Lithuanian Laboratory Implementation Guide
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Lithuanian Laboratory Implementation Guide, published by Lithuanian Medical Library. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7LT/ig-lt-lab/ and changes regularly. See the Directory of published versions

Resource Profile: Observation: Her2 Receptor Status - Detailed Descriptions

Draft as of 2026-03-29

Definitions for the her2-receptor-status-observation-lt-lab resource profile

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

0. Observation
Definition

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

ShortPathology Observation Her2 Receptor StatusMeasurements 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
Must Supportfalse
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present (bodySite.exists() implies bodyStructure.empty())
inv-obs-1: Observation must have either value[x] or dataAbsentReason (value.exists() or dataAbsentReason.exists())
dom-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present (bodySite.exists() implies bodyStructure.empty())
2. 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 its 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 its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

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..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. 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 managable, 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
Must Supportfalse
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
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())
ele-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())
8. 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
Must Supporttrue
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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.instantiates[x]
Definition

The reference to a FHIR ObservationDefinition resource that provides the definition that is adhered to in whole or in part by this Observation instance.

ShortInstantiates FHIR ObservationDefinition
Comments

ObservationDefinition can be referenced by its canonical url using instantiatesCanonical, or by a name or an identifier using the appropriate sub-elements of instantiatesReference.

Control0..1
TypeChoice of: canonical(ObservationDefinition), Reference(ObservationDefinition)
[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
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. 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..1*
TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Observation.triggeredBy
Definition

Identifies the observation(s) that triggered the performance of this observation.

ShortTriggering observation(s)
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Observation.triggeredBy.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 managable, 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())
ele-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())
18. Observation.triggeredBy.observation
Definition

Reference to the triggering observation.

ShortTriggering observation
Control1..1
TypeReference(ObservationLt, Observation)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Observation.triggeredBy.type
Definition

The type of trigger. Reflex | Repeat | Re-run.

Shortreflex | repeat | re-run
Control1..1
BindingThe codes SHALL be taken from TriggeredBytypehttp://hl7.org/fhir/ValueSet/observation-triggeredbytype|5.0.0
(required to http://hl7.org/fhir/ValueSet/observation-triggeredbytype|5.0.0)

The type of TriggeredBy Observation.

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

Provides the reason why this observation was performed as a result of the observation(s) referenced.

ShortReason that the observation was triggered
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. 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, GenomicStudy)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Alternate NamesContainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. 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 ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/observation-status|5.0.0)

Codes providing the status of an observation.

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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. 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 ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|5.0.0
(preferred to http://hl7.org/fhir/ValueSet/observation-category|5.0.0)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Observation.code
Definition

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
This element is affected by the following invariants: obs-7
BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|5.0.0
(example to http://hl7.org/fhir/ValueSet/observation-codes|5.0.0)

Codes identifying names of simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

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

Alternate NamesName
Pattern Value{
  "coding" : [{
    "system" : "http://loinc.org",
    "code" : "31150-6",
    "display" : "ERBB2 gene duplication [Presence] in Tissue by FISH"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Observation.subject
Definition

The patient, or group of patients, location, device, organization, procedure or practitioner this observation is about and into whose or what 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.

ShortPatientWho 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. The subject of an Observation may in some cases be a procedure. This supports the regulatory inspection use case where observations are captured during inspections of a procedure that is being performed (independent of any particular patient or whether patient related at all).

Control10..1
TypeReference(PatientLt, Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance, BiologicallyDerivedProduct, NutritionProduct)
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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. 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.

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.

Control10..1
This element is affected by the following invariants: ref-2, 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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. 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 http://hl7.org/fhir/StructureDefinition/observation-focusCode.

Control0..*
TypeReference(Resource)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. 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(EncounterLt, Encounter)
Is Modifierfalse
Must Supporttrue
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()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. 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
TypedateTime, 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
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()))
ele-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.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
  • 42. Observation.effective[x]:effectiveDateTime
    Slice NameeffectiveDateTime
    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
    TypedateTime, 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
    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()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. 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
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    46. Observation.performer
    Definition

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

    ShortPractitioner if resident physician or Organization Department if hospitalWho is responsible for the observation
    Control0..*
    TypeReference(PractitionerLt, OrganizationLt, Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    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()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. 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.

    Control10..1
    This element is affected by the following invariants: ref-2, 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()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    50. Observation.value[x]
    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
      3. only a set of related or component values.
    • If a value is present, the datatype for this element should be determined by the code.
    • 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 code defines a coded value.
    • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
    • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
    • For additional guidance, see the Notes section below.
    Control0..1
    This element is affected by the following invariants: obs-7, obs-6
    TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)
    [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()))
    ele-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 Open, and can be differentiated using the following discriminators:
    • type @ $this
    • 52. Observation.value[x]:valueCodeableConcept
      Slice NamevalueCodeableConcept
      Definition

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

      ShortThe Her2 (human epidermal growth factor receptor 2) expression status of the tumour.Actual result
      Comments
      • An observation may have:
        1. a single value here
        2. both a value and a set of related or component values
        3. only a set of related or component values.
      • If a value is present, the datatype for this element should be determined by the code.
      • 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 code defines a coded value.
      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
      • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
      • For additional guidance, see the Notes section below.
      Control0..1
      This element is affected by the following invariants: obs-7, obs-6
      BindingThe codes SHOULD be taken from For codes, see Her2ReceptorStatusVSLtLab (0.1.0)
      (preferred to https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status|0.1.0)
      TypeCodeableConcept, dateTime, string, Reference(MolecularSequence), Quantity, Period, Attachment, integer, Range, boolean, SampledData, Ratio, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      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()))
      inv-her2receptorstatus: At least one of the codings should come from the preferred value set (coding.where(code.memberOf('https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status')).exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. Observation.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..*
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      56. Observation.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 be an absolute 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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. Observation.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
      This element is affected by the following invariants: cod-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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. Observation.dataAbsentReason
      Definition

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

      ShortThe Her2 expression status of the tumour is not performed or unknown whether performed or notWhy 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 DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|5.0.0
      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|5.0.0)

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      62. Observation.dataAbsentReason.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..*
      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()))
      inv-obs-2: The value for code must be either 'unknown' or 'not-performed' (code='unknown' or code='not-performed')
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. Observation.dataAbsentReason.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 be an absolute 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://terminology.hl7.org/CodeSystem/data-absent-reason
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      66. Observation.dataAbsentReason.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
      This element is affected by the following invariants: cod-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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. 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
      Must Supporttrue
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      70. Observation.bodyStructure
      Definition

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

      ShortObserved body structure
      Comments

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

      Control0..1
      This element is affected by the following invariants: obs-8
      TypeReference(BodyStructure)
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      72. 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, Group)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      obs-9: If Observation.specimen is a reference to Group, the group can only have specimens ((reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      obs-9: If Observation.specimen is a reference to Group, the group can only have specimens ((reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen))
      74. Observation.device
      Definition

      A reference to the device that generates the measurements or the device settings for the device.

      ShortA reference to the device that generates the measurements or the device settings for the 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
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. 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
      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..*
      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())
      ele-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())
      78. 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 managable, 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())
      ele-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())
      80. 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
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. 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
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      84. Observation.referenceRange.normalValue
      Definition

      The value of the normal value of the reference range.

      ShortNormal value, if relevant
      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from ObservationReferenceRangeNormalValueCodeshttp://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue|5.0.0
      (extensible to http://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue|5.0.0)

      Codes identifying the normal value of the observation.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      86. 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
      Must Supporttrue
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      88. 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
      This element is affected by the following invariants: obs-3
      Typemarkdown
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      90. 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.


      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(ObservationLt, QuestionnaireResponse, Observation, MolecularSequence)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      92. 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 resource from which the observation is made
      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, QuestionnaireResponse, ObservationLt, ImagingSelection, Observation, MolecularSequence, GenomicStudy)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      94. 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..*
      This element is affected by the following invariants: obs-7
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      96. 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 managable, 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())
      ele-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())
      98. 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
      This element is affected by the following invariants: obs-7
      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|5.0.0
      (example to http://hl7.org/fhir/ValueSet/observation-codes|5.0.0)

      Codes identifying names of simple observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      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()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      100. 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 the code.
      • 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 code defines a coded value.
      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
      • If a value is present, the datatype for this element should be determined by the code.
      • 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 code defines a coded value.
      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
      • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
      • For additional guidance, see the Notes section below.
      Control0..1
      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)
      [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()))
      ele-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 foundhere

      0. Observation
      ShortPathology Observation Her2 Receptor Status
      Invariantsinv-obs-1: Observation must have either value[x] or dataAbsentReason (value.exists() or dataAbsentReason.exists())
      2. Observation.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "31150-6",
          "display" : "ERBB2 gene duplication [Presence] in Tissue by FISH"
        }]
      }
      4. Observation.subject
      ShortPatient
      Control1..?
      TypeReference(PatientLt)
      6. Observation.subject.reference
      Control1..?
      8. Observation.effective[x]
      Control1..?
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 10. Observation.effective[x]:effectiveDateTime
        Slice NameeffectiveDateTime
        Control1..1
        TypedateTime
        [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
        12. Observation.performer
        ShortPractitioner if resident physician or Organization Department if hospital
        TypeReference(PractitionerLt, OrganizationLt)
        14. Observation.performer.reference
        Control1..?
        16. Observation.value[x]
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        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
        • 18. Observation.value[x]:valueCodeableConcept
          Slice NamevalueCodeableConcept
          ShortThe Her2 (human epidermal growth factor receptor 2) expression status of the tumour.
          Control0..1
          BindingThe codes SHOULD be taken from Her2ReceptorStatusVSLtLab (0.1.0)
          (preferred to https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status|0.1.0)
          TypeCodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Invariantsinv-her2receptorstatus: At least one of the codings should come from the preferred value set (coding.where(code.memberOf('https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status')).exists())
          20. Observation.value[x]:valueCodeableConcept.coding
          Control1..?
          22. Observation.value[x]:valueCodeableConcept.coding.system
          Control1..?
          24. Observation.value[x]:valueCodeableConcept.coding.code
          Control1..?
          26. Observation.dataAbsentReason
          ShortThe Her2 expression status of the tumour is not performed or unknown whether performed or not
          28. Observation.dataAbsentReason.coding
          Control1..?
          Invariantsinv-obs-2: The value for code must be either 'unknown' or 'not-performed' (code='unknown' or code='not-performed')
          30. Observation.dataAbsentReason.coding.system
          Control1..?
          Fixed Valuehttp://terminology.hl7.org/CodeSystem/data-absent-reason
          32. Observation.dataAbsentReason.coding.code
          Control1..?

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

          0. Observation
          Definition

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

          ShortPathology Observation Her2 Receptor Status
          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
          Must Supportfalse
          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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
          obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present (bodySite.exists() implies bodyStructure.empty())
          inv-obs-1: Observation must have either value[x] or dataAbsentReason (value.exists() or dataAbsentReason.exists())
          2. Observation.id
          Definition

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

          ShortLogical id of this artifact
          Comments

          Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

          Control0..1
          Typeid
          Is Modifierfalse
          Must Supportfalse
          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 Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. 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 its 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 its meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. 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 SHALL be taken from AllLanguages
          (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

          IETF language tag for a human language

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. 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 a 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
          This element is affected by the following invariants: dom-6
          TypeNarrative
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. Observation.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

          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..*
          This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
          TypeResource
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. 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 managable, 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
          Must Supportfalse
          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())
          16. 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 managable, 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
          Must Supportfalse
          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
          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())
          18. 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
          Must Supporttrue
          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()))
          20. Observation.instantiates[x]
          Definition

          The reference to a FHIR ObservationDefinition resource that provides the definition that is adhered to in whole or in part by this Observation instance.

          ShortInstantiates FHIR ObservationDefinition
          Comments

          ObservationDefinition can be referenced by its canonical url using instantiatesCanonical, or by a name or an identifier using the appropriate sub-elements of instantiatesReference.

          Control0..1
          TypeChoice of: canonical(ObservationDefinition), Reference(ObservationDefinition)
          [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
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. 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..1
          TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          24. Observation.triggeredBy
          Definition

          Identifies the observation(s) that triggered the performance of this observation.

          ShortTriggering observation(s)
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. Observation.triggeredBy.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
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          28. Observation.triggeredBy.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 managable, 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())
          30. Observation.triggeredBy.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 managable, 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())
          32. Observation.triggeredBy.observation
          Definition

          Reference to the triggering observation.

          ShortTriggering observation
          Control1..1
          TypeReference(ObservationLt)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Observation.triggeredBy.type
          Definition

          The type of trigger. Reflex | Repeat | Re-run.

          Shortreflex | repeat | re-run
          Control1..1
          BindingThe codes SHALL be taken from TriggeredBytype
          (required to http://hl7.org/fhir/ValueSet/observation-triggeredbytype|5.0.0)

          The type of TriggeredBy Observation.

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. Observation.triggeredBy.reason
          Definition

          Provides the reason why this observation was performed as a result of the observation(s) referenced.

          ShortReason that the observation was triggered
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summaryfalse
          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, GenomicStudy)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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 ObservationStatus
          (required to http://hl7.org/fhir/ValueSet/observation-status|5.0.0)

          Codes providing the status of an observation.

          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|5.0.0)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          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

          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
          This element is affected by the following invariants: obs-7
          BindingFor example codes, see LOINCCodes
          (example to http://hl7.org/fhir/ValueSet/observation-codes|5.0.0)

          Codes identifying names of simple observations.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

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

          Alternate NamesName
          Pattern Value{
            "coding" : [{
              "system" : "http://loinc.org",
              "code" : "31150-6",
              "display" : "ERBB2 gene duplication [Presence] in Tissue by FISH"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. Observation.subject
          Definition

          The patient, or group of patients, location, device, organization, procedure or practitioner this observation is about and into whose or what 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
          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. The subject of an Observation may in some cases be a procedure. This supports the regulatory inspection use case where observations are captured during inspections of a procedure that is being performed (independent of any particular patient or whether patient related at all).

          Control1..1
          TypeReference(PatientLt)
          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
          This element is affected by the following invariants: ele-1
          Typeid
          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 managable, 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.

            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.

            Control1..1
            This element is affected by the following invariants: ref-2, 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") - must be a resource in resources
            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 known RESTful URL) or by resolving the target of the reference.

            Control0..1
            BindingUnless not suitable, these codes SHALL be taken from ResourceType
            (extensible to http://hl7.org/fhir/ValueSet/resource-types|5.0.0)

            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).

            This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..1
            This element is affected by the following invariants: ref-2
            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..1
            This element is affected by the following invariants: ref-2
            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 http://hl7.org/fhir/StructureDefinition/observation-focusCode.

            Control0..*
            TypeReference(Resource)
            Is Modifierfalse
            Must Supporttrue
            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(EncounterLt)
            Is Modifierfalse
            Must Supporttrue
            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
            TypedateTime
            [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
            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()))
            SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 66. Observation.effective[x]:effectiveDateTime
              Slice NameeffectiveDateTime
              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
              TypedateTime
              [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
              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()))
              68. 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
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. Observation.performer
              Definition

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

              ShortPractitioner if resident physician or Organization Department if hospital
              Control0..*
              TypeReference(PractitionerLt, OrganizationLt)
              Is Modifierfalse
              Must Supporttrue
              Must Support TypesNo must-support rules about the choice of types/profiles
              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()))
              72. 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
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              74. 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 managable, 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
              • 76. 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.

                Control1..1
                This element is affected by the following invariants: ref-2, 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()))
                78. 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") - must be a resource in resources
                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 known RESTful URL) or by resolving the target of the reference.

                Control0..1
                BindingUnless not suitable, these codes SHALL be taken from ResourceType
                (extensible to http://hl7.org/fhir/ValueSet/resource-types|5.0.0)

                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()))
                80. 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).

                This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                This element is affected by the following invariants: ref-2
                TypeIdentifier
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                82. Observation.performer.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..1
                This element is affected by the following invariants: ref-2
                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()))
                84. Observation.value[x]
                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
                  3. only a set of related or component values.
                • If a value is present, the datatype for this element should be determined by the code.
                • 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 code defines a coded value.
                • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                • For additional guidance, see the Notes section below.
                Control0..1
                This element is affected by the following invariants: obs-7, obs-6
                TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)
                [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 Open, and can be differentiated using the following discriminators:
                • type @ $this
                • 86. Observation.value[x]:valueCodeableConcept
                  Slice NamevalueCodeableConcept
                  Definition

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

                  ShortThe Her2 (human epidermal growth factor receptor 2) expression status of the tumour.
                  Comments
                  • An observation may have:
                    1. a single value here
                    2. both a value and a set of related or component values
                    3. only a set of related or component values.
                  • If a value is present, the datatype for this element should be determined by the code.
                  • 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 code defines a coded value.
                  • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                  • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                  • For additional guidance, see the Notes section below.
                  Control0..1
                  This element is affected by the following invariants: obs-7, obs-6
                  BindingThe codes SHOULD be taken from Her2ReceptorStatusVSLtLab (0.1.0)
                  (preferred to https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status|0.1.0)
                  TypeCodeableConcept
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Must Supporttrue
                  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()))
                  inv-her2receptorstatus: At least one of the codings should come from the preferred value set (coding.where(code.memberOf('https://tx.hl7.lt/fhir/ValueSet/her2-receptor-status')).exists())
                  88. Observation.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
                  This element is affected by the following invariants: ele-1
                  Typeid
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  90. Observation.value[x]:valueCodeableConcept.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 managable, 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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 92. Observation.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..*
                    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()))
                    94. Observation.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
                    This element is affected by the following invariants: ele-1
                    Typeid
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    96. Observation.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 managable, 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.value[x].coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 98. Observation.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 be an absolute 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()))
                      100. Observation.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()))
                      102. Observation.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
                      This element is affected by the following invariants: cod-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()))
                      104. Observation.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
                      This element is affected by the following invariants: cod-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()))
                      106. Observation.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()))
                      108. Observation.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()))
                      110. Observation.dataAbsentReason
                      Definition

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

                      ShortThe Her2 expression status of the tumour is not performed or unknown whether performed or not
                      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|5.0.0)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      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()))
                      112. Observation.dataAbsentReason.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
                      This element is affected by the following invariants: ele-1
                      Typeid
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      114. Observation.dataAbsentReason.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 managable, 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.dataAbsentReason.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 116. Observation.dataAbsentReason.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..*
                        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()))
                        inv-obs-2: The value for code must be either 'unknown' or 'not-performed' (code='unknown' or code='not-performed')
                        118. Observation.dataAbsentReason.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
                        This element is affected by the following invariants: ele-1
                        Typeid
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        120. Observation.dataAbsentReason.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 managable, 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.dataAbsentReason.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 122. Observation.dataAbsentReason.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 be an absolute 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://terminology.hl7.org/CodeSystem/data-absent-reason
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          124. Observation.dataAbsentReason.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()))
                          126. Observation.dataAbsentReason.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
                          This element is affected by the following invariants: cod-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()))
                          128. Observation.dataAbsentReason.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
                          This element is affected by the following invariants: cod-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()))
                          130. Observation.dataAbsentReason.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()))
                          132. Observation.dataAbsentReason.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()))
                          134. 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|5.0.0)

                          Codes identifying interpretations of observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          136. 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
                          Must Supporttrue
                          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()))
                          138. 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.

                          Control0..1
                          This element is affected by the following invariants: obs-8
                          BindingFor example codes, see SNOMEDCTBodyStructures
                          (example to http://hl7.org/fhir/ValueSet/body-site|5.0.0)

                          SNOMED CT Body site concepts

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

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

                          ShortObserved body structure
                          Comments

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

                          Control0..1
                          This element is affected by the following invariants: obs-8
                          TypeReference(BodyStructure)
                          Is Modifierfalse
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          142. 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|5.0.0)

                          Methods for simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          144. 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, Group)
                          Is Modifierfalse
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          obs-9: If Observation.specimen is a reference to Group, the group can only have specimens ((reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen))
                          146. Observation.device
                          Definition

                          A reference to the device that generates the measurements or the device settings for the device.

                          ShortA reference to the device that generates the measurements or the device settings for the 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
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          148. 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
                          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..*
                          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())
                          150. 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
                          This element is affected by the following invariants: ele-1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          152. 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 managable, 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())
                          154. 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 managable, 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())
                          156. 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
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          158. 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
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          160. Observation.referenceRange.normalValue
                          Definition

                          The value of the normal value of the reference range.

                          ShortNormal value, if relevant
                          Control0..1
                          BindingUnless not suitable, these codes SHALL be taken from ObservationReferenceRangeNormalValueCodes
                          (extensible to http://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue|5.0.0)

                          Codes identifying the normal value of the observation.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          162. 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|5.0.0)

                          Code for the meaning of a reference range.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          164. 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|5.0.0)

                          Codes identifying the population the reference range applies to.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          166. 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
                          Must Supporttrue
                          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()))
                          168. 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
                          This element is affected by the following invariants: obs-3
                          Typemarkdown
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          170. 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(ObservationLt, QuestionnaireResponse)
                          Is Modifierfalse
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          172. 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 resource from which the observation is made
                          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, QuestionnaireResponse, ObservationLt)
                          Is Modifierfalse
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          174. 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..*
                          This element is affected by the following invariants: obs-7
                          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()))
                          176. 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
                          This element is affected by the following invariants: ele-1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          178. 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 managable, 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())
                          180. 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 managable, 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())
                          182. 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
                          This element is affected by the following invariants: obs-7
                          BindingFor example codes, see LOINCCodes
                          (example to http://hl7.org/fhir/ValueSet/observation-codes|5.0.0)

                          Codes identifying names of simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supporttrue
                          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()))
                          184. 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 the code.
                          • 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 code defines a coded value.
                          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                          • If a value is present, the datatype for this element should be determined by the code.
                          • 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 code defines a coded value.
                          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                          • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                          • For additional guidance, see the Notes section below.
                          Control0..1
                          TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)
                          [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()))
                          186. 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
                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|5.0.0)

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

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          188. 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|5.0.0)

                          Codes identifying interpretations of observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          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()))
                          190. 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
                          Must Supportfalse
                          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()))