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: SHCCovid19LaboratoryResultObservationAD - Detailed Descriptions

Draft as of 2024-12-04

Definitions for the shc-covid19-laboratory-result-observation-ad resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Observation
2. Observation.id
Definition

For data minimization reasons, this element SHOULD NOT be populated when generating a resource conforming to this profile for inclusion in one of the Bundles profiled in this IG.

ShortShould not be populated
Comments

Not including id may result in FHIR validation errors of resources. These errors can be ignored for the purposes of assessing conformance to this IG.

4. Observation.meta
Must Supporttrue
6. Observation.meta.security
Definition

Limited security metadata which conveys an attestation that the lab testing provider performed a certain level of identity verification at the time of service. If known, Issuers SHALL attest to the highest level that applies.

ShortLimited security label to convey identity level of assurance for patient referenced by this resource.
Control0..1
BindingThe codes SHALL be taken from Identity Assurance Level
(required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level)
Must Supporttrue
8. Observation.status
BindingThe codes SHALL be taken from Completed observation status
(required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status)
Must Supporttrue
10. Observation.code
Definition

If an appropriate code is not found in the bound value set, use the SHCInfectiousDiseaseLaboratoryResultObservation profile instead, which allows for any SNOMED CT descendant of 441742003 "Evaluation finding (finding)" or 362981000 "Qualifier value (qualifier value)".

BindingThe codes SHALL be taken from LOINCs identifying qualitative COVID lab tests
(required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid)
Must Supporttrue
12. Observation.subject
Definition

Reference to a VaccinationCredentialPatient-conforming resource who is subject of lab result.

ShortPatient to whom lab result applies
Control1..?
TypeReference(Patient Profile - General - Allowable Data)
Must Supporttrue
14. Observation.subject.reference
ShortThis SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
Control1..?
16. Observation.subject.type
Control0..0
18. Observation.subject.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..0
20. Observation.subject.display
Control0..0
22. Observation.effective[x]
Control1..?
TypeChoice of: dateTime, Period, Timing, instant
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
24. Observation.performer
Definition

Only Observation.performer.display SHOULD be populated. See the definition of that element for details.

ShortOrganization which was responsible for the laboratory test result.
Control0..1
TypeReference(Organization)
Must Supporttrue
26. Observation.performer.display
Definition

Organization which was responsible for the laboratory test result. Issuers SHOULD provide display name only. This is provided to Verifiers in case of invalid data in the credential, to support manual validation. This is not expected to be a computable Organization identifier.

ShortShort, human-readable text representation of the organization.
Control1..?
Must Supporttrue
Invariantsvc-should-be-under-30-chars: Length SHOULD be <30 for data minimization. ($this.length() < 30)
28. Observation.value[x]
Comments

Issuers SHALL provide a computable representation of laboratory results if at all possible. If the Issuer is unable to accurately translate laboratory results into a computable form, it is unlikely a Verifier will be able to interpret the results. Issuers SHALL make every possible effort to resolve non-computable results prior to issuing credentials. In rare cases when this is not possible, Issuers MAY populate valueString with a free text result.

Control1..?
TypeChoice of: Quantity, CodeableConcept, string, dateTime, boolean, SampledData, Period, Ratio, integer, time, Range
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
  • 30. Observation.value[x]:valueCodeableConcept
    Slice NamevalueCodeableConcept
    Control0..1
    BindingThe codes SHALL be taken from Qualitative infectious disease-related lab test result codes
    (required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result)
    TypeCodeableConcept
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    32. Observation.value[x]:valueQuantity
    Slice NamevalueQuantity
    Control0..1
    TypeQuantity
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Invariantsvc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range (%resource.referenceRange.exists())
    34. Observation.value[x]:valueString
    Slice NamevalueString
    ShortString representation of results; used ONLY when a computable representation is not possible
    Control0..1
    Typestring
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Invariantsvc-should-be-under-20-chars: Length SHOULD be <20 for data minimization. ($this.length() < 20)
    36. Observation.referenceRange
    ShortProvides guide for interpretation. SHOULD include if using valueQuantity.
    Comments

    Issuers SHOULD provide a reference range for quantitative lab results to allow recipients to correctly interpret the results. Issuers MAY provide a reference range for free text (string) results.

    Must Supporttrue
    Invariantsvc-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 ($this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists()))
    38. Observation.component
    SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ code
    • 40. Observation.component:specimen-supervision-status
      Slice Namespecimen-supervision-status
      Control0..1
      Must Supporttrue
      42. Observation.component:specimen-supervision-status.code
      44. Observation.component:specimen-supervision-status.code.coding
      Control1..1
      46. Observation.component:specimen-supervision-status.code.coding.system
      Control1..?
      Fixed Valuehttp://snomed.info/sct
      48. Observation.component:specimen-supervision-status.code.coding.code
      ShortSNOMED CT concept 'Type of supervision for specimen collection (observable entity)'
      Control1..?
      Fixed Value1208522006
      50. Observation.component:specimen-supervision-status.value[x]
      Control1..?
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 52. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept
        Slice NamevalueCodeableConcept
        Control1..1
        BindingThe codes SHALL be taken from Specimen Collection Supervision Status
        (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status)
        TypeCodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        54. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.extension
        Control0..0
        56. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding
        Control1..1
        58. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.system
        Control1..?
        60. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.code
        Control1..?

        Guidance on how to interpret the contents of this table can be found here

        0. Observation
        Definition

        Measurements and simple assertions made about a patient, device or other subject.

        ShortMeasurements and simple assertions
        Comments

        Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

        Control0..*
        Is Modifierfalse
        Summaryfalse
        Alternate NamesVital Signs, Measurement, Results, Tests
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
        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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
        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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
        2. Observation.id
        Definition

        For data minimization reasons, this element SHOULD NOT be populated when generating a resource conforming to this profile for inclusion in one of the Bundles profiled in this IG.


        The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

        ShortShould not be populatedLogical id of this artifact
        Comments

        Not including id may result in FHIR validation errors of resources. These errors can be ignored for the purposes of assessing conformance to this IG.


        The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

        Control0..1
        Typeidstring
        Is Modifierfalse
        Summarytrue
        4. Observation.meta
        Definition

        The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

        ShortMetadata about the resource
        Control0..1
        TypeMeta
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        6. Observation.meta.security
        Definition

        Limited security metadata which conveys an attestation that the lab testing provider performed a certain level of identity verification at the time of service. If known, Issuers SHALL attest to the highest level that applies.


        Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

        ShortLimited security label to convey identity level of assurance for patient referenced by this resource.Security Labels applied to this resource
        Comments

        The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

        Control0..1*
        BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from Identity Assurance Levelhttp://hl7.org/fhir/ValueSet/security-labels
        (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level)
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        8. Observation.implicitRules
        Definition

        A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

        ShortA set of rules under which this content was created
        Comments

        Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

        Control0..1
        Typeuri
        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        10. Observation.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
        Summaryfalse
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        12. Observation.status
        Definition

        The status of the result value.

        Shortregistered | preliminary | final | amended +
        Comments

        This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

        Control1..1
        BindingThe codes SHALL be taken from Completed observation statushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
        (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status)
        Typecode
        Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to track the status of individual results. Some results are finalized before the whole report is finalized.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. Observation.code
        Definition

        If an appropriate code is not found in the bound value set, use the SHCInfectiousDiseaseLaboratoryResultObservation profile instead, which allows for any SNOMED CT descendant of 441742003 "Evaluation finding (finding)" or 362981000 "Qualifier value (qualifier value)".


        Describes what was observed. Sometimes this is called the observation "name".

        ShortType of observation (code / type)
        Comments

        All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

        Control1..1
        BindingThe codes SHALL be taken from For example codes, see LOINCs identifying qualitative COVID lab testshttp://hl7.org/fhir/ValueSet/observation-codes
        (required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Knowing what kind of observation is being made is essential to understanding the observation.

        Alternate NamesName
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. Observation.subject
        Definition

        Reference to a VaccinationCredentialPatient-conforming resource who is subject of lab result.


        The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

        ShortPatient to whom lab result appliesWho and/or what the observation is about
        Comments

        One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

        Control10..1
        TypeReference(Patient Profile - General - Allowable Data, Patient, Group, Device, Location)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Observations have no value if you don't know who or what they're about.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. Observation.subject.reference
        Definition

        A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

        ShortThis SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.Literal reference, Relative, internal or absolute URL
        Comments

        Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

        Control10..1
        This element is affected by the following invariants: ref-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. Observation.subject.type
        Definition

        The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

        The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

        ShortType the reference refers to (e.g. "Patient")
        Comments

        This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

        Control0..01
        BindingUnless not suitable, these codes SHALL be taken from ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types
        (extensible to http://hl7.org/fhir/ValueSet/resource-types)

        Aa resource (or, for logical models, the URI of the logical model).

        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. Observation.subject.identifier
        Definition

        An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

        ShortLogical reference, when literal reference is not known
        Comments

        When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

        When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

        Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

        Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..01
        TypeIdentifier
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. Observation.subject.display
        Definition

        Plain text narrative that identifies the resource in addition to the resource reference.

        ShortText alternative for the resource
        Comments

        This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

        Control0..01
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. Observation.effective[x]
        Definition

        The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

        ShortClinically relevant time/time-period for observation
        Comments

        At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

        Control10..1
        TypeChoice of: dateTime, Period, Timing, instant
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Requirements

        Knowing when an observation was deemed true is important to its relevance as well as determining trends.

        Alternate NamesOccurrence
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. Observation.performer
        Definition

        Only Observation.performer.display SHOULD be populated. See the definition of that element for details.


        Who was responsible for asserting the observed value as "true".

        ShortOrganization which was responsible for the laboratory test result.Who is responsible for the observation
        Control0..1*
        TypeReference(Organization, Practitioner, PractitionerRole, CareTeam, Patient, RelatedPerson)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. Observation.performer.display
        Definition

        Organization which was responsible for the laboratory test result. Issuers SHOULD provide display name only. This is provided to Verifiers in case of invalid data in the credential, to support manual validation. This is not expected to be a computable Organization identifier.


        Plain text narrative that identifies the resource in addition to the resource reference.

        ShortShort, human-readable text representation of the organization.Text alternative for the resource
        Comments

        This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

        Control10..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization. ($this.length() < 30)
        32. Observation.value[x]
        Definition

        The information determined as a result of making the observation, if the information has a simple value.

        ShortActual result
        Comments

        Issuers SHALL provide a computable representation of laboratory results if at all possible. If the Issuer is unable to accurately translate laboratory results into a computable form, it is unlikely a Verifier will be able to interpret the results. Issuers SHALL make every possible effort to resolve non-computable results prior to issuing credentials. In rare cases when this is not possible, Issuers MAY populate valueString with a free text result.


        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

        Control10..1
        This element is affected by the following invariants: obs-7
        TypeChoice of: Quantity, CodeableConcept, string, dateTime, boolean, SampledData, Period, Ratio, integer, time, Range
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Requirements

        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • type @ $this
        • 34. Observation.value[x]:valueCodeableConcept
          Slice NamevalueCodeableConcept
          Definition

          The information determined as a result of making the observation, if the information has a simple value.

          ShortActual result
          Comments

          An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

          Control0..1
          This element is affected by the following invariants: obs-7
          BindingThe codes SHALL be taken from For codes, see Qualitative infectious disease-related lab test result codes
          (required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result)
          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summarytrue
          Requirements

          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. Observation.value[x]:valueQuantity
          Slice NamevalueQuantity
          Definition

          The information determined as a result of making the observation, if the information has a simple value.

          ShortActual result
          Comments

          An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

          Control0..1
          This element is affected by the following invariants: obs-7
          TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summarytrue
          Requirements

          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range (%resource.referenceRange.exists())
          38. Observation.value[x]:valueString
          Slice NamevalueString
          Definition

          The information determined as a result of making the observation, if the information has a simple value.

          ShortString representation of results; used ONLY when a computable representation is not possibleActual result
          Comments

          An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

          Control0..1
          This element is affected by the following invariants: obs-7
          Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization. ($this.length() < 20)
          40. Observation.referenceRange
          Definition

          Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

          ShortProvides guide for interpretation. SHOULD include if using valueQuantity.
          Comments

          Issuers SHOULD provide a reference range for quantitative lab results to allow recipients to correctly interpret the results. Issuers MAY provide a reference range for free text (string) results.


          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Requirements

          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
          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 ($this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists()))
          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
          42. Observation.referenceRange.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          44. Observation.component
          Definition

          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

          ShortComponent results
          Comments

          For a discussion on the ways Observations can be assembled in groups together see Notes below.

          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Summarytrue
          Requirements

          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ code
          • 46. Observation.component.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            48. Observation.component.code
            Definition

            Describes what was observed. Sometimes this is called the observation "code".

            ShortType of component observation (code / type)
            Comments

            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

            Control1..1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

            Knowing what kind of observation is being made is essential to understanding the observation.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. Observation.component:specimen-supervision-status
            Slice Namespecimen-supervision-status
            Definition

            Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

            ShortComponent results
            Comments

            For a discussion on the ways Observations can be assembled in groups together see Notes below.

            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            52. Observation.component:specimen-supervision-status.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            54. Observation.component:specimen-supervision-status.code
            Definition

            Describes what was observed. Sometimes this is called the observation "code".

            ShortType of component observation (code / type)
            Comments

            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

            Control1..1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

            Knowing what kind of observation is being made is essential to understanding the observation.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. Observation.component:specimen-supervision-status.code.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. Observation.component:specimen-supervision-status.code.coding.system
            Definition

            The identification of the code system that defines the meaning of the symbol in the code.

            ShortIdentity of the terminology system
            Comments

            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

            Control10..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            Need to be unambiguous about the source of the definition of the symbol.

            Fixed Valuehttp://snomed.info/sct
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. Observation.component:specimen-supervision-status.code.coding.code
            Definition

            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

            ShortSNOMED CT concept 'Type of supervision for specimen collection (observable entity)'Symbol in syntax defined by the system
            Control10..1
            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            Need to refer to a particular code in the system.

            Fixed Value1208522006
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. Observation.component:specimen-supervision-status.value[x]
            Definition

            The information determined as a result of making the observation, if the information has a simple value.

            ShortActual component result
            Comments

            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

            Control10..1
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Summarytrue
            Requirements

            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 64. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control10..1
              BindingThe codes SHALL be taken from For codes, see Specimen Collection Supervision Status
              (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status)
              TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              66. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.extension
              Definition

              An Extension


              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortExtensionAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..0*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 68. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding
                Definition

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                Control10..1*
                TypeCoding
                Is Modifierfalse
                Summarytrue
                Requirements

                Allows for alternative encodings within a code system, and translations to other code systems.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.system
                Definition

                The identification of the code system that defines the meaning of the symbol in the code.

                ShortIdentity of the terminology system
                Comments

                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                Control10..1
                Typeuri
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                Need to be unambiguous about the source of the definition of the symbol.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                72. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.code
                Definition

                A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                ShortSymbol in syntax defined by the system
                Control10..1
                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                Need to refer to a particular code in the system.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                Guidance on how to interpret the contents of this table can be found here

                0. Observation
                Definition

                Measurements and simple assertions made about a patient, device or other subject.

                ShortMeasurements and simple assertions
                Comments

                Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

                Control0..*
                Is Modifierfalse
                Summaryfalse
                Alternate NamesVital Signs, Measurement, Results, Tests
                Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                dom-6: A resource should have narrative for robust management (text.`div`.exists())
                obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
                2. Observation.id
                Definition

                For data minimization reasons, this element SHOULD NOT be populated when generating a resource conforming to this profile for inclusion in one of the Bundles profiled in this IG.

                ShortShould not be populated
                Comments

                Not including id may result in FHIR validation errors of resources. These errors can be ignored for the purposes of assessing conformance to this IG.

                Control0..1
                Typeid
                Is Modifierfalse
                Summarytrue
                4. Observation.meta
                Definition

                The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                ShortMetadata about the resource
                Control0..1
                TypeMeta
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                6. Observation.meta.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                8. Observation.meta.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on Observation.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 10. Observation.meta.versionId
                  Definition

                  The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                  ShortVersion specific identifier
                  Comments

                  The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                  Control0..1
                  Typeid
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  12. Observation.meta.lastUpdated
                  Definition

                  When the resource last changed - e.g. when the version changed.

                  ShortWhen the resource version last changed
                  Comments

                  This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                  Control0..1
                  Typeinstant
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  14. Observation.meta.source
                  Definition

                  A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                  ShortIdentifies where the resource comes from
                  Comments

                  In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

                  This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                  Control0..1
                  Typeuri
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  16. Observation.meta.profile
                  Definition

                  A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                  ShortProfiles this resource claims to conform to
                  Comments

                  It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                  Control0..*
                  Typecanonical(StructureDefinition)
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  18. Observation.meta.security
                  Definition

                  Limited security metadata which conveys an attestation that the lab testing provider performed a certain level of identity verification at the time of service. If known, Issuers SHALL attest to the highest level that applies.

                  ShortLimited security label to convey identity level of assurance for patient referenced by this resource.
                  Comments

                  The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                  Control0..1
                  BindingThe codes SHALL be taken from Identity Assurance Level
                  (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/identity-assurance-level)
                  TypeCoding
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  20. Observation.meta.tag
                  Definition

                  Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                  ShortTags applied to this resource
                  Comments

                  The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                  Control0..*
                  BindingFor example codes, see CommonTags
                  (example to http://hl7.org/fhir/ValueSet/common-tags)

                  Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  22. Observation.implicitRules
                  Definition

                  A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                  ShortA set of rules under which this content was created
                  Comments

                  Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                  Control0..1
                  Typeuri
                  Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  24. Observation.language
                  Definition

                  The base language in which the resource is written.

                  ShortLanguage of the resource content
                  Comments

                  Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                  Control0..1
                  BindingThe codes SHOULD be taken from CommonLanguages
                  (preferred to http://hl7.org/fhir/ValueSet/languages)

                  A human language.

                  Additional BindingsPurpose
                  AllLanguagesMax Binding
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  26. Observation.text
                  Definition

                  A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                  ShortText summary of the resource, for human interpretation
                  Comments

                  Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                  Control0..1
                  TypeNarrative
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesnarrative, html, xhtml, display
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  28. Observation.contained
                  Definition

                  These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                  ShortContained, inline Resources
                  Comments

                  This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                  Control0..*
                  TypeResource
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesinline resources, anonymous resources, contained resources
                  30. Observation.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  32. Observation.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                  Summaryfalse
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  34. Observation.identifier
                  Definition

                  A unique identifier assigned to this observation.

                  ShortBusiness Identifier for observation
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..*
                  TypeIdentifier
                  Is Modifierfalse
                  Summarytrue
                  Requirements

                  Allows observations to be distinguished and referenced.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  36. Observation.basedOn
                  Definition

                  A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

                  ShortFulfills plan, proposal or order
                  Control0..*
                  TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                  Is Modifierfalse
                  Summarytrue
                  Requirements

                  Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

                  Alternate NamesFulfills
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  38. Observation.partOf
                  Definition

                  A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

                  ShortPart of referenced event
                  Comments

                  To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

                  Control0..*
                  TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                  Is Modifierfalse
                  Summarytrue
                  Alternate NamesContainer
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  40. Observation.status
                  Definition

                  The status of the result value.

                  Shortregistered | preliminary | final | amended +
                  Comments

                  This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

                  Control1..1
                  BindingThe codes SHALL be taken from Completed observation status
                  (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/completed-observation-status)
                  Typecode
                  Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Need to track the status of individual results. Some results are finalized before the whole report is finalized.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  42. Observation.category
                  Definition

                  A code that classifies the general type of observation being made.

                  ShortClassification of type of observation
                  Comments

                  In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                  Control0..*
                  BindingThe codes SHOULD be taken from ObservationCategoryCodes
                  (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                  Codes for high level observation categories.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Summaryfalse
                  Requirements

                  Used for filtering what observations are retrieved and displayed.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. Observation.code
                  Definition

                  If an appropriate code is not found in the bound value set, use the SHCInfectiousDiseaseLaboratoryResultObservation profile instead, which allows for any SNOMED CT descendant of 441742003 "Evaluation finding (finding)" or 362981000 "Qualifier value (qualifier value)".

                  ShortType of observation (code / type)
                  Comments

                  All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                  Control1..1
                  BindingThe codes SHALL be taken from LOINCs identifying qualitative COVID lab tests
                  (required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-test-covid)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Knowing what kind of observation is being made is essential to understanding the observation.

                  Alternate NamesName
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. Observation.subject
                  Definition

                  Reference to a VaccinationCredentialPatient-conforming resource who is subject of lab result.

                  ShortPatient to whom lab result applies
                  Comments

                  One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

                  Control1..1
                  TypeReference(Patient Profile - General - Allowable Data)
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Observations have no value if you don't know who or what they're about.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. Observation.subject.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  50. Observation.subject.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on Observation.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 52. Observation.subject.reference
                    Definition

                    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                    ShortThis SHOULD use an absolute URI like `resource:0` that will resolve within the containing Bundle.
                    Comments

                    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                    Control1..1
                    This element is affected by the following invariants: ref-1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    54. Observation.subject.type
                    Definition

                    The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                    The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                    ShortType the reference refers to (e.g. "Patient")
                    Comments

                    This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                    Control0..0
                    BindingUnless not suitable, these codes SHALL be taken from ResourceType
                    (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                    Aa resource (or, for logical models, the URI of the logical model).

                    Typeuri
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    56. Observation.subject.identifier
                    Definition

                    An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                    ShortLogical reference, when literal reference is not known
                    Comments

                    When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                    When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                    Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                    Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..0
                    TypeIdentifier
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    58. Observation.subject.display
                    Definition

                    Plain text narrative that identifies the resource in addition to the resource reference.

                    ShortText alternative for the resource
                    Comments

                    This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                    Control0..0
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    60. Observation.focus
                    Definition

                    The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

                    ShortWhat the observation is about, when it is not about the subject of record
                    Comments

                    Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

                    Control0..*
                    TypeReference(Resource)
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    62. Observation.encounter
                    Definition

                    The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

                    ShortHealthcare event during which this observation is made
                    Comments

                    This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

                    Control0..1
                    TypeReference(Encounter)
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    For some observations it may be important to know the link between an observation and a particular encounter.

                    Alternate NamesContext
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. Observation.effective[x]
                    Definition

                    The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                    ShortClinically relevant time/time-period for observation
                    Comments

                    At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

                    Control1..1
                    TypeChoice of: dateTime, Period
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Must Support TypesNo must-support rules about the choice of types/profiles
                    Summarytrue
                    Requirements

                    Knowing when an observation was deemed true is important to its relevance as well as determining trends.

                    Alternate NamesOccurrence
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. Observation.issued
                    Definition

                    The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

                    ShortDate/Time this version was made available
                    Comments

                    For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

                    Control0..1
                    Typeinstant
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    68. Observation.performer
                    Definition

                    Only Observation.performer.display SHOULD be populated. See the definition of that element for details.

                    ShortOrganization which was responsible for the laboratory test result.
                    Control0..1
                    TypeReference(Organization)
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    70. Observation.performer.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    72. Observation.performer.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on Observation.performer.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 74. Observation.performer.reference
                      Definition

                      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                      ShortLiteral reference, Relative, internal or absolute URL
                      Comments

                      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                      Control0..1
                      This element is affected by the following invariants: ref-1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      76. Observation.performer.type
                      Definition

                      The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                      The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                      ShortType the reference refers to (e.g. "Patient")
                      Comments

                      This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                      Control0..1
                      BindingUnless not suitable, these codes SHALL be taken from ResourceType
                      (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                      Aa resource (or, for logical models, the URI of the logical model).

                      Typeuri
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      78. Observation.performer.identifier
                      Definition

                      An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                      ShortLogical reference, when literal reference is not known
                      Comments

                      When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                      When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                      Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                      Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      Control0..1
                      TypeIdentifier
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      80. Observation.performer.display
                      Definition

                      Organization which was responsible for the laboratory test result. Issuers SHOULD provide display name only. This is provided to Verifiers in case of invalid data in the credential, to support manual validation. This is not expected to be a computable Organization identifier.

                      ShortShort, human-readable text representation of the organization.
                      Comments

                      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                      Control1..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      vc-should-be-under-30-chars: Length SHOULD be <30 for data minimization. ($this.length() < 30)
                      82. Observation.value[x]
                      Definition

                      The information determined as a result of making the observation, if the information has a simple value.

                      ShortActual result
                      Comments

                      Issuers SHALL provide a computable representation of laboratory results if at all possible. If the Issuer is unable to accurately translate laboratory results into a computable form, it is unlikely a Verifier will be able to interpret the results. Issuers SHALL make every possible effort to resolve non-computable results prior to issuing credentials. In rare cases when this is not possible, Issuers MAY populate valueString with a free text result.

                      Control1..1
                      This element is affected by the following invariants: obs-7
                      TypeChoice of: Quantity, CodeableConcept, string
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Must Support TypesNo must-support rules about the choice of types/profiles
                      Summarytrue
                      Requirements

                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 84. Observation.value[x]:valueCodeableConcept
                        Slice NamevalueCodeableConcept
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortActual result
                        Comments

                        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control0..1
                        This element is affected by the following invariants: obs-7
                        BindingThe codes SHALL be taken from Qualitative infectious disease-related lab test result codes
                        (required to https://terminology.smarthealth.cards/ValueSet/lab-qualitative-result)
                        TypeCodeableConcept
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        86. Observation.value[x]:valueQuantity
                        Slice NamevalueQuantity
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortActual result
                        Comments

                        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control0..1
                        This element is affected by the following invariants: obs-7
                        TypeQuantity
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        vc-observation-quantity-should-have-range: Quantitative lab results SHOULD include reference range (%resource.referenceRange.exists())
                        88. Observation.value[x]:valueString
                        Slice NamevalueString
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortString representation of results; used ONLY when a computable representation is not possible
                        Comments

                        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control0..1
                        This element is affected by the following invariants: obs-7
                        Typestring
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        vc-should-be-under-20-chars: Length SHOULD be <20 for data minimization. ($this.length() < 20)
                        90. Observation.dataAbsentReason
                        Definition

                        Provides a reason why the expected value in the element Observation.value[x] is missing.

                        ShortWhy the result is missing
                        Comments

                        Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

                        Control0..1
                        This element is affected by the following invariants: obs-6
                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                        Codes specifying why the result (Observation.value[x]) is missing.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        For many results it is necessary to handle exceptional values in measurements.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        92. Observation.interpretation
                        Definition

                        A categorical assessment of an observation value. For example, high, low, normal.

                        ShortHigh, low, normal, etc.
                        Comments

                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                        Control0..*
                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                        Codes identifying interpretations of observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                        Alternate NamesAbnormal Flag
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        94. Observation.note
                        Definition

                        Comments about the observation or the results.

                        ShortComments about the observation
                        Comments

                        May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

                        Control0..*
                        TypeAnnotation
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Need to be able to provide free text additional information.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        96. Observation.bodySite
                        Definition

                        Indicates the site on the subject's body where the observation was made (i.e. the target site).

                        ShortObserved body part
                        Comments

                        Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

                        If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

                        Control0..1
                        BindingFor example codes, see SNOMEDCTBodyStructures
                        (example to http://hl7.org/fhir/ValueSet/body-site)

                        Codes describing anatomical locations. May include laterality.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        98. Observation.method
                        Definition

                        Indicates the mechanism used to perform the observation.

                        ShortHow it was done
                        Comments

                        Only used if not implicit in code for Observation.code.

                        Control0..1
                        BindingFor example codes, see ObservationMethods
                        (example to http://hl7.org/fhir/ValueSet/observation-methods)

                        Methods for simple observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        100. Observation.specimen
                        Definition

                        The specimen that was used when this observation was made.

                        ShortSpecimen used for this observation
                        Comments

                        Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                        Control0..1
                        TypeReference(Specimen)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        102. Observation.device
                        Definition

                        The device used to generate the observation data.

                        Short(Measurement) Device
                        Comments

                        Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

                        Control0..1
                        TypeReference(Device, DeviceMetric)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        104. Observation.referenceRange
                        Definition

                        Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                        ShortProvides guide for interpretation. SHOULD include if using valueQuantity.
                        Comments

                        Issuers SHOULD provide a reference range for quantitative lab results to allow recipients to correctly interpret the results. Issuers MAY provide a reference range for free text (string) results.

                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        Requirements

                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                        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 ($this.exists() and (%resource.value.ofType(Quantity).exists() or %resource.value.ofType(string).exists()))
                        106. Observation.referenceRange.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        108. Observation.referenceRange.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        ShortAdditional content defined by implementations
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        110. Observation.referenceRange.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        112. Observation.referenceRange.low
                        Definition

                        The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                        ShortLow Range, if relevant
                        Control0..1
                        This element is affected by the following invariants: obs-3
                        TypeQuantity(SimpleQuantity)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        114. Observation.referenceRange.high
                        Definition

                        The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                        ShortHigh Range, if relevant
                        Control0..1
                        This element is affected by the following invariants: obs-3
                        TypeQuantity(SimpleQuantity)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        116. Observation.referenceRange.type
                        Definition

                        Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                        ShortReference range qualifier
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                        Control0..1
                        BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                        (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                        Code for the meaning of a reference range.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        118. Observation.referenceRange.appliesTo
                        Definition

                        Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                        ShortReference range population
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                        Control0..*
                        BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                        (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                        Codes identifying the population the reference range applies to.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Need to be able to identify the target population for proper interpretation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        120. Observation.referenceRange.age
                        Definition

                        The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                        ShortApplicable age range, if relevant
                        Control0..1
                        TypeRange
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Some analytes vary greatly over age.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        122. Observation.referenceRange.text
                        Definition

                        Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                        ShortText based reference range in an observation
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        124. Observation.hasMember
                        Definition

                        This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

                        ShortRelated resource that belongs to the Observation group
                        Comments

                        When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                        Control0..*
                        TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        126. Observation.derivedFrom
                        Definition

                        The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                        ShortRelated measurements the observation is made from
                        Comments

                        All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

                        Control0..*
                        TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        128. Observation.component
                        Definition

                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                        ShortComponent results
                        Comments

                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ code
                        • 130. Observation.component.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          132. Observation.component.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          134. Observation.component.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          136. Observation.component.code
                          Definition

                          Describes what was observed. Sometimes this is called the observation "code".

                          ShortType of component observation (code / type)
                          Comments

                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                          Control1..1
                          BindingFor example codes, see LOINCCodes
                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                          Codes identifying names of simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Knowing what kind of observation is being made is essential to understanding the observation.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          138. Observation.component.value[x]
                          Definition

                          The information determined as a result of making the observation, if the information has a simple value.

                          ShortActual component result
                          Comments

                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                          Control0..1
                          TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          140. Observation.component.dataAbsentReason
                          Definition

                          Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                          ShortWhy the component result is missing
                          Comments

                          "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                          Control0..1
                          This element is affected by the following invariants: obs-6
                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                          Codes specifying why the result (Observation.value[x]) is missing.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Requirements

                          For many results it is necessary to handle exceptional values in measurements.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          142. Observation.component.interpretation
                          Definition

                          A categorical assessment of an observation value. For example, high, low, normal.

                          ShortHigh, low, normal, etc.
                          Comments

                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                          Control0..*
                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                          Codes identifying interpretations of observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Requirements

                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                          Alternate NamesAbnormal Flag
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          144. Observation.component.referenceRange
                          Definition

                          Guidance on how to interpret the value by comparison to a normal or recommended range.

                          ShortProvides guide for interpretation of component result
                          Comments

                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                          Control0..*
                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                          Is Modifierfalse
                          Summaryfalse
                          Requirements

                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          146. Observation.component:specimen-supervision-status
                          Slice Namespecimen-supervision-status
                          Definition

                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                          ShortComponent results
                          Comments

                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                          Control0..1
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          148. Observation.component:specimen-supervision-status.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          150. Observation.component:specimen-supervision-status.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          152. Observation.component:specimen-supervision-status.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          154. Observation.component:specimen-supervision-status.code
                          Definition

                          Describes what was observed. Sometimes this is called the observation "code".

                          ShortType of component observation (code / type)
                          Comments

                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                          Control1..1
                          BindingFor example codes, see LOINCCodes
                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                          Codes identifying names of simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Knowing what kind of observation is being made is essential to understanding the observation.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          156. Observation.component:specimen-supervision-status.code.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          158. Observation.component:specimen-supervision-status.code.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Observation.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 160. Observation.component:specimen-supervision-status.code.coding
                            Definition

                            A reference to a code defined by a terminology system.

                            ShortCode defined by a terminology system
                            Comments

                            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                            Control1..1
                            TypeCoding
                            Is Modifierfalse
                            Summarytrue
                            Requirements

                            Allows for alternative encodings within a code system, and translations to other code systems.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            162. Observation.component:specimen-supervision-status.code.coding.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            164. Observation.component:specimen-supervision-status.code.coding.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on Observation.component.code.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 166. Observation.component:specimen-supervision-status.code.coding.system
                              Definition

                              The identification of the code system that defines the meaning of the symbol in the code.

                              ShortIdentity of the terminology system
                              Comments

                              The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                              Control1..1
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to be unambiguous about the source of the definition of the symbol.

                              Fixed Valuehttp://snomed.info/sct
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              168. Observation.component:specimen-supervision-status.code.coding.version
                              Definition

                              The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                              ShortVersion of the system - if relevant
                              Comments

                              Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                              NoteThis is a business version Id, not a resource version Id (see discussion)
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              170. Observation.component:specimen-supervision-status.code.coding.code
                              Definition

                              A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                              ShortSNOMED CT concept 'Type of supervision for specimen collection (observable entity)'
                              Control1..1
                              Typecode
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to refer to a particular code in the system.

                              Fixed Value1208522006
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              172. Observation.component:specimen-supervision-status.code.coding.display
                              Definition

                              A representation of the meaning of the code in the system, following the rules of the system.

                              ShortRepresentation defined by the system
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              174. Observation.component:specimen-supervision-status.code.coding.userSelected
                              Definition

                              Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                              ShortIf this coding was chosen directly by the user
                              Comments

                              Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                              Control0..1
                              Typeboolean
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              176. Observation.component:specimen-supervision-status.code.text
                              Definition

                              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                              ShortPlain text representation of the concept
                              Comments

                              Very often the text is the same as a displayName of one of the codings.

                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              178. Observation.component:specimen-supervision-status.value[x]
                              Definition

                              The information determined as a result of making the observation, if the information has a simple value.

                              ShortActual component result
                              Comments

                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                              Control1..1
                              TypeCodeableConcept
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Is Modifierfalse
                              Summarytrue
                              Requirements

                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                              • type @ $this
                              • 180. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept
                                Slice NamevalueCodeableConcept
                                Definition

                                The information determined as a result of making the observation, if the information has a simple value.

                                ShortActual component result
                                Comments

                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                Control1..1
                                BindingThe codes SHALL be taken from Specimen Collection Supervision Status
                                (required to http://hl7.org/fhir/uv/shc-vaccination/ValueSet/specimen-collection-supervision-status)
                                TypeCodeableConcept
                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                Is Modifierfalse
                                Summarytrue
                                Requirements

                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                182. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                184. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.extension
                                Definition

                                An Extension

                                ShortExtension
                                Control0..0
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 186. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..1
                                  TypeCoding
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  188. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  Typestring
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  190. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.extension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on Observation.component.value[x].coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 192. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.system
                                    Definition

                                    The identification of the code system that defines the meaning of the symbol in the code.

                                    ShortIdentity of the terminology system
                                    Comments

                                    The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                                    Control1..1
                                    Typeuri
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    Need to be unambiguous about the source of the definition of the symbol.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    194. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.version
                                    Definition

                                    The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                    ShortVersion of the system - if relevant
                                    Comments

                                    Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                    NoteThis is a business version Id, not a resource version Id (see discussion)
                                    Control0..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    196. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.code
                                    Definition

                                    A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                    ShortSymbol in syntax defined by the system
                                    Control1..1
                                    Typecode
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    Need to refer to a particular code in the system.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    198. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.display
                                    Definition

                                    A representation of the meaning of the code in the system, following the rules of the system.

                                    ShortRepresentation defined by the system
                                    Control0..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    200. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.coding.userSelected
                                    Definition

                                    Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                    ShortIf this coding was chosen directly by the user
                                    Comments

                                    Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                    Control0..1
                                    Typeboolean
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    202. Observation.component:specimen-supervision-status.value[x]:valueCodeableConcept.text
                                    Definition

                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                    ShortPlain text representation of the concept
                                    Comments

                                    Very often the text is the same as a displayName of one of the codings.

                                    Control0..1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    204. Observation.component:specimen-supervision-status.dataAbsentReason
                                    Definition

                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                    ShortWhy the component result is missing
                                    Comments

                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                    Control0..1
                                    This element is affected by the following invariants: obs-6
                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                    Codes specifying why the result (Observation.value[x]) is missing.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summaryfalse
                                    Requirements

                                    For many results it is necessary to handle exceptional values in measurements.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    206. Observation.component:specimen-supervision-status.interpretation
                                    Definition

                                    A categorical assessment of an observation value. For example, high, low, normal.

                                    ShortHigh, low, normal, etc.
                                    Comments

                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                    Control0..*
                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                    Codes identifying interpretations of observations.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summaryfalse
                                    Requirements

                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                    Alternate NamesAbnormal Flag
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    208. Observation.component:specimen-supervision-status.referenceRange
                                    Definition

                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                    ShortProvides guide for interpretation of component result
                                    Comments

                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                    Control0..*
                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                    Is Modifierfalse
                                    Summaryfalse
                                    Requirements

                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))