This page is part of the Loinc/IVD Mapping FHIR IG (v0.3.0: STU 1 (FHIR R4) Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions
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. |
Control | 0..* |
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. |
Invariants | Defined 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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..1 |
Type | Meta |
Invariants | Defined 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
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. |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHOULD be taken from CommonLanguages Max Binding: AllLanguages A human language. |
Type | code |
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). |
Invariants | Defined 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. |
Control | 0..1 |
Type | Narrative |
Alternate Names | narrative, 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. |
Invariants | Defined 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. |
Control | 0..* |
Type | Resource |
Alternate Names | inline 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 |
Control | 1..* |
Type | Extension |
Must Support | true |
Invariants | Defined 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()) |
Slicing | This element introduces a set of slices on ObservationDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
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9. ObservationDefinition.extension:ObservationDefinitionDevice | |
SliceName | ObservationDefinitionDevice |
Definition | An Extension |
Control | 1..* This element is affected by the following invariants: ele-1 |
Type | Extension(LIVDDevice) (Extension Type: Reference) |
Must Support | true |
Invariants | Defined 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 | |
SliceName | ObservationDefinitionVendorReferenceIdentifier |
Definition | An Extension |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(LIVDVendorReferenceIdentifier) (Extension Type: Identifier) |
Must Support | true |
Comments | Provides an alternate reference identifier by which the IVD Test is known. Only the identifier.value is required. |
Invariants | Defined 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 Names | extensions, 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. |
Invariants | Defined 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. |
Control | 0..0 |
Binding | For example codes, see ObservationCategoryCodes Codes for high level observation categories. |
Type | CodeableConcept |
Requirements | Used for filtering what observations are retrieved and displayed. |
Alternate Names | Class 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. |
Invariants | Defined 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". |
Control | 1..1 |
Binding | For example codes, see LOINCCodes Codes identifying names of simple observations. |
Type | CodeableConcept |
Must Support | true |
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. |
Alternate Names | Name |
Comments | Contains both the IVD Test Code and Name of the analyte. |
Invariants | Defined 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. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Must Support | true |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHALL be taken from ObservationDataType Permitted data type for observation value. |
Type | code |
Must Support | true |
Example | General:CodeableConcept |
Invariants | Defined 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. |
Control | 0..0 |
Type | boolean |
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 |
Invariants | Defined 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. |
Control | 0..1 |
Binding | For example codes, see ObservationMethods Methods for simple observations. |
Type | CodeableConcept |
Must Support | true |
Requirements | In some cases, method can impact results. |
Comments | Only used if not implicit in observation code. |
Invariants | Defined 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. |
Control | 0..0 |
Type | string |
Invariants | Defined 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. |
Control | 0..1 |
Type | BackboneElement |
Must Support | true |
Invariants | Defined 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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
Invariants | Defined 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 Names | extensions, 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. |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHALL be taken from UCUMCodes; other codes may be used where these codes are not suitable Codes identifying units of measure. |
Type | CodeableConcept |
Must Support | true |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHALL be taken from UCUMCodes; other codes may be used where these codes are not suitable Codes identifying units of measure. |
Type | CodeableConcept |
Must Support | true |
Invariants | Defined 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. |
Control | 0..1 |
Type | decimal |
Must Support | true |
Invariants | Defined 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. |
Control | 0..1 |
Type | integer |
Must Support | true |
Invariants | Defined 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. |
Control | 0..0 |
Type | BackboneElement |
Requirements | multiple reference ranges, for different patient contexts. |
Invariants | Defined 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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
Invariants | Defined 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 Names | extensions, 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. |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHALL be taken from ObservationRangeCategory Codes identifying the category of observation range. |
Type | code |
Example | General:critical |
Invariants | Defined 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. |
Control | 0..1 |
Type | Range |
Requirements | The unit may be not relevant for ordinal values. In case it is there, it is the same as SIunit or customaryUnit. |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The 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. |
Type | CodeableConcept |
Requirements | what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. |
Comments | normal range is the default. |
Invariants | Defined 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. |
Control | 0..* |
Binding | For example codes, see ObservationReferenceRangeAppliesToCodes Codes identifying the population the reference range applies to. |
Type | CodeableConcept |
Requirements | target population (male, female, pregnancy, a specific race …. |
Comments | If this element is not present then the global population is assumed. |
Invariants | Defined 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. |
Control | 0..1 |
Binding | The codes SHALL be taken from AdministrativeGender The gender of a person used for administrative purposes. |
Type | code |
Example | General:female |
Invariants | Defined 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. |
Control | 0..1 |
Type | Range |
Requirements | Some analytes vary greatly over age. |
Comments | Some analytes vary greatly over age. |
Invariants | Defined 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. |
Control | 0..1 |
Type | Range |
Invariants | Defined 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. |
Control | 0..1 |
Type | string |
Invariants | Defined 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. |
Control | 0..1 |
Type | Reference(ValueSet) |
Must Support | true |
Invariants | Defined 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. |
Control | 0..0 |
Type | Reference(ValueSet) |
Invariants | Defined 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. |
Control | 0..0 |
Type | Reference(ValueSet) |
Invariants | Defined 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. |
Control | 0..0 |
Type | Reference(ValueSet) |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |