SMART Health Cards: Vaccination & Testing Implementation Guide
1.0.0 - STU1 Release International flag

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

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

Official URL: http://hl7.org/fhir/uv/shc-vaccination/StructureDefinition/shc-covid19-laboratory-result-observation-dm Version: 1.0.0
Draft as of 2024-12-04 Computable Name: SHCCovid19LaboratoryResultObservationDM

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

See here for implementation details.

↓ Start here!

Description:

For representing laboratory test results related to infection with or immunity to an infectious disease.

Primary profile (DM) Fallback profile (AD) Scope of profile pair
Lab results - COVID-19 Fallback COVID-19 only
Lab results - Generic Fallback Other infectious diseases
For more information about the types of profiles in this IG, see the profiles page.

Usage:

Formal Views of Profile Content

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

This structure is derived from SHCCovid19LaboratoryResultObservationAD

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation SHCCovid19LaboratoryResultObservationAD
... id 0..0
... meta
.... id 0..0
.... extension 0..0
.... versionId 0..0
.... lastUpdated 0..0
.... source 0..0
.... profile 0..0
.... tag 0..0
... implicitRules 0..0
... language 0..0
... text 0..0
... contained 0..0
... extension 0..0
... modifierExtension 0..0
... identifier 0..0
... basedOn 0..0
... partOf 0..0
... category 0..0
... code
.... id 0..0
.... extension 0..0
.... coding 1..1 Coding Code defined by a terminology system
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system
..... display 0..0
..... userSelected 0..0
.... text 0..0
... subject 1..1 Reference(Patient Profile - General - Allowable Data) Patient to whom lab result applies
.... id 0..0
.... extension 0..0
... focus 0..0
... encounter 0..0
... issued 0..0
... performer
.... id 0..0
.... extension 0..0
.... reference 0..0
.... type 0..0
.... identifier 0..0
... Slices for value[x] Content/Rules for all slices
.... value[x]:valueCodeableConcept 0..1 CodeableConcept Actual result
..... id 0..0
..... extension 0..0
..... coding 1..1 Coding Code defined by a terminology system
...... id 0..0
...... extension 0..0
...... system 1..1 uri Identity of the terminology system
...... version 0..0
...... code 1..1 code Symbol in syntax defined by the system
...... display 0..0
...... userSelected 0..0
..... text 0..0
.... value[x]:valueQuantity 0..1 Quantity Actual result
..... id 0..0
.... value[x]:valueString 0..1 string String representation of results; used ONLY when a computable representation is not possible
..... id 0..0
... dataAbsentReason 0..0
... interpretation 0..0
... note 0..0
... bodySite 0..0
... method 0..0
... specimen 0..0
... device 0..0
... referenceRange
.... id 0..0
.... extension 0..0
.... modifierExtension 0..0
.... type
..... id 0..0
..... extension 0..0
..... text 0..0
.... appliesTo 0..0
.... age 0..0
... hasMember 0..0
... derivedFrom 0..0
... Slices for component 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... id 0..0
..... extension 0..0
..... modifierExtension 0..0
..... dataAbsentReason 0..0
..... interpretation 0..0
..... referenceRange 0..0
.... component:specimen-supervision-status 0..1 BackboneElement Component results
..... id 0..0
..... extension 0..0
..... modifierExtension 0..0
..... code
...... id 0..0
...... extension 0..0
...... coding
....... id 0..0
....... extension 0..0
....... version 0..0
....... display 0..0
....... userSelected 0..0
...... text 0..0
..... Slices for value[x] Content/Rules for all slices
...... value[x]:valueCodeableConcept 1..1 CodeableConcept Actual component result
....... id 0..0
....... coding
........ id 0..0
........ extension 0..0
........ version 0..0
........ display 0..0
........ userSelected 0..0
....... text 0..0
..... dataAbsentReason 0..0
..... interpretation 0..0
..... referenceRange 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* SHCCovid19LaboratoryResultObservationAD 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
... meta SΣ 0..1 Meta Metadata about the resource
.... extension 0..0
.... 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)
... 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)
.... extension 0..0
.... coding Σ 1..1 Coding Code defined by a terminology system
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system
..... code Σ 1..1 code Symbol in syntax defined by the system
.... extension 0..0
.... 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.
.... extension 0..0
.... 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
.... valueCodeableConcept CodeableConcept
.... valueQuantity Quantity
.... valueString string
.... value[x]:valueCodeableConcept ΣC 0..1 CodeableConcept Actual result
Binding: Qualitative infectious disease-related lab test result codes (required)
..... extension 0..0
..... coding Σ 1..1 Coding Code defined by a terminology system
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system
...... code Σ 1..1 code Symbol in syntax defined by the system
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result
vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... 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
... Slices for component Σ 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... 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
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

...... extension 0..0
...... coding Σ 1..1 Coding Code defined by a terminology system
....... extension 0..0
....... 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
........ extension 0..0
........ system Σ 1..1 uri Identity of the terminology system
........ code Σ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.meta.securityrequiredIdentityAssuranceLevel
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level
from this IG
Observation.statusrequiredCompletedObservationStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status
from this IG
Observation.coderequiredLabQualitativeTestCovidValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConceptrequiredLabQualitativeResultValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConceptrequiredSpecimenCollectionSupervisionStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-rangewarningObservation.value[x]:valueQuantityQuantitative lab results SHOULD include reference range
: %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-stringwarningObservation.referenceRangeReference 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-charswarningObservation.value[x]:valueStringLength SHOULD be <20 for data minimization.
: $this.length() < 20
vc-should-be-under-30-charswarningObservation.performer.displayLength SHOULD be <30 for data minimization.
: $this.length() < 30
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* SHCCovid19LaboratoryResultObservationAD Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
... meta SΣ 0..1 Meta Metadata about the resource
.... extension 0..0
.... security SΣ 0..1 Coding Limited security label to convey identity level of assurance for patient referenced by this resource.
Binding: Identity Assurance Level (required)
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: Completed observation status (required)
... code SΣ 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCs identifying qualitative COVID lab tests (required)
.... extension 0..0
.... coding Σ 1..1 Coding Code defined by a terminology system
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system
..... code Σ 1..1 code Symbol in syntax defined by the system
.... extension 0..0
.... reference ΣC 1..1 string This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
... effective[x] SΣ 1..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
... performer SΣ 0..1 Reference(Organization) Organization which was responsible for the laboratory test result.
.... extension 0..0
.... display SΣC 1..1 string Short, human-readable text representation of the organization.
vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization.
... Slices for value[x] SΣC 1..1 Actual result
Slice: Unordered, Closed by type:$this
.... valueCodeableConcept CodeableConcept
.... valueQuantity Quantity
.... valueString string
.... value[x]:valueCodeableConcept ΣC 0..1 CodeableConcept Actual result
Binding: Qualitative infectious disease-related lab test result codes (required)
..... extension 0..0
..... coding Σ 1..1 Coding Code defined by a terminology system
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system
...... code Σ 1..1 code Symbol in syntax defined by the system
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result
vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value Σ 0..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code Σ 0..1 code Coded form of the unit
.... 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.
..... extension 0..* Extension Additional content defined by implementations
..... value 0..1 string Primitive value for string
Max Length:1048576
... 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
.... 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.

..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
.... text 0..1 string Text based reference range in an observation
... Slices for component Σ 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... 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
.... component:specimen-supervision-status SΣ 0..1 BackboneElement Component results
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

...... extension 0..0
...... coding Σ 1..1 Coding Code defined by a terminology system
....... extension 0..0
....... 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
........ extension 0..0
........ system Σ 1..1 uri Identity of the terminology system
........ code Σ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.meta.securityrequiredIdentityAssuranceLevel
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level
from this IG
Observation.statusrequiredCompletedObservationStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status
from this IG
Observation.coderequiredLabQualitativeTestCovidValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConceptrequiredLabQualitativeResultValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConceptrequiredSpecimenCollectionSupervisionStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-rangewarningObservation.value[x]:valueQuantityQuantitative lab results SHOULD include reference range
: %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-stringwarningObservation.referenceRangeReference 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-charswarningObservation.value[x]:valueStringLength SHOULD be <20 for data minimization.
: $this.length() < 20
vc-should-be-under-30-charswarningObservation.performer.displayLength SHOULD be <30 for data minimization.
: $this.length() < 30

This structure is derived from SHCCovid19LaboratoryResultObservationAD

Summary

Mandatory: 3 elements(3 nested mandatory elements)
Prohibited: 90 elements

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from SHCCovid19LaboratoryResultObservationAD

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation SHCCovid19LaboratoryResultObservationAD
... id 0..0
... meta
.... id 0..0
.... extension 0..0
.... versionId 0..0
.... lastUpdated 0..0
.... source 0..0
.... profile 0..0
.... tag 0..0
... implicitRules 0..0
... language 0..0
... text 0..0
... contained 0..0
... extension 0..0
... modifierExtension 0..0
... identifier 0..0
... basedOn 0..0
... partOf 0..0
... category 0..0
... code
.... id 0..0
.... extension 0..0
.... coding 1..1 Coding Code defined by a terminology system
..... id 0..0
..... extension 0..0
..... system 1..1 uri Identity of the terminology system
..... version 0..0
..... code 1..1 code Symbol in syntax defined by the system
..... display 0..0
..... userSelected 0..0
.... text 0..0
... subject 1..1 Reference(Patient Profile - General - Allowable Data) Patient to whom lab result applies
.... id 0..0
.... extension 0..0
... focus 0..0
... encounter 0..0
... issued 0..0
... performer
.... id 0..0
.... extension 0..0
.... reference 0..0
.... type 0..0
.... identifier 0..0
... Slices for value[x] Content/Rules for all slices
.... value[x]:valueCodeableConcept 0..1 CodeableConcept Actual result
..... id 0..0
..... extension 0..0
..... coding 1..1 Coding Code defined by a terminology system
...... id 0..0
...... extension 0..0
...... system 1..1 uri Identity of the terminology system
...... version 0..0
...... code 1..1 code Symbol in syntax defined by the system
...... display 0..0
...... userSelected 0..0
..... text 0..0
.... value[x]:valueQuantity 0..1 Quantity Actual result
..... id 0..0
.... value[x]:valueString 0..1 string String representation of results; used ONLY when a computable representation is not possible
..... id 0..0
... dataAbsentReason 0..0
... interpretation 0..0
... note 0..0
... bodySite 0..0
... method 0..0
... specimen 0..0
... device 0..0
... referenceRange
.... id 0..0
.... extension 0..0
.... modifierExtension 0..0
.... type
..... id 0..0
..... extension 0..0
..... text 0..0
.... appliesTo 0..0
.... age 0..0
... hasMember 0..0
... derivedFrom 0..0
... Slices for component 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... id 0..0
..... extension 0..0
..... modifierExtension 0..0
..... dataAbsentReason 0..0
..... interpretation 0..0
..... referenceRange 0..0
.... component:specimen-supervision-status 0..1 BackboneElement Component results
..... id 0..0
..... extension 0..0
..... modifierExtension 0..0
..... code
...... id 0..0
...... extension 0..0
...... coding
....... id 0..0
....... extension 0..0
....... version 0..0
....... display 0..0
....... userSelected 0..0
...... text 0..0
..... Slices for value[x] Content/Rules for all slices
...... value[x]:valueCodeableConcept 1..1 CodeableConcept Actual component result
....... id 0..0
....... coding
........ id 0..0
........ extension 0..0
........ version 0..0
........ display 0..0
........ userSelected 0..0
....... text 0..0
..... dataAbsentReason 0..0
..... interpretation 0..0
..... referenceRange 0..0

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* SHCCovid19LaboratoryResultObservationAD 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
... meta SΣ 0..1 Meta Metadata about the resource
.... extension 0..0
.... 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)
... 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)
.... extension 0..0
.... coding Σ 1..1 Coding Code defined by a terminology system
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system
..... code Σ 1..1 code Symbol in syntax defined by the system
.... extension 0..0
.... 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.
.... extension 0..0
.... 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
.... valueCodeableConcept CodeableConcept
.... valueQuantity Quantity
.... valueString string
.... value[x]:valueCodeableConcept ΣC 0..1 CodeableConcept Actual result
Binding: Qualitative infectious disease-related lab test result codes (required)
..... extension 0..0
..... coding Σ 1..1 Coding Code defined by a terminology system
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system
...... code Σ 1..1 code Symbol in syntax defined by the system
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result
vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... 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
... Slices for component Σ 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... 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
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

...... extension 0..0
...... coding Σ 1..1 Coding Code defined by a terminology system
....... extension 0..0
....... 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
........ extension 0..0
........ system Σ 1..1 uri Identity of the terminology system
........ code Σ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.meta.securityrequiredIdentityAssuranceLevel
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level
from this IG
Observation.statusrequiredCompletedObservationStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status
from this IG
Observation.coderequiredLabQualitativeTestCovidValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConceptrequiredLabQualitativeResultValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConceptrequiredSpecimenCollectionSupervisionStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-rangewarningObservation.value[x]:valueQuantityQuantitative lab results SHOULD include reference range
: %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-stringwarningObservation.referenceRangeReference 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-charswarningObservation.value[x]:valueStringLength SHOULD be <20 for data minimization.
: $this.length() < 20
vc-should-be-under-30-charswarningObservation.performer.displayLength SHOULD be <30 for data minimization.
: $this.length() < 30

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* SHCCovid19LaboratoryResultObservationAD 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
... meta SΣ 0..1 Meta Metadata about the resource
.... extension 0..0
.... 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)
... 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)
.... extension 0..0
.... coding Σ 1..1 Coding Code defined by a terminology system
..... extension 0..0
..... system Σ 1..1 uri Identity of the terminology system
..... code Σ 1..1 code Symbol in syntax defined by the system
.... extension 0..0
.... 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.
.... extension 0..0
.... 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
.... valueCodeableConcept CodeableConcept
.... valueQuantity Quantity
.... valueString string
.... value[x]:valueCodeableConcept ΣC 0..1 CodeableConcept Actual result
Binding: Qualitative infectious disease-related lab test result codes (required)
..... extension 0..0
..... coding Σ 1..1 Coding Code defined by a terminology system
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system
...... code Σ 1..1 code Symbol in syntax defined by the system
.... value[x]:valueQuantity ΣC 0..1 Quantity Actual result
vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... value Σ 0..1 decimal Numerical value (with implicit precision)
..... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

..... unit Σ 0..1 string Unit representation
..... system ΣC 0..1 uri System that defines coded unit form
..... code Σ 0..1 code Coded form of the unit
.... 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.
..... extension 0..* Extension Additional content defined by implementations
..... value 0..1 string Primitive value for string
Max Length:1048576
... 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
.... 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.

..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
.... text 0..1 string Text based reference range in an observation
... Slices for component Σ 0..1 BackboneElement Component results
Slice: Unordered, Closed by value:code
.... component:All Slices Content/Rules for all slices
..... 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
.... component:specimen-supervision-status SΣ 0..1 BackboneElement Component results
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

...... extension 0..0
...... coding Σ 1..1 Coding Code defined by a terminology system
....... extension 0..0
....... 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
........ extension 0..0
........ system Σ 1..1 uri Identity of the terminology system
........ code Σ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.meta.securityrequiredIdentityAssuranceLevel
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level
from this IG
Observation.statusrequiredCompletedObservationStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status
from this IG
Observation.coderequiredLabQualitativeTestCovidValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid
Observation.value[x]:valueCodeableConceptrequiredLabQualitativeResultValueSet
https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result
Observation.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component:specimen-supervision-status.value[x]:valueCodeableConceptrequiredSpecimenCollectionSupervisionStatus
http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
vc-observation-quantity-should-have-rangewarningObservation.value[x]:valueQuantityQuantitative lab results SHOULD include reference range
: %resource.referenceRange.exists()
vc-observation-range-only-quantity-or-stringwarningObservation.referenceRangeReference 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-charswarningObservation.value[x]:valueStringLength SHOULD be <20 for data minimization.
: $this.length() < 20
vc-should-be-under-30-charswarningObservation.performer.displayLength SHOULD be <30 for data minimization.
: $this.length() < 30

This structure is derived from SHCCovid19LaboratoryResultObservationAD

Summary

Mandatory: 3 elements(3 nested mandatory elements)
Prohibited: 90 elements

Slices

This structure defines the following Slices:

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

 

Other representations of profile: CSV, Excel, Schematron