Retrieval of Real World Data for Clinical Research
1.0.0-ballot - ballot
Retrieval of Real World Data for Clinical Research
1.0.0-ballot - ballot
This page is part of the Retrieval of Real World Data for Clinical Research (v1.0.0-ballot: STU1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/vulcan-rwd/StructureDefinition/ObservationLaboratoryResultsRwd | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | Computable Name: ObservationLaboratoryResultsRwd | |||
A profile on Observation that indicates the minimum set of attributes detailing laboratory results for use in research studies.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ObservationResultsLaboratoryUvIps
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study | |
  component | ||||
  code | S | 1..1 | CodeableConcept | Type of component observation (code / type) |
| value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result |
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. |
 referenceRange | S | 0..* | Provides guide for interpretation of component result | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final |
  Slices for category | 1..* | CodeableConceptIPS | Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |
   category:laboratory | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following |
  coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
 code | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred) |
 subject | SΣ | 1..1 | Reference(Patient (IPS) | Group | Device | Location) | Who and/or what the observation is about |
| reference | SΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL |
 effective[x] | SΣ | 1..1 | Clinically relevant time/time-period for observation | |
| effective[x]:All Types | Content/Rules for all Types | |||
 data-absent-reason | S | 0..1 | code | effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing. |
| effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| performer | SΣ | 1..* | Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson) | Who is responsible for the observation |
| Slices for value[x] | SΣC | 0..1 | Actual result Slice: Unordered, Open by type:$this | |
 valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueRatio | Ratio | |||
| valueSampledData | SampledData | |||
| valueTime | time | |||
| valueDateTime | dateTime | |||
| valuePeriod | Period | |||
| value[x]:valueString | SΣC | 0..1 | string | Actual result |
| value[x]:valueRange | SC | 0..1 | RangeIPS | Set of values bounded by low and high |
| value[x]:valueRatio | SC | 0..1 | RatioIPS | A ratio of two Quantity values - a numerator and a denominator |
| value[x]:valueTime | SΣC | 0..1 | time | Actual result |
| value[x]:valueDateTime | SΣC | 0..1 | dateTime | Actual result |
| value[x]:valuePeriod | SΣC | 0..1 | Period | Actual result |
| value[x]:valueQuantity | SC | 0..1 | QuantityIPS | A measured amount using UCUM |
| value[x]:valueCodeableConcept | S | 0..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) |
| component | SΣ | 0..* | BackboneElement | Component results |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. |
| value[x] | SΣ | 0..1 | Actual component result | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueRatio | Ratio | |||
| valueSampledData | SampledData | |||
| valueTime | time | |||
| valueDateTime | dateTime | |||
| valuePeriod | Period | |||
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. |
| referenceRange | S | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | ||||||||||||
| Observation.status | required | Fixed Value: final | ||||||||||||
| Observation.category | preferred | ObservationCategoryCodes | ||||||||||||
| Observation.category:laboratory | preferred | Pattern: laboratory | ||||||||||||
| Observation.code | preferred | ResultsLaboratoryObservationUvIps | ||||||||||||
| Observation.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIps
| ||||||||||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||||||||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | 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 | error | Observation | 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 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ips-2 | error | Observation | if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| qty-3 | error | Observation.value[x]:valueQuantity | If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists() | |
| rat-1 | error | Observation.value[x]:valueRatio | Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()) | |
| rng-2 | error | Observation.value[x]:valueRange | If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high) |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
| partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
| status | ?!Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final | ||||
| Slices for category | 1..* | CodeableConceptIPS | Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |||||
| category:laboratory | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following | ||||
 id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
 coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
 id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
 text | 0..1 | string | Plain text representation of the concept | |||||
| code | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred) | ||||
| subject | SΣ | 1..1 | Reference(Patient (IPS) | Group | Device | Location) | Who and/or what the observation is about | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | SΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| focus | ΣTU | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣ | 1..1 | Clinically relevant time/time-period for observation | |||||
| effective[x]:All Types | Content/Rules for all Types | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| data-absent-reason | S | 0..1 | code | effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing. | ||||
| effectiveDateTime | dateTime | |||||||
| effectivePeriod | Period | |||||||
| issued | Σ | 0..1 | instant | Date/Time this version was made available | ||||
| performer | SΣ | 1..* | Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson) | Who is responsible for the observation | ||||
| Slices for value[x] | SΣC | 0..1 | Actual result Slice: Unordered, Open by type:$this | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| value[x]:valueString | SΣC | 0..1 | string | Actual result | ||||
| value[x]:valueRange | SC | 0..1 | RangeIPS | Set of values bounded by low and high | ||||
| value[x]:valueRatio | SC | 0..1 | RatioIPS | A ratio of two Quantity values - a numerator and a denominator | ||||
| value[x]:valueTime | SΣC | 0..1 | time | Actual result | ||||
| value[x]:valueDateTime | SΣC | 0..1 | dateTime | Actual result | ||||
| value[x]:valuePeriod | SΣC | 0..1 | Period | Actual result | ||||
| value[x]:valueQuantity | SC | 0..1 | QuantityIPS | A measured amount using UCUM | ||||
| value[x]:valueCodeableConcept | S | 0..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) | ||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | 0..* | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note | 0..* | Annotation | Comments about the observation | |||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen | 0..1 | Reference(Specimen (IPS)) | Specimen used for this observation | |||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
| high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age | 0..1 | Range | Applicable age range, if relevant | |||||
| text | 0..1 | string | Text based reference range in an observation | |||||
| hasMember | Σ | 0..* | Reference(Observation Results: laboratory (IPS) | Observation Results (IPS)) | Related resource that belongs to the Observation group | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
| component | SΣ | 0..* | BackboneElement | Component results | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] | SΣ | 0..1 | Actual component result | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | ||||
| referenceRange | S | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||||||||||
| Observation.language | preferred | CommonLanguages
| ||||||||||||
| Observation.status | required | Fixed Value: final | ||||||||||||
| Observation.category | preferred | ObservationCategoryCodes | ||||||||||||
| Observation.category:laboratory | preferred | Pattern: laboratory | ||||||||||||
| Observation.code | preferred | ResultsLaboratoryObservationUvIps | ||||||||||||
| Observation.subject.type | extensible | ResourceType | ||||||||||||
| Observation.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIps
| ||||||||||||
| Observation.dataAbsentReason | extensible | DataAbsentReason | ||||||||||||
| Observation.interpretation | extensible | ObservationInterpretationCodes | ||||||||||||
| Observation.bodySite | example | SNOMEDCTBodyStructures | ||||||||||||
| Observation.method | example | ObservationMethods | ||||||||||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||||||||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||||||||||
| Observation.hasMember.type | extensible | ResourceType | ||||||||||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||||||||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||||||||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
| qty-3 | error | Observation.value[x]:valueQuantity | If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists() | |
| rat-1 | error | Observation.value[x]:valueRatio | Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()) | |
| rng-2 | error | Observation.value[x]:valueRange | If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high) |
This structure is derived from ObservationResultsLaboratoryUvIps
Differential View
This structure is derived from ObservationResultsLaboratoryUvIps
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study | |
| component | ||||
| code | S | 1..1 | CodeableConcept | Type of component observation (code / type) |
| value[x] | S | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result |
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. |
| referenceRange | S | 0..* | Provides guide for interpretation of component result | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final |
| Slices for category | 1..* | CodeableConceptIPS | Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |
| category:laboratory | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
| code | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred) |
| subject | SΣ | 1..1 | Reference(Patient (IPS) | Group | Device | Location) | Who and/or what the observation is about |
| reference | SΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL |
| effective[x] | SΣ | 1..1 | Clinically relevant time/time-period for observation | |
| effective[x]:All Types | Content/Rules for all Types | |||
| data-absent-reason | S | 0..1 | code | effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing. |
| effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| performer | SΣ | 1..* | Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson) | Who is responsible for the observation |
| Slices for value[x] | SΣC | 0..1 | Actual result Slice: Unordered, Open by type:$this | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueRatio | Ratio | |||
| valueSampledData | SampledData | |||
| valueTime | time | |||
| valueDateTime | dateTime | |||
| valuePeriod | Period | |||
| value[x]:valueString | SΣC | 0..1 | string | Actual result |
| value[x]:valueRange | SC | 0..1 | RangeIPS | Set of values bounded by low and high |
| value[x]:valueRatio | SC | 0..1 | RatioIPS | A ratio of two Quantity values - a numerator and a denominator |
| value[x]:valueTime | SΣC | 0..1 | time | Actual result |
| value[x]:valueDateTime | SΣC | 0..1 | dateTime | Actual result |
| value[x]:valuePeriod | SΣC | 0..1 | Period | Actual result |
| value[x]:valueQuantity | SC | 0..1 | QuantityIPS | A measured amount using UCUM |
| value[x]:valueCodeableConcept | S | 0..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) |
| component | SΣ | 0..* | BackboneElement | Component results |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. |
| value[x] | SΣ | 0..1 | Actual component result | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueRatio | Ratio | |||
| valueSampledData | SampledData | |||
| valueTime | time | |||
| valueDateTime | dateTime | |||
| valuePeriod | Period | |||
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. |
| referenceRange | S | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | ||||||||||||
| Observation.status | required | Fixed Value: final | ||||||||||||
| Observation.category | preferred | ObservationCategoryCodes | ||||||||||||
| Observation.category:laboratory | preferred | Pattern: laboratory | ||||||||||||
| Observation.code | preferred | ResultsLaboratoryObservationUvIps | ||||||||||||
| Observation.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIps
| ||||||||||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||||||||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | 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 | error | Observation | 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 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ips-2 | error | Observation | if no "hasMember" element is present then Observation must have a" value" : value.exists() or hasMember.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| qty-3 | error | Observation.value[x]:valueQuantity | If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists() | |
| rat-1 | error | Observation.value[x]:valueRatio | Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()) | |
| rng-2 | error | Observation.value[x]:valueRange | If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high) |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | ObservationResultsLaboratoryUvIps | Laboratory result for a simple test or for a panel/study | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
| partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
| status | ?!Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final | ||||
| Slices for category | 1..* | CodeableConceptIPS | Concept - reference to a terminology or just text Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |||||
| category:laboratory | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| code | S | 1..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Laboratory Observation - IPS (preferred) | ||||
| subject | SΣ | 1..1 | Reference(Patient (IPS) | Group | Device | Location) | Who and/or what the observation is about | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | SΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| focus | ΣTU | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣ | 1..1 | Clinically relevant time/time-period for observation | |||||
| effective[x]:All Types | Content/Rules for all Types | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| data-absent-reason | S | 0..1 | code | effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required): Used to specify why the normally expected content of the data element is missing. | ||||
| effectiveDateTime | dateTime | |||||||
| effectivePeriod | Period | |||||||
| issued | Σ | 0..1 | instant | Date/Time this version was made available | ||||
| performer | SΣ | 1..* | Reference(Practitioner (IPS) | PractitionerRole (IPS) | Organization (IPS) | CareTeam | Patient (IPS) | RelatedPerson) | Who is responsible for the observation | ||||
| Slices for value[x] | SΣC | 0..1 | Actual result Slice: Unordered, Open by type:$this | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| value[x]:valueString | SΣC | 0..1 | string | Actual result | ||||
| value[x]:valueRange | SC | 0..1 | RangeIPS | Set of values bounded by low and high | ||||
| value[x]:valueRatio | SC | 0..1 | RatioIPS | A ratio of two Quantity values - a numerator and a denominator | ||||
| value[x]:valueTime | SΣC | 0..1 | time | Actual result | ||||
| value[x]:valueDateTime | SΣC | 0..1 | dateTime | Actual result | ||||
| value[x]:valuePeriod | SΣC | 0..1 | Period | Actual result | ||||
| value[x]:valueQuantity | SC | 0..1 | QuantityIPS | A measured amount using UCUM | ||||
| value[x]:valueCodeableConcept | S | 0..1 | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: Results Coded Values Laboratory - IPS (preferred) | ||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | 0..* | CodeableConceptIPS | Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note | 0..* | Annotation | Comments about the observation | |||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen | 0..1 | Reference(Specimen (IPS)) | Specimen used for this observation | |||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
| high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age | 0..1 | Range | Applicable age range, if relevant | |||||
| text | 0..1 | string | Text based reference range in an observation | |||||
| hasMember | Σ | 0..* | Reference(Observation Results: laboratory (IPS) | Observation Results (IPS)) | Related resource that belongs to the Observation group | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display | Σ | 0..1 | string | Text alternative for the resource | ||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
| component | SΣ | 0..* | BackboneElement | Component results | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | SΣ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] | SΣ | 0..1 | Actual component result | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | S | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | ||||
| referenceRange | S | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||||||||||
| Observation.language | preferred | CommonLanguages
| ||||||||||||
| Observation.status | required | Fixed Value: final | ||||||||||||
| Observation.category | preferred | ObservationCategoryCodes | ||||||||||||
| Observation.category:laboratory | preferred | Pattern: laboratory | ||||||||||||
| Observation.code | preferred | ResultsLaboratoryObservationUvIps | ||||||||||||
| Observation.subject.type | extensible | ResourceType | ||||||||||||
| Observation.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIps
| ||||||||||||
| Observation.dataAbsentReason | extensible | DataAbsentReason | ||||||||||||
| Observation.interpretation | extensible | ObservationInterpretationCodes | ||||||||||||
| Observation.bodySite | example | SNOMEDCTBodyStructures | ||||||||||||
| Observation.method | example | ObservationMethods | ||||||||||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||||||||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||||||||||
| Observation.hasMember.type | extensible | ResourceType | ||||||||||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||||||||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||||||||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
| qty-3 | error | Observation.value[x]:valueQuantity | If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists() | |
| rat-1 | error | Observation.value[x]:valueRatio | Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()) | |
| rng-2 | error | Observation.value[x]:valueRange | If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high) |
This structure is derived from ObservationResultsLaboratoryUvIps
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.vulcan-rwd#1.0.0-ballot based on FHIR 4.0.1. Generated 2022-12-04
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