<status value="draft" /> <experimental value="false" /> <date value="2025-04-15" /> <publisher value="ARS@rki.de" /> <description value="Dieses Profil beschreibt die durchgeführte mikrobiologische Diagnostik und ihr Ergebnis. Es ist für ARS nur ein Profil für die Labortestung vorgesehen. Besonderheiten unterschiedlicher Verfahren und Ergebnisse werden über die verwendeten Codes abgebildet, siehe hierzu Kapitel 'Semantik' im Implementierungsleitfaden." /> <fhirVersion value="4.0.1" /> <kind value="resource" /> <abstract value="false" /> <type value="Observation" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Observation" /> <derivation value="constraint" /> <differential> <element id="Observation.id"> <path value="Observation.id" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.meta"> <path value="Observation.meta" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.meta.id"> <path value="Observation.meta.id" /> <max value="0" /> </element> <element id="Observation.meta.extension"> <path value="Observation.meta.extension" /> <max value="0" /> </element> <element id="Observation.meta.versionId"> <path value="Observation.meta.versionId" /> <max value="0" /> </element> <element id="Observation.meta.lastUpdated"> <path value="Observation.meta.lastUpdated" /> <max value="0" /> </element> <element id="Observation.meta.source"> <path value="Observation.meta.source" /> <max value="0" /> </element> <element id="Observation.meta.profile"> <path value="Observation.meta.profile" /> <slicing> <discriminator> <type value="pattern" /> <path value="$this" /> </discriminator> <rules value="closed" /> </slicing> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.meta.profile:arsProfile"> <path value="Observation.meta.profile" /> <sliceName value="arsProfile" /> <min value="1" /> <max value="1" /> <patternCanonical value="https://demis.rki.de/fhir/ars/StructureDefinition/Observation" /> <mustSupport value="true" /> </element> <element id="Observation.meta.security"> <path value="Observation.meta.security" /> <max value="0" /> </element> <element id="Observation.meta.tag"> <path value="Observation.meta.tag" /> <max value="0" /> </element> <element id="Observation.extension"> <path value="Observation.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy"> <path value="Observation.extension" /> <sliceName value="triggeredBy" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy" /> </type> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension"> <path value="Observation.extension.extension" /> <max value="2" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation"> <path value="Observation.extension.extension" /> <sliceName value="observation" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.url"> <path value="Observation.extension.extension.url" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]"> <path value="Observation.extension.extension.value[x]" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]:valueReference"> <path value="Observation.extension.extension.value[x]" /> <sliceName value="valueReference" /> <type> <code value="Reference" /> <targetProfile value="https://demis.rki.de/fhir/ars/StructureDefinition/Observation" /> </type> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]:valueReference.reference"> <path value="Observation.extension.extension.value[x].reference" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]:valueReference.type"> <path value="Observation.extension.extension.value[x].type" /> <max value="0" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]:valueReference.identifier"> <path value="Observation.extension.extension.value[x].identifier" /> <max value="0" /> </element> <element id="Observation.extension:triggeredBy.extension:observation.value[x]:valueReference.display"> <path value="Observation.extension.extension.value[x].display" /> <max value="0" /> </element> <element id="Observation.extension:triggeredBy.extension:type"> <path value="Observation.extension.extension" /> <sliceName value="type" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:type.url"> <path value="Observation.extension.extension.url" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:type.value[x]"> <path value="Observation.extension.extension.value[x]" /> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.extension:type.value[x]:valueCode"> <path value="Observation.extension.extension.value[x]" /> <sliceName value="valueCode" /> <type> <code value="code" /> </type> <mustSupport value="true" /> </element> <element id="Observation.extension:triggeredBy.url"> <path value="Observation.extension.url" /> <mustSupport value="true" /> </element> <element id="Observation.identifier"> <path value="Observation.identifier" /> <max value="0" /> </element> <element id="Observation.basedOn"> <path value="Observation.basedOn" /> <max value="0" /> </element> <element id="Observation.partOf"> <path value="Observation.partOf" /> <max value="0" /> </element> <element id="Observation.status"> <path value="Observation.status" /> <mustSupport value="true" /> </element> <element id="Observation.category"> <path value="Observation.category" /> <max value="0" /> </element> <element id="Observation.code"> <path value="Observation.code" /> <short value="Frage nach dem durchgeführten Test (LOINC)" /> <definition value="Beschreibt durch einen LOINC-Code die Frage nach dem durchgeführten Test." /> <mustSupport value="true" /> </element> <element id="Observation.code.coding"> <path value="Observation.code.coding" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> <binding> <strength value="extensible" /> <valueSet value="https://demis.rki.de/fhir/ars/ValueSet/testLOINC" /> </binding> </element> <element id="Observation.code.coding.system"> <path value="Observation.code.coding.system" /> <min value="1" /> <patternUri value="http://loinc.org" /> <mustSupport value="true" /> </element> <element id="Observation.code.coding.version"> <path value="Observation.code.coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.code.coding.code"> <path value="Observation.code.coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.code.text"> <path value="Observation.code.text" /> <short value="Originalbezeichnung" /> <definition value="Originalbezeichnung aus dem Laborinformationssystem (LIS) oder aus dem sendenden System. Diese Angabe wird zum Datenqualitätsmanagement verwendet." /> <mustSupport value="true" /> </element> <element id="Observation.subject"> <path value="Observation.subject" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="https://demis.rki.de/fhir/ars/StructureDefinition/Patient" /> </type> <mustSupport value="true" /> </element> <element id="Observation.subject.reference"> <path value="Observation.subject.reference" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.subject.type"> <path value="Observation.subject.type" /> <max value="0" /> </element> <element id="Observation.subject.identifier"> <path value="Observation.subject.identifier" /> <max value="0" /> </element> <element id="Observation.subject.display"> <path value="Observation.subject.display" /> <max value="0" /> </element> <element id="Observation.focus"> <path value="Observation.focus" /> <max value="0" /> </element> <element id="Observation.encounter"> <path value="Observation.encounter" /> <max value="0" /> </element> <element id="Observation.effective[x]"> <path value="Observation.effective[x]" /> <max value="0" /> </element> <element id="Observation.issued"> <path value="Observation.issued" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.performer"> <path value="Observation.performer" /> <max value="0" /> </element> <element id="Observation.value[x]"> <path value="Observation.value[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <rules value="closed" /> </slicing> <short value="Ergebnis des durchgeführten Tests" /> <definition value="Das Ergebnis des durchgeführten Tests kann sowohl als qualitative Angabe (valueCodeableConcept), als auch als quantitative Angabe (valueQuantity) beschrieben werden." /> <type> <code value="Quantity" /> </type> <type> <code value="CodeableConcept" /> </type> <type> <code value="Range" /> </type> <type> <code value="Ratio" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept"> <path value="Observation.value[x]" /> <sliceName value="valueCodeableConcept" /> <short value="Ergebnis des durchgeführten Tests (SNOMED)" /> <definition value="Als qualitative Angabe des Ergebnisses werden SNOMED-Codes erwartet, die den Nachweis oder nicht-Nachweis eines Analyten, den nachgewiesenen Erreger, das nachgewiesene Gen, Antigen, Toxin, den nachgewiesenen Antikörper etc. beschreiben." /> <min value="0" /> <max value="1" /> <type> <code value="CodeableConcept" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept.coding"> <path value="Observation.value[x].coding" /> <slicing> <discriminator> <type value="pattern" /> <path value="system" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept.coding:snomedCode"> <path value="Observation.value[x].coding" /> <sliceName value="snomedCode" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> <binding> <strength value="extensible" /> <valueSet value="https://demis.rki.de/fhir/ars/ValueSet/antwortSNOMED" /> </binding> </element> <element id="Observation.value[x]:valueCodeableConcept.coding:snomedCode.system"> <path value="Observation.value[x].coding.system" /> <min value="1" /> <patternUri value="http://snomed.info/sct" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept.coding:snomedCode.version"> <path value="Observation.value[x].coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept.coding:snomedCode.code"> <path value="Observation.value[x].coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueCodeableConcept.text"> <path value="Observation.value[x].text" /> <short value="Originalbezeichnung" /> <definition value="Originalbezeichnung aus dem Laborinformationssystem (LIS) oder aus dem sendenden System. Diese Angabe wird zum Datenqualitätsmanagement verwendet." /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity"> <path value="Observation.value[x]" /> <sliceName value="valueQuantity" /> <short value="Ergebnis des durchgeführten Tests (quantitativ, dezimal)" /> <definition value="Hier wird ein quantitatives Ergebnis mit der Einheit nach UCUM erwartet. Es kann dabei bedeutsam sein, einen Referenzbereich für die beschriebenen Werte anzugeben. Dies kann unter Observation.referenceRange erfolgen." /> <min value="0" /> <max value="1" /> <type> <code value="Quantity" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity.value"> <path value="Observation.value[x].value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity.comparator"> <path value="Observation.value[x].comparator" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity.system"> <path value="Observation.value[x].system" /> <min value="1" /> <patternUri value="http://unitsofmeasure.org" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity.code"> <path value="Observation.value[x].code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio"> <path value="Observation.value[x]" /> <sliceName value="valueRatio" /> <short value="Ergebnis des durchgeführten Tests (quantitativ, ratio)" /> <definition value="Hier kann eine Ratios als quantitatives Ergebnis der mikrobiologischen Diagnostik angegeben werden." /> <min value="0" /> <max value="1" /> <type> <code value="Ratio" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.numerator"> <path value="Observation.value[x].numerator" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.numerator.value"> <path value="Observation.value[x].numerator.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.numerator.system"> <path value="Observation.value[x].numerator.system" /> <patternUri value="http://unitsofmeasure.org" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.numerator.code"> <path value="Observation.value[x].numerator.code" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.denominator"> <path value="Observation.value[x].denominator" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.denominator.value"> <path value="Observation.value[x].denominator.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.denominator.system"> <path value="Observation.value[x].denominator.system" /> <patternUri value="http://unitsofmeasure.org" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRatio.denominator.code"> <path value="Observation.value[x].denominator.code" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange"> <path value="Observation.value[x]" /> <sliceName value="valueRange" /> <short value="Ergebnis des durchgeführten Tests (quantitativ, range)" /> <definition value="Hier kann ein Bereich, bestehend aus Low und High, als quantitative Angabe gemacht werden." /> <min value="0" /> <max value="1" /> <type> <code value="Range" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.low"> <path value="Observation.value[x].low" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.low.value"> <path value="Observation.value[x].low.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.low.system"> <path value="Observation.value[x].low.system" /> <min value="1" /> <patternUri value="http://unitsofmeasure.org" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.low.code"> <path value="Observation.value[x].low.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.high"> <path value="Observation.value[x].high" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.high.value"> <path value="Observation.value[x].high.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.high.system"> <path value="Observation.value[x].high.system" /> <min value="1" /> <patternUri value="http://unitsofmeasure.org" /> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueRange.high.code"> <path value="Observation.value[x].high.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.dataAbsentReason"> <path value="Observation.dataAbsentReason" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation"> <path value="Observation.interpretation" /> <short value="Interpretation des Ergebnisses" /> <definition value="Es wird immer eine Interpretation des Ergebnisses erwartet. Diese kann bei ordinalen qualitativen Angaben unter Observation.valueCodeableConcept dem dort beschriebenen Ergebnis entsprechen. Insbesondere bei quantitativen Angaben zum Ergebnis unter Observation.valueQuantity kann hier allerdings die Bewertung des Ergebnisses angegeben werden. Die Angaben sind als SNOMED-Code oder unter Angabe eines Codes entsprechend dem FHIR-Basisstandard zu machen." /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding"> <path value="Observation.interpretation.coding" /> <slicing> <discriminator> <type value="pattern" /> <path value="system" /> </discriminator> <rules value="closed" /> </slicing> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:hl7Interpretation"> <path value="Observation.interpretation.coding" /> <sliceName value="hl7Interpretation" /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> <binding> <strength value="extensible" /> <valueSet value="http://hl7.org/fhir/ValueSet/observation-interpretation" /> </binding> </element> <element id="Observation.interpretation.coding:hl7Interpretation.system"> <path value="Observation.interpretation.coding.system" /> <min value="1" /> <patternUri value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:hl7Interpretation.version"> <path value="Observation.interpretation.coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:hl7Interpretation.code"> <path value="Observation.interpretation.coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:snomedInterpretation"> <path value="Observation.interpretation.coding" /> <sliceName value="snomedInterpretation" /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> <binding> <strength value="extensible" /> <valueSet value="https://demis.rki.de/fhir/ars/ValueSet/interpretationSNOMED" /> </binding> </element> <element id="Observation.interpretation.coding:snomedInterpretation.system"> <path value="Observation.interpretation.coding.system" /> <min value="1" /> <patternUri value="http://snomed.info/sct" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:snomedInterpretation.version"> <path value="Observation.interpretation.coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding:snomedInterpretation.code"> <path value="Observation.interpretation.coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.text"> <path value="Observation.interpretation.text" /> <max value="0" /> </element> <element id="Observation.note"> <path value="Observation.note" /> <max value="0" /> </element> <element id="Observation.bodySite"> <path value="Observation.bodySite" /> <max value="0" /> </element> <element id="Observation.method"> <path value="Observation.method" /> <short value="Labormethode" /> <definition value="Die verwendete Labormethode wird als SNOMED-Code erwartet." /> <mustSupport value="true" /> </element> <element id="Observation.method.coding"> <path value="Observation.method.coding" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> <binding> <strength value="extensible" /> <valueSet value="https://demis.rki.de/fhir/ars/ValueSet/methodeSNOMED" /> </binding> </element> <element id="Observation.method.coding.system"> <path value="Observation.method.coding.system" /> <min value="1" /> <patternUri value="http://snomed.info/sct" /> <mustSupport value="true" /> </element> <element id="Observation.method.coding.version"> <path value="Observation.method.coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.method.coding.code"> <path value="Observation.method.coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.method.text"> <path value="Observation.method.text" /> <mustSupport value="true" /> </element> <element id="Observation.specimen"> <path value="Observation.specimen" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="https://demis.rki.de/fhir/ars/StructureDefinition/Specimen" /> </type> <mustSupport value="true" /> </element> <element id="Observation.specimen.reference"> <path value="Observation.specimen.reference" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.specimen.type"> <path value="Observation.specimen.type" /> <max value="0" /> </element> <element id="Observation.specimen.identifier"> <path value="Observation.specimen.identifier" /> <max value="0" /> </element> <element id="Observation.specimen.display"> <path value="Observation.specimen.display" /> <max value="0" /> </element> <element id="Observation.device"> <path value="Observation.device" /> <max value="0" /> </element> <element id="Observation.referenceRange"> <path value="Observation.referenceRange" /> <short value="Referenzwerte und Norm" /> <definition value="Angabe von Referenzwerten, die zur Interpretation eines quantitativen Testergebnisses herangezogen wurden. Die Referenzwerte sind häufig Testkit-spezifisch. Insbesondere soll unter der extension 'norm' auch die Angabe der Norm, nachdem das Ergebnis der phänotypischen Empfindlichkeitsprüfung bewertet wurde angegeben werden." /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension"> <path value="Observation.referenceRange.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <max value="1" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm"> <path value="Observation.referenceRange.extension" /> <sliceName value="norm" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://demis.rki.de/fhir/ars/StructureDefinition/Norm" /> </type> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.url"> <path value="Observation.referenceRange.extension.url" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x]"> <path value="Observation.referenceRange.extension.value[x]" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x].coding"> <path value="Observation.referenceRange.extension.value[x].coding" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x].coding.system"> <path value="Observation.referenceRange.extension.value[x].coding.system" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x].coding.version"> <path value="Observation.referenceRange.extension.value[x].coding.version" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x].coding.code"> <path value="Observation.referenceRange.extension.value[x].coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.extension:norm.value[x].text"> <path value="Observation.referenceRange.extension.value[x].text" /> <mustSupport value="true" /> </element> <element id="Observation.referenceRange.text"> <path value="Observation.referenceRange.text" /> <comment value="Eine Angabe in 'referenceRange' muss mindestens eines der Felder 'low', 'high' oder 'text' enthalten. Bei Bedarf kann an dieser Stelle für ARS ein Dummy-Text eingefügt werden, z.B. 'nur Angabe Norm'." /> <mustSupport value="true" /> </element> <element id="Observation.hasMember"> <path value="Observation.hasMember" /> <type> <code value="Reference" /> <targetProfile value="https://demis.rki.de/fhir/ars/StructureDefinition/Observation" /> </type> <mustSupport value="true" /> </element> <element id="Observation.hasMember.reference"> <path value="Observation.hasMember.reference" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.hasMember.type"> <path value="Observation.hasMember.type" /> <max value="0" /> </element> <element id="Observation.hasMember.identifier"> <path value="Observation.hasMember.identifier" /> <max value="0" /> </element> <element id="Observation.hasMember.display"> <path value="Observation.hasMember.display" /> <max value="0" /> </element> <element id="Observation.derivedFrom"> <path value="Observation.derivedFrom" /> <max value="0" /> </element> </differential> </StructureDefinition>