SMART Health Cards: Vaccination & Testing Implementation Guide, published by HL7 International / Public Health. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-shc-vaccination-ig/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• JSON

Resource Profile: COVID-19 Laboratory Result Observation Profile - Allowable Data

Defines a fallback (AD) profile representing a laboratory testing result for COVID-19 in a health card.

See here for implementation details.

Usage:

• Derived from this Resource Profile: COVID-19 Laboratory Result Observation Profile - Data Minimization
• Use this Resource Profile: COVID-19-specific Laboratory Test Results Bundle - Allowable Data

Formal Views of Profile Content

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

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

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation			Observation
id		0..1	id	Should not be populated
meta	S	0..1	Meta	Metadata about the resource
security	S	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
status	S	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	S	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
reference		1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
type		0..0
identifier		0..0
display		0..0
effective[x]	S	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
performer	S	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
display	SC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	S	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	C	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	C	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:specimen-supervision-status	S	0..1	BackboneElement	Component results
code
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
Slices for value[x]		1..1	CodeableConcept	Actual component result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept		1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
extension		0..0
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system
code		1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
id	Σ	0..1	id	Should not be populated
meta	SΣ	0..1	Meta	Metadata about the resource
security	SΣ	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	SΣ	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
reference	ΣC	1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x]	SΣ	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
performer	SΣ	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
display	SΣC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	SΣC	1..1		Actual result Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	ΣC	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. obs-3: Must have at least a low or a high or text vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
component:specimen-supervision-status	SΣ	0..1	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.
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code	Σ	1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	Σ	1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
extension		0..0
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system
code	Σ	1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-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()
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
id	Σ	0..1	id	Should not be populated
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	SΣ	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
category		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	SΣ	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
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	1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
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		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
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	SΣC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	SΣC	1..1		Actual result Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	ΣC	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. obs-3: Must have at least a low or a high or text vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
component:specimen-supervision-status	SΣ	0..1	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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	Σ	1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..0
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:specimen-supervision-status.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG
Observation.component:specimen-supervision-status.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:specimen-supervision-status.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

This structure is derived from Observation

Summary

Mandatory: 4 elements(9 nested mandatory elements)
Must-Support: 11 elements
Fixed: 2 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• Patient Profile - General - Allowable Data (http://hl7.org/fhir/uv/shc-vaccination/StructureDefinition/shc-patient-general-ad)

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation			Observation
id		0..1	id	Should not be populated
meta	S	0..1	Meta	Metadata about the resource
security	S	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
status	S	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	S	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
reference		1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
type		0..0
identifier		0..0
display		0..0
effective[x]	S	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
performer	S	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
display	SC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	S	1..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	C	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	C	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:specimen-supervision-status	S	0..1	BackboneElement	Component results
code
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
Slices for value[x]		1..1	CodeableConcept	Actual component result Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept		1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
extension		0..0
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system
code		1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
id	Σ	0..1	id	Should not be populated
meta	SΣ	0..1	Meta	Metadata about the resource
security	SΣ	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	SΣ	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
reference	ΣC	1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x]	SΣ	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
performer	SΣ	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
display	SΣC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	SΣC	1..1		Actual result Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	ΣC	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. obs-3: Must have at least a low or a high or text vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
component:specimen-supervision-status	SΣ	0..1	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.
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code	Σ	1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	Σ	1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
extension		0..0
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system
code	Σ	1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-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()
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
id	Σ	0..1	id	Should not be populated
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	Σ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	SΣ	0..1	Coding	Limited security label to convey identity level of assurance for patient referenced by this resource. Binding: Identity Assurance Level (required)
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: Completed observation status (required)
category		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCs identifying qualitative COVID lab tests (required)
subject	SΣ	1..1	Reference(Patient Profile - General - Allowable Data)	Patient to whom lab result applies
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	1..1	string	This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
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		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this version was made available
performer	SΣ	0..1	Reference(Organization)	Organization which was responsible for the laboratory test result.
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	SΣC	1..1	string	Short, human-readable text representation of the organization. vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
Slices for value[x]	SΣC	1..1		Actual result Slice: Unordered, Closed by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Qualitative infectious disease-related lab test result codes (required)
value[x]:valueQuantity	ΣC	0..1	Quantity	Actual result vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
value[x]:valueString	ΣC	0..1	string	String representation of results; used ONLY when a computable representation is not possible vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization.
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	SC	0..*	BackboneElement	Provides guide for interpretation. SHOULD include if using valueQuantity. obs-3: Must have at least a low or a high or text vc-observation-range-only-quantity-or-string: Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Slices for component	Σ	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
component:specimen-supervision-status	SΣ	0..1	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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	SNOMED CT concept 'Type of supervision for specimen collection (observable entity)' Fixed Value: 1208522006
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	Σ	1..1	CodeableConcept	Actual component result Binding: Specimen Collection Supervision Status (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..0
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.meta.security	required	IdentityAssuranceLevel http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level from this IG
Observation.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	CompletedObservationStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status from this IG
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	required	LabQualitativeTestCovidValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	required	LabQualitativeResultValueSet https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.component:specimen-supervision-status.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept	required	SpecimenCollectionSupervisionStatus http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status from this IG
Observation.component:specimen-supervision-status.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component:specimen-supervision-status.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-range	warning	Observation.value[x]:valueQuantity	Quantitative lab results SHOULD include reference range : %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-string	warning	Observation.referenceRange	Reference range SHOULD be included for quantitative lab results, MAY be included for free text (string) results, and SHOULD NOT be included otherwise : $this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists())
vc-should-be-under-20-chars	warning	Observation.value[x]:valueString	Length SHOULD be <20 for data minimization. : $this.length() < 20
vc-should-be-under-30-chars	warning	Observation.performer.display	Length SHOULD be <30 for data minimization. : $this.length() < 30

This structure is derived from Observation

Summary

Mandatory: 4 elements(9 nested mandatory elements)
Must-Support: 11 elements
Fixed: 2 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• Patient Profile - General - Allowable Data (http://hl7.org/fhir/uv/shc-vaccination/StructureDefinition/shc-patient-general-ad)

Slices

This structure defines the following Slices:

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