This page is part of the WHO Digital Documentation of COVID-19 Certificates (DDCC) (v1.0.0: releases Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
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Resource Profile: DDCC Observation

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:

• Use this Resource Profile: DDCC:VS Document
• Refer to this Resource Profile: DDCC Diagnostic Report and DDCC:TR Composition

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 ObservationResultsLaboratoryUvIps

Name	Flags	Card.	Type	Description & Constraints
Observation			ObservationResultsLaboratoryUvIps
category		1..*	CodeableConceptIPS	Concept - reference to a terminology or just text 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://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text
effective[x]		1..1	dateTime	Clinically relevant time/time-period for observation
value[x]		1..1	CodeableConcept	Actual result
method	S	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.method	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryUvIps	Laboratory result for a simple test or for a panel/study 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 ips-2: if no "hasMember" element is present then Observation must have a" value"
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. Fixed Value: final
Slices for category		1..*	CodeableConceptIPS	Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:laboratory	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred)
subject	SΣ	1..1	Reference(Patient (IPS) | Group | Device | Location)	Who and/or what the observation is about
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]	SΣ	1..1	dateTime	Clinically relevant time/time-period for observation
Slices for extension				Content/Rules for all slices
data-absent-reason	S	0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
performer	SΣ	1..*	Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	1..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString	SΣC	0..1	string	Actual result
value[x]:valueRange	SC	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	SC	0..1	RatioIPS	A ratio of two Quantity values - a numerator and a denominator rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
value[x]:valueTime	SΣC	0..1	time	Actual result
value[x]:valueDateTime	SΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	SΣC	0..1	Period	Actual result
value[x]:valueQuantity	SC	0..1	QuantityIPS	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept	S	0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
method	S	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
component	SΣ	0..*	BackboneElement	Component results
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	preferred	ResultsLaboratoryObservationUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.value[x]:valueCodeableConcept	preferred	ResultsCodedValuesLaboratoryUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.method	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes 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()
ips-2	error	Observation	if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.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()
qty-3	error	Observation.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio	Numerator 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-2	error	Observation.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryUvIps	Laboratory result for a simple test or for a panel/study 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 ips-2: if no "hasMember" element is present then Observation must have a" value"
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. Fixed Value: final
Slices for category		1..*	CodeableConceptIPS	Concept - 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
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://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laboratory	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text 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: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred)
subject	SΣ	1..1	Reference(Patient (IPS) | Group | Device | Location)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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	1..1	dateTime	Clinically relevant time/time-period for observation
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
data-absent-reason	S	0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	1..*	Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	1..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString	SΣC	0..1	string	Actual result
value[x]:valueRange	SC	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	SC	0..1	RatioIPS	A ratio of two Quantity values - a numerator and a denominator rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
value[x]:valueTime	SΣC	0..1	time	Actual result
value[x]:valueDateTime	SΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	SΣC	0..1	Period	Actual result
value[x]:valueQuantity	SC	0..1	QuantityIPS	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept	S	0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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..*	CodeableConceptIPS	Concept - reference to a terminology or just text 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	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
specimen		0..1	Reference(Specimen (IPS))	Specimen used for this observation
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 Results: laboratory (IPS) | Observation Results (IPS))	Related resource that belongs to the Observation group
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	SΣ	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 / 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	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	preferred	ResultsLaboratoryObservationUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	preferred	ResultsCodedValuesLaboratoryUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
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	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG
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.hasMember.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types 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()
ips-2	error	Observation	if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.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()
qty-3	error	Observation.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio	Numerator 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-2	error	Observation.value[x]:valueRange	If 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

Name	Flags	Card.	Type	Description & Constraints
Observation			ObservationResultsLaboratoryUvIps
category		1..*	CodeableConceptIPS	Concept - reference to a terminology or just text 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://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text
effective[x]		1..1	dateTime	Clinically relevant time/time-period for observation
value[x]		1..1	CodeableConcept	Actual result
method	S	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.method	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryUvIps	Laboratory result for a simple test or for a panel/study 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 ips-2: if no "hasMember" element is present then Observation must have a" value"
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. Fixed Value: final
Slices for category		1..*	CodeableConceptIPS	Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:laboratory	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
code	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred)
subject	SΣ	1..1	Reference(Patient (IPS) | Group | Device | Location)	Who and/or what the observation is about
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]	SΣ	1..1	dateTime	Clinically relevant time/time-period for observation
Slices for extension				Content/Rules for all slices
data-absent-reason	S	0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
performer	SΣ	1..*	Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	1..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString	SΣC	0..1	string	Actual result
value[x]:valueRange	SC	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	SC	0..1	RatioIPS	A ratio of two Quantity values - a numerator and a denominator rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
value[x]:valueTime	SΣC	0..1	time	Actual result
value[x]:valueDateTime	SΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	SΣC	0..1	Period	Actual result
value[x]:valueQuantity	SC	0..1	QuantityIPS	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept	S	0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
method	S	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
component	SΣ	0..*	BackboneElement	Component results
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	preferred	ResultsLaboratoryObservationUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.value[x]:valueCodeableConcept	preferred	ResultsCodedValuesLaboratoryUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.method	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes 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()
ips-2	error	Observation	if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.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()
qty-3	error	Observation.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio	Numerator 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-2	error	Observation.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryUvIps	Laboratory result for a simple test or for a panel/study 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 ips-2: if no "hasMember" element is present then Observation must have a" value"
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. Fixed Value: final
Slices for category		1..*	CodeableConceptIPS	Concept - 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
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://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
category:laboratory	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text 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: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	S	1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred)
subject	SΣ	1..1	Reference(Patient (IPS) | Group | Device | Location)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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	1..1	dateTime	Clinically relevant time/time-period for observation
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
data-absent-reason	S	0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	1..*	Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣC	1..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString	SΣC	0..1	string	Actual result
value[x]:valueRange	SC	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	SC	0..1	RatioIPS	A ratio of two Quantity values - a numerator and a denominator rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
value[x]:valueTime	SΣC	0..1	time	Actual result
value[x]:valueDateTime	SΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	SΣC	0..1	Period	Actual result
value[x]:valueQuantity	SC	0..1	QuantityIPS	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept	S	0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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..*	CodeableConceptIPS	Concept - reference to a terminology or just text 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	0..1	CodeableConcept	How it was done Binding: WHO Speciman Sample Origin (COVID-19) (required)
specimen		0..1	Reference(Specimen (IPS))	Specimen used for this observation
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 Results: laboratory (IPS) | Observation Results (IPS))	Related resource that belongs to the Observation group
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	SΣ	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 / 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	Fixed Value: final http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	preferred	ResultsLaboratoryObservationUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	preferred	ResultsCodedValuesLaboratoryUvIps http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
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	required	WHODDCCSampleOriginCOVID19 http://smart.who.int/ddcc/ValueSet/WHODDCCSampleOriginCOVID19 from this IG
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.hasMember.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types 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()
ips-2	error	Observation	if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.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()
qty-3	error	Observation.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio	Numerator 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-2	error	Observation.value[x]:valueRange	If 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