WHO Digital Documentation of COVID-19 Certificates (DDCC)
1.0.0 - CI Build International flag

This is the continuous build for version 1.0.0. This version is based on the current content of https://github.com/WorldHealthOrganization/ddcc and changes regularly.

Resource Profile: DDCC Observation

Official URL: http://smart.who.int/ddcc/StructureDefinition/DDCCObservation Version: 1.0.0
Draft as of 2024-01-19 Computable Name: DDCCObservation

A DDCC Observation contains the content corresponding to a row in the Test Events section of a Paper DDCC. While this is not a further profile of the International Patient Summary (IPS) Observation resouce, this is intended to map into an IPS Observation resource.

Usage:

Formal Views of Profile Content

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

This structure is derived from ObservationResultsLaboratoryUvIps

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation ObservationResultsLaboratoryUvIps
... category 1..*CodeableConceptIPSConcept - reference to a terminology or just text
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
... code 1..1CodeableConceptIPSConcept - reference to a terminology or just text
... effective[x] 1..1dateTimeClinically relevant time/time-period for observation
... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationResultsLaboratoryUvIpsLaboratory result for a simple test or for a panel/study
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.


Fixed Value: final
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
.... category:laboratory S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
... code S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Laboratory Observation - IPS (preferred)
... subject SΣ1..1Reference(Patient (IPS) | Group | Device | Location)Who and/or what the observation is about
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
... effective[x] SΣ1..1dateTimeClinically relevant time/time-period for observation
.... data-absent-reason S0..1codeeffective[x] absence reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing.


... performer SΣ1..*Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)Who is responsible for the observation
... Slices for value[x] SΣC1..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this
.... value[x]:valueString SΣC0..1stringActual result
.... value[x]:valueRange SC0..1RangeIPSSet of values bounded by low and high
.... value[x]:valueRatio SC0..1RatioIPSA ratio of two Quantity values - a numerator and a denominator
.... value[x]:valueTime SΣC0..1timeActual result
.... value[x]:valueDateTime SΣC0..1dateTimeActual result
.... value[x]:valuePeriod SΣC0..1PeriodActual result
.... value[x]:valueQuantity SC0..1QuantityIPSA measured amount using UCUM
.... value[x]:valueCodeableConcept S0..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Coded Values Laboratory - IPS (preferred)
Additional BindingsPurpose
Results Blood Group - SNOMED CT IPS Free Setcandidate
Results Presence Absence - SNOMED CT IPS Free Setcandidate
Results Microorganism - SNOMED CT IPS Free Setcandidate
... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)
... component SΣ0..*BackboneElementComponent results
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredFixed Value: final
Observation.categorypreferredPattern: laboratory
Observation.category:laboratorypreferredPattern: laboratory
Observation.codepreferredResultsLaboratoryObservationUvIps
Observation.value[x]:valueCodeableConceptpreferredResultsCodedValuesLaboratoryUvIps
Additional Bindings Purpose Documentation
Results Blood Group - SNOMED CT IPS Free Set candidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Set candidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Set candidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ips-2errorObservationif no "hasMember" element is present then Observation must have a" value"
: value.exists() or hasMember.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3errorObservation.value[x]:valueQuantityIf a code for the unit is present, the system SHALL also be present
: code.empty() or system.exists()
rat-1errorObservation.value[x]:valueRatioNumerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
: (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2errorObservation.value[x]:valueRangeIf present, low SHALL have a lower value than high
: low.empty() or high.empty() or (low <= high)
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationResultsLaboratoryUvIpsLaboratory result for a simple test or for a panel/study
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!Σ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.


Fixed Value: final
... Slices for category 1..*CodeableConceptIPSConcept - reference to a terminology or just text
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
..... display0..1stringRepresentation defined by the system
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
.... category:laboratory S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Laboratory Observation - IPS (preferred)
... subject SΣ1..1Reference(Patient (IPS) | Group | Device | Location)Who and/or what the observation is about
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ1..1dateTimeClinically relevant time/time-period for observation
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... data-absent-reason S0..1codeeffective[x] absence reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing.


... issued Σ0..1instantDate/Time this version was made available
... performer SΣ1..*Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)Who is responsible for the observation
... Slices for value[x] SΣC1..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this
.... value[x]:valueString SΣC0..1stringActual result
.... value[x]:valueRange SC0..1RangeIPSSet of values bounded by low and high
.... value[x]:valueRatio SC0..1RatioIPSA ratio of two Quantity values - a numerator and a denominator
.... value[x]:valueTime SΣC0..1timeActual result
.... value[x]:valueDateTime SΣC0..1dateTimeActual result
.... value[x]:valuePeriod SΣC0..1PeriodActual result
.... value[x]:valueQuantity SC0..1QuantityIPSA measured amount using UCUM
.... value[x]:valueCodeableConcept S0..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Coded Values Laboratory - IPS (preferred)
Additional BindingsPurpose
Results Blood Group - SNOMED CT IPS Free Setcandidate
Results Presence Absence - SNOMED CT IPS Free Setcandidate
Results Microorganism - SNOMED CT IPS Free Setcandidate
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)
... specimen 0..1Reference(Specimen (IPS))Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation Results: laboratory (IPS) | Observation Results (IPS))Related resource that belongs to the Observation group
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component SΣ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredFixed Value: final
Observation.categorypreferredPattern: laboratory
Observation.category:laboratorypreferredPattern: laboratory
Observation.codepreferredResultsLaboratoryObservationUvIps
Observation.subject.typeextensibleResourceType
Observation.value[x]:valueCodeableConceptpreferredResultsCodedValuesLaboratoryUvIps
Additional Bindings Purpose Documentation
Results Blood Group - SNOMED CT IPS Free Set candidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Set candidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Set candidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.hasMember.typeextensibleResourceType
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ips-2errorObservationif no "hasMember" element is present then Observation must have a" value"
: value.exists() or hasMember.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3errorObservation.value[x]:valueQuantityIf a code for the unit is present, the system SHALL also be present
: code.empty() or system.exists()
rat-1errorObservation.value[x]:valueRatioNumerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
: (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2errorObservation.value[x]:valueRangeIf present, low SHALL have a lower value than high
: low.empty() or high.empty() or (low <= high)

This structure is derived from ObservationResultsLaboratoryUvIps

Summary

Mandatory: 1 element
Must-Support: 1 element

Differential View

This structure is derived from ObservationResultsLaboratoryUvIps

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation ObservationResultsLaboratoryUvIps
... category 1..*CodeableConceptIPSConcept - reference to a terminology or just text
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
... code 1..1CodeableConceptIPSConcept - reference to a terminology or just text
... effective[x] 1..1dateTimeClinically relevant time/time-period for observation
... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationResultsLaboratoryUvIpsLaboratory result for a simple test or for a panel/study
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.


Fixed Value: final
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
.... category:laboratory S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
... code S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Laboratory Observation - IPS (preferred)
... subject SΣ1..1Reference(Patient (IPS) | Group | Device | Location)Who and/or what the observation is about
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
... effective[x] SΣ1..1dateTimeClinically relevant time/time-period for observation
.... data-absent-reason S0..1codeeffective[x] absence reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing.


... performer SΣ1..*Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)Who is responsible for the observation
... Slices for value[x] SΣC1..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this
.... value[x]:valueString SΣC0..1stringActual result
.... value[x]:valueRange SC0..1RangeIPSSet of values bounded by low and high
.... value[x]:valueRatio SC0..1RatioIPSA ratio of two Quantity values - a numerator and a denominator
.... value[x]:valueTime SΣC0..1timeActual result
.... value[x]:valueDateTime SΣC0..1dateTimeActual result
.... value[x]:valuePeriod SΣC0..1PeriodActual result
.... value[x]:valueQuantity SC0..1QuantityIPSA measured amount using UCUM
.... value[x]:valueCodeableConcept S0..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Coded Values Laboratory - IPS (preferred)
Additional BindingsPurpose
Results Blood Group - SNOMED CT IPS Free Setcandidate
Results Presence Absence - SNOMED CT IPS Free Setcandidate
Results Microorganism - SNOMED CT IPS Free Setcandidate
... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)
... component SΣ0..*BackboneElementComponent results
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredFixed Value: final
Observation.categorypreferredPattern: laboratory
Observation.category:laboratorypreferredPattern: laboratory
Observation.codepreferredResultsLaboratoryObservationUvIps
Observation.value[x]:valueCodeableConceptpreferredResultsCodedValuesLaboratoryUvIps
Additional Bindings Purpose Documentation
Results Blood Group - SNOMED CT IPS Free Set candidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Set candidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Set candidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ips-2errorObservationif no "hasMember" element is present then Observation must have a" value"
: value.exists() or hasMember.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3errorObservation.value[x]:valueQuantityIf a code for the unit is present, the system SHALL also be present
: code.empty() or system.exists()
rat-1errorObservation.value[x]:valueRatioNumerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
: (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2errorObservation.value[x]:valueRangeIf present, low SHALL have a lower value than high
: low.empty() or high.empty() or (low <= high)

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationResultsLaboratoryUvIpsLaboratory result for a simple test or for a panel/study
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!Σ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.


Fixed Value: final
... Slices for category 1..*CodeableConceptIPSConcept - reference to a terminology or just text
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
..... display0..1stringRepresentation defined by the system
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
.... category:laboratory S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code S1..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Laboratory Observation - IPS (preferred)
... subject SΣ1..1Reference(Patient (IPS) | Group | Device | Location)Who and/or what the observation is about
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ1..1dateTimeClinically relevant time/time-period for observation
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... data-absent-reason S0..1codeeffective[x] absence reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing.


... issued Σ0..1instantDate/Time this version was made available
... performer SΣ1..*Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)Who is responsible for the observation
... Slices for value[x] SΣC1..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this
.... value[x]:valueString SΣC0..1stringActual result
.... value[x]:valueRange SC0..1RangeIPSSet of values bounded by low and high
.... value[x]:valueRatio SC0..1RatioIPSA ratio of two Quantity values - a numerator and a denominator
.... value[x]:valueTime SΣC0..1timeActual result
.... value[x]:valueDateTime SΣC0..1dateTimeActual result
.... value[x]:valuePeriod SΣC0..1PeriodActual result
.... value[x]:valueQuantity SC0..1QuantityIPSA measured amount using UCUM
.... value[x]:valueCodeableConcept S0..1CodeableConceptIPSConcept - reference to a terminology or just text
Binding: Results Coded Values Laboratory - IPS (preferred)
Additional BindingsPurpose
Results Blood Group - SNOMED CT IPS Free Setcandidate
Results Presence Absence - SNOMED CT IPS Free Setcandidate
Results Microorganism - SNOMED CT IPS Free Setcandidate
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptIPSConcept - reference to a terminology or just text
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method S0..1CodeableConceptHow it was done
Binding: WHO Speciman Sample Origin (COVID-19) (required)
... specimen 0..1Reference(Specimen (IPS))Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation Results: laboratory (IPS) | Observation Results (IPS))Related resource that belongs to the Observation group
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC0..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component SΣ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredFixed Value: final
Observation.categorypreferredPattern: laboratory
Observation.category:laboratorypreferredPattern: laboratory
Observation.codepreferredResultsLaboratoryObservationUvIps
Observation.subject.typeextensibleResourceType
Observation.value[x]:valueCodeableConceptpreferredResultsCodedValuesLaboratoryUvIps
Additional Bindings Purpose Documentation
Results Blood Group - SNOMED CT IPS Free Set candidate

Additional conformance binding to a blood group findings value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Presence Absence - SNOMED CT IPS Free Set candidate

Additional conformance binding to a presence and absence findings (qualifier values) value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Results Microorganism - SNOMED CT IPS Free Set candidate

Additional conformance binding to a microorganisms value set for laboratory result values from the SNOMED CT IPS free set for use globally (in SNOMED member and non-member jurisdictions).

Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodrequiredWHO_DDCC_Sample_Origin_COVID_19
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.hasMember.typeextensibleResourceType
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ips-2errorObservationif no "hasMember" element is present then Observation must have a" value"
: value.exists() or hasMember.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3errorObservation.value[x]:valueQuantityIf a code for the unit is present, the system SHALL also be present
: code.empty() or system.exists()
rat-1errorObservation.value[x]:valueRatioNumerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
: (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2errorObservation.value[x]:valueRangeIf present, low SHALL have a lower value than high
: low.empty() or high.empty() or (low <= high)

This structure is derived from ObservationResultsLaboratoryUvIps

Summary

Mandatory: 1 element
Must-Support: 1 element

 

Other representations of profile: CSV, Excel, Schematron