
specimen | I | 1..1 | Reference(Specimen) | Element IdShort description Specimen used for this observation 観察(観測、検査)に使われた検体材料 Definition The specimen that was used when this observation was made.
この検査に使用された検体(標本)。
Comments Should only be used if not implicit in code found in Observation.code . Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).
【JP仕様】
検体検査プロファイルでは必須とする。
---SS-MIX2メモ--- SPM セグメントに相当する。
Data Type Reference(Specimen) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- sct-concept:< 123038009 |Specimen|
- v2:SPM segment
- rim:participation[typeCode=SPC].specimen
- sct-attr:704319004 |Inherent in|
|
device | I | 0..1 | Reference(Device | DeviceMetric) | Element IdShort description (Measurement) Device 測定機器 Definition The device used to generate the observation data.
検査装置、機器。
Comments Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.
【JP仕様】
検査に使用した機器等の情報に使用する。
---SS-MIX2メモ--- OBX-18 装置ID (EI) SS-MIX2では未使用。
Data Type Reference(Device | DeviceMetric) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- sct-concept:< 49062001 |Device|
- v2:OBX-17 / PRT -10
- rim:participation[typeCode=DEV]
- sct-attr:424226004 |Using device|
|
referenceRange | I | 0..* | BackboneElement | Element IdObservation.referenceRange Short description Provides guide for interpretation 解釈のためのガイドを与える Definition Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.
推奨範囲として結果値を解釈するためのガイダンス。基準値。
Requirements Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.
どの値が「正常」と見なされるかを知ることは、特定の結果の意義を評価するのに役立つ。さまざまなコンテキストに対応するため複数の参照範囲を提供できる必要がある。
Comments Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.
【JP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。
---SS-MIX2メモ--- OBX-7 基準値範囲 (ST文字列型) ex) 6.5-8.2 、>10、<15
Data Type BackboneElement Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - obs-3:Must have at least a low or a high or text
low.exists() or high.exists() or text.exists()
Mappings- rim:n/a
- v2:OBX.7
- rim:outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
|
low | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.low Short description Low Range, if relevant 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).
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. ---SS-MIX2メモ--- OBX-7 基準値範囲 (ST文字列型)
Data Type SimpleQuantity Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - qty-3:If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists() - sqty-1:The comparator is not used on a SimpleQuantity
comparator.empty()
Mappings- rim:n/a
- v2:SN (see also Range) or CQ
- rim:PQ, IVL<PQ>, MO, CO, depending on the values
- v2:OBX-7
- rim:value:IVL_PQ.low
|
high | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.high Short description High Range, if relevant 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).
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. ---SS-MIX2メモ--- OBX-7 基準値範囲 (ST文字列型)
Data Type SimpleQuantity Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - qty-3:If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists() - sqty-1:The comparator is not used on a SimpleQuantity
comparator.empty()
Mappings- rim:n/a
- v2:SN (see also Range) or CQ
- rim:PQ, IVL<PQ>, MO, CO, depending on the values
- v2:OBX-7
- rim:value:IVL_PQ.high
|
type | | 0..1 | CodeableConceptBinding | Element IdObservation.referenceRange.type Short description Reference range qualifier Definition Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.
対象となる母集団のどの部分に適用するかを示すコード。正常範囲、要治療範囲、など。
Requirements Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.
Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. ---SS-MIX2メモ--- OBX-10 異常検査の特質 SS-MIX2では未使用
Data Type CodeableConcept Binding Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values| OR
< 365860008 |General clinical state finding|
OR
< 250171008 |Clinical history or observation findings| OR
< 415229000 |Racial group| OR
< 365400002 |Finding of puberty stage| OR
< 443938003 |Procedure carried out on subject|
- v2:OBX-10
- rim:interpretationCode
|
appliesTo | | 0..* | CodeableConcept | Element IdObservation.referenceRange.appliesTo Short description Reference range population Definition Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.
基準値が適用される母集団を示すコード。人種、性別など。
Requirements Need to be able to identify the target population for proper interpretation.
Comments This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. ---SS-MIX2メモ--- OBX-10 異常検査の特質 基準値の適応対象(地域)を示す。SS-MIX2では未使用
Data Type CodeableConcept Binding Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values| OR
< 365860008 |General clinical state finding|
OR
< 250171008 |Clinical history or observation findings| OR
< 415229000 |Racial group| OR
< 365400002 |Finding of puberty stage| OR
< 443938003 |Procedure carried out on subject|
- v2:OBX-10
- rim:interpretationCode
|
age | I | 0..1 | Range | Element IdObservation.referenceRange.age Short description Applicable age range, if relevant Definition The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.
基準値が適用される年齢。新生児の場合、週数もありうる。
Requirements Some analytes vary greatly over age.
Comments The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3. ---SS-MIX2メモ--- 基準値の適応対象年齢を示す。SS-MIX2では該当フィールドなし。
Data Type Range Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - rng-2:If present, low SHALL have a lower value than high
low.empty() or high.empty() or (low <= high)
Mappings- rim:n/a
- v2:NR and also possibly SN (but see also quantity)
- rim:IVL<QTY[not(type="TS")]> [lowClosed="true" and highClosed="true"]or URG<QTY[not(type="TS")]>
- rim:outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value
|
text | | 0..1 | string | Element IdObservation.referenceRange.text Short description Text based reference range in an observation Definition Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".
量的範囲で表せない場合などに使用する。
Comments Note that FHIR strings SHALL NOT exceed 1MB in size ---SS-MIX2メモ--- OBX-7 基準値範囲 (ST文字列型)
Data Type string Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:OBX-7
- rim:value:ST
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hasMember | Σ I | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Element IdShort description Related resource that belongs to the Observation group observationグループに属する関連リソース Definition This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.
この検査が含まれるグループを示す。
Comments When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.
【JP仕様】
1検査で複数の検査項目が実施される場合の親検査項目を設定する。
【要検討】
componentと合わせて、具体的な検査項目、使用例で、使い分けを明確にする。
---SS-MIX2メモ--- (OBX-4 検査副 ID)
Data Type Reference(Observation | QuestionnaireResponse | MolecularSequence) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- v2:Relationships established by OBX-4 usage
- rim:outBoundRelationship
|
derivedFrom | Σ I | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Element IdShort description Related measurements the observation is made from observation がつくりゃれる元の関連する測定 Definition The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.
この検査値の発生元である関連リソース。例えば他のObservation を受けて、本検査値が発生した場合など。
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.
【要検討】 検体検査としての用途として具体例を検討。
---SS-MIX2メモ--- OBX-4 検査副 ID
Data Type Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1:SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings- rim:n/a
- rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- v2:Relationships established by OBX-4 usage
- rim:.targetObservation
|
component | Σ | 0..* | BackboneElement | Element IdShort description Component results コンポーネント結果 Definition Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.
一度のタイミングでの1回の検査で複数の結果を同時に得る場合にのみ使用される。例えば、血圧の収縮期、拡張期。新生児のApgarスコア。質問に対する複数の回答(飲んだアルコールの種類、など)。
Requirements Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.
コンポーネントobservation は プライマリobservation としてのobservation リソースの中で同じ属性を共有し、常に単一のobservation の一部として扱われる(つまりそれらは分離可能ではないん)。ただし、プライマリobservationのreference rangeはコンポーネント値に継承されないため、reference rangeは各コンポーネントobservation に適切であれば必要である。
Comments For a discussion on the ways Observations can be assembled in groups together see Notes below.
【要検討】
hasMemberと合わせて、具体的な検査項目、使用例で、使い分けを明確にする。
検体検査で、該当する検査項目の調査が必要。分析器の都合でセットにしたい場合と、検査項目としてセットにしたい場合がある。後者か。血圧の収縮期だけ欲しい場合は、どうするのか。
---SS-MIX2メモ--- OBX-4 検査副 ID
Data Type BackboneElement Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:containment by OBX-4?
- rim:outBoundRelationship[typeCode=COMP]
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code | Σ | 1..1 | CodeableConcept | Element IdObservation.component.code Short description Type of component observation (code / type) Definition Describes what was observed. Sometimes this is called the observation "code".
Requirements Knowing what kind of observation is being made is essential to understanding the observation.
Comments All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. ---SS-MIX2メモ--- Observation.code と同様(2020/1/15)
Data Type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- w5:FiveWs.what[x]
- sct-concept:< 363787002 |Observable entity| OR
< 386053000 |Evaluation procedure|
- v2:OBX-3
- rim:code
|
value[x] | Σ | 0..1 | | Element IdObservation.component.value[x] Short description Actual component result Definition The information determined as a result of making the observation, if the information has a simple value.
Requirements An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.
Comments Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below. ---SS-MIX2メモ--- Observation.value と同様(2020/1/15)
Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- sct-concept:363714003 |Interprets| < 441742003 |Evaluation finding|
- v2:OBX.2, OBX.5, OBX.6
- rim:value
- sct-attr:363714003 |Interprets|
|
valueQuantity | | | Quantity | There are no (further) constraints on this element Data Type Quantity |
valueCodeableConcept | | | CodeableConcept | There are no (further) constraints on this element Data Type CodeableConcept |
valueString | | | string | There are no (further) constraints on this element Data Type string |
valueBoolean | | | boolean | There are no (further) constraints on this element Data Type boolean |
valueInteger | | | integer | There are no (further) constraints on this element Data Type integer |
valueRange | | | Range | There are no (further) constraints on this element Data Type Range |
valueRatio | | | Ratio | There are no (further) constraints on this element Data Type Ratio |
valueSampledData | | | SampledData | There are no (further) constraints on this element Data Type SampledData |
valueTime | | | time | There are no (further) constraints on this element Data Type time |
valueDateTime | | | dateTime | There are no (further) constraints on this element Data Type dateTime |
valuePeriod | | | Period | There are no (further) constraints on this element Data Type Period |
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.dataAbsentReason Short description Why the component result is missing Definition Provides a reason why the expected value in the element Observation.component.value[x] is missing.
Requirements For many results it is necessary to handle exceptional values in measurements.
Comments "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".
The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.
Data Type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- v2:N/A
- rim:value.nullFlavor
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interpretation | | 0..* | CodeableConceptBinding | Element IdObservation.component.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal.
Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
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. ---SS-MIX2メモ--- OBX-8 異常フラグ(2020/1/15)
Data Type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints- ele-1:All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- rim:n/a
- v2:CE/CNE/CWE
- rim:CD
- orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
- sct-concept:< 260245000 |Findings values|
- v2:OBX-8
- rim:interpretationCode
- sct-attr:363713009 |Has interpretation|
|
referenceRange | | 0..* | see (referenceRange) | Element IdObservation.component.referenceRange Short description Provides guide for interpretation of component result Definition Guidance on how to interpret the value by comparison to a normal or recommended range.
Requirements Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.
Comments Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties. ---SS-MIX2メモ--- OBX-7 基準値範囲 (ST文字列型)(2020/1/15)
Mappings- v2:OBX.7
- rim:outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
|