臺灣核心實作指引(TW Core IG)
0.1.0 - Trial Use

This page is part of the 臺灣核心實作指引(TW Core IG) (v0.1.0: Releases) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: TWCoreObservationVitalSigns - Detailed Descriptions

Active as of 2023-07-05

Definitions for the Observation-vitalSigns-twcore resource profile.

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

1. Observation
Definition

對病人、設備或其他對象進行的測量和簡單判定。

The FHIR Vitals Signs profile sets minimum expectations for the Observation Resource to record, search and fetch the vital signs associated with a patient.

2. Observation.id
Definition

resource的邏輯ID,在resource的URL中使用。一旦指定,這個值永遠不會改變。

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

Comments

一個resource使用新增操作(create operation)提交給伺服器時是此resource唯一沒有id的時刻

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

3. Observation.meta
Definition

關於resource的metadata。這是由基礎建設維護的內容。對內容的改變可能並不總是與resource的版本改變相關。

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.

4. Observation.implicitRules
Definition

構建resource時遵循的一系列規則的參照,在處理內容時必須理解這些規則。通常這是IG定義特殊規則及其他profiles的參照。

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.

Comments

宣告這套規則限制了內容只能被有限的貿易夥伴所理解。這從本質上限制了資料的長期有用性。然而,現有的健康生態體系高度分裂,還沒有準備好以普遍可計算的方式定義、收集和交換資料。只要有可能,實作者和/或規範編寫者應該避免使用這個資料項目。通常,在使用時,此URL是對實作指引的參照,此指引將這些特殊規則與其他profiles、value sets等一起定義為其敘述的一部分。

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.

5. Observation.language
Definition

編寫此resource的基礎語言

The base language in which the resource is written.

Binding

人類語言;鼓勵使用CommonLanguages代碼表中的代碼,但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Comments

提供語言是為了支援索引和可存取性(通常,文字表述轉語音等服務使用此語言標籤)。html lanuage tag適用於此敘述。resource上的語言標籤可用於指定從resource中的資料所產成的其他表述之語言。不是所有的內容都必須使用此基礎語言。不應該假定Resource.language自動適用於敘述。如果指定語言,它也應該被指定在html中的div元素(關於xml:lang和html lang屬性之間的關係,見HTML5中的規則)。

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).

Example
Value:zh-TW
6. Observation.text
Definition

人可讀的敘述,包含resource的摘要,可用於向人表述resource的內容。敘述不需要對所有的結構化資料進行編碼,但需要包含足夠的細節使人在閱讀敘述時理解「臨床安全性」。resource定義可定義哪些內容應該在敘述中表示,以確保臨床安全。

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.

Must Supporttrue
Comments

內嵌(contained)的resource沒有敘述,非內嵌(contained)的resource則 建議應該(SHOULD) 有敘述。在某些情況下,resource可能只有文字表述,很少或沒有額外的離散資料(只要滿足所有minOccurs=1的資料項目)。這對於來自舊有系統的資料可能是必要的,在這些系統中,從 「文字表述區塊(text blob) 」獲取訊息,或者文字表述是額外的原始輸入或敘述,而編碼訊息是後來添加的。

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.

7. Observation.contained
Definition

這些resource內嵌(contains)的resource不會另外存於任何FHIR伺服器,意即它們無法在任何FHIR伺服器中被找到,也無法有自己獨立的資料異動/交易(transaction)範圍。

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.

Comments

當內容可以從任何FHIR伺服器找到時,不應該以內嵌(contained)resource的方式呈現,因為一旦識別丟失,要再次恢復它是非常困難的(並且取決於情境)。內嵌(contained)的resource可在它們的meta資料項目中表述profiles和tag(標籤),但 必須沒有(SHALL NOT) 資訊安全標號(security labels)。

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

8. Observation.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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.

9. Observation.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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).

10. Observation.identifier
Definition

此檢驗檢查的唯一識別碼

A unique identifier assigned to this observation.

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

允許對檢驗檢查結果進行區分和參照

Allows observations to be distinguished and referenced.

11. Observation.basedOn
Definition

依據的計劃、提議或醫令或其部分要求進行檢驗檢查。例如:一個MedicationRequest可能要求給病人藥之前要先進行實驗室檢查。

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.

TypeReference(CarePlan|DeviceRequest|ImmunizationRecommendation|TWCoreMedicationRequest|NutritionOrder|ServiceRequest|MedicationRequest)
Requirements

允許授權追踪檢驗檢查事件並追踪提議/建議是否有落實

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

12. Observation.partOf
Definition

此特定的檢驗檢查(Observation)是一個更大事件中的一個組成或步驟。例如:一項處置裡的一項檢驗檢查。

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

TypeReference(MedicationAdministration|MedicationDispense|MedicationStatement|TWCoreProcedure|Immunization|ImagingStudy|Procedure)
Comments

使用encounter將一個檢驗檢查(Observation)與一個就醫(Encounter)連結起來。關於參照另一個Observation的作法,請參閱下面的Notes小節。

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

13. Observation.status
Definition

結果值的狀態

The status of the result value.

Binding 檢驗檢查的狀態代碼;應填入ObservationStatus代碼表中的其中一個代碼
Requirements

需要追踪單個結果狀態,有些結果在整個報告確定之前就已經確定了。

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

Comments

這個資料項目被標記為修飾語/修飾用,因為附加到其他文件上的文件,其本身是不完整的文件。

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

14. Observation.category
Definition

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

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

Binding

高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Codes for high level observation categories.

TypeCodeableConcept(CodeableConceptTW)
Requirements

用於篩選取得及顯示之檢驗檢查

Used for filtering what observations are retrieved and displayed.

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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.

15. Observation.category:VSCat
SliceNameVSCat
Definition

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

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

Binding

高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Codes for high level observation categories.

TypeCodeableConcept(CodeableConceptTW)
Requirements

用於篩選取得及顯示之檢驗檢查

Used for filtering what observations are retrieved and displayed.

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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.

16. Observation.category:VSCat.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

17. Observation.category:VSCat.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

18. Observation.category:VSCat.coding
Definition

由專門術語系統(terminology system)所定義之代碼的參照。

A reference to a code defined by a terminology system.

Requirements

允許使用者在不知道識別碼系統的情況下利用識別碼

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

Comments

代碼可以在列舉清單(enumerations)或代碼清單(code lists)中非常隨意地定義,直至有非常正式的定義,如SNOMED CT—更多資訊見HL7 v3核心原則(Core Principles )。編碼的排序是未定義的因而 必須沒有(SHALL NOT) 被用來推斷意義。一般來說,最多只有一個編碼值(coding values)會被標記為UserSelected = true。

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.

19. Observation.category:VSCat.coding.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

20. Observation.category:VSCat.coding.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

21. Observation.category:VSCat.coding.system
Definition

定義代碼中符號意義的代碼系統識別。

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

Requirements

需要明確說明符號定義的來源

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

Comments

URI可以是一個OID(urn:oid:...)或一個UUID(urn:uuid:...);OID和UUID 必須(SHALL) 參照HL7 OID註冊中心;否則,URI應該來自HL7的FHIR定義的特殊URI列表,或者它應該參照一些明確建立的系统定義。

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.

22. Observation.category:VSCat.coding.version
Definition

選擇此代碼時使用的代碼系統版本;請注意,一個維護良好的代碼系統不需要版本報告,因為代碼的意義在不同系統版本中是一致的;然而,不能始終保證這點,當不能保證意義一致時, 必須(SHALL) 將版本資訊也一併作交換。

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

NoteThis is a business versionId, not a resource version id (see discussion)
Comments

如果專門術語沒有明確定義應該使用什麼字串來識別代碼系統的版本,建議使用版本正式發布的日期(用FHIR日期格式表示)作為版本日期。

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.

23. Observation.category:VSCat.coding.code
Definition

系統定義的語法之符號;符號可能是一個預先定義的代碼,也可能是代碼系統定義的語法中的表達式(如後組合配對/後組合式)。

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

需要參照系統中的一個特定代碼

Need to refer to a particular code in the system.

24. Observation.category:VSCat.coding.display
Definition

遵循系統的規則以呈現代碼含義的表示法

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

Requirements

需要能為不了解此系統的讀者呈現可讀的代碼含義

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

25. Observation.category:VSCat.coding.userSelected
Definition

表明此編碼是由使用者直接選擇,例如:從可用項目(代碼或顯示名稱)的清單中選擇。

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

Requirements

已被確定為一個臨床安全準則—此確切的系統/代碼對(code pair)是被明確選擇的,而不是由系統根據一些規則或是程式語言處理判斷。

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

在一系列備選方案中,直接選擇的代碼是新翻譯最合適的起點;關於「直接選擇」的確切意義,存在模糊不清之處,可能需要貿易夥伴的同意,以更完整澄清此資料項目的使用及其後果。

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.

26. Observation.category:VSCat.text
Definition

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

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

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

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

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

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

27. Observation.code
Definition

可以透過正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

Coded Responses from C-CDA Vital Sign Results.

BindingThe codes SHALL be taken from 生命體徵值集The codes SHALL be taken from VitalSigns; other codes may be used where these codes are not suitable

應填入生命體徵值集代碼表中的其中一個代碼。

This identifies the vital sign result type.

TypeCodeableConcept(CodeableConceptTW)
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

  1. SHALL contain exactly one [1..1] code, where the @code SHOULD be selected from ValueSet HITSP Vital Sign Result Type 2.16.840.1.113883.3.88.12.80.62 DYNAMIC (CONF:7301).
Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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.

28. Observation.code.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..?
29. Observation.code.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..?
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

30. Observation.code.text
Definition

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

Control0..?
Must Supporttrue
Requirements

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

Comments

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

31. Observation.subject
Definition

此檢驗檢查是關於一位病人、一群病人、地點、或設備。如果檢驗檢查的實際焦點與對象(或其樣本、其部分或其區域)不同,則焦點資料項目或代碼本身會具體說明檢驗檢查的實際焦點。

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.

TypeReference(TWCorePatient|Patient)
Requirements

如果你不知道他們是誰或關於什麼,檢驗檢查不會有值。

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

Comments

人們期望這個資料項目的cardinality為1...1。唯一可能缺少對象的情況是當檢驗檢查是由一個不認識病人的設備進行的。在這種情況下,應透過一些情境/通道對應(context/channel matching)技術將檢驗檢查與病人對應,此時,應更新檢驗檢查資訊。

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.

32. Observation.focus
Definition

檢驗檢查的實際焦點,當它不是記錄病人時,代表是與病人有關的事物或人,如配偶、父母、胎兒或捐贈者。例如:母親的記錄中有關胎兒檢驗檢查。檢驗檢查的焦點也可以是現有的狀況、疾病或問題(condition)、介入(intervention)、此對象的飲食、對此對象的另一項檢驗檢查,或身體結構像是腫瘤或植入裝置。有一個案例是使用Observation Resource來取得母親是否已接受更換她的小孩的氣管插管訓練之資訊,在這個例子中,孩子是此記錄的病人,而母親是focus。

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.

Comments

通常檢驗檢查的對象是一位病人或一群病人、地點或設備,檢驗檢查對象與直接測量內容之間的區別在observation.code已具體說明(例如: 「血糖」),不需要使用這個資料項目(focus)單獨表示。如果需要參照檢體,則使用specimen,如果需要一個代碼而不是一個resource,則使用bodysite來表示bodysites或標準擴充focusCode。

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.

33. Observation.encounter
Definition

執行檢驗檢查的健康照護事件(例如:病人及健康照護提供人員的互動)

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

TypeReference(TWCoreEncounter|Encounter)
Requirements

對於某些檢驗檢查來說,知道某個檢驗檢查和某個特定的就醫事件之間的連結可能很重要。

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

Comments

這通常指檢驗檢查發生於哪次就醫,但有些檢驗檢查可能是在就醫前或就醫後發生,但仍與就醫的情境有關(如入院前的實驗室檢驗檢查)。

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).

34. Observation.effective[x]
Definition

宣告檢驗檢查值的產出時間或時間區段是真的。對於生物學研究對象—例如病人—這通常被稱為「生理相關時間」。這通常是處置的時間或採樣的時間,但很多時候不知道日期或時間的來源,只知道日期或時間本身。

Often just a dateTime for Vital Signs.

TypeChoice of: ,
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

知道一項檢驗檢查何時被認為是真的,對其相關性和確定趨勢都很重要。

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

Comments

除非這是一份檢驗檢查的歷史報告,否則至少應該有一個日期。為了記錄不精確或「模煳」的時間(例如:測量「早餐後 」血糖),使用Timing datatype以允許測量能與常規生活事件連結。

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.

35. Observation.issued
Definition

此版本的檢驗檢查資訊可供健康照護提供人員取得的日期和時間,通常是在結果被審查與核實之後。

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

Comments

對於不需要審查和核實的檢驗檢查值,發佈日期時間可能與resource本身的最後更新日期時間相同。對於需要對某些更新進行審查和核實的檢驗檢查,若為非臨床上的重要更新則不需要對新版本進行再次審查和驗證,所以發佈日期時間可能與resource本身的最後更新日期時間不一樣。

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.

36. Observation.performer
Definition

誰負責宣告檢驗檢查結果值為「真的」

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

TypeReference(TWCorePractitioner|TWCoreOrganization|TWCorePatient|PractitionerRole|CareTeam|Practitioner|Organization|Patient|RelatedPerson)
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Requirements

可以對此檢驗檢查有一定程度的信任,並指出後續問題的方向。

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

37. Observation.value[x]
Definition

如果此資訊有一個簡單的值,則將其作為此項檢驗檢查的結果。

Vital Signs value are recorded using the Quantity data type. For supporting observations such as Cuff size could use other datatypes such as CodeableConcept.

BindingThe codes SHALL be taken from VitalSignsUnits; other codes may be used where these codes are not suitableFor codes, see (unbound) 用於記錄生命體徵的常用UCUM單元;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeChoice of: , , , , , , , , , ,
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

  1. SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7305).
Comments

一項檢驗檢查可能有:1)單一值、2)一個值及一組相關或組成之檢驗檢查的多個值、或者3)只有一組相關或組成之檢驗檢查的多個值。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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.

38. Observation.dataAbsentReason
Definition

提供資料項目Observation.value[x]中的預期值缺少的原因

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

Binding

代碼具體說明檢驗檢查結果缺少的原因;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

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

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於許多結果,必須處理測量中的異常值。

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

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

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.

39. Observation.interpretation
Definition

對一項檢驗檢查值的分類評估,例如:高、低、正常。

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

Binding

代碼指明檢驗檢查結果的解釋;應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

Codes identifying interpretations of observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

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

Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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.

40. Observation.note
Definition

關於檢驗檢查或結果的解說

Comments about the observation or the results.

Requirements

需能提供純文字表述的附加資訊

Need to be able to provide free text additional information.

Comments

可包括關於檢驗檢查的一般陳述,或關於重要的、非預期的或不可靠的結果值的陳述,或與資料項目interpretation有關的來源資訊。

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.

41. Observation.bodySite
Definition

表示在檢驗檢查對象身上進行檢驗檢查的部位(即目標部位)

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

Binding

代碼說明解剖學位置,可能包含側邊;可參考SNOMEDCTBodyStructures代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

Codes describing anatomical locations. May include laterality.

TypeCodeableConcept(CodeableConceptTW)
Comments

只有在Observation.code中的代碼未隱含時才會使用。在許多系統中,這可能被表示為一個相關的檢驗檢查,而不是一個行內的組成之檢驗檢查(inline component)。

如果使用案例(use-case)要求將BodySite作為一個單獨的resource來處理(例如:單獨指明和追踪),那麼就使用標準的資料項目擴充方式來擴充bodySite。

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.

42. Observation.method
Definition

指明用於執行檢驗檢查的機制

Indicates the mechanism used to perform the observation.

Binding

檢驗檢查的方法;可參考ObservationMethods代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

Methods for simple observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

在某些情況下,方法會影響結果,因此用於確認結果是否可以比較或確認結果的顯著性(significance)。

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

Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。

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

43. Observation.specimen
Definition

進行這項檢驗檢查時使用的檢體

The specimen that was used when this observation was made.

Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。 檢驗檢查不是針對檢體本身進行,而是針對對象,但在很多情況下是透過檢體的方式進行檢驗檢查。請注意,雖然經常涉及到檢體,但並不總是明確地對其進行追踪和報告。還要注意的是Observation resources可在明確追踪檢體的情境下使用(例如:Diagnostic Report)。

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).

44. Observation.device
Definition

用於產生檢驗檢查資料的設備

The device used to generate the observation data.

Comments

請注意,這不是用來表示結果傳輸的設備,例如:閘道器(gateway)等可在相關情況下使用 Provenance resource進行記錄。

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.

45. Observation.referenceRange
Definition

指導如何透過與正常或建議範圍值的比較來解釋此值。多個參考範圍值以「OR」解釋。換句話說,為了代表兩個不同的目標人群,將使用兩個referenceRange資料項目。

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.

Requirements

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

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

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

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.

46. Observation.referenceRange.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

47. Observation.referenceRange.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

48. Observation.referenceRange.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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).

Requirements

修飾用的資料項目擴充將不能安全地忽略的擴充與絕大多數可以安全地忽略的擴充明確區分開來。透過消除禁止實作者擴充存在的需求來促進可互操作性。更多訊息,請參見修飾用的資料項目擴充之定義

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

49. Observation.referenceRange.low
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

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).

50. Observation.referenceRange.high
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

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).

51. Observation.referenceRange.type
Definition

代碼表明適用的目標人群,例如:正常值或治療範圍值。

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

Binding

用以表述參考範圍值之含意的代碼;鼓勵使用ObservationReferenceRangeMeaningCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Code for the meaning of a reference range.

TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠說出這是什麼樣的參考範圍值:正常的、建議的、治療的等,以便正確解釋。

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

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

52. Observation.referenceRange.appliesTo
Definition

代碼表明此參考範圍值所適用的目標人群,例如:一個參考範圍值可能是一般人群或特定的性別或種族。多個適用對象需以「AND」解釋目標人群。例如:為了表示一個非裔美國人女性的目標人群,將同時使用女性的代碼和非裔美國人的代碼。

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.

Binding

用以指明參考範圍值適用的對象或人口群之代碼;可參考ObservationReferenceRangeAppliesToCodes代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼代碼表中的代碼。

Codes identifying the population the reference range applies to.

TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠指明目標人群以進行適當的解釋。

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

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

53. Observation.referenceRange.age
Definition

此參考範圍值適用的年齡,如果意思是說足月時的週數,這就是指新生兒年齡。

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.

Requirements

有些分析隨著年齡的增長變化很大

Some analytes vary greatly over age.

54. Observation.referenceRange.text
Definition

檢驗檢查中以文字表述的參考範圍值,可在不適合以定量範圍值呈現某項檢驗檢查時使用。例如:「陰性 」的參照值或 「正常」的清單/列表。

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".

55. Observation.hasMember
Definition

這項檢驗檢查是一組檢驗檢查,例如:一個套組(battery)、一個檢驗套組(panel)或一組生命徵象測量,其組成的檢驗檢查為此資料項目的目標resource。

Used when reporting vital signs panel components.

Comments

使用這個資料項目時,一項檢驗檢查通常會有一個值或者一組相關的resources,儘管在某些情況下兩者都可能存在。有關討論如何將Observations組合在一起的方法,請參閱下面的Notes小節。請注意,系統可能針對問卷調查的結果( QuestionnaireResponse)計算成一個最終的分數,並將這個分數表示為一個Observation。

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.

56. Observation.derivedFrom
Definition

目標resource為一種測量,此檢驗檢查就是從那個測量中得出。例如:陰離子間隙(an anion gap)或胎兒的測量值是從超音波影像計算而得。

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.

Comments

在這個資料項目中列出可以代表臨床檢檢查和其他測量的所有參照選項,可能是衍生值的來源。最常見參照另一個Observation,關於Observations如何組合在一起的討論,請參閱下面的Notes小節。

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.

57. Observation.component
Definition

有有些檢驗檢查有多個組成之檢驗檢查,這些組成之檢驗檢查被表達為具有相同屬性的獨立的代碼值對(code value pair)。例子包括血壓測量的收縮壓和舒張壓即為組成之檢驗檢查(component observations),以及遺傳學檢驗檢查的多個組成之檢驗檢查。

Used when reporting systolic and diastolic blood pressure.

Requirements

組成之檢驗檢查在Obsrvation resource中與主要檢驗檢查共享相同的屬性,並且總是被視為單個檢驗檢查的一部分(它們是不可分離的)。然而,主要檢驗檢查的參考範圍值並不被組成之檢驗檢查所繼承,在適當的時候需給予每項組成之檢驗檢查參考範圍值。

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

Comments

有關如何組合Observations的方法討論,請參閱下面的Notes小節。

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

58. Observation.component.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

59. Observation.component.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

60. Observation.component.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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).

Requirements

修飾用的資料項目擴充不能被忽略,它與絕大多數可以被忽略的資料項目擴充有所區別。透過不禁止實作者擴充存在的需求可促進可互操作性。若需要更多訊息,請參見修飾用的資料項目擴充之定義

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.

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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.

61. Observation.component.code
Definition

描述所觀察到的情況,有時這被稱為檢驗檢查「代碼」。

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

BindingThe codes SHALL be taken from 生命體徵值集The codes SHALL be taken from VitalSigns; other codes may be used where these codes are not suitable

代碼指明檢驗檢查的名稱;可參考生命體徵值集代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

This identifies the vital sign result type.

TypeCodeableConcept(CodeableConceptTW)
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

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

Comments

所有的code-value和component.code-component.value都需要考慮到,以正確理解檢驗檢查的意義。

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

62. Observation.component.value[x]
Definition

如果資訊中帶有一個值(simple value)則其可作為檢驗檢查的結果。

Vital Sign Value recorded with UCUM.

Binding

用於記錄生命體徵的常用UCUM單元。;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

Common UCUM units for recording Vital Signs.

[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

  1. SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7305).
Comments

一項檢驗檢查可能有一個值(如Apgar評分)和組成之檢驗檢查值(Apgar評分所來自多項檢驗檢查)。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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.

63. Observation.component.dataAbsentReason
Definition

提供資料項目Observation.component.value[x]中的預期值缺少的原因

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

Binding

代碼指明為什麼結果(Observation.value[x])缺少;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

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

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於許多結果,必須處理測量中的異常值。

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

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

"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.

64. Observation.component.interpretation
Definition

對一項檢驗檢查值的分類評估,例如:高、低、正常。

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

Binding

用以指明檢驗檢查的解釋之代碼。應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

Codes identifying interpretations of observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

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

Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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.

65. Observation.component.referenceRange
Definition

關於如何透過與正常值或建議範圍值的比較來解釋此值

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

Requirements

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

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

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

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.

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

1. Observation
Definition

對病人、設備或其他對象進行的測量和簡單判定。

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

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

Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

InvariantsDefined on this element
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (: text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (: dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
vs-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present. (: (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()))
2. Observation.id
Definition

resource的邏輯ID,在resource的URL中使用。一旦指定,這個值永遠不會改變。

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

Control0..1
Typeidstring
Summarytrue
Comments

一個resource使用新增操作(create operation)提交給伺服器時是此resource唯一沒有id的時刻

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

3. Observation.meta
Definition

關於resource的metadata。這是由基礎建設維護的內容。對內容的改變可能並不總是與resource的版本改變相關。

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

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

構建resource時遵循的一系列規則的參照,在處理內容時必須理解這些規則。通常這是IG定義特殊規則及其他profiles的參照。

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

Control0..1
Typeuri
Is Modifiertrue
Summarytrue
Comments

宣告這套規則限制了內容只能被有限的貿易夥伴所理解。這從本質上限制了資料的長期有用性。然而,現有的健康生態體系高度分裂,還沒有準備好以普遍可計算的方式定義、收集和交換資料。只要有可能,實作者和/或規範編寫者應該避免使用這個資料項目。通常,在使用時,此URL是對實作指引的參照,此指引將這些特殊規則與其他profiles、value sets等一起定義為其敘述的一部分。

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

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

編寫此resource的基礎語言

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages

人類語言;鼓勵使用CommonLanguages代碼表中的代碼,但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Summaryfalse
Comments

提供語言是為了支援索引和可存取性(通常,文字表述轉語音等服務使用此語言標籤)。html lanuage tag適用於此敘述。resource上的語言標籤可用於指定從resource中的資料所產成的其他表述之語言。不是所有的內容都必須使用此基礎語言。不應該假定Resource.language自動適用於敘述。如果指定語言,它也應該被指定在html中的div元素(關於xml:lang和html lang屬性之間的關係,見HTML5中的規則)。

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).

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

人可讀的敘述,包含resource的摘要,可用於向人表述resource的內容。敘述不需要對所有的結構化資料進行編碼,但需要包含足夠的細節使人在閱讀敘述時理解「臨床安全性」。resource定義可定義哪些內容應該在敘述中表示,以確保臨床安全。

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

Control0..1
TypeNarrative
Must Supporttrue
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

內嵌(contained)的resource沒有敘述,非內嵌(contained)的resource則 建議應該(SHOULD) 有敘述。在某些情況下,resource可能只有文字表述,很少或沒有額外的離散資料(只要滿足所有minOccurs=1的資料項目)。這對於來自舊有系統的資料可能是必要的,在這些系統中,從 「文字表述區塊(text blob) 」獲取訊息,或者文字表述是額外的原始輸入或敘述,而編碼訊息是後來添加的。

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

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

這些resource內嵌(contains)的resource不會另外存於任何FHIR伺服器,意即它們無法在任何FHIR伺服器中被找到,也無法有自己獨立的資料異動/交易(transaction)範圍。

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

Control0..*
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Comments

當內容可以從任何FHIR伺服器找到時,不應該以內嵌(contained)resource的方式呈現,因為一旦識別丟失,要再次恢復它是非常困難的(並且取決於情境)。內嵌(contained)的resource可在它們的meta資料項目中表述profiles和tag(標籤),但 必須沒有(SHALL NOT) 資訊安全標號(security labels)。

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

8. Observation.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
9. Observation.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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

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

Control0..*
TypeExtension
Is Modifiertrue
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
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. Observation.identifier
Definition

此檢驗檢查的唯一識別碼

A unique identifier assigned to this observation.

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

允許對檢驗檢查結果進行區分和參照

Allows observations to be distinguished and referenced.

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

依據的計劃、提議或醫令或其部分要求進行檢驗檢查。例如:一個MedicationRequest可能要求給病人藥之前要先進行實驗室檢查。

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.

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

允許授權追踪檢驗檢查事件並追踪提議/建議是否有落實

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

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

此特定的檢驗檢查(Observation)是一個更大事件中的一個組成或步驟。例如:一項處置裡的一項檢驗檢查。

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

Control0..*
TypeReference(MedicationAdministration|MedicationDispense|MedicationStatement|TWCoreProcedure|Immunization|ImagingStudy|Procedure)
Summarytrue
Alternate NamesContainer
Comments

使用encounter將一個檢驗檢查(Observation)與一個就醫(Encounter)連結起來。關於參照另一個Observation的作法,請參閱下面的Notes小節。

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

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

結果值的狀態

The status of the result value.

Control1..1
BindingThe codes SHALL be taken from ObservationStatus

檢驗檢查的狀態代碼;應填入ObservationStatus代碼表中的其中一個代碼。

Codes providing the status of an observation.

Typecode
Is Modifiertrue
Must Supporttrue
Summarytrue
Requirements

需要追踪單個結果狀態,有些結果在整個報告確定之前就已經確定了。

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

Comments

這個資料項目被標記為修飾語/修飾用,因為附加到其他文件上的文件,其本身是不完整的文件。

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

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

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

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

Control10..*
BindingThe codes SHOULD be taken from ObservationCategoryCodes

高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Codes for high level observation categories.

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Summaryfalse
Requirements

用於篩選取得及顯示之檢驗檢查

Used for filtering what observations are retrieved and displayed.

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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.

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

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

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

Control10..1* This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodes

高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Codes for high level observation categories.

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

用於篩選取得及顯示之檢驗檢查

Used for filtering what observations are retrieved and displayed.

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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.

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
17. Observation.category:VSCat.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.category.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
18. Observation.category:VSCat.coding
Definition

由專門術語系統(terminology system)所定義之代碼的參照。

A reference to a code defined by a terminology system.

Control10..*
TypeCoding
Must Supporttrue
Summarytrue
Requirements

允許使用者在不知道識別碼系統的情況下利用識別碼

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

Comments

代碼可以在列舉清單(enumerations)或代碼清單(code lists)中非常隨意地定義,直至有非常正式的定義,如SNOMED CT—更多資訊見HL7 v3核心原則(Core Principles )。編碼的排序是未定義的因而 必須沒有(SHALL NOT) 被用來推斷意義。一般來說,最多只有一個編碼值(coding values)會被標記為UserSelected = true。

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.

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
20. Observation.category:VSCat.coding.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.category.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
21. Observation.category:VSCat.coding.system
Definition

定義代碼中符號意義的代碼系統識別。

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

Control10..1
Typeuri
Must Supporttrue
Summarytrue
Requirements

需要明確說明符號定義的來源

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

Comments

URI可以是一個OID(urn:oid:...)或一個UUID(urn:uuid:...);OID和UUID 必須(SHALL) 參照HL7 OID註冊中心;否則,URI應該來自HL7的FHIR定義的特殊URI列表,或者它應該參照一些明確建立的系统定義。

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.

Fixed Valuehttp://terminology.hl7.org/CodeSystem/observation-category
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. Observation.category:VSCat.coding.version
Definition

選擇此代碼時使用的代碼系統版本;請注意,一個維護良好的代碼系統不需要版本報告,因為代碼的意義在不同系統版本中是一致的;然而,不能始終保證這點,當不能保證意義一致時, 必須(SHALL) 將版本資訊也一併作交換。

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

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

如果專門術語沒有明確定義應該使用什麼字串來識別代碼系統的版本,建議使用版本正式發布的日期(用FHIR日期格式表示)作為版本日期。

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

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

系統定義的語法之符號;符號可能是一個預先定義的代碼,也可能是代碼系統定義的語法中的表達式(如後組合配對/後組合式)。

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).

Control10..1
Typecode
Must Supporttrue
Summarytrue
Requirements

需要參照系統中的一個特定代碼

Need to refer to a particular code in the system.

Fixed Valuevital-signs
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. Observation.category:VSCat.coding.display
Definition

遵循系統的規則以呈現代碼含義的表示法

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

Control0..1
Typestring
Summarytrue
Requirements

需要能為不了解此系統的讀者呈現可讀的代碼含義

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

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

表明此編碼是由使用者直接選擇,例如:從可用項目(代碼或顯示名稱)的清單中選擇。

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

Control0..1
Typeboolean
Summarytrue
Requirements

已被確定為一個臨床安全準則—此確切的系統/代碼對(code pair)是被明確選擇的,而不是由系統根據一些規則或是程式語言處理判斷。

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

在一系列備選方案中,直接選擇的代碼是新翻譯最合適的起點;關於「直接選擇」的確切意義,存在模糊不清之處,可能需要貿易夥伴的同意,以更完整澄清此資料項目的使用及其後果。

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.

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

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

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

Control0..1
Typestring
Summarytrue
Requirements

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

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

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

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

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

可以透過正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

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

Control1..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from 生命體徵值集For example codes, see LOINCCodes

應填入生命體徵值集代碼表中的其中一個代碼。

Codes identifying names of simple observations.

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

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

Alternate NamesName
Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
29. Observation.code.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.code.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
30. Observation.code.coding
Definition

由專門術語系統(terminology system)所定義之代碼的參照

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding(CodingTW)
Must Supporttrue
Requirements

允許代碼系統中的替代編碼,以及翻譯到其他編碼系統。

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

Comments

代碼可以在列舉清單(enumerations)或代碼清單(code lists)中非常隨意地定義,直至有非常正式的定義,例如:SNOMED CT—更多資訊見HL7 v3核心原則(Core Principles )。編碼的排序是未定義的因而 必須沒有(SHALL NOT) 被用來推斷意義。一般來說,最多只有一個編碼值(coding values)會被標記為UserSelected = true。

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.

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

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

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

Control0..1
Typestring
Must Supporttrue
Summarytrue
Requirements

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

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

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

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

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

此檢驗檢查是關於一位病人、一群病人、地點、或設備。如果檢驗檢查的實際焦點與對象(或其樣本、其部分或其區域)不同,則焦點資料項目或代碼本身會具體說明檢驗檢查的實際焦點。

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.

Control10..1
TypeReference(TWCorePatient|Patient|Group|Device|Location)
Must Supporttrue
Summarytrue
Requirements

如果你不知道他們是誰或關於什麼,檢驗檢查不會有值。

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

Comments

人們期望這個資料項目的cardinality為1...1。唯一可能缺少對象的情況是當檢驗檢查是由一個不認識病人的設備進行的。在這種情況下,應透過一些情境/通道對應(context/channel matching)技術將檢驗檢查與病人對應,此時,應更新檢驗檢查資訊。

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

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

檢驗檢查的實際焦點,當它不是記錄病人時,代表是與病人有關的事物或人,如配偶、父母、胎兒或捐贈者。例如:母親的記錄中有關胎兒檢驗檢查。檢驗檢查的焦點也可以是現有的狀況、疾病或問題(condition)、介入(intervention)、此對象的飲食、對此對象的另一項檢驗檢查,或身體結構像是腫瘤或植入裝置。有一個案例是使用Observation Resource來取得母親是否已接受更換她的小孩的氣管插管訓練之資訊,在這個例子中,孩子是此記錄的病人,而母親是focus。

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.

Control0..*
TypeReference(Resource)
Summarytrue
Comments

通常檢驗檢查的對象是一位病人或一群病人、地點或設備,檢驗檢查對象與直接測量內容之間的區別在observation.code已具體說明(例如: 「血糖」),不需要使用這個資料項目(focus)單獨表示。如果需要參照檢體,則使用specimen,如果需要一個代碼而不是一個resource,則使用bodysite來表示bodysites或標準擴充focusCode。

Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

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

執行檢驗檢查的健康照護事件(例如:病人及健康照護提供人員的互動)

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

Control0..1
TypeReference(TWCoreEncounter|Encounter)
Summarytrue
Requirements

對於某些檢驗檢查來說,知道某個檢驗檢查和某個特定的就醫事件之間的連結可能很重要。

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

Alternate NamesContext
Comments

這通常指檢驗檢查發生於哪次就醫,但有些檢驗檢查可能是在就醫前或就醫後發生,但仍與就醫的情境有關(如入院前的實驗室檢驗檢查)。

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).

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

宣告檢驗檢查值的產出時間或時間區段是真的。對於生物學研究對象—例如病人—這通常被稱為「生理相關時間」。這通常是處置的時間或採樣的時間,但很多時候不知道日期或時間的來源,只知道日期或時間本身。

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.

Control10..1 This element is affected by the following invariants: vs-1
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesdateTime
Summarytrue
Requirements

知道一項檢驗檢查何時被認為是真的,對其相關性和確定趨勢都很重要。

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

Alternate NamesOccurrence
Comments

除非這是一份檢驗檢查的歷史報告,否則至少應該有一個日期。為了記錄不精確或「模煳」的時間(例如:測量「早餐後 」血糖),使用Timing datatype以允許測量能與常規生活事件連結。

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
vs-1: if Observation.effective[x] is dateTime and has a value then that value shall be precise to the day (: ($this as dateTime).toString().length() >= 8)
36. Observation.issued
Definition

此版本的檢驗檢查資訊可供健康照護提供人員取得的日期和時間,通常是在結果被審查與核實之後。

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

Control0..1
Typeinstant
Summarytrue
Comments

對於不需要審查和核實的檢驗檢查值,發佈日期時間可能與resource本身的最後更新日期時間相同。對於需要對某些更新進行審查和核實的檢驗檢查,若為非臨床上的重要更新則不需要對新版本進行再次審查和驗證,所以發佈日期時間可能與resource本身的最後更新日期時間不一樣。

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.

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

誰負責宣告檢驗檢查結果值為「真的」

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

Control0..*
TypeReference(TWCorePractitioner|TWCoreOrganization|TWCorePatient|PractitionerRole|CareTeam|Practitioner|Organization|Patient|RelatedPerson)
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

可以對此檢驗檢查有一定程度的信任,並指出後續問題的方向。

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

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

如果此資訊有一個簡單的值,則將其作為此項檢驗檢查的結果。

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

Control0..1 This element is affected by the following invariants: obs-7, vs-2
BindingThe codes SHALL be taken from VitalSignsUnits; other codes may be used where these codes are not suitableFor codes, see (unbound) 用於記錄生命體徵的常用UCUM單元;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesQuantity
Summarytrue
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

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

一項檢驗檢查可能有:1)單一值、2)一個值及一組相關或組成之檢驗檢查的多個值、或者3)只有一組相關或組成之檢驗檢查的多個值。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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

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

提供資料項目Observation.value[x]中的預期值缺少的原因

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

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

代碼具體說明檢驗檢查結果缺少的原因;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

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

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

對於許多結果,必須處理測量中的異常值。

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

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

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.

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

對一項檢驗檢查值的分類評估,例如:高、低、正常。

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

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

代碼指明檢驗檢查結果的解釋;應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

Codes identifying interpretations of observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

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

Alternate NamesAbnormal Flag
Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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

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

關於檢驗檢查或結果的解說

Comments about the observation or the results.

Control0..*
TypeAnnotation
Summaryfalse
Requirements

需能提供純文字表述的附加資訊

Need to be able to provide free text additional information.

Comments

可包括關於檢驗檢查的一般陳述,或關於重要的、非預期的或不可靠的結果值的陳述,或與資料項目interpretation有關的來源資訊。

May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

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

表示在檢驗檢查對象身上進行檢驗檢查的部位(即目標部位)

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

Control0..1 This element is affected by the following invariants: ele-1
BindingFor example codes, see SNOMEDCTBodyStructures

代碼說明解剖學位置,可能包含側邊;可參考SNOMEDCTBodyStructures代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

Codes describing anatomical locations. May include laterality.

TypeCodeableConcept(CodeableConceptTW)
Comments

只有在Observation.code中的代碼未隱含時才會使用。在許多系統中,這可能被表示為一個相關的檢驗檢查,而不是一個行內的組成之檢驗檢查(inline component)。

如果使用案例(use-case)要求將BodySite作為一個單獨的resource來處理(例如:單獨指明和追踪),那麼就使用標準的資料項目擴充方式來擴充bodySite。

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.

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

指明用於執行檢驗檢查的機制

Indicates the mechanism used to perform the observation.

Control0..1 This element is affected by the following invariants: ele-1
BindingFor example codes, see ObservationMethods

檢驗檢查的方法;可參考ObservationMethods代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

Methods for simple observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

在某些情況下,方法會影響結果,因此用於確認結果是否可以比較或確認結果的顯著性(significance)。

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

Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。

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

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

進行這項檢驗檢查時使用的檢體

The specimen that was used when this observation was made.

Control0..1
TypeReference(Specimen)
Summaryfalse
Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。 檢驗檢查不是針對檢體本身進行,而是針對對象,但在很多情況下是透過檢體的方式進行檢驗檢查。請注意,雖然經常涉及到檢體,但並不總是明確地對其進行追踪和報告。還要注意的是Observation resources可在明確追踪檢體的情境下使用(例如:Diagnostic Report)。

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).

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

用於產生檢驗檢查資料的設備

The device used to generate the observation data.

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

請注意,這不是用來表示結果傳輸的設備,例如:閘道器(gateway)等可在相關情況下使用 Provenance resource進行記錄。

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.

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

指導如何透過與正常或建議範圍值的比較來解釋此值。多個參考範圍值以「OR」解釋。換句話說,為了代表兩個不同的目標人群,將使用兩個referenceRange資料項目。

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.

Control0..*
TypeBackboneElement
Summaryfalse
Requirements

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

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

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
obs-3: Must have at least a low or a high or text (: low.exists() or high.exists() or text.exists())
47. Observation.referenceRange.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
48. Observation.referenceRange.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
49. Observation.referenceRange.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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

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

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

修飾用的資料項目擴充將不能安全地忽略的擴充與絕大多數可以安全地忽略的擴充明確區分開來。透過消除禁止實作者擴充存在的需求來促進可互操作性。更多訊息,請參見修飾用的資料項目擴充之定義

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

Alternate Namesextensions, user content, modifiers
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
50. Observation.referenceRange.low
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

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

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. Observation.referenceRange.high
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

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

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. Observation.referenceRange.type
Definition

代碼表明適用的目標人群,例如:正常值或治療範圍值。

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

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes

用以表述參考範圍值之含意的代碼;鼓勵使用ObservationReferenceRangeMeaningCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示。

Code for the meaning of a reference range.

TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠說出這是什麼樣的參考範圍值:正常的、建議的、治療的等,以便正確解釋。

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

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

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

代碼表明此參考範圍值所適用的目標人群,例如:一個參考範圍值可能是一般人群或特定的性別或種族。多個適用對象需以「AND」解釋目標人群。例如:為了表示一個非裔美國人女性的目標人群,將同時使用女性的代碼和非裔美國人的代碼。

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.

Control0..* This element is affected by the following invariants: ele-1
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes

用以指明參考範圍值適用的對象或人口群之代碼;可參考ObservationReferenceRangeAppliesToCodes代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼代碼表中的代碼。

Codes identifying the population the reference range applies to.

TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠指明目標人群以進行適當的解釋。

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

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

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

此參考範圍值適用的年齡,如果意思是說足月時的週數,這就是指新生兒年齡。

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.

Control0..1
TypeRange
Summaryfalse
Requirements

有些分析隨著年齡的增長變化很大

Some analytes vary greatly over age.

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

檢驗檢查中以文字表述的參考範圍值,可在不適合以定量範圍值呈現某項檢驗檢查時使用。例如:「陰性 」的參照值或 「正常」的清單/列表。

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".

Control0..1
Typestring
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. Observation.hasMember
Definition

這項檢驗檢查是一組檢驗檢查,例如:一個套組(battery)、一個檢驗套組(panel)或一組生命徵象測量,其組成的檢驗檢查為此資料項目的目標resource。

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.

Control0..*
TypeReference(QuestionnaireResponse|MolecularSequence|observation-vitalsigns|Observation)
Summarytrue
Comments

使用這個資料項目時,一項檢驗檢查通常會有一個值或者一組相關的resources,儘管在某些情況下兩者都可能存在。有關討論如何將Observations組合在一起的方法,請參閱下面的Notes小節。請注意,系統可能針對問卷調查的結果( QuestionnaireResponse)計算成一個最終的分數,並將這個分數表示為一個Observation。

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.

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

目標resource為一種測量,此檢驗檢查就是從那個測量中得出。例如:陰離子間隙(an anion gap)或胎兒的測量值是從超音波影像計算而得。

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.

Control0..*
TypeReference(DocumentReference|ImagingStudy|Media|QuestionnaireResponse|MolecularSequence|observation-vitalsigns|Observation)
Summarytrue
Comments

在這個資料項目中列出可以代表臨床檢檢查和其他測量的所有參照選項,可能是衍生值的來源。最常見參照另一個Observation,關於Observations如何組合在一起的討論,請參閱下面的Notes小節。

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

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

有有些檢驗檢查有多個組成之檢驗檢查,這些組成之檢驗檢查被表達為具有相同屬性的獨立的代碼值對(code value pair)。例子包括血壓測量的收縮壓和舒張壓即為組成之檢驗檢查(component observations),以及遺傳學檢驗檢查的多個組成之檢驗檢查。

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.

Control0..*
TypeBackboneElement
Must Supporttrue
Summarytrue
Requirements

組成之檢驗檢查在Obsrvation resource中與主要檢驗檢查共享相同的屬性,並且總是被視為單個檢驗檢查的一部分(它們是不可分離的)。然而,主要檢驗檢查的參考範圍值並不被組成之檢驗檢查所繼承,在適當的時候需給予每項組成之檢驗檢查參考範圍值。

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

Comments

有關如何組合Observations的方法討論,請參閱下面的Notes小節。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
vs-3: If there is no a value a data absent reason must be present (: value.exists() or dataAbsentReason.exists())
59. Observation.component.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
60. Observation.component.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

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

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
61. Observation.component.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

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

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

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

修飾用的資料項目擴充不能被忽略,它與絕大多數可以被忽略的資料項目擴充有所區別。透過不禁止實作者擴充存在的需求可促進可互操作性。若需要更多訊息,請參見修飾用的資料項目擴充之定義

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

Alternate Namesextensions, user content, modifiers
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
62. Observation.component.code
Definition

描述所觀察到的情況,有時這被稱為檢驗檢查「代碼」。

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

Control1..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from 生命體徵值集For example codes, see LOINCCodes

代碼指明檢驗檢查的名稱;可參考生命體徵值集代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼。

Codes identifying names of simple observations.

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

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

Comments

所有的code-value和component.code-component.value都需要考慮到,以正確理解檢驗檢查的意義。

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

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

如果資訊中帶有一個值(simple value)則其可作為檢驗檢查的結果。

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

Control0..1 This element is affected by the following invariants: vs-3
BindingThe codes SHALL be taken from VitalSignsUnitsFor codes, see (unbound) 用於記錄生命體徵的常用UCUM單元。;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

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

一項檢驗檢查可能有一個值(如Apgar評分)和組成之檢驗檢查值(Apgar評分所來自多項檢驗檢查)。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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

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

提供資料項目Observation.component.value[x]中的預期值缺少的原因

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

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

代碼指明為什麼結果(Observation.value[x])缺少;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

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

TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

對於許多結果,必須處理測量中的異常值。

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

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

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

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

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

對一項檢驗檢查值的分類評估,例如:高、低、正常。

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

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

用以指明檢驗檢查的解釋之代碼。應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示。

Codes identifying interpretations of observations.

TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

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

Alternate NamesAbnormal Flag
Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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

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

關於如何透過與正常值或建議範圍值的比較來解釋此值

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

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

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

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

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

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

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

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

1. Observation
Definition

對病人、設備或其他對象進行的測量和簡單判定。

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

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.

2. Observation.id
Definition

resource的邏輯ID,在resource的URL中使用。一旦指定,這個值永遠不會改變。

Control0..1
Typeid
Summarytrue
Comments

一個resource使用新增操作(create operation)提交給伺服器時是此resource唯一沒有id的時刻

3. Observation.meta
Definition

關於resource的metadata。這是由基礎建設維護的內容。對內容的改變可能並不總是與resource的版本改變相關。

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

構建resource時遵循的一系列規則的參照,在處理內容時必須理解這些規則。通常這是IG定義特殊規則及其他profiles的參照。

Control0..1
Typeuri
Is Modifiertrue
Summarytrue
Comments

宣告這套規則限制了內容只能被有限的貿易夥伴所理解。這從本質上限制了資料的長期有用性。然而,現有的健康生態體系高度分裂,還沒有準備好以普遍可計算的方式定義、收集和交換資料。只要有可能,實作者和/或規範編寫者應該避免使用這個資料項目。通常,在使用時,此URL是對實作指引的參照,此指引將這些特殊規則與其他profiles、value sets等一起定義為其敘述的一部分。

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

編寫此resource的基礎語言

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages 人類語言;鼓勵使用CommonLanguages代碼表中的代碼,但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Summaryfalse
Comments

提供語言是為了支援索引和可存取性(通常,文字表述轉語音等服務使用此語言標籤)。html lanuage tag適用於此敘述。resource上的語言標籤可用於指定從resource中的資料所產成的其他表述之語言。不是所有的內容都必須使用此基礎語言。不應該假定Resource.language自動適用於敘述。如果指定語言,它也應該被指定在html中的div元素(關於xml:lang和html lang屬性之間的關係,見HTML5中的規則)。

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

人可讀的敘述,包含resource的摘要,可用於向人表述resource的內容。敘述不需要對所有的結構化資料進行編碼,但需要包含足夠的細節使人在閱讀敘述時理解「臨床安全性」。resource定義可定義哪些內容應該在敘述中表示,以確保臨床安全。

Control0..1
TypeNarrative
Must Supporttrue
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

內嵌(contained)的resource沒有敘述,非內嵌(contained)的resource則 建議應該(SHOULD) 有敘述。在某些情況下,resource可能只有文字表述,很少或沒有額外的離散資料(只要滿足所有minOccurs=1的資料項目)。這對於來自舊有系統的資料可能是必要的,在這些系統中,從 「文字表述區塊(text blob) 」獲取訊息,或者文字表述是額外的原始輸入或敘述,而編碼訊息是後來添加的。

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

這些resource內嵌(contains)的resource不會另外存於任何FHIR伺服器,意即它們無法在任何FHIR伺服器中被找到,也無法有自己獨立的資料異動/交易(transaction)範圍。

Control0..*
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Comments

當內容可以從任何FHIR伺服器找到時,不應該以內嵌(contained)resource的方式呈現,因為一旦識別丟失,要再次恢復它是非常困難的(並且取決於情境)。內嵌(contained)的resource可在它們的meta資料項目中表述profiles和tag(標籤),但 必須沒有(SHALL NOT) 資訊安全標號(security labels)。

8. Observation.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
9. Observation.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

Control0..*
TypeExtension
Is Modifiertrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. Observation.identifier
Definition

此檢驗檢查的唯一識別碼

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

允許對檢驗檢查結果進行區分和參照

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

依據的計劃、提議或醫令或其部分要求進行檢驗檢查。例如:一個MedicationRequest可能要求給病人藥之前要先進行實驗室檢查。

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

允許授權追踪檢驗檢查事件並追踪提議/建議是否有落實

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

此特定的檢驗檢查(Observation)是一個更大事件中的一個組成或步驟。例如:一項處置裡的一項檢驗檢查。

Control0..*
TypeReference(MedicationAdministration|MedicationDispense|MedicationStatement|TWCoreProcedure|Immunization|ImagingStudy)
Summarytrue
Alternate NamesContainer
Comments

使用encounter將一個檢驗檢查(Observation)與一個就醫(Encounter)連結起來。關於參照另一個Observation的作法,請參閱下面的Notes小節。

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

結果值的狀態

Control1..1
BindingThe codes SHALL be taken from ObservationStatus 檢驗檢查的狀態代碼;應填入ObservationStatus代碼表中的其中一個代碼
Typecode
Is Modifiertrue
Must Supporttrue
Summarytrue
Requirements

需要追踪單個結果狀態,有些結果在整個報告確定之前就已經確定了。

Comments

這個資料項目被標記為修飾語/修飾用,因為附加到其他文件上的文件,其本身是不完整的文件。

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

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

Control1..*
BindingThe codes SHOULD be taken from ObservationCategoryCodes 高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Summaryfalse
Requirements

用於篩選取得及顯示之檢驗檢查

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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

可以正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

Control1..1 This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationCategoryCodes 高層次的檢驗檢查分類;鼓勵使用ObservationCategoryCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

用於篩選取得及顯示之檢驗檢查

Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
17. Observation.category:VSCat.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.category.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
18. Observation.category:VSCat.coding
Definition

由專門術語系統(terminology system)所定義之代碼的參照。

Control1..*
TypeCoding
Must Supporttrue
Summarytrue
Requirements

允許使用者在不知道識別碼系統的情況下利用識別碼

Comments

代碼可以在列舉清單(enumerations)或代碼清單(code lists)中非常隨意地定義,直至有非常正式的定義,如SNOMED CT—更多資訊見HL7 v3核心原則(Core Principles )。編碼的排序是未定義的因而 必須沒有(SHALL NOT) 被用來推斷意義。一般來說,最多只有一個編碼值(coding values)會被標記為UserSelected = true。

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
20. Observation.category:VSCat.coding.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.category.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
21. Observation.category:VSCat.coding.system
Definition

定義代碼中符號意義的代碼系統識別。

Control1..1
Typeuri
Must Supporttrue
Summarytrue
Requirements

需要明確說明符號定義的來源

Comments

URI可以是一個OID(urn:oid:...)或一個UUID(urn:uuid:...);OID和UUID 必須(SHALL) 參照HL7 OID註冊中心;否則,URI應該來自HL7的FHIR定義的特殊URI列表,或者它應該參照一些明確建立的系统定義。

Fixed Valuehttp://terminology.hl7.org/CodeSystem/observation-category
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. Observation.category:VSCat.coding.version
Definition

選擇此代碼時使用的代碼系統版本;請注意,一個維護良好的代碼系統不需要版本報告,因為代碼的意義在不同系統版本中是一致的;然而,不能始終保證這點,當不能保證意義一致時, 必須(SHALL) 將版本資訊也一併作交換。

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

如果專門術語沒有明確定義應該使用什麼字串來識別代碼系統的版本,建議使用版本正式發布的日期(用FHIR日期格式表示)作為版本日期。

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

系統定義的語法之符號;符號可能是一個預先定義的代碼,也可能是代碼系統定義的語法中的表達式(如後組合配對/後組合式)。

Control1..1
Typecode
Must Supporttrue
Summarytrue
Requirements

需要參照系統中的一個特定代碼

Fixed Valuevital-signs
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. Observation.category:VSCat.coding.display
Definition

遵循系統的規則以呈現代碼含義的表示法

Control0..1
Typestring
Summarytrue
Requirements

需要能為不了解此系統的讀者呈現可讀的代碼含義

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

表明此編碼是由使用者直接選擇,例如:從可用項目(代碼或顯示名稱)的清單中選擇。

Control0..1
Typeboolean
Summarytrue
Requirements

已被確定為一個臨床安全準則—此確切的系統/代碼對(code pair)是被明確選擇的,而不是由系統根據一些規則或是程式語言處理判斷。

Comments

在一系列備選方案中,直接選擇的代碼是新翻譯最合適的起點;關於「直接選擇」的確切意義,存在模糊不清之處,可能需要貿易夥伴的同意,以更完整澄清此資料項目的使用及其後果。

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

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

Control0..1
Typestring
Summarytrue
Requirements

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

Comments

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

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

可以透過正式參照一個專門術語或本體論來定義一個概念,或者也可以文字表述此概念。

Control1..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from 生命體徵值集 應填入生命體徵值集代碼表中的其中一個代碼
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

Alternate NamesName
Comments

並非所有的專門術語使用都符合這個一般模式。在某些情況下,資料模型不應該使用CodeableConcept而應直接使用Coding,並提供他們自己的結構來管理text、codings、translation、資料項目之間的關係、以及先組合配對/前組合式(pre-coordination)和後組合配對/後組合式(post-coordination)。

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

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
29. Observation.code.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何汙名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.code.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
30. Observation.code.coding
Definition

由專門術語系統(terminology system)所定義之代碼的參照

Control0..* This element is affected by the following invariants: ele-1
TypeCoding(CodingTW)
Must Supporttrue
Requirements

允許代碼系統中的替代編碼,以及翻譯到其他編碼系統。

Comments

代碼可以在列舉清單(enumerations)或代碼清單(code lists)中非常隨意地定義,直至有非常正式的定義,例如:SNOMED CT—更多資訊見HL7 v3核心原則(Core Principles )。編碼的排序是未定義的因而 必須沒有(SHALL NOT) 被用來推斷意義。一般來說,最多只有一個編碼值(coding values)會被標記為UserSelected = true。

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

輸入資料的使用者所見/所選/所說的人類可讀文字表述,和(或)其代表使用者的預期含義。

Control0..1
Typestring
Must Supporttrue
Summarytrue
Requirements

專門術語中的代碼並不總是能捕捉人類使用的細微差別的正確意義,或者根本就沒有合適的代碼;這些情況下,文字表述被用來捕捉來源的全部意義。

Comments

很多時候,此文字表述與其中一個代碼的顯示名稱相同。

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

此檢驗檢查是關於一位病人、一群病人、地點、或設備。如果檢驗檢查的實際焦點與對象(或其樣本、其部分或其區域)不同,則焦點資料項目或代碼本身會具體說明檢驗檢查的實際焦點。

Control1..1
TypeReference(TWCorePatient)
Must Supporttrue
Summarytrue
Requirements

如果你不知道他們是誰或關於什麼,檢驗檢查不會有值。

Comments

人們期望這個資料項目的cardinality為1...1。唯一可能缺少對象的情況是當檢驗檢查是由一個不認識病人的設備進行的。在這種情況下,應透過一些情境/通道對應(context/channel matching)技術將檢驗檢查與病人對應,此時,應更新檢驗檢查資訊。

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

檢驗檢查的實際焦點,當它不是記錄病人時,代表是與病人有關的事物或人,如配偶、父母、胎兒或捐贈者。例如:母親的記錄中有關胎兒檢驗檢查。檢驗檢查的焦點也可以是現有的狀況、疾病或問題(condition)、介入(intervention)、此對象的飲食、對此對象的另一項檢驗檢查,或身體結構像是腫瘤或植入裝置。有一個案例是使用Observation Resource來取得母親是否已接受更換她的小孩的氣管插管訓練之資訊,在這個例子中,孩子是此記錄的病人,而母親是focus。

Control0..*
TypeReference(Resource)
Summarytrue
Comments

通常檢驗檢查的對象是一位病人或一群病人、地點或設備,檢驗檢查對象與直接測量內容之間的區別在observation.code已具體說明(例如: 「血糖」),不需要使用這個資料項目(focus)單獨表示。如果需要參照檢體,則使用specimen,如果需要一個代碼而不是一個resource,則使用bodysite來表示bodysites或標準擴充focusCode。

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

執行檢驗檢查的健康照護事件(例如:病人及健康照護提供人員的互動)

Control0..1
TypeReference(TWCoreEncounter)
Summarytrue
Requirements

對於某些檢驗檢查來說,知道某個檢驗檢查和某個特定的就醫事件之間的連結可能很重要。

Alternate NamesContext
Comments

這通常指檢驗檢查發生於哪次就醫,但有些檢驗檢查可能是在就醫前或就醫後發生,但仍與就醫的情境有關(如入院前的實驗室檢驗檢查)。

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

宣告檢驗檢查值的產出時間或時間區段是真的。對於生物學研究對象—例如病人—這通常被稱為「生理相關時間」。這通常是處置的時間或採樣的時間,但很多時候不知道日期或時間的來源,只知道日期或時間本身。

Control1..1 This element is affected by the following invariants: vs-1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesdateTime
Summarytrue
Requirements

知道一項檢驗檢查何時被認為是真的,對其相關性和確定趨勢都很重要。

Alternate NamesOccurrence
Comments

除非這是一份檢驗檢查的歷史報告,否則至少應該有一個日期。為了記錄不精確或「模煳」的時間(例如:測量「早餐後 」血糖),使用Timing datatype以允許測量能與常規生活事件連結。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
vs-1: if Observation.effective[x] is dateTime and has a value then that value shall be precise to the day (: ($this as dateTime).toString().length() >= 8)
36. Observation.issued
Definition

此版本的檢驗檢查資訊可供健康照護提供人員取得的日期和時間,通常是在結果被審查與核實之後。

Control0..1
Typeinstant
Summarytrue
Comments

對於不需要審查和核實的檢驗檢查值,發佈日期時間可能與resource本身的最後更新日期時間相同。對於需要對某些更新進行審查和核實的檢驗檢查,若為非臨床上的重要更新則不需要對新版本進行再次審查和驗證,所以發佈日期時間可能與resource本身的最後更新日期時間不一樣。

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

誰負責宣告檢驗檢查結果值為「真的」

Control0..*
TypeReference(TWCorePractitioner|TWCoreOrganization|TWCorePatient|PractitionerRole|CareTeam)
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

可以對此檢驗檢查有一定程度的信任,並指出後續問題的方向。

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

如果此資訊有一個簡單的值,則將其作為此項檢驗檢查的結果。

Control0..1 This element is affected by the following invariants: obs-7, vs-2
BindingThe codes SHALL be taken from VitalSignsUnits; other codes may be used where these codes are not suitable 用於記錄生命體徵的常用UCUM單元;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesQuantity
Summarytrue
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

Comments

一項檢驗檢查可能有:1)單一值、2)一個值及一組相關或組成之檢驗檢查的多個值、或者3)只有一組相關或組成之檢驗檢查的多個值。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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

提供資料項目Observation.value[x]中的預期值缺少的原因

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable 代碼具體說明檢驗檢查結果缺少的原因;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

對於許多結果,必須處理測量中的異常值。

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

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

對一項檢驗檢查值的分類評估,例如:高、低、正常。

Control0..* This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable 代碼指明檢驗檢查結果的解釋;應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

Alternate NamesAbnormal Flag
Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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

關於檢驗檢查或結果的解說

Control0..*
TypeAnnotation
Summaryfalse
Requirements

需能提供純文字表述的附加資訊

Comments

可包括關於檢驗檢查的一般陳述,或關於重要的、非預期的或不可靠的結果值的陳述,或與資料項目interpretation有關的來源資訊。

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

表示在檢驗檢查對象身上進行檢驗檢查的部位(即目標部位)

Control0..1 This element is affected by the following invariants: ele-1
BindingFor example codes, see SNOMEDCTBodyStructures 代碼說明解剖學位置,可能包含側邊;可參考SNOMEDCTBodyStructures代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼
TypeCodeableConcept(CodeableConceptTW)
Comments

只有在Observation.code中的代碼未隱含時才會使用。在許多系統中,這可能被表示為一個相關的檢驗檢查,而不是一個行內的組成之檢驗檢查(inline component)。

如果使用案例(use-case)要求將BodySite作為一個單獨的resource來處理(例如:單獨指明和追踪),那麼就使用標準的資料項目擴充方式來擴充bodySite。

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

指明用於執行檢驗檢查的機制

Control0..1 This element is affected by the following invariants: ele-1
BindingFor example codes, see ObservationMethods 檢驗檢查的方法;可參考ObservationMethods代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼
TypeCodeableConcept(CodeableConceptTW)
Requirements

在某些情況下,方法會影響結果,因此用於確認結果是否可以比較或確認結果的顯著性(significance)。

Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。

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

進行這項檢驗檢查時使用的檢體

Control0..1
TypeReference(Specimen)
Summaryfalse
Comments

只有在Observation.code中的代碼未隱含此資料項目概念時才會使用。 檢驗檢查不是針對檢體本身進行,而是針對對象,但在很多情況下是透過檢體的方式進行檢驗檢查。請注意,雖然經常涉及到檢體,但並不總是明確地對其進行追踪和報告。還要注意的是Observation resources可在明確追踪檢體的情境下使用(例如:Diagnostic Report)。

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

用於產生檢驗檢查資料的設備

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

請注意,這不是用來表示結果傳輸的設備,例如:閘道器(gateway)等可在相關情況下使用 Provenance resource進行記錄。

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

指導如何透過與正常或建議範圍值的比較來解釋此值。多個參考範圍值以「OR」解釋。換句話說,為了代表兩個不同的目標人群,將使用兩個referenceRange資料項目。

Control0..*
TypeBackboneElement
Summaryfalse
Requirements

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

Comments

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
obs-3: Must have at least a low or a high or text (: low.exists() or high.exists() or text.exists())
47. Observation.referenceRange.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
48. Observation.referenceRange.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
49. Observation.referenceRange.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

修飾用的資料項目擴充將不能安全地忽略的擴充與絕大多數可以安全地忽略的擴充明確區分開來。透過消除禁止實作者擴充存在的需求來促進可互操作性。更多訊息,請參見修飾用的資料項目擴充之定義

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
50. Observation.referenceRange.low
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. Observation.referenceRange.high
Definition

參考範圍值的下限值。參考範圍值endpoint的下限值包含在此值中(例如:參考範圍值是>=5 - <=9)。如果省略下限值,則被認為是沒有意義的(例如:參考範圍值是<=2.3)。

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. Observation.referenceRange.type
Definition

代碼表明適用的目標人群,例如:正常值或治療範圍值。

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes 用以表述參考範圍值之含意的代碼;鼓勵使用ObservationReferenceRangeMeaningCodes代碼表中的代碼, 但不強制一定要使用此代碼表,你也可使用其他代碼表的代碼或單純以文字表示
TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠說出這是什麼樣的參考範圍值:正常的、建議的、治療的等,以便正確解釋。

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

代碼表明此參考範圍值所適用的目標人群,例如:一個參考範圍值可能是一般人群或特定的性別或種族。多個適用對象需以「AND」解釋目標人群。例如:為了表示一個非裔美國人女性的目標人群,將同時使用女性的代碼和非裔美國人的代碼。

Control0..* This element is affected by the following invariants: ele-1
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes 用以指明參考範圍值適用的對象或人口群之代碼;可參考ObservationReferenceRangeAppliesToCodes代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼代碼表中的代碼
TypeCodeableConcept(CodeableConceptTW)
Requirements

需要能夠指明目標人群以進行適當的解釋。

Comments

如果有一個以上的範圍值,此資料項目 建議應該(SHOULD) 填寫。如果這個資料項目不存在,則假定是正常範圍值。

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

此參考範圍值適用的年齡,如果意思是說足月時的週數,這就是指新生兒年齡。

Control0..1
TypeRange
Summaryfalse
Requirements

有些分析隨著年齡的增長變化很大

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

檢驗檢查中以文字表述的參考範圍值,可在不適合以定量範圍值呈現某項檢驗檢查時使用。例如:「陰性 」的參照值或 「正常」的清單/列表。

Control0..1
Typestring
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. Observation.hasMember
Definition

這項檢驗檢查是一組檢驗檢查,例如:一個套組(battery)、一個檢驗套組(panel)或一組生命徵象測量,其組成的檢驗檢查為此資料項目的目標resource。

Control0..*
TypeReference(QuestionnaireResponse|MolecularSequence|observation-vitalsigns)
Summarytrue
Comments

使用這個資料項目時,一項檢驗檢查通常會有一個值或者一組相關的resources,儘管在某些情況下兩者都可能存在。有關討論如何將Observations組合在一起的方法,請參閱下面的Notes小節。請注意,系統可能針對問卷調查的結果( QuestionnaireResponse)計算成一個最終的分數,並將這個分數表示為一個Observation。

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

目標resource為一種測量,此檢驗檢查就是從那個測量中得出。例如:陰離子間隙(an anion gap)或胎兒的測量值是從超音波影像計算而得。

Control0..*
TypeReference(DocumentReference|ImagingStudy|Media|QuestionnaireResponse|MolecularSequence|observation-vitalsigns)
Summarytrue
Comments

在這個資料項目中列出可以代表臨床檢檢查和其他測量的所有參照選項,可能是衍生值的來源。最常見參照另一個Observation,關於Observations如何組合在一起的討論,請參閱下面的Notes小節。

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

有有些檢驗檢查有多個組成之檢驗檢查,這些組成之檢驗檢查被表達為具有相同屬性的獨立的代碼值對(code value pair)。例子包括血壓測量的收縮壓和舒張壓即為組成之檢驗檢查(component observations),以及遺傳學檢驗檢查的多個組成之檢驗檢查。

Control0..*
TypeBackboneElement
Must Supporttrue
Summarytrue
Requirements

組成之檢驗檢查在Obsrvation resource中與主要檢驗檢查共享相同的屬性,並且總是被視為單個檢驗檢查的一部分(它們是不可分離的)。然而,主要檢驗檢查的參考範圍值並不被組成之檢驗檢查所繼承,在適當的時候需給予每項組成之檢驗檢查參考範圍值。

Comments

有關如何組合Observations的方法討論,請參閱下面的Notes小節。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
vs-3: If there is no a value a data absent reason must be present (: value.exists() or dataAbsentReason.exists())
59. Observation.component.id
Definition

resource中資料項目的唯一ID(用於內部參照)。這可以是任何不含空格的字串。

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
60. Observation.component.extension
Definition

可用於表示不屬於此資料項目基本定義的附加資訊。為了擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。

Control0..*
TypeExtension
Summaryfalse
Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
61. Observation.component.modifierExtension
Definition

可以用來表示不屬於資料項目的基本定義的附加資訊,並且修改對它所內嵌(contained)的資料項目的理解和(或)對包含資料項目之後續使用的理解。通常,修飾用的資料項目提供否定或限定。為了使擴充的使用安全和可管理,對擴充的定義和使用有一套嚴格的管理。儘管任何實作者都可以定義一個擴充,但作為擴充定義的一部分,有一套要求 必須(SHALL) 滿足。處理resource的應用程式被要求檢查修飾用的擴充資料項目。
修飾用的擴充資料項目 必須沒有(SHALL NOT) 改變resource或DomainResource上任何資料項目的含義(包括不能改變modifierExtension本身的含義)。

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

修飾用的資料項目擴充不能被忽略,它與絕大多數可以被忽略的資料項目擴充有所區別。透過不禁止實作者擴充存在的需求可促進可互操作性。若需要更多訊息,請參見修飾用的資料項目擴充之定義

Comments

無論使用或定義擴充的機構或管轄區,任何應用程式、專案或標準使用擴充都不背負任何污名(stigma)。使用擴充是允許FHIR規範為每個人保留一個核心的簡易性。

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
62. Observation.component.code
Definition

描述所觀察到的情況,有時這被稱為檢驗檢查「代碼」。

Control1..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from 生命體徵值集 代碼指明檢驗檢查的名稱;可參考生命體徵值集代碼表,但此代碼表只是針對這個欄位的一個可能值的示例,不預期也不鼓勵使用者一定要使用此代碼表的代碼
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

知道正在進行的是哪種檢驗檢查是理解檢驗檢查的關鍵

Comments

所有的code-value和component.code-component.value都需要考慮到,以正確理解檢驗檢查的意義。

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

如果資訊中帶有一個值(simple value)則其可作為檢驗檢查的結果。

Control0..1 This element is affected by the following invariants: vs-3
BindingThe codes SHALL be taken from VitalSignsUnits 用於記錄生命體徵的常用UCUM單元。;應填入VitalSignsUnits代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

通常一項檢驗檢查就會有一個值,雖然若它有錯誤或者它代表一組檢驗檢查可能不會有值。

Comments

一項檢驗檢查可能有一個值(如Apgar評分)和組成之檢驗檢查值(Apgar評分所來自多項檢驗檢查)。如果有一個值,這個資料項目的datatype應該由Observation.code決定。如果這個資料項目是編碼或者如果與Observation.code相關的type定義一個編碼值,那麼將使用只有文字表述的CodeableConcept來代替字串。若需要更多的說明,請參閱下面Notes小節。

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

提供資料項目Observation.component.value[x]中的預期值缺少的原因

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable 代碼指明為什麼結果(Observation.value[x])缺少;應填入DataAbsentReason代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeCodeableConcept(CodeableConceptTW)
Must Supporttrue
Requirements

對於許多結果,必須處理測量中的異常值。

Comments

空值(Null)或例外值可以在FHIR Observations中以兩種方式表示,一種方法是簡單地將它們含括在值集中,並在值中表示例外。例如:血清檢測的測量值可以是「檢測到」、「未檢測到」、「不確定」或「檢測未完成」。

另一種方法是使用資料項目value呈現實際檢驗檢查值,並使用資料項目dataAbsentReason來明確記錄例外值。例如:當測量沒有完成,可使用dataAbsentReason代碼「error」。請注意,只有在有值的情況下,才可以報告檢驗檢查。例如:只有在>0的情況下才可能報告細胞計數的差值。由於有這些選項,所以需要有使用案例協議(use-case agreements)來解釋一般檢驗檢查的例外值。

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

對一項檢驗檢查值的分類評估,例如:高、低、正常。

Control0..* This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable 用以指明檢驗檢查的解釋之代碼。應填入ObservationInterpretationCodes代碼表中適合的代碼,確定無適合的代碼才可以使用其他代碼中的代碼來表示
TypeCodeableConcept(CodeableConceptTW)
Requirements

對於某些結果,特別是數值結果,需有一個解釋以便完全理解結果之意義。

Alternate NamesAbnormal Flag
Comments

歷史上用於實驗室結果【被稱為 「異常標記(abnormal flag)」】,它的使用延伸到其他與編碼解釋有關的使用情況中。通常報告為一個或多個簡單的緊密碼(compact code,一種可以解譯且具有最小平均字長的唯一資料代碼),這個資料項目經常被放置在報告和流程表的結果值的旁邊,以表示結果的意義或正常狀態。

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

關於如何透過與正常值或建議範圍值的比較來解釋此值

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

知道什麼值被認為是「正常的」,可以幫助評估某一特定結果的意義。需要能夠為不同的情境提供多個參考範圍值。

Comments

大多數檢驗檢查只有一個通用的參考範圍值。系統 可能可以(MAY) 選擇限制只提供病人的相關參考範圍值(例如:具體的病人年齡、性別、體重和其他因素),但這可能是不可能的或也不合適。只要提供了一個以上的參考範圍值,就 建議應該(SHOULD) 提供不同年齡的參考範圍值差異。

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