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

SMART Health Cards: Vaccination &amp; 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
Standards status: Trial-use | Maturity Level: 4 | 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!

Usages:

- Use this Profile: COVID-19-specific Laboratory Test Results Bundle - Data Minimization

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

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

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | SHCCovid19LaboratoryResultObservationAD | Measurements and simple assertions Constraints: obs-6, obs-7
meta | S Σ | 0..1 | Meta | Metadata about the resource
extension |  | 0..0 |  |
security | S Σ | 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 Σ | 1..1 | code | registered | preliminary | final | amended + Binding: Completed observation status (required)
code | S Σ | 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
subject | S Σ | 1..1 | Reference(Patient Profile - General - Allowable Data) | Patient to whom lab result applies
extension |  | 0..0 |  |
reference | Σ C | 1..1 | string | This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x] | S Σ | 1..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
performer | S Σ | 0..1 | Reference(Organization) | Organization which was responsible for the laboratory test result.
extension |  | 0..0 |  |
display | S Σ C | 1..1 | string | Short, human-readable text representation of the organization. Constraints: vc-should-be-under-30-chars
Slices for value[x] | S Σ C | 1..1 |  | Actual result Slice: Unordered, Closed by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueString |  |  | string |
value[x]:valueCodeableConcept | S Σ C | 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 | S Σ C | 0..1 | Quantity | Actual result Constraints: vc-observation-quantity-should-have-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 | S Σ C | 0..1 | string | String representation of results; used ONLY when a computable representation is not possible Constraints: vc-should-be-under-20-chars
referenceRange | S C | 0..* | BackboneElement | Provides guide for interpretation. SHOULD include if using valueQuantity. Constraints: obs-3, vc-observation-range-only-quantity-or-string
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 | S Σ | 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 | S 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
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 `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-test-covid` From this IG
Observation.value[x]:valueCodeableConcept | required | LabQualitativeResultValueSet `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-result` From this IG
Observation.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` 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: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()) |
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 SHCCovid19LaboratoryResultObservationAD

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | SHCCovid19LaboratoryResultObservationAD | Measurements and simple assertions Constraints: obs-6, obs-7
meta | S Σ | 0..1 | Meta | Metadata about the resource
extension |  | 0..0 |  |
security | S Σ | 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 Σ | 1..1 | code | registered | preliminary | final | amended + Binding: Completed observation status (required)
code | S Σ | 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
subject | S Σ | 1..1 | Reference(Patient Profile - General - Allowable Data) | Patient to whom lab result applies
extension |  | 0..0 |  |
reference | Σ C | 1..1 | string | This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x] | S Σ | 1..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
performer | S Σ | 0..1 | Reference(Organization) | Organization which was responsible for the laboratory test result.
extension |  | 0..0 |  |
display | S Σ C | 1..1 | string | Short, human-readable text representation of the organization. Constraints: vc-should-be-under-30-chars
Slices for value[x] | S Σ C | 1..1 |  | Actual result Slice: Unordered, Closed by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueString |  |  | string |
value[x]:valueCodeableConcept | S Σ C | 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 | S Σ C | 0..1 | Quantity | Actual result Constraints: vc-observation-quantity-should-have-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 | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ | 0..1 | code | Coded form of the unit
value[x]:valueString | S Σ C | 0..1 | string | String representation of results; used ONLY when a computable representation is not possible Constraints: vc-should-be-under-20-chars
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | string | Primitive value for string Max Length:1048576
referenceRange | S C | 0..* | BackboneElement | Provides guide for interpretation. SHOULD include if using valueQuantity. Constraints: obs-3, vc-observation-range-only-quantity-or-string
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 | S Σ | 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 | S 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
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 `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-test-covid` From this IG
Observation.value[x]:valueCodeableConcept | required | LabQualitativeResultValueSet `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-result` From this IG
Observation.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` From the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` 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: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 |

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)

Maturity: 4

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | SHCCovid19LaboratoryResultObservationAD | Measurements and simple assertions Constraints: obs-6, obs-7
meta | S Σ | 0..1 | Meta | Metadata about the resource
extension |  | 0..0 |  |
security | S Σ | 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 Σ | 1..1 | code | registered | preliminary | final | amended + Binding: Completed observation status (required)
code | S Σ | 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
subject | S Σ | 1..1 | Reference(Patient Profile - General - Allowable Data) | Patient to whom lab result applies
extension |  | 0..0 |  |
reference | Σ C | 1..1 | string | This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x] | S Σ | 1..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
performer | S Σ | 0..1 | Reference(Organization) | Organization which was responsible for the laboratory test result.
extension |  | 0..0 |  |
display | S Σ C | 1..1 | string | Short, human-readable text representation of the organization. Constraints: vc-should-be-under-30-chars
Slices for value[x] | S Σ C | 1..1 |  | Actual result Slice: Unordered, Closed by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueString |  |  | string |
value[x]:valueCodeableConcept | S Σ C | 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 | S Σ C | 0..1 | Quantity | Actual result Constraints: vc-observation-quantity-should-have-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 | S Σ C | 0..1 | string | String representation of results; used ONLY when a computable representation is not possible Constraints: vc-should-be-under-20-chars
referenceRange | S C | 0..* | BackboneElement | Provides guide for interpretation. SHOULD include if using valueQuantity. Constraints: obs-3, vc-observation-range-only-quantity-or-string
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 | S Σ | 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 | S 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
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 `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-test-covid` From this IG
Observation.value[x]:valueCodeableConcept | required | LabQualitativeResultValueSet `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-result` From this IG
Observation.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` 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: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()) |
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 |

Differential View

This structure is derived from SHCCovid19LaboratoryResultObservationAD

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | SHCCovid19LaboratoryResultObservationAD | Measurements and simple assertions Constraints: obs-6, obs-7
meta | S Σ | 0..1 | Meta | Metadata about the resource
extension |  | 0..0 |  |
security | S Σ | 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 Σ | 1..1 | code | registered | preliminary | final | amended + Binding: Completed observation status (required)
code | S Σ | 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
subject | S Σ | 1..1 | Reference(Patient Profile - General - Allowable Data) | Patient to whom lab result applies
extension |  | 0..0 |  |
reference | Σ C | 1..1 | string | This SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
effective[x] | S Σ | 1..1 |  | Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
performer | S Σ | 0..1 | Reference(Organization) | Organization which was responsible for the laboratory test result.
extension |  | 0..0 |  |
display | S Σ C | 1..1 | string | Short, human-readable text representation of the organization. Constraints: vc-should-be-under-30-chars
Slices for value[x] | S Σ C | 1..1 |  | Actual result Slice: Unordered, Closed by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueString |  |  | string |
value[x]:valueCodeableConcept | S Σ C | 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 | S Σ C | 0..1 | Quantity | Actual result Constraints: vc-observation-quantity-should-have-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 | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ | 0..1 | code | Coded form of the unit
value[x]:valueString | S Σ C | 0..1 | string | String representation of results; used ONLY when a computable representation is not possible Constraints: vc-should-be-under-20-chars
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | string | Primitive value for string Max Length:1048576
referenceRange | S C | 0..* | BackboneElement | Provides guide for interpretation. SHOULD include if using valueQuantity. Constraints: obs-3, vc-observation-range-only-quantity-or-string
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 | S Σ | 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 | S 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
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 `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-test-covid` From this IG
Observation.value[x]:valueCodeableConcept | required | LabQualitativeResultValueSet `http://hl7.org/fhir/uv/shc-vaccination/ValueSet/lab-qualitative-result` From this IG
Observation.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1` From the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` 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: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 |

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)

Maturity: 4

Other representations of profile: CSV, Excel, Schematron