ISiK Vitalparameter Implementierungsleitfaden
Version 6.0.0-rc1 - ballot

Resource Profile: ISiKEKG - Detailed Descriptions

Active as of 2026-06-10

Definitions for the ISiKEKG resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Observation
Definition

Measurements and simple assertions made about a patient, device or other subject.

ShortMeasurements and simple assertions
Comments

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.

Control0..*
Is Modifierfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Shortserverseitige, interne ID des DatensatzesLogical id of this artifact
Comments

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.


The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurdeA set of rules under which this content was created
Comments

Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.


Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..01
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Requirements

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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Observation.status
    Definition

    The status of the result value.

    ShortUntersuchungsstatusregistered | preliminary | final | amended +
    Comments

    WICHTIGER Hinweis für Implementierer:

    • Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch final.
    • 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 Ressourcen mit dem status entered-in-error und Ausgrauen von Ressourcen, die einen Plan- oder Entwurfs-Status haben.

    This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

    Control1..1
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
    (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

    Codes providing the status of an observation.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to track the status of individual results. Some results are finalized before the whole report is finalized.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Observation.category
    Definition

    A code that classifies the general type of observation being made.

    ShortUntersuchungskategorieClassification of type of observation
    Comments

    Motivation MS: Dieses Feld erlaubt die Sortierung und Abfrage anhand der Kategorie der Untersuchung


    In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

    Control10..*
    This element is affected by the following invariants: ele-1
    BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
    (preferred to http://hl7.org/fhir/ValueSet/observation-category)

    Codes for high level observation categories.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Requirements

    Used for filtering what observations are retrieved and displayed.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Observation.category.coding
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Pattern Value{
      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
      "code" : "procedure"
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Observation.code
    Definition

    Describes what was observed. Sometimes this is called the observation "name".

    ShortCodeType of observation (code / type)
    Comments

    Motivation MS: Die Observation wird anhand des Codes identifiziert.


    All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

    Control1..1
    This element is affected by the following invariants: ele-1
    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
    (example to http://hl7.org/fhir/ValueSet/observation-codes)

    Codes identifying names of simple observations.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Knowing what kind of observation is being made is essential to understanding the observation.

    Alternate NamesName
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Observation.code.coding
    Definition

    A reference to a code defined by a terminology system.

    ShortCodingCode defined by a terminology system
    Comments

    Motivation MS: Semantische Kodierung


    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control10..*
    This element is affected by the following invariants: ele-1
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • pattern @ $this
    • 18. Observation.code.coding:loinc
      Slice Nameloinc
      Definition

      A reference to a code defined by a terminology system.

      ShortLOINC KodierungCode defined by a terminology system
      Comments

      Motivation MS: Kodierung des Vitalparameters mittels LOINC.


      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeCoding(ISiKLoincCoding)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

      Pattern Value{
        "system" : "http://loinc.org",
        "code" : "11524-6"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.code.coding:snomed
      Slice Namesnomed
      Definition

      A reference to a code defined by a terminology system.

      ShortSNOMED CT KodierungCode defined by a terminology system
      Comments

      Motivation MS: Kodierung des Vitalparameters mittels SNOMED CT.


      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control0..*
      This element is affected by the following invariants: ele-1
      TypeCoding(ISiKSnomedCTCoding)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

      Pattern Value{
        "system" : "http://snomed.info/sct",
        "code" : "106073009"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Observation.subject
      Definition

      The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

      ShortPatientWho and/or what the observation is about
      Comments

      Motivation MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.


      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.

      Control10..1
      This element is affected by the following invariants: ele-1
      TypeReference(Patient, Group, Device, Location, Patient, Group, Device, Location)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summarytrue
      Requirements

      Observations have no value if you don't know who or what they're about.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      24. Observation.encounter
      Definition

      The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

      ShortAufenthaltsbezugHealthcare event during which this observation is made
      Comments

      Motivation MS: Der Behandlungskontext ist für die Interpretation der Untersuchungsergebnisse relevant


      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).

      Control0..1
      This element is affected by the following invariants: ele-1
      TypeReference(Encounter, Encounter)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      For some observations it may be important to know the link between an observation and a particular encounter.

      Alternate NamesContext
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      26. Observation.encounter.reference
      Definition

      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

      ShortEncounter-LinkLiteral reference, Relative, internal or absolute URL
      Comments

      Begründung Pflichtfeld: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. WICHTIGER Hinweis für Implementierer: Die Zuordnung MUSS auf einen Encounter der Ebene "Abteilungskontakt" (siehe hierzu Basismodul > UseCases > Abbildung des Konstruktes "Fall") erfolgen.
      Bei der Auswahl des Encounters ist zu beachten, dass unter einer (Abrechnungs-)"Fallnummer" (hier: Encounter.account) unter Umständen mehrere Encounter gruppiert sein können (z.B. stationärer Besuch mit mehreren vor- und nachstationären Aufenthalten.) Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.


      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

      Control10..1
      This element is affected by the following invariants: ref-1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. Observation.effective[x]
      Definition

      The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

      ShortDatum und Uhrzeit der UntersuchungClinically relevant time/time-period for observation
      Comments

      Motivation MS: Das Datum und die Uhrzeit der Untersuchung sind für die Interpretation der Untersuchungsergebnisse relevant


      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 datatype which allow the measurement to be tied to regular life events.

      Control10..1
      This element is affected by the following invariants: ele-1
      TypedateTime, Period, Timing, instant
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      Knowing when an observation was deemed true is important to its relevance as well as determining trends.

      Alternate NamesOccurrence
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      vs-de-1: If Observation.effective[x] has a value then that value shall be precise to the day ((($this is dateTime) implies ($this as dateTime).toString().length() >= 10) and ($this.start.exists() implies ($this.start as dateTime).toString().length() >= 10) and ($this.end.exists() implies ($this.end as dateTime).toString().length() >= 10))
      30. Observation.performer
      Definition

      Who was responsible for asserting the observed value as "true".

      ShortUntersuchenderWho is responsible for the observation
      Comments

      Motivation MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit

      Control0..*
      This element is affected by the following invariants: ele-1
      TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson, Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summarytrue
      Requirements

      May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      32. Observation.value[x]
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      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 below.

      Control0..01
      This element is affected by the following invariants: ele-1, obs-7
      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. Observation.dataAbsentReason
      Definition

      Provides a reason why the expected value in the element Observation.value[x] is missing.

      ShortGrund für fehlende UntersuchungsergebnisseWhy the result is missing
      Comments

      Motivation MS: Dieses Feld erlaubt die Angabe von Gründen für fehlende Untersuchungsergebnisse


      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.

      Control0..1
      This element is affected by the following invariants: ele-1, obs-6
      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

      Codes specifying why the result (Observation.value[x]) is missing.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Requirements

      For many results it is necessary to handle exceptional values in measurements.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. Observation.method
      Definition

      Indicates the mechanism used to perform the observation.

      ShortUntersuchungsmethodeHow it was done
      Comments

      Einschränkung der übergreifenden MS-Definition:
      Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Untersuchungsmethode, so MUSS dieses System die Information NICHT abbilden

      Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.


      Only used if not implicit in code for Observation.code.

      Control0..1
      This element is affected by the following invariants: ele-1
      BindingFor example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
      (example to http://hl7.org/fhir/ValueSet/observation-methods)

      Methods for simple observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Requirements

      In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. Observation.device
      Definition

      The device used to generate the observation data.

      ShortGerät(Measurement) Device
      Comments

      Einschränkung der übergreifenden MS-Definition:
      Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung des Geräts, mittels dessen der Parameter erhoben worden ist, so MUSS dieses System die Information NICHT abbilden.

      Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.


      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.

      Control0..1
      This element is affected by the following invariants: ele-1
      TypeReference(Device, DeviceMetric, Device, DeviceMetric)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      40. Observation.component
      Definition

      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

      ShortVitalparameter-KomponenteComponent results
      Comments

      Motivation MS: Erfassung der Komponenten eines Vitalparameters


      For a discussion on the ways Observations can be assembled in groups together see Notes below.

      Control10..*
      This element is affected by the following invariants: ele-1
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • pattern @ code
      • 42. Observation.component.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        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.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        44. Observation.component.code
        Definition

        Describes what was observed. Sometimes this is called the observation "code".

        ShortCodeType of component observation (code / type)
        Comments

        Motivation MS: Die Komponente wird anhand des Codes identifiziert.


        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

        Control1..1
        This element is affected by the following invariants: ele-1
        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
        (example to http://hl7.org/fhir/ValueSet/observation-codes)

        Codes identifying names of simple observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Knowing what kind of observation is being made is essential to understanding the observation.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        46. Observation.component.code.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCodingCode defined by a terminology system
        Comments

        Motivation MS: Semantische Kodierung


        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..*
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. Observation.component.value[x]
        Definition

        The information determined as a result of making the observation, if the information has a simple value.

        ShortWert der KomponenteActual component result
        Comments

        Motivation MS: Der Wert der Komponente ist ein Ergebnis der Untersuchung


        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 below.

        Control0..1
        This element is affected by the following invariants: ele-1
        TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Requirements

        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. Observation.component.dataAbsentReason
        Definition

        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

        ShortWhy the component result is missing
        Comments

        "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 "test not done".

        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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

        Control0..1
        This element is affected by the following invariants: ele-1, obs-6
        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

        Codes specifying why the result (Observation.value[x]) is missing.

        TypeCodeableConcept
        Is Modifierfalse
        Requirements

        For many results it is necessary to handle exceptional values in measurements.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        52. Observation.component:ekgLeads
        Slice NameekgLeads
        Definition

        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

        ShortEKG-AbleitungenComponent results
        Comments

        Motivation MS: Die einzelnen Ableitungen des EKG werden als component abgebildet. Begründung: Bei einer EKG Untersuchung werden mehrere Ableitungen gemeinsam erfasst und bilden zusammen das Gesamtbild des EKGs. Siehe auch Observation.component im FHIR R4 Standard.


        For a discussion on the ways Observations can be assembled in groups together see Notes below.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        54. Observation.component:ekgLeads.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        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.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        56. Observation.component:ekgLeads.code
        Definition

        Describes what was observed. Sometimes this is called the observation "code".

        ShortType of component observation (code / type)
        Comments

        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

        Control1..1
        This element is affected by the following invariants: ele-1
        BindingThe codes SHALL be taken from For example codes, see SNOMED CT codes der EKG Ableitungenhttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
        (required to http://fhir.de/ValueSet/EkgAbleitungenVS)

        Loinc Part Codes identifying the EKG lead


        Codes identifying names of simple observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Knowing what kind of observation is being made is essential to understanding the observation.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        58. Observation.component:ekgLeads.code.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control10..*
        This element is affected by the following invariants: ele-1
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        60. Observation.component:ekgLeads.value[x]
        Definition

        The information determined as a result of making the observation, if the information has a simple value.

        ShortSampledDataActual component result
        Comments

        Motivation MS: Die EKG-Daten werden mittels des SampledData Datentyps abgebildet.


        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 below.

        Control10..1
        This element is affected by the following invariants: ele-1
        TypeSampledData, dateTime, boolean, string, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        62. Observation.component:ekgLeads.value[x].origin
        Definition

        The base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series.

        ShortAusgangswertZero value and units
        Comments

        Motivation MS: Das Feld origin definiert den Referenzpunkt und die Einheit der Messreihe, um sicherzustellen, dass die gemessenen Werte im richtigen Kontext interpretiert werden können.

        Control1..1
        This element is affected by the following invariants: ele-1
        TypeQuantity(SimpleQuantity, SimpleQuantity)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
        sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
        64. Observation.component:ekgLeads.value[x].period
        Definition

        The length of time between sampling times, measured in milliseconds.

        ShortMessintervallNumber of milliseconds between samples
        Comments

        Motivation MS: Das Feld period definiert die zeitliche Distanz zwischen zwei aufeinanderfolgenden Messwerten.


        This is usually a whole number.

        Control1..1
        This element is affected by the following invariants: ele-1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        66. Observation.component:ekgLeads.value[x].dimensions
        Definition

        The number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once.

        ShortDimensionenNumber of sample points at each time point
        Comments

        Motivation MS: Das Feld dimensions gibt die Anzahl der Achsen oder Dimensionen an, die in der Messreihe enthalten sind, und ist notwendig, um die Struktur der Daten korrekt zu verstehen.


        If there is more than one dimension, the code for the type of data will define the meaning of the dimensions (typically ECG data).

        Control1..1
        This element is affected by the following invariants: ele-1
        TypepositiveInt
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        68. Observation.component:ekgLeads.value[x].data
        Definition

        A series of data points which are decimal values separated by a single space (character u20). The special values "E" (error), "L" (below detection limit) and "U" (above detection limit) can also be used in place of a decimal value.

        ShortMesswerteDecimal values with spaces, or "E" | "U" | "L"
        Comments

        Motivation MS: Das Feld data enthält die eigentlichen Messwerte der EKG-Daten.


        Data may be missing if it is omitted for summarization purposes. In general, data is required for any actual use of a SampledData.

        Control10..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        70. Observation.component:ekgLeads.dataAbsentReason
        Definition

        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

        ShortWhy the component result is missing
        Comments

        "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 "test not done".

        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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

        Control0..1
        This element is affected by the following invariants: ele-1, obs-6
        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

        Codes specifying why the result (Observation.value[x]) is missing.

        TypeCodeableConcept
        Is Modifierfalse
        Requirements

        For many results it is necessary to handle exceptional values in measurements.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        72. Observation.component:deprecatedLeadCodes
        Slice NamedeprecatedLeadCodes
        Definition

        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

        ShortComponent results
        Comments

        Diese deprecated Slice verwendet Loinc Part Codes die nicht für die Nutzung in Instanzdaten vorgesehen sind


        For a discussion on the ways Observations can be assembled in groups together see Notes below.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeBackboneElement
        Is Modifierfalse
        Summarytrue
        Requirements

        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        74. Observation.component:deprecatedLeadCodes.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        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.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        76. Observation.component:deprecatedLeadCodes.code
        Definition

        Describes what was observed. Sometimes this is called the observation "code".

        ShortType of component observation (code / type)
        Comments

        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

        Control1..1
        This element is affected by the following invariants: ele-1
        BindingThe codes SHALL be taken from For example codes, see EKG/ECG leadshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
        (required to http://fhir.de/ValueSet/EkgLeads)

        Loinc Part Codes identifying the EKG lead


        Codes identifying names of simple observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Knowing what kind of observation is being made is essential to understanding the observation.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        78. Observation.component:deprecatedLeadCodes.code.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control10..*
        This element is affected by the following invariants: ele-1
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        80. Observation.component:deprecatedLeadCodes.value[x]
        Definition

        The information determined as a result of making the observation, if the information has a simple value.

        ShortActual component result
        Comments

        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 below.

        Control10..1
        This element is affected by the following invariants: ele-1
        TypeSampledData, dateTime, boolean, string, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        82. Observation.component:deprecatedLeadCodes.value[x].origin
        Definition

        The base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series.

        ShortZero value and units
        Comments

        The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

        Control1..1
        This element is affected by the following invariants: ele-1
        TypeQuantity(SimpleQuantity, SimpleQuantity)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
        sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
        84. Observation.component:deprecatedLeadCodes.value[x].period
        Definition

        The length of time between sampling times, measured in milliseconds.

        ShortNumber of milliseconds between samples
        Comments

        This is usually a whole number.

        Control1..1
        This element is affected by the following invariants: ele-1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        86. Observation.component:deprecatedLeadCodes.value[x].dimensions
        Definition

        The number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once.

        ShortNumber of sample points at each time point
        Comments

        If there is more than one dimension, the code for the type of data will define the meaning of the dimensions (typically ECG data).

        Control1..1
        This element is affected by the following invariants: ele-1
        TypepositiveInt
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        88. Observation.component:deprecatedLeadCodes.value[x].data
        Definition

        A series of data points which are decimal values separated by a single space (character u20). The special values "E" (error), "L" (below detection limit) and "U" (above detection limit) can also be used in place of a decimal value.

        ShortDecimal values with spaces, or "E" | "U" | "L"
        Comments

        Data may be missing if it is omitted for summarization purposes. In general, data is required for any actual use of a SampledData.

        Control10..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        90. Observation.component:deprecatedLeadCodes.dataAbsentReason
        Definition

        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

        ShortWhy the component result is missing
        Comments

        "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 "test not done".

        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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

        Control0..1
        This element is affected by the following invariants: ele-1, obs-6
        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

        Codes specifying why the result (Observation.value[x]) is missing.

        TypeCodeableConcept
        Is Modifierfalse
        Requirements

        For many results it is necessary to handle exceptional values in measurements.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

        Guidance on how to interpret the contents of this table can be foundhere

        0. Observation
        2. Observation.id
        Shortserverseitige, interne ID des Datensatzes
        Comments

        bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

        Must Supporttrue
        4. Observation.meta
        6. Observation.meta.versionId
        ShortEindeutiger Name der serverseitigen Version des Datensatzes
        Comments

        Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

        8. Observation.meta.lastUpdated
        ShortZeitpunkt der letzten Änderung
        Comments

        Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

        10. Observation.implicitRules
        ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurde
        Comments

        Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.

        Control0..0
        12. Observation.status
        ShortUntersuchungsstatus
        Comments

        WICHTIGER Hinweis für Implementierer:

        • Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch final.
        • 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 Ressourcen mit dem status entered-in-error und Ausgrauen von Ressourcen, die einen Plan- oder Entwurfs-Status haben.
        Must Supporttrue
        14. Observation.category
        ShortUntersuchungskategorie
        Comments

        Motivation MS: Dieses Feld erlaubt die Sortierung und Abfrage anhand der Kategorie der Untersuchung

        Must Supporttrue
        16. Observation.code
        ShortCode
        Comments

        Motivation MS: Die Observation wird anhand des Codes identifiziert.

        Must Supporttrue
        18. Observation.code.coding
        ShortCoding
        Comments

        Motivation MS: Semantische Kodierung

        Must Supporttrue
        20. Observation.code.coding:loinc
        Slice Nameloinc
        ShortLOINC Kodierung
        Comments

        Motivation MS: Kodierung des Vitalparameters mittels LOINC.

        TypeCoding(ISiKLoincCoding)
        Must Supporttrue
        22. Observation.code.coding:snomed
        Slice Namesnomed
        ShortSNOMED CT Kodierung
        Comments

        Motivation MS: Kodierung des Vitalparameters mittels SNOMED CT.

        TypeCoding(ISiKSnomedCTCoding)
        Must Supporttrue
        24. Observation.subject
        ShortPatient
        Comments

        Motivation MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

        Must Supporttrue
        26. Observation.encounter
        ShortAufenthaltsbezug
        Comments

        Motivation MS: Der Behandlungskontext ist für die Interpretation der Untersuchungsergebnisse relevant

        Must Supporttrue
        28. Observation.encounter.reference
        ShortEncounter-Link
        Comments

        Begründung Pflichtfeld: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. WICHTIGER Hinweis für Implementierer: Die Zuordnung MUSS auf einen Encounter der Ebene "Abteilungskontakt" (siehe hierzu Basismodul > UseCases > Abbildung des Konstruktes "Fall") erfolgen.
        Bei der Auswahl des Encounters ist zu beachten, dass unter einer (Abrechnungs-)"Fallnummer" (hier: Encounter.account) unter Umständen mehrere Encounter gruppiert sein können (z.B. stationärer Besuch mit mehreren vor- und nachstationären Aufenthalten.) Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

        Control1..?
        Must Supporttrue
        30. Observation.effective[x]
        ShortDatum und Uhrzeit der Untersuchung
        Comments

        Motivation MS: Das Datum und die Uhrzeit der Untersuchung sind für die Interpretation der Untersuchungsergebnisse relevant

        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        32. Observation.performer
        ShortUntersuchender
        Comments

        Motivation MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit

        Must Supporttrue
        34. Observation.dataAbsentReason
        ShortGrund für fehlende Untersuchungsergebnisse
        Comments

        Motivation MS: Dieses Feld erlaubt die Angabe von Gründen für fehlende Untersuchungsergebnisse

        Must Supporttrue
        36. Observation.method
        ShortUntersuchungsmethode
        Comments

        Einschränkung der übergreifenden MS-Definition:
        Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Untersuchungsmethode, so MUSS dieses System die Information NICHT abbilden

        Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.

        Must Supporttrue
        38. Observation.device
        ShortGerät
        Comments

        Einschränkung der übergreifenden MS-Definition:
        Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung des Geräts, mittels dessen der Parameter erhoben worden ist, so MUSS dieses System die Information NICHT abbilden.

        Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.

        Must Supporttrue
        40. Observation.component
        ShortVitalparameter-Komponente
        Comments

        Motivation MS: Erfassung der Komponenten eines Vitalparameters

        Must Supporttrue
        42. Observation.component.code
        ShortCode
        Comments

        Motivation MS: Die Komponente wird anhand des Codes identifiziert.

        Must Supporttrue
        44. Observation.component.code.coding
        ShortCoding
        Comments

        Motivation MS: Semantische Kodierung

        Must Supporttrue
        46. Observation.component.value[x]
        ShortWert der Komponente
        Comments

        Motivation MS: Der Wert der Komponente ist ein Ergebnis der Untersuchung

        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        48. Observation.component:ekgLeads
        Slice NameekgLeads
        ShortEKG-Ableitungen
        Comments

        Motivation MS: Die einzelnen Ableitungen des EKG werden als component abgebildet. Begründung: Bei einer EKG Untersuchung werden mehrere Ableitungen gemeinsam erfasst und bilden zusammen das Gesamtbild des EKGs. Siehe auch Observation.component im FHIR R4 Standard.

        Must Supporttrue
        50. Observation.component:ekgLeads.code
        Must Supporttrue
        52. Observation.component:ekgLeads.code.coding
        Must Supporttrue
        54. Observation.component:ekgLeads.value[x]
        ShortSampledData
        Comments

        Motivation MS: Die EKG-Daten werden mittels des SampledData Datentyps abgebildet.

        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        56. Observation.component:ekgLeads.value[x].origin
        ShortAusgangswert
        Comments

        Motivation MS: Das Feld origin definiert den Referenzpunkt und die Einheit der Messreihe, um sicherzustellen, dass die gemessenen Werte im richtigen Kontext interpretiert werden können.

        Must Supporttrue
        58. Observation.component:ekgLeads.value[x].period
        ShortMessintervall
        Comments

        Motivation MS: Das Feld period definiert die zeitliche Distanz zwischen zwei aufeinanderfolgenden Messwerten.

        Must Supporttrue
        60. Observation.component:ekgLeads.value[x].dimensions
        ShortDimensionen
        Comments

        Motivation MS: Das Feld dimensions gibt die Anzahl der Achsen oder Dimensionen an, die in der Messreihe enthalten sind, und ist notwendig, um die Struktur der Daten korrekt zu verstehen.

        Must Supporttrue
        62. Observation.component:ekgLeads.value[x].data
        ShortMesswerte
        Comments

        Motivation MS: Das Feld data enthält die eigentlichen Messwerte der EKG-Daten.

        Must Supporttrue
        64. Observation.component:deprecatedLeadCodes
        Slice NamedeprecatedLeadCodes
        66. Observation.component:deprecatedLeadCodes.code
        Must Supporttrue
        68. Observation.component:deprecatedLeadCodes.code.coding
        Must Supporttrue
        70. Observation.component:deprecatedLeadCodes.value[x]
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue

        Guidance on how to interpret the contents of this table can be foundhere

        0. Observation
        Definition

        Measurements and simple assertions made about a patient, device or other subject.

        ShortMeasurements and simple assertions
        Comments

        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.

        Control0..*
        Alternate NamesVital Signs, Measurement, Results, Tests
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        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 (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
        2. Observation.id
        Definition

        The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

        Shortserverseitige, interne ID des Datensatzes
        Comments

        bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

        Control0..1
        Typeid
        Must Supporttrue
        Summarytrue
        4. Observation.meta
        Definition

        The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

        ShortMetadata about the resource
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeMeta
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        6. Observation.meta.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        8. Observation.meta.extension
        Definition

        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.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Observation.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 10. Observation.meta.versionId
          Definition

          The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

          ShortEindeutiger Name der serverseitigen Version des Datensatzes
          Comments

          Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

          Control0..1
          Typeid
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. Observation.meta.lastUpdated
          Definition

          When the resource last changed - e.g. when the version changed.

          ShortZeitpunkt der letzten Änderung
          Comments

          Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

          Control0..1
          Typeinstant
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          14. Observation.meta.source
          Definition

          A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

          ShortIdentifies where the resource comes from
          Comments

          In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

          This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

          Control0..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          16. Observation.meta.profile
          Definition

          A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

          ShortProfiles this resource claims to conform to
          Comments

          It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

          Control0..*
          Typecanonical(StructureDefinition)
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. Observation.meta.security
          Definition

          Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

          ShortSecurity Labels applied to this resource
          Comments

          The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

          Control0..*
          BindingUnless not suitable, these codes SHALL be taken from All Security Labels
          (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

          Security Labels from the Healthcare Privacy and Security Classification System.

          TypeCoding
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. Observation.meta.tag
          Definition

          Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

          ShortTags applied to this resource
          Comments

          The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

          Control0..*
          BindingFor example codes, see CommonTags
          (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

          Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

          TypeCoding
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. Observation.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurde
          Comments

          Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.

          Control0..0
          This element is affected by the following invariants: ele-1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          24. Observation.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          This element is affected by the following invariants: ele-1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. Observation.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeNarrative
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Observation.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          ShortContained, inline Resources
          Comments

          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

          Control0..*
          TypeResource
          Alternate Namesinline resources, anonymous resources, contained resources
          30. Observation.extension
          Definition

          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.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 32. Observation.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
            Requirements

            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.

            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 34. Observation.identifier
              Definition

              A unique identifier assigned to this observation.

              ShortBusiness Identifier for observation
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control0..*
              This element is affected by the following invariants: ele-1
              TypeIdentifier
              Summarytrue
              Requirements

              Allows observations to be distinguished and referenced.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              36. Observation.basedOn
              Definition

              A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

              ShortFulfills plan, proposal or order
              Comments

              References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

              Control0..*
              This element is affected by the following invariants: ele-1
              TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
              Summarytrue
              Requirements

              Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

              Alternate NamesFulfills
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
              38. Observation.partOf
              Definition

              A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

              ShortPart of referenced event
              Comments

              To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

              Control0..*
              This element is affected by the following invariants: ele-1
              TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
              Summarytrue
              Alternate NamesContainer
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
              40. Observation.status
              Definition

              The status of the result value.

              ShortUntersuchungsstatus
              Comments

              WICHTIGER Hinweis für Implementierer:

              • Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch final.
              • 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 Ressourcen mit dem status entered-in-error und Ausgrauen von Ressourcen, die einen Plan- oder Entwurfs-Status haben.
              Control1..1
              This element is affected by the following invariants: ele-1
              BindingThe codes SHALL be taken from ObservationStatus
              (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

              Codes providing the status of an observation.

              Typecode
              Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Need to track the status of individual results. Some results are finalized before the whole report is finalized.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. Observation.category
              Definition

              A code that classifies the general type of observation being made.

              ShortUntersuchungskategorie
              Comments

              Motivation MS: Dieses Feld erlaubt die Sortierung und Abfrage anhand der Kategorie der Untersuchung

              Control1..*
              This element is affected by the following invariants: ele-1
              BindingThe codes SHOULD be taken from ObservationCategoryCodes
              (preferred to http://hl7.org/fhir/ValueSet/observation-category)

              Codes for high level observation categories.

              TypeCodeableConcept
              Must Supporttrue
              Requirements

              Used for filtering what observations are retrieved and displayed.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. Observation.category.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              XML FormatIn the XML format, this property is represented as an attribute.
              46. Observation.category.extension
              Definition

              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.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              This element is affected by the following invariants: ele-1
              TypeExtension
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 48. Observation.category.coding
                Definition

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeCoding
                Summarytrue
                Requirements

                Allows for alternative encodings within a code system, and translations to other code systems.

                Pattern Value{
                  "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                  "code" : "procedure"
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                50. Observation.category.text
                Definition

                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                ShortPlain text representation of the concept
                Comments

                Very often the text is the same as a displayName of one of the codings.

                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                52. Observation.code
                Definition

                Describes what was observed. Sometimes this is called the observation "name".

                ShortCode
                Comments

                Motivation MS: Die Observation wird anhand des Codes identifiziert.

                Control1..1
                This element is affected by the following invariants: ele-1
                BindingFor example codes, see LOINCCodes
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept
                Must Supporttrue
                Summarytrue
                Requirements

                Knowing what kind of observation is being made is essential to understanding the observation.

                Alternate NamesName
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                54. Observation.code.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                XML FormatIn the XML format, this property is represented as an attribute.
                56. Observation.code.extension
                Definition

                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.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on Observation.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 58. Observation.code.coding
                  Definition

                  A reference to a code defined by a terminology system.

                  ShortCoding
                  Comments

                  Motivation MS: Semantische Kodierung

                  Control1..*
                  This element is affected by the following invariants: ele-1
                  TypeCoding
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Allows for alternative encodings within a code system, and translations to other code systems.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • pattern @ $this
                  • 60. Observation.code.coding:loinc
                    Slice Nameloinc
                    Definition

                    A reference to a code defined by a terminology system.

                    ShortLOINC Kodierung
                    Comments

                    Motivation MS: Kodierung des Vitalparameters mittels LOINC.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeCoding(ISiKLoincCoding)
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    Allows for alternative encodings within a code system, and translations to other code systems.

                    Pattern Value{
                      "system" : "http://loinc.org",
                      "code" : "11524-6"
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    62. Observation.code.coding:snomed
                    Slice Namesnomed
                    Definition

                    A reference to a code defined by a terminology system.

                    ShortSNOMED CT Kodierung
                    Comments

                    Motivation MS: Kodierung des Vitalparameters mittels SNOMED CT.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCoding(ISiKSnomedCTCoding)
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    Allows for alternative encodings within a code system, and translations to other code systems.

                    Pattern Value{
                      "system" : "http://snomed.info/sct",
                      "code" : "106073009"
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. Observation.code.text
                    Definition

                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                    ShortPlain text representation of the concept
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. Observation.subject
                    Definition

                    The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

                    ShortPatient
                    Comments

                    Motivation MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Patient, Group, Device, Location)
                    Must Supporttrue
                    Must Support TypesNo must-support rules about the choice of types/profiles
                    Summarytrue
                    Requirements

                    Observations have no value if you don't know who or what they're about.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    68. Observation.focus
                    Definition

                    The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

                    ShortWhat the observation is about, when it is not about the subject of record
                    Comments

                    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.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeReference(Resource)
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    70. Observation.encounter
                    Definition

                    The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

                    ShortAufenthaltsbezug
                    Comments

                    Motivation MS: Der Behandlungskontext ist für die Interpretation der Untersuchungsergebnisse relevant

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Encounter)
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    For some observations it may be important to know the link between an observation and a particular encounter.

                    Alternate NamesContext
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    72. Observation.encounter.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    74. Observation.encounter.extension
                    Definition

                    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.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on Observation.encounter.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 76. Observation.encounter.reference
                      Definition

                      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                      ShortEncounter-Link
                      Comments

                      Begründung Pflichtfeld: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. WICHTIGER Hinweis für Implementierer: Die Zuordnung MUSS auf einen Encounter der Ebene "Abteilungskontakt" (siehe hierzu Basismodul > UseCases > Abbildung des Konstruktes "Fall") erfolgen.
                      Bei der Auswahl des Encounters ist zu beachten, dass unter einer (Abrechnungs-)"Fallnummer" (hier: Encounter.account) unter Umständen mehrere Encounter gruppiert sein können (z.B. stationärer Besuch mit mehreren vor- und nachstationären Aufenthalten.) Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

                      Control1..1
                      This element is affected by the following invariants: ref-1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      78. Observation.encounter.type
                      Definition

                      The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                      The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                      ShortType the reference refers to (e.g. "Patient")
                      Comments

                      This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                      Control0..1
                      BindingUnless not suitable, these codes SHALL be taken from ResourceType
                      (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                      Aa resource (or, for logical models, the URI of the logical model).

                      Typeuri
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      80. Observation.encounter.identifier
                      Definition

                      An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                      ShortLogical reference, when literal reference is not known
                      Comments

                      When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                      When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                      Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                      Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      Control0..1
                      TypeIdentifier
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      82. Observation.encounter.display
                      Definition

                      Plain text narrative that identifies the resource in addition to the resource reference.

                      ShortText alternative for the resource
                      Comments

                      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      84. Observation.effective[x]
                      Definition

                      The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                      ShortDatum und Uhrzeit der Untersuchung
                      Comments

                      Motivation MS: Das Datum und die Uhrzeit der Untersuchung sind für die Interpretation der Untersuchungsergebnisse relevant

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      TypedateTime
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Requirements

                      Knowing when an observation was deemed true is important to its relevance as well as determining trends.

                      Alternate NamesOccurrence
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      vs-de-1: If Observation.effective[x] has a value then that value shall be precise to the day ((($this is dateTime) implies ($this as dateTime).toString().length() >= 10) and ($this.start.exists() implies ($this.start as dateTime).toString().length() >= 10) and ($this.end.exists() implies ($this.end as dateTime).toString().length() >= 10))
                      86. Observation.issued
                      Definition

                      The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

                      ShortDate/Time this version was made available
                      Comments

                      For Observations that don’t require review and verification, it may be the same as the 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.

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      Typeinstant
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      88. Observation.performer
                      Definition

                      Who was responsible for asserting the observed value as "true".

                      ShortUntersuchender
                      Comments

                      Motivation MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                      Must Supporttrue
                      Must Support TypesNo must-support rules about the choice of types/profiles
                      Summarytrue
                      Requirements

                      May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                      90. Observation.value[x]
                      Definition

                      The information determined as a result of making the observation, if the information has a simple value.

                      ShortActual result
                      Comments

                      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 below.

                      Control0..0
                      This element is affected by the following invariants: ele-1, obs-7
                      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      92. Observation.dataAbsentReason
                      Definition

                      Provides a reason why the expected value in the element Observation.value[x] is missing.

                      ShortGrund für fehlende Untersuchungsergebnisse
                      Comments

                      Motivation MS: Dieses Feld erlaubt die Angabe von Gründen für fehlende Untersuchungsergebnisse

                      Control0..1
                      This element is affected by the following invariants: ele-1, obs-6
                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                      Codes specifying why the result (Observation.value[x]) is missing.

                      TypeCodeableConcept
                      Must Supporttrue
                      Requirements

                      For many results it is necessary to handle exceptional values in measurements.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      94. Observation.interpretation
                      Definition

                      A categorical assessment of an observation value. For example, high, low, normal.

                      ShortHigh, low, normal, etc.
                      Comments

                      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.

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                      Codes identifying interpretations of observations.

                      TypeCodeableConcept
                      Requirements

                      For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                      Alternate NamesAbnormal Flag
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      96. Observation.note
                      Definition

                      Comments about the observation or the results.

                      ShortComments about the observation
                      Comments

                      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.

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeAnnotation
                      Requirements

                      Need to be able to provide free text additional information.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      98. Observation.bodySite
                      Definition

                      Indicates the site on the subject's body where the observation was made (i.e. the target site).

                      ShortObserved body part
                      Comments

                      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.

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      BindingFor example codes, see SNOMEDCTBodyStructures
                      (example to http://hl7.org/fhir/ValueSet/body-site)

                      Codes describing anatomical locations. May include laterality.

                      TypeCodeableConcept
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      100. Observation.method
                      Definition

                      Indicates the mechanism used to perform the observation.

                      ShortUntersuchungsmethode
                      Comments

                      Einschränkung der übergreifenden MS-Definition:
                      Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Untersuchungsmethode, so MUSS dieses System die Information NICHT abbilden

                      Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      BindingFor example codes, see ObservationMethods
                      (example to http://hl7.org/fhir/ValueSet/observation-methods)

                      Methods for simple observations.

                      TypeCodeableConcept
                      Must Supporttrue
                      Requirements

                      In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      102. Observation.specimen
                      Definition

                      The specimen that was used when this observation was made.

                      ShortSpecimen used for this observation
                      Comments

                      Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      TypeReference(Specimen)
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                      104. Observation.device
                      Definition

                      The device used to generate the observation data.

                      ShortGerät
                      Comments

                      Einschränkung der übergreifenden MS-Definition:
                      Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung des Geräts, mittels dessen der Parameter erhoben worden ist, so MUSS dieses System die Information NICHT abbilden.

                      Motivation zum eingeschränkten MS: Dieses Feld stellt präzisierende Angaben zum Zweck der Qualitätsbewertung bereit. Allerdings rechtfertigt der Stand der Umsetzung in gängigen Systemen eine Implementierungspflicht (MS) für die Schnittstelle nicht.

                      Control0..1
                      This element is affected by the following invariants: ele-1
                      TypeReference(Device, DeviceMetric)
                      Must Supporttrue
                      Must Support TypesNo must-support rules about the choice of types/profiles
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                      106. Observation.referenceRange
                      Definition

                      Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                      ShortProvides guide for interpretation
                      Comments

                      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.

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeBackboneElement
                      Requirements

                      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                      108. Observation.referenceRange.id
                      Definition

                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                      ShortUnique id for inter-element referencing
                      Control0..1
                      Typestring
                      XML FormatIn the XML format, this property is represented as an attribute.
                      110. Observation.referenceRange.extension
                      Definition

                      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.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeExtension
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on Observation.referenceRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 112. Observation.referenceRange.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        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.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        114. Observation.referenceRange.low
                        Definition

                        The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                        ShortLow Range, if relevant
                        Comments

                        The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                        Control0..1
                        This element is affected by the following invariants: ele-1, obs-3
                        TypeQuantity(SimpleQuantity)
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                        sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                        116. Observation.referenceRange.high
                        Definition

                        The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                        ShortHigh Range, if relevant
                        Comments

                        The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                        Control0..1
                        This element is affected by the following invariants: ele-1, obs-3
                        TypeQuantity(SimpleQuantity)
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                        sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                        118. Observation.referenceRange.type
                        Definition

                        Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                        ShortReference range qualifier
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                        (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                        Code for the meaning of a reference range.

                        TypeCodeableConcept
                        Requirements

                        Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        120. Observation.referenceRange.appliesTo
                        Definition

                        Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                        ShortReference range population
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                        (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                        Codes identifying the population the reference range applies to.

                        TypeCodeableConcept
                        Requirements

                        Need to be able to identify the target population for proper interpretation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        122. Observation.referenceRange.age
                        Definition

                        The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                        ShortApplicable age range, if relevant
                        Comments

                        The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeRange
                        Requirements

                        Some analytes vary greatly over age.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        rng-2: If present, low SHALL have a lower value than high (low.empty() or high.empty() or (low <= high))
                        124. Observation.referenceRange.text
                        Definition

                        Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                        ShortText based reference range in an observation
                        Comments

                        Note that FHIR strings SHALL NOT exceed 1MB in size

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        126. Observation.hasMember
                        Definition

                        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.

                        ShortRelated resource that belongs to the Observation group
                        Comments

                        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 below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        128. Observation.derivedFrom
                        Definition

                        The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                        ShortRelated measurements the observation is made from
                        Comments

                        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 below.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        130. Observation.component
                        Definition

                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                        ShortVitalparameter-Komponente
                        Comments

                        Motivation MS: Erfassung der Komponenten eines Vitalparameters

                        Control1..*
                        This element is affected by the following invariants: ele-1
                        TypeBackboneElement
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • pattern @ code
                        • 132. Observation.component.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          XML FormatIn the XML format, this property is represented as an attribute.
                          134. Observation.component.extension
                          Definition

                          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.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          This element is affected by the following invariants: ele-1
                          TypeExtension
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 136. Observation.component.modifierExtension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            This element is affected by the following invariants: ele-1
                            TypeExtension
                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                            Summarytrue
                            Requirements

                            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.

                            Alternate Namesextensions, user content, modifiers
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            138. Observation.component.code
                            Definition

                            Describes what was observed. Sometimes this is called the observation "code".

                            ShortCode
                            Comments

                            Motivation MS: Die Komponente wird anhand des Codes identifiziert.

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            BindingFor example codes, see LOINCCodes
                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                            Codes identifying names of simple observations.

                            TypeCodeableConcept
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Knowing what kind of observation is being made is essential to understanding the observation.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            140. Observation.component.code.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            142. Observation.component.code.extension
                            Definition

                            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.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on Observation.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 144. Observation.component.code.coding
                              Definition

                              A reference to a code defined by a terminology system.

                              ShortCoding
                              Comments

                              Motivation MS: Semantische Kodierung

                              Control0..*
                              TypeCoding
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Requirements

                              Allows for alternative encodings within a code system, and translations to other code systems.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              146. Observation.component.code.text
                              Definition

                              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                              ShortPlain text representation of the concept
                              Comments

                              Very often the text is the same as a displayName of one of the codings.

                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              148. Observation.component.value[x]
                              Definition

                              The information determined as a result of making the observation, if the information has a simple value.

                              ShortWert der Komponente
                              Comments

                              Motivation MS: Der Wert der Komponente ist ein Ergebnis der Untersuchung

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Must Support TypesNo must-support rules about the choice of types/profiles
                              Summarytrue
                              Requirements

                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              150. Observation.component.dataAbsentReason
                              Definition

                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                              ShortWhy the component result is missing
                              Comments

                              "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 "test not done".

                              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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                              Control0..1
                              This element is affected by the following invariants: ele-1, obs-6
                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                              Codes specifying why the result (Observation.value[x]) is missing.

                              TypeCodeableConcept
                              Requirements

                              For many results it is necessary to handle exceptional values in measurements.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              152. Observation.component.interpretation
                              Definition

                              A categorical assessment of an observation value. For example, high, low, normal.

                              ShortHigh, low, normal, etc.
                              Comments

                              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.

                              Control0..*
                              This element is affected by the following invariants: ele-1
                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                              Codes identifying interpretations of observations.

                              TypeCodeableConcept
                              Requirements

                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                              Alternate NamesAbnormal Flag
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              154. Observation.component.referenceRange
                              Definition

                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                              ShortProvides guide for interpretation of component result
                              Comments

                              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.

                              Control0..*
                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                              Requirements

                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                              156. Observation.component:ekgLeads
                              Slice NameekgLeads
                              Definition

                              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                              ShortEKG-Ableitungen
                              Comments

                              Motivation MS: Die einzelnen Ableitungen des EKG werden als component abgebildet. Begründung: Bei einer EKG Untersuchung werden mehrere Ableitungen gemeinsam erfasst und bilden zusammen das Gesamtbild des EKGs. Siehe auch Observation.component im FHIR R4 Standard.

                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeBackboneElement
                              Must Supporttrue
                              Summarytrue
                              Requirements

                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              158. Observation.component:ekgLeads.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              XML FormatIn the XML format, this property is represented as an attribute.
                              160. Observation.component:ekgLeads.extension
                              Definition

                              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.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeExtension
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 162. Observation.component:ekgLeads.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                This element is affected by the following invariants: ele-1
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                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.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                164. Observation.component:ekgLeads.code
                                Definition

                                Describes what was observed. Sometimes this is called the observation "code".

                                ShortType of component observation (code / type)
                                Comments

                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                Control1..1
                                This element is affected by the following invariants: ele-1
                                BindingThe codes SHALL be taken from SNOMED CT codes der EKG Ableitungen
                                (required to http://fhir.de/ValueSet/EkgAbleitungenVS)

                                Loinc Part Codes identifying the EKG lead

                                TypeCodeableConcept
                                Must Supporttrue
                                Summarytrue
                                Requirements

                                Knowing what kind of observation is being made is essential to understanding the observation.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                166. Observation.component:ekgLeads.code.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                Typestring
                                XML FormatIn the XML format, this property is represented as an attribute.
                                168. Observation.component:ekgLeads.code.extension
                                Definition

                                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.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                This element is affected by the following invariants: ele-1
                                TypeExtension
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on Observation.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 170. Observation.component:ekgLeads.code.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..*
                                  This element is affected by the following invariants: ele-1
                                  TypeCoding
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  172. Observation.component:ekgLeads.code.text
                                  Definition

                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                  ShortPlain text representation of the concept
                                  Comments

                                  Very often the text is the same as a displayName of one of the codings.

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typestring
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  174. Observation.component:ekgLeads.value[x]
                                  Definition

                                  The information determined as a result of making the observation, if the information has a simple value.

                                  ShortSampledData
                                  Comments

                                  Motivation MS: Die EKG-Daten werden mittels des SampledData Datentyps abgebildet.

                                  Control1..1
                                  This element is affected by the following invariants: ele-1
                                  TypeSampledData
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  176. Observation.component:ekgLeads.value[x].id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  Typestring
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  178. Observation.component:ekgLeads.value[x].extension
                                  Definition

                                  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.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeExtension
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 180. Observation.component:ekgLeads.value[x].origin
                                    Definition

                                    The base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series.

                                    ShortAusgangswert
                                    Comments

                                    Motivation MS: Das Feld origin definiert den Referenzpunkt und die Einheit der Messreihe, um sicherzustellen, dass die gemessenen Werte im richtigen Kontext interpretiert werden können.

                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    TypeQuantity(SimpleQuantity)
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                                    sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                                    182. Observation.component:ekgLeads.value[x].period
                                    Definition

                                    The length of time between sampling times, measured in milliseconds.

                                    ShortMessintervall
                                    Comments

                                    Motivation MS: Das Feld period definiert die zeitliche Distanz zwischen zwei aufeinanderfolgenden Messwerten.

                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    Typedecimal
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    184. Observation.component:ekgLeads.value[x].factor
                                    Definition

                                    A correction factor that is applied to the sampled data points before they are added to the origin.

                                    ShortMultiply data by this before adding to origin
                                    Comments

                                    Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typedecimal
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Meaning if MissingIf no factor is assigned, the data is not adjusted before adding to the origin
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    186. Observation.component:ekgLeads.value[x].lowerLimit
                                    Definition

                                    The lower limit of detection of the measured points. This is needed if any of the data points have the value "L" (lower than detection limit).

                                    ShortLower limit of detection
                                    Comments

                                    Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typedecimal
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    188. Observation.component:ekgLeads.value[x].upperLimit
                                    Definition

                                    The upper limit of detection of the measured points. This is needed if any of the data points have the value "U" (higher than detection limit).

                                    ShortUpper limit of detection
                                    Comments

                                    Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typedecimal
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    190. Observation.component:ekgLeads.value[x].dimensions
                                    Definition

                                    The number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once.

                                    ShortDimensionen
                                    Comments

                                    Motivation MS: Das Feld dimensions gibt die Anzahl der Achsen oder Dimensionen an, die in der Messreihe enthalten sind, und ist notwendig, um die Struktur der Daten korrekt zu verstehen.

                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    TypepositiveInt
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supporttrue
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    192. Observation.component:ekgLeads.value[x].data
                                    Definition

                                    A series of data points which are decimal values separated by a single space (character u20). The special values "E" (error), "L" (below detection limit) and "U" (above detection limit) can also be used in place of a decimal value.

                                    ShortMesswerte
                                    Comments

                                    Motivation MS: Das Feld data enthält die eigentlichen Messwerte der EKG-Daten.

                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Must Supporttrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    194. Observation.component:ekgLeads.dataAbsentReason
                                    Definition

                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                    ShortWhy the component result is missing
                                    Comments

                                    "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 "test not done".

                                    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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                    Control0..1
                                    This element is affected by the following invariants: ele-1, obs-6
                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                    Codes specifying why the result (Observation.value[x]) is missing.

                                    TypeCodeableConcept
                                    Requirements

                                    For many results it is necessary to handle exceptional values in measurements.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    196. Observation.component:ekgLeads.interpretation
                                    Definition

                                    A categorical assessment of an observation value. For example, high, low, normal.

                                    ShortHigh, low, normal, etc.
                                    Comments

                                    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.

                                    Control0..*
                                    This element is affected by the following invariants: ele-1
                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                    Codes identifying interpretations of observations.

                                    TypeCodeableConcept
                                    Requirements

                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                    Alternate NamesAbnormal Flag
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    198. Observation.component:ekgLeads.referenceRange
                                    Definition

                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                    ShortProvides guide for interpretation of component result
                                    Comments

                                    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.

                                    Control0..*
                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                    Requirements

                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                    200. Observation.component:deprecatedLeadCodes
                                    Slice NamedeprecatedLeadCodes
                                    Definition

                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                    ShortComponent results
                                    Comments

                                    Diese deprecated Slice verwendet Loinc Part Codes die nicht für die Nutzung in Instanzdaten vorgesehen sind

                                    Control0..*
                                    This element is affected by the following invariants: ele-1
                                    TypeBackboneElement
                                    Summarytrue
                                    Requirements

                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    202. Observation.component:deprecatedLeadCodes.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    Typestring
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    204. Observation.component:deprecatedLeadCodes.extension
                                    Definition

                                    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.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    This element is affected by the following invariants: ele-1
                                    TypeExtension
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 206. Observation.component:deprecatedLeadCodes.modifierExtension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      This element is affected by the following invariants: ele-1
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      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.

                                      Alternate Namesextensions, user content, modifiers
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      208. Observation.component:deprecatedLeadCodes.code
                                      Definition

                                      Describes what was observed. Sometimes this is called the observation "code".

                                      ShortType of component observation (code / type)
                                      Comments

                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                      Control1..1
                                      This element is affected by the following invariants: ele-1
                                      BindingThe codes SHALL be taken from EKG/ECG leads
                                      (required to http://fhir.de/ValueSet/EkgLeads)

                                      Loinc Part Codes identifying the EKG lead

                                      TypeCodeableConcept
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      210. Observation.component:deprecatedLeadCodes.code.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      Typestring
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      212. Observation.component:deprecatedLeadCodes.code.extension
                                      Definition

                                      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.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      This element is affected by the following invariants: ele-1
                                      TypeExtension
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on Observation.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 214. Observation.component:deprecatedLeadCodes.code.coding
                                        Definition

                                        A reference to a code defined by a terminology system.

                                        ShortCode defined by a terminology system
                                        Comments

                                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                        Control1..*
                                        This element is affected by the following invariants: ele-1
                                        TypeCoding
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Allows for alternative encodings within a code system, and translations to other code systems.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        216. Observation.component:deprecatedLeadCodes.code.text
                                        Definition

                                        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                        ShortPlain text representation of the concept
                                        Comments

                                        Very often the text is the same as a displayName of one of the codings.

                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typestring
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

                                        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        218. Observation.component:deprecatedLeadCodes.value[x]
                                        Definition

                                        The information determined as a result of making the observation, if the information has a simple value.

                                        ShortActual component result
                                        Comments

                                        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 below.

                                        Control1..1
                                        This element is affected by the following invariants: ele-1
                                        TypeSampledData
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        220. Observation.component:deprecatedLeadCodes.value[x].id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        Typestring
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        222. Observation.component:deprecatedLeadCodes.value[x].extension
                                        Definition

                                        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.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 224. Observation.component:deprecatedLeadCodes.value[x].origin
                                          Definition

                                          The base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series.

                                          ShortZero value and units
                                          Comments

                                          The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                                          Control1..1
                                          This element is affected by the following invariants: ele-1
                                          TypeQuantity(SimpleQuantity)
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                                          sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                                          226. Observation.component:deprecatedLeadCodes.value[x].period
                                          Definition

                                          The length of time between sampling times, measured in milliseconds.

                                          ShortNumber of milliseconds between samples
                                          Comments

                                          This is usually a whole number.

                                          Control1..1
                                          This element is affected by the following invariants: ele-1
                                          Typedecimal
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          228. Observation.component:deprecatedLeadCodes.value[x].factor
                                          Definition

                                          A correction factor that is applied to the sampled data points before they are added to the origin.

                                          ShortMultiply data by this before adding to origin
                                          Comments

                                          Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typedecimal
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Meaning if MissingIf no factor is assigned, the data is not adjusted before adding to the origin
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          230. Observation.component:deprecatedLeadCodes.value[x].lowerLimit
                                          Definition

                                          The lower limit of detection of the measured points. This is needed if any of the data points have the value "L" (lower than detection limit).

                                          ShortLower limit of detection
                                          Comments

                                          Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typedecimal
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          232. Observation.component:deprecatedLeadCodes.value[x].upperLimit
                                          Definition

                                          The upper limit of detection of the measured points. This is needed if any of the data points have the value "U" (higher than detection limit).

                                          ShortUpper limit of detection
                                          Comments

                                          Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)

                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typedecimal
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          234. Observation.component:deprecatedLeadCodes.value[x].dimensions
                                          Definition

                                          The number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once.

                                          ShortNumber of sample points at each time point
                                          Comments

                                          If there is more than one dimension, the code for the type of data will define the meaning of the dimensions (typically ECG data).

                                          Control1..1
                                          This element is affected by the following invariants: ele-1
                                          TypepositiveInt
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          236. Observation.component:deprecatedLeadCodes.value[x].data
                                          Definition

                                          A series of data points which are decimal values separated by a single space (character u20). The special values "E" (error), "L" (below detection limit) and "U" (above detection limit) can also be used in place of a decimal value.

                                          ShortDecimal values with spaces, or "E" | "U" | "L"
                                          Comments

                                          Data may be missing if it is omitted for summarization purposes. In general, data is required for any actual use of a SampledData.

                                          Control1..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          238. Observation.component:deprecatedLeadCodes.dataAbsentReason
                                          Definition

                                          Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                          ShortWhy the component result is missing
                                          Comments

                                          "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 "test not done".

                                          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. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                          Control0..1
                                          This element is affected by the following invariants: ele-1, obs-6
                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                          Codes specifying why the result (Observation.value[x]) is missing.

                                          TypeCodeableConcept
                                          Requirements

                                          For many results it is necessary to handle exceptional values in measurements.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          240. Observation.component:deprecatedLeadCodes.interpretation
                                          Definition

                                          A categorical assessment of an observation value. For example, high, low, normal.

                                          ShortHigh, low, normal, etc.
                                          Comments

                                          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.

                                          Control0..*
                                          This element is affected by the following invariants: ele-1
                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                          Codes identifying interpretations of observations.

                                          TypeCodeableConcept
                                          Requirements

                                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                          Alternate NamesAbnormal Flag
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          242. Observation.component:deprecatedLeadCodes.referenceRange
                                          Definition

                                          Guidance on how to interpret the value by comparison to a normal or recommended range.

                                          ShortProvides guide for interpretation of component result
                                          Comments

                                          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.

                                          Control0..*
                                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                          Requirements

                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.