| Left: | ISiKLaboruntersuchung (https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung) |
| Right: | Observation Results: laboratory (http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab) |
| Error | StructureDefinition.url | Values for url differ: 'https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung' vs 'http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab' |
| Error | StructureDefinition.version | Values for version differ: '5.0.0' vs '0.2.0-ci' |
| Information | StructureDefinition.name | Values for name differ: 'ISiKLaboruntersuchung' vs 'ObservationResultsLaboratoryEu' |
| Information | StructureDefinition.status | Values for status differ: 'active' vs 'draft' |
| Information | StructureDefinition.date | Values for date differ: '2025-06-26' vs '2025-04-01T09:29:47+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'gematik GmbH' vs 'HL7 Europe' |
| Information | StructureDefinition.jurisdiction | Added the item 'http://unstats.un.org/unsd/methods/m49/m49.htm#150' |
| Information | StructureDefinition.short | Values for short differ: 'Measurements and simple assertions' vs 'Laboratory result for a simple test or for a panel/study' |
| Information | StructureDefinition.definition | Values for definition differ: 'Measurements and simple assertions made about a patient, device or other subject.' vs '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 references the atomic results of the study as 'has-member' child observations' |
| Information | StructureDefinition.comment | Values for comment differ: 'Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.' vs 'Represents either a lab simple observation or the group of observations produced by a laboratory study.' |
| Information | StructureDefinition.short | Values for short differ: 'Additional content defined by implementations' vs 'Laboratory Test Kit' |
| Information | StructureDefinition.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'The laboratory test kit used for this test.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.comment | Values for comment differ: 'To link an Observation to an Encounter use `encounter`. See the [Notes](observation.html#obsgrouping) below for guidance on referencing another Observation.' vs 'To link an Observation to an Encounter use `encounter`. See the [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below for guidance on referencing another Observation.' |
| Information | StructureDefinition.short | Values for short differ: 'Status der Laboruntersuchung' vs 'Status of this observation (e.g. preliminary, final,...)' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. **WICHTIGER Hinweis für Implementierer**: * Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte `final` und `unknown`. * Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status `entered-in-error` und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä.' vs 'This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.' |
| Warning | Observation.status | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Kategorie der Laboruntersuchung' vs 'Classification of type of observation' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen.' vs ''laboratory' includes laboratory medicine and pathology' |
| Warning | Observation.category | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Gegenstand der Untersuchung (Laborparameter)' vs 'Type of observation (code / type)' |
| Information | StructureDefinition.definition | Values for definition differ: 'Describes what was observed. Sometimes this is called the observation 'name'.' vs 'Describes what was observed. Sometimes this is called the observation 'name'. In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext dokumentiert.' vs 'In the context of this Observation-laboratory-uv-ips profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.' |
| Warning | Observation.code | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.code | Example/preferred bindings differ at Observation.code using binding from ObservationResultsLaboratoryEu |
| Information | StructureDefinition.short | Values for short differ: 'Referenz auf den Patienten' vs 'Who and/or what the observation is about' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.' vs 'One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.' |
| Warning | Observation.subject | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.comment | Values for comment differ: 'Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., 'Blood Glucose') and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](extension-observation-focuscode.html).' vs 'Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., 'Blood Glucose') and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](http://hl7.org/fhir/R4/extension-observation-focuscode.html).' |
| Information | StructureDefinition.short | Values for short differ: 'Referenz auf den Abteilungskontakt' vs 'Healthcare event during which this observation is made' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.' vs 'This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).' |
| Warning | Observation.encounter | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Zeitpunkt der Untersuchung' vs 'Clinically relevant time/time-period for observation' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung Must Support**: Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für: * die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund), * Verlaufsauswertungen und Trendanalysen, * zeitlich abhängige Entscheidungsunterstützung, * eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts.' vs 'At least a date should be present unless this observation is a historical report. For recording imprecise or 'fuzzy' times (For example, a blood glucose measurement taken 'after breakfast') use the [Timing](http://hl7.org/fhir/R4/datatypes.html#timing) datatype which allow the measurement to be tied to regular life events.' |
| Warning | Observation.effective[x] | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.effective[x] | Element minimum cardinalities differ: '0' vs '1' |
| Information | StructureDefinition.short | Values for short differ: 'Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses' vs 'Date/Time this result was made available' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.' vs 'For Observations that don’t require review and verification, it may be the same as the [`lastUpdated` ](http://hl7.org/fhir/R4/resource-definitions.html#Meta.lastUpdated) time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the `lastUpdated` time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.' |
| Warning | Observation.issued | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.performer | Element minimum cardinalities differ: '0' vs '1' |
| Error | Observation.performer | Type Mismatch: Reference([CanonicalType[http://hl7.org/fhir/StructureDefinition/Practitioner], CanonicalType[http://hl7.org/fhir/StructureDefinition/PractitionerRole], CanonicalType[http://hl7.org/fhir/StructureDefinition/Organization], CanonicalType[http://hl7.org/fhir/StructureDefinition/CareTeam], CanonicalType[http://hl7.org/fhir/StructureDefinition/Patient], CanonicalType[http://hl7.org/fhir/StructureDefinition/RelatedPerson]]) vs Reference([CanonicalType[http://hl7.eu/fhir/base/StructureDefinition/practitionerRole-eu-core], CanonicalType[http://hl7.eu/fhir/base/StructureDefinition/practitioner-eu-core], CanonicalType[http://hl7.org/fhir/uv/ips/StructureDefinition/Organization-uv-ips], CanonicalType[http://hl7.org/fhir/StructureDefinition/CareTeam], CanonicalType[http://hl7.eu/fhir/base/StructureDefinition/patient-eu-core], CanonicalType[http://hl7.org/fhir/StructureDefinition/RelatedPerson]]) |
| Information | StructureDefinition.short | Values for short differ: 'Festgestellter (Mess)Wert für den Laborparameter' vs 'Actual result' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz.' vs '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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below.' |
| Warning | Observation.value[x] | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt' vs 'Provides a reason why the expected value is missing.' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung Must Support**: Nicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen' vs 'Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be 'detected', 'not detected', 'inconclusive', or 'specimen unsatisfactory'. The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code 'error' could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.' |
| Warning | Observation.dataAbsentReason | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)' vs 'High, low, normal, etc.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen.' vs 'Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.' |
| Warning | Observation.interpretation | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)' vs 'Comments about the observation' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.' vs 'May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.' |
| Warning | Observation.note | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.comment | Values for comment differ: 'Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension[ bodySite](extension-bodysite.html).' vs 'Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension[ bodySite](http://hl7.org/fhir/R4/extension-bodysite.html).' |
| Information | StructureDefinition.definition | Values for definition differ: 'Indicates the mechanism used to perform the observation.' vs 'Laboratory technigue that has been used' |
| Information | StructureDefinition.comment | Values for comment differ: '**Einschränkung der übergreifenden MS-Definition:** Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend. Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird.' vs 'Laboratory technique (method of measurement) are integral parts of the test specification of some laboratory test coding systems (e.g. NPU), in LOINC hovewer measurement principle is not always present in the test definition. In some cases however knowledge of the used measurment techique is important for proper interpretation of the test result. That's why it is important to explicitly include informaiton about measurement method is such cases.' |
| Warning | Observation.method | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.method | Example/preferred bindings differ at Observation.method using binding from ObservationResultsLaboratoryEu |
| Information | StructureDefinition.comment | Values for comment differ: '**Einschränkung der übergreifenden MS-Definition:** Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System die Information NICHT abbilden. Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend. Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird' vs 'When the specimen is applicable and known it shall be documented' |
| Warning | Observation.specimen | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung' vs 'Measuring instrument' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung Must Support**: Das verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben.' vs 'Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.' |
| Warning | Observation.device | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)' vs 'Provides guide for interpretation' |
| Information | StructureDefinition.comment | Values for comment differ: '**Begründung MS**: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes' vs 'Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.' |
| Warning | Observation.referenceRange | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.short | Values for short differ: 'Untergrenze des Referenzbereichs' vs 'Low Range, if relevant' |
| Warning | Observation.referenceRange.low | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Obergrenze des Referenzbereichs' vs 'High Range, if relevant' |
| Warning | Observation.referenceRange.high | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Art des Referenzbereichs (z. B. normal, kritisch)' vs 'Reference range qualifier' |
| Warning | Observation.referenceRange.type | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Für wen der Referenzbereich gilt (z. B. Geschlecht, Alter)' vs 'Reference range population' |
| Warning | Observation.referenceRange.appliesTo | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Altersbereich, für den der Referenzbereich gilt' vs 'Applicable age range, if relevant' |
| Warning | Observation.referenceRange.age | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Freitextbeschreibung des Referenzbereichs' vs 'Text based reference range in an observation' |
| Warning | Observation.referenceRange.text | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.definition | Values for definition differ: 'This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.' vs 'A reference to another Observation profiled by Observation-results-laboratory-uv-ips. The target observation (for instance an individual test member of a panel) is considered as a sub-observation of the current one, which plays the role of a grouper.' |
| Information | StructureDefinition.comment | Values for comment differ: 'When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see [Notes](observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](questionnaireresponse.html) into a final score and represent the score as an Observation.' vs 'This element is used in the context of international patient summary when there is a need to group a collection of observations, because they belong to the same panel, or because they share a common interpretation comment, or a common media attachment (illustrative image or graph). In these cases, the current observation is the grouper, and its set of sub-observations are related observations using the type 'has-member'. For a discussion on the ways Observations can be assembled in groups together see [Observation Grouping](http://hl7.org/fhir/observation.html#obsgrouping).' |
| Information | StructureDefinition.comment | Values for comment differ: 'All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see [Notes](observation.html#obsgrouping) below.' vs 'All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below.' |
| Information | StructureDefinition.short | Values for short differ: 'Component results' vs 'Laboratory result' |
| Information | StructureDefinition.comment | Values for comment differ: 'For a discussion on the ways Observations can be assembled in groups together see [Notes](observation.html#notes) below.' vs 'For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/observation.html#notes) below.' |
| Information | StructureDefinition.short | Values for short differ: 'Additional content defined by implementations' vs 'Extension' |
| Information | StructureDefinition.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'An Extension' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).' |
| Information | Observation.component.code | Example/preferred bindings differ at Observation.component.code using binding from ObservationResultsLaboratoryEu |
| Information | StructureDefinition.comment | Values for comment differ: 'Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). 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 additional guidance, see the [Notes section](observation.html#notes) below.' vs 'Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below.' |
| Name | Value | Comments | |
|---|---|---|---|
abstract | false | ||
baseDefinition | http://hl7.org/fhir/StructureDefinition/Observation | ||
copyright | Used by permission of HL7 Europe, all rights reserved Creative Commons License |
| |
date | 2025-06-26 | 2025-04-01T09:29:47+00:00 |
|
description | Dieses Profil ermöglicht die Abbildung von Informationen zur Laboruntersuchungen eines Patienten in ISiK Szenarien. Es dient primär als Vorlage, von der spezifische Laboruntersuchungs-Profile abgeleitet werden, kann aber grundsätzlich auch zur Repräsentation von nicht weiter ausspezifizierten Laboruntersuchungen genutzt werden. Viele medizinischen Entscheidungen benötigen Informationen zu den Laboruntersuchungen eines Patienten. Hierzu gehören z.B. aktuelle Nierenfunktionswerte, Leberwerte, Blutbildwerte oder Hormone aus Schilddrüse. Jede dieser Untersuchungen wird durch bestimmte [[https://loinc.org/ LOINC]] oder [[http://snomed.info/sct SNOMED CT]] Codes bezeichnet. Der angegebene Wert ist durch genaue Einheitenangaben in [[http://unitsofmeasure.org UCUM]] zu konkretitiseren. Motivierender Use-Case zur Einführung dieser Profile ist die [Arzneitmitteltherapiesicherheit im Krankenhaus - AMTS](https://simplifier.net/guide/isik-medikation-v4/ImplementationGuide-markdown-UseCases-AMTS?version=current). In FHIR werden Untersuchungen, bzw. Beobachtungen als [`Observation`](https://hl7.org/fhir/R4/observation.html)-Ressource repräsentiert. Zugehörige Codes und Einheiten sind den entsprechenden Valuessets zu entnehmen. | This profile constrains the Observation resource to represent results produced by laboratory tests or panels/studies for the HL7 Europe 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. |
|
experimental | false | ||
fhirVersion | 4.0.1 | ||
jurisdiction | |||
![]() jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#150 |
| |
kind | resource | ||
name | ISiKLaboruntersuchung | ObservationResultsLaboratoryEu |
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publisher | gematik GmbH | HL7 Europe |
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purpose | 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. |
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status | active | draft |
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title | Observation Results: laboratory |
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type | Observation | ||
url | https://gematik.de/fhir/isik/StructureDefinition/ISiKLaboruntersuchung | http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab |
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version | 5.0.0 | 0.2.0-ci |
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| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments![]() | ||||||||
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![]() | C | 0..* | Observation | Measurements and simple assertions 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 | C | 0..* | Observation | Laboratory result for a simple test or for a panel/study 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 eu-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" eu-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" | |||||||||
![]() ![]() | Σ | 0..1 | string | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
![]() ![]() | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
![]() ![]() | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
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![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
![]() ![]() | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Laboratory Test Kit Slice: Unordered, Open by value:url | |||||||||||
![]() ![]() | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
![]() ![]() | Σ | 0..* | Identifier | Business Identifier for observation | Σ | 0..* | Identifier | Business Identifier for observation | |||||||||
![]() ![]() | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | |||||||||
![]() ![]() | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | |||||||||
![]() ![]() | ?!SΣ | 1..1 | code | Status der Laboruntersuchung Binding: ?? (required): Codes providing the status of an observation. | ?!Σ | 1..1 | code | Status of this observation (e.g. preliminary, final,...) Binding: ?? (required): Codes providing the status of an observation. |
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![]() ![]() | S | 1..* | CodeableConcept | Kategorie der Laboruntersuchung Binding: ?? (preferred): Codes for high level observation categories. Required Pattern: {"coding":[{"system":"http://terminology.hl7.org/CodeSystem/observation-category","code":"laboratory"}]} | 1..* | ?? | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. |
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![]() ![]() | SΣ | 1..1 | CodeableConcept | Gegenstand der Untersuchung (Laborparameter) Binding: ?? (example): Codes identifying names of simple observations. | Σ | 1..1 | ?? | Type of observation (code / type) Binding: ?? (preferred) |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() | SΣ | 1..* | Coding | Kodierung des Laborparameters Slice: Unordered, Open by pattern:$this |
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![]() ![]() ![]() | SΣ | 0..1 | string | Plain text representation of the concept |
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![]() ![]() | SΣ | 1..1 | Reference(Patient) | Referenz auf den Patienten | Σ | 1..1 | Reference(Patient: Animal | Patient (EU core) | Group | Device | Location) | Who and/or what the observation is about |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() | ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL |
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![]() ![]() ![]() | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). |
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![]() ![]() ![]() | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
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![]() ![]() ![]() | Σ | 0..1 | string | Text alternative for the resource |
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![]() ![]() | ΣTU | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | |||||||||
![]() ![]() | SΣ | 0..1 | Reference(Encounter) | Referenz auf den Abteilungskontakt | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made |
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![]() ![]() | SΣ | 0..1 | dateTime, Period, Timing, instant | Zeitpunkt der Untersuchung Slice: Unordered, Open by type:$this | Σ | 1..1 | dateTime, Period | Clinically relevant time/time-period for observation |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() | SΣ | 0..1 | instant | Zeitpunkt der Verfügbarkeit des Untersuchungsergebnisses | Σ | 0..1 | instant | Date/Time this result was made available |
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![]() ![]() | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | Σ | 1..* | Reference(PractitionerRole (EU core) | Practitioner (EU core) | Organization (IPS) | CareTeam | Patient (EU core) | RelatedPerson) | Who is responsible for the observation |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
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![]() ![]() ![]() | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). |
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![]() ![]() ![]() | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
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![]() ![]() ![]() | Σ | 0..1 | string | Text alternative for the resource |
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![]() ![]() | SΣC | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Festgestellter (Mess)Wert für den Laborparameter Slice: Unordered, Open by type:$this | ΣC | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result Slice: Unordered, Open by type:$this |
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![]() ![]() | SC | 0..1 | CodeableConcept | Angabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Provides a reason why the expected value is missing. Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
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![]() ![]() | S | 0..* | CodeableConcept | Interpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“) Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | ?? | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. |
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![]() ![]() | S | 0..* | Annotation | Freitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors) | 0..* | Annotation | Comments about the observation |
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![]() ![]() | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | |||||||||||
![]() ![]() | S | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | 0..1 | ?? | How it was done Binding: ?? (preferred) |
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![]() ![]() | S | 0..1 | Reference(Specimen) | Specimen used for this observation | 0..1 | Reference(Specimen: Laboratory) | Specimen used for this observation |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() | SΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
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![]() ![]() ![]() | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). |
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![]() ![]() ![]() | SΣ | 0..1 | Identifier | Logical reference, when literal reference is not known |
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![]() ![]() ![]() | Σ | 0..1 | string | Text alternative for the resource |
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![]() ![]() | S | 0..1 | Reference(Device | DeviceMetric) | Verwendetes Gerät oder Instrument zur Durchführung der Untersuchung | 0..1 | Reference(Device | DeviceMetric) | Measuring instrument |
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![]() ![]() | SC | 0..* | BackboneElement | Referenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte) obs-3: Must have at least a low or a high or text | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text |
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![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | SC | 0..1 | ?? | Untergrenze des Referenzbereichs | C | 0..1 | ?? | Low Range, if relevant |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() ![]() | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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![]() ![]() ![]() ![]() | ?!Σ | 0..0 |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | string | Unit representation |
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![]() ![]() ![]() ![]() | SΣC | 1..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org |
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![]() ![]() ![]() ![]() | SΣ | 1..1 | code | Coded form of the unit |
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![]() ![]() ![]() | SC | 0..1 | ?? | Obergrenze des Referenzbereichs | C | 0..1 | ?? | High Range, if relevant |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() ![]() | SΣ | 1..1 | decimal | Numerical value (with implicit precision) |
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![]() ![]() ![]() ![]() | ?!Σ | 0..0 |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | string | Unit representation |
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![]() ![]() ![]() ![]() | SΣC | 1..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org |
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![]() ![]() ![]() ![]() | SΣ | 1..1 | code | Coded form of the unit |
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![]() ![]() ![]() | S | 0..1 | CodeableConcept | Art des Referenzbereichs (z. B. normal, kritisch) Binding: ?? (preferred): Code for the meaning of a reference range. | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() ![]() | SΣ | 0..* | Coding | Code defined by a terminology system |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | string | Plain text representation of the concept |
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![]() ![]() ![]() | S | 0..* | CodeableConcept | Für wen der Referenzbereich gilt (z. B. Geschlecht, Alter) Binding: ?? (example): Codes identifying the population the reference range applies to. | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() ![]() | SΣ | 0..* | Coding | Kodierte Angabe zur Zielgruppe |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | string | Plain text representation of the concept |
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![]() ![]() ![]() | S | 0..1 | Range | Altersbereich, für den der Referenzbereich gilt | 0..1 | Range | Applicable age range, if relevant |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing |
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![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | ?? | Low limit |
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![]() ![]() ![]() ![]() | SΣ | 0..1 | ?? | High limit |
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![]() ![]() ![]() | S | 0..1 | string | Freitextbeschreibung des Referenzbereichs | 0..1 | string | Text based reference range in an observation |
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![]() ![]() | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | Σ | 0..* | Reference(Observation Results: laboratory) | Related resource that belongs to the Observation group | |||||||||
![]() ![]() | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | |||||||||
![]() ![]() | Σ | 0..* | BackboneElement | Component results | Σ | 0..* | BackboneElement | Laboratory result | |||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. | Σ | 1..1 | ?? | Type of component observation (code / type) Binding: ?? (preferred) |
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![]() ![]() ![]() | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result Slice: Unordered, Open by type:$this | |||||||||
![]() ![]() ![]() | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
![]() ![]() ![]() | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | |||||||||||
![]() ![]() ![]() | 0..* | See referenceRange | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
Documentation for this format | |||||||||||||||||