This page is part of the 臺灣癌症用藥事前審查實作指引(TWPAS IG) (v0.1.1: Releases) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 1.0.4. For a full list of available versions, see the Directory of published versions

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Resource Profile: 基因資訊-Observation Diagnostic TWPAS

此基因資訊-Observation Diagnostic TWPAS Profile說明本IG如何進一步定義FHIR的Observation Resource以呈現癌藥事前審查之基因資訊

Usage:

• Use this Resource Profile: 事前審查-Bundle TWPAS
• Refer to this Resource Profile: 事前審查-Claim TWPAS
• Examples for this Resource Profile: Observation/obs-diagnostic-min

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation			Observation
category		1..1	CodeableConcept	因FHIR設計而需必填 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
code		1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
coding		1..1	Coding	Code defined by a terminology system
code	S	1..1	code	Symbol in syntax defined by the system
subject	S	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
effective[x]	S	0..1	dateTime	基因檢測日期
performer	S	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	S	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
coding	S	1..1	Coding	Code defined by a terminology system
code	S	1..1	code	Symbol in syntax defined by the system
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
derivedFrom	S	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Closed by pattern:code
component:All Slices				Content/Rules for all slices
code	S	1..1	CodeableConcept	Type of component observation (code / type)
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result
component:gene-test-code	S	0..1	BackboneElement	基因檢測代碼
code		1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINC-基因檢測代碼值集 (required)
coding		1..1	Coding	Code defined by a terminology system
component:coding-change-type	S	0..1	BackboneElement	基因突變類型
code		1..1	CodeableConcept	48019-4 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: 48019-4
coding		1..1	Coding	Code defined by a terminology system
value[x]		1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		1..1	CodeableConcept	因FHIR設計而需必填 Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
code	Σ	1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
coding	Σ	1..1	Coding	Code defined by a terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
subject	SΣ	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
effective[x]	SΣ	0..1	dateTime	基因檢測日期
performer	SΣ	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	SΣC	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
coding	SΣ	1..1	Coding	Code defined by a terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
derivedFrom	SΣ	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Closed by pattern:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	SΣ	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
component:gene-test-code	SΣ	0..1	BackboneElement	基因檢測代碼
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINC-基因檢測代碼值集 (required)
coding	Σ	1..1	Coding	Code defined by a terminology system
component:coding-change-type	SΣ	0..1	BackboneElement	基因突變類型
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	48019-4 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: 48019-4
coding	Σ	1..1	Coding	Code defined by a terminology system
value[x]	Σ	1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: companionDiagnostics http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: LOINC Code 69548-6 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:coding-change-type.code	example	Pattern: LOINC Code 48019-4 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions 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
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		1..1	CodeableConcept	因FHIR設計而需必填 Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
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
code	Σ	1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣ	0..1	dateTime	基因檢測日期
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	SΣC	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	SΣ	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Closed 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	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	SΣ	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
component:gene-test-code	SΣ	0..1	BackboneElement	基因檢測代碼
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: LOINC-基因檢測代碼值集 (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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
component:coding-change-type	SΣ	0..1	BackboneElement	基因突變類型
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	48019-4 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: 48019-4
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: companionDiagnostics http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: LOINC Code 69548-6 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:gene-test-code.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:gene-test-code.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:coding-change-type.code	example	Pattern: LOINC Code 48019-4 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG
Observation.component:coding-change-type.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:coding-change-type.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

This structure is derived from Observation

Summary

Mandatory: 5 elements(5 nested mandatory elements)
Must-Support: 15 elements

Structures

This structure refers to these other structures:

• 病人資訊-Patient TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Patient-twpas)
• 機構-Organization TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Organization-twpas)
• 基因檢測檢體-Specimen TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Specimen-twpas)
• 文件參照-DocumentReference TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/DocumentReference-twpas)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.component (Closed)

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation			Observation
category		1..1	CodeableConcept	因FHIR設計而需必填 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
code		1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
coding		1..1	Coding	Code defined by a terminology system
code	S	1..1	code	Symbol in syntax defined by the system
subject	S	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
effective[x]	S	0..1	dateTime	基因檢測日期
performer	S	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	S	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
coding	S	1..1	Coding	Code defined by a terminology system
code	S	1..1	code	Symbol in syntax defined by the system
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
derivedFrom	S	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Closed by pattern:code
component:All Slices				Content/Rules for all slices
code	S	1..1	CodeableConcept	Type of component observation (code / type)
value[x]	S	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result
component:gene-test-code	S	0..1	BackboneElement	基因檢測代碼
code		1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINC-基因檢測代碼值集 (required)
coding		1..1	Coding	Code defined by a terminology system
component:coding-change-type	S	0..1	BackboneElement	基因突變類型
code		1..1	CodeableConcept	48019-4 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: 48019-4
coding		1..1	Coding	Code defined by a terminology system
value[x]		1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		1..1	CodeableConcept	因FHIR設計而需必填 Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
code	Σ	1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
coding	Σ	1..1	Coding	Code defined by a terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
subject	SΣ	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
effective[x]	SΣ	0..1	dateTime	基因檢測日期
performer	SΣ	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	SΣC	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
coding	SΣ	1..1	Coding	Code defined by a terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
derivedFrom	SΣ	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Closed by pattern:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	SΣ	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
component:gene-test-code	SΣ	0..1	BackboneElement	基因檢測代碼
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINC-基因檢測代碼值集 (required)
coding	Σ	1..1	Coding	Code defined by a terminology system
component:coding-change-type	SΣ	0..1	BackboneElement	基因突變類型
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	48019-4 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: 48019-4
coding	Σ	1..1	Coding	Code defined by a terminology system
value[x]	Σ	1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: companionDiagnostics http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: LOINC Code 69548-6 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:coding-change-type.code	example	Pattern: LOINC Code 48019-4 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions 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
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		1..1	CodeableConcept	因FHIR設計而需必填 Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: https://nhicore.nhi.gov.tw/pas/CodeSystem/nhi-supporting-info-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: companionDiagnostics
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
code	Σ	1..1	CodeableConcept	Type of observation (code / type) 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: 69548-6
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(病人資訊-Patient TWPAS)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣ	0..1	dateTime	基因檢測日期
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..*	Reference(機構-Organization TWPAS)	基因檢測機構，衛福部公告名冊或LDTs核定函上之「案件編號」
value[x]	SΣC	0..1	CodeableConcept	基因檢測分析結果，Indeterminate | No call | Present | Absent Binding: LOINC Answer List LL1971-2 (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	S	0..*	CodeableConcept	基因臨床判讀結果，醫師判讀結果，Positive | Negative | Not Determined Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	1..1	CodeableConcept	基因檢測方法 Binding: LOINC Answer List LL4048-6 (extensible)
specimen	S	0..1	Reference(基因檢測檢體-Specimen TWPAS)	基因檢測檢體類型
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	SΣ	0..*	Reference(文件參照-DocumentReference TWPAS)	基因報告
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Closed 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	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	SΣ	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
component:gene-test-code	SΣ	0..1	BackboneElement	基因檢測代碼
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: LOINC-基因檢測代碼值集 (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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
component:coding-change-type	SΣ	0..1	BackboneElement	基因突變類型
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	48019-4 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: 48019-4
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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	1..1	CodeableConcept	LA6692-3: Deletion | LA6686-5: Duplication | LA6687-3: Insertion | LA6688-1: Insertion/Deletion (indel) | LA6689-9: Inversion | LA6690-7: Substitution Binding: LOINC-基因突變類型值集 (required)
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: companionDiagnostics http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	example	Pattern: LOINC Code 69548-6 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]	required	LOINC LL1971-2 http://loinc.org/vs/LL1971-2
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	extensible	LOINC LL4048-6 http://loinc.org/vs/LL4048-6
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:gene-test-code.code	required	GeneTestCode https://nhicore.nhi.gov.tw/pas/ValueSet/gene-test-code from this IG
Observation.component:gene-test-code.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:gene-test-code.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:coding-change-type.code	example	Pattern: LOINC Code 48019-4 http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:coding-change-type.value[x]	required	DNAChangeType https://nhicore.nhi.gov.tw/pas/ValueSet/dna-change-type from this IG
Observation.component:coding-change-type.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:coding-change-type.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	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	error	Observation	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	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	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()

This structure is derived from Observation

Summary

Mandatory: 5 elements(5 nested mandatory elements)
Must-Support: 15 elements

Structures

This structure refers to these other structures:

• 病人資訊-Patient TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Patient-twpas)
• 機構-Organization TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Organization-twpas)
• 基因檢測檢體-Specimen TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/Specimen-twpas)
• 文件參照-DocumentReference TWPAS (https://nhicore.nhi.gov.tw/pas/StructureDefinition/DocumentReference-twpas)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.component (Closed)