<status value="draft" /> <publisher value="Healthdata.be (Sciensano)" /> <contact> <name value="Service portal – healthdata.be" /> <telecom> <system value="url" /> <value value="https://sciensano.service-now.com/sp" /> <use value="work" /> </telecom> </contact> <description value="A laboratory result describes the result of a laboratory analysis. These are specimen-oriented tests as performed in laboratories such as Clinical Chemistry, Serology, Microbiology, etc. In addition to the results of tests with a singular result, this concept can also contain the results of more complex tests with multiple results or a ‘panel’." /> <copyright value="Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise." /> <fhirVersion value="4.0.1" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <uri value="https://zibs.nl/wiki/LaboratoryTestResult-v4.6(2020EN)" /> <name value="zib LaboratoryTestResult-v4.6(2020EN)" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <uri value="https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-LaboratoryTestResult" /> <name value="HdBe logical model LaboratoryTestResult" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Observation" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Observation" /> <derivation value="constraint" /> <differential> <element id="Observation"> <path value="Observation" /> <short value="LaboratoryTestResult / LaboratoryTest" /> <definition value="An instance of CBB LaboratoryTestResult or of a single LaboratoryTest within this CBB." /> <comment value="**1. Guidance on use for singular tests and panels** The CBB LaboratoryTestResult captures both singular laboratory tests and panels/clusters of multiple related tests requested together (e.g., blood gases and EBV serology)*. This profile should be used slightly different in these two situations: * For singular laboratory test results * A single instance of this profile is to be used. * `Observation.code` represents concept TestCode (the name and code of the executed test) while concept PanelOrBattery (the name and code of the compound test) is not expected to be present. * `Observation.status` represents concept TestResultStatus (the status of the test result). ResultStatus is redundant in this situation and not expected to be present. * For a panel or cluster: * There is a single instance for the overall result plus an instance for each test result. * The concepts Comment (`Observation.note`), ResultType ( `Observation.category:resultType`) and Performer ( `Observation.performer`) are repeated in the instance for the overall result and in all instances for the individual test results. * For the instance representing the overall result: * `Observation.code` represents concept PanelOrBattery (the name and code of the compound test), which is required for panels/clusters. * `Observation.status` represents concept ResultStatus (the overall status of the test result). This status should be in accordance with the statuses of each individual test. * The instances representing the individual test results are referenced using `Observation.hasMember`. * For the instances representing the individual test results: * `Observation.code` represents concept TestCode (the name and code of the executed test) for that particular test. * `Observation.status` represents concept TestResultStatus (the status of the test result) for that particular test. Note 1: The CBB also recognizes the RelatedResult concept. This is unrelated to the use of panels/clusters. This concept is represented using `Observation.extension:relatedResult`. **2. Unmapped CBB concept** * The concept InterpretationMethod is not implemented because there's no obvious mapping to FHIR while the definition is problematic, and there doesn't seem to be a use case for exchanging this information (see <https://bits.nictiz.nl/browse/ZIB-1292> for more information). **3. Unmapped zib concept** * Although the concept Requester is not implemented in the zib profile because it is deemed unimplementable as-is, it has been implemented by this profile using a light profile on ServiceRequest. The profile does not contain enough guidance to implement a requesting service fully. It merely allows capturing the requester information in a native FHIR element. The ServiceRequest is referenced by `Observation.basedOn`." /> <alias value="LaboratoriumUitslag" /> <alias value="LaboratoriumTest" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.1" /> <comment value="LaboratoryTestResult" /> </mapping> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.3" /> <comment value="LaboratoryTest" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest" /> </mapping> </element> <element id="Observation.extension"> <path value="Observation.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <rules value="open" /> </slicing> <min value="0" /> </element> <element id="Observation.extension:relatedResult"> <path value="Observation.extension" /> <sliceName value="relatedResult" /> <min value="0" /> <type> <code value="Extension" /> <profile value="http://hl7.org/fhir/StructureDefinition/observation-sequelTo" /> </type> </element> <element id="Observation.extension:relatedResult.value[x]"> <path value="Observation.extension.value[x]" /> <short value="RelatedResult" /> <definition value="Reference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures." /> <alias value="GerelateerdeUitslag" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult" /> </type> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.33" /> <comment value="RelatedResult" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.RelatedResult" /> </mapping> </element> <element id="Observation.basedOn"> <path value="Observation.basedOn" /> <comment value="The ServiceRequest.requester holds the information on who requested the laboratory test. This ServiceRequest is linked through this element." /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/CarePlan" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceRequest" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionOrder" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ServiceRequest" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Requester" /> </type> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.Requester" /> <comment value="implicit (main mapping on the referenced ServiceRequest.requester)" /> </mapping> </element> <element id="Observation.status"> <path value="Observation.status" /> <short value="ResultStatus / TestResultStatus" /> <definition value="The status of the laboratory test result or test result panel/cluster." /> <comment value="If this resource represents a singular test result or a single test in a cluster/panel, this will be the status of this particular test result. However, if it represents the overall result of a panel/cluster, this status should represent the status of the panel/cluster and should be in accordance with the test result statuses of the individual tests." /> <alias value="TestUitslagStatus" /> <binding> <strength value="required" /> <valueSet value="https://fhir.healthdata.be/ValueSet/TestResultStatus" /> </binding> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.6" /> <comment value="ResultStatus" /> </mapping> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.31" /> <comment value="TestResultStatus" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.ResultStatus" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.TestResultStatus" /> </mapping> </element> <element id="Observation.category"> <path value="Observation.category" /> <slicing> <discriminator> <type value="value" /> <path value="$this" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Observation.category:laboratoryCategory"> <path value="Observation.category" /> <sliceName value="laboratoryCategory" /> <min value="1" /> <patternCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/observation-category" /> <code value="laboratory" /> </coding> </patternCodeableConcept> </element> <element id="Observation.category:resultType"> <path value="Observation.category" /> <sliceName value="resultType" /> <short value="ResultType" /> <definition value="The type of result defines the laboratory specialty under which the test is categorized." /> <alias value="ResultaatType" /> <max value="1" /> <binding> <strength value="required" /> <valueSet value="https://fhir.healthdata.be/ValueSet/ResultType" /> </binding> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.ResultType" /> </mapping> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.7" /> <comment value="ResultType" /> </mapping> </element> <element id="Observation.code"> <path value="Observation.code" /> <short value="PanelOrBattery / TestCode" /> <definition value="The name and code of the executed test. For laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name and code of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology." /> <comment value="`Observation.code` SHOULD be populated with LOINC codes as per the subset defined by the FPS Health, for the majority of commonly used lab measurements and demands. This subset is available on the [website of the FPS Health](https://www.vas.ehealth.fgov.be/webretam/retam/home.htm). At least the below stated rules need to be followed. 1. The actual observation is coded in LOINC (subset as defined by FPS Health). ``` "code":{ "coding":[ { "system": "http://loinc.org", "code": "30341-2", "display": "Erythrocyte sedimentation rate" } ] } ``` 2. If the above is not possible, ALBERT codes are used (subset as defined by FPS Health). The NamingSystem 'https://www.ehealth.fgov.be/standards/fhir/lab/CodeSystem/albert' is used for `code.coding.system`. ``` "code":{ "coding":[ { "system": "https://www.ehealth.fgov.be/standards/fhir/lab/CodeSystem/albert", "code": "26224", "display": "Glucose (urine 24h)" } ] } ``` 3. If the above is not possible, other (internally used) codes plus obligatory a text element to further explain are used. ``` "code":{ "coding":[ { "system": "OWNSYSTEM", "code": "OWNCODE", "display": "DISPLAYOWNCODE" } ], "text": "TEXTEXPLAINING" } ``` 4. If the above is not possible the kind of observation may be expressed only in text (allowed but discouraged). ``` "code":{ "text": "TEXTEXPLAINING" } ``` Note that the FHIR CodeableConcept data type allows multiple codes (if they represent the same concept) because `code.coding` is 0..*. For example, LOINC codes may be supplemented with codes from other codesystems." /> <alias value="Onderzoek" /> <alias value="TestCode" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.4" /> <comment value="PanelOrBattery" /> </mapping> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.8" /> <comment value="TestCode" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.PanelOrBattery" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.TestCode" /> </mapping> </element> <element id="Observation.subject"> <path value="Observation.subject" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-Patient" /> </type> </element> <element id="Observation.effective[x]"> <path value="Observation.effective[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="Observation.effective[x]:effectiveDateTime"> <path value="Observation.effective[x]" /> <sliceName value="effectiveDateTime" /> <short value="TestDateTime" /> <definition value="The date and if possible the time at which the test was carried out." /> <alias value="TestDatumTijd" /> <type> <code value="dateTime" /> </type> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.13" /> <comment value="TestDateTime" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.TestDateTime" /> </mapping> </element> <element id="Observation.performer"> <path value="Observation.performer" /> <slicing> <discriminator> <type value="profile" /> <path value="resolve()" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="Observation.performer:performer"> <path value="Observation.performer" /> <sliceName value="performer" /> <short value="Performer" /> <definition value="The HealthProfessional responsible for the LaboratoryTestResult. The performing laboratory (HealthcareOrganization) is referenced through the HealthProfessional." /> <alias value="Uitvoerder" /> <max value="1" /> <type> <code value="Reference" /> <profile value="https://fhir.healthdata.be/StructureDefinition/pattern-HealthProfessionalReference" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-HealthProfessional-PractitionerRole" /> </type> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.Performer.HealthProfessional" /> </mapping> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.35" /> <comment value="Performer" /> </mapping> </element> <element id="Observation.value[x]"> <path value="Observation.value[x]" /> <short value="TestResult" /> <definition value="The test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal)." /> <comment value="An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For quantitative results, it is mandatory to provide an unit. For additional guidance, see the [Notes section](observation.html#notes) below." /> <alias value="TestUitslag" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.10" /> <comment value="TestResult" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.TestResult" /> </mapping> </element> <element id="Observation.interpretation"> <path value="Observation.interpretation" /> <slicing> <discriminator> <type value="exists" /> <path value="coding" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="Observation.interpretation:resultFlags"> <path value="Observation.interpretation" /> <sliceName value="resultFlags" /> <short value="ResultFlags" /> <definition value="Attention codes indicating whether the result of a quantitative test is above or below certain reference values or interpreting the result otherwise.(Resistent). The values Resistant, Intermediate en Susceptible are used with microbiological test results." /> <alias value="InterpretatieVlaggen" /> <binding> <strength value="extensible" /> <description value="Use ConceptMap 'ResultFlags-to-ObservationInterpretation' to translate CBB terminology to profile terminology in ValueSet 'Observation-interpretation'" /> <valueSet value="https://fhir.healthdata.be/ValueSet/ResultFlags"> <extension url="http://hl7.org/fhir/StructureDefinition/11179-permitted-value-conceptmap"> <valueCanonical value="https://fhir.healthdata.be/ConceptMap/ResultFlags-to-ObservationInterpretationCodes" /> </extension> </valueSet> </binding> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.14" /> <comment value="ResultFlags" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ResultFlags" /> </mapping> </element> <element id="Observation.interpretation:resultFlags.coding"> <path value="Observation.interpretation.coding" /> <min value="1" /> </element> <element id="Observation.interpretation:resultInterpretation"> <path value="Observation.interpretation" /> <sliceName value="resultInterpretation" /> <max value="1" /> </element> <element id="Observation.interpretation:resultInterpretation.coding"> <path value="Observation.interpretation.coding" /> <max value="0" /> </element> <element id="Observation.interpretation:resultInterpretation.text"> <path value="Observation.interpretation.text" /> <short value="ResultInterpretation" /> <definition value="Comment of the laboratory specialist regarding the interpretation of the results" /> <alias value="UitslagInterpretatie" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.32" /> <comment value="ResultInterpretation" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ResultInterpretation" /> </mapping> </element> <element id="Observation.note"> <path value="Observation.note" /> <max value="1" /> </element> <element id="Observation.note.text"> <path value="Observation.note.text" /> <short value="Comment" /> <definition value="Comments, such as a textual interpretation or advice accompanying the result, for example." /> <alias value="Toelichting" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.5" /> <comment value="Comment" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.Comment" /> </mapping> </element> <element id="Observation.method"> <path value="Observation.method" /> <short value="TestMethod" /> <definition value="The test method used to obtain the result." /> <alias value="Testmethode" /> <binding> <strength value="required" /> <valueSet value="https://fhir.healthdata.be/ValueSet/TestMethod" /> </binding> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.9" /> <comment value="TestMethod" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.TestMethod" /> </mapping> </element> <element id="Observation.specimen"> <path value="Observation.specimen" /> <comment value="The Specimen concept of the CCB defines either the collected source material without further processing, or a microorganism, optionally including the source material from which it whas isolated. * If the Specimen pertains a material (CCB concept SpecimenMaterial), the `Specimen.type` of the resource referenced here should contain a coding indicating a specimen material. * If the Specimen pertains a microorganism (CCB concept Microorganism), the `Specimen.type` of the resource referenced here should contain a coding indicating the microorganims. If required, the sample material from which the microorganism was isolated can be referenced using `Specimen.parent` on that resource, but it is not referenced here." /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Specimen" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen" /> </type> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.Specimen" /> </mapping> </element> <element id="Observation.referenceRange.low"> <path value="Observation.referenceRange.low" /> <short value="ReferenceRangeLowerLimit" /> <definition value="The lower reference limit for the patient of the value measured with the test." /> <alias value="ReferentieOndergrens" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.12" /> <comment value="ReferenceRangeLowerLimit" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ReferenceRangeLowerLimit" /> </mapping> </element> <element id="Observation.referenceRange.high"> <path value="Observation.referenceRange.high" /> <short value="ReferenceRangeUpperLimit" /> <definition value="The upper reference limit for the patient of the value measured in the test." /> <alias value="ReferentieBovengrens" /> <mapping> <identity value="zib-laboratorytestresult-v4.6-2020EN" /> <map value="NL-CM:13.1.11" /> <comment value="ReferenceRangeUpperLimit" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ReferenceRangeUpperLimit" /> </mapping> </element> <element id="Observation.referenceRange.text"> <path value="Observation.referenceRange.text" /> <comment value="Text based reference ranges is only used when the ReferenceRangeLowerLimit and/or ReferenceRangeUpperLimit cannot be expressed as quantity in `.low` and `.high`." /> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ReferenceRangeLowerLimit" /> </mapping> <mapping> <identity value="HdBe-LaboratoryTestResult" /> <map value="LaboratoryTestResult.LaboratoryTest.ReferenceRangeUpperLimit" /> </mapping> </element> <element id="Observation.hasMember"> <path value="Observation.hasMember" /> <comment value="When this resource is used to represent the overall result of a panel/cluster of laboratory tests, the individual test results SHOULD be referenced here. See the root of this profile for guidance." /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MolecularSequence" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult" /> </type> </element> </differential> </StructureDefinition>