Fujitsu Healthy Living Implementation Guide
1.1.28 - release

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Resource Profile: Fujitsu Observation Tumor Mutation Burden Profile

Official URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-observation-tumor-mutation-burden Version: 1.1.28
Active as of 2025-07-09 Computable Name: FujitsuObservationTumorMutationBurden

Copyright/Legal: Copyright 2022 FUJITSU LIMITED

This profile defines the Tumor Mutation Burden.
このプロファイルは、腫瘍突然変異負荷(TMB)を定義します。

Usage:

  • This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from TMB

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
... id 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta 0..1 Meta Metadata about the resource (リソースのメタデータ)
... implicitRules 0..0
... language 0..0
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... extension 0..* Extension Additional content defined by implementations (要素の拡張)
... extension:secondary-finding 0..0
... extension:body-structure 0..0
... modifierExtension 0..0
... identifier 0..* Identifier Business Identifier for observation (識別子)
... basedOn 0..0
... partOf 0..0
... status 1..1 code registered | preliminary | final | amended + (状態)
... category 1..* CodeableConcept Classification of type of observation (カテゴリ)
... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
.... id 0..0
.... extension 0..0
.... coding 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
..... display 1..1 string Representation defined by the system (カテゴリの種類の表示名)
..... userSelected 0..0
... code 1..1 CodeableConcept 94076-7 (検査名)
.... id 0..0
.... extension 0..0
.... coding 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display 1..1 string Representation defined by the system (検査の種類の表示名)
..... userSelected 0..0
... subject 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... id 0..0
.... extension 0..0
.... reference 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... type 0..0
.... identifier 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
.... display 0..0
... focus 0..0
... encounter 0..0
... effective[x] 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... issued 0..0
... performer 0..0
... value[x] 0..1 Quantity Actual result (結果)
... value[x]:valueQuantity 0..1 Quantity Actual result (結果)
.... id 0..0
.... extension 0..0
.... value 1..1 decimal Numerical value (with implicit precision) (測定値)
.... comparator 0..0
.... unit 1..1 string Unit representation (測定値の単位)
.... system 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
.... code 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason 0..1 CodeableConcept Why the result is missing (欠損理由)
... interpretation 0..0
... note 0..0
... bodySite 0..0
... method 0..0
... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... id 0..0
.... extension 0..0
.... reference 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... type 0..0
.... identifier 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
.... display 0..0
... device 0..0
... referenceRange 0..0
... hasMember 0..0
... derivedFrom 0..0
... component:conclusion-string 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... identifier Σ 0..* Identifier Business Identifier for observation (識別子)
... status ?!Σ 1..1 code registered | preliminary | final | amended + (状態)
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category 1..* CodeableConcept Classification of type of observation (カテゴリ)
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


..... extension 0..0
..... coding Σ 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)

Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
...... code Σ 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
...... display Σ 1..1 string Representation defined by the system (カテゴリの種類の表示名)
... code Σ 1..1 CodeableConcept 94076-7 (検査名)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 94076-7
.... extension 0..0
.... coding Σ 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... code Σ 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display Σ 1..1 string Representation defined by the system (検査の種類の表示名)
... subject Σ 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... effective[x] Σ 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... Slices for value[x] ΣC 0..1 Quantity Actual result (結果)
Slice: Unordered, Closed by type:$this
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result (結果)
Required Pattern: At least the following
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code Coded form of the unit
Fixed Value: 1/1000000{Base}
..... extension 0..0
..... value Σ 1..1 decimal Numerical value (with implicit precision) (測定値)
..... unit Σ 1..1 string Unit representation (測定値の単位)
Required Pattern: Mutations/Megabase
..... system ΣC 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
..... code Σ 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing (欠損理由)
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... Slices for component Σ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:labCategorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexamplePattern: LOINC code 94076-7
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:conclusion-string.codeexamplePattern: conclusion-string
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... identifier Σ 0..* Identifier Business Identifier for observation (識別子)
... status ?!Σ 1..1 code registered | preliminary | final | amended + (状態)
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category 1..* CodeableConcept Classification of type of observation (カテゴリ)
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


..... extension 0..0
..... coding Σ 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
...... code Σ 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
...... display Σ 1..1 string Representation defined by the system (カテゴリの種類の表示名)
..... text Σ 0..1 string Plain text representation of the concept
... code Σ 1..1 CodeableConcept 94076-7 (検査名)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 94076-7
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
.... extension 0..0
.... coding Σ 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... code Σ 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display Σ 1..1 string Representation defined by the system (検査の種類の表示名)
.... text Σ 0..1 string Plain text representation of the concept
... subject Σ 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... effective[x] Σ 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... Slices for value[x] ΣC 0..1 Quantity Actual result (結果)
Slice: Unordered, Closed by type:$this
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result (結果)
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... value 0..1 decimal Numerical value (with implicit precision)
..... comparator 0..1 code < | <= | >= | > - how to understand the value
..... unit 0..1 string Unit representation
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code Coded form of the unit
Fixed Value: 1/1000000{Base}
..... extension 0..0
..... value Σ 1..1 decimal Numerical value (with implicit precision) (測定値)
..... unit Σ 1..1 string Unit representation (測定値の単位)
Required Pattern: Mutations/Megabase
..... system ΣC 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
..... code Σ 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing (欠損理由)
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... Slices for component Σ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

..... value[x] Σ 0..1 Actual component result
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueRatio Ratio
...... valueSampledData SampledData
...... valueTime time
...... valueDateTime dateTime
...... valuePeriod Period
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:labCategorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexamplePattern: LOINC code 94076-7
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.component:conclusion-string.codeexamplePattern: conclusion-string
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:conclusion-string.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component:conclusion-string.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()

This structure is derived from TMB

Summary

Mandatory: 3 elements(9 nested mandatory elements)
Prohibited: 43 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from TMB

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
... id 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta 0..1 Meta Metadata about the resource (リソースのメタデータ)
... implicitRules 0..0
... language 0..0
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... extension 0..* Extension Additional content defined by implementations (要素の拡張)
... extension:secondary-finding 0..0
... extension:body-structure 0..0
... modifierExtension 0..0
... identifier 0..* Identifier Business Identifier for observation (識別子)
... basedOn 0..0
... partOf 0..0
... status 1..1 code registered | preliminary | final | amended + (状態)
... category 1..* CodeableConcept Classification of type of observation (カテゴリ)
... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
.... id 0..0
.... extension 0..0
.... coding 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
..... display 1..1 string Representation defined by the system (カテゴリの種類の表示名)
..... userSelected 0..0
... code 1..1 CodeableConcept 94076-7 (検査名)
.... id 0..0
.... extension 0..0
.... coding 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display 1..1 string Representation defined by the system (検査の種類の表示名)
..... userSelected 0..0
... subject 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... id 0..0
.... extension 0..0
.... reference 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... type 0..0
.... identifier 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
.... display 0..0
... focus 0..0
... encounter 0..0
... effective[x] 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... issued 0..0
... performer 0..0
... value[x] 0..1 Quantity Actual result (結果)
... value[x]:valueQuantity 0..1 Quantity Actual result (結果)
.... id 0..0
.... extension 0..0
.... value 1..1 decimal Numerical value (with implicit precision) (測定値)
.... comparator 0..0
.... unit 1..1 string Unit representation (測定値の単位)
.... system 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
.... code 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason 0..1 CodeableConcept Why the result is missing (欠損理由)
... interpretation 0..0
... note 0..0
... bodySite 0..0
... method 0..0
... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... id 0..0
.... extension 0..0
.... reference 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... type 0..0
.... identifier 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
.... display 0..0
... device 0..0
... referenceRange 0..0
... hasMember 0..0
... derivedFrom 0..0
... component:conclusion-string 0..0

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... identifier Σ 0..* Identifier Business Identifier for observation (識別子)
... status ?!Σ 1..1 code registered | preliminary | final | amended + (状態)
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category 1..* CodeableConcept Classification of type of observation (カテゴリ)
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


..... extension 0..0
..... coding Σ 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)

Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
...... code Σ 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
...... display Σ 1..1 string Representation defined by the system (カテゴリの種類の表示名)
... code Σ 1..1 CodeableConcept 94076-7 (検査名)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 94076-7
.... extension 0..0
.... coding Σ 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... code Σ 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display Σ 1..1 string Representation defined by the system (検査の種類の表示名)
... subject Σ 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... effective[x] Σ 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... Slices for value[x] ΣC 0..1 Quantity Actual result (結果)
Slice: Unordered, Closed by type:$this
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result (結果)
Required Pattern: At least the following
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code Coded form of the unit
Fixed Value: 1/1000000{Base}
..... extension 0..0
..... value Σ 1..1 decimal Numerical value (with implicit precision) (測定値)
..... unit Σ 1..1 string Unit representation (測定値の単位)
Required Pattern: Mutations/Megabase
..... system ΣC 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
..... code Σ 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing (欠損理由)
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... Slices for component Σ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:labCategorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexamplePattern: LOINC code 94076-7
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:conclusion-string.codeexamplePattern: conclusion-string
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* TMB Fujitsu Observation Tumor Mutation Burden Profile (腫瘍突然変異負荷(TMB)プロファイル)
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... identifier Σ 0..* Identifier Business Identifier for observation (識別子)
... status ?!Σ 1..1 code registered | preliminary | final | amended + (状態)
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category 1..* CodeableConcept Classification of type of observation (カテゴリ)
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:labCategory 1..1 CodeableConcept Classification of type of observation (検査カテゴリ)
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


..... extension 0..0
..... coding Σ 1..* Coding Code defined by a terminology system (カテゴリの種類を表すコード)

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (カテゴリの種類を定義するコード体系)
...... code Σ 1..1 code Symbol in syntax defined by the system (カテゴリの種類を表すコード値)
...... display Σ 1..1 string Representation defined by the system (カテゴリの種類の表示名)
..... text Σ 0..1 string Plain text representation of the concept
... code Σ 1..1 CodeableConcept 94076-7 (検査名)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 94076-7
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
.... extension 0..0
.... coding Σ 0..* Coding Code defined by a terminology system (検査の種類を表すコード)
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system (検査の種類を定義するコード体系)
..... code Σ 1..1 code Symbol in syntax defined by the system (検査の種類を表すコード値)
..... display Σ 1..1 string Representation defined by the system (検査の種類の表示名)
.... text Σ 0..1 string Plain text representation of the concept
... subject Σ 0..1 Reference(Fujitsu Patient Profile) Who and/or what the observation is about (患者)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... effective[x] Σ 0..1 dateTime Clinically relevant time/time-period for observation (検査日)
... Slices for value[x] ΣC 0..1 Quantity Actual result (結果)
Slice: Unordered, Closed by type:$this
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result (結果)
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... value 0..1 decimal Numerical value (with implicit precision)
..... comparator 0..1 code < | <= | >= | > - how to understand the value
..... unit 0..1 string Unit representation
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code Coded form of the unit
Fixed Value: 1/1000000{Base}
..... extension 0..0
..... value Σ 1..1 decimal Numerical value (with implicit precision) (測定値)
..... unit Σ 1..1 string Unit representation (測定値の単位)
Required Pattern: Mutations/Megabase
..... system ΣC 1..1 uri System that defines coded unit form (単位形式を定義するコード体系)
..... code Σ 1..1 code Coded form of the unit (単位を表すコード値)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing (欠損理由)
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... specimen 0..1 Reference(Fujitsu Specimen Profile) Specimen used for this observation (検体)
.... extension 0..0
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL (相対URLのリテラル参照)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known (データ取り込みで使用する論理参照)
... Slices for component Σ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

..... value[x] Σ 0..1 Actual component result
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueRatio Ratio
...... valueSampledData SampledData
...... valueTime time
...... valueDateTime dateTime
...... valuePeriod Period
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:labCategorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexamplePattern: LOINC code 94076-7
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.component:conclusion-string.codeexamplePattern: conclusion-string
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:conclusion-string.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component:conclusion-string.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()

This structure is derived from TMB

Summary

Mandatory: 3 elements(9 nested mandatory elements)
Prohibited: 43 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron