IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions

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Resource Profile: Observation: test results

This profile constrains the Observation resource to represent test results for the purpose of the IDEA4RC project.

Usages:

• Refer to this Profile: Condition: Primary Cancer
• Examples for this Profile: Observation/observation-id-31, Observation/observation-id-32, Observation/observation-id-33, Observation/observation-id-34 and Observation/observation-id-35

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7, obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure: Surgery | 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.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject	Σ	1..1	Reference(Patient: IDEA4RC)	Who and/or what the observation is about
Slices for value[x]	ΣC	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 From the FHIR Standard
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs 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()
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
partOf		0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure: Surgery | Immunization | ImagingStudy)	Part of referenced event
code		1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject		1..1	Reference(Patient: IDEA4RC)	Who and/or what the observation is about
Slices for value[x]		1..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity		0..1	Quantity	Actual result
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs From this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7, obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: Surgery | 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		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject	Σ	1..1	Reference(Patient: IDEA4RC)	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]	Σ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	ΣC	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result
dataAbsentReason	C	0..1	CodeableConcept	Why the 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.
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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
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	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 From the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category From the FHIR Standard
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs From this IG
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	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods From the FHIR Standard
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

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()
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

This structure is derived from Observation

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

• Procedure: Surgery (http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Procedure-surgery-eu-i4rc)
• Patient: IDEA4RC (http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/patient-eu-i4rc)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.value[x]

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7, obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure: Surgery | 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.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject	Σ	1..1	Reference(Patient: IDEA4RC)	Who and/or what the observation is about
Slices for value[x]	ΣC	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 From the FHIR Standard
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs 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()
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
partOf		0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure: Surgery | Immunization | ImagingStudy)	Part of referenced event
code		1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject		1..1	Reference(Patient: IDEA4RC)	Who and/or what the observation is about
Slices for value[x]		1..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity		0..1	Quantity	Actual result
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs From this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7, obs-valueOftype-quantity, obs-valueOftype-codeable, obs-valueMemberof-mitotic, obs-valueMemberof-positiveNegativeNoTest
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: Surgery | 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		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Simple measures (required)
subject	Σ	1..1	Reference(Patient: IDEA4RC)	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]	Σ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	ΣC	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Coded test results: Athena. (example)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result
dataAbsentReason	C	0..1	CodeableConcept	Why the 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.
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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
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	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 From the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category From the FHIR Standard
Observation.code	required	VsSimpleResultI4rc http://hl7.eu/fhir/ig/idea4rc/ValueSet/simpleResult-eu-i4rc From this IG
Observation.value[x]:valueCodeableConcept	example	CodedTestResultsVS http://hl7.eu/fhir/ig/idea4rc/ValueSet/coded-test-results-athena-vs From this IG
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	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods From the FHIR Standard
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

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()
obs-valueMemberof-mitotic	warning	Observation	If the type is Mitotic index than the value is in Mitotic Index: Athena : (code = '4099595') implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/mitotic-index-athena-vs).exists()
obs-valueMemberof-positiveNegativeNoTest	warning	Observation	If the type is 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is in PositiveNegativeNoTestVS : ( (code = '3043849') or (code = '46236082') or (code = '3000965') ) implies value.memberOf(http://hl7.eu/fhir/ig/idea4rc/ValueSet/positive-negative-notest-athena-vs).exists()
obs-valueOftype-codeable	warning	Observation	If the type is 'Mitotic index' or 'Epstein Barr virus DNA [Units/volume] (viral load) in Serum or Plasma by NAA with probe detection' or 'Human papilloma virus 16 and 18 and 31+33+35+39+45+51+52+56+58+59+66+68 DNA [Interpretation] in Specimen' or 'C reactive protein [Presence] in Serum or Plasma' then the value is a CodeableConcept : ((code = '4099595') or (code = '3043849') or (code = '46236082') or (code = 3000965) ) implies value.ofType(CodeableConcept).exists()
obs-valueOftype-quantity	warning	Observation	If the type is 'Dimension of tumor' or 'Number of mitoses per 10 high power fields' or 'Invasion into the fascia then the value is a Quantity' : ((code = '36768664') or (code = '4227243') or or (code = '36768749')) implies value.ofType(Quantity).exists()

This structure is derived from Observation

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

• Procedure: Surgery (http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Procedure-surgery-eu-i4rc)
• Patient: IDEA4RC (http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/patient-eu-i4rc)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.value[x]

Other representations of profile: CSV, Excel, Schematron