LOINC – IVD Test Code (LIVD) Mapping
0.3.0 - ballot

LOINC – IVD Test Code (LIVD) Mapping, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version 0.3.0). This version is based on the current content of https://github.com/HL7/livd/ and changes regularly. See the Directory of published versions

Resource Profile: LIVDObservationDefinition - Detailed Descriptions

Definitions for the observationdefinition-uv-livd resource profile.

1. ObservationDefinition
Definition

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

Control0..*
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.

InvariantsDefined on this element
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().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.

Control0..1
Typestring
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.

3. 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.

Control0..1
TypeMeta
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. 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.

Control0..1
Typeuri
Is Modifiertrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. ObservationDefinition.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages
Max Binding: AllLanguages A human language.

Typecode
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. 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.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. 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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained 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.

8. ObservationDefinition.extension
Definition

An Extension

Control1..*
TypeExtension
Must Supporttrue
InvariantsDefined on this element
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())
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
9. ObservationDefinition.extension:ObservationDefinitionDevice
SliceNameObservationDefinitionDevice
Definition

Add a reference from the ObservationDefinition to the Device.

Control1..* This element is affected by the following invariants: ele-1
TypeExtension(LIVDDevice) (Extension Type: Reference)
Must Supporttrue
InvariantsDefined on this element
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())
10. ObservationDefinition.extension:ObservationDefinitionVendorReferenceIdentifier
SliceNameObservationDefinitionVendorReferenceIdentifier
Definition

Add a vendor reference identifier to ObservationDefinition.

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(LIVDVendorReferenceIdentifier) (Extension Type: Identifier)
Must Supporttrue
Comments

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

InvariantsDefined on this element
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())
11. 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
12. ObservationDefinition.category
Definition

A code that classifies the general type of observation.

Control0..0
BindingFor example codes, see ObservationCategoryCodes Codes for high level observation categories.

TypeCodeableConcept
Requirements

Used for filtering what observations are retrieved and displayed.

Alternate NamesClass 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. ObservationDefinition.code
Definition

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

Control1..1
BindingFor example codes, see LOINCCodes Codes identifying names of simple observations.

TypeCodeableConcept
Must Supporttrue
Requirements

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

Alternate NamesName
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. ObservationDefinition.identifier
Definition

A unique identifier assigned to this ObservationDefinition artifact.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. ObservationDefinition.permittedDataType
Definition

data type allowed for the result of the observation.

Control0..1
BindingThe codes SHALL be taken from ObservationDataType Permitted data type for observation value.

Typecode
Must Supporttrue
Example
General:CodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for this kind of observation.

Control0..0
Typeboolean
Comments

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

Example
General:true
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. ObservationDefinition.method
Definition

The method or technique used to perform the observation.

Control0..1
BindingFor example codes, see ObservationMethods Methods for simple observations.

TypeCodeableConcept
Must Supporttrue
Requirements

In some cases, method can impact results.

Comments

Only used if not implicit in observation code.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. ObservationDefinition.preferredReportName
Definition

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

Control0..0
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. ObservationDefinition.quantitativeDetails
Definition

Characteristics for quantitative results of this observation.

Control0..1
TypeBackboneElement
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. 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.

Control0..1
Typestring
21. 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
22. 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
23. ObservationDefinition.quantitativeDetails.customaryUnit
Definition

Customary unit used to report quantitative results of this observation.

Control0..1
BindingThe codes SHALL be taken from UCUMCodes; other codes may be used where these codes are not suitable Codes identifying units of measure.

TypeCodeableConcept
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. ObservationDefinition.quantitativeDetails.unit
Definition

SI unit used to report quantitative results of this observation.

Control0..1
BindingThe codes SHALL be taken from UCUMCodes; other codes may be used where these codes are not suitable Codes identifying units of measure.

TypeCodeableConcept
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. ObservationDefinition.quantitativeDetails.conversionFactor
Definition

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

Control0..1
Typedecimal
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. ObservationDefinition.quantitativeDetails.decimalPrecision
Definition

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

Control0..1
Typeinteger
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. ObservationDefinition.qualifiedInterval
Definition

Reference range for ordinal and continuous observations.

Control0..0
TypeBackboneElement
Requirements

multiple reference ranges, for different patient contexts.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. ObservationDefinition.qualifiedInterval.id
Definition

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

Control0..1
Typestring
29. ObservationDefinition.qualifiedInterval.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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
30. ObservationDefinition.qualifiedInterval.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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
31. ObservationDefinition.qualifiedInterval.category
Definition

The category of interval of values for continuous or ordinal observations conforming to this ObservationDefinition.

Control0..1
BindingThe codes SHALL be taken from ObservationRangeCategory Codes identifying the category of observation range.

Typecode
Example
General:critical
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. ObservationDefinition.qualifiedInterval.range
Definition

The value and associated unit of the low bound (inclusive) of the reference range.

Control0..1
TypeRange
Requirements

The unit may be not relevant for ordinal values. In case it is there, it is the same as SIunit or customaryUnit.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. ObservationDefinition.qualifiedInterval.context
Definition

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

Control0..1
BindingThe codes SHALL be taken from ObservationReferenceRangeMeaningCodes; other codes may be used where these codes are not suitable Code identifying the health context of a range.

TypeCodeableConcept
Requirements

what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

Comments

normal range is the default.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. ObservationDefinition.qualifiedInterval.appliesTo
Definition

Codes to indicate the target population this reference range applies to.

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes Codes identifying the population the reference range applies to.

TypeCodeableConcept
Requirements

target population (male, female, pregnancy, a specific race ….

Comments

If this element is not present then the global population is assumed.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. ObservationDefinition.qualifiedInterval.gender
Definition

Sex of the population the range applies to.

Control0..1
BindingThe codes SHALL be taken from AdministrativeGender The gender of a person used for administrative purposes.

Typecode
Example
General:female
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. ObservationDefinition.qualifiedInterval.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.

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

Comments

Some analytes vary greatly over age.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. ObservationDefinition.qualifiedInterval.gestationalAge
Definition

The gestational age at which this reference range is applicable, in the context of pregnancy.

Control0..1
TypeRange
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. ObservationDefinition.qualifiedInterval.condition
Definition

Text based condition for which the reference range is valid.

Control0..1
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. ObservationDefinition.validCodedValueSet
Definition

The set of valid coded results for the observation.

Control0..1
TypeReference(ValueSet)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. ObservationDefinition.normalCodedValueSet
Definition

The set of normal coded results for the observation.

Control0..0
TypeReference(ValueSet)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. ObservationDefinition.abnormalCodedValueSet
Definition

The set of abnormal coded results for the observation.

Control0..0
TypeReference(ValueSet)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. ObservationDefinition.criticalCodedValueSet
Definition

The set of critical coded results for the observation.

Control0..0
TypeReference(ValueSet)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))