LOINC – IVD Test Code (LIVD) Mapping
1.0.0-ballot - ballot International flag

This page is part of the Loinc/IVD Mapping FHIR IG (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. . For a full list of available versions, see the Directory of published versions

Resource Profile: LIVDObservationDefinition - Detailed Descriptions

Active as of 2018-08-14

Definitions for the observationdefinition-uv-livd resource profile.

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

0. ObservationDefinition
ShortLIVDObservationDefinition
Must Supportfalse
2. ObservationDefinition.extension
Control1..?
Must Supporttrue
SlicingThis element introduces a set of slices on ObservationDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
4. ObservationDefinition.extension:ObservationDefinitionDevice
Slice NameObservationDefinitionDevice
Control1..*
TypeExtension(LIVD Device) (Extension Type: Reference)
Must Supporttrue
6. ObservationDefinition.extension:ObservationDefinitionVendorReferenceIdentifier
Slice NameObservationDefinitionVendorReferenceIdentifier
Comments

Provides an alternate reference identifier by which the IVD Test is known. Only the identifier.value is required.

Control0..1
TypeExtension(LIVD Vendor Reference Identifier) (Extension Type: Identifier)
Must Supporttrue
8. ObservationDefinition.category
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..0
Must Supportfalse
Requirements

Used for filtering what observations are retrieved and displayed.

10. ObservationDefinition.code
Comments

Contains both the IVD Test Code and Name of the analyte.

Must Supporttrue
12. ObservationDefinition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Must Supporttrue
14. ObservationDefinition.permittedDataType
Definition

data type allowed for the result of the observation.

Control0..1
Must Supporttrue
16. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for this kind of observation.

Control0..0
Must Supportfalse
18. ObservationDefinition.method
Must Supporttrue
20. ObservationDefinition.preferredReportName
Definition

The preferred name to be used when reporting the results of this observation.

Control0..0
Must Supportfalse
22. ObservationDefinition.quantitativeDetails
Must Supporttrue
24. ObservationDefinition.quantitativeDetails.customaryUnit
Definition

Customary unit used to report quantitative results of this observation.

Must Supporttrue
26. ObservationDefinition.quantitativeDetails.unit
Definition

SI unit used to report quantitative results of this observation.

Must Supporttrue
28. ObservationDefinition.quantitativeDetails.conversionFactor
ShortSI unit to customary unit conversion factor
Must Supporttrue
30. ObservationDefinition.quantitativeDetails.decimalPrecision
Definition

number of digits after decimal separator when the results of this observation are of type Quantity.

Must Supporttrue
32. ObservationDefinition.qualifiedInterval
Definition

Reference range for ordinal and continuous observations.

Control0..0
Must Supportfalse
Requirements

multiple reference ranges, for different patient contexts.

42. ObservationDefinition.validCodedValueSet
Definition

The set of valid coded results for the observation.

Must Supporttrue
44. ObservationDefinition.normalCodedValueSet
Definition

The set of normal coded results for the observation.

Control0..0
Must Supportfalse
46. ObservationDefinition.abnormalCodedValueSet
Definition

The set of abnormal coded results for the observation.

Control0..0
Must Supportfalse
48. ObservationDefinition.criticalCodedValueSet
Definition

The set of critical coded results for the observation.

Control0..0
Must Supportfalse

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

0. ObservationDefinition
Definition

Set of definitional characteristics for a kind of observation or measurement produced or consumed by an orderable health care service.

ShortLIVDObservationDefinitionDefinition of an observation
Comments

An instance of this resource informs the consumer of a health-related service (such as a lab diagnostic test or panel) about how the observations used or produced by this service will look like.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ObservationDefinition.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

Control10..*
TypeExtension
Is Modifierfalse
Must Supporttrue
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 ObservationDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
6. ObservationDefinition.extension:ObservationDefinitionDevice
Slice NameObservationDefinitionDevice
Definition

Add a reference from the ObservationDefinition to the Device.

ShortLIVD Device
Control1..*
This element is affected by the following invariants: ele-1
TypeExtension(LIVD Device) (Extension Type: Reference)
Is Modifierfalse
Must Supporttrue
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())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. ObservationDefinition.extension:ObservationDefinitionVendorReferenceIdentifier
Slice NameObservationDefinitionVendorReferenceIdentifier
Definition

Add a vendor reference identifier to ObservationDefinition.

ShortLIVD Vendor Reference Identifier
Comments

Provides an alternate reference identifier by which the IVD Test is known. Only the identifier.value is required.

Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(LIVD Vendor Reference Identifier) (Extension Type: Identifier)
Is Modifierfalse
Must Supporttrue
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())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
10. ObservationDefinition.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

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

A code that classifies the general type of observation.

ShortCategory 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.


This element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used for one instance of ObservationDefinition. The level of granularity is defined by the category concepts in the value set.

Control0..0*
BindingFor example codes, see ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Used for filtering what observations are retrieved and displayed.


Used for filtering what kinds of observations are retrieved and displayed.

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

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

ShortType of observation (code / type)
Comments

Contains both the IVD Test Code and Name of the analyte.

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

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

A unique identifier assigned to this ObservationDefinition artifact.

ShortBusiness identifier for this ObservationDefinition instance
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ObservationDefinition.permittedDataType
Definition

data type allowed for the result of the observation.


The data types allowed for the value element of the instance observations conforming to this ObservationDefinition.

ShortQuantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Control0..1*
BindingThe codes SHALL be taken from ObservationDataTypehttp://hl7.org/fhir/ValueSet/permitted-data-type|4.0.1

Permitted data type for observation value.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Example<br/><b>General</b>:CodeableConcept
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for this kind of observation.


Multiple results allowed for observations conforming to this ObservationDefinition.

ShortMultiple results allowed
Comments

An example of observation allowing multiple results is "bacteria identified by culture". Conversely, the measurement of a potassium level allows a single result.

Control0..01
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Example<br/><b>General</b>:true
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ObservationDefinition.method
Definition

The method or technique used to perform the observation.

ShortMethod used to produce the observation
Comments

Only used if not implicit in observation code.

Control0..1
BindingFor example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods

Methods for simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

In some cases, method can impact results.

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

The preferred name to be used when reporting the results of this observation.


The preferred name to be used when reporting the results of observations conforming to this ObservationDefinition.

ShortPreferred report name
Control0..01
Typestring
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()))
26. ObservationDefinition.quantitativeDetails
Definition

Characteristics for quantitative results of this observation.

ShortCharacteristics of quantitative results
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ObservationDefinition.quantitativeDetails.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

Customary unit used to report quantitative results of this observation.


Customary unit used to report quantitative results of observations conforming to this ObservationDefinition.

ShortCustomary unit for quantitative results
Control0..1
BindingUnless not suitable, these codes SHALL be taken from UCUMCodeshttp://hl7.org/fhir/ValueSet/ucum-units

Codes identifying units of measure.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. ObservationDefinition.quantitativeDetails.unit
Definition

SI unit used to report quantitative results of this observation.


SI unit used to report quantitative results of observations conforming to this ObservationDefinition.

ShortSI unit for quantitative results
Control0..1
BindingUnless not suitable, these codes SHALL be taken from UCUMCodeshttp://hl7.org/fhir/ValueSet/ucum-units

Codes identifying units of measure.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ObservationDefinition.quantitativeDetails.conversionFactor
Definition

Factor for converting value expressed with SI unit to value expressed with customary unit.

ShortSI unit to customary unit conversion factorSI to Customary unit conversion factor
Control0..1
Typedecimal
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()))
36. ObservationDefinition.quantitativeDetails.decimalPrecision
Definition

number of digits after decimal separator when the results of this observation are of type Quantity.


Number of digits after decimal separator when the results of such observations are of type Quantity.

ShortDecimal precision of observation quantitative results
Control0..1
Typeinteger
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. ObservationDefinition.qualifiedInterval
Definition

Reference range for ordinal and continuous observations.


Multiple ranges of results qualified by different contexts for ordinal or continuous observations conforming to this ObservationDefinition.

ShortQualified range for continuous and ordinal observation results
Control0..0*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

multiple reference ranges, for different patient contexts.

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

The set of valid coded results for the observation.


The set of valid coded results for the observations conforming to this ObservationDefinition.

ShortValue set of valid coded values for the observations conforming to this ObservationDefinition
Control0..1
TypeReference(ValueSet)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
51. ObservationDefinition.normalCodedValueSet
Definition

The set of normal coded results for the observation.


The set of normal coded results for the observations conforming to this ObservationDefinition.

ShortValue set of normal coded values for the observations conforming to this ObservationDefinition
Control0..01
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
53. ObservationDefinition.abnormalCodedValueSet
Definition

The set of abnormal coded results for the observation.


The set of abnormal coded results for the observation conforming to this ObservationDefinition.

ShortValue set of abnormal coded values for the observations conforming to this ObservationDefinition
Control0..01
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
55. ObservationDefinition.criticalCodedValueSet
Definition

The set of critical coded results for the observation.


The set of critical coded results for the observation conforming to this ObservationDefinition.

ShortValue set of critical coded values for the observations conforming to this ObservationDefinition
Control0..01
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

0. ObservationDefinition
Definition

Set of definitional characteristics for a kind of observation or measurement produced or consumed by an orderable health care service.

ShortLIVDObservationDefinition
Comments

An instance of this resource informs the consumer of a health-related service (such as a lab diagnostic test or panel) about how the observations used or produced by this service will look like.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ObservationDefinition.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

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

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. ObservationDefinition.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
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ObservationDefinition.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages

A human language.

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

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

ShortText summary of the resource, for human interpretation
Comments

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

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

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

ShortContained, inline Resources
Comments

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

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. ObservationDefinition.extension
Definition

An Extension

ShortExtension
Control1..*
TypeExtension
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ObservationDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
16. ObservationDefinition.extension:ObservationDefinitionDevice
Slice NameObservationDefinitionDevice
Definition

Add a reference from the ObservationDefinition to the Device.

ShortLIVD Device
Control1..*
This element is affected by the following invariants: ele-1
TypeExtension(LIVD Device) (Extension Type: Reference)
Is Modifierfalse
Must Supporttrue
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. ObservationDefinition.extension:ObservationDefinitionVendorReferenceIdentifier
Slice NameObservationDefinitionVendorReferenceIdentifier
Definition

Add a vendor reference identifier to ObservationDefinition.

ShortLIVD Vendor Reference Identifier
Comments

Provides an alternate reference identifier by which the IVD Test is known. Only the identifier.value is required.

Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(LIVD Vendor Reference Identifier) (Extension Type: Identifier)
Is Modifierfalse
Must Supporttrue
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())
20. ObservationDefinition.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

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

A code that classifies the general type of observation.

ShortCategory 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..0
BindingFor example codes, see ObservationCategoryCodes

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Used for filtering what observations are retrieved and displayed.

Alternate NamesClass of observation
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ObservationDefinition.code
Definition

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

ShortType of observation (code / type)
Comments

Contains both the IVD Test Code and Name of the analyte.

Control1..1
BindingFor example codes, see LOINCCodes

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

A unique identifier assigned to this ObservationDefinition artifact.

ShortBusiness identifier for this ObservationDefinition instance
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ObservationDefinition.permittedDataType
Definition

data type allowed for the result of the observation.

ShortQuantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Control0..1
BindingThe codes SHALL be taken from ObservationDataType

Permitted data type for observation value.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Example<br/><b>General</b>:CodeableConcept
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for this kind of observation.

ShortMultiple results allowed
Comments

An example of observation allowing multiple results is "bacteria identified by culture". Conversely, the measurement of a potassium level allows a single result.

Control0..0
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Example<br/><b>General</b>:true
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. ObservationDefinition.method
Definition

The method or technique used to perform the observation.

ShortMethod used to produce the observation
Comments

Only used if not implicit in observation code.

Control0..1
BindingFor example codes, see ObservationMethods

Methods for simple observations.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

In some cases, method can impact results.

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

The preferred name to be used when reporting the results of this observation.

ShortPreferred report name
Control0..0
Typestring
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()))
36. ObservationDefinition.quantitativeDetails
Definition

Characteristics for quantitative results of this observation.

ShortCharacteristics of quantitative results
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ObservationDefinition.quantitativeDetails.id
Definition

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

Customary unit used to report quantitative results of this observation.

ShortCustomary unit for quantitative results
Control0..1
BindingUnless not suitable, these codes SHALL be taken from UCUMCodes

Codes identifying units of measure.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ObservationDefinition.quantitativeDetails.unit
Definition

SI unit used to report quantitative results of this observation.

ShortSI unit for quantitative results
Control0..1
BindingUnless not suitable, these codes SHALL be taken from UCUMCodes

Codes identifying units of measure.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ObservationDefinition.quantitativeDetails.conversionFactor
Definition

Factor for converting value expressed with SI unit to value expressed with customary unit.

ShortSI unit to customary unit conversion factor
Control0..1
Typedecimal
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()))
50. ObservationDefinition.quantitativeDetails.decimalPrecision
Definition

number of digits after decimal separator when the results of this observation are of type Quantity.

ShortDecimal precision of observation quantitative results
Control0..1
Typeinteger
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()))
52. ObservationDefinition.qualifiedInterval
Definition

Reference range for ordinal and continuous observations.

ShortQualified range for continuous and ordinal observation results
Control0..0
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

multiple reference ranges, for different patient contexts.

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

The set of valid coded results for the observation.

ShortValue set of valid coded values for the observations conforming to this ObservationDefinition
Control0..1
TypeReference(ValueSet)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
67. ObservationDefinition.normalCodedValueSet
Definition

The set of normal coded results for the observation.

ShortValue set of normal coded values for the observations conforming to this ObservationDefinition
Control0..0
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
69. ObservationDefinition.abnormalCodedValueSet
Definition

The set of abnormal coded results for the observation.

ShortValue set of abnormal coded values for the observations conforming to this ObservationDefinition
Control0..0
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
71. ObservationDefinition.criticalCodedValueSet
Definition

The set of critical coded results for the observation.

ShortValue set of critical coded values for the observations conforming to this ObservationDefinition
Control0..0
TypeReference(ValueSet)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))