HL7 Laboratory Report
1.0.0-ballot - STU 1 Ballot
HL7 Laboratory Report
1.0.0-ballot - STU 1 Ballot
HL7 Laboratory Report, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-lab-rep-ig/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/lab-report/StructureDefinition/Observation-resultslab-uv-lab | Version: 1.0.0-ballot | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: ObservationResultsUvLab | ||
This profile constrains the Observation resource to represent results produced by laboratory tests or panels/studies for the HL7 UV Lab project. This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and or a global interpretation by the producer of the study, in the comment element; and references the atomic results of the study as "has-member" child observations.
This profile constrains the Observation resource to represent a laboratory in vitro diagnostic test or panel/study. In case of a panel/study, the results of the panel appear as sub-observations. In this case this top-level Observation acts as a grouper of all the observations belonging to the panel or study. The top-level observation may carry a conclusion in the value element and or a global interpretation by the producer of the study, in the comment element.
This profile offers two options to indicate the Certified Reference Material used for the calibration (in general when the UCUM International Units are used for the results [IU]).
- The first to be used when the Certified Reference Material is represented by a coded concept
- The second when the Certified Reference Material is identified with an Identifier.
Adopters are invited to give their feedback about
- The most proper way to refer the Certified Reference Material, that is by using an Identifier or a CodeableConcept
- If a CodeableReference should be used
- If this information should be an extension of the Observation resource, or of other elements (e.g. DeviceMetric.calibration)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
  Observation |
C | 0..* | Observation | Laboratory result for a simple test or for a panel/study dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present uv-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" uv-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" | ||||||||
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children | ||||||||
  Slices for extension |
0..* | Extension | Laboratory Test Kit Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
   supportingInfo |
0..* | Reference(Resource) | Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
 triggeredBy-r5 |
0..* | (Complex) | Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
   Slices for extension |
Content/Rules for all slices | |||||||||||
 extension:observation |
0..* | Extension | Triggering observation. ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
 extension |
0..0 | |||||||||||
| url |
1..1 | uri | "observation" | |||||||||
  value[x] |
1..1 | Reference(Observation) | Value of extension ele-1: All FHIR elements must have a @value or children | |||||||||
| extension:type |
0..* | Extension | The type of trigger ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| extension |
0..0 | |||||||||||
| url |
1..1 | uri | "type" | |||||||||
| value[x] |
1..1 | code | Value of extension ele-1: All FHIR elements must have a @value or children | |||||||||
 extension:reason |
0..* | Extension | Extension ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
 extension |
0..0 | |||||||||||
| url |
1..1 | uri | "reason" | |||||||||
| value[x] |
1..1 | string | Value of extension ele-1: All FHIR elements must have a @value or children | |||||||||
| url |
1..1 | uri | "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy" | |||||||||
| certifiedRefMaterialCodeable |
0..* | CodeableConcept | Certified Reference Material: CodeableConcept URL: http://hl7.org/fhir/uv/lab-report/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| certifiedRefMaterialIdentifer |
0..* | Identifier | Certified Reference Material: Identifier URL: http://hl7.org/fhir/uv/lab-report/StructureDefinition/observation-certifiedRefMaterialIdentifer ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| labTestKit |
0..* | Reference(Device) | Device Laboratory Test Kit URL: http://hl7.org/fhir/uv/lab-report/StructureDefinition/observation-deviceLabTestKit ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| value-r5 |
0..1 | (Complex) | only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x] ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| extension |
0..0 | |||||||||||
| url |
1..1 | uri | "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]" | |||||||||
 value[x] |
1..1 | Attachment | Value of extension ele-1: All FHIR elements must have a @value or children | |||||||||
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||||||
| status |
?!Σ | 1..1 | code | Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation. ele-1: All FHIR elements must have a @value or children | ||||||||
| Slices for category |
1..* | CodeableConceptIPS | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children | |||||||||
| category:laboratory |
1..1 | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children 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 | |||||||||
| category:studyType |
0..* | CodeableConcept | The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required) ele-1: All FHIR elements must have a @value or children | |||||||||
 category:specialty |
0..* | CodeableConcept | The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required) ele-1: All FHIR elements must have a @value or children | |||||||||
| code |
Σ | 1..1 | CodeableConceptIPS | Type of observation (code / type) Binding: Laboratory Code (preferred) ele-1: All FHIR elements must have a @value or children | ||||||||
| subject |
Σ | 1..1 | Reference(Patient: Animal | Patient: Person | Group | Device | Location) | Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children | ||||||||
| reference |
ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children | ||||||||
 effective[x] |
Σ | 1..1 | Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children | |||||||||
 effective[x]All Types |
Content/Rules for all Types | |||||||||||
| Slices for extension |
Content/Rules for all slices | |||||||||||
| data-absent-reason |
0..1 | code | effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| effectiveDateTime |
dateTime | |||||||||||
| effectivePeriod |
Period | |||||||||||
| issued |
Σ | 0..1 | instant | Date/Time this result was made available ele-1: All FHIR elements must have a @value or children | ||||||||
| performer |
Σ | 1..* | Reference(PractitionerRole: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson) | Who is responsible for the observation ele-1: All FHIR elements must have a @value or children | ||||||||
 Slices for extension |
Content/Rules for all slices | |||||||||||
| performerFunction |
0..* | CodeableConcept | Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| Slices for value[x] |
ΣC | 0..1 | Actual result Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children | |||||||||
| 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 |
ΣC | 0..1 | string | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueRange |
ΣC | 0..1 | RangeIPS | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueRatio |
ΣC | 0..1 | RatioUvLab | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueTime |
ΣC | 0..1 | time | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueDateTime |
ΣC | 0..1 | dateTime | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valuePeriod |
ΣC | 0..1 | Period | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueQuantity |
ΣC | 0..1 | QuantityUvLab | Actual result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueCodeableConcept |
ΣC | 0..1 | CodeableConceptIPS | Actual result Binding: Results Coded Values Laboratory - IPS (preferred)
ele-1: All FHIR elements must have a @value or children | ||||||||
| dataAbsentReason |
C | 0..1 | CodeableConcept | Provides a reason why the expected value is missing. Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. ele-1: All FHIR elements must have a @value or children | ||||||||
| interpretation |
0..* | CodeableConceptIPS | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. ele-1: All FHIR elements must have a @value or children | |||||||||
| method |
0..1 | CodeableConceptIPS | How it was done Binding: Laboratory Techniques (preferred) ele-1: All FHIR elements must have a @value or children | |||||||||
| specimen |
0..1 | Reference(Specimen: Laboratory) | Specimen used for this observation ele-1: All FHIR elements must have a @value or children | |||||||||
| device |
0..1 | Reference(Device | DeviceMetric) | Measuring instrument ele-1: All FHIR elements must have a @value or children | |||||||||
| hasMember |
Σ | 0..* | Reference(Observation Results: laboratory) | Related resource that belongs to the Observation group ele-1: All FHIR elements must have a @value or children | ||||||||
| component |
Σ | 0..* | BackboneElement | Laboratory result ele-1: All FHIR elements must have a @value or children | ||||||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| value-r5 |
0..1 | (Complex) | only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x] ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||||||
| extension |
0..0 | |||||||||||
| url |
1..1 | uri | "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]" | |||||||||
| value[x] |
1..1 | Attachment | Value of extension ele-1: All FHIR elements must have a @value or children | |||||||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||||||
| code |
Σ | 1..1 | CodeableConceptIPS | Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred) ele-1: All FHIR elements must have a @value or children | ||||||||
| Slices for value[x] |
Σ | 0..1 | Actual component result Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children | |||||||||
| 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 |
Σ | 0..1 | string | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueRange |
Σ | 0..1 | RangeIPS | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueRatio |
Σ | 0..1 | RatioUvLab | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueTime |
Σ | 0..1 | time | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueDateTime |
Σ | 0..1 | dateTime | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valuePeriod |
Σ | 0..1 | Period | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueQuantity |
Σ | 0..1 | QuantityUvLab | Actual component result ele-1: All FHIR elements must have a @value or children | ||||||||
| value[x]:valueCodeableConcept |
Σ | 0..1 | CodeableConceptIPS | Actual component result Binding: Results Coded Values Laboratory - IPS (preferred)
ele-1: All FHIR elements must have a @value or children | ||||||||
| Documentation for this format | ||||||||||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1from the FHIR Standard | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:laboratory | preferred | Pattern: laboratoryhttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:studyType | required | LabStudyTypesVshttp://hl7.org/fhir/uv/lab-report/ValueSet/studyType-uv-labfrom this IG | |
| Observation.category:specialty | required | LabSpecialtyVshttp://hl7.org/fhir/uv/lab-report/ValueSet/specialty-uv-labfrom this IG | |
| Observation.code | preferred | LaboratoryResultStandardVshttp://hl7.org/fhir/uv/lab-report/ValueSet/obsCode-uv-labfrom this IG | |
| Observation.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIpshttp://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips | |
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | |
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard | |
| Observation.method | preferred | LabTechniqueVshttp://hl7.org/fhir/uv/lab-report/ValueSet/technique-uv-labfrom this IG | |
| Observation.component.code | preferred | ResultsLaboratoryObservationUvIpshttp://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips | |
| Observation.component.value[x]:valueCodeableConcept | preferred | ResultsCodedValuesLaboratoryUvIpshttp://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips |
| 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() | |
| 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() | |
| uv-lab-1 | error | Observation | If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" : (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists() | |
| uv-lab-2 | error | Observation | If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists() |
Other representations of profile: CSV, Excel, Schematron
IG © 2023+ HL7 International / Orders and Observations. Package hl7.fhir.uv.lab-report#1.0.0-ballot based on FHIR 4.0.1. Generated 2025-01-25
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change